Home Drug Infusion Therapy Under Medicare

Home Drug Infusion Therapy UnderMedicare

May 1992

OTA-H-509NTIS order #PB92-182112

Recommended Citation:

U.S. Congress, Office of Technology Assessment, Home Drug Infusion Therapy UnderMedicare, OTA-H-509 (Washington, DC: U.S. Government Printing Office, May 1992).

Foreword

Home drug infusion therapy (HDIT) is an example of a mode of treatment that involvesa multitude of new technologies: innovations in medical equipment and supplies, new drugsand drug protocols, and novel ways of organizing and delivering health care services. Therapid development and diffusion of HDIT is a product of our time; it has bloomed in an erain which the United States has searched with increasing intensity for ways to provide bothbetter and cheaper health care to its citizens.

HDIT holds out the promise of making sophisticated, medically intensive drug therapiesavailable to Medicare patients in their own homes, but the full consequences of a MedicareHDIT benefit are unclear. Because of interest in such a benefit and concern about its potentialcosts, the Senate Committee on Finance asked OTA to examine Medicare coverage andpayment issues relating to this technology. This report was prepared in response to thatrequest.

A related OTA report, Outpatient Immunosuppressive Drugs Under Medicare, wasreleased in August 1991.

~ Director

. . .w

OTA Project Staff—Home Drug Infusion Therapy Under Medicare

Roger C. Herdman, Assistant Director, OTAHealth and L&e Sciences Division

Clyde J. Behney, Health Program Manager

Project StaffElaine J. Power, Project Director

Sharon Y. Hamilton, Research Assistant

David P. Reeker, Congressional Fellowl

Leah Wolfe, Analyst

Other Contributing StaffFrank Gianfrancesco, Senior Analyst2

Arna Lane, Research Assistant

Administrative StaffMarian Grochowski, Office Administrator

Kim Holmlund, Word Processor Specialist4

Eileen Murphy, P.C. Specialist

ContractorsTom Grarnnemann, Brookline, MA

Julie Ostrowsky, Chicago, IL

1Until May 19912Until August 19903Until January 19924Since December 1991

iv

Home Drug Infusion Therapy Under Medicare: Discussion of the OTA DraftList of Workshop Participants

Maredith F. BucoConsultantBlue Cross and Blue Shield AssociationChicago, IL

Patrick A. CarmichaelDirector of Pharmaceutical ServiceVisiting Nurse Service, Inc.Atlanta, GA(Representing Visiting Nurse Association

of America)

William A. DombiDirector, Center for Health Care LawNational Association for Home CareWashington, DC

Thomas GrannemannSenior EconomistSystemetricsLexington, MA

Craig JeffiiesExecutive DirectorHealth Industry Distributors AssociationAlexandria, VA

Chris M. KozmaAssistant ProfessorUniversity of South CarolinaCollege of PharmacyColumbia, SC

Mary LarkinExecutive Director, CEOIntravenous Nurses SocietyBelmont, MA

Dan LerrnanIndependent Home Care ConsultantChicago, IL

Khalid MahrnudDirectorAmerican Academy of Home Care PhysiciansEdina, MN

Alan ParverPresidentNational Alliance for Infusion TherapyWashington, DC

Tim RedmonDirector, Home Health Care Regulatory AffairsNational Association of Retail DruggistsAlexandria, VA

Joanne G. SchwartzbergDirector, Department of Geriatric HealthAmerican Medical AssociationChicago, IL

Brian G. SwiftManager, Jefferson Home Infusion ServicePhiladelphia, PA(Representing American Society of Hospital

Pharmacists)

Alan D. TicePresident, OPIVITA (Outpatient Intravenous

Infusion Therapy Association)Tacoma, WA

Elisa TunanidasHealth Care Financing AdministrationBaltimore, MD

NOTE: OTA appreciates and is grateful for the valuable assistance and thoughtful critiques provided by the workshop participants.The workshop participants do not, however, necessarily either endorse or disagree with the findings and conclusions of thisreport. OTA assumes full responsibility for the report and the accuracy of its contents.

v

List of Abbreviations

—American Hospital AssociationAIDS —acquired immunodeficiency

syndromeALOS —average length of stay

—American Medical AssociationASHP —American Society of Hospital

PharmacistsAWP —average wholesale priceBC/BS —Blue Cross and Blue Shield

AssociationBCBS/NCA-Blue Cross and Blue Shield of the

National Capital AreaCFF -Cystic Fibrosis FoundationCFR -Code of Federal RegulationsCHAMPUS -Civilian Health and Medical

CHFCOPDHHS

DMEDRGESRDFDA

FIFRFTEGAOG-CSF

GM-CSF

HCFA

HDIT

Program of the Uniformed Services-congestive heart failure-conditions of participation—U.S. Department of Health and Human

Services-durable medical equipment-diagnosis-related group-end-stage renal disease—Food and Drug Administration (U.S.

Public Health Service)—fiscal intermediary—Federal Register—full-time equivalent-General Accounting Office—granulocyte colony stimulating

factor—granulocyte microphage-colony

stimulating factor—Health Care Financing

Administration (DHHS)—home drug infusion therapy

HHA —home health agencyHMO —health maintenance organizationINS —Intravenous Nurses SocietyIv —intravenousJCAHO —Joint Commission on the

Accreditation of HealthcareOrganizations

MCCA —Medicare Catastrophic Coverage ActMCP —monthly cavitation paymentNABP —National Association of Boards of

PharmacyNAHC —National Association for Home CareNAIT —National Alliance for Infusion

TherapyNLN/CHAP-National League for Nursing’s

Community Health AccreditationProgram

OBRA -Omnibus Budget Reconciliation ActOIG -Office of Inspector General (DHHS)OTA -Office of Technology Assessment

(U.S. Congress)PCA —patient-controlled analgesiaPharm.D. -doctor of pharmacyPICC —peripherally inserted central catheterPPIC —Preferred Physician’s Infusion

Center, Inc.PRO —peer review organizationsRN —registered nurseR. Ph. —registered pharmacistSNF —skilled nursing facilitySSA -Social Security ActTPN —total parenteral nutritionVNA —Visiting Nurses AssociationVNA-LA —Visiting Nurses Association of Los

Angeles

vi

Contents

Chapter 1.

Chapter 2.

Chapter 3.

Chapter 4.

Chapter 5.

Chapter 6.

Chapter 7.

PageSummary and Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

The Safety and Effectiveness of Home Drug Infusion Therapy . . . . . . . . . . . . . . . . . 27

Home Drug Infusion Therapy Equipment and Semites . . . . . . . . . . . . . . . . . . . . . . . . 45

The Home Drug Infusion Industry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71

Quality Assurance in Home Drug Infusion Therapy . . . . . . . . . . . . . . . . . . . . . . . . . . . 87

Covering Home Drug Infusion Therapy: Implications for Medicare . . . . . . . . . . . . . 111

Paying for Home Drug Infusion Therapy Under Medicare.. . . . . . . . . . . . . . . . . . . . 133

Appendix A. Method of the Study . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 155

Appendix B. Acknowledgments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 157

Appendix C.Home Intravenous Drug Therapy: Proposed Regulations Under theMedicare Catastrophic Coverage Act.... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 161

Appendix D.A Basic Economic Model of Home Drug Infusion Provider Behavior . . . . . . . . 192

Appendix E. Glossary of Terms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 196

References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ..** 201

vii

Chapter 1

SUMMARY AND OPTIONS

ContentsPage

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3Summary and Conclusions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

What Is Home Drug Infusion Therapy? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3The Home Drug Infusion Industry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7Is HDIT Safe and Effective? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

Issues and Options for Medicare . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10Implications of Medicare Coverage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10Coverage Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12Administrative Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15Payment Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18Research and Demonstration Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

FigureFigure Page1-1. Three Examples of Potential Relationships Between Providers and Patients

Receiving Both Home Drug Infusion Therapy and Routine Home HealthServices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

TablesTable Pagel-1. Existing Medicare Benefits Applicable to Home Drug Infusion Therapy . . . . . . . . . . 71-2. Issues and Options for Covering Home Drug Infusion Therapy Under

Medicare . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 111-3. Options for Conducting Research and Demonstrations Relating to Home Drug

Infusion Therapy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

Chapter 1

SUMMARY AND OPTIONS

IntroductionFew changes in the organization and provision of

health care in the United States have been asdramatic as the shift away from hospital inpatientcare that occurred during the 1980s. The past decadewitnessed tremendous growth in such diverse activi-ties as the establishment of ambulatory surgerycenters, physicians’ office laboratory testing, andfreestanding cancer and cardiac centers (272a). Anespecially striking change was the development andmaturation of a system to provide intensive andhighly sophisticated medical treatments to patientsin their own homes. Home drug infusion is one suchmedical therapy.

Almost unknown before the late 1970s, homedrug infusion therapy (HDIT) is now a majorindustry with net revenues in the billions of dollars(289,307). Its growth is no accident. Many healthinsurers view this technology as a potential cost-saver. Providers view it as a welcome way ofenhancing revenues. Market analysts view it as aninvestment opportunity. And patients view HDIT asan opportunity to resume a reasonably normal lifewhile continuing sophisticated medical treatment.

But the widespread enthusiasm for this novelmode of medical therapy has been tempered in somecases by uncertainty about its potential applicationsand possible hidden costs. Medicare, the Nation’ssingle largest health care insurer, has no benefit thatexplicitly covers HDIT. The Medicare CatastrophicCoverage Act of 1988 (MCCA, Public Law 100-360), which would have extended coverage to thisbenefit, was repealed before it was ever imple-mented. In 1990, in the context of continued interestin such a benefit, the Senate Committee on Financeasked the Office of Technology Assessment (OTA)to revisit the implications of covering HDIT underMedicare and to analyze alternative ways of payingfor this therapy. This report was prepared in responseto that request.l

Although the literature on HDIT is considerable,most of it deals either with specific techniques andprocedures or with the feasibility of providing thisservice. To gather information for this study, there-fore, OTA relied not only on the published literaturebut also on site visits to HDIT providers, discussionswith persons involved in HDIT, and data supplied byindividual insurers and providers (see app. A). Theremainder of this chapter presents a summary ofOTA’s findings and conclusions and contains op-tions for congressional consideration.

Summary and Conclusions

What Is Home Drug Infusion Therapy?OTA found that HDIT is a medical therapy that

involves the prolonged (and usually repeated) injec-tion of pharmaceutical products, most often deliv-ered intravenously (into a vein) but also sometimesdelivered via other routes (e.g., subcutaneously orepidurally).2 Some drugs, such as antibiotics, maybeinfused over relatively short periods (e.g., 30 min-utes) a few times each day; others, such as analgesicsto relieve extreme pain, maybe administered aroundthe clock. All of these infusion therapies have incommon the need for specialized equipment andsupplies and skilled nursing care in order to beadministered safely. At present, patients or theirfamily caregivers3 are usually, although not always,trained to perform some of these needed skilledservices themselves.

Until the end of the 1970s, drug infusion therapywas almost always a hospital inpatient procedure.The components of care associated with this therapy(e.g., inserting the needle in the vein, regulating theinfusion, monitoring the patient, and changing thedressing (bandage) around the needle’s entry site)usually required the meticulous care of trainednurses to avoid life-threatening infections and allerg-ic reactions. Indeed, these requirements still exist.During the late 1970s, however, a few hospitals and

1 Aotherreportprepared in response to the same general request OutpatientZmmunosuppressive Drugs Under Medicare, was released in September1991.

z ~~subutiwusly>! r~ers t. ~jwtiom ~der me s- “epid~~y” refers to injections into the epidund sp~e mo~d tie sP~ ~rd”3 In this repo~ “family caregivers” refer to both immediate family members and other unpaid individurds (e.g., close fiends) who are trained to

perform some of the nursing-related infusion services.

-3-

4. Home Drug Infusion Therapy Under Medicare

physicians began to train highly selected patientswith prolonged infections (or their caregivers) toperform some of these procedures themselves athome (16,188,290,324). In the early 1980s, with thepublication of successful results from some of theseprograms and the implementation of payer-inducedconstraints on hospital inpatient care, a new mode oftherapy-and a new industry-was born.

This report deals with the drug and biologicalinfusion treatments (including blood transfusions)being used in the home but not yet explicitly coveredby Medicare in that setting. Medicare does covertotal parenteral nutrition (TPN) in the home forindividuals with long-term disabilities that preventthem from being able to digest food.4 TPN has manysimilarities to the therapies discussed in detail in thisreport, and many providers of HDIT also provideTPN and other nutritional products and services. Infact, nutritional therapies still produce a substantialproportion of the revenues for the home infusionindustry (34,307). However, because the purpose ofthis report is to examine other noncovered infusiontherapies, TPN is discussed only as it is relevant tothe issues surrounding HDIT.

Uses and Recipients of Therapy

The number of patients who currently receivedrug infusion therapy at home is unknown butprobably in the vicinity of a quarter of a millionpersons per year. A 1987 market analysis estimatedthat in the previous year, approximately 39,000 suchpatients received home treatment, and it predictedthat over 225,000 would do so in 1990 (289). A morerecent investment report estimated the 1990 marketat roughly 200,000 patients (275). Given that themarket has continued to grow, a 1991 estimate ofbetween 200,000 and 250,000 persons in HDITduring the year seems reasonable.5

Most HDIT patients presently served are non-elderly adults. Two HDIT providers with data onpatient age report that the great majority of theirpatients are between the ages of 18 and 65 (3,250).About 15 percent of each provider’s patients areelderly (age 65 or over), a figure that includes somepatients on nutritional and other infusion therapies

as well as HDIT A survey of six national infusionspecialty firms found that slightly less than 18percent of patients are age 65 or over (256); again,this number included patients receiving TPN. Con-versations with other providers suggest that many ofthem consider elderly patients on HDIT to berelatively rare. Thus, excluding patients on TPN, a“best guess” estimate is that about 10 to 15 percentof current HDIT patients are elderly. Based on thesevery rough assumptions, OTA estimates thatbetween 20,000 and 35,000 elderly individualsreceived HDIT in 1991.

HDIT patients fall into a few major groups andmany smaller ones. The first and largest group iscomposed of those patients who require intravenous(IV) drug therapy for infections (e.g., bone infec-tions) that require prolonged treatment and are notusually susceptible to oral drugs. Persons withcancer make up another major group; these individu-als may need not only antineoplastic drugs to combatthe cancer but also antibiotics, analgesics, hydration,and other infusion therapies at times. A thirdcategory of HDIT recipients are those with AIDS.Like persons with cancer, those with AIDS may betreated with any of a number of therapies (e.g.,antibiotics, antifungal medications, and blood trans-fusions) depending on their particular medicalconditions.

Other categories of individuals whose conditionsare sometimes treated with home infusion therapiesinclude individuals with congestive heart failure,persons with certain immune disorders, pregnantwomen receiving infusions of drugs to preventpremature labor, and patients with severe anemia orother blood disorders who need blood transfusions.Some of these treatments are experimental or are notyet widely available in the home.

Components of Therapy

Drugs-At present, antibiotics and other anti-infectives are the most common drugs involved inhome infusion therapy. Based on estimates bymarket analysts and other sources, it appears thatabout two-thirds of current drug orders for HDITinvolve anti-infective drugs (34,193,193a).G Ap-

4 ~~pm~t=~~~ ~~fem genm~y t. meth~s of ams~ation that bypass the digestive tract. ‘rpN is nutient solution that is ~“ “ teredintravenously.

5 This number probably includes some individuals receiving outpatient clinic-based rather than home therapy, since the market analyses did notdistinguish clearly between these two settings.

6 Although antibiotics are responsible for about two-thirds of HUT drug orders, only about half of HDIT patients receive antibiotics (193%256).

Chapter 1-—Summary and Options .5

proximately another 15 percent of HDIT drugs areantineoplastics or pain medications. The diverseremaining group of drugs makes up somewherebetween 10 and 20 percent of HDIT at present.

Equipment—Whatever the route of administra-tion, HDIT requires two crucial pieces of equipment:the access device that is inserted into the body (e.g.,an N catheter), and the Infusion device that controlsthe rate of drug flow. The choice of this equipmentdepends on the patient’s condition, the length andtype of drug therapy prescribed, and the preferencesof the patient and provider. The methods of accessand infusion control chosen, in turn, can affect theneed for supplies and for nursing care and the overallcost of the therapy.

The continual emergence of new home infusiontherapy technologies broadens the types of patientswho can be treated at home and changes theparameters of service delivery. Some recently devel-oped technologies have reduced the amount ofskilled nursing intervention required for patients athome and made it easier for patients to self-administer complex drug regimens (see ch. 3).Nonetheless, despite the development of increas-ingly sophisticated infusion pumps over the pastdecade, less expensive gravity drip systems are stillsafe and appropriate for some patients receivingantibiotic and hydration therapies.

Services-HDIT involves a complex array ofservices that must be coordinated with each other.They also must be coordinated as a unit with anyother home health care services and supplies thepatient receives. Although the responsibilities andinvolvement of particular types of personnel varygreatly among HDIT providers, all HDIT requiresthat at least certain core services be provided in someway.

. Pharmacy services involve, at a minimum,compounding the drugs to be infused and beingavailable to respond to emergencies and ques-tions regarding the therapy.7 Pharmacists’ re-sponsibilities often also extend to participatingin patient education, anticipating drug sideeffects, dealing with nonemergency issues re-lating to the therapy, monitoring patients viaconversations with nurses or patients them-

Photo credit: Ivion Corp.

New technologies such as this multiple-drug infusion pump

●

●

allow patients to self-administer complex drugregimens at home.

selves, monitoring laboratory results, and col-laborating with physicians on prescription changes.Nursing services include educating the patientand family caregiver regarding administrationof the infusion and care of the infusion site,8

dressing and infusion site changes, and in-home monitoring of the patient’s health status.Nurses may perform a wide variety of otherfunctions as well, ranging from overseeing theactual infusion to patient assessment and carecoordination.Physician services provided by the patient’sphysician include ordering the home care,prescribing the therapy, overseeing the pa-tient’s progress through patient visits andmonitoring laboratory and clinical reports,dealing with emergencies, and making changesin the therapy as needed. In practice, the extentof physician involvement in HDIT appears tobe highly varied. Some physicians take a veryactive role—for example, seeing all patients inperson at least twice a week and holdingextensive telephone conversations with nursesand pharmacists involved in the therapy—

7 Larger infusion providers often employ pharmacy technicians to assist pharmacists in compounding drugs.8 Pharmacists, social workers, or other professionals may also be involved in aspects of patient assessment and education.


●

while others have much less contact with thepatient and professional caregivers during thecourse of the therapy.

Laboratory services are necessary to monitorthe patient’s status and response to therapy asdetected through blood samples and other tests.Most HDIT providers do not have in-houselaboratories.

Based on numerous site visits and conversationswith HDIT providers, patients, and others, it appearsthat most HDIT providers are skilled at coordinatingthe services specific to the home infusion therapy.For patients receiving other home care as well,however (e.g., basic home nursing, physical therapy,or respiratory therapy), the complex of HDIT-specific services must also be coordinated with thesehome health care services. Such coordination acrossdifferent home care services may be particularlyimportant for Medicare patients, but it is a servicemany HDIT providers are not currently well-equipped to offer.

Many of the tasks necessary for HDIT would beperformed by a skilled nurse in a hospital setting. Athome, however, these tasks can often be performedby the patient or a family caregiver who has beentaught the proper techniques by a qualified healthprofessional. Medicare beneficiaries are morelikely than other patients to have disabilities thatlimit their ability to learn or perform infusiontechniques and other most basic self-care tasks(e.g., dressing and bathing). Their spouses mayalso have functional limitations. Thus, OTAconcludes, Medicare patients are more likelythan other patients to require paid assistiveservices in order to receive medical care such asdrug infusion therapy at home. If the frequencyand intensity of professional services required by ahome infusion patient are great (e.g., a functionallydisabled patient on a 4-dose/day antibiotic regimenwho has no family caregiver available), a skillednursing facility (SNF) or other nonhospital institu-tional setting that offers 24-hour care might be amore reasonable alternative to hospitalization thantraditional home care.

Current Medicare Coverage of HDIT

Medicare pays for “medically necessary” serv-ices and supplies associated with drug infusion whenit takes place in hospitals, outpatient clinics, orphysicians’ offices. (Some of these settings (e.g.,physicians’ offices) may be subject to locally setlimitations on infusion payments and coverage.)9

Medicare does not have an HDIT benefit; the needfor this therapy when provided at home does notqualify a beneficiary for Medicare coverage of anyparticular items. However, certain components ofHDIT are sometimes covered by Medicare underexisting benefits for beneficiaries in their ownhomes.

The core nursing services used in HDIT aresometimes covered by Medicare under the Part Ahome health benefit, while pharmacy services andsupplies are sometimes covered under the Part Bdurable medical equipment (DME) benefit (table1-1).10 The home health benefit covers intermittentskilled nursing care, and home infusion therapypatients’ need for such care would also qualify themfor additional home health aide and therapy services.The Part B DME benefit covers reusable equipmentsuch as infusion pumps and the supplies associatedwith such equipment. Some carriers also cover awide variety of drugs when used in an infusion pump(365) (see ch. 6).

Current coverage of the core HDIT services has anumber of problems. First, it is incomplete andfragmented; coverage is piecemeal, administrativelysplit between Part A and Part B fiscal intermediaries(FIs-Medicare’s administrative contractors), andhighly variable. Some carriers, for example (the PartB FIs), interpret the DME benefit to include evencoverage for antibiotics administered by gravity drip(365). Other carriers almost never pay for any drugthrough this benefit. Second, there are no guidelinesfor who can provide HDIT, and thus there are nominimum quality standards for such providers underMedicare.

A third problem with the existing benefit structureis that it tends to discourage the most independentlyfunctional patients from leaving the hospital. To be

9 ~Sion iS ~w Sometimes provid~ ~ hospic~ @ ~~ed nurs@ fmilities (Sws). Although M~ic~e “covers” the infusion ill th(Xe iIIShIiC~,payment rates to hospices and SNPS are generally unaffected by whether the service is performed. These providers thus have a strong disincentive tooffer inlision while a patient is served by the hospice or SNF.

10 my the pm B D~ &nefit Someties encompmses ~gs. me pm A D~ benefit tit is Subsumd under the home health care benefitspeeiilcally excludes drugs from coverage.

Chapter l-Summary and Options .7

Table l-l—Existing Medicare Benefits Applicable to Home Drug Infusion Therapy

Components of Selected relevantBenefit HDIT covered limitations

Part AHome health services

Hospice

Part BDurable medical equipment

Laboratory services

Physician services

Hospital outpatient services

Nursing, supplies,durable medicalequipment (DME).

Those components the hospicechooses to provide to its in-homepatients.

Pumps, other DME, supplies, se-lected drugs.

Laboratory tests.

Physician visits, some office-based infusion therapy servicesprovided to home patients.a

On-site outpatient infusion therapyservices provided to home pa-tients. a

Patient must be homebound. Drugsnot covered under home healthDME benefit.

Providing infusion does not affecthospice’s flat-fee payment rate.

Drug coverage varies greatly bycarrier. Disposable “pumps” notconsidered DME.

No payment for administrative re-sponsibilities; may be local limitson office-based therapy.

—

asome patients, forexanlple, may Url&rtake ttiek own daily routine infusion-related care but return to an OUtpi3hIt

clinic or office for more specialized services such as catheter site changes.

SOURCE: Office of Tdnology Assessment, 1992.

eligible for home health nursing benefits, for exam-ple, beneficiaries must be homebound-i.e., unableto leave their homes without some kind of assist-ance. And while nearly all carriers at least some-times pay for infused cancer therapies (analgesicsand antineoplastics) as part of the DME benefit,considerably fewer pay for antibiotics-and some ofthe latter pay only when a patient is so ill as to bealready receiving other infusion therapies.

In addition to the core pharmacy and nursingcomponents, Medicare routinely pays for the labora-tory services associated with HDIT as part of thestandard Part B laboratory benefit (table l-l).Medicare also routinely pays for physician services,including physician visits (home or office) tomonitor the status of HDIT patients. However, theprogram does not pay for telephone or administra-tive time of physicians overseeing home care plans.Because of the level of medical monitoring neededfor HDIT patients, the amount of time spent in theseactivities can be substantial. Consequently, the lackof payment for these services-and the relativegenerosity of payment for daily visits to hospitalizedinfusion patients—is a disincentive for physicians todischarge some patients to home care under thecurrent system.

The Home Drug Infusion Industry

The development and shape of the HDIT industryhas been influenced by two important factors. First,the development of the industry has followed pastchanges in Federal policies. Medicare coverage forhome parenteral and enteral nutrition (begun in1977) and the implementation of prospective pay-ment for Medicare inpatient services (in 1983) bothcontributed to the explosion in the home infusionindustry that occurred during the first half of the1980s. If Medicare should choose to cover and payfor HDIT in the future, how it does so may have asimilarly profound impact on the shape of theindustry. Not only could the number of elderlypatients being treated at home expand far beyond theestimated 20,000 to 35,000 now served, but Medi-care’s policies could serve as a model (or a caution)for other public and private insurance programs.

Second, the growth in the home infusion serviceindustry-those organizations that provide the nurs-ing and pharmacy services and products directly topatients—has been enabled by the technologies thathave permitted drug infusion therapy to be self-administered in the home. Increasingly sophisticatedinfusion pumps, administration kits, therapy proto-cols, venous access devices, and drugs that need be


Photo credit: CADD-PCA@ Ambulatory Infusion Pump Model 5800,Pharmacia Deltec Inc., St. Paul, MN

Sophisticated infusion pumps have been developed forspecific segments of the HDIT market. This pump delivers

a constant dose of pain medication, with a specialbutton that allows the patient to self-administer

occasional larger doses as needed up to apreprogrammed maximum amount.

administered only once or twice a day have allcontributed to the feasibility of home therapy for anever-growing number of patients.

As manufacturers have developed new suppliesand equipment, providers have become adept atincorporating them and marketing both products andservices to patients, physicians, and payers. Providersuccess at encouraging HDIT, in turn, stimulateseven greater effort in developing technologies forthis market.

The present assortment of HDIT providers in-cludes a few large (national or regional) infusionspecialty providers that offer most of the basicservices and products associated with drug infusiontherapy, including pharmacy supplies and services,equipment and medical supplies, and specialtynursing. In addition, there are a multitude of smallerregional and local providers, for most of whomHDIT is a relatively small proportion of a largerbusiness. These local providers include home healthagencies (HHAs), community pharmacies, physi-cians, medical equipment suppliers, and hospitals.

In many cases, smaller providers may offer onlyone or two components of the therapy directly. Apatient from a small town who is on HDIT, forexample, might receive infusion-related nursingfrom the local HHA, pharmacy products and serv-ices from the local pharmacy, and an infusion pumpfrom the local medical equipment dealer. In fact, itappears that many HDIT providers contract with atleast one other type of provider to provide somecomponents of the therapy. Where patients needroutine as well as infusion specialty nursing, theroutine nursing is ah-nest always performed by aseparate agency (except where the HHA itself is alsothe primary home infusion provider) (see figure l-l).

The continually expanding revenues and, appar-ently, relatively high profit margins that have beenenjoyed by the HDIT industry thus far have facili-tated and encouraged the entry of new providers intothe marketplace, expanding access to HDIT servicesand stimulating the development of new products.The increasing revenues are in part due to the liberalreimbursement that these companies have often beenable to garner. Future controls over what companiescan charge Medicare patients for home infusiontherapy might slow the growth of certain sectors ofthe marketplace.

Is HDIT Safe and Effective?

Home drug infusion technologies have becomecommonplace. Most are effective and can be per-formed safely in the home when patients arecarefully selected and trained and home care provid-ers have adequate procedures and qualified staff.However, HDIT is not without substantial risks.When those qualifications are not met, OTA be-lieves that patients on home therapy can be at a highrisk of adverse events, including severe infection,shock, and even death.

In a few cases, the effectiveness of the drug itselfused in HDIT is open to question. For example,existing studies on long-term dobutamine, a drugsometimes used to treat severe congestive heartfailure in the home, suggest that this use of the drugmay actually be harmful for some patients (see ch.2). Immune globulin is an example of a product thathas some clearly indicated uses, but that is alsofinding use in a variety of conditions where itseffectiveness is less well established (and its costshigh).

Chapter 1—Summary and Options .9

Figure l-l—Three Examples of Potential Relationships Between Providers andPatients Receiving Both Home Drug Infusion Therapy (HDIT) and

Routine Home Health Services

Example 1

Laboratory

: ;-< ~ .

Home health agency(routine home health services)

Physician

Example 2Home health agency

Pharmacy (HDITnursing, routine home DME supplier

health services)

?-y‘

Physician

Example 3Pharmacy(HDITpharmacy and DME)

Laboratory/ 1

PATlENT>-i

Home health agency(HDITnursing, routine home

Physician\ health services) I

SOURCE: Office of Technology Assessment, 1992.

Infusion therapy carries some risks regardless ofthe setting in which it occurs. Although mostcomplications (e.g., vein irritation at the catheterentry site) are minor if recognized and treatedimmediately, conditions such as sepsis (systemicinfection) and shock (from drug allergic reactions)can be life-threatening. Mechanical complicationsof the infusion (e.g., air entering the vein) andequipment malfunctions can also cause seriousmedical problems.

Some risks (e.g., the risk of acquiring g serioussecondary infections) are probably lower whenpatients are home than when they are in the hospital.On the other hand, in the hospital, constant nursingsupervision and rapid access to sophisticated emer-gency care ameliorates many of the other risks ofinfusion therapy. In the home, there is rarelycontinuous professional monitoring, and emergencycare is not available on site. Consequently, the mostclearly appropriate drugs for the home are those in

297-913 0 - 92 - 2


which life-threatening side effects or complicationsare rare, and those in which most side effects areapparent when the first dose is given (which can bemonitored in a hospital or physician’s office). Manyantibiotics fit this description. Although infusedanalgesics and antineoplastics require more care tobe used safely at home, the need for these therapieslifelong by many patients may justify their use in thissetting.

OTA found that, in addition to the choice of drug,patient selection and provider procedures are crucialto making the level of risk at home comparable tothat in the hospital. Patients who are medicallyunstable (e.g., have a very high fever) are notappropriately discharged from the hospital. In addi-tion, patients who have no supportive familycaregivers, who are unable to understand andcarry out infusion therapy procedures, or whoare unwilling to continue therapy at home are athigh risk of complications and are poor candi-dates for home care. Provider procedures, such asperforming rigorous patient selection, requiringspecial pharmacist and nurse training, carryinganaphylaxis treatment kits, and requiring 24-houron-call pharmacist and nurse availability, minimizerisk. Physician involvement is also critical to thesafe and effective delivery of HDIT services.

The relationship between patient suitability, pro-vider procedures, and medical risk in HDIT warrantsquality assurance efforts on the part of the FederalGovernment in the event of Medicare coverage.Quality assurance efforts should include some levelof case review to monitor instances of possiblepoor-quality patient care. They should also includeexplicit and stringent conditions of participation thatHDIT providers must meet to receive Medicarereimbursement. Such conditions can assure thatalthough some direct patient care services may beperformed under contract, certain functions (e.g.,initial patient assessment, service coordination,periodic drug regimen review, clinical recordkeep-ing, and providing an ongoing and emergencypoint-of-contact for patient) remain the responsibil-ity of the “primary” HDIT provider. This “pri-mary” provider is the one that undertakes theresponsibility for coordinating the HDIT and thatsubcontracts or arranges with others to provide thoseHDIT services it does not provide in-house.

Issues and Options for Medicare

Implications of Medicare CoverageSubstantial numbers of Medicare patients are

currently receiving HDIT, although the exact num-ber is unknown. As described above, OTA estimatesthat roughly 20,000 to 35,000 persons age 65 andover will receive this therapy in 1991, and of elderlypersons the great majority is eligible for Medicare.In addition, some disabled Medicare beneficiariesprobably receive HDIT

Many of the Medicare beneficiaries receivingHDIT at present have other insurance (e.g., privateinsurance or Medicaid) that presumably pays for thetherapy. However, as described above, despite thelack of an explicit Medicare HDIT benefit, somebeneficiaries do receive Medicare coverage for someof the components of HDIT some of the time. Thefrost decision regarding Medicare coverage of HDITis whether to pass a comprehensive benefit.

Considerations regarding whether an HDIT bene-fit should be enacted are addressed in optionbelow. Options 1 through 9 (summarized in table1-2) then discuss some of the different forms such abenefit might take. Finally, options 10 through 19present possible research and demonstration proj-ects that might inform Federal policymakers regard-ing various aspects of HDIT These options, whichcould be implemented in either the presence orabsence of a Medicare HDIT benefit, are summa-rized in table 1-3.

Option O: Enact a home drug infusion benefitunder Medicare.

Many patients would prefer to receive druginfusion therapy at home rather than in the hospital,and when appropriate precautions are in place theyreceive good quality care. At present, however,existing “back door” mechanisms through whichspecific components of HDIT are currently coveredresult in fragmented and inconsistent coverage inwhich there are no qualifications required by Medi-care for HDIT providers and no quality control of theoverall set of services received by the patient. Thus,a Medicare HDIT benefit would offer enhancedpatient benefits compared with the current policy.

The cost implications of extending Medicarecoverage are less straightforward. In the short run,the addition of this benefit would almost certainly

Chapter 1—Summary and Options . 11

Table l-2—issues and Options for Covering Home Drug Infusion Therapy (HDIT) Under Medicare

Basic Issue: Should Medicare cover HDIT?Option O: Enact a home drug infusion benefit under Medicare.

(If so:)

issue 1: What routes of drug admlnlstratlon shouldbe covered?Option 1A: Cover only intravenously administered drugs.

Option 1 B: Cover both intravenous and other routes of parenteraladministration.

Issue 2: What drugs and conditions should be covered?Option 2A: Cover drugs and conditions specified on a list devised

by the Health Care Financing Administration (HCFA).

Option 2B: Permit fiscal intermediaries to determine specificcovered drugs and conditions, based on general coveragecategories and guidelines from HCFA.

Issue 3: Who should be eligible for the benefit?Option 3A: Cover only patients who can self-administer their

therapies (after initial instruction) or who have family care-givers to perform this service.

Option 3B: Extend coverage to all patients who can be safelytreated at home, including patients who need assistance withtheir infusion-related or other home health care.

Option 3C: Extend coverage to patients who cannot self-administer, but limit the amount of assistive services suchpatients may receive.

Issue 4: Who should be able to provide and bill for HDIT?Option 4A: For patients needing only HDIT, permit providers of

different components of this therapy (e.g., pharmacy andnursing services) to bill separately for their respective compo-nents.

Option 4B: For patients needing only HDIT, require that a singlecertified home infusion therapy provider bill for all servicesreceived by that patient.

Option 4C: For patients needing both infusion and other homehealth services, permit a certified home infusion provider andthe home health agency provider to bill separately for theirrespective services.

Option 4D: Require that the primary provider for patients needingboth infusion therapy and other home services-i.e., theprovider who coordinates services and submits a bill toMedicare-be a certified home health agency.

Issue 5: Where should a benefit be placed In Medicare’sstructure?Option 5A: Make HDIT a Part A benefit.

Option 5B: Make HDIT a Part B benefit.

Option 5C: Make HDIT a benefit under both Parts A and B,depending on the patient’s circumstance and concordantbenefits.

Issue 6: Should benefit administration be consolidated?Option 6: Require that the benefit be administered through a few

regional fiscal intermediaries.

issue 7: What level of case review should be required, and bywhom?Option 7A: Do not require preauthorization for HDIT.

Option 7B: Require Peer Review Organizations (PROS) topreauthorize some or all HDIT patients.

Option 7C: Require fiscal intermediaries to preauthorize HDITpatients.

Option 7D: Require PROS to retrospectively review some homeinfusion patient claims.

issue 8: How should providers be paid for HDIT?Option 8A: Pay for the various components of an HDIT benefit

under existing payment mechanisms that apply to homehealth, durable medical equipment, and other benefits.

Option 8B: Pay for HDIT on the basis of actual costs, with a capon the total costs allowed.

Option 8C: Pay a prospective per-diem rate for HDIT services.

issue 9: How should physicians be paid for HDIT-relatedservices?Option 9A. Pay physicians for their additional supervisory time in

HDIT cases on the basis of existing fee-for-service methods.

Option 9B. Pay supervisory physicians a fixed rate (e.g., perpatient or per day) for patients on HDIT.

Option 9C. Do not pay physicians for supervisory and advisoryactivities related to oversight of HDIT.


raise program costs, because Medicare cannot im-mediately recoup the financial benefits of shorterhospital stays. In the long run such a benefit could becost-saving to the program, particularly if it werelimited to independent patients who, when trained,needed little additional paid assistance. The benefitcould be cost-raising in the long run, however, ifMedicare were to pay for more costly home care inorder to improve the quality of life during treatmentfor beneficiaries who need assistance to receiveHDIT. The extent of long-run cost savings alsodepends on the ability of Medicare to bargain for lowrates from providers, and its ability to identifypatients who would be more costly at home and

ensure that these patients are treated in alternativesettings.

Covering HDIT would affect not only the Medi-care program and HDIT providers and payers butalso many facilities that are alternative sites ofinfusion therapy: skilled nursing facilities (SNFs),outpatient infusion providers, and hospitals. Outpa-tient clinics may be more appropriate settings thanacute-care hospitals for some Medicare patients whoneed assistance with their infusion therapy, andSNFs may be more appropriate for many patientswho need other assistive care as well. At present,however, SNFs have high occupancy rates and fewempty beds, and most SNFs do not usually retain the


Table 1-3-Options for Conducting Research andDemonstrations Relating to Home Drug Infusion

Therapy (HDIT)

Clinical studiesOption 11: Provide provisional or augmented coverage for drugs

administered by HDIT providers participating in certain clinicalstudies.

Cost studiesOption 12. Examine the resource costs of providing HDIT and the

economic characteristics of the HDIT industry.

Option 13. Examine the relative costs of providing drug infusiontherapy in home and outpatient settings.

Option 14. Examine the use of basic home health services, andthe need for infusion assistance, among elderly patients onHDIT

Payment studiesOption 15. Examine different potential methods of paying for

HDIT.

Option 16. Examine the feasibility and effects of paying hospitalsless than the full inpatient rate for patients subsequentlydischarged to HDIT.

Option 17. Examine alternative methods of paying for druginfusion therapy in skilled nursing facilities and hospital swingbeds.

Option 18. Examine the effects of an HDIT benefit on rural andinner-city hospitals.

Quality studiesOption 19: Examine the outcomes of HDIT under various

conditions (e.g., different types of patients and therapies) todetermine which measures might be appropriately used asindicators of good- or poor-quality care.


in-house expertise to provide drug infusion therapy.They may be unwilling to accept drug infusionpatients, or to treat existing patients in the nursinghome, either due to lack of expertise or lack ofreimbursement to cover the expense of intensivedrug therapy.

For hospitals, covering HDIT would lead to lowerpayments in the future for some diagnosis-relatedgroups (DRGs), to account for shorter averagelengths of hospital stays and lower average costs inthese DRGs. Hospitals unable to discharge patientshome (e.g., due to the lack of a qualified home careprovider in the area) would be disadvantaged despitetheir best efforts. This disadvantage will be minim-ized if these hospitals have “swing beds’ ’11 towhich they can discharge patients needing only druginfusion therapy and associated skilled nursing, andif they are adequately reimbursed for that care.

If current policies are unchanged, Medicare islikely to find itself paying for a substantial amountof HDIT in the future even in the absence of adefined benefit. Under current DME and homehealth rules, the actual coverage is increasing andwill probably continue to do so, as Medicare’s FIsuse their discretion to cover drugs as well as theassociated equipment, supplies, and nursing care.This coverage, however, will continue to be frag-mented, uncoordinated, and inconsistent across areas.The absence of a coordinated benefit limits theability of Medicare to assess, monitor, or influencethe safety, quality, and effectiveness with whichhome infusion services are delivered.

Thus, OTA concludes that covering HDIT andplacing defined requirements on providers andpatients is likely to improve the quality of homecare that Medicare patients receive. It may notsave costs, however; to the contrary, it couldeasily increase Medicare spending. Program costsavings are probably more likely if the benefitplaces some restrictions on those who can use it.

Coverage OptionsIf Congress should decide to make HDIT a

Medicare benefit, it must first decide what and whoshould be covered. Options 1 through 3 presentpossible alternative decisions regarding three cover-age issues:

1.

2.

3.

whether coverage should extend beyond IVadministration to other forms of parenteraldrug administration;what drugs and medical conditions should becovered and how these coverage decisionsshould be made; andwhether patients who need assistance withtheir care (and have no family caregiver)should be eligiblebenefit.

Route of Administration

Option 1A: Cover onlytered drugs.

Option IB: Cover both

for the home infusion

intravenously

IV and otherparenteral administration.

adminis-

routes of

11 sag beds me ~ute-c~e MS desi~ted by a hospital to provide either acute or long-term care services. Medicine and Medicaid pay fOr careprovided to swing-bed patients in qual@ng rural hospitals.

Chapter 1-Summary and Options ● 13

Most drugs infused at home (e.g., most antibiot-ics) are administered intravenously. However, de-pending on the drug and the condition of the patient,drugs may also be infused into an artery (intraarteri-ally), under the skin (subcutaneously), into themuscle (intramuscularly), into the abdomen (in-traperitoneally), or into the areas around the spinalcord (epidurally or intrathecally).

In some cases, one of these latter modes ofdelivery is used because the drug itself is mosteffective, or causes the least complications, ifadministered in that manner. In a few cases, a drugmay usually be most effective when administeredintravenously, but a patient maybe unsuitable for IVtherapy (e.g., because the veins are very fragile).Such a patient might instead get the drug by the nextmost favorable route (e.g., subcutaneously) .12

Choosing to cover drugs only if they are adminis-tered intravenously (as would have been the caseunder the MCCA) has the virtue of applying a rulethat is unambiguous, simple to administer, andapplicable to many of the drugs most amenable tohome therapy (e.g., most antibiotics). Its drawbackis that it will also exclude many drugs and patientsthat would otherwise be equally qualified for hometherapy. It would also inhibit the use of drugs thatmight in the future be found equally effective andsafer if given by some route other than IV.

In contrast, covering a broad general category ofinfused drugs in statute gives much greater latitudeto the Health Care Financing Administration (HCFA)(or its FIs) to cover drugs delivered by means otherthan IV when such coverage is deemed appropriateat home. The great virtue of this option is itsflexibility and adaptability to future changes in drugand device technology that make alternative deliv-ery modes attractive. Its drawback is that it could beinterpreted to include a wide variety of drugs andpatients that were not intended to be included in abenefit. “Infusion,” for example, might be appliedto slowly administered liquid oral medications, or todrugs administered through a rapid injection as aone-time ‘‘shot. ’

One strategy to address this drawback would be todefine “infusion” carefully in statute, either byspecifying excluded categories (e.g., fluids administ-ered into the digestive tract) or included categories(e.g., intravenously and subcutaneously adminis-

tered fluids injected over a period of at least 10minutes). A second strategy would be to leave thedefinition of “infusion” and the delivery routes itencompasses up to HCFA.

Drugs and Conditions Covered

Option 2A: Cover drugs and conditions specifiedon a list devised by HCFA.

Option 2B: Permit fiscal intermediaries to deter-mine specific covered drugs and conditions,based on general coverage categories andguidelines from HCFA.

Drug-level coverage decisions-whether to coverparticular types of drugs for particular conditions ororganisms-can theoretically be made at almost anylevel. The potential decisionmakers range fromCongress, which could specify particular drugs instatute, to physicians, who could be permitted toprescribe (and receive payment for) any drug for anycondition they deemed appropriate.

Greater levels of regulatory intervention in thedecisionmaking process are associated with bothgreater checks on imprudent physician prescribingand less flexibility to accommodate new, effectivedrugs and treatment protocols. The choice of whoshould designate the drugs and conditions covered,therefore, becomes one whose point of compromisedepends on the degree to which one values flexibil-ity at the expense of oversight and consistency.

It is unlikely that Congress would choose to takeupon itself the burden of identifying specific drugsand conditions to be reimbursed under Medicare. Itis also unlikely that Congress would want Medicareto pay for all physician prescriptions. Option 2 thusoutlines two intermediate alternatives. Option 2Aexercises the greatest regulatory control, permittingcoverage only for drugs determined by HCFA to besafe and effective in the home. In option 2B, thebasic decision regarding what drugs are generallyeffective when delivered at home is left to theFIs-those contractors (usually private insurancecompanies) who would administer the benefit at thelocal or regional level on Medicare’s behalf.

Federal-level decisionmaking would result in thegreatest coverage consistency. HCFA has littleexperience in drug evaluation and is not currentlyinvolved in any drug approval process. If HCFA is

IZ Mtemtively, a patient witi fra~e ve~ rni@t have a central catheter surgically implanted to avoid the need for repeated venous puIIctures.


required to approve drugs for home infusion use,either the agency must retain additional advisorypersonnel who have clinical experience, or anotheragency with such expertise (e.g., the Agency forHealth Care Policy and Research, or the Food andDrug Administration) must be directed to assistHCFA in thiS task.

Local decisionmaking offers more adaptabilitybut less consistency across locales (and, thus,presumably somewhat less equity across patients).Many FIs already have some familiarity with homeinfusion therapy in the context of either theirMedicare or their private business, and they havemedical advisory structures in place. If option 2B ischosen, administering an HDIT benefit through afew regionalized FIs might enhance coverage con-sistency (see option 6).

In addition to (or instead of) covering a basicdefined set of drugs (whether set by HCFA or FIs),Congress could choose to provide provisional oraugmented coverage for drugs that were part ofspecified demonstration projects. This possibility isdiscussed in option 11 below.

Patient Eligibility

Option 3A: Cover only patients who can self-administer their therapies (after initial in-struction) or who have family caregiverstrained to perform this service.

Option 3B: Extend coverage to all patients whocan be safely treated at home, including pa-tients who need assistance with their infusion-related or other home health care.

Option 3C: Extend coverage to patients whocannot self-administer, but limit the amount ofassistive services such patients may receive.

Many beneficiaries who would prefer HDIT overhospital infusion might require assistance with theirinfusion or other health care needs in order to gohome. However, providing assistive health servicesgreatly increases the costs of care for a patient onHDIT, and the extent to which Medicare coversthese services for HDIT beneficiaries would greatlyaffect Medicare expenditures.

Under option 3A, Medicare would cover HDITonly for patients who can demonstrate the capacityto administer the infusion without the assistance ofa paid caregiver.

13 This alternative would restrict thebenefit to a small number of patients and offers thesurest opportunity to achieve program cost savings.However, it restricts the ability of disabled home-bound patients, or those who (with assistance) mightbe able to avoid hospitalization altogether, to receiveHDIT from a professional caregiver.

Under option 3B, any patient meeting basicmedical appropriateness criteria could make use ofthe benefit. However, it would permit unlimited useof assistive home services, no matter how expensive,unless adjunct policies were also in place to limitthese services.

Option 3C permits any patient to be eligible forHDIT but restricts the covered benefits that patientcan receive. For example, the HDIT benefit mightinclude coverage of daily nursing to accommodatepatients with needs for occasional nurse-admin-istered infusions (e.g., up to 10 visits or 20 hours ofhome skilled nursing per week). To avoid unwit-tingly paying for assistive services through the homehealth benefit in this example, HDIT patients couldbe disqualified from concurrent eligibility for thatbenefit. This alternative eliminates the possibility ofpaying for home care for patients who need veryextensive services, but it could prevent some pa-tients who currently qualify for home care servicesfrom receiving their infusion at home as well.

Alternatively, the HDIT benefit could be verylimited in its coverage of assistive services butbeneficiaries could be permitted (if they qualified) toretain home health benefit eligibility at the sametime. Under this scenario, home health coverage forthese dual-coverage patients could be limited torestrain utilization of assistive services. For exam-ple, HDIT patients who were homebound could bepermitted concurrent coverage for home healthservices up to a stated maximum limit.14 Thisalternative would allow for some assistance whileproviding an incentive for home providers to acceptpatients only if their anticipated assistive needs werefew. However, it might also result in some under-service or rehospitalization of patients whose assis-

13 F~~ ~mple, ~ @ySic~m@t & rqfi~ to Ce@ tit the patient or family mem~r could p~orm the ~ion w a prerqukite for eligibilityfor the benefit.

14 For emple, coverage for ~oncwmthome h~thben#lts co~d ~ limit~ to a dol~ amo~t CXI@ to some yr~n~ge Of the average per-patienthome health payment in that area.


tive needs were eventually greater than originallyanticipated.

Option 3C might be somewhat complex to admin-ister, since it presumes that the FIs involved canmonitor HDIT and home health benefits simultane-ously. Its implementation would be most straightfor-ward if both benefits were administered by the sameintermediary so that concurrent benefit eligibilitycould be detected easily (see option 5).

Administrative OptionsThe choice of how an HDIT benefit is to be

administered can be made by Congress, or it can beleft to HCFA to decide. Traditionally, the responsi-bility for administrative decisions has been primar-ily the purview of the executive branch of thegovernment. Some administrative aspects of anHDIT benefit, however, have broad implications forthe shape of the benefit itself. In these cases,Congress may want to provide HCFA with eitherstatutory or nonbinding language to indicate howHCFA should address these issues.

Options 4 through 7 address some of the majordecisions that must be made regarding administra-tion of a home drug infusion benefit. These include:

1.

2.

3.

4.

how the primary provider responsible for thehome benefit is specified;whether an HDIT benefit should be placedadministratively under part A or part B of theMedicare program;whether the administration of the benefitshould be consolidated under a few regionalMedicare FIs; andwho should conduct appropriate case approvaland review activities.

Provider Designation and Service Integration

Option 4A: For patients needing only HDIT,permit providers of different components ofthis therapy (e.g., pharmacy and nursingservices) to bill separately for their respectivecomponents.

Option 4B: For patients needing only HDIT,require that a single certified home infusiontherapy provider bill for all services receivedby that patient.

Option 4C: For patients needing both infusionand other home health services, permit a

certified home infusion provider and the HHAprovider to bill separately for their respectiveservices.

Option 4D: Require that the primary providerfor patients needing both infusion therapy andother home services-i.e., the provider whocoordinates services and submits a bill toMedicare--be a certified HHA.

Some Medicare patients will need only HDIT andno additional assistive services in order to continuetheir medical treatment at home. (In fact, underoption 3A above, only these patients would beeligible for the benefit.) For these patients, Congresscould permit providers to bill Medicare as theysometimes do other payers, with one or manyproviders submitting bills according to the specificcomponents of therapy they provide.

However, Congress may wish to ensure serviceintegration and provider accountability by requiringthat a single provider bill Medicare for all HDITservices provided to that patient. As was the caseunder the Medicare Catastrophic Coverage Act, theprimary HDIT provider could be required to meetdetailed criteria, as outlined in regulations, to becertified as a qualified HDIT provider.

Many Medicare patients medically stable enoughto go home on HDIT, however, may need basichome health assistive services in order to function inthis setting. Many (if not most) of the major HDITproviders are not Medicare-certified HHAs and donot provide basic home nursing, therapy, and homehealth aide services. For these patients, Medicarecould permit separate billing by the respective HDITand HHA providers (option 4C), with one or theother required to coordinate the two types ofservices; or, Medicare could require a certified HHAto bill for and coordinate all in-home health servicesprovided to a given patient, including HDIT (whichmight be provided under contract to the HHA)(option 4D).

The coordination of infusion and other homehealth services is an important issue for benefici-aries, providers, and the Medicare program alike.For beneficiaries, dealing with two separate provid-ers of home care services might mean duplicationsand gaps in services, with no single source of contactfor coordinating or discussing the overall care withthe patient. If a single HHA provider is responsiblefor both sets of services, coordination of these


services would be done by that HHA. If separateHDIT and HHA providers were recognized (as inoption 4C), Medicare might want to require one ofthe providers (or an outside case manager) toundertake the coordination responsibilities.

For providers, permitting separate HDIT andHHA billing has the advantage of leaving the billingfor a service to that provider with the most back-ground in that service. There would be little need forHHAs to learn new HDIT-related billing and over-sight responsibilities unless they undertook themvoluntarily. Separate billing is preferred by manyHDIT providers, because most are not currentlycertified by Medicare as HHAs (and some reportedlycannot do so because of certificate-of-need laws intheir States that restrict new HHAs).

The Medicare program, on the other hand, mightfind single HHA-based billing simpler once HHAslearned the necessary procedures. Single billingwould also reduce the difficulty of identifying andavoiding duplicate payment for HDIT and otherhome nursing services. Since home health is a PartA service unless the beneficiary has no Part Acoverage, Medicare Part A intermediaries (ratherthan Part B carriers) would be the logical administra-tors to deal with claims if only HHA single-billingwere permitted. However, this option might requireconsiderable training of HHAs to familiarize themwith HDIT and the necessary billing procedures.

Note that even if single HHA billing wererequired for patients receiving both HDIT and otherhome health services, Medicare could still permitHDIT-only providers to bill for infusion-only pa-tients. In this case, claims might be handled by eitherPart A or Part B FIs, depending on the intent ofCongress and the Medicare program (see option 5).

Administrative Placement

Option 5A: Make HDIT a Part A benefit.

Option 5B: Make HDIT a Part B benefit.

Option 5C: Make HDIT a benefit under bothParts A and B, depending on the patient’scircumstance and concordant benefits.

The choice of administrative placement for anHDIT benefit affects who administers it and howeasily it can be integrated with other Medicarebenefits. Medicare Part A generally covers hospital,SNF?, home health, and hospice care and is administ-

ered through one set of FIs. Medicare Part B coversphysician and laboratory services, hospital outpa-tient and ambulatory surgical services, and DMEand is administered through a separate set of FIs. TheParts A and B FIs are private insurance companies,but only rarely does the same company fill both rolesin its given locality.

At present, both Part A and Part B benefits overlapsomewhat with a potential home drug infusionbenefit. Existing home health benefits are usuallyunder Part A and administered by 10 regional FIs,but home health services are also a Part B benefit forbeneficiaries not eligible for Part A coverage. (In thelatter case the benefit is still admini stered by the PartA FIs.) TPN, an existing infusion benefit, is aprosthetic device benefit under Part B and consoli-dated under two regional Part B FIs. DME benefitsare usually administered through Part B FIs, butDME supplied by an HHA as part of the home healthbenefit is administered through the 10 Part A homehealth FIs. Hospice care, which sometimes includeshome infusion therapy, is a Part A benefit; outpatientinfusion and physician and laboratory services arePart B benefits.

Thus, the choice of where to place an HDITbenefit administratively depends in part on how it isto be integrated with existing benefits. If the benefitis to be linked with home health benefits, it would beadministratively simplest to place it under Part A. If,however, it is to be entirely distinct from homehealth nursing, it would be simpler to place it underPart B, where some administrative experience withreimbursing for the component equipment and drugsis developing. Finally, it could be administeredunder Part A for some patients (e.g., those alsoqualifying for home health benefits) and under PartB for others (e.g., those needing no adjunct services)(see option 4).

The split of bills for patients receiving infusionservices between Part A and Part B Fls could beproblematic, since it would require all administrat-ive contractors to gain some expertise in handlinginfusion claims and would increase variation in thathandling. On the other hand, if home health andinfusion providers were permitted to bill separately,Medicare might find it difficult to identify duplicateclaims for home health nursing services.

One way to minimize claim-handling variation inthe former case might be by consolidating FIs for thepurposes of administrating this provision (option 6).


Fiscal Intermediary Consolidation

Option 6: Require that the benefit be adminis-tered through a few regional FIs.

Regardless of whether an HDIT benefit is placedunder Part A, Part B, or both, Congress (or HCFA)may want to consider consolidating the administra-tion of the benefit under a few regional Medicareadministrative contractors. Such a consolidation hasprecedent both under Part A (for home healthbenefits) and under Part B (for TPN benefits).

The great advantage of consolidation is that thefew administrative FIs can amass greater experiencein administering the benefit, leading to more consist-ent coverage decisions, more rapid claims process-ing, and more information with which to updatecoverage decisions or payment amounts. In addition,the fewer number of administrative organizationsmeans that the potential for widely varying andinconsistent coverage policies would be reduced.The advantage of greater claims experience might beespecially important if the benefit were split be-tween Part A and Part B, depending on the particularpatient and circumstances (see option 5C).

The primary disadvantage of regional FIs is thatthe crossing of traditional contractor boundariesmight pose difficulties for peer review organization(PRO) review, since PROS are located in each localcontractor area. To overcome this disadvantage, thebenefit might need to be overseen by a few regionalPROS, corresponding to the regional intermediariesor carriers. To date, however, HCFA has relativelylittle experience in designating PROS with responsi-bilities across local contractor lines whose activitiesinclude prior authorizations.

Case Review

Option 7A: Do not require preauthorization forHDIT.

Option 7B: Require PROS to preauthorize someor all HDIT patients.

Option 7C: Require FIs to preauthorize HDITpatients.

Option 7D: Require PROS to retrospectivelyreview some home infusion patient claims.

A critical element in the safe and effectivedelivery of HDIT is patient screening to ensure that

hospital discharge (or, for nonhospitalized patients,drug therapy) is appropriate. Performing patientscreening is one of the functions of HDIT providers.If they do it well, Medicare oversight—i.e., preau-thorization-of HDIT patients at the onset of hometherapy may not be necessary.

It may be difficult for Medicare to assure itselfthat HDIT patients are being appropriately screened,however, especially in the frost years when there islittle experience with an HDIT benefit. In particular,Medicare may be justifiably concerned about prema-ture hospital discharge. One detriment to a MedicareHDIT benefit is the strong financial incentive itcould provide to both hospitals and home careproviders to remove patients from the hospital, evenwhen home care may be inappropriate or the patientis unwilling to be discharged. In the case of patientswho are not hospitalized at the time HDIT isprescribed, Medicare may still wish to be assuredthat the patient can be safely treated at home. And inall cases, Medicare may wish to document who willbe responsible for therapy and assure that theprescribed infusion therapy meets some basic cri-teria of medical necessity (e.g., oral drugs are noteffective for the given condition).

There are two logical parties to perform HDITpreauthorization. First, the FIs who would laterprocess the claim could conduct the review. Alterna-tively, PROS could give the preauthorization.

PROS are physician-run private organizations thatcontract with Medicare to review the appropriate-ness and necessity of medical interventions in avariety of settings, including hospitals. They arecapable of detailed medical assessment and wouldprobably be the most appropriate reviewers if theprior review were to involve an extensive discussionof the patient’s therapy and condition. (The MCCArequired PROS to conduct preauthorization reviewof all patients recommended for HDIT. In addition,HCFA’s proposed regulations required PROS toapprove prescription changes and other alterationsmade during the course of therapy, and to conductretrospective review of a random sample of HDITcases.) The disadvantage of this proposal is thatPROS are poorly organized for quick response (aswould be required where home discharge is immin-ent), and the extensive review that they are mostqualified to provide is time-consuming, expensive,and would probably delay patient discharge some-what.


FIs, in contrast, have traditionally had relativelyless in-house medical expertise15 but are moregeared to day-to-day decisionmaking and detail. FIsthus might be more appropriate organizations toconduct preauthorization if the goal is a lesscomprehensive and less expensive check on basicappropriateness. For example, a FI-based priorapproval mechanism might be simply to tentativelyapprove home therapy based on affirmative answersto a short list of screening questions, with finalapproval for payment made retrospectively byclaims personnel on the basis of documentation inthe record for these questions. Since brevity wouldbe one of the goals of preauthorization in this case,quick turnaround (e.g., within 24 hours) could alsobe a requirement.

If FIs were judged to be the appropriate organiza-tions to conduct prior review, it may still bedesirable for PROS to participate in the developmentof the screening questions. Infusion professionals(e.g., infectious disease physicians, IV specialtynurses) could also be involved.

Prior authorization of all patients beginning HDITmay not be necessary, particularly in the long run ifconcerns about premature hospital discharge proveunwarranted. For drugs that are relatively safe (e.g.,many antibiotics) and for which the indications areclear, issuing clear instructions to providers andconducting retrospective review may be sufficient.

Accordingly, in addition to requiring preauthori-zation of some home care cases, Congress or HCFAcould require PROS to perform a detailed retrospec-tive review of the appropriateness of care of a sampleof claims to identify problems of care.l6 The reviewcould be a simple random sample of cases (e.g., 10percent of all claims). The review could be aug-mented by targeted review of all claims in certaincategories indicative of possible problems (e.g., allclaims associated with a beneficiary complaint; allclaims in which the patient died or was rehospital-ized within 30 days after home therapy; all claimsfor certain categories of drugs).

Payment OptionsThe way in which Medicare pays for HDIT would

affect the shape of the industry, the willingness ofproviders to offer services to Medicare patients, thequality of the services provided, and the costs toMedicare. Options 8 and 9 deal with how Medicaremight pay HDIT providers, whether providers willbe required to accept Medicare assignment to serveMedicare patients, and the different ways Medicaremight choose to compensate physicians for theirservices relating to a course of home infusiontherapy.

Provider Payment Methods

Option 8A: Pay for the various components of anHDIT benefit under existing payment mecha-nisms that apply to home health, DME, andother benefits.

Option 8B: Pay for HDIT on the basis of actualcosts, with a cap on the total costs allowed.

Option 8C: Pay a prospective per-diem rate forHDIT services.

The potential ways of paying for an HDIT benefitinclude both retrospective methods, in which theamount of payment is determined after the service isdelivered; and prospective payment, in which the feeis determined before the service takes place. Retro-spective methods include cost-based payment (thecurrent method of paying for home health andhospital outpatient services) and charge-based pay-ment (which historically has been the method ofpaying for DME and physicians’ services). Prospec-tive methods are varied and generally rely on someform of a fee schedule. Fees maybe established foreach individual item or service, or these servicesmay be “bundled’ across time into, for example, aper-diem or per-discharge payment. Fees may eitherbe set by the payer or be established on the basis ofnegotiation or provider competition.

Although any of these methods could theoreti-cally be applied to HDIT, only three are sufficiently

15 Seved Ctitis told OT.A tit their in-house medic~ expertise has increased over time and is now comparable to that in pROS. OTA k nOtindependently evaluated this claim.

16 Under the MCCA, health maintenance org animations (HMOs) would have been excluded from PRO review for this service. However, HMOS thatprovide HDIT may face the same incentives as non-HMO hospitals to discharge patients to home care with inadequate support. Thus, PRO review ofMedicare home infusion patients in HMOS and other capitated plans patients maybe justitled.


well developed that they could, if desired, beimplemented immediately. Of these, a methodcombining cost- and charge-based reimbursementwould be the simplest to implement. In essence, thismethod would simply extend current rules (e.g.,cost-based payment for home health services andcharge-based payment for drugs, equipment, andsupplies) where they applied and augment theexisting system with refinements where necessary(e.g., better drug codes, allowances for pharmacyservices). Non-HHA infusion providers might needto be permitted to bill for nursing (in a manneranalogous to home health nursing visits) when thenursing visits were for infusion. This method iseasily compatible with a policy that allows differentproviders to pay for different components of HDIT.It would probably have few negative consequencesfor quality or access to care, but it also offers thefewest possibilities for cost control.

All-cost-based reimbursement also offers incen-tives to provide high-quality, accessible care toMedicare beneficiaries, but it may be somewhatinflationary. Placing a capon allowable costs mightreduce cost increases to some extent. All-cost-basedreimbursement would be relatively easy to imple-ment if HHAs were the primary providers, butHDIT-specialty providers have little experiencewith cost reporting. For these providers, this pay-ment method would require some administrativeeffort. In any case, this payment method wouldprobably require that a primary HDIT provider billfor all HDIT-related services in order for provider-specific Medicare costs to be assessed accurately.

Prospectively set rates (e.g., per-diem rates) forHDIT have been used successfully by privateinsurers, and more information is available to setrates now than at the time the MCCA was passed.This method offers the greatest possibility for costcontrol, but it could endanger patient access andquality of care if rates are low and quality of carecannot be monitored adequately.

If prospectively set rates are chosen as the methodof payment for HDIT, bundling at least nursingservices, supplies, and equipment into a single rate(or set of rates) may reduce paperwork burdens andsystem ‘ ‘gaming. ’ ‘ Continual advances in newtechnology and potential tradeoffs between nursingneeds and equipment costs for some technologiesmeans that, if payment were according to anitemized fee schedule, Medicare might find it

difficult to keep up with changes in the therapy andstill keep costs under control.

Competitively set prospective rates offer someadvantages over HCFA-designated rates. Since ratesare set according to the market based on providerbids, the data problems HCFA might otherwiseencounter (e.g., setting rates too high or too low dueto lack of information on provider costs) would berelatively less important. However, the need tocompete and contract separately in each area of thecountry, and the need to monitor quality of care veryclosely, might make competitively set rates adminis-tratively very burdensome and costly. In addition, ifcontracts were awarded to only a few providers, themarket advantage given to these providers mightresult in future market concentration. Thus, in latercontracting rounds, there might be fewer providersbidding for contracts, and higher future paymentrates.

Other payment methods-for example, bundlingthe payment for HDIT into the hospital’s DRGpayment—are also possible, but it would be difficultto implement these methods quickly. Some of thesemethods could be tested through demonstrationprojects if desired (see below).

Regardless of the payment method chosen, Medi-care might want to take measures to limit beneficiaryliability for charges greater than what Medicarepays. Private insurers have successfully imple-mented ‘preferred provider’ programs, under whichproviders agree to meet quality standards and acceptthe insurer’s payment rate as payment in full, inexchange for the likelihood that more of thatinsurer’s patients will use the provider’s services. Asimilar program requiring mandatory assignment forHDIT providers serving Medicare patients wouldreduce patients’ risk of being billed for charges inexcess of the Medicare payment rate. A lack ofproviders willing to participate could be one indica-tor that Medicare payment rates were set too low.

Physician Reimbursement

Option 9A: Pay physicians for their additionalsupervisory time in HDIT cases on the basis ofexisting fee-for-service methods.

Option 9B: Pay supervisory physicians a fixedrate (e.g., per patient or per day) for patientson HDIT.


Option 9C: Do not pay physicians for supervisoryand advisory activities related to oversight ofHDIT.

OTA found that active physician participation ina patient’s home infusion care enhances the qualityof that care and may help prevent potential untowardeffects. In the hospital, physician involvement takesthe form of frequent (usually daily) visits, each ofwhich is often separately billable to Medicare. Forpatients in home care, however, physicians facesubstantially fewer opportunities to bill for services.Patients have fewer billable physician visits, whilephysicians spend time monitoring and adjustingtherapy outside of visits and consulting with phar-macists, nurses, and patients over the telephone.None of these latter activities are currently reimbur-sable under Medicare.

Some physicians and home infusion providershave devised compensation mechanisms to counter-act the financial disincentives related to payerpolicies. Some infusion providers, for example,reputedly pay physicians “consulting fees” inexchange for referrals. In other cases, physicians areco-owners of an infusion provider and thus share inprofits that arise from referring patients to thatprovider. These arrangements may arise out of alegitimate desire to influence the quality of careprovided and to receive some kind of reasonablecompensation for the physician services associatedwith home care. Nonetheless, physicians have avirtual monopoly on referrals to HDIT providers.Physician compensation that is linked to the patientutilization of a particular provider introduces thepossibility that physicians will refer patients to ahigher-cost or lower-quality service in order for thatphysician to receive financial benefits. Even in amore benign form, physicians may be less active inseeking out the best provider for their patients whenthey share in the profits from a referral.

Medicare can, if it wishes, prohibit physicianswho are co-owners of an HDIT provider fromreceiving payment, and existing Medicare anti-kickback provisions prohibit payment where physi-cians gain a fee for referral. If these forms ofcompensation are banned, however, many physi-cians will continue to be financially penalized forreferring patients to home care. To avoid such apenalty, Medicare could pay physicians more com-prehensively for the services they provide to HDITpatients.

Although there are many possible permutationson physician payment, one possibility is to permitphysicians to bill for the time they spend in certainactivities relating to overseeing the care of HDITpatients. Under this option, for example, physiciansmight be permitted to bill for the time spent intelephone consultation during a patient’s course ofhome therapy. The advantage of this option is itssimplicity and compatibility with current billingmethods. Its primary disadvantage is its ‘‘blankcheck’ characteristic; there are few ways to confirmthat the time billed was actually spent on issuesrelating to a particular patient’s HDIT. This optionalso sets a precedent for billing for telephoneservices and home care oversight generally, whichcould substantially increase Medicine costs.

A second option is to pay physicians a flat fee forthe management of patients on HDIT. This fee couldbe a nominal one intended to cover only the averagecosts of oversight time exceeding what would benormally expected of a home care patient. Altern-atively, the fee could be intended to cover allphysician services relating to the infusion therapyduring the course of therapy, including office andhome visits. The amount could be set per day or perepisode of therapy; it could vary depending on thetype of therapy, the expected or actual duration oftherapy, or other factors. There is a precedent forsuch a payment method; under the Medicare End-Stage Renal Disease program, physicians oversee-ing the dialysis treatment receive a flat monthly feeper patient. Additional billing is permitted forservices performed for unrelated conditions (e.g.,treating a broken arm).

A potential drawback of a flat comprehensive fee(rather than a daily fee) is the financial incentive tounderprovide services. Under a comprehensive fee,fewer visits do not bring commensurately lessrevenue. Medicare could choose to assume that thisproblem would be minimal due to physicians’desires to provide good care to their patients, andtheir desire to avoid legal liability for poor care. Or,Medicare could set a mandatory minimum numberof visits to ensure at least a basic level of service.Fees could vary depending on the type of therapyinvolved and whether the patient was on multipletherapies under the direction supervision of severalphysician specialists.


Research and Demonstration OptionsA great many things that Medicare might want to

know about HDIT are unknown or the subject ofcontroversy. Areas of uncertainty range from clini-cal questions about the use of specific therapies inthe home to questions about the needs of elderlyHDIT patients and questions of costs and paymentfor HDIT. Many of these uncertainties could beaddressed through specific research or demonstra-tion projects aimed at investigating the particularissue.

Options 11 through 19 present examples ofpossible studies. Although this list is by no meansexhaustive, it includes some of the major areas ofcontroversy or uncertainty in which the findingscould have a significant effect on the policiesMedicare might choose to pursue. These projectscould be undertaken to refine an existing basic HDITbenefit that had already been put in place. Alterna-tively, demonstration projects could predate a bene-fit, with the findings used to determine the shape ofa later national HDIT Medicare policy.

Clinical Studies

Option 11: Provide provisional or augmentedcoverage for drugs administered by HDITproviders participating in certain clinical stud-ies.

Medicare does not usually cover experimentaldrugs or procedures. Given the uncertainty abouthome use even for some drugs commonly used inhospitals, however, Medicare could choose to de-velop a framework to investigate drugs for theirappropriateness in HDIT and their eligibility forMedicare coverage in that setting.

For example, Congress could authorize provi-sional coverage for drug infusion therapies for whichinsufficient evidence on home use in the Medicarepopulation exists, but for which there are a priorireasons to think that the drug is likely to be effectivein this setting and this population. Provisionalcoverage could be limited to drugs that had alreadyreceived Food and Drug Administration (FDA)approval for use in the hospital, and participation inan organized research protocol (with enhanced datacollection) that had been approved by HCFA couldbe required of providers for reimbursement duringthe provisional period. Such studies could gathereconomic as well as clinical information.

Congress could also choose to authorize provi-sional coverage for some projects involving drugswith greater clinical uncertainties. Such projectsmight be used to address the relative effectiveness ofan approved drug for a new use that was likely to belong-term and applicable to the home setting. Forexample, a project might provisionally cover dobu-tamine while collecting and examining the evidencethat this drug actually does improve health whenused as an intermittent long-term therapy. This typeof project involves greater potential for provision-ally funding drugs that will eventually be provenineffective, however. Congress might wish to distin-guish between studies of drugs that have previouslybeen proven effective for a particular use in thehospital, and those for which effectiveness for theuse itself is still in doubt.

Cost Studies

Option 12: Examine the resource costs of provid-ing HDIT and the economic characteristics ofthe HDIT industry.

An important problem in determining an appro-priate method and level of Medicare payment forHDIT is that the true costs of providing HDIT areunknown. Existing studies of the “costs” of HDIToften rely on provider charges to estimate costs.However, charges (i.e., provider-assigned prices)and costs (the true resource costs faced by theprovider) are by no means the same and may varyacross therapies, patients, and providers. Differencesin provider-specific costs would be especially usefulfor Medicare to understand, so that payment ratescan accommodate those differences where desiredwithout unnecessarily increasing Medicare expendi-tures.

Option 13: Examine the relative costs of provid-ing drug infusion therapy in home and outpa-tient settings.

Although the focus of this report is home therapy,drug infusion therapy is also sometimes provided inoutpatient clinics. Proponents of outpatient therapyargue that it enables better quality control, greaterphysician involvement, and greater economic effi-ciencies because there is no need to send a nurse toevery patient’s home. If these arguments are validfor at least some patients and providers, Medicaremay want to be especially careful not to put in placean HDIT benefit that would unintentionally discour-age patients from outpatient infusion therapy where


it is available. Understanding the relative costs anduses of outpatient and home therapy would helpinform such a policy.

Option 14: Examine the use of basic home healthservices, and the need for infusion assistance,among elderly patients on HDIT.

As mentioned above, an HDIT benefit could belimited to patients who (with family caregiverassistance) were capable of self-care. Many otherbeneficiaries, however, might also prefer HDIT toinstitutional treatment. A major question for Medi-care is the extent of this potential demand, thecharacteristics of the patients who would use adjunctservices, and the costs of the home health servicesinvolved.

A demonstration project could examine thisquestion either generally or for one or more groupsof beneficiaries of particular interest to Medicare.Groups of potential interest, for example, might behomebound beneficiaries currently receiving homehealth services who develop a need for infusiontherapy; patients needing help with the actualinfusion but no other home health assistance; andpatients for whom it is anticipated that inpatienthospitalization for drug therapy could be avoided ifHDIT and other home health services were availa-ble.

Payment Studies

Option 15: Examine different potential methodsof paying for HDIT.

Although cost- and charge-based payment meth-ods could be applied to HDIT with relatively modestadministrative effort, other methods are more diffi-cult or rely on less certain information. Per-diemmethods, for example, are feasible at present, but theinformation on which appropriate rates could bebased is scanty. A demonstration project testing apreliminary rate for its effects on provider participa-tion and quality of care would add greatly to thatinformation base. Other payment methods that couldbe tested include:

●

●

competitive bidding methods;per-diem methods in which components were“bundled’ in various ways (e.g., the per-diemrate might include or exclude such items asDME, nursing services, pharmacy services, andlaboratory services);

●

●

per-patient prospective payment methods basedon episodes of care; andhospital-based payment, in which the hospitalmight receive the HDIT payment as a DRGadd-on and be responsible for providing orarranging for all care, whether inpatient oroutpatient.

Option 16: Examine the feasibility and effects ofpaying hospitals less than the full inpatientrate for patients subsequently discharged toHDIT.

A major barrier to Medicare program savings inthe first years of an HDIT benefit is the fact thathospitals are entitled to receive the full DRG-basedpayment for all patients in that DRG, even if apatient is discharged to HDIT after a few days. Onepossible solution to reduce expenditures would be topay hospitals less than the full DRG amount forpatients discharged to HDIT. For example, if thedischarge destination on a patient’s hospital bill isrecorded as HDIT, the inpatient stay might be treatedas a transfer, with the “transferring” hospitalreceiving a prorated amount depending on the actualinpatient length of stay.

A philosophically troublesome aspect of such a“transfer” policy is that it contradicts the basictheoretical structure of Medicare’s hospital paymentsystem, which is intended to reward hospitals thatbehave efficiently (e.g., by discharging patientsquickly). In addition, the actual effects of such apolicy on hospital discharge behavior and Medicareexpenditures are unclear. For example, hospitalsmight simply encourage physicians to dischargesuch patients only at the point where the hospital hadrecouped the full DRG payment. On the other hand,such a policy might have some effect on expenditurereduction even in the event of such hospital behav-ior.

Option 17: Examine alternative methods of pay-ing for drug infusion therapy in SNFs andhospital swing beds.

Where patients are medically stable but needcontinual supervision or substantial assistive care inaddition to their drug infusion therapy, institutionalcare that is less intensive than hospital inpatient caremay be the most appropriate and least expensive. Atpresent, however, there appear to be considerablestaffing-related problems and some financial disin-centives to providing drug infusion therapy in SNF


and swing-bed settings. Other methods of paying forsuch therapy in these settings warrant investigation.

Option 18: Examine the effects of an HDITbenefit on rural and inner-city hospitals.

If an HDIT benefit is put in place, most hospitalswill be able to discharge relevant patients to a homecare provider in their area. These hospitals willbenefit financially by doing so, because they receivethe full DRG payment for each patient regardless ofthe actual length of the inpatient stay.

Some hospitals, however, may not be able todischarge patients easily. Some rural hospitals, forexample, may be located in areas with no qualifiedHDIT provider. Inner-city hospitals may servepatients who live in high-crime areas that localproviders may be unwilling to serve. Thus, it ispossible that hospitals in these categories may befinancially disadvantaged, through no fault of theirown, by their inability to discharge patients to HDITand lower their costs. A study of hospitals that arepotentially at risk of being disadvantaged coulddetermine whether Medicare policies needed toaccommodate this factor.

Quality Studies

Option 19: Examine the outcomes of HDIT undervarious conditions (e.g., different types ofpatients and therapies) to determine whichmeasures might be appropriately used asindicators of good- or poor-quality care.

Medicare’s ability to monitor the quality of careprovided under an HDIT benefit is crucial. Partici-pating providers, for example, might be required toshow that their record on care quality was acceptablebefore being able to renew their Medicare certifica-tion. Indicators of poor quality could be used toscreen cases for more in-depth retrospective review.

And certain payment systems, particularly prospec-tive payment systems with fixed rates, includeincentives to underprovide care, making Medicare’sability to detect and censure poor-quality care evenmore critical.

Despite their importance, measures of the qualityof HDIT are not well-studied and reported in theliterature. Examples of measures that deserve studyinclude:

●

●

●

●

average complication rates (e.g., the rate ofcatheter-related infection) among different typesof patients and therapies;differences in complication rates, rehospitaliza-tion rates, and other factors that are related todifferent drug delivery systems (e.g., whetherpatients on simple gravity drips experiencemore complications of therapy than patientsusing more sophisticated infusion devices);the different factors that affect patient satisfac-tion with therapy; andwhether provider-specific factors (e.g., con-tracting v. providing in-house services) areconsistently related to other possible qualitymeasures.

Because HDIT technologies have been changing sorapidly, even professional associations that establishcare standards (e.g., the frequency with whichcatheters should be changed to avoid infection) arehard-pressed to keep their recommendations in pacewith technological change.

The Federal Government could fund studies toexamine various outcome measures to determinewhich measures can most appropriately be used tomonitor the quality of HDIT care provided toMedicare beneficiaries. Such studies could be donein conjunction with a new HDIT benefit or as part ofa larger demonstration study of HDIT.

Chapter 2

THE SAFETY AND EFFECTIVENESS OFHOME DRUG INFUSION THERAPY

ContentsPage

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27Summary of Conclusions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

Drug Administration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28Considerations in Oral v. Parenteral Administration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28Routes of Parenteral Drug Administration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

Conditions Treated With HDIT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29Infections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29Cancer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31AIDS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

The Safety of HDIT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32Considerations and Risks of Infusion Therapy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32Factors Affecting Complication Rate and Severity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33Relative Risks: Home v. Hospital Drug Infusion Therapy . . . . . . . . . . . . . . . . . . . . . . . . . . 34

The Effectiveness and Use of HDIT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35Antibiotics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35Antineoplastic Therapy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36Analgesics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38Other Therapies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39Emerging Therapies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41

TablesTable Page2-1. Some Characteristics of Common Routes of Drug Administration . . . . . . . . . . . . . . . . 302-2. Relative Prevalence of Conditions Treated With Home

or Outpatient Intravenous Antibiotic Therapy in Two Programs . . . . . . . . . . . . . . . . . . . 312-3. Potential Complications of Intravenous Therapy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 322-4. The Home Drug Infusion Market, 1989 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 352-5. Percentage of Intravenous Antibiotics Used in Home Treatment

in Two States, 1989 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 352-6. Complications of Infusion Therapy Reported by One Home Infusion Provider . . . . . 362-7. Toxicity of Antineoplastic Drugs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 372-8. Examples of Special Considerations in Administering Intravenous (IV)

Antineoplastics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38

Chapter 2

THE SAFETY AND EFFECTIVENESS OFHOME DRUG INFUSION THERAPY

OverviewIntroduction

There is no well-established or formal definitionof home drug infusion therapy (HDIT). In thisreport, HDIT describes treatment that consists ofprolonged (or continuous) injections of drugs thatare administered in the home, usually repeatedly.

Spurred by public- and private-sector policies thathave encouraged alternatives to hospital inpatientcare, HDIT has become a widespread mode oftherapy affecting hundreds of thousands of people.Market analysts have estimated that between 1986and 1990 alone, the number of patients treatedoutside the hospital with drug infusion therapy grewfrom approximately 39,000 to between 200,000 and225,000 (275,289). These numbers may overesti-mate the number of patients actually treated at home,since they probably include some patients treated inoutpatient clinics.

HDIT encompasses an increasingly wide varietyof specific drugs and therapies, each with its owncharacteristics and considerations. Accordingly, thischapter describes how the drugs used in HDIT aredelivered, the patients who use this therapy, thedrugs they use, and the safety and effectiveness ofthose drugs when infused in the home.

Properly speaking, HDIT should include onlydrug therapy. In this report, however, it is often alsoused for the sake of simplicity to include sometherapies other than drugs (e.g., hydration and bloodtransfusions) that are not usually covered by Medi-care when administered in the home. Another relatedtherapy, total parenteral nutrition (TPN), is currentlycovered; it is discussed in this report only as aseparate form of infusion therapy and is not consid-ered part of HDIT.

●

Summary of ConclusionsMost prescriptions for HDIT are for anti-infective drugs. However, the mumber andvariety of drugs that are being infused in thehome are large and increasing.

-27-

●

●

●

In general, HDIT can be provided safely andeffectively if adequate precautions are takenagainst side effects of the therapy and potentialadverse drug reactions. The safety and effec-tiveness in any given situation, however, de-pends critically on the particular drug and thecondition of the patient receiving it. The safetyand effectiveness of anti-infective drugs inindividuals who are healthy in all respectsexcept the infection being treated are well-established. Therapies used in patients withcancer and acquired immunodeficiency syn-drome (AIDS) are also well-established, buttheir use in the home requires special cautionbecause of the disabilities of the patientstreated, the multitude of therapies these patientsmay require, and the potential toxicity of manyof the drugs they receive.

The ability to deliver infused drugs safely in thehome HDIT has enabled the use of therapies inways that might rarely have been tried if,instead, the patient had to be continuallyhospitalized. HDIT thus can sometimes makenew, more powerfully effective drug protocolsmore attractive to try. However, it also mayencourage the rapid transfer of new drugs andnew protocols into the relatively unmonitoredhome setting without a thorough testing of theireffectiveness in this setting or an appreciationof their costs. Dobutamine, for example, isbeing infused at home despite evidence sug-gesting that long-term therapy increases mor-tality rates in some patient groups. Immuneglobulin infusion is likewise a small butgrowing home technology whose effectivenesshas been documented in a few cases but whoseactual uses are expanding extremely rapidlyand whose costs may be extremely high.

Even among well-established home infusiontherapies, questions exist that can probablyonly be answered by research and experiencethat involve home patients. For example, de-spite the fact that most HDIT in the UnitedStates involves drugs administered intrave-nously, recent studies from Europe and Britain


suggest that some therapies (e.g., pain manage-ment, heparin, immune globulin) may be ad-ministered more simply, safely, and effectivelysubcutaneously.

Drug Administration

Considerations in Oral v. ParenteralAdministration

From both the patient’s and the physician’sperspective, the most desirable route of administrat-ion is the one that is easiest, most effective, andposes the lowest risk of side effects and potentialcomplications. Oral administration often fullfillsthese criteria and is the route of choice for mostdrugs. Sometimes, however, oral administration isinadequate or inappropriate, necessitating paren-teral drugs (i.e., drugs not administered into thedigestive tract). Factors that can lead to a preferencefor parenteral over oral administration include thedrugs’s absorption and metabolic characteristics, itsside effects, its predictability, and the condition ofthe patient.

Drug Absorption

To perform their intended functions, drugs mustbe delivered to the relevant tissues of the body.Orally administered drugs are first absorbed fromthe digestive tract and then carried in the blood to thetissues. The absorption of drugs from the digestivetract is highly variable. Some drugs (e.g., aspirin) arealmost completely absorbed into the blood. Others,such as the aminoglycosides (a class of antibiotic),pass through the entire digestive system with lessthan 1 percent absorption (129).

Drugs that are not adequately absorbed cannotattain blood levels sufficient to treat the particularcondition and must, therefore, be administeredparenterally. The factors that determine the absorp-tion of a particular drug include its physical andchemical properties (e.g., its volubility), the pres-ence of other substances in the digestive tract, therelative acidity of the digestive tract, and the time ittakes the stomach to empty (11).

Even if a particular drug is eventually completelyabsorbed, the rate of absorption may be too slow toproduce a therapeutic concentration in the blood(i.e., the concentration that is necessary to treat thatcondition). Or, the absorption rate may be so rapid

that high concentrations of the drug cause adversereactions (11).

Drug Metabolism

The degree of metabolism that a drug undergoes—i.e., its biological decomposition-also influencesthe route of administration. While many drugs canbe given orally with little loss of biologic activity,others are metabolized by digestive enzymes andtheir potency either reduced greatly or lost entirely.

Human immune globulin, for example, is anaturally occurring substance composed of antibod-ies produced by a particular kind of white blood cell.Immune globulin has been used to supplement thedeficiency of normal antibodies in certain individu-als with rare diseases (e.g., severe combined immu-nodeficiency syndrome) whose bodies are unable tomanufacture their own (54). If given orally, immuneglobulin would be digested and biologically de-stroyed. Consequently, it must be administeredparenterally in order to retain its function.

Side Effects

Many drugs can be administered effectively eitherorally or parenterally, but the side effects theyproduce may vary depending on the route ofadministration. Orally administered drugs often cancause nausea and vomiting, which limit the amountof that drug that can be given by mouth.

Methotrexate, for example, can be given eitherorally or intravenously-i. e., directly into a vein.When used in small doses to treat diseases such aspsoriasis and rheumatoid arthritis, oral methotrexateis usually well-tolerated and has minimal sideeffects (216). When used as an antineoplastic agentto treat certain cancers, however, the dose of the drugthat is required to be effective would produce severedigestive upset if administered orally. Thus, for thisuse it is usually administered intravenously.

Predictability of Parenteral Administration

Parenterally administered drugs are subject to farless variability of absorption than oral drugs, and theamount of delivered drug that reaches therapeuticconcentration is far more predictable. Consequently,drugs that have a narrow ‘therapeutic window,’ therange in which a drug is effective but does notproduce toxic effects, are often administered paren-terally so that the amount absorbed can be bettercontrolled. In addition, intravenously administeredmedication is essentially completely absorbed, be-

Chapter 2—The Safety and Effectiveness of Home Drug Infusion Therapy .29

cause it goes directly into the blood. This character-istic usually leads not only to more predictable butto higher drug levels than those produced by anyother route.

Erythromycin, for example, is a common antibi-otic used to treat a variety of infections. After asingle oral dose of 500 mg, peak concentration ofactive drug in the bloodstream ranges from 0.3 to 1.9ug/ml, depending on the particular preparation used.The same 500-mg dose administered intravenously,however, results in a peak blood level of approxi-mately 10 ug/ml, a level 5 to 30 times greater thanthat obtained by oral administration (129).

Patient Condition

The choice of oral v. parenteral administrationdepends not only on the characteristics of the drugbut also on the condition for which it is being used.Urinary tract infections, for example, are usuallysusceptible to oral antibiotics, while bone infectionsare not. In the past, parenteral administration hasbeen the only feasible way of administering suffi-cient antibiotic to achieve adequate concentrationsof the drug in the bone. A recently developed classof antibiotic, however, the fluoroquinolones, cannow be used orally to treat some bone infections(125).

A patient’s physical condition can also affect theroute of drug administration. A patient with oralcancer, for example, may be unable to swallow oralanalgesics and may require parenteral narcotics evenfor mild to moderate pain (37).

Routes of Parenteral Drug AdministrationMost commonly, drugs that cannot be adminis-

tered orally and must be infused over a period of timeare administered intravenously. For certain drugs,however, or for patients in whom access to the veinis for some reason compromised, drugs may beinfused into the body through other routes. Someantineoplastic l drugs, for example, may be infusedinto an artery (intraarterially), which carries thedrug directly to the site of the tumor. Intraperitonealdrugs, administered into the peritoneal (abdominal)cavity, are also occasionally used for certain cancers.Drugs used to manage pain in terminal cancer maybe infused in the epidural or intrathecal spaces

surrounding the spinal cord, where they are absorbeddirectly into the central nervous system. Some drugsmay be infused under the skin (subcutaneously)rather than by other routes, either because the drugis best absorbed that way, because of a reduced riskof serious infection, or because the patient’s veinsare not adequate to sustain venous infusion.

As with the choice of oral v. parenteral drugs, thechoice of which parenteral route of drug administra-tion to use depends heavily on the characteristics ofthe drugs and its limitations (table 2-l). For exam-ple, some drugs (e.g., many antibiotics) are effectivewhen given either intravenously or intramuscularly(injected into the muscle). Intramuscular injection,however, can cause severe pain and discomfort if thedrug must be administered gradually, frequently, orin large doses. In such cases, intravenous (IV)administration is usually preferred.

The preferred route of parenteral administrationcan change over time with new evidence. Two recentreports, for example, suggest that heparin-usuallyadministered intravenously when used as extendedtherapy for deep-vein thrombosis2-can be safelyand effectively administered subcutaneously as well(165,271). Furthermore, one of these reports sug-gests that subcutaneous administration reduces theneed for continual laboratory monitoring and doseadjustment, enhancing the drug’s attractiveness forhome use (271).

Conditions Treated With HDITIndividuals on HDIT may be treated for any of a

wide variety of diverse medical conditions, rangingfrom high-risk pregnancy to congestive heart failure.The most common conditions treated with HDIT,however, fall into three general categories: infec-tions, cancer, and AIDS. Each of these conditionsand the home infusion therapies that may be used totreat it are described below.

InfectionsThe classic candidate for HDIT is the patient who

has an infection requiring a long course of IVantibiotics, but who has no other complicatingconditions. These patients are likely to have two ofthe characteristics that allow for home IV administ-ration and make this form of drug delivery an

1 Antineoplastic drugs act against cancerous tumors.z ~Pveti ~om~sis is tie fomtion of a clot in a b vein of the ti or extremities, Mbit@ blood flow.


Table 2-l-Some Characteristics of Common Routes of Drug Administration’

Route Absorption pattern Special utility Limitations and precautions

Oral ingestion .

Intravenous .●

Subcutaneous .●

Intramuscular .●

Variable, depends on many ●

factors●

Absorption circumvented ●

Potentially immediate effects ●

●

Prompt (from aqueous solution) ●

Slow and sustained (fromrepository preparations)

Prompt (from aqueous solution) .Slow and sustained (fromrepository preparations)

Most convenient andeconomicalUsually safer than othermethods

Valuable for emergency usePermits titration of dosageSuitable for large volumes andfor irritating substances, whendiluted

Suitable for some insolublesuspensions and forimplantation of solid pellets

Suitable for moderate volumes,oily vehicles, and some irritatingsubstances

●

●

●

●

●

●

●

●

●

Requires patient cooperationAvailability potentially erratic andincomplete for drugs that are poorlysoluble, slowly absorbed, unstable, orextensively metabolized by the liverIncreased risk of adverse effectsMust inject solutions slowly, as a ruleNot suitable for oily solutions or insolublesubstances

Not suitable for large volumesPossible pain or necrosis from irritatingsubstancesPrecluded during anticoagulantmedicationMay interfere with interpretation ofcertain diagnostic tests- (e.g., creatninephosphokinase). , r

Wther routes include topical, transdermal, otic, sublingual, buccal, intranasal, rectal, occular, intraarterial, epidural, and intrathecal.

SOURCE: Adapted from A.G. Gilman, L.S. Goodman, R.W. Rail, et al., Goodman and Gihnan’s The Phannaco/ogica/ 6asis of 7herapeufks (New YorlG NY:McMillan Publishing Co., 1985).

attractive alternative. First, many of these patientshave stable medical conditions and require littleadditional medical attention besides their course ofantibiotics. Second, as discussed later in this chap-ter, most IV antibiotics are relatively free fromserious side effects and adverse reactions, makingthem less dangerous than other IV therapies. Conse-quently, antibiotics and other anti-infectives makeup about two-thirds of the HDIT market (34).

Osteomyelitis (infection of the bone) was one ofthe earliest conditions to be treated at home with IVantibiotics (see, e.g., 16). This condition occurswhen bacteria invade the bone, such as after acompound fracture that opens the broken bone to theoutside environment. Long courses of therapy withhigh concentrations of antibiotics are often requiredto treat this condition; treatment of 4 or more weeksduration is common (106,148,325). In publishedstudies of home and outpatient IV antibiotic use,high proportions of the patients studied-over halfin some reports-had osteomyelitis (16,136,148,267).The condition remains a popular one for treatingwith outpatient or home antibiotics. A recent reportof drug infusion therapy in one large outpatientpractice found that 32 percent of the patients treatedhad osteomyelitis (340).

Cellulitis (infection of the skin and surroundingtissue) is another condition frequently treated withhome IV antibiotics. This condition, often found in

persons with impaired immune systems, can resultwhen bacteria enters a break in the skin and thebody’s immune system is unable to fend off theinvading organisms. Persons with diabetes, forexample, often have poorly functioning immunesystems, and even a minor local infection candevelop into a life-threatening problem. Other infec-tions sometimes treated with home IV antibiotictherapy when oral drugs are insufficient includerespiratory infections (e.g., pneumonia and bronchi-tis), urinary tract infections, pelvic inflammatorydisease, and endocarditis (infection of the heartvalves). Examples of the relative prevalence of theseconditions in programs that treat patients with homeor outpatient IV antibiotics are presented in table2-2.

The relative prevalence of conditions treatedvaries considerably among providers. For example,in contrast to the two programs represented in thetable 2-2, the National Alliance for Infusion Therapyreports that in a sample of its members, Lymedisease (which was not even separately listed in thereports of the programs represented in table 2-2)accounted for 13 percent of patients treated withantibiotics (256).

Sometimes, IV antibiotics are used to combatrepeated infections in persons with underlyingdisorders that predispose them to these diseases.Persons with cystic fibrosis, for example, are espe-

Chapter 2—The Safety and Effectiveness of Home Drug Infusion Therapy ● 31

Table 2-2—Relative Prevalence of Conditions TreatedWith Home or Outpatient Intravenous Antibiotic

Therapy in Two Programs

Percent of patients with condition

Type of infection Poretz, 1989 Tice, 1991

Bone and joint.. . . . . . . . . 38 41Skin/skin structure . . . . . . 22 18Respiratory . . . . . . . . . . . . 13 2Urinary tract . . . . . . . . . . . 8Endocarditis . . . . . . . . . . . 2 :Gynecologic . . . . . . . . . . . 3 19Other . . . . . . . . . . . . . . . . . 12 16

Total . . . . . . . . . . . . . . . 100’ 100aTotal may not add to exaetly 100 due to rounding.

SOURCES: D.M. Poretz, “Home Management of Antibiotic Therapy,”Current Clinical Topics in infectious Diseases 10:27-42, 1989;A. D. Tice, “AnOffice Model of Outpatient Parenteral AntibioticTherapy,” Reviews of Infectious Diseases13(Suppl2):S184-8, 1991.

cially susceptible to certain respiratory infections(64). Traditionally, these individuals required fre-quent hospitalizations to treat the infections. Anumber of studies published since the mid-1970s,however, have documented safe and effective hometreatment of cystic fibrosis patients with IV antibiot-ics (128,290,328,400).

More recently, investigators have begun testingprophylactic (i.e., preventive) IV antibiotic regi-mens for persons with cystic fibrosis (88,102). Thelong-term effectiveness of these regimens in pre-venting infections, however, is still uncertain.

CancerIndividuals with cancer make up another large

group of patients utilizing HDIT. Many cancertreatment protocols require frequent administrationof antineoplastics, toxic antitumor drugs that mustbe delivered directly into the bloodstream due totheir inherently caustic properties. One of thetherapeutic regimens for metastatic3 breast cancer,for example, involves the continuous infusion ofvinblastine, an antineoplastic drug, every 3 weeksfor a 5-day period (1 16). Rather than returning to thehospital for each successive round of treatment,some patients on this (and other) protocols are

receiving their treatment in the home. The particularantineoplastic that is used, more than the type ofcancer being treated, determines the appropriatenessof home IV use (35).

Unlike patients with simple infections, cancerpatients may receive a number of different infusiontherapies simultaneously. In addition to antineoplas-tics, persons with cancer may at sometime during thecourse of their disease receive:

parenterally administered narcotic analgesicsto relieve severe pain;TPN or hydration4 to help to minimize theanorexia and physical deterioration caused bythe disease and by the drugs used to treat it;blood transfusions necessitated by the anemiathat results from both the therapy and theunderlying disease;5 andIV antibiotics to combat infection. (The sup-pression of bone marrow that results in anemiaalso makes cancer patients susceptible to infec-tion).

All of these therapies are sometimes administeredat home. In addition, the patient may receive otherdrugs, such as antinausea drugs, that are adminis-tered as periodic rapid injections (rather than as slowinfusions).

AIDSLike persons with cancer, those with AIDS often

require a multitude of parenteral therapies to combatthe disease and the secondary effects of some of themedications used to treat it. Characteristic infusiontherapies that might be administered in the homeinclude:

. Anti-infective drugs such as gancyclovir (anantiviral agent) and amphotericin (an antifum-gal drug) to treat opportunistic infections;

● TPN to maintain in adequate weight and nutrition;and

. Blood transfusions to treat the anemia thatresults from both the underlying disease and the

3 Metas~tic dis~e is the sp~d of a malignant cancer to distit p- Of the body.4 TPN (total parenteralnutrition) is the administration of nutrients directly into the bloodstream. Hydration is the adrmms“ “ trationof simple fluids (e.g.,

dextrose solutions).5 Antineoplastic drugs act by inhibiting the growth of rapidly dividing cells, such as those in the tumor. However, they also inhibit the division of

normal cells that divide rapidly, such as the blood preeursor cells in bone marrow, causing anemia (a lack of red blood cells). The cancer itselfean alsoenter the bone marrow and inhibit normal growth in these cells.


drugs used to treat it.6 Azidothymidine, forexample, was until very recently the only drugapproved by the Food and Drug Administration(FDA) to treat the infection that causes AIDS.A major side effect of this drug, as withantineoplastic drugs, is its toxic effect on theblood precursor cells in bone marrow. Gancy-clovir and amphotericin also produce anemia.

Pain medication and adjunct injectibles, such asantinausea drugs, are also sometimes used byindividuals with AIDS. (Aerosolized pentamidine,an inhaled drug sometimes prescribed for pneumo-nia in AIDS patients, is widely used in thispopulation and is often also supplied by HDITproviders.)

The Safety of HDITConsiderations and Risks Infusion Therapy

All medical therapies carry some degree of risk.Although drug infusion therapy has been a routineinpatient procedure for many years and is generallysafe, adverse outcomes do occur, even in closelymonitored hospital settings. Each year almost 1.5million patients of the 17 to 24 million that receiveIV therapy (mostly as inpatients) experience someform of complication (345). Of these, about 3,000die from complications of IV therapy (93).

Complications of infusion therapy fall into twogeneral categories: local and systemic (i.e., notconfined to a specific area of the body). Table 2-3summarizes some of these potential complications,the more common of which are described brieflybelow. Although the complications described areapplicable to most types of infusion therapy, IVtherapy is the most common, and complications aredescribed in this context.

Local Complications

Phlebitis--Perhaps the most frequently encoun-tered complication of any infusion therapy is phlebi-tis-inflammation at the site of the catheter inser-tion. (If there is also a blood clot at the IV site, thecondition is termed thrombophlebitis.) Dependingon the situation, this complication has been esti-mated to occur in 3.5 to 70 percent of all patientsreceiving IV medication (61). Phlebitis can result

Table 2-3-Potential Complications ofIntravenous Therapy

Local complicationsPhlebitis, thrombosis, thrombophlebitis

(inflammation and/or blood clot of a vessel)

Suppurative thrombophlebitis(infected blood clot in a blood vessel)

Infiltration and extravasation(seepage of infusate into surrounding tissue)

Cellulitis(infection of the soft tissue)

Nerve, tendon, or ligament damageHematoma

(accumulation of blood within tissues)

Collapsed blood vesselVenous spasmPain

Systemic complicationsSepticemia, bacteremia, pyrogenic reation

(diffuse, blood-bome infection)

Embolism(obstructIon of a Hood vessel)

Pneumothorax, hemothorax, hydrothorax(air, blood, or fluid in the chest cavity)

Hypersensitivity/allergic reactionSOURCE: Adapted from C.W. Delaney and M.L. Lauer, Intravenous

T3erqy; A Guids ?0 Qua/ify Care (Philadelphia, PA: J.B.Uppincott Co., 1988).

from chemical (e.g., a highly irritating drug), me-chanical (e.g., catheter-caused irritation), and bio-logic causes (e.g., contamination of the drug con-tainer). Careful attention to proper procedure canreduce the rate of infection (see ch. 3). If leftuntreated, infectious thrombophlebitis has the po-tential to cause more severe complications, includ-ing septicemia and death (see below).

Infiltration-Venous catheters that are improp-erly placed or have dislodged from the vein deliverthe infused solution into the tissue around the veinrather than into the vein itself. This complication canbe extremely painfull, especially if the infusate (theinfused solution) consists of some kind of irritant. Inthe case of ant.ineoplastic therapy for cancer patients,an IV infusion that has infiltrated can be particularlydevastating. Antineoplastic drugs are, by nature,very caustic, and infiltration of these agents into softtissue can cause widespread tissue destruction,necessitating tissue debridement, skin grafting, andother surgical procedures (398).

c The need for blood transfusions maybe reduced somewhat with the introduction on the market of the drug erythropoei~ recently approved bythe FDA to treat anemia in AIDS patients.

7 Septicemia is the presence of disease-causing bacteria in the bloodstream.


Systemic Complications

Sepsis--One of the causes of phlebitis is infectionat the site of IV catheter insertion. Untreatedinfectious thrombophlebitis can lead to severe con-sequences. If the patient’s immune system is unableto destroy the invading organism, it can continue tomultiply and infect virtually all recesses of the body.This condition, known as sepsis, can be fatal; eachyear 20,000 to 30,000 patients die from catheter-related sepsis (79). Careful attention to early signs ofcatheter infection or even early sepsis can mitigatethe impact of this devastating condition.

Embolism—Particulate matter that is introducedinto the venous system by an IV catheter (theembolus) becomes lodged in small vessels and stopscirculation (embolism). If the tissue supplied by thatblood vessel does not have adequate collateralcirculation, it dies. The consequence of this compli-cation depends on where the embolus lodges.Because of the dynamics of circulation, an embolusfrom a venous catheter usually ends up in the lung,causing a variable amount of destruction-and evendeath-depending on the size of the embolus.

Embolic material maybe of several sources. Themost frequent form of catheter-associated embolismis a blood clot that has formed at the site ofthrombophlebitis, then broken loose and lodgedelsewhere in the bloodstream (93). Improperlyinserted catheters can also break off or dislodge andform a source of embolic material. Air, if mistakenlyintroduced into the catheter, can also serve as anembolic source (93).

Allergic Reaction—Almost all IV drugs have thecapacity to produce an allergic reaction. The mani-festation of that reaction, however, can range from amild skin eruption to circulatory shock and death.Unless there is a prior history of drug allergy in theparticular patient, allergic reactions are not predicta-ble. Safe administration of parenteral drugs thusrequires prompt identification and early treatment ofreactions.

Drug allergies are relatively common. For exam-ple, about 2 percent of the population is allergic topenicillin (387), and an estimated 400 to 800 deathsin this country are attributable to this cause (320).Elderly patients (who may have more exposure to adrug and, therefore, more chance to develop anallergy to it), patients with a history of otherallergies, patients with a history of a prior drug

reaction, and patients with certain underlying condi-tions all represent groups at risk for drug allergy.Certain biological and chemical characteristics ofthe drug also affect the frequency with which itcauses allergic reactions in those exposed to it.

Other Drug Reactions-Besides allergic reac-tions, drugs can cause a variety of other problems.Some of these are predictable occurrences and arefrequent, recognized side effects of the drugs that areused. Other complications are less predictable andare termed idiosyncratic. For example, patientstreated with the antibiotic chloramphenicol have asmall but distinct chance of developing completedestruction of their bone marrow. Only about 1 outof 30,000 patients will develop this complication,but the mortality rate in those patients who dodevelop it is quite high (129). The consequences ofmany idiosyncratic drug reactions can be minimizedif the reaction is identified early. Thus, prevention ofserious complications from many drug reactionsrelies on prompt recognition and early intervention.

Factors Affecting ComplicationRate and Severity

The frequency and severity of complications inpatients receiving infusion therapy depends heavilyon the clinical characteristics of the patient, thetherapy given, and the clinical competence of theprovider.

Of these factors, the patient’s underlying condi-tion is probably the most fundamentally important.Comorbid conditions that predispose individuals tocomplications significant.ly affect the outcome ofpatients treated with infusion therapy (131). AnAIDS patient treated for bacterial pneumonia, forexample, would be expected to be at a far greater riskfor complications than would another pneumoniapatient without the underlying problem of AIDS.

The specific diagnosis for which any particulardrug infusion therapy is employed also influences itssafety. For example, a patient treated for cellulitiswith IV antibiotics can tolerate the complicationsassociated with that therapy much better than apatient with meningitis treated with the sametherapy; the patient with meningitis has an inher-ently less stable condition and is more at risk forpoor outcome should any drug side effect occur. Forthis as well as many other reasons, the cellulitispatient might be treated at home, but the meningitispatient would remain in the hospital for therapy.


Some categories of therapeutics are inherentlymore risky than others. Antineoplastic drugs, forinstance, are usually more toxic than are anti-infectives. Within each category, however, is ahierarchy of toxicities; some anti-infectives have thepotential for more serious side effects than someantineoplastics. Amphotericin B, a drug used to treatsevere fungal infections, for example, causes “po-tentially dangerous reactions in most patients” (11)and can be fatal if inadequately administered andmonitored. In contrast, the side effects of leupride, ahormone used in the management of prostaticcancer, include bone pain, hot flashes, nausea, andimpotence (11). Although these side effects areunquestionably unpleasant, they are far less poten-tially lethal than those seen with amphotericin B.

Similarly, the choice of vascular access device8

can affect the types and rates of complications thatarise. Central venous catheters, which lie near majorvessels, nerves, and organs, have the potential tocause more severe consequences if infiltrated orinserted improperly than a standard peripheral IVcatheter, and the long-term implantation and directvascular access of central catheters makes themmore susceptible to potentially dangerous infections(see ch. 3).

The provider also plays a major factor in theoutcome of patients treated with infusion therapy.Adherence to published guidelines for the propercare of infusions and infusion devices reduces thefrequency and severity of complications (311). Strictaseptic technique, regular changing of the site wherea peripheral catheter is inserted, and careful attentionto any early sign or symptom of an infusion-relatedcomplication is required of any home care provider(312). (The role of quality review to ensure thecompetency of providers is explored in chapter 5.)

Relative Risks: Home v. Hospital DrugInfusion Therapy

None of the complications of infusion therapydescribed above is setting-specific. The conse-quence of these problems, however, may differdepending on whether the therapy is given in thehome or in a medical setting.

The degree of monitoring that occurs in thestandard inpatient setting is usually greater than canoccur in the home, because of the use of electronic

monitoring in many patients and because nurses andphysicians are on site. One tradeoff to homeadministration of infusion therapy, therefore, is apotentially higher frequency of unrecognized and/oruntreated complications from the drugs themselves.Infection at the catheter site, for example, canpotentially be recognized at an earlier stage bytrained personnel in the hospital and be treatedeffectively by IV site rotation. The same catheter siteinfection may not be recognized as early at home anda more extensive infection may ensue.

Alternatively, there are certain complications thatcan actually be worse in the hospital setting than ifthey were encountered in the outpatient (or home)setting. Catheter site infections that occur in theoutpatient setting, for example, are usually causedby organisms that are fairly susceptible to mostantibiotics. Those acquired in the hospital, on theother hand, are usually caused by more aggressive,less sensitive organisms which can be more difficultto treat. In one survey of a hospital-based homeinfusion therapy program, nosocomial (hospital-acquired) infections were seen in approximately 14percent of hospitalized patients compared withalmost no infections in the patient group beingtreated as outpatients (15). Some of this difference isundoubtedly due to the presence of more stablepatients in the outpatient group, but some is proba-bly also due to the reduced exposure of outpatientsto potentially significant nosocomial infections.

Any patient who is starting a new drug is at riskof experiencing an unpredictable allergic reaction orother drug-related complications. Thus, even whenhome infusion is otherwise feasible and safe, the firstdose of any infused drug is usually administeredunder medical supervision, in the hospital, physi-cian’s office, or outpatient clinic, where personnelhave access to needed resources should a dangerousreaction occur (15,131). Similarly, when the drug ischanged during the course of home therapy (e.g.,when a more sensitive antibiotic is substituted toachieve better therapeutic results), many providersbelieve the patient should return to a supervisedsetting for the initial dose (15).

Whether the elderly are, on average, at greater riskof infusion-related complications than younger pa-tients is not entirely clear. One the one hand, elderlyindividuals are more likely to have other disabilities

8 See chapter 3 for a discussion of venous access devices.

Chapter 2—The Safety and Effectiveness of Home Drug Infusion Therapy ● 35

that may affect their health state, and they may bemore likely to develop allergic reactions to a drugdue to a greater chance of past exposure. On the otherhand, there is no clear evidence that well-screenedelderly patients on HDIT are at higher risk ofcomplications. The single study in the literature onthe topic found no difference in the therapeuticoutcome of elderly and nonelderly patients treatedwith home IV antibiotic therapy when similarclinical and social inclusion criteria were used forboth groups (65). It may be that fewer elderly thannonelderly patients would meet strict screeningcriteria, but that once those criteria are met the risksof HDIT in the two groups are comparable.

The Effectiveness and Use of HDITReports on home use of a multitude of drug

infusion therapies can be found in the literature. Byfar, the most common category of drugs is antibiot-ics and other anti-infectives. Based on estimates bymarket analysts and other sources, it appears thatabout two-thirds of current HDIT involve anti-infective drugs (34,193) (table 2-4). Approximatelyanother 15 percent of HDIT drugs are antineoplas-tics or pain medications. The diverse remaininggroup of drugs makes up somewhere between 10 and20 percent of HDIT at present. Although small andencompassing many unrelated drugs, this “other”group appears to be have grown rapidly (364).

Estimates based on drug orders and drug revenuesmay not reflect exactly the actual distribution ofpatients on different therapies. One investigator, forexample, reports that antibiotics accounted for abouttwo-thirds of drug orders but only about one-half ofpatients in his study (193a). A recent survey of therecords of 35,000 patients served primarily by largeinfusion specialty companies likewise found thatjust over one-half (52 percent) of drug infusionpatients were on antibiotics, another 21 percent werereceiving either antineoplastics or pain medications,and over 5 percent were receiving more than onetype of drug infusion therapy (256).

AntibioticsAntibiotic and other anti-infective drugs consti-

tute the bulk of HDIT for good reason. Their safetyand efficacy when provided in nonhospital settingshas been demonstrated in a number of studies(106,148,267,325). In virtually all of these studies,home patients achieved cure rates as good as orbetter than those attained in the inpatient setting.

Table 2-4-The Home Drug Infusion Market, 1989

Total revenues

Millions Percent ofTherapy of dollars market

Antibiotic therapy . . . . . . . . . . 600.0 69.6Pain management . . . . . . . . . 91.1 10.6Antineoplastic therapy. . . . . . 125.8 5.1Other therapies . . . . . . . . . . . 484.2 14.6Total . . . . . . . . . . . . . . . . . . . . 1.301.1 100.0’Wumbers do not add to exactly 100 due to rounding.

SOURCE: Adapted from Biomedical Business International, Santa Ana,CA, “Home Infusion Therapy Markets,” 1989.

Table 2-5-Percentage of Intravenous Antibiotics Usedin Home Treatment in Two States, 1989

Drug North Carolina Florida

Amphotericin . . . . . . . . . . . . . 6.5Cefazolin . . . . . . . . . . . . . . . . 3.2Cefotetan . . . . . . . . . . . . . . . . 8.1Ceftazidime . . . . . . . . . . . . . . 8.1Ceftriaxone. . . . . . . . . . . . . . . 25.8Gentamicin . . . . . . . . . . . . . . . 8.1Tobramycin . . . . . . . . . . . . . . 3.2Vancomycin . . . . . . . . . . . . . . 12.9All other drugs . . . . . . . . . . . . 22.8

—16.7—2.7

11.16.98.3

15.335.9

SOURCE: Adapted from C. Kozma and J. Glaze, “Impact of Home LV.Benefits on Beneficiary Utilization of Services,” interim paperprepared for Health Care Financing Administration, Baltimore,MD, Cooperative Agreement No. 17-C-9957/4-01, April 1990.

Home antibiotic therapy is reported to be effective inover 90 percent of cases (148,325).

The frequency with which a particular compoundor class of compounds finds use in HDIT is relatedto the severity of associated complications. Moreaggressive and potentially complicated drugs areused less often.

Cefazolin and ceftriaxone, two members of a classof antibiotics known as cephalosporins, account forabout half of all home IV antibiotics (table 2-5).Cephalosporins are relatively new antibiotics thatshare a number of characteristics that make themattractive for use in the home setting. In general, theyare comparatively safe and act on a fairly broadspectrum of disease-causing organisms. Addition-ally, they require little monitoring and fairly infre-quent administration. Ceftriaxone, for example, isusually administered only once or twice a day (11).Its infrequent administration makes it much moreconvenient for home use than penicillin, which hasa similar spectrum of action but must be given muchmore frequently to be effective.

Unfortunately, ceftriaxone may not be particu-larly effective against Staphylococcus aureus, a


common organism that is frequently encountered inthe kinds of infections seen in the home care setting(148,317). Other antibiotics, such as cefazolin andmethicillin, appear to be more effective and can beused in the home to treat infections from thisorganism, although they require a more frequentdosing schedule (317).9

Another consideration in choosing a particularantibiotic for use in the home is the stability of thecompound once the drug is mixed. Several antibiot-ics that are used extensively in hospitals, such asampicillin and trimethoprim-sulfamethoxizole, havea very short period of stability when prepared for anIV infusion. Thus, they are rarely used in the home,where drugs and supplies are often delivered nomore than once every week or two to minimize costs(3,317,364).

Complications

The incidence of complications arising fromhome IV antibiotic use is small. Although no drug isentirely safe, antibiotics, in general, are relativelysafe and without significant adverse side effectswhen compared with other classes of drugs. Specificcomplication rates documented in published studiesand in data provided to the Office of TechnologyAssessment (OTA) range from 6 to 20 percent(106,148,250,267). Almost none of the complica-tions encountered were unique to the home settingbut were inherent to IV therapy per se. A detailedrecord review performed by one HDIT providerfound an IV-related complication rate of 10 percent(250) (table 2-6).

One complication unique to the home setting is an“antabuse” type of reaction10 seen with certaincephalosporins. When a patient treated with thesedrugs also consumes alcoholic beverages, the com-bination can produce symptoms that include severeflushing, nausea and vomiting, chest pain, markeduneasiness, weakness, and confusion. Hospitalizedpatients do not usually consume alcohol and are notprone to developing this side effect. Patients athome, on the other hand, have free access to alcoholand thus have the potential for developing this druginteraction (106). The severity of the reaction is

Table 2-6-Complications of Infusion TherapyReported by One Home Infusion Provider

Complications presumed related to infusion therapy

Catheter infectionHIVa infection complication

(resulting in immunosuppression)Diarrhea/dehydrationRespiratory distressIncreased wound infection symptomsFever of unknown originCentral venous catheter replacementSepsisExacerbation of condition

(possibly drug related)Bacteremia

Proportion of all home infusion patients experiencingcomplication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10.1%

aHIV - human immunodefieieney virus.

SOURCE: H. O’Keiff, Barnes Home Health Ageney, Inc., St. Louis, MO,letter to the Office of Technology Assessment, Feb. 28, 1991.

roughly proportional to the amount of alcoholingested (11).

Antineoplastic TherapyThe goal of antineoplastic therapy is to selectively

inhibit or destroy the rapidly dividing cells of amalignant tumor, while leaving the patient’s normalcells intact. Different classes of antineoplastic drugsaccomplish this goal in a variety of ways, with nosingle therapy universally applicable to all forms ofcancer. Often, multiple antineoplastic agents arecombined in a regimen to take advantage of thedifferent modes of action while minimizing thevaried toxicities.

Several trials and pilot studies have demonstratedthe efficacy and safety of home IV antineoplastictherapy (116,201,263,294). In practice, a widevariety of agents are employed. One home infusionprovider, for example, supplied seven differentantineoplastics and related services to home patientsin 1989 (250).11

Antineoplastic agents are frequently accompa-nied by serious side effects (table 2-7). The drugsfind use despite these side effects because theunderlying condition being treated has such a grimprognosis. Nonetheless, antineoplastic therapy pre-sents a particular concern for safety in the home,

g There is not complete agreement on the relative effectiveness of these drugs; some physicians maintain that ceftriaxone maybe nearly as effectiveas eefazolin against this organism (340a).

10 ~s ~emtion is identi~ t. tit seen in pati~ts ~g the ~g ~~~~ (~~buse), a ~g u~d w m adjwct to &w@ dlKMlk alcoholism(129), and has, therefore, been termed the ‘%ntabuse reaction.”

11 me ~gs Wae fitom~one, v~bl~~e, metho~mte, flu~ro~acfl, doxorubic~ ~clophosp~de, ~d vincristine.


Table 2-7—Toxicity of Antineoplastic Drugs

Major acute toxicity Major delayed toxicity

Diarrhea/ Hypersensitivity BoneChills/ nausea/ Local irritant/ reactions and

Drugmarrow

fever vomiting local pain anaphylaxis Othera depression Othera

Asparaginase . . . . . . . . . . . . . . . . . . XBleomycin . . . . . . . . . . . . . . . . . . . . . . XCarmustine . . . . . . . . . . . . . . . . . . . . .Cisplatin. . . . . . . . . . . . . . . . . . . . . . . XCyolosphosphamide . . . . . . . . . . . . .Cytarabine, cytosine arabinoside . . . XDacarbazine . . . . . . . . . . . . . . . . . . .Dactinomycin . . . . . . . . . . . . . . . . . . .Daunorubicin . . . . . . . . . . . . . . . . . . .Doxorubicin , . . . . . . . . . . . . . . . . . . .Floxuridine (FUDR) . . . . . . . . . . . . . .Fluorouracil (5-FU) . . . . . . . . . . . . . .Mechlorethamine . . . . . . . . . . . . . . .Methotrexate . . . . . . . . . . . . . . . . . . .Mitomycin . . . . . . . . . . . . . . . . . . . . . .Plicamycin . . . . . . . . . . . . . . . . . . . . .Streptozocin/streptozotocin . . . . . . .Thioquanine . . . . . . . . . . . . . . . . . . .Thiotepa . . . . . . . . . . . . . . . . . . . . . . .Vinblastine . . . . . . . . . . . . . . . . . . . . .Vincristine . . . . . . . . . . . . . . . . . . . . . .

xxxxx

xxxxxxxxxxxxxx

x

xxxx

xx

x

x

xxx

xx

xx

xx x

xx x

xxxxxxxxxxxxxxx

xxxx

x

xxxxx

xxxx

xx

a~tother” amte toxi~ties in~~e r~ urine, elWtrm~iWram &anges, and orthostatic hypotension. “Other” delayed toxicities include such side eff~~ ashair loss, liver and kidney damage, oral ulcers, stomatitis, neurological defects, and thrombocytopenia.

SOURCE: Based on T.M. Speight (cd.), Avery’s Drug Treatment (Auckland, New Zealand: ADIS Press Ltd., 1987).

where both the ability to deal with the side effectsand the system to dispose of the toxic drugsthemselves are less available.

Many antineoplastic agents are vesicants and cancause severe irritation to the vein. When adminis-tered through a peripheral catheter, the incidence ofthrombophlebitis is much higher than for mostantibiotics and other nonvesicant drugs. To mini-mize the damage done to the vein, antineoplasticagents are frequently administered directly into alarge, central vein to dilute the drug and diminish itstoxicity. Table 2-8 lists some examples of IVantineoplastic agents and the requirements for ad-ministration.

Depending on the particular kind and location ofthe cancer, some antineoplastic drugs can be givendirectly into the artery that supplies it with blood. Bydelivering a more concentrated dose of a drug to thetumor, the potential for side effects can be mini-mized. Thus, intraarterially delivered antineoplas-tics produce fewer systemic side effects than theywould if given intravenously. The tradeoff, in thisinstance, is the potential problems associated withintraarterial drug administration.

The advent of continuous infusion therapy hasexpanded the number and kinds of antineoplasticagents that may be delivered in the home setting(201,297). To achieve effective concentrations whengiven intermittently, a drug may need to be given atsuch high dosage that it causes serious side effects.As a continuous infusion, however, the concentra-tion required for efficacy is often not as great andsome adverse consequences can be avoided. Thus,the toxic effects of certain antineoplastic agents canbe reduced by utilizing a longer exposure to a lowerdose without losing any of the clinical efficacy.

The appropriateness of home antineoplastic ther-apy for a particular patient depends heavily on theunderlying condition of that patient. Cancer patientsare often weakened or incapacitated by the devastat-ing effects of the disease and the therapies used totreat it. Unless these patients have sufficient in-homehelp in the form of a family member or othercaregiver, home IV antineoplastic therapy is oftennot possible. Patients who are unwilling to learn thetechniques, have an inadequate support system, orare physically unable to master the skills requiredthus represent poor risks for home IV therapy (35).Even if help and support are available, the tremen-dous demands frequently presented by cancer pa-


Table 2-8-Examples of Special Considerations in Administering Intravenous (IV) Antineoplastics

Drug Special considerations

Asparaginase . . . . . . . . . . Life-threatening anaphylaxis can occur. Skin testing and desensitization recommended before administration.During administration, a physician/life support equipment and epinephrine, antihistamine, andcorticosteroids should be available; monitor blood pressure.

Bleomycin sulfate. . . . . . . Increased incidence of anaphyiaxis in lymphoma patients; give test dose. Give acetaminophen andantihistamine 30 min. before chemotherapy to prevent fever and chills.

Carmustine . . . . . . . . . . . . Pain, burning at IV site and facial flushing may occur secondary to alcohol diluent; if this occurs decrease rate,increase volume in which drug is diluted.

Cisplatin . . . . . . . . . . . . . . Before and during treatment, hydration and raised urinary output are essential to prevent nephotoxicity. Shorterinfusion time may be associated with increased risk of kidney toxicity. Avoid the use of needles containingaluminum, as it reacts with Platinol to create a black precipitate and loss of potency. Anaphyiactic reactionsmay be controlled by epinephrine and corticosteroids.

Cyciophosphamide . . . . . To prevent hemorrhagic cystitis, patient should drink 3 to 4 liters of fluid per day and void frequently. Dizziness,rhinorrhea, sneezing and diaphoresis have been reported with doses of greater than 500 mg when givenquickly.

Etoposide . . . . . . . . . . . . . Hypotension and wheezing may occur if given too rapidly (in less than 30 min.). Stop infusion if wheezingoccurs; antihistamines may be helpfull.

SOURCE: Based on C.B. Hughes, “Giving Cancer Drugs IV: Some Guidelines,” American Journal of Nursing 86:34-38, 1986.

tients can easily overwhelm the support system,requiring inpatient hospitalization.

AnalgesicsPain is a dominant feature of many disease

conditions. Up to 70 percent of cancer patients suffersevere pain (401). Pain can usually be managedeffectively with oral medication, but certain circum-stances preclude this form of therapy. Patients withoral, esophageal, or other cancers which preventnormal swallowing, patients with breakthrough paindespite high doses of oral narcotics, and patientswho suffer side effects related to the high doses oforal narcotics often required to control pain arecandidates for parenteral analgesics (185).

Parenteral narcotic analgesics include meperid-ine, morphine, and hydromorphone. Their use inparenteral pain management varies widely; in onesurvey, the average duration of pain managementtherapy for different drugs ranged from 2 to 240 days(193). This variation probably reflects the relativelyfew patients on this therapy represented in thesurvey and the heterogeneous conditions for whichpain control is used. IV narcotic pain relief has evenbeen reported in a 2-year-old child being treated athome for advanced cancer of the brain (286).

While IV narcotic administration for pain controlhas been available for many years, the concept ofhome administration is fairly new. Two recentdevelopments have been particularly important toenabling home parenteral pain control in manypatients. First has been the development of infusion

pumps with a patient-controlled analgesia feature.This feature allows patients to optimize pain reliefbut minimize drug side effects, by combining aconstant preprogrammed baseline level of relief withthe option to self-administer larger boluses ofmedicine when pain is particularly severe (265).Second, subcutaneous administration of narcoticshas become a more accepted alternative that avoidssome of the potential complications of IV therapy. Infact, subcutaneous pain management is consideredby some to be superior to IV administration becauseof its equivalent effectiveness in many patients andits technical advantages (227).

Additionally, intrathecal and epidural adminis-tration of narcotics have been used for several yearsand are being increasingly considered as options forthe home. A number of reports of parenteral painmanagement through one of these routes have beenpublished (316,326,327), and HDIT providers reporthaving provided them (250). However, intraspinaladministration of narcotics is associated with com-plications including urinary retention, nausea andvomiting, and respiratory depression (202). Narcotic-induced respiratory depression, which is especiallydangerous, can be detected by using an apneamonitor and can be counteracted by infusing anantagonistic agent (e.g., for morphine, Narcan is theantagonist) (202). Because respiratory complica-tions may not present for up to 22 hours afterepidural narcotics administration (309), these pa-tients require extended monitoring and therefore canpose additional challenges for home care.

Chapter 2—The Safety and effectiveness of Home Drug Infusion Therapy .39

One concern unique to home parenteral narcoticsadministration is the potential for abuse of the drugson the part of patients or family caregivers.12

Providers of this therapy report such measures ashospitalizing patients with a history of IV drugabuse, rather than treating them at home, to mini-mize the opportunity for abuse; and discontinuinghome therapy when it became apparent that a familymember was diverting drugs intended for the patient(364). Special measures, such as using infusionpumps that enable the drug cassette to be locked andreplaced only by a visiting nurse, may be requiredfor home parenteral narcotic administration to be asafe option.

Other Therapies13

Dobutamine

Patients with congestive heart failure (CHF)suffer from an inability of the heart to pump asufficient amount of blood to the vital organs.Dobutamine, which acts by increasing the force ofcontraction of the heart, has been used convention-ally as a temporary measure in patients withunderlying CHF whose heart needs assistance todeal with additional stress (e.g., an acute viralinfection) (198). Dobutamine can only be adminis-tered intravenously, and until recently it was onlyadministered in the hospital. In 1977, however,researchers discovered that 72-hour intermittentinfusions of dobutamine improved cardiac functionfor prolonged periods (196). Subsequent studiesconfirmed these findings and furthered the idea thatperiodic outpatient admini stration of IV dobutaminemay add to the treatment options for patients withCHF (205,348,349).

While the hemodynamic benefits of outpatientdobutamine are encouraging, the unexpected findingof increased mortality in these patients is not. Onecontrolled study of the treatment found that despitesignificant improvement in symptoms during thestudy, 15 of 37 dobutamine patients (40 percent)died, while only 5 of 23 placebo-treated patients (22percent) did so (94). The increased mortality wassubsequently attributed to cardiac arrhythmias (irreg-ular heartbeats). A recent study of an oral drug

related to dobutamine likewise found that, despitethe drug’s predicted benefits, long-term therapyactually increased morbidity and mortality in pa-tients with severe CHF (251).

Some researchers believe that many of the pa-tients at risk of death during dobutamine treatmentcould be identified by means of pretreatment cardiacmonitoring (322). The poor record of this and relateddrugs in existing studies, however, suggests thatthey do not merit long-term use in the home unlesseffectiveness in specific patient groups can bedemonstrated.

One final argument favoring the use of IVdobutamine is that it may enable a patient with CHFwho is a heart transplant candidate to survive untila suitable organ becomes available. Dobutamine isprescribed by some physicians for this purpose(73,365). Given the current evidence describedabove, this strategy may not really enhance a givenindividual’s chance of receiving a transplant. Evenif it does, it cannot increase the total number ofpeople who ultimately can receive a new heart,because the number of heart transplants is limited bythe supply of donor organs. The number of personson the waiting list for heart transplants exceeds thenumber of transplants by about 30 percent (385a).

Immune Globulin

Human immune globulin was first used to treatpatients whose bodies were naturally deficient inthis substance in 1952 (52). Early administrationconsisted of periodic intramuscular injections (54).Intravenous preparations became available in theUnited States in 1981, and they are generallypreferred for long-term therapy because they are lesspainful to receive and enable much larger doses to begiven (54).

The clearest and most accepted indications forimmune globulin therapy are for treating patientswith severely impaired antibody-producing capacity(54). These patients may have any of a number ofrare primary immunodeficiency diseases, such assevere combined immunodeficiency. Many of theseconditions are chronic, and some individuals with

12 6CF~y ~m~vem!! me d~m~ ~ this ~pfi ~ cme@rms who are close friends or relatives of the patient and who gene~ly receive no f~cialcompensation for their services.

13 ~ addition t. tie therwies de~fibed here, the list of ~gs some~es infused at home includes tocolytic drugs to prevent preterm labor (e.g.,terbutaline and ritodrine); anticoagulant drugs (e.g., heparin); certain autiulcer drugs; and chelating drugs to rid the body of toxic levels of metals (e.g.,deferoxarnin e).


them conditions require IV immune globulin ther-apy for life.

IV immune globulin is also sometimes used tobolster the immune systems of persons whoseimmunodeficiencies are secondary to another condi-tion (e.g., those who have received immunosuppres-sive drugs in connection with their cancer treatment)(54,235). Recently, immune globulin has beenshown to be effective in reducing the incidence ofinfections in children with AIDS (234) and inpatients with chronic lymphocytic leukemia (77).The therapy is also gaining acceptance in treatingother disorders that involve the immune system insome way, such as immune thrombocytopenicpurpura, Kawasaki syndrome, and steroid-depend-ent asthma (323). Some have suggested that it maybe successful in treating intractable seizure disor-ders, but it has not been tested for this use in acontrolled study (235).

As IV immune globulin therapy has become usedto treat a wide variety of diseases, questions havebeen raised about its cost. The charge for a singleinfusion of immune globulin has been reportedanecdotally to be $125 to $250, making the annualcharge for therapy for a typical adult requiringregular infusions over $25,000 for the drug alone(54). In some hospitals, immune globulin hasbecome one of the top four drug expenditures (323).Some researchers have calculated the cost of pro-phylactic IV immune globulin for chronic lympho-cytic leukemia to be $6 million for every quality-adjusted year of life gained (394).

The high cost of IV immune globulin therapy inthe hospital, the fact that many patients are ontherapy indefinitely, and the fact that many of thesepatients are children make home therapy attractive.A number of studies have shown that IV immuneglobulin therapy can indeed be provided safely in thehome, with an effectiveness comparable to hospitaltherapy (17,190,191,247). Home use, however, willnot reduce the costs of the drug itself.

Immune globulin therapy is not entirely free fromthe possibility of adverse events associated with theinfusion of this substance. Mild reactions includenausea, fatigue, and headache; more serious reac-tions include severe chest pain, abnormal heartbeat,and mental confusion (122,235). These reactions can

occur during or within minutes of treatment and mayrequire immediate countermeasures (122). One re-cent study found that, of three methods of adminis-tering home immune globulin (intramuscular injec-tion, IV infusion, or rapid subcutaneous infusion),rapid subcutaneous infusion resulted in the fewestadverse events while retaining its effectiveness(122). The results of this study, which was carriedout in Sweden, suggest that more examination ofsubcutaneous administration in U.S. patients onlong-term immune globulin therapy is warranted.

Blood Transfusions

The prototypical home transfusion patient is onewho is anemic because of a chronic, debilitatingcondition, such as cancer or AIDS, and for whomtransportation to a hospital or outpatient clinicwould cause great difficulty (3,7,223,261). Anemia,by definition, is a reduction in the volume of redblood cells, and anemic patients usually haveinsufficient oxygen-carrying capacity in the blood(262). In addition to cancer- and AIDS-relatedanemias, certain other anemias (e.g., sickle-cellanemia) also may require transfusions of red bloodcells14 and might occasionally be treated in thehome.

Individuals with thrombocytopenia (platelet defi-ciency), which impairs blood clotting at the sitewhere a blood vessel is injured, may be candidatesfor home platelet transfusions. Thrombocytopeniacan be caused by many different mechanisms, suchas a bacterial infection or secondary to certain typesof liver disease and bone marrow disorders (184).

Transfusion therapy poses certain risks unique tothis form of infusion. It requires strict patientselection criteria and rigid transfusion proceduresdue to the potential severity of the body’s reaction toforeign blood components.

The most serious reactions result from an incom-patibility between antigens of the transfused bloodcomponent and the patient’s antibodies. The conse-quence of this incompatibility is hemolysis, the vastdestruction of red blood cells (7,184). Hemolysis canbe fatal. Clinical symptoms include fever, chills,back pain, and possible shock. Proper followup andgood patient records are imperative to ensure thatdonor and recipient blood are appropriately

14 r-r~m~ blind &-iom “My ~wayS involve tisio~ of o~y c- ex~ct~ blood components. patients in ned Of whole bloodtransfusions usually are those in need of urgent and intensive care (e.g., trauma patients) who are therefore unsuitable for home therapy.

Chapter 2—The Safety and effectiveness of Home Drug Infusion Therapy ● 41

matched; all home acute hemolytic reactions are dueto clerical errors.

Febrile, non-hemolytic reactions are usually dueto antibodies that cause clumping of the white bloodcells that poison or destroy cells. Such a reactionusually occurs within the frost 1 or 2 hours of thetransfusion. Characterized by chills and fever, non-hemolytic reactions usually can be treated success-fully with aspirin or acetaminophen. However, anon-hemolytic reaction may signal a hemolyticreaction; symptoms must be considered potentiallylife-threatening until a hemolytic reaction can beruled out (7,184).

Emerging TherapiesThe broad acceptance of home drug infusion

makes it likely that new and future drugs that mustbe given parenterally may find application in thehome. Following are some examples of drugs thathave recently begun to be used in this setting, orwhich might be provided in this setting in the future.

Granulocyte colony stimulating factor(G-CSF)—A bioengineered version of a natural sub-stance that regulates the growth and develop-ment of certain white blood cells, G-CSF hasrecently been approved by the FDA for use incancer patients with low white blood cellscounts and fever (15 1). Because it is a proteinand subject to degradation by digestive en-zymes, G-CSF must be administered paren-terally (either IV or subcutaneously). It isadministered as a daily injection for up to 2weeks in conjunction with the patient’s antine-oplastic therapy cycle (14a). Because manypatients are now receiving their antineoplastictherapy at home, G-CSF is also sometimesadministered concomitantly at home (176).

Granulocyte microphage-colony stimulatingfactor (GM-CSF)-Closely related to G-CSF,GM-CSF plays a similar biological role inacting to raise the white blood cell count. It alsohas been recently approved by the FDA for usein patients with Hodgkin’s disease, rlOrl-Hodgkin>s lymphoma, and acute lymphoblasticleukemia who undergo bone marrow transplant(151). GM-CSF must be administered parented-ally and may be used in the home by post-transplant patients. In addition, it has possibleuses in cancer and AIDS patients who are at riskof infections (302).

Post-transplant immunosuppressive drugs—Transplant recipients must usually take drugsthat suppress their immune systems, preventingthe body from rejecting the grafted organ. Mostdrugs currently used for long-term post-transplant immunosuppression are oral drugssuch as cyclosporine. One FDA-approved drug,however-Orthoclone OKT-3—is an IV drug.Although its prophylactic use thus far has takenplace while the patient is still hospitalized afterthe transplant (91), this and any future paren-teral immunosuppressives might move home aspart of strategies to reduce the hospital stays oftransplant patients.

Interleukin-2-Still under development, inter-leukin-2 holds promise as a future treatment forkidney cancer (282). The drug is not yetapproved by the FDA for use in the UnitedStates, but its mode of administration (subcuta-neous or IV) and the long-term nature of thedisease it treats make it a likely candidate forhome therapy if it should receive marketingapproval.

297-913 0 - 92 - 4

Chapter 3

HOME DRUG INFUSION THERAPYEQUIPMENT AND SERVICES

ContentsPage

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45Summary of Conclusions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45

Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46Vascular Access Devices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46Infusion Devices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49

Techniques and Supplies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51Services and Staffing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55

Patient Screening and Assessment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58Ongoing HDIT Services . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61

BoxesBox Page3-A. Aseptic Technique . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 533-B. Controversy Over Catheter Flushing Methods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 553-C. Staffing and Organization of Home Drug Infusion Therapy Services:

Two Contrasting Models . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 573-D. Patient Screening Criteria for One Home Intravenous (IV) Antibiotic

Therapy Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 583-E. Screening Criteria for Home Transfusion Therapy Patients . . . . . . . . . . . . . . . . . . . . . . 613-F. The Peripherally Inserted Central Catheter (PICC Line):

New Technology and Nursing Practice . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 653-G. Home Blood Transfusion Services: Special Considerations . . . . . . . . . . . . . . . . . . . . . . 66

TablesTable Page3-1. Typical Supplies in a Delivery by One Company for Four Types of Home

Infi.mien Therapy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 523-2. Recommended Routine Frequency of Selected Catheter Maintenance Procedures

Performed for Home Infusion Therapy Patients, by Type of Vascular AccessDevice . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56

3-3. Average Number of Nursing Visits Per Week for Home Infusion Therapy Patients,by Selected Types of Vascular Access Device, Type of Therapy, and FunctionalStatus of Patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60

Chapter 3

HOME DRUG INFUSION THERAPY EQUIPMENT AND SERVICES


The home infusion therapy industry today is theproduct of technological and medical advancementsachieved primarily during the past two decades, andit is still evolving in response to continuing changesin both these areas. Twenty years ago, home druginfusion therapy (HDIT) without round-the-clocknursing services would have been unthinkable.Today, programmable infusion devices with built-insafety mechanisms and safer, more comfortablevascular access devices that can remain in place forlonger periods of time have enabled even bedriddenpatients on complex therapeutic regimens to gohome.

Skills as well as equipment have advanced, andmany nurses and pharmacists now specialize in theparticular professional skills needed in HDIT (e.g.,placement of a peripherally inserted central catheter,drug regimen review). But not all HDIT techniquesdemand such a high level of skill. Some (e.g., simplewound care, drug administration) can be performedby trained family caregiversl or by patients them-selves. This chapter describes the variety of equip-ment and supplies used, the broad range of tech-niques and services involved, and the skilled andnonskilled caregivers who provide HDIT in the1990s.

●

Summary of ConclusionsThe services and supplies needed for HDITvary significantly depending on the route ofadministration, type of vascular access de-vice, type of therapy, and rate of administra-tion. For example, patients with peripheralvenous access require more ongoing skillednursing visits than patients with central venousaccess. Patients with central access, however,may need more intense training, more earlysupervisory visits, and more phone supportuntil they become comfortable caring for theircatheter and administering their medication.Patients who self-administer antibiotics threetimes a day may require 20 times as many

●

●

intravenous (IV) administration supplies aspatients on continuous-infusion antineoplastictherapy or pain management.

Although infusion devices have become in-creasingly sophisticated during the last dec-ade, less expensive gravity drip systems arestill safe and appropriate for many thera-pies. Most antibiotic therapy and hydrationtherapy can be delivered via gravity drip orspecial disposable infusion devices, providedpatients (or their caregivers) are capable ofoperating these devices. In-home gravity dripsystems often include special devices thatenhance safety and ease of operation by pa-tients. Factors that may necessitate the use ofprogrammable infusion pumps include: cogni-tive or functional limitations of patients/caregivers; extremely high or low dose volume;therapies of long or otherwise inconvenientduration; therapies requiring frequent adminis-tration; intraarterial infusions; and need forcarefully controlled rate of administration.

While some of the specific techniques used inHDIT require the skills of specially trainedregistered nurses (RNs), many tasks can beperformed by the patient or by a family memberwho has been taught the proper techniques bya qualified health professional. However, be-cause Medicare beneficiaries are likely to besicker than other patients and they and theirspouses are more likely to have functionallimitations than younger patients, they aremore likely to need paid assistive services inorder to receive infusion therapy at home. Ifthe frequency and intensity of professionalservices required by a home infusion patient aregreat (e.g., a functionally disabled patient on a4-dose per day antibiotic regimen who has noinformal caregiver available), a skilled nursingfacility (SNF) or other nonhospital institutionalsetting that offers 24-hour supervision might bea more reasonable alternative to hospitalizationthan traditional home care.

● Within the nursing and pharmacy professions,home infusion specialization is based primarily

1 k MS reW~ the tem “f@y ~e@er” refers to a mend or family member who assists an HDIT patient in self-care talcs on a nonptid bmk.

-45-

46. Home Drug infusion Therapy Under Medicare

on experience and has not yet achieved separaterecognition by professional organizations. In-creasing availability of formal training ininfusion therapy techniques, however, is ex-panding the pool of qualified personnel. Al-though HDIT providers may occasionally havedifficulty recruiting qualified staff, availableevidence does not suggest a critical shortage ofqualified personnel.

The continual emergence of new HDIT tech-nologies constantly broadens the types ofpatients who can be treated at home andchanges the parameters of service delivery.Each new device involves the use of newtechniques that must be learned by nurses,pharmacists, and patients and caregivers. Somerecently developed technologies have reducedthe amount of skilled nursing interventionrequired for patients at home and made it easierfor patients to self-administer complex drugregimens.

EquipmentThe two fundamental items of equipment used in

HDIT are the vascular access device2 (the paththrough which a drug enters the bloodstream) andthe infusion device (the means of controlling the rateof an infusion). Advances in vascular access andinfusion technology during the past two decades arewhat have made HDIT possible, and the range ofpatients who can receive therapy at home continuesto expand as new technologies emerge.

Vascular Access DevicesTwenty years ago, the most common mode of

parenteral administration was a steel needle insertedinto a vein in the hand or arm (peripheral vein).Today, an increasingly broad array of vascularaccess devices is available, ranging from peripheralcatheters (thin tubes inserted into a hand or forearmvein) to totally implantable catheters that access thecentralmost vein of the body. The type of vascularaccess device used in HDIT has implications forboth the amount of skilled nursing interventionrequired and the nature and extent of certaintherapy-related risks for infusion patients.

The choice of a vascular access device depends onthe drug(s) to be infused, the route of administration,the duration of therapy, and the physical condition ofthe patient. Data from a recent survey of specialtyHDIT providers show that peripheral catheters areused most frequently for antibiotic therapy, whilecentral catheters are more common for antineoplas-tic therapy, pain management, and patients onmultiple therapies (256). Most vascular accessdevices can be used for more than one route ofadministration. For example, tunneled catheters andsubcutaneous ports (see below) can be used forintravenous, intraarterial, epidural, intrathecal, orintraperitoneal administration; and peripheral cathe-ters can be used for intravenous or intraarterialtherapy.

Peripheral Catheters

Many drugs (e.g., most antibiotics) can be infusedinto a vein in the arm by way of a small catheterinserted into the blood vessel. Peripheral cathetersare particularly appropriate in patients who requirerelatively short-term therapy (e.g., 1 to 3 weeks) andwhose veins are healthy and can withstand repeatedpunctures (145). Maintenance of peripheral routes ofadministration requires frequent skilled nursingintervention. Although able-bodied patients canoften manage the dressing changes (periodic re-placement of bandages covering the catheter exitsite) with the assistance of family caregivers,3

catheter insertion requires professional skills.

Peripheral catheters must be changed frequentlyto prevent swelling and irritation at the entry site thatcan lead to infection. When this is done, the oldcatheter is discarded and a new one inserted, usuallyat a different site in the vein. Catheter change mustbe performed by a nurse or physician skilled inperipheral catheter insertion technique (174). Al-though the Intravenous Nurses Society (INS) stand-ards of practice recommend that peripheral venoussites be changed every 48 hours (174), recent studiessuggest that, barring other complications, peripheralvenous catheters can often remain in place for up to72 hours (206). The 72-hour rotation schedule hasbeen widely adopted by HDIT providers (364). Forperipheral arterial catheters, the INS recommends

z my observerswo~d categorize vascular access devices as “supplies,” since they are generally intended for one-time use, but they are consideredequipment hem to distinguish them from the routine disposable HDIT supplies discussed later.

3 Assistance maybe required for dressing changes on peripheral catheters because the exit site is typically on the lower arm, precluding the use ofone of the patient’s hands.

Chapter 3-Home Drug Infusion Therapy Equipment and Services .47

less frequent site rotation (every 96 hours) due to themore limited number of arterial access sites (174).

Certain factors may necessitate more frequent siterotation for peripheral catheters. For example, apatient receiving a particularly irritating drug mayexperience painful swelling at the catheter site afteronly a small number of doses (390). Some elderlypatients with poor venous access may experiencemore rapid site deterioration than younger, healthierpatients (364).

Most peripheral catheters today are made of rigidTeflonTM rather than steel. The rigidity of thematerial sometimes contributes to mechanical phle-bitis, an inflammation caused by irritation of thesurrounding tissues (154). Some newer peripheralcatheters are made of a polymer that expands to therequired diameter after it is in the vein, makinginsertion less painful (141). The reported increasedcomfort and lower risk of complications associatedwith these catheters may reduce the frequency withwhich they must be replaced (84,154,330).

This new technology highlights the difficulty ofadjusting protocols quickly to reflect new productsand techniques. Some home infusion companies arehesitant to use the new catheters; others use them butreplace them at the recommended intervals forTeflonTM catheters; and at least one large homeinfusion company reportedly has protocols thatallow the new catheters to be left in place for up to14 days if there are no complications (84,141 ).4

For HDIT patients, it is generally the nurse whois responsible for deciding when peripheral cathetersshould be changed. The decision to leave a catheterin place for a longer or shorter period than therecommended standard is based on an assessmentthat includes consideration of the condition of thecurrent catheter site, availability of new sites,condition of the patient’s skin, type of drug, andexpected duration of therapy (141).

Central Catheters

Drugs that are potentially toxic or irritating to avein must be introduced into a large volume ofblood, to dilute the drug and reduce the likelihood ofblood vessel damage. These drugs are delivered by

way of a catheter whose tip rests in a large centralvein such as the subclavian vein or the superior venacava (which feeds directly into the heart). Centralcatheters require especially meticulous care by thepatient or caregiver to prevent infection at the opensite where the catheter enters the body, but theyusually require less frequent skilled nursing inter-vention than peripheral catheters. Routine site changesare not necessary with central catheters, and patientscan use both hands for catheter care procedures.Another advantage of central over peripheral cathe-ters is that patients are spared the discomfort ofrepeated venipuncture, because central catheters canremain in place much longer (145). The implantationof a traditional central catheter is a minor hospitalsurgical procedure that must be performed by aphysician (161). Placement of the tip of the cathetermust be confirmed by x-ray.

Central catheters may be appropriate not only fordrugs requiring greater dilution, but for long-terminfusions of other drugs, for patients needing infu-sions of multiple drugs,5 for patients likely to needrepeated episodes of infusion, and for patients withperipheral veins unsuitable for repeated puncture(140,145).

The two traditional types of central catheters are:

●

●

Nontunneledcatheters (e.g., Hohn, subclavian),which are inserted through an opening in theneck or shoulder directly into the vasculature(blood system). The tip of the catheter rests ina large vein near the heart-either the sub-clavian vein or the superior vena cava.Tunneled catheters (e.g., Corcath, Hickman,Broviac), which are inserted into the chest walland are tunneled through the skin severalinches before entering the vasculature.

Tunneled catheters are used commonly in homepatients because they are associated with a lowerrisk of infection and are easier to care for (260).

A relatively recent addition to the menu ofcatheter choices is the peripherally inserted centralcatheter (PICC line), which is being used increas-ingly in the home setting (50). The PICC line is analternative to both surgically placed central cathetersand traditional peripheral venous access. In this

4 The use of these new catheters has not yet been reflected in recognized standards of practice, which still state that peripheral lines should be changedevery 48 hours (174).

5 Centrrd catheters come in single- or multiple-lumen styles. Each lumen is a separate path tiough which a drug can be administered. Multiple-lumencatheters facilitate multiple infusions and, in some cases, allow for continuous venous pressure monitoring during and between therapy (264).


case, a long catheter is inserted into a small vein,usually in the forearm, and threaded up the veintoward the heart (50). The catheter is anchored witha suture or special tape at the exit site in the arm; likethe exit site of a surgically placed central catheter,this site requires meticulous care to prevent infection(140,145). Unlike other modes of central venousaccess, placement of the PICC line does not neces-sarily have to be performed by a physician; in mostStates, specially trained nurses can insert it. Becausethe specific point of placement of a PICC line iscrucial, proper placement should be confirmed byx-ray (50,174).

PICC lines are sometimes favored over traditionalperipheral catheters because they allow for greaterdilution of the drug and do not have to be changedas often. Complications of PICC line insertion caninclude tendon or nerve damage, bleeding, cardiacarrhythmias, chest pain, respiratory distress, catheterembolism, and malposition of the catheter (50).However, many consider these complications to befewer and less severe than those associated withtraditional central catheter implantation and use(50). Furthermore, the risk of an air embolism (seech. 2) is decreased because the line is maintainedbelow the heart.

The quality and safety of PICC line use in thehome setting depends on the skill of the healthprofessional who inserts and maintains the devicePICC. Safety also depends on the ability of thehealth professional, patient, and/or caregiver toproperly care for the PICC line and recognize relatedcomplications.

For some medications, the peripherally insertedcatheter need only be threaded up to the large veinin the upper arm to achieve adequate dilution. Whenthis method of placement is used, the catheter isreferred to as “midline’ and radioscopic confirmat-ion of placement is not usually necessary (50). Aswith the PICC line, midline insertion can beperformed either by a physician or (in most States)a nurse specialist at the patient’s bedside (174).Although midline catheters allow for greater dilu-tion of the drug than traditional peripheral cathetersand are frequently left in place for considerablylonger periods of time (141), they are still consideredperipheral lines by the INS for purposes of mainte-nance and replacement (i.e., INS recommends re-placement every 48 to 72 hours) (174).

PICC lines and midline catheters are made of oneof three materials: polyurethane, which is rigid butsoftens once in the vein; silicone elastomer, which isvery soft and must be inserted through a needle oranother TeflonTM catheter; and elastomeric hydro-gel, which is rigid but both softens and expands oncein the vein (140).

Totally Implantable Catheters

Because they exit through an opening in the skin,all of the above types of central catheters areaccompanied by the risk of infusion-related phlebitisand infection. To reduce these risks, totally im-plantable catheters were developed for patients onlong-term infusion therapy (396).

Totally implantable catheters, also known assubcutaneous ports, consist of a small reservoir thatis surgically implanted under the skin and tunneledto a catheter. The catheter itself may lead to a centralvein, a large artery, or into the intrathecal or epiduralspace (174). The side of the port facing the skinconsists of a self-sealing septum. The port isaccessed by a special needle designed for thispurpose which is inserted through the patient’s skininto the septum. If desired, the needle can remain inplace up to 7 days at a time, at which point it ischanged by the patient or a nurse to minimize therisk of contamination (174). The drug is infusedthrough the needle into the port and thence into thecatheter (80,145).

Like other central catheters, subcutaneous portsare appropriate for patients on long-term therapiesand those for whom peripheral infusion is unsuitable(145). One disadvantage is that the patient’s skinmust be punctured at least once a week. Also,although the need for surgical replacement due tocatheter site infection is reduced, the port itself mustbe replaced approximately every 2,000 punctures(about once every 5 years if punctured once a day)(145).

Access Devices for Other Modes of Drug Delivery

For patients with relatively short-term needs forinfusion, or who for some reason are unsuitable foralternative modes of access, some drugs may beinfused by way of a needle that is simply insertedunder the skin. Subcutaneous infusion is limited todrugs that require administration of a relatively lowvolume of fluid over any given period of time (seech. 2). Narcotics to manage pain in patients withadvanced cancer, for example, can be administered

Chapter 3-Home Drug Infusion Therapy Equipment and Services ● 49

by continuous subcutaneous infusion. When infu-sion is continuous, needles should be changed every48 hours (174).

Narcotics to manage pain may also be delivereddirectly into the epidural or intrathecal spacessurrounding the spinal cord. In either case, a catheteris inserted between the vertebrae and threadedseveral inches up along the spinal cord in a minorsurgical procedure (326). The procedure is per-formed by a physician and may be done in thehospital or in an ambulatory surgical setting. As withcentral venous catheters, epidural and intrathecalcatheters may be connected to a subcutaneous portor tunneled under the skin to an exit on the side of thebody. Patients with intrathecal catheters intended forlong-term use may have the catheter connected to aimplanted infusion pump, requiring no externalapparatus at home at all and greatly reducing the riskof infection (326).

For a given HDIT provider, the proportion ofpatients with a particular type of vascular accessdevice is a function of both patient needs andcharacteristics and the provider’s preference for andexpertise in the use of certain devices. For example,providers who serve pimarily terminal cancer andparenteral nutrition patients may use surgicallyimplanted central catheters almost exclusively, whileproviders of shorter-term antibiotic therapies mayuse peripheral catheters more frequently (364).PICC lines have become the device of choice forsome providers, while others do not use thembecause their staff are not trained in PICC lineinsertion and maintenance (364).

Infusion Devices

Any drug infusion requires some kind of devicethat controls the rate at which the drug enters thebody. Infusion devices used in home therapy todayrange from simple gravity drip systems to highlysophisticated programmable electronic pumps. Thechoice of an infusion device depends on boththerapy and patient characteristics. Some IV thera-pies can be delivered safely and effectively throughgravity drip systems, while others require theincreased control, positive pressure, and greater flowrate range offered by electronic pumps.

Gravity Drip Systems

The simplest infusion device is the “gravitydrip”: the bag or bottle is hung on a hook or poleabove the level of the patient, and fluid flows bygravity down the line and into the catheter. The rateof flow in a simple gravity drip system is controlledprimarily by a special clamp or valve on the line thatcan be manually adjusted to permit the prescribedamount of fluid to flow through (usually describedin drops per minute). These devices range incomplexity and ease of operation from roller andslide clamps to more sophisticated rotating valves.Compared with slide and roller clamps, rotatingvalves are less awkward to manipulate and providea more consistent flow rate (264). Even the mostsophisticated manual drip valve, however, cannotoffer precise flow control, because the viscosity ofthe solution being infused (the infusate) affects thevolume of each drop and hence the rate of flow(264). The size of the needle at the end of the line,through which the fluid flows into the catheter,offers a second flow control; the smaller the needle,the slower the maximum rate of flow into the body.

Controllers can provide an added measure ofsecurity against uneven or ‘‘runaway’ flow ofinfusate in a gravity drip system (264). Theseelectronic devices use a drop sensor to monitor flowrate and can detect infiltrations and malpositioningof the catheter or IV tubing by measuring backflow.An alarm sounds when flow rate is altered or whenbackflow is detected (264).

The gravity drip is conceptually simple, cheap,and requires less equipment than most other infusionsystems. In the home setting, however, it has somelimitations. First, it is difficult to maintain a constantinfusion rate in a gravity drip system due to factorssuch as the decreasing volume of fluid in the bag(i.e., the infusion rate will decrease as the bagempties) and changes in the shape of the tubingaround the clamp (264). Consequently, a gravitysystem may provide insufficient flow control fordrugs that require a very slow, very precise, or verylong infusion time, such as antineoplastic (103).Second, errors in using the gravity drip that remainunnoticed can result in serious complications. Forexample, if the clamp malfunctions or the flow rateis improperly set, a drug may flow virtually unre-stricted into the body, giving rise to severe adversedrug reactions and other complications.

50 ● Home Drug Infusion Therapy Under Medicare

In addition, a gravity drip system may be aninappropriate choice for certain patients due tofunctional limitations of the patients or their care-givers. Because the IV bag is suspended well abovethe catheter site in this system, patients withdecreased mobility may have difficulty changing thebag. Ambulatory patients on continuous infusionmay also find gravity drip frustrating because thesystem is not easily portable.

Despite the drawbacks of this traditional methodof IV administration, it does maintain some impor-tant fuctional advantages over more the expensiveelectronic infusion devices discussed below. Be-cause the drugs are forced into the vein under thepressure of gravity alone, there maybe less irritationat the catheter site, especially peripheral cathetersites (390). Gravity drip systems may also bepreferred for patients who are confused by andresistant to learning how to use more complex,computerized drug delivery systems.

Infusion Pumps

The availability of an electronically controlleddevice that could deliver constant and preciseamounts of fluid over time was a major technologi-cal advance in infusion therapy. Although manytherapies can be delivered safely and effectively viagravity drip systems, others require the highlyprecise and constant flow rate offered by electronicinfusion devices (103). For example, intraarterialinfusions usually require positive pressure pumpsbecause the back pressure is higher in arteries thanin veins (397).

Most infusion pumps work by peristaltic action—i.e., by alternately squeezing and releasing the tubecontaining the fluid to force the fluid through at apredetermined rate. A second type of pump uses asyringe-type pushing action to force the drug downthe tubing. Most infusion pumps used in HDIT aremodern, sophisticated versions of one of these twotypes of pumps (103).

With the advent of home infusion therapies in the1980s has come the development of small, portablepumps with specialized uses for particular types oftherapies and adaptations for use by nonprofession-als. Because computerized pumps can deliver medi-cation at a wide range of dose frequencies andintensities, they broaden the scope of therapies thatcan be safely and effectively administered at home.Pumps specifically for the infusion of narcotics to

treat cancer-related pain, for example, may haveadaptations that provide a low level of ongoinginfusion but also permit patients to dose themselveswith bursts of medication when pain becomesintense, up to a preprogrammed number of suchextra doses per day (215). Other pumps, designed forthe volume of fluid typical of most antibiotictherapy, can be preprogrammed to deliver infusionsat standard intervals (e.g., 4 times per day), thusenabling patients to sleep undisturbed while receiv-ing therapy (215). Pumps used for long-term IVnutrition administration, on the other hand, may bedesigned to administer the large volume of fluidrequired for the overnight infusions typical ofpatients receiving this therapy (103,283). One syringe-type pump permits the simultaneous administrationof several different therapies at different intervals,with dosages and administration regimens prepro-grammed on a microchip which fits in the back of thepump (86).

Pumps currently available for home use range incomplexity and sophistication from very simple,single-medication stationary infusion pumps to fullyprogrammable, ambulatory pumps that can delivermultiple medications and are equipped with avariety of alarms, bells, and other ‘failsafe’ mecha-nisms (103). While stationary pumps may be appro-priate for patients who are bedridden or whosemedications are delivered over shorter periods oftime, ambulatory pumps provide greater independ-ence for patients on continuous, frequent, or long-term therapy regimens. For example, ambulatorypumps enable patients to receive antineoplastictherapy continuously while engaging in normaldaily tasks. Many pumps also have automatic“piggyback” mechanisms that control secondaryinfusions at an independent rate, decreasing thenursing time required for multiple infusions (103).

Infusion pumps do have certain disadvantages. Ifpatients, caregivers, or even health professionalsfind the level of sophistication of these pumpsconfusing, the patients’ safety could be jeopardizedthrough misuse of equipment (103). Many patients,and the nurses who instruct and care for them, mightprefer simpler models that are easier to operate. Evenmany hospital nurses are unfamiliar with or unawareof sophisticated features of pumps they use on aregular basis (103). Highly sophisticated pumps costmore and often require considerably more trainingfor both the health professional and the patient thansimpler models (283).


New types of electronic infusion pumps areconstantly evolving, widening the menu from whichproviders must choose and which patients and healthprofessionals must learn to operate. For example,one recently developed pump uses a built-in scannerto self-program, based on a bar code on the bag ofinfusate, thereby eliminating the extra step ofmanually programming the pump (40). Anotherdevice currently under development is a watch-sizeddelivery system for low-volume therapies such aspain management and antineoplastics (228).6

Elastomeric Infusers

Elastomeric infusers are recently developed de-vices that can be used as substitutes for infusionpumps. These infusers consist of disposable contain-ers with inner elastic bladders that can be filled withthe medication. The devices are sold empty and arefilled by the pharmacist through a port at the top ofthe bladder (28,29,40). The drug flows through anopening at the base of the bladder membrane andinto the tube leading to the patient. The force of theflow, and thus the rate of infusion, is determined bythe elasticity of the bladder (which pushes inward,delivering the drug under positive pressure) and theconcentration of the drug in the infusate, regardlessof whether the bladder is above, below, or on levelwith the IV site (28,29,40). Different drugs anddosages require devices of differing size and bladdermembrane composition.

Most devices currently on the market are designedfor either antibiotic or antineoplalstic therapy ad-ministration. They can be used for IV, intraarterial,and subcutaneous administration of drugs (28). Apatient on a twice-a-day regimen of home IVantibiotics would use two infusers per day, while apatient on continuous antineoplastic therapy mightuse a single device for several days at a time (28).Some devices allow patient-controlled administra-tion of bolus doses above and beyond the continuousinfusion rate. A disadvantage to the use of thesedevices for patient-controlled analgesia is the lack ofa memory function that can record the frequency ofpatient-requested bolus doses, like that found insome electronic infusion pumps (see above). Blad-der devices are also not appropriate for multiple drugregimens.

According to one home infusion provider, theavailability of disposable elastomeric infusion de-vices has increased the feasibility of home-basedcare for disabled elderly patients (249). Like sophis-ticated electronic infusion pumps, these devices candeliver a precise dose over a specific period of time.However, because they are self-contained and muchsimpler to operate, they may be less confusing forpatients who are uncomfortable with high-techequipment. The patient or caregiver need only hookthe device to the catheter at dosing time anddisconnect and dispose of it when the dose has beencompleted.

Implantable Pumps

Some therapies that require very small drugdosages can be administered by way of totallyimplantable pumps. Examples include insulin deliv-ery, continuous epidural morphine administrationfor chronic pain management, and continuous ve-nous antineoplastic therapy infusion for liver cancerpatients (the catheter is threaded into the portal veinleading to the liver). Due to the limited range ofconditions for which they are currently used and themuch lower intensity of services required, however,they are not discussed further in this report. The onlyservice directly related to infusion therapy for thesedevices is refilling of the pump’s reservoir, whichmay be done weekly or even less frequently in amedical outpatient or home setting (260).

Techniques and SuppliesThe supplies and skills needed for HDIT depend

on the type of therapy being administered, thevascular access device, and the infusion device. Thissection describes procedures associated with the useof different types of home infusion equipment andthe supplies required for those procedures.

Some supplies are needed by nearly all patients onHDIT, although specific amounts vary depending onthe patient (table 3-l). Examples of general HDITsupplies include such items as special soaps, swabs,catheter clamps, and sterile gloves.

Other supplies relate to specific HDIT procedures(table 3-1).7 A patient receiving antineoplastictherapy, for example, needs special containers to

6 The system includes a miniature progr ammable pump that operates electrolytically rather than by peristaltic orsyringe-pump action. A weak electriccurrent causes gas in a tiny reservoir to expand, thereby expelling the drug from a neighboring chamber into the catheter (228).

7 The specitlc supplies listed in the table reflect the practice of this particular infusion company. Other providers may use different supplies.


Table 3-l—Typical Suppliesa in a Delivery by One Company for Four Types of Home Infusion Therapy

Type of therapy

Central catheter Peripheral catheter

Pain Continuous infusion Antibiotic Hydrationmanagementb antineopiastic therapyb therapy therapyb

Supplies a (1 dose/5 days) (1 dose/5 days) (2 doses/day) (1 dose/day)

Drug administrationIntravenous (IV) pump (monthly rental) . . . . . .Pump cassette (100 ml) (5-day) . . . . . . . . . . . .Battery, 9VC . . . . . . . . . . . . . . . . . . . . . . . . . . . .Disposable elastomeric pump. . . . . . . . . . . . . .Gravity drip flow regulator (disposable) . . . . . .IV pole . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .IV administration set, 96 inch . . . . . . . . . . . . . .IV administration set, 66 inch . . . . . . . . . . . . . .IV in-line filter set, 1.2 micron . . . . . . . . . . . . . .Extension set, 6 inch . . . . . . . . . . . . . . . . . . . . .Extension set, 30 inch . . . . . . . . . . . . . . . . . . . .Extension set, 36 inch . . . . . . . . . . . . . . . . . . . .Catheter clamp . . . . . . . . . . . . . . . . . . . . . . . . . .Peripheral catheter kitd . . . . . . . . . . . . . . . . . . .IV catheter, 22 gaugee . . . . . . . . . . . . . . . . . . . .Click lock needles. . . . . . . . . . . . . . . . . . . . . . . .Needles, 21 gauge X 1 . . . . . . . . . . . . . . . . . . .

174

174———77————2——8—

——

——

56—28

128

—.—

——

——— —772

——

——

4—

—4—

8 —56 28—

Catheter/site careAlcohol preps (box) . . . . . . . . . . . . . . . . . . . . . .lodine preps (box) (central line only) . . . . . . . .Antiseptic hand cleanser, 8 oz. bottle . . . . . . . .Sterile gloves . . . . . . . . . . . . . . . . . . . . . . . . . . .Antiseptic table wipes (for work area) . . . . . . .Disposable sterile work surface . . . . . . . . . . . .Dressing change kit (central line only) . . . . . . .Tegaderm dressing medication . . . . . . . . . . . . .Tape, plastic 1 inch wide (roll) . . . . . . . . . . . . . .SASH kits (for catheter flushing)f . . . . . . . . . . .Injection caps, click lock. . . . . . . . . . . . . . . . . . .

Other10 cc syringe with needle (for drawing blood) .Sharps container/disposal . . . . . . . . . . . . . . . . .Anaphylaxis kit . . . . . . . . . . . . . . . . . . . . . . . . . .Chemo spill emergency kitg . . . . . . . . . . . . . . .Chemo waste bag . . . . . . . . . . . . . . . . . . . . . . .Chemo protection kith.... . . . . . . . . . . . . . . . . .

111877

1212

17

12

111877

1212

17

12

1 1—

1565656

—1

282828

—9 to 12

156

9 to 12

—9 to 12

128

9to12

411

411121

421

41

———

—asupplies may va~ depending on individual patient characteristics and needs. Does not include drugs or therapeutics.bsuwlies list~ are for a j-month r~imen of the following therapies: pain rnanagemenf-rnorphine sulfate approximately 100 mg *se *iM

antibioti~efobid 1 g twice daily; hydrath+dextrose 0.45 percent in 1 liter saline once daiiy; chemotherqy+luorouracil 2500 mg/50 ml every 5 dayscontinuous infusion.

~he antineoplastic therapy and pain management pumps need 9-volt batteries for backup power.d[n~~esallsupplies rquir~todothree [Vrestarts (~theter, SASH kit, n~d[es, etc,).Theseare usuallype~orm~ every Sdays, although antibiotic patients

may require more frequent restarts due to irritation.eFor hydration therapy, the full peripheral catheter kit is not rSCIUirSd.fSASH -saline.administration-saline-hepa~n. These are prepa~ag~ ~ts us~ for period~ flushing of ~theters. Some infusion therapy providers chooseto use heparin alone rather than a SASH kit (see box 3-B).

91ndudes special towels, goggles, warning signs, etc. in the event of a spill.hus~ by nurse, patient, or other caregiver who administers antineoplastic therapy.SOURCE: S. Wyremski, Abel Health Management Services, Inc., Great Neck, NY, personal communications, Jan. 18 and 22, 1991.

ensure that the wastes associated with the therapy with a 7-day cassette for continuous antineoplasticare suitably disposed of. A patient with a small, therapy. A patient with a subcutaneous port requiresambulatory pump may not require an IV pole to hang specially designed needles that do not puncture thethe pump, but he or she may need the special base of the port.drug-containing pump cassettes. A patient on a2-dose-per-day course of antibiotics needs 14 times Most supplies fall into two categories: those usedas many dose administration supplies as a patient to prevent infection, and those needed to actually


Box 3-A—Aseptic Technique

To minimize the risk of infectious contamination in home infusion therapy, aseptic technique must be usedeach time the catheter site is exposed or the catheter or tubing is accessed. Examples include dressing changes, IVadministration set changes, drug administration, and catheter care procedures (e.g., catheter flushing). The aseptictechnique requires:

. A clean, disinfected work area (disposable sterile work surfaces can be used for extra protection).● Meticulous handwashing with a disinfect soap before performing any home infusion therapy procedure.● Care in handling syringes so the hands do not come in contact with the sterile needle or the lower part of

the syringe plunger.. Care in use of needles. When needles are used to access catheters or administration sets via external or

subcutaneous injection ports, or are inserted directly into the skin for subcutaneous infusions, they must befully engaged up to the hub and taped securely to the patient to prevent in-and-out motion of the needle fromintroducing bacteria into the vascular system.

* Disinfection and cleaning of injection ports (if they are used) prior to access with a needle.. Use of sterile gloves for catheter site care and dressing change.. Metculous care of the catheter site, which should be cleaned three times in an outward circular motion with

an alcohol swab, using a new swab each time, and then with three providone-iodine swabs in the samepattern. Sterile gauze can be used to gently pat the site dry. After applying the new dressing, catheter tubingshould be resecured with tape to prevent motion.

SOURCES: A.L. Plumer, “Baeterial,Fung@ and Particulate Contamma“ tiom” inPrinciplesandPractice ofIntravenowr Therapy, 4th Ed., A.L.Plumer and F. Cosentino (eds.) (New YorlG NY: Little, Brown and Co., 198’7); National Medieal Care, Inc., Homeeare Division,Central Line Catheter Care: Patient Znfomation Guiak (WalthauL MA: National Medieal Care, IQC., 1989).

administer the drug. These are discussed in more aseptic technique requires ample backup supplies,detail below.8

Infection Control

The three main sources of microbial (bacterial andfungal) contamination that can cause infusion-related infection are the skin, the air, and the blood(264). Although risk of infusion-related infectioncan be reduced by minimizing exposure of thecatheter site, the administration set, and the con-tainer of infusate to these sources, exposure cannotbe eliminated. To further reduce the risk of contamina-tion, additional steps must be taken.

The most important method of controlling the riskof infection, whether at home or in the hospital, is theaseptic technique (see box 3-A). This techniquemust be applied to all procedures that involveexposure of any part of the infusion administrationassembly (catheter site, catheter lock, tubing, etc.) orof any infused substances to the environment (264).These procedures include drug compounding andmixing, drug administration, peripheral site changes,catheter flushing, dressing changes, and administra-tion set changes (see below). Strict adherence to the

because if a piece of sterile equipment (e.g., admin-istration set tubing, catheter cap, injection port,syringe plunger) is accidentally contaminated itmust be discarded and replaced with a new one.

Another factor that can increase the risk ofinfusion-related infection is the use of multiple-dosevials of drugs for home administration. Becausemultiple-dose vials must be accessed repeatedly,they increase the risk of contamination from envi-ronmental sources. They may also be more suscepti-ble to tampering by patients or other individuals whohandle them (207). To minimize the risk of infectionand tampering, some hospitals and home infusioncompanies use single-dose vials of drugs that arediscarded after each administration (207,364). In-line bacterial and particulate filters and simplifiedcatheter flushing procedures are additional infectioncontrol measures (see below).

Drug Administration

The supplies used in drug administration dependon the delivery system being used.9 Most patientshave separate tubing-the administration set—that

8 Although peripheral and midline catheters are treated in this chapter as equipment, they are usually considered supplies because they are notreusable.

9 patien~ who use elastomeric bladder devices may not need additional administration tubing because the bladder pump comes with ~bing.


connects the infusion device to the catheter. Admin-istration sets, which come in varying lengths andconfigurations, must be changed on a regular basisto prevent infection, clogging, and harmful drugdecomposition or interaction (174). Some adminis-tration sets have special extensions for ‘piggyback’infusions, where a second drug is administeredthrough a Y-gap at the patient’s end of the adminis-tration set, thereby avoiding mixture of the twodrugs in the tubing. Many electronic infusiondevices require admini stration sets that are designedspecifically for that pump (103). Extension tubing isalso available to increase the patient’s mobilityduring drug administration.

The INS recommends that administration sets bechanged at least every 48 hours (174). However,some types of drugs and drug regimens require thattubing be changed with every new drug administra-tion (15).10

Injection ports are rubber caps that are attached tothe administration set or directly to the catheter andare used for the periodic injection of drugs or othersolutions into the vascular system (174). Ports thatare integral to the administration set are changedwhenever the administration set is replaced. Portsattached to peripheral catheters should be replacedwhenever the catheter is changed, and ports oncentral catheters should be changed at least every 7days (174).

In-line filters may be attached to administrationsets to prevent air, particulate matter, or bacteriafrom entering the vascular system and causinginfection or other complications. The cost-effectiveness of using in-line filters has been thesubject of some debate (5,107,117,147,277), andpractices vary among HDIT providers (3,15). INSstandards, however, advocate their use inmost cases(174).

The type of filter needed varies depending on thetherapy. A small (0.2 micron) filter is recommendedfor routine use in most IV therapy because itprevents bacteria as well as air and particulate matterfrom entering the vein (174). Transfusion of bloodand blood products requires special falters, with aseparate filter used for each unit of blood product

transfused so that signs of contamination can betraced to a specific unit. Special surfactant-freefilters are required for intraspinal infusion of anymedication (174).

Some in-line falters are add-ens that must beattached to the IV administration set; others are

integral to the infusion device or the IV administra-tion set itself. The INS recommends that in-linefalters be changed each time the administation set ischanged (every 48 hours) (174). A recent study,however, found that some disposable in-line antimi-crobial filters lose their ability to retain bacteria after24 hours (27), indicating that more frequent changemight be appropriate.

Catheter and Site Care

Patients with either central or peripheral vascularaccess must care for their catheters and the sitewhere their catheter exits the body in order tominimize risk of catheter malfunction (e.g., cloggingor breakage), site irritation, and secondary infection.The following are typical methods used to accom-plish this care.

●

●

●

Catheter protection—To protect a catheterfrom contamination between doses, specialcannula caps are used. The INS recommendsthat these caps be replaced whenever they areremoved to minimize risk of infection (174).Catheter site care—The INS recommends thatthe bandages (dressings) that cover the exit siteof a catheter be changed at least every 48 hoursor whenever they are soiled, wet, or loose (174).Dressing changes can be conveniently per-formed by the patient or caregiver at the sametime as administration set changes. Whendressing change coincides with rotation of aperipheral IV site, it may be performed by theskilled nurse. For subcutaneous ports, dress-ings need only remain in place when the port isaccessed by a needle.Catheter flushing-AIl catheters are suscepti-ble to clogging either by the patient’s ownblood or by other deposits (174,396). For thisreason, most catheters are flushed periodically,most commonly with saline (salt solution) orwith heparin, an anticoagulant.11 Catheters are

10 For eqle, when two incompatible drugs are infused through the same catheter, the admirds-tion Set mUSt be C~ged between ~gs (174).Also, some drugs with limited periods of stability may form precipitates after a certain number of hours (15). When these drugs are being infused, IVadministration tubing must be changed with every new drug admns‘ “ tration (15).

II Hepfi is used because it is the only soluble anticOa@ant.


Box 3-B-Controversy Over Catheter Flushing Methods

The issue of saline v. heparin v. SASH (saline-administration-saline-heparin) flushing is one of considerabledebate, and literature exists to support the relative efficacy and cost-effectiveness of each method (18,72,104,124,144,166,245,337). There is as yet no consensus on which method is most appropriate, and practices vary amongproviders (36). Current published standards suggest that the SASH method should be the exception rather than therule (174). However, some home infusion providers use the SASH method with every type of therapy because theybelieve it results in decreased complications (36,402).

One argument against the use of the SASH procedure (as opposed to heparin or saline alone) as a default forcatheter flushing is that it increases the risk of infection because it necessitates multiple accesses to the catheter lock(36). Risk of conlamination may also be increased when catheter flushing substances are provided to the patient inmultiple-use vials. Although some home infusion therapy providers supply patients with a larger vial of heparinsolution from which they fill their own syringe for each flushing procedure (181), most providers use prefilledsyringes to avoid increased risk of contamination and to simplify the procedure for the patient (181,402). Onemedical equipment company has recently introduced a closed, 3-chamber SASH flushing system that reduces toone the number of catheter accesses required (40). Some catheters are pre-heparinized or have special valves at eachend that minimize the backflow of blood into the catheter, decreasing the need for flushing (138,260). 1

lfih~ catheters eanonly be used inpatients whoarenot sensitive to hoparirtandwith heparin-canpatibledr ugs. ‘lMwecathetersmay be routinely flushed with saline alone (260).

generally flushed after each administration ofmedication and after the drawing of a bloodsample. When two incompatible drugs areadministered through the same catheter, orwhen the drug being administered is incompati-ble with heparin, a special flushing procedurecalled the SASH (saline-administration-saline-heparin) method is often used. In this proce-dure, the catheter is flushed with saline beforeand after administration of the drug to avoidany contact with the heparin solution (174).Catheter flushing supplies are often deliveredto the patient in prepackaged kits. There isconsiderable variation among providers in theflushing methods they recommend to patients(see box 3-B).

. Catheter clearance—The risk and expense ofsurgically replacing a clogged central cathetercan sometimes be avoided by using urokinase,an enzyme that helps degrade clots and restorecatheter patency (2). The urokinase is injectedinto the catheter using a syringe and allowed tosit for several minutes before the catheter isaspirated to remove the clot (2). This proceduremust be performed by a skilled nurse or aphysician (260).

Table 3-2 describes variation in the frequency ofprocedures required by HDIT patients with differenttypes of vascular access devices and therapeuticregimens.

Certain therapies require special techniques andsupplies. For example, home transfusion patientsmay need special warmers to bring blood products tonormal body temperature prior to infusion (174).Patients on antineoplastic therapies need specialsupplies to protect them from exposure to these toxicdrugs when performing routine catheter mainte-nance or drug administration (174). Patients onintraspinal therapy need special diluent solutionsand in-line filters because many preservatives,stabilizing agents, antioxidants, and surfactants12

typically found in dilutents and filters can causenerve damage if they enter the intraspinal area(100,202).

Services and StaffingHDIT involves a broad range of services, includ-

ing patient screening and assessment; patient train-ing; and ongoing medical, pharmacy, nursing, labo-ratory, delivery, and coordination services. Theseservices, in turn, are performed by a variety of healthprofessionals, including registered nurses (RNs),RN specialists (e.g., IV, oncology, and critical care

12A surfaetant is a substance added to a solution to redu~ surface tension of the fluid. The use of Surfactant-containing antimicrobial or pticUlatefilters on intraspinal adxninistration sets is strictly contraindicated because surfactants often contain alcohol (202).


Table 3-2—Recommended Routine Frequency of Selected Catheter Maintenance Procedures Performed forHome Infusion Therapy Patients, by Type of Vascular Access Devicea

Procedure

Catheter Needle Catheter Dressing AdministrationVascular access device Changeb Changec flushingd changee set Changef

Peripheral catheterVenous . . . . . . . . . . . . . . . . . . . ● 48 hours NA Variable 48 hours 48 hoursArterial . . . . . . . . . . . . . . . . . . . ● 96 hours NA Variable 48 hours 48 hours

Midline catheter . . . . . . . . . . . . . ● 48 hours NA Variable 48 hours 48 hours

Central venous catheterTunneled catheter . . . . . . . . . . NA NA Variable 48 hours 48 hoursNontunneled catheter . . . . . . . NA NA Variable 48 hours 48 hoursPeripherally inserted central

venous catheter . . . . . . . . . NA NA Variable 48 hours 48 hours

Totally implanted catheter . . . . NA 7 days Variable NA NA

Subcutaneous Infusion . . . . . . NA ● 48 hours NA 48 hours 48 hoursNOTE: NA = not applicable. Asterisks (*) indicate that this procedure can only be performed by a qualified health professional-usualiy a registered nurse.

Some procedures may be performed by a nonskilled person (e.g., patient orcaregiver). In manycaaes, the functional ability of the patient determineswhowill perform thetask. In eomecaaea,the patient’smedical condition may besuchthatskilled personnel are requiredtoperform what would normallybe nonskilled functions (e.g., a dressing change if the catheter site shows signs of infection). Nonskilled procedures may also be performed by skilledstaff in conjunction with skilled procedures (e.g., a dressing change when a peripheral catheter site is rotated).

aFrquen~W refl=t r~mme~ations of the Intravenous Nurs~ ~iety in i~ revis~ standa~ of practice for intravenous nursing (both in inpatient andoutpatient settings). Actual frequency of procedures may vary among providers.

%atheters other than peripheral or midline are not routinely changed, but change maybe necessary if an infection or malfunction occurs.~he needles on implanted catheters can remain in placs for up to 7 days, and all infusions and heparin flushing can be achieved through that needle.%athetersaregenerally flushed after each administration of medication andafterabloodsample isdrawn; hence, flushing could occuras infrequentfyaaonce

aweekfor patients on continuous infusion or as often as fourtimes a day for patients on four times a day antibiotics. Frequency and type of flushing dependson type of catheter and drug being used. When not in use, catheters require less frequent flushing.

eDressinW must also be changed whenever they become Soiied, Wet, or loose.fForpatients on~ntinuous infusion of chemotherapy via an Infusion pump with a multipleday drug reservoir, set can be left in @aOe until re$ervoir is ~an9$d.

SOURCES: Intravenous Nurses Society, Intravenous Nursing Standards of Practice (revised 1990), Joumaf of Mravenous IVursirw Supplement 1990, APril. .1990; OTAsite visits to providers, 1990-91. -

nurses), licensed practical nurses, nurses’ aides,pharmacists,pharma cy technicians, and other on-the-job trained personnel. Because HDIT is a relativelynew mode of practice, providers generally look foremployees with extensive hospital infusion therapyor pharmacy experience and rely heavily on in-housetraining to prepare their staff for the specificdemands of HDIT patients (364). For some nursesand pharmacists, HDIT practice is an attractivecareer choice because it allows them to gainindependence and further their career in ways thatpractice in other settings does not (364).

The distribution and coordination of responsibili-ties among HDIT staff depend on the organizationalstructure of the home infusion provider, the capabil-ities of individual staff, limitations of State licensureand practice acts, and size of the geographic servicearea. For example, pharmacy-based providers oftenutilize clinical pharmacists for patient assessment,

education, and clinical monitoring tasks (see box3-C), while nursing-based providers place theseresponsibilities in the hands of nurses.13 Smallproviders with limited staff and a small service areamay have one pharmacist and one nurse as the soleproviders of services. Other providers may contractwith home health agencies or visiting nurses associa-tions to provider nursing services to patients inmore remote areas (see ch. 4). Large, full-serviceproviders in concentrated metropolitan areas mayorganize their many nursing personnel into teamsresponsible for the care of a defined group of patientsand rely heavily on central coordination staff toensure that services are delivered properly and in atimely fashion (box 3-C).

The next section describes in more detail thespecific services involved in HDIT and the qualifica-tions, abilities, and availability of the staff whoprovide those services.

13 See ch. 4 for a description of the different types of HDI’I’ pmvidem.

Chapter 3--Home Drug Infusion Therapy Equipment and Services .57

Box 3-C-Staffing and Organization of Home Drug Infusion Therapy Services:Two Contrasting Models

Anne Arundel General Hospital Outpatient IV Therapy Services Program, Annapolis, MD

Outpatient specialists are pharmacy technicians with a minimum of 3 years’ hospital experience. Under thesupervision of pharmacist staff, they are responsible for patient training, care coordination, and preparation of allIV medication in the outpatient center pharmacy facility.

The RN specialist, a registered nurse (RN) with extensive experience in hospital IV therapy, is responsible forthe initial patient assessment, some patient training, and all peripheral catheter insertions and changes. The RNspecialist also plays an active role in training outpatient specialists and any other health professionals who maybecome involved in home IV therapy services (e.g., home health nurses who see homebound patients).

Clinical pharmacists are Pharm.D.s with hospital pharmacy experience and a minimum of 2 years’ experiencein a clinical setting. They are responsible for designing and monitoring therapy and examining patients in theoutpatient center three times per week, Although the pharmacists do not diagnose and treat patients, they do examinepatients and report any concerns immediately to the physician for further investigation. Pharmacists are also directlyinvolved in developing and prescribing therapy regimens, under the supervision of staff physicians.

The microbiologist performs and/or coordinates IV therapy-related laboratory work which is generally doneat the referring hospital.

Physicians see patients at least once a week in their offices or in the outpatient center and consult with thepharmacist and other staff about patient progress, therapeutic changes and response, etc. A medical director is onstaff at the center.

ABEL Health Management Services, Inc., Great Neck, NY

Field nurses are primarily RNs with strong clinical skills and experience, although some are licensed practicalnurses (LPNs). Field nurses are organized in teams depending on their qualifications and availability. Each patientis assigned a team of field nurses who share call duty. Each field nurse is equipped with a 4-wheel-drive vehicle,car phone, fax machine, and 24-hour beeper. Field nurses average 6 to 8 patients per day overall, but the numberfor any one nurse depends on geography and patient needs.

Patient education specialists are baccalaureate-prepared RNs who do initial patient assessments and initiatethe patient training process (field nurses finish it). They also train other staff in home infusion techniques.

Nursing care coordinators (NCCs) are baccalaureate-prepared RNs who serve as the point persons for allcommunication from nursing, pharmacy, lab, and patients. They generally do not perform clinical functions.

Nurse managers are baccalaureate-prepared RNs who are responsible for overseeing the activities of NCCsand managing and monitoring any problems that may arise.

Clinical pharmacists are registered pharmacists (R.Ph.s). They are responsible for coordination of all clinicalfunctions of pharmacy service, including receiving physicians’ telephone prescriptions, maintaining patientmedication profiles and checking for possible drug interactions, providing drug information to other nursing andpharmacy staff, and reviewing patient lab work. They are recruited from both retail and hospita1 settings and undergo8 to 10 weeks of initial training in infusion therapy techniques before assuming full staff responsibility.

Staff pharmacists are R.Ph.s who are primarily responsible for drug preparation and compounding.Pharmacy liaisons are on-the-job trained personnel who act as support staff for staff and clinical pharmacists,

aiding in the preparation of drugs and facilitating communication between nurses, physicians, pharmacists, andpatients +

Other staff include customer service representatives (responsible for distribution of drugs, supplies, andequipment), armed escorts for staff who serve patients in dangerous neighborhoods, and others.

SOURCES: Anne Arundel GeneraI Hospital Outpatient IV Therapy Services Prow Annapolis, MD, informational visit with O’J14 staff, Oct.25, 19X$ ABEL Health Management Services, Inc., Great Neck NY, informational visit with OTA staff, Nov. 9, 1990.

297-913 0 - 92 - 5


Patient Screening and AssessmentPatient screening is perhaps the most critical

element in the decision of whether or not toadminister HDIT (see ch. 2), and it is the first servicean HDIT provider renders to a prospective patient. Indetermining candidacy for HDIT, the provider mustconsider the patient’s medical condition, the pa-tient’s and caregiver’s willingness and ability toperform self-care, and the environmental character-istics of the home setting. These considerations mustbe balanced against both the demands and associatedrisks of the prescribed HDIT regimen and the levelof services the provider itself is capable of deliver-ing. At a minimum, patient assessment includes avisit to the patient in the hospital prior to discharge,in which the patient’s medical stability is evaluatedand where the patient is questioned about otherrelevant aspects of the home and family environ-ment. In addition, it may include a visit to thepatient’s home to confirm that the home environ-ment is suitable (24). Patients who are referred fromoutpatient care may receive their assessment visits ina physician’s or provider’s office.

Although the actual assessment is usually per-formed by a nurse (364), other professionals (e.g.,physician, social worker, clinical pharmacist, dieti-tian) may also participate (24,270,335). Box 3-Dprovides an example of criteria that one home IVantibiotic therapy program uses to screen patients.

Patient Characteristics

The overall condition—medical, physical, mental-of a patient will affect the level and nature of carerequired. Specific conditions that typically affectadministration of IV therapy in the elderly includecardiovascular disease, poor venous access, thinningof the skin and underlying tissues, diabetes, jointdisease, paralysis, effects of long-term use of certaindrugs, and poor response to acute disease processes(62). Therapeutic decisions and patient safety mayalso be complicated when a patient is taking otherdrugs in addition to the prescribed therapy. HDITcan only be safe and effective if the nurse andpharmacist are aware of the patient’s individualneeds and (in conjunction with daily caregivers) cananticipate and handle related complications.

Some elderly patients are fully capable of per-forming self-care and need only periodic skillednursing services to receive HDIT. Other patientswho normally require no assistance may have

Box 3-D—Patient Screening Criteria forOne Home Intravenous IV) Antibiotic

Therapy Program

Disease Criteria. Infection responded clinically/clinically stable. Has not had a fever for at least 5 days prior to

discharge● Only in hospital for IV therapy

Treatment Criteria. Good venous access● Received and tolerated IV antibiotics in hos-

pitalPatient Criteria

● Alert● Cooperative. Average intelligence● Good motivation. Reliable. Emotionally stable● Acceptable lifestyle/home environment. Likelihood of compliance● No history of mental problems or substance

abuse. Understands therapy and gives consent. Patient and one family member taught. patient’s family agrees to therapy● Adequate support system at home● Completed IV training session● Proficiency in IV techniques● Can care for venous catheter and reliably

self-administer antibiotics● Telephone and refrigerator at home. Access to health area● Transportation available

SOURCE: K. be and J.I). Andrews, “Assessment of the Needfor a Home Intravenous Antibiotic PrograuL” Cana-dian Journal of Hospital Pharmacy 41(6):295-301,307, Deeember 1988.

specific fictional or cognitive problems that limittheir ability to perform the specific self-care proce-dures associated with HDIT. These patients requiremore supportive services to make HDIT feasible andsafe.

Still other patients require assistance with normalactivities of daily living even without infusiontherapy due to certain conditions that are especiallyprevalent among this population. For example:

● Eighty-six percent of elderly persons have oneor more chronic conditions, compared with 50percent of the general population (361).


●

●

●

●

●

●

Dementia, which can limit both cognitive andfunctional capacity, affects an estimated 15percent of persons of 65 years of age or over,compared with approximately 1 percent ofyounger persons (336,339).14

Depression, which can also cause cognitive andfunctional impairment, affects 2 to 10 percentof the elderly (39,139).Visual and auditory impairment, which canlimit a patient’s ability to learn and performself-care functions, are common among theelderly. Nine percent of persons 65 years of ageor older are visually impaired, and 32 percent ofelderly persons are hearing impaired (4).Orthopedic impairments or deformities, whichcan limit a patient’s ability to perform self-care,are present in 13 percent of the elderly com-pared with 8 percent of the general population(361).Within the population with chronic conditions,the rate of functional limitations is much higherfor the elderly: 18 percent of elderly peoplewith chronic conditions reported limitation in amajor normal activity of daily living,15 com-pared with 4 percent of the general populationwith such conditions (361).Two-fifths of community-dwelling elderly 65years of age and over report limitation in amajor normal activity of daily living, comparedwith 14 percent of the total noninstitutionalizedpopulation (361).

The patient’s role in HDIT will vary depending onthe type of therapy, venous access device, and drugdelivery device. Some drug delivery systems andaccess devices require considerable manual dexter-ity and physical mobility to operate. For example, apatient on a gravity drip system must be able to reachthe bag, remove it from the IV pole or hanger,change the bag, and assemble anew set of tubing. Abedridden patient with debilitating arthritis would beincapable of performing these tasks. In the absenceof a capable caregiver, the patient could be put on anautomatic drug delivery system (e.g., a fully pro-grammable infusion pump) that would greatly re-duce the amount of effort required on the part of thepatient. Some patients, however, would be toodebilitated to operate even the simplest infusion

pump and would require assistance in drug administ-ration either by an informal caregiver or a nurse.

A patient who is willing and physically able toadminister HDIT may still be unable to do so due tocognitive barriers. For example, an impaired patientwho is instructed in central catheter care andadministration of his or her specific drug regimenmay be able to repeat the required proceduresperfectly right after training but may be unable torepeat them on the following day.

If a patient is incapable of performing the requiredself-care, a capable and reliable home caregiver mustbe available for HDIT to be feasible. Even when thepatient is capable of self-care, an additional trainedcaregiver can be an important backup mechanismshould the patient become temporarily or perma-nently unable to perform certain tasks (24,209,335).For patients who require 24-hour attention (e.g.,some terminal cancer patients), more than one homecaregiver maybe required for the safe administrationof therapy (246). Dysfunctional patients with noavailable caregiver may be able to receive HDIT ifthe risks of that therapy are not life-threatening, butthese patients will require considerably more paidnursing visits (table 3-3).

Regardless of their clinical stability and objectiveability to perform the required tasks, some patientsmay simply be unwilling to undergo treatment in thehome setting due to fear or discomfort with thetherapy, equipment, or associated risks. Unwilling-ness is an absolute contraindication to HDIT;providers and the published literature unanimouslyagree that safe and effective home therapy cannot beprovided to patients (or by caregivers) who do notwant to be on it. The right of the patient (or thecaregiver) to decline treatment in the home setting inspite of the urging of other interested parties is anissue of quality assurance as well as of patient rights.

Home Environment

In order to safely and effectively carry out HDIT,a home must have certain basic features. Theseinclude running water, electricity, refrigerator spacefor drug and supplies storage, a clean area whereaseptic catheter and simple wound care can beperformed, and, perhaps most importantly, access toa telephone for emergency and routine communica-

14 Includes moderate and severe dementia.15 For example, hous&eeptig.


Table 3-3-Average Number of Nursing Visits Per Week for Home Infusion Therapy Patients, by Selected Types ofVascular Access Device, Type of Therapy, and Functional Status of Patienta

Number of other nursing or assistive servicevisits per week if patient/caregiver.c

Number of skilled can perform all cannot perform anynursing visits drug administration drug administration

Type of vascular access device and therapy per weekb and self-care tasks or self-care tasks

Peripheral or midline venous catheterHydration therapy once a day... . . . . . . . . . . . . . . .Antibiotics three times a day. . . . . . . . . . . . . . . . . .

Tunneled or nontunneled central catheter orperipherally Inserted central catheter

Hydration therapy once a day... . . . . . . . . . . . . . . .Antibiotics three times a day . . . . . . . . . . . . . . . . . .Continuous chemotherapy or pain

management with infusion pump. . . . . . . . . . . . .Totally Implanted catheter

Hydration therapy once a day. . . . . . . . . . . . . . . . . .Antibiotics three times a day . . . . . . . . . . . . . . . . . .Continuous chemotherapy or pain

management with infusion pump. . . . . . . . . . . . .Totally implanted pump . . . . . . . . . . . . . . . . . . . . . . .Continuous subcutaneous morphine

Infusion with Infusion pump . . . . . . . . . . . . . . .

2 to 3 0 72 to 3 0 21

1 0 71 0 21

1 to 2d o 2 to 3

1 0 71 0 21

1 to 2d o 2 to 31 0 0

3 to 4 0 0aRepre~nts the average minimum num~r of r~mme~~ nursing visits per week for drug administration, catheter care, and dressing dlan9e bas~ on

recognized standards of infusion therapy practice and actual practice of current home infusion therapy providers. Nursing visits maybe more frequent towardbeginning of therapy as patient is still becoming familiar with sekare techniques. Number of visits will vary depending on medical condition of patient andoccurrence of infusion therapy-related complications.

b~e~ not indu~ initiai as%=ment ~~ tmining ~sits. ~s not incfu& additional skiii~ nursing ~sits (up to thr~ per week) required for drawing ~OOd

sampies for laboratory monitoring. The minimum of one skiileci nursing visit for ail types of patients and therapies is for ongoing skiiied assessment andmonitoring of patient’s condition.

CDO= not imiu~ Sepamte Suwiies ~iivevv~its. ~s not refl~t r~wtion in nonskilled visits due to performa~e of nonstiiled tasks during skiiied nursingvisits.

dDepends on capacity of pump’s drug resewoir.SOURCE: Office of Ttinology Assessment, 1992. Based on information from: /nfravenous Nurses Soa.eCy, /ntiavenous Nursing Sfandatds of Practke

(revised 1990), Jourrra/ of Intravenous Nursing Supplement 1990, April 1990; A.L. Piumer and F. Cosentino (eds.), Pnk@/es and Practice otMravenous 7%erqy4fh Edition (New York, NY: Littie, Brown and Company, 1987); Perivascuiar Nurse Consultants, Rockiedge, PA, informationon frequency and cost of infusion therapy nursing visits, provided to OTAJan. 18, 1991; L.C. Hadaway, “An Overview of Vascuiar Access DevicesInserted vfathe Antecubitai Area,” Journa/of/nfravenous Nursing 13(5):297-306, September/October 1990; information provided to OTAby homedrug infusion therapy providers, manufacturers, and others, 1990-91.

tion between the patient and home infusion therapystaff (24,364). In certain instances, some of thesefeatures may not be necessary (e.g., some drugs needno refrigeration). Generally, however, the HDITprovider must ascertain during initial patient assess-ment whether the patient’s home is adequatelyequipped for the patient’s particular therapy needs(24).

Other characteristics of the home environmentcan also pose problems for HDIT For example,large pets or small children may tamper with thedrug delivery system (tubing, buttons on a compu-terized infusion device), potentially interrupting adose or causing more serious harm to the patient.

Proximity to Service Provider

Accessibility of needed services, drugs, equip-ment, and supplies is another important considera-tion in the patient screening process. In an urban

area, patients may be close enough to an HDITprovider to obtain emergency drugs, supplies, equip-ment, or services within a short time. Patients inareas more remote from the provider, however, mayhave to wait longer to obtain the supplies or servicesthey need.

This problem can be addressed in part by thedecentralized provider model. For example, aninfusion company in an urban location may contractwith a local home health agency to provide skillednursing care to a patient in an outlying area. Becausethere is no guarantee that the local home healthagency nurses possess the knowledge and skillsrequired for HDIT maintenance, the infusion com-pany may have to provide special training to thesenurses before releasing a patient to their care. Forpatients who are either very ill and require intensiveservices or who are in an area where skilled home


Box 3-E—Screening Critetia for Home Transfusion Therapy Patients

In order to be accepted for home transfusion therapy, the American Association of Blood Banks (AABB)recommends that patients meet all of the following criteria:

. They are not ambulatory (mobile patients are more appropriately treated in hospital or outpatient facilities); They have a stable cardiorespiratory status (i.e., no recent history of acute angina or congestive heartfailure); The patient’s transfusion history has been carefully screened, paying special attention to reactions (if

present) and appropriate chronic diagnoses; They did not experience a reaction during the administration of their last transfusion;● They are cooperative and able to respond to verbal commands;● They we able to detect and respond appropriately to body symptoms;. A responsible adult is present during the duration of the transfusion (this does not include the nurse),

presumably to assist in getting emergency services to the patient in the event of a situation that requires thenurse to give the patient undivided attention;

● A working telephone is available during the transfusion; and● The patient’s medical condition is suitable for home transfusion. (Diagnoses the AABB considers

potentially appropriate for home transfusion therapy include chronic gastrointestinal bleeding, anemia in thepresence of chronic renal disease, anemia with bone marrow failure, anemia associated with malignancies,sickle cell anemia, and thalassemia).

SOURCE: American Association of Blood Banks, Improving Trarq%sion Practice: The Role of QuulityAssurance, S. Kurtz, S. Summers, andM. Km&all (eds.) (Arlingto~ VA: American Association of Blood Banks, 1989).

nursing services are simply not available, HDIT may Home blood transfusion patients also requirenot be a reasonable alternative.

Disease- and Therapy-Specific Considerations

Some patients-either due to complicationsstemming from their medical condition or otherfactors (environmental and social) that can interferewith the safe and successful administration ofinfusion therapy-will require special considerationand attention by HDIT providers. Acquired immu-nodeficiency syndrome (AIDS) patients, for exam-ple, are highly susceptible to infections, which mayaffect decisions regarding their treatment (e.g.,which kind of catheter to use) (238).16 AIDS patientson HDIT who have a history of IV drug abuse willrequire close monitoring to assure that they are notusing their venous access devices for self-administration of illicit drugs. Also, patients withAIDS-related dementia may be unable to understandor perform self-care functions adequately (238).Although the patient may be able to performself-care initially, he or she is likely to lose thatability as the dementia progresses. Ongoing nursingassessment is key in determiningg the specific homeinfusion therapy needs of AIDS patients.

special consideration. The American Association ofBlood Banks (AABB) has published specific criteriathat patients should meet before they can receivein-home transfusion (see box 3-E).

Ongoing HDIT Services

All HDIT involves at some level medical, phar-macy, nursing, laboratory, and coordination serv-ices. Although the exact responsibilities of each ofthe types of service personnel (e.g., nurses orpharmacists) varies among infusion providers (seebox 3-C), all of the basic services must be availablefor HDIT to take place. The setting in which specificservices are delivered varies depending on both theprovider and the patient (see ch. 4). Some patientsreceive all services in their home; others receivesome services in an outpatient center but administerthe drugs themselves at home; still others receivetheir infusions in a physician’s office or outpatientcenter and have no home care or self-care responsi-bilities at all. The following describes existingvariation in how certain HDIT services are providedand by whom. It does not attempt to define optimumarrangements.

16 Stidies su~est that tunneled central catheters present a lower risk of site infection than surgically implanted ports or Permtieomly ~ert~eathetem (238).


Medical Services

All professional services provided to HDIT pa-tients must be overseen by the patient’s physician,who prescribes the therapy and orders the home care.The physician has primary responsibility for inform-ing the patient about the anticipated results andpotential complications of therapy, and the physi-cian is consulted in the case of emergency or lessercomplications of therapy. The physician also re-ceives the results of laboratory tests and orders anynecessary changes in the therapy, based on theresults of those tests and on the patient’s visits to thephysician during the course of the therapy.

The extent of physician involvement during thecourse of HDIT can range from an arm’s-length role(e.g., endorsing prescription changes suggested bythe home infusion pharmacist) to a highly interactiveone (e.g., seeing patients several times a week andinitiating any therapy changes). Physician involve-ment is affected by both clinical and nonclinicalconsiderations. Some medical conditions routinelydemand frequent physician contact (either over thetelephone or an actual patient encounter), whileothers can be followed by a skilled nurse who reportspatient progress and complications back to thereferring physician. Patients in poor physical healthmay need to see a physician more frequently thanotherwise healthy patients on HDIT. Some programsrecommend weekly physician visits for patients onantibiotic therapy, to confirm patient response totherapy and monitor progress in the resolution ofinfection, but this practice is apparently not univer-sal (96,364).

organizational characteristics of an HDIT pro-vider can also influence the frequency of physician-patient or physician-staff contacts. A center-basedprovider, for example, has patients come to anoutpatient center for their supplies, catheter sitechanges, physician visits, and other professionalservices (15). Other HDIT providers play a lessactive role in ensuring patient-physician contact;many leave the scheduling and frequency of fol-lowup visits entirely to the discretion of the referringphysician (203,364).

Patient Training

Patient education is required before a particularpatient begins home therapy. At a minimum, thisservice includes a visit to the patient in the hospitalprior to discharge, where the patient’s ability to

perform the needed infusion-related functions areaffirmed (24). In addition, patient education maybecontinued once the patient has returned home.Patients are instructed in infusion techniques, sitecare, the nature and risks of their therapy, drugstorage and stability, equipment maintenance anduse, recognition of signs and symptoms of possiblecomplications, and recordkeeping (134,209). Thisinstruction may be performed by one or more of anumber of professionals, including nurses, pharma-cists, and medical equipment personnel proficient inthe use of a particular infusion pump. Writteninstructional materials should be provided for refer-ence and reinforcement of skills (209,364).

The time required for instruction varies dependingon the level of complication involved in that care andpatient factors (209,364). Sometimes the initialtraining visit must be followed up with one or moreadditional visits to ensure that the patient is indeedcapable of and comfortable performing the neces-sary procedures (240,364). All instruction should bedocumented in the patient record (209). Manyproviders have patients sign forms stating that theyhave been instructed in and are capable of perform-ing the requisite self-care (209,364).

Pharmacy Services

At the least, HDIT pharmacy services involvecompounding the drugs to be infused, educatingnurses and patients regarding potential drug interac-tions and side effects, monitoring the patient’s drugregimen, and being available to respond to concernsregarding the therapy. Pharmacist responsibilitiesmay also extend to participating in patient educationregarding self-care technique; monitoring patientsvia conversations with nurses or patients them-selves; monitoring laboratory results; collaboratingwith physicians in establishing drug regimens andmaking prescription changes; and, in some cases,educating physicians about which therapies aresafest and most effective in the home setting (14,24).Home infusion pharmacists also monitor patientsduring therapy and consult with the referring physi-cian on patient progress (24,364). The degree towhich a pharmacist talks on the telephone or visitsthe patient in his or her home varies depending onthe provider.

An infusion pharmacy differs dramatically frommost retail pharmacies. While retail pharmaciesgenerally dispense only oral medication, infusionpharmacies must have the equipment necessary to


safely prepare and store parenteral solutions. Theseusually include laminar flow hoods to reduce risk ofcontamination,17 modified storage areas for certaindrugs, and additional supplies and equipment neededfor mixing solutions (364).

How a parenteral drug is prepared depends on: 1)the specific drug prescribed, 2) the dosage, and 3) thetype of drug delivery system (149). Preparation caninclude mixing or titrating to the proper concentra-tion. Some therapies, such as hydration therapy,require little preparation because the solutions comein premixed bags with varying dilutions of dextrose.Other therapies require more extensive preparationeither in-pharmacy (e.g., an antineoplastic drug mustbe prepared in a special vertical flow cabinet) or inthe patient’s home.

Some infusion delivery systems require special-ized in-pharmacy computer hardware. One type ofinfusion pump sometimes used for multiple drugs,for example, has a removable microchip that must beprogrammed in the pharmacy. Another newly devel-oped pump requires a barcode labeler in the phar-macy (40).

Some pharmacy-based providers delegate drugcompounding tasks to pharmacy technicians whoare supervised by managerial pharmacists (149).Others use only registered pharmacists for drugcompounding (see below) (3).

Pharmacist Training and Recruitment—Although some formal training in infusion phar-macy is available, it is not a nationally recognizedspecialty .18 The pharmacy profession includes bac-calaureate-prepared registered pharmacists (R. Ph.s),who undergo a 5-year training program, and doctoral-level pharmacists (Pharm.D.s), who complete 6years of training (385).19 Either one of these degreesis required for Iicensure in all States (385). Resi-dency training in hospital pharmacy, clinical phar-macy, and a variety of other specialties is alsoavailable (385). A 1989 survey of the 74 schools ofpharmacy in the United States20 found that 42

offered some form of instruction specific to homeinfusion therapy (224). Of those 42, only 13 had acourse primarily devoted to home infusion therapy,and only 2 schools required all their students to takethat course.

Home infusion pharmacists are quite differentfrom retail (’‘community drug store’ pharmacists,who usually have comparatively little experience ininfusate compounding techniques or the pharmaco-kinetic21 aspects of infusion therapy (14). Existingstandards for home infusion therapy providers makeexplicit a wide range of proficiencies that a commu-nity pharmacist must have in order to be anaccredited infusion therapy provider (see ch. 5)(179,237). Although most States do not have aseparate license category for infusion pharmacists,an increasing number of States license and regulatepharmacies that prepare drugs for infusion (210).These laws act as a “back door” regulatory mecha-nism for the practice of home infusion pharmacy bymandating certain physical plant characteristics andstaff proficiencies.

Thus, although some pharmacists may receiveformal training in home infusion therapy techniques,the majority of training takes place on the job. ManyHDIT providers rely on hospitals as both recruitmentand training grounds for their pharmacists, requiringanywhere from 1 to 3 years previous hospitalpharmacy experience (364). Additional training,both initial and ongoing, is provided to thesepharmacists on the job (364).

Physician acceptance of the pharmacist in anexpanded clinical role varies. Some physicians valuepharmacists’ contributions greatly and rely uponthem extensively for advice in drug therapy deci-sions, while others consider pharmacists’ involve-ment an encroachment on physician’s clinical deci-sionmaking (177,329). Physicians coming out oftraining today are more likely than their predeces-sors to have had interdisciplinary training experi-ences and hence may be more aware of and

17 Some fiion Pbcies ~ve ~eciauy comtruct~ positive pressure “cleanrooms” for the preparation of parenteral SOlutiOnS. While these doprovide an additional level of protection against contamimm“01.L they are costly to build and are not required in existing infusion pharmacy standards(178331,237).

18 ~aemecm~y~=mtio~y mcognizedpharmacy specialties: nuclearpharmacy, pharmacotherapy, ~dnutritiotip harmacy. TheknericrmSociety of Hospital Pharmacists is proposing two new specialties, psychopharmacy and oncology pharmacy (14).

19 Bo~ pm- include baccalaureate ~u~tio~m M 74 schools responded to the survey.21 ~ or ~- t. cbt~stic ~tmtiom of a ~g ~d tie body in t- of its &soI@o~ &tributio~ me~bofi~ and excretion (393).


accepting of the capabilities of the clinical pharmac-ist (177).

Pharmacy Technician Training and Recruit-ment—Larger infusion providers often employpharmacy technicians to assist pharmacists in com-pounding drugs. Pharmacy technicians are trainedeither on the job or in 2-year certificate programs(14,385). The American Society of Hospital Phar-macists (ASHP) accredits technician training pro-grams in hospitals and community and vocationalcolleges (14). In 1988 there were 68 formal trainingprograms in 19 States, of which 11 were accreditedby ASHP (385).

The degree to which HDIT providers use phar-macy technicians to compound drugs depends onState practice acts and licensure mechanisms. FourStates (Illinois, Massachusetts, Michigan, and NewHampshire) offer certification exams for pharmacytechnicians, and three States (Illinois, Nevada, andWashington) require licensing (385). In some States(e.g., California and Arizona), pharmacy techniciansin retail pharmacies cannot compound or otherwiseprepare drugs (186). This may explain the fact that,although pharmacy technicians can be found inhospitals in all States, 9 States have no pharmacytechnicians in retail pharmacies (385).

Nursing Services

HDIT services that must be provided by a skillednurse (usually an RN) include:

●

●

●

●

●

●

patient education regarding administration ofthe infusion and care of the infusion site,22

periodic monitoring of the catheter exit site forsigns of infection or other complications,peripheral catheter site changes,peripherally inserted central catheter place-ment,drawing blood samples for laboratory tests, andgeneral monitoring of the patient’s healthstatus.

Many other tasks (e.g., dressing changes, drugadministration, general catheter maintenance) canbe performed by less highly skilled personnel underthe direct or indirect supervision of IV nursespecialists. These personnel (including licensedpractical nurses, nurse aides, and home health aides)can play an especially important role for patientswith limited self-care ability. They may also be

involved in ongoing service coordination activities,acting as liaisons between patients and staff.

The amount and skill level of nursing servicesrequired by an HDIT patient varies dramaticallydepending on the route of administration, type ofdrug delivery system, type of therapy, and functionalstatus of the patient (see table 3-3). For example, apatient with a peripheral catheter who receivesantibiotics 4 times a day will need a skilled nursingvisit every 2 to 3 days for catheter site changes. Atthe other extreme, a patient with a totally implantedcatheter may need only weekly visits. Skillednursing visits for these latter patients generallyconsist of catheter site inspection and other monitor-ing activities. Patients unable to perform self-careprocedures may need additional paid assistive serv-ices on a daily basis if no family caregiver isavailable.

Additional skilled visits may be needed forpatients who require frequent laboratory tests (seech. 2). Drawing blood, either directly from a vein orthrough a catheter, is a skilled procedure that mustbe performed by or under the direction of a skillednurse or phlebotomist.

Placement of peripheral catheters (includingmidline catheters) must be performed by an RN withtraining and experience in this procedure (174,291).The procedure usually takes from 10 to 20 minutesto perform, although it may take longer if the patienthas poor venous access or other complicatingconditions (291). Peripheral lines and midlines areusually inserted in the patient’s home (291,364).

Insertion of a PICC line is a more involved andhighly skilled procedure that takes from 1 to 2 hoursto perform (see box 3-F) (291). In order to place aPICC line, an RN must have special training andexperience (174,291). INS standards require radio-graphic confirmation of PICC line placement (174),which is most convenient to perform in a hospital oroutpatient setting where x-ray facilities are avail-able. However, some nurses reportedly performPICC line insertions in the patient’s home eitherwith or without portable x-ray equipment (291). Theability of RNs to perform PICC line insertion islimited by availability of training and by State nursepractice acts (see box 3-F). Although this particulararea of specialty practice has yet to be officiallyrecognized and is even prohibited in some States,

n Pharmacists may also participate in patient education activities.


Box 3-.F—The Peripherally Inserted Central Catheter (PICC Line):New Technology and Nursing Practice

The PICC line is an example of how recent technological advances innfusion therapy are shaping new areasof nursing specialty practice. Insertion of a PICC line is a highly skilled procedure that can be performed only bya physician or by registered nurse with special training (174,291). The procedure involves:

* measuring the patient to determine the length of catheter required;* aseptic/ antiseptic preparation of the catheter entry site;. insertion and threading of the catheter. radiographic confirmation of catheter placement; and. suturing and dressing of the exit site (50,291).

Although training in PICC line insertion technique is widely available, the quality of training programs variestremendously (291). Some courses are 8 hours long and involve no practice on live subjects. other courses are longerand require numerous supervised and documented successes on live subjects. Some programs present “certificates”to participants on completing the course, but them is no officially recognized “certification’ in PICC line insertionor any other specific nursing skill (e.g., peripheral catheter insertion, catheter repair). To date, no nationallyrecognized accrediting bodies accredit PICC line insertion training programs (291).

State nurse practice acts sometimes limit the ability of nurses to perform PICC line insertions, From 60 to 70percent of States’ nurse practice acts can be interpreted as allowing PICC line insertion by an RN (291). In someStates, however, the wording of the acts suggests that such a skill would not be approved, and in a few States,language has been adopted that specifically prohibits nurses from performing PICC line insertions (291). As the useof PICC lines in both home and hospital settings grows, the role of the registered nurse in PICC. line insertion willlikely be increasingly recognized at both the State and national level through standardization of training and furthermodification of nurse practice acts.

IAlt.hoUghpraCtiee on live subjects is preferable from a quality of tmining standpoin~ it poses legal risks and has b@m the SUbjCCtof somecontroversy among trainers and practitioners (291).

many home infusion providers employ nurses with settings is high (291), home infusion providers havethis skill (364).

Nurse Training and Recruitment—HDIT pro-viders generally look for nurses with extensiveexperience in infusion therapy nursing (364). Nurseswith national certification in certain areas of ad-vanced practice (e.g., IV nurses, critical care nurses,oncology nurses) are more likely to have the skillsand experience needed for home infusion practice,although certification is not a guarantee of profi-ciency in particular skills (291,364). The burden istherefore upon the employer to determine, throughtesting, practice, and knowledge of educational andtraining background, whether an individual is profi-cient in those skills. Providers often recruit hospitalnurses who have done infusion therapy in cardiaccare units, critical care units, or emergency rooms.Although demand for skilled nurses in hospital

been successfull in drawing some nurses out of thesesettings because they offer greater autonomy ofpractice and, in some cases, more opportunities forcareer advancement (364).23 Nurses who specializein or are skilled in transfusion therapy are alsoincreasingly being sought by home infusion provid-ers as the demand for home blood transfusionexpands (box 3-G).

Home infusion companies that provide nursingservices through contractual arrangements oftenmust take additional steps to ensure that the nursesare qualified to perform the required services.Contract nurses in visiting nurses associations andhome health agencies, or nursing personnel inskilled nursing facilities or other nonhospital institu-tional settings, may not be familiar with particularHDIT equipment and techniques. To address this

23 For ~xaple, one home infusion provider has a five-step “career ladder” for its field nurses based on qualitlcatio~ expertise, and specialtycertification (3). Nurses can move up the career ladder by seeking outside continuing professio~ education or wrtificatio~ or by participating inin-house continuing education and certification pro-. Five factors considered in the career ladder are: 1) antineophtic therapy skills/certMcatiou2) blood transfusion skills, 3) PICC line insertion skills, 4) catheter repair skiUS, and 5) degr~ of dfilculty of venous across the nurse is capable ofhandling (3).


Box 3-G-Home Blood Transfusion Services: Special Considerations

Home blood transfusion is a relatively new service in the home infusion therapy market, and it involvesintensive, specialized nursing services and careful coordination with suppliers of blood products (e.g., local bloodbanks). The great risks associated with blood transfusion therapy demand that home providers develop distinct andstringent protocols that address the unique aspects of this therapy.

According to the American Association of Blood Banks (AABB), in-home transfusions should be performedby a registered nurse (RN) with formal training and extensive knowledge and skills relating to IV therapy generally.During the nurse’s initial visit 24 to 48 hours before the actual transfusion, a blood sample for type and crossmatchis drawn, carefully labeled, and delivered to the blood bank for compatibility testing. The blood bank must keepan accurate record of the physician’s orders, informed consent form, laboratory results, nurse’s notes, and atransfusion flow chart for each patient transfused.

On the day of the transfusion, the crossmatched and inspected units of the relevant blood component are pickedup by the nurse, who reinspects them for gas formation, streaking, and color. The blood is transported in aquality-controlled insulated cooled container. At the patient’s home, the nurse doublechecks the patient’sidentification and checks each unit to be given for compatibility.

The nurse then reviews the physician’s orders, evaluates the patient’s condition, administers any prescribedpremedications (e.g., antihistamines to avoid mild allergic reactions), and starts the infusion therapy. During theinfusion, the nurse monitors vital signs and other signs of the patient’s reaction every 30 minutes. once thecomponents have been infused, the nurse discontinues the transfusion, the IV line is kept open, and the nurse remainswith the patient in order to watch for adverse reactions and take the 30-minute posttransfusion vital signs. Beforeleaving, the nurse gives the patient and any caregiver present posttransfusion instructions and collects equipmentand contaminated supplies. The nurse returns the day after the transfusion for a followup visit that includes testssuch as hemotocrit, platelet count, and coagulation test. In the event of a medical emergency during the transfusionprocedure, the patient’s residence must be easily accessible. AABB guidelines for procedures in event of a reactionare as follows:

●

●

●

Mild reaction (e.g., rash or itching): The transfusion is stopped and the physician is notified. Usuallyantihistamines are given and, if the reaction ceases, the nurse will continue with the transfusion whilemonitoring the patient closely.Severe reaction (symptoms including rash, increased heart rate, fever, chills): The transfusion is stopped,the physician is notified, and the nurse administers appropriate medications as ordered by the physician. Theblood units, administration set, a fresh urine specimen (to inspect for free red blood cells), and a bloodsample (to regroup and crosshatch to donor blood, and to perform a Coombs test for hemolytic antibodies)are sent to the blood bank. The nurse stays with the patient until the patient is stabilized, or makesarrangements for transportation of the patient to the hospital.Life-threatening reaction (symptoms include red urine, unexplained bleeding, fever, chills): The transfusionis stopped and another person present contacts the emergency number while the nurse attempts to stabilizethe patient (performing resuscitation if necessary). The patient is immediately transported to the nearesthospital.

Under all of the above circumstances, there remaining blood components and administration set are returned to theblood bank for crossmatching. A transfusion reaction report, completed by the nurse, is also required.

Safe disposal of equipment, such as empty blood bags, IV tubing, blood-soaked gauze, needles, and othercontaminated objects is a major concern. The nurse must collect all such materials in special biohazard containersand return then-i to the blood bank for proper disposal.

If blood warming in the home is desired either for patient comfort or clinical considerations, only approvedelectric blood warmers should be used because overheated blood can lead to hemolysis (rupture of red blood cells)and protein precipitation.

SOURCES: ArnMWMIAssoci.ationof Blood Banks, Howe Transjhsion Therapy, E.L. Snyder and J.E. Menitove (eds.} @i.ngto% VA: AmericanAssociation of BlmdBanks, 1986); American Association of Blood Banks, Improving Transfusion Practice: The Role uf QwdityAssurance, S, Kortz, S. S urn.mers, and M Krusl@ (eds.) (Arlingtoa VA: Arn@can Association of Blood Banks, 1989); M. Monks,“Home Transfusion Therapy,” Journal of Intravenous Nurses 11(6):389-3%, November-December 1988; P.C. Nldler, ‘WineBlood C!oq)onent The~y: AII Alternatw“ e,” NllX 9:213-217, May-June 1986.


problem, some HDIT companies have highly spe-cialized nurses on staff who train personnel incontracting agencies before they are allowed to servepatients (364).

Delivery Services

In HDIT, all drugs, equipment, and supplies mustreach the patient at home in a timely manner. Insome cases, a pharmacist or nurse may deliver thesupplies directly in the course of a patient visit.Larger providers may deliver supplies to patients’homes in a truck or van. Occasionally, patients maybe responsible for collecting their own home sup-plies (e.g., at each visit to an outpatient clinic).

Most supplies are delivered to patients on amonthly basis in quantities great enough to allow acomfortable margin for the accidental contaminationof sterile products by the patient (see box 3-A) andfor accidental loss or damage. Additional suppliesare brought by visiting nurses as needed.

The drugs themselves must sometimes be deliv-ered more frequently, with frequency depending onthe drug prescribed (209). Some require weekly, andsome monthly delivery (149). Some parenteralsolutions can be stored safely at room temperature orin a refrigerator for days, while others lose theirpotency after several hours (364) (ch. 2).

For some highly unstable drugs, delivery to thehome setting may be unsafe or impractical. Forothers, increased frequency of delivery from thepharmacy or patient involvement in drug preparationcan make home infusion feasible. New technologi-cal developments can also affect drug storage life inthe home environment. For example, 5-fluorouracilhas been found to remain stable for 16 weeks whenstored at low temperatures in either polyvinylchloride drug reservoirs used in electronic infusionpumps or in elastomeric bladder devices (276).

Laboratory Services

Most HDIT requires some degree of laboratorymonitoring, either to keep track of the level ofinfused drugs in a patient’s bloodstream or tomonitor the patient’s bodily reactions to the therapy.Laboratory results are used by the physician and

pharmacist to monitor the effects of the chosentherapy and to alter the dosage level or change thetherapy when necessary.

Specimens (e.g., blood samples) are usually takenby a nurse during a home or outpatient visit and sentto a laboratory, which reports the results back to thepharmacist and the physician. The pharmacist andthe physician, and often the attending nurse, thendiscuss any changes in therapy that maybe indicatedbased on those results. It is generally the nurse whoimplements the prescribed therapeutic changes byreprogr amming the rate of the infusion pump orinstructing the patient in a different dosing schedule.Although a few HDIT providers operate their ownlaboratories, most rely on an outside, independentlaboratory for analyses (364).

Coordination Services

Centralized coordination services are critical toHDIT, but the extent and type of coordination andthe staff who perform these services vary tremen-dously among providers. Coordination exists on twolevels. First, the various HDIT-related servicesthemselves must be coordinated: the appropriatesupplies must reach the patient in a timely manner,the appropriate nurse must visit the home on theappropriate day and time, and emergencies, compli-cations, and patient questions must be dealt with.Second, the infusion services must be coordinatedwith other services the patient may be receiving,such as basic home nursing, physical therapy, orrespiratory therapy. If the patient is receivingseparate care for medical conditions not related tothe infusion therapy, the HDIT provider mustmaintain communication with other care providersto ensure that their efforts are not duplicative or inany way harmful to the patient.

Coordination services are often performed by anurse who acts as case manager (see box 3-C), butsome organizations employ nonnurse personnel toperform some of the coordination functions (364). Invery small organizations, such as an independentpharmacy provider, the pharmacist may performsome coordination functions as well as pharmacyservice (391).

Chapter 4

THE HOME DRUG INFUSIONINDUSTRY

ContentsPage

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 1

Summary of Conclusions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71History and Growth of the Home Drug Infusion Marketplace . . . . . . . . . . . . . . . . . . . . . . . . 71Medicare and the Shape of the Home Infusion Industry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72Home Drug Infusion Providers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73

Hospital-Based Providers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73Home Health Agencies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74Community Pharmacies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75Medical Equipment Suppliers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76Specialty Home Infusion Therapy Providers. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77Physician-Owned Providers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77Other HDIT Providers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ..*. 79

Economic Characteristics of the Home Drug Infusion Marketplace . . . . . . . . . . . . . . . . . . . 79Market Concentration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79Providers’ Scale and Scope of Services . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81Ease of Entry Into the Market . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81

Alternatives to HDIT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82

BoxesBox Page4-A. Example of a Hospital-Based Provider: Anne Arundel General Hospital

Outpatient Intravenous (IV) Therapy Services . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 744-B. Home Health Agency-Based Providers: Two Examples . . . . . . . . . . . . . . . . . . . . . . . . . . 754-C. Example of a Pharmacy-Based Provider: Vital Care, Inc. . . . . . . . . . . . . . . . . . . . . . . . . 774-D. Example of a Medical Equipment Company-Based Provider: Mediq, Inc. . . . . . . . . . 774-E. Example of Home Infusion Therapy Specialty Provider: HMSS, Inc. . . . . . . . . . . . . . 784-F. Example of a Physician-Based Outpatient Infusion Therapy Provider:

Infections Limited, P.S. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 784-G. Specialized Home Infusion Therapy Providers: Cystic Fibrosis Foundation

Home Health Services, Inc. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 794-H. Alternatives to Service-Intensive Infusion Therapy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82

TablesTable Page4-1. Medicare-Certified Home Health Agencies (HHAs) by Ownership,

Selected Years, 1974-90 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 764-2. Relative Share in the Home Infusion Market of Eight National Proprietary

Providers, Estimated 1988 and Projected 1991 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80 -

Chapter 4

THE HOME DRUG INFUSION INDUSTRY


The home infusion industryl is evolving rapidly,and its characteristics will inevitably have an impacton how Medicare policies regarding home druginfusion therapy (HDIT) play out. This chapterdescribes some of the more important of thosecharacteristics and their implications.

The chapter first describes the history and growthof the HDIT marketplace and how past Medicarepolicies have helped to shape it. It then describes thedifferent providers of HDIT and the implications ofsome of their similarities and differences. Next, thechapter discusses the economic characteristics of theHDIT marketplace: market concentration, ease ofentry of new providers into the market, and the scopeand scale of services of different providers. Finally,it describes some of the alternatives to HDIT-thechoices available to physicians and patients whendeciding on the mode and setting of therapy.

●

●

Summary of ConclusionsFederal policies have played a significant rolein the development of the home drug infusionindustry thus far. Medicare coverage for homeenteral and total parenteral nutrition (TPN)2

(begun in 1977) and the implementation ofprospective payment for Medicare inpatientservices in 1983 both contributed to the rapidgrowth of the home infusion industry duringthe 1980s. Broadening Medicare coverage ofhome infusion therapies would have a similarlyprofound impact on the future shape of theindustry.

The diverse nature of providers that constitutethe current home drug infusion marketplacepresent unique challenges for Medicare indeveloping possible future coverage, payment,and quality assurance policies. Although someproviders offer directly the full range of sup-plies and services needed by HDIT patients,

●

●

many provide one or more aspects of thetherapy by contracting with another entity (e.g.,a home health agency (HHA), pharmacy, ormedical equipment supplier).

With the exceptions of hospitals and HHAs thathave entered the HDIT business, most provid-ers have limited experience with Medicarebeneficiaries due to the current limited Medi-care coverage for this therapy. Medicare bene-ficiaries, because they are on average less welland less capable of performing self-care tasksthan younger patients, may require specialconsideration and additional supportive serv-ices.

Future controls over what companies cancharge Medicare patients for HDIT may slowthe growth of certain sectors of the market-place. The revenue growth and seeminglycomfortable profit margins that have beenenjoyed by the HDIT industry thus far havefacilitated and encouraged the entry of newproviders into the marketplace, expanding ac-cess to home infusion therapy services. Thecomfortable profit margins are in part due to thefact that these companies have often been ableto charge anything short of inpatient charges forsimilar therapies and still sell their services tohospitals, physicians, and patients.

History and Growth of the Home DrugInfusion Marketplace

The home infusion providers of the 1970s werelargely hospitals providing TPN solutions for pa-tients who were individually treated and whosesupplies came by way of the hospital pharmacy(288). Technologic advances during the decade werestill diffusing; during the period 1970-78, a registryof TPN patients documented a total of 469 suchpatients discharged home, or an average of onlyslightly more than 50 patients a year (308). But in thelate 1970s, two events sparked the changes thatwould form the home infusion industry of the 1980s.

1 Most providers in the home infusion industry offer parenteral nutrition as well as drug infusion therapies.2 In enteral nufritio~ nutrients are delivered direetly into the digestive tract (commonly referred to as “tube feeding”). In total parenteral nutritio~

the digestive tract is circumvented and nutrients me delivered directly into the bloodstream.

-71-


The first of these events was a decision byMedicare in 1977 to cover TPN solutions andsupplies for disabled persons receiving the solutionsat home. At the time, the Health Care FinancingAdministration (HCFA) did not anticipate homeTPN to be a major expense; it was expected that onlyabout 10 Medicare-eligible patients per year wouldneed home coverage and that most of these patientswould not live long (359). On the grounds that TPNsolutions and associated equipment and supplieswere a replacement for the digestive tract, HCFAdeclared these components of TPN therapy to beeligible for reimbursement as a prosthetic device(45).3

The second event was the startup of a newcompany. In 1979, a private firm, Home Health Careof America, entered the market as a specialistsupplier of home infusion equipment, supplies, andservices (189). In doing so, it established a model forserving TPN and other patients at home through anonhospita1 provider. In addition, its rapid growth—with stock prices rising from $7.75 per share in 1979to $30 per share in 1983 (189,288)-drew attentionto home infusion therapy as a potentially profitableenterprise.

By 1983, the home infusion industry was suffi-ciently developed to draw the attention of invest-ment analysts. A report by the investment researchfirm Hambrecht & Quist separated the market intothree types of players: the large hospital supplycompanies, which manufactured and distributedhome infusion solutions and supplies and had anestimated 24 percent of the market; smaller and morediverse companies with backgrounds in such areasas medical equipment and pharmacy services, whichoccupied another 22 percent; and hospitals and otherproviders, including the large hospital managementcompanies, which shared the remainder (288).Therapies included primarily TPN and enteral nutri-tion, with intravenous (IV) antibiotics and antineo-plastics a distant third and fourth (288). That sameyear, Medicare instituted prospective payment forhospital inpatients, drawing attention to the relativefinancial benefits of providing nonhospital care.

Between 1983 and 1990 the home infusionindustry exploded, from an infant industry withestimated revenues of $265 million to a sophisti-

cated and highly competitive market worth nearly $2billion (288,307). The industry’s high rate of growthcontinues to be one of its most prominent character-istics. Total market revenues for home infusionsupplies and services (including TPN and HDIT)have increased by an estimated 5 to 10 times their1983 level (34,289,307). Although market analystsdisagree somewhat on the exact total revenuevolume of the market, all agree that growth rates inthe mid-1980s were over 30 percent per year andwere still predicted to be over 25 percent in 1991(307).

One consequence of this enormous expansion hasbeen that new players have been able to enter themarket with the expectation of realizing profitsfairly quickly. Many of the marketing efforts ofhome infusion providers during the 1980s wereaimed not at drawing patients from competitors butin enlarging the total demand by convincing physi-cians to refer their patients to home care (364). Asthe industry growth amply demonstrates, this efforthas been successful.

Medicare and the Shapeof the Home Infusion Industry

Despite the lack of a direct benefit for HDIT,Medicare coverage and payment policies helpedform the fabric from which the home drug infusionindustry is made. Probably the most importantinfluence Medicare had on the industry was thedecision to cover the products associated with TPNin the 1970s. Because TPN was covered as aprosthetic device, and because only supplies andequipment were covered, supplying TPN and enteralnutrition products became the province of themedical equipment and supply industry. Companiesthat manufactured the nutritional components (e.g.,Baxter) also moved into the retail side of the TPNbusiness, and a few entrepreneurs such as HomeHealth Care of America actually created high-techhome care businesses around the core of TPN, withits secure reimbursement.

The decision to cover only the products associatedwith TPN had a secondary effect: it inhibited HHAs,which are service- rather than product-oriented,

s Medicare does not ~ver partial parenteral nutritio~i.e., for patients who Mve a wholly or parti~y functioning digestive tract-in the homesetting.

Chapter 4—The Home Drug Infusion Industry .73

from entering the TPN business. Although mostHHAs rely heavily on Medicare business, thepatients they serve are traditionally and by definitionrelatively dependent on nursing and assistive serv-ices; Medicare patients must be homebound andrequire periodic skilled nursing visits to be eligiblefor home health benefits (see ch. 6). In contrast, thelack of Medicare coverage for services associatedwith TPN meant that most TPN patients were quiteindependent. TPN patients had to be able to self-administer their solutions unless they were alsohomebound and thus eligible for some supplemen-tary home health benefits. Thus, the history ofMedicare reimbursement for infusion therapy (i.e.,TPN) has resulted in home infusion therapy equip-ment and supplies, on the one hand, and homenursing, on the other hand, being entirely distinctfrom one another.

As providers of home infusion therapy looked fornew sources of revenue, they began to apply theirexpertise in pharmaceutical preparation and equipment/supply distribution to drug therapies. Private insur-ers began reimbursing for some of these therapieswhen convinced of their ability to avoid hospital-related charges by covering self-administered hometherapy. Medicare began covering a few speci.tieddrugs under the durable medical equipment benefitwhen those drugs were used in an infusion pump (seech. 6), further reinforcing the relationship betweenhome infusion therapy and the medical supply andpharmaceutical industries.

With the continually expanding opportunities forincreasing revenue through providing new kinds ofhome infusion therapies, the growing industry hasattracted providers from all directions. Hospitals,physicians, pharmacists, HHAs, dialysis providers,and a diverse variety of other health care providershave branched into the home infusion therapybusiness. Some provide a number of differentcomponents of HDIT; some provide only one or twocomponents. Each provider type brings with it itsown particular bias in the organization of therapy,the kinds of patients it serves, and its relationshipswith other providers of the therapy. The followingsection describes some of these provider-specificcharacteristics.

Home Drug Infusion ProvidersHDIT providers vary in three basic ways:

1.

2.

3.

Home-based v. center-based models—Home-based models provide all aspects of therapy inthe patient’s home. Center-based providersusually train patients for basic self-care (e.g.,dressing changes), but provide needed skillednursing services (e.g., catheter site changes)and delivery of supplies to the patient in anoutpatient center.Pharmacy-based v. nursing-based models—Most home infusion therapy has historicallybeen pharmacy-based-i.e., the focus has beenon pharmacy-related services, with nursingservices provided or contracted as needed. Forpatients capable of full self-care, these havebeen only occasional nursing visits. As morepersons with multiple nursing needs (e.g.,persons with AIDS)4 have been served, asmore complicated therapeutic regimens havebeen transferred to the home setting, and asHHAs have diversified into infusion therapy,more nursing-based models have arisen. (Ex-amples of the different staffing responsibilitiesbetween the two models can be found inchapter 3, box 3-B).Ownership and orientation—The ownership,parent company, and original mission of theinfusion provider can dramatically affect howit provides services, what it offers, and who itserves.

Seven basic types of providers, and their individualstrengths and weaknesses, are described below.

Hospital-Based ProvidersThe intensive nature of HDIT and the fact that it

is often an extension of, or a replacement for,hospital care has made the service attractive to manyhospitals. For some, providing home infusion serv-ices is simply an extension of the services of apre-existing hospital-based HHA; for others, it is anentirely new venture into home care (see box 4-A).The total number of hospitals currently providingHDIT services, either through special outpatientinfusion therapy units or their own HHAs, isunknown. However, recent survey data suggest that

4 Acquired immunodeficiency syndrome.

297-913 0 - 92 - 6

74 . Home Drug Infusion Therapy Under Medicare

Box 4-A—Example of a Hospital/BasedProvider: Anne Arundel General Hospital

Outpatient Intravenous (IV)Therapy Services

The Anne Arundel General Outpatient IV Ther-apy Services Program, started in 1978, is anoutpatient department of Anne Arundel GeneralHospital, a 330-bed facility near Annapolis, MD.The hospital, which previously had been discharg-ing some patients in need of home infusion therapyto proprietary providers, decided to start its ownprogram because none of the proprietary providersoffered antibiotic therapy. As of 1990 the programprovided only antibiotic therapy, but it planned tobegin offering IV antineoplastic therapy, painmanagement, and total parenteral nutrition.

All patients are referred from the parent hospital.Most start their infusions as inpatients and receivetheir training while still in the hospital The fewwho start as outpatients are trained in the outpatientcenter. Because the typical course of IV antibioticsrequires infusions two to three times a &y, mostpatients administer the drugs themselves at homeand come into the outpatient center several times aweek to see a nurse and clinical pharmacist and atleast once a week to see a physician. During thesevisits, patients pick up their drugs and supplies,receive any required skilled services (e.g., cathetersite changes), and are checked for possible compli-cations of therapy. If a patient is homebound, careis provided through the hospital’s hospice/homehealth department but is still coordinated by theoutpatient IV therapy team. Home health nursesinvolved in care of homebound patients are trainedby the center staff. All staff involved in patient caremeet on a weekly basis to review each patient’sprogress.SOURCE: Anne Arundel General Hospital Outpatient Intrave-

nous Therapy Serviees, Annapolis, MD, site visit byO’IA Stt%ff, Oct. 25, 1990.

a growing number of hospitals are providing theseservices either directly or indirectly. According tothe American Hospital Association, 31 percent ofnonfederal hospitals provided some kind of homehealth services in 1988 (10). A 1990 survey ofhospitals with home care programs5 found that 62percent of these hospitals directly provide home IVtherapy and 23 percent provide home medical

equipment (197). By comparison, a 1982 survey of243 Medicare-certified hospital-based HHAs6 foundthat only 29 percent offered some kind of home IVtherapy (120).

An advantage to hospitals of developing their ownhome infusion programs is the ability to keeppatients within the hospital-based system, ratherthan losing revenues to other providers once apatient is discharged. The on-site physician andpharmacy resources of hospital-based home infusionprograms may also confer some advantages on theseprograms. However, HDIT is not simply a transplan-tation of hospital infusion to a home setting; itrequires additional skills on the part of nurses andpharmacists, and it often requires much closercommunication between pharmacists and patientsthan hospital pharmacists may be accustomed to (seech. 3). Additionally, hospital-based programs mayraise concerns about anticompetitive behavior ifhospital patients are routinely referred to the hospi-tal’s own program rather than enabling them tochoose among competing providers in the commu-nity. Large hospitals are generally in a betterposition to implement a successful HDIT programbecause they are more likely than small (e.g., under200-bed) hospitals to have a sufficient patient baseand the specialized staff needed to support suchservices (364).

Home Health AgenciesHHAs view HDIT as an extension of the home

nursing and associated services they provide. HHAsmay opt to become full-service HDIT providersthemselves, either acquiring necessary pharmaceuti-cal expertise in-house or contracting outside forpharmacy services (see box 4-B). Alternatively, anHHA may act as a contractor to another provider tosupply only the nursing (or nursing and equipment)components of a home infusion service. For exam-ple, an HDIT provider located in a major city butwith patients in a more distant town might contractwith an HHA in that town to provide nursing andother infusion-related services to local patients.Although no hard data are available, the NationalAssociation for Home Care (NAHC) estimates thatat least 75 percent of HHAs nationally are involvedat some level in home infusion therapy. About halfof these act as primary providers, while the remain-

5 The survey was mailed to 1,983 hospitals with home care programs in May 1990. ‘lhe response rate was 41 percent (197).h The response rate was 73.7 percent.

Chapter 4—The Home Drug Infusion Industry . 75

Box 4-B—Home Health Agency-Based Providers: Two ExamplesVisiting Nurses Association of Los Angeles

In 1986, the Visiting Nurses Association of Los Angeles (VNA-LA), a Medicare-certified home health agency(HHA), expanded its business to include home infusion therapy by entering into a partnership with an establishedpharmacy, which provides clinical pharmacy expertise and parenteral drug compounding services. VNA-LA viewedhome infusion therapy as a potentially profitable enterprise, especially given the high number of AIDS patients theywere already serving at the time.

Since the partnership was formed, VNA-LA has become a key competitor in the Los Angeles home infusiontherapy market, marketing its services to abroad range of providers including physician group practices, hospitals,and local health maintenance organizations. Unlike some other HHA-based providers, VNA-LA provides directlythe full range of drugs, supplies, and services.Handmaker Home Health Services, Tucson, AZ

Handmaker Home Health Services, Inc., also a Medicare- certified HHA, is an offshoot of a Jewish geriatriccenter. For the last 9 years, Handmaker has provided home infusion therapy services to patients referred from itsgeriatric center, from a nearby local hospital, and from local physicians familiar with its services. The majority ofHandmaker’s business is antibiotic therapy, although it has provided antineoplastic therapy and parenteral nutritionon occasion. All nursing and coordination services are provided by a single staff nurse specialist. Most parenteralsolutions and associated supplies are obtained from a nearby hospital pharmacy whose staff provide 24-hourpharmacy coverage. Durable medical equipment (e.g., pumps) are obtained through an outside supplier.

Handmaker’s home infusion therapy business is very small---no more than 25 patients at any given time-dueto limited staff and the intensity of services required by most of its patients. Almost all clients are over 65 years ofage, all are confined to their homes, and few of them are capable of self-administering; thus, the nurse must makea home visit for each drug administration.SO~CES: L.J. l%y and SF. Grigsby, “Visiting Nurse HOW ~: A suecesti Home l%muwy Venture,” Caring, May 1990, pp.

28-32; site visit by O’lA staff to Handmak or Home Health Services, Inc., fic~ AZ, May 2, 1991./

der participate as subcontractors to other providers They already have systems in place for providingfor a limited portion of home infusion therapyservices (97).7

Although a growing number of Medicare-certified HHAs are proprietary, most are still non-profit (e.g., many visiting nurses associations) andsome are associated with government agencies (e.g.,public health departments) (table 4-1) (372). Conse-quently, the kinds of patients HHAs see may differconsiderably from those seen by other home infusiontherapy providers. Based on conversations withproviders, it appears that HHA infusion patients aremore likely to have additional disabilities (e.g., behomebound) and less likely to have private insur-ance than the infusion patients seen by otherproviders (364). Medicare-certified HHAs see Medi-care patients, while other HDIT. providers may not.

A strength of HHAs is that, since they provide avariety of home services in addition to infusiontherapy, they are in a good position to coordinateservices for patients with multiple health problems.

medical equipment, and their experience with treat-ing patients at home may translate into a greater baseof expertise for patient evaluation and monitoring inthe home setting and identification of the kinds ofenvironmental and emotional barriers that can im-pede effective home care.

A drawback for HHAs providing HDIT is thatthey usually have no in-house pharmacy services,making the availability of 24-hour communicationwith pharmacists familiar with a particular patient’scondition and treatment of greater challenge andconcern. In addition, some HHAs lack the special-ized nursing skills needed to support HDIT services.A few HHAs do specialize in HDIT and have the fullrange of services in-house (347).

Community PharmaciesHDIT’s attraction for community pharmacies lies

in the ability to extend the scope of pharmacyservices beyond those of the traditional ‘comer drug

7 Based on informal surveys conducted in 1990 by NAHC (97).


Table 4-l—Medicare-Certified Home Health Agencies (HHAs) by Ownership,Selected Years, 1974-90

Number of HHAs

Type of HHA 1974 1979 1989 1990

Visiting nurses association . . . . . . . . . . . . . . . .Combined government and voluntarary . . . . . . .Official (government) . . . . . . . . . . . . . . . . . . . . .Rehabilitation facility-based.. . . . . . . . . . . . . .Hospital-based . . . . . . . . . . . . . . . . . . . . . . . . . .Skilled nursing facility-based.. . . . . . . . . . . . . .Proprietary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Private nonprofit . . . . . . . . . . . . . . . . . . . . . . . .Otherb . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Total . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

53252

1,298NA269NANANA178

2.329

52865

1,298NA363NA197461

612.973

47845

9748

1,466102

1,870714

5,721

47845

9528

1,508102

1,918710NA

5,721

NOTE: NA - not applicable. See footnote b.aAvoluntaryorganization (e.g., a~siting nurses association) that receives some operational funding from 90vernment

sources.bln 1974, ‘Cothef’ ind~es rehabilitation faality and skilled nursing faality-based HHAs, proprietary HHAs, and Private

nonprofit HHAs. In 1979, “other” includes rehabilitation facility and skilled nursing faality-based HHAs. In 1989 and1990, each type of HHA is counted as a separate category.

SOURCE: U.S. Department of Health and Human Services, Health Care Financing Administration, Bureau of DataManagement and Strategy, Office of Statistics and Data Management, April 1991.

store.” Pharmacists may view the expansion intohome infusion services as not only a new source ofrevenue but a way to enhance the pharmacy’sreputation as a health care provider (364). Somepharmacies are independent providers of homeinfusion therapy; others operate their home infusionservice as a franchise of larger home infusioncompany (see box 4-C). Pharmacy-based homeinfusion providers may contract with other providers(e.g., an HHA) for the nursing component of theservice if they do not have skilled nurses in-house.Alternatively, a community pharmacy may provideonly the drugs and pharmaceutical services undercontract to another home infusion provider.

Community pharmacies, like HHAs, have theadvantage of being familiar, local sources of serv-ices. They may be an especially valuable source ofHDIT in small communities with no alternative localproviders, where they often cooperate with localhospitals or nursing agencies to provide the fullspectrum of necessary services (see box 4-C). Theymay also be in a better position than larger providersto provide continuity of care, since communitypharmacists may have ongoing familiarity with theirpatients’ health care needs.

On the other hand, few such pharmacists routinelyemploy nurses, and many may not see a sufficientnumber of patients to make the startup and ongoingcosts associated with providing high-quality infu-sion services feasible. Another disadvantage is thatmost existing community pharmacists entered prac-

tice before most pharmacy schools routinely trainedstudents in the variety and depth of skills necessaryfor home infusion therapy (see ch. 3). Such pharma-cists must receive substantial additional trainingbefore they are qualified to provide these services.

Medical Equipment SuppliersMany hospital-based agencies, HHAs, and com-

munity pharmacies that provide home infusiontherapy also provide medical equipment and sup-plies as part of their broader array of services.Conversely, companies that specialize in providingmedical equipment and supplies may expand theirservices to include home infusion therapy. They doso either by acquiring nursing and pharmaceuticalexpertise in-house or by contracting with other homeinfusion providers to supply patients with the drugsand services necessary for their conditions (see box4-D).

The role of contractor to provide deliveriesdirectly to the patient is a natural one for manyequipment suppliers, since it is a relatively minorextension of services they already provide. Acquir-ing sufficient in-house expertise to become a full-service home infusion therapy provider is a muchlarger venture; it may require a greater investment innew areas of expertise for medical equipmentsuppliers than for most other providers expandinginto this service area. Some medical equipmentsuppliers have entered the home infusion market-place by offering coordination services.


Box 44—Example of a Pharmacy-BasedProvider: Vital Care, Inc.

Vital Care, Inc., based in Livingston, AL, is anetwork of parenteral and enteral service supplierslocally owned and operated by independent com-munity pharmacists. The network began with threesites in 1986 and by 1990 had grown to 61 sites inAlabama, Mississippi, Florida, Kentucky, Georgia,Tennessee, and Louisiana. Each franchise operationis capable of providing the full range of homeinfusion therapies, including enteral and parentednutrition, antibiotic therapy, antineoplastic therapy,pain management, and hydration therapy.

Vital Care, Inc. provides franchisees with acomplete initial training program at the franchiselocation. It also offers centralized billing andcollection, patient training materials, quality assur-ance standards, operation protocols and forms,phone consultation, ongoing training in homeinfusion techniques, and technical assistance in avariety of other areas.

All drugs and supplies required for therapy areprovided in-house. Each site has at least a registeredpharmacist, and some have registered nurses onstaff. Generally, if nursing services are required,they are provided by local home health nurses undercontract who have been given additional training bythe Vital Care nurse or pharmacist.SOURCE: J. Hindmaq Director of Marketing, Vital Care, Inc.,

Livingston AL, personal communicdioIL Aug. 30,1990.

Specialty Home Infusion Therapy Providers

Whatever their origins, a number of organizationshave specialized in home infusion therapy to theextent that they have become independent full-rangeproviders of this service. Most of the largest playersin the national marketplace fall more or less into thiscategory; nearly all are for-profit companies. Someare subsidiaries of a larger corporation, while othersare smaller companies that specialize primarily orexclusively in home infusion therapy (see box 4-E).Some are national companies that operate throughbranches in various States and localities, whileothers serve a more limited geographic area. Theprimary characteristic of all of these HDIT providersis that they provide most or all of the nursing,pharmacy, coordination, and equipment-related serv-ices themselves. (Laboratory services are still usu-ally performed in outside clinical laboratories.)

Box 4-D—Example of a Medical EquipmentCompany-Based Provider: Mediq, Inc.

Mediq is a medical equipment supply companythat branched into the home services market viarespiratory therapy in 1975, providing the equip-ment and supplies as well as the respiratorytherapist and other consultative services. In 1984the company branched into infusion therapy on asimilar model. Mediq provides the equipment andmedical supplies, trains health personnel in theirmaintenance and use, and coordinates the servicesof all entities involved in home infusion therapy. Itcontracts with or helps to coordinate the services ofindependent and hospital pharmacies for pharma-ceutical supplies and services (e.g., require thepharmacist to be on call 24 hours a day). Localnurses and patients are trained in home infusiontherapy techniques by Mediq personnel. Mediq’sown specialty nurses are on call and go to patients’homes should problems arise.

The company’s goal is to provide continuity ofcare to patients by utilizing existing resources in thecommunity. It believes its model maybe especiallyappropriate in smaller communities where it makesmore sense to utilize local providers than to have alarge specialist company.SOURCE : L.M. Ferry, ~IliVfXSd Management Systems, k.,

NewtorI Squarq Pi% personal communicatio~ Oct.22, 1990.

The major strength of providers in this category istheir ability to coordinate in-house three centralHDIT services: nursing, pharmacy, and supplies.Specialization may also enable such providers tooperate at a level of economic efficiency thatproviders with smaller caseloads and other functionscannot match. Potential drawbacks of these provid-ers are that they may not find it efficient to provideservices in areas of sparse population, and sincemost such companies are for-profit they may bemore reluctant to provide charity care than smallerorganizations with broader missions and local repu-tations to maintain. Also, companies that specializein home infusion therapy may be poorly positionedto coordinate the diversity of other home careservices that some patients—for example, home-bound elderly patients-need.

Physician-Owned ProvidersSome physicians (or groups of physicians) have

started their own home infusion therapy servicesoutside of the hospital setting. These providers may


Box 4-E-Example of Home InfusionTherapy Specialty Provider: HMSS, Inc.

HMSS, Inc. is a specialized home infusioncompany with 28 locations in 15 States (as of 1989).The majority of its business (55 percent) is inparenteral antibiotic therapy, with the remainder intotal parenteral nutrition (20 percent) and othertherapies (25 percent). HMSS sites typically pro-vide skilled nursing, pharmacy, and medical equip-ment and supplies in-house, with laboratory andgeneral home health nursing services providedunder contract. All billing is done through theHMSS central office in Houton, Texas.

Although only a small proportion (7 percent) ofthe company’s total revenues nationally are fromMedicare and Medicaid, individual sites may see agreater proportion of Medicare patients. SomeHMSS sites have sought Medicare home healthagency certification, while others serve Medicarehome health patients under contract to certifiedproviders, For example, 30 percent of patients seenby a Medicare-certified HMSS site in Phoenix, AZhave Medicare coverage.

Referrals come mostly from national contractswith national health care or insurance companiesand from local physicians to whom HMSS branchesmarket their services. HMSS targets its marketingefforts to surgeons, general and family practition-ers, and infectious disease specialists.SWRCES: i@neHea2thLi#e, VOL XVI, p. 109, Mm. 27, 1991;

HMss, w., I%3m& AZ site visit by OTA staff,May 3,1991.

specialize in therapies relevant to their area orspeciality practice. For example, an oncologist-owned group might provide primarily home antineo-plastic therapy and pain management, while acompany owned by infectious disease specialistsprovides mostly antibiotic therapy (see box 4-F).Some groups may specialize in treatment for aparticular condition, such as Lyme disease (seebelow). Alternatively, physician-based companiesmay provide a wider range of infusion therapies andmarket their services to a large number of physi-cians.

Like other providers, the range of services thatphysician-owned companies provide in-house var-ies. Some may provide only the physician servicesdirectly; others also have in-house pharmacy and nursing. Physician-owned companies may be either

Box 4-F—Example of a Physician-BasedOutpatient Infusion Therapy Provider:

Infections Limited, P.S.

Started in 1981 as part of a clinical investigationof the use of the antibiotic ceftiaxone for thetreatment of ostomyelitis, Infections Limited, P.S.,is now a full-fledged outpatient parenteral antibioticprogram offering a wide range of antibiotic thera-pies. The program is based in the office of a groupof five infectious disease specialists who employfive intravenous (IV) therapy nurses, a pharmacist,a pharmacist technician, microbiologists, and othersupport personnel.

Patients are trained either in the hospital or in theoutpatient center by an IV nurse from the center.They receive all skilled services in the outpatientcenter, where they are seen by an IV nurse every 3to 4 days and by a physician at least weekly. Mostpatients self-administer their antibiotics at home,although a few prefer to come into the outpatientcenter to have them administered. Medicare pa-tients are only infused in the outpatient centerbecause the cost of the drugs is not covered if theyself-administer. The outpatient center is open 7 daysper week and staff are available by phone 24 hoursa day.

Currently, the program serves an average of 30patients each day. Patients are referred either by oneof the group’s own physicians, all of whom consultat local hospitals, or by other physicians who arefamiliar with the program’s services.SOURCE: A.I). Tice, “An Office Model of Outpathmt Parm-

teral Antibiotic Therapy,” Reviews # I#ecfioza~iseuses 13(Suppl. 2):S184-188, 1991+

office-based, where patients visit the office or centerfor most of their HDIT needs; or home-based, wherenurses provide all needed services at the patient’shome.

Potential advantages to physician-owned and-operated infusion companies include increasedcommunication between physicians (both inside andoutside the company) and other health professionalstaff, and increased frequency of physician contactwith patients. Physician-owned providers also enjoythe potential for local market monopolizationthrough self- and peer-referral networks. Althoughthese providers might view such monopolization asan advantage, payers might not (see ch. 7).

Chapter4—The Home Drug Infusion Industry .79 .

Box 4-G-Specialized Home InfusionTherapy Providers: Cystic Fibrosis

Fondation Home Health Services, Inc.

The Cystic Fibrosis Foundation (CFF) enteredthe home infusion therapy business in January 1990as a nonprofit organization that provides intrave-nous drugs and supplies to cystic fibrosis patientson home therapy. CFF seined approximately 300patients in its first year of operation, averagingabout 20 patients at any one time.

CFF provides pharmacy services in-house andmails the drugs overnight to its patients. Nursingservices are provided by local nursing agenciesunder contract, and physician consultation is avail-able from physician specialists in the nationaloffice. Transportation, which is used for marketingand for travel to inservice training at local nursingagencies, accounts for a significant proportion ofthe program’s costs. In some large cities where theyexpect to have at least some patients, staff doinservice training prospectively at visiting nursesassociations or other home health agencies (HHAs);in other cases, they must travel to a previouslyunidentified HHA in a new city after a patient hasbeen identified.

Because cystic fibrosis patients are the onlyclients, CFF’s inservice training is more disease-focused than that provided by other home infusioncompanies. Local nurses are trained not only ininfusion technique but also in how to monitorpatients for other potential conditions not immedi-ately related to infusion therapy that might signalchanges in the well-being of patients or in thecourse of their disease.SOURCE: X3. Pax- Vice Pmsideng Cystic Fibrosis Rxmda-

tionHmneHealth Services, Rockville, MD, personalcQImmmi@m‘ m TAX. 4, 1990.

Other HDIT Providers

Although most HDIT providers fall into at leastone of the above categories, other types of organiza-tions may also expand their services to includeHDIT if they see sufficient demand in their servicepopulation. The Cystic Fibrosis Foundation, forexample, in 1990 began providing home infusiontherapy to patients with this disorder across thecountry (see box 4-G). The advantage for patients inthis case is the provision of low-cost services that arecoordinated by individuals with in-depth knowledgeabout the underlying disorder. Disadvantages arethat the scope of services may be limited and there

may be logistical difficulties in providing services topatients in distant locations.

One very recent example of a specialized provideris Women’s Homecare, Inc., a network of physician-owned women’s home obstetrical and gynecologicalhealth care providers (164). This new company is ajoint venture of Tokos Medical Corp., a companythat manufactures home uterine monitoring devicesand operates 70 company-owned home uterinemonitoring locations nationwide, and T2 Medical,Inc., a national company that owns or managesapproximately 145 physician-based home infusiontherapy providers. Women’s Homecare locationswill combine home uterine monitoring and associ-ated IV therapies to serve high-risk obstetric pa-tients. In the future it may branch out to providehome IV antibiotic therapies for a wider range ofgynecological indications (164).

Another specialized physician-based provider,Preferred Physicians Infusion Center, Inc. (PPIC), isthe result of a recent joint venture between thenational home infusion company Preferred Home-care of America, Inc. and a local physician specialtygroup in Monmouth County, NJ (162). PPIC, aclinic-based infusion center, specializes in IV antibi-otic therapy for patients with Lyme disease. It wasdeveloped to serve the growing need for suchtherapy in Monmouth County, which reportedly hasthe Nation’s highest incidence of Lyme disease(162).

Economic Characteristics of the HomeDrug Infusion Marketplace

Market ConcentrationThe home infusion market is characterized by a

few large firms that dominate the national market, anumber of midsized companies that individuallyhave very small national market shares but strongshares in certain regions of the country, and manysmall providers. Table 4-2 presents one estimate ofthe relative national market shares of eight of thelargest home infusion providers in 1988. Caremarkhad by far the largest share of any single provider inthat year, with other major providers holding sharesranging from 1 to 6 percent. Between one-third andtwo-thirds of the total market, on the other hand, wasin the hands of small providers, most of whomindividually had less than 1 percent of the nationalmarket (289,307).


Table 4-2—Relative Share in the Home Infusion Marketof Eight National Proprietary Providers, Estimated

1988 and Projected 1991a

Company 1988 1991

Caremark . . . . . . . . . . . . . . . . . . . . . . . . . . .New England Critical Careb . . . . . . . . . . . . .Home Nutritional Servfces . . . . . . . . . . . . . .HMSS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .National Medical Carec. . . . . . . . . . . . . . . . .Care Plusb . . . . . . . . . . . . . . . . . . . . . . . . . . .Continental Affiliates. . . . . . . . . . . . . . . . . . .T 2 d

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Other . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

37.3%4.14.03.02.51.92.82.8

41.9

29.3%7.14.24.74.22.42.22.7

43.3aind~es revenues from tOtf31 pfirded WhftiOfI.b]n Feb~ary ISW, after these projections were made, New England

Cntieal Care merged with Care Plus to form Critical Care of America, Inc.clnci~ revenue projections for Infusion Care, acquired by National

Medical Care in January 1989.dw~ on estimat~ revenues of the partnerships it manages.SOURCE: Prudential-Bache Securities, Inc., New Eng/and Critica/ Care

Company F@oti(New Yo~ NY: Prudential-8ache Seeurfties,Inc., 1990).

Consolidations among the larger providers andnew entry by small providers have been the rule inthe past few years. Caremark, for example, is theproduct of two major acquisitions of other compa-nies during the 1980s by Baxter-Travenol, a majormanufacturer of medical equipment and supplies.Recently, New England Critical Care purchasedCare Plus, a move which will most likely position itsolidly in second place behind Caremark (161).

At the other end of the spectrum, a growingnumber of community pharmacists are expandinginto the home infusion business, as evidenced by therapid growth of pharmacy franchise companies.Vital Care, Inc., for example, expanded its numberof franchise pharmacies from 3 in 1986 to 61 in 1990(see box 4-C) (158). O.P.T I.O.N. Care, which hasbeen growing at a rate of 20 or 30 franchises per yearfor the last 4 years, currently has 182 franchisesthroughout the country (272). The Parenteral andAlimentation Provider’s Alliance, an association ofindependent pharmacies that have cooperative grouppurchasing arrangements, increased in size from 3participating pharmacies in 1987 to 30 in 1990(109).

As with pharmacies, HHAs view home infusionas a natural and profitable expansion of theirbusinesses. For most HHAs, infusion is only a small

part of their total home nursing and supply business,but where HHAs are large even this small proportionmay amount to a large total number of patients anda significant source of revenues. For example,Kimberly Quality Care, a large home health servicesprovider with 409 branches throughout the country,8

served 2,941 home infusion therapy clients9 in 1990,but these patients made up only 0.7 percent of itstotal national client population for that year (333).

Providing nursing services for home infusionpatients has been a natural extension of the generalhome nursing done by HHAs, and most HHAs haveprobably now served at least some such patients. Anumber of HHAs, however, are establishing teamsof IV nurses and even in-house pharmacies tobecome more comprehensive providers of infusionservices, placing them in direct competition with thehome infusion speciality companies (see box 4-B)(338,347,390). In some cases, high concentrations ofAIDS patients in the HHAs’ vicinities have servedas a catalyst for expansion into full-scope homeinfusion therapy services (163,338).

Hospital-based home infusion services are com-mon as well, although there seems to be littleindication that these providers are increasing innumber as fast as other market participants (307,364).

Although individually each of the many smallhome infusion providers represents a negligibleshare of the total national market, they can have asubstantial share of the local markets in which theyoperate. Hospitals, HHAs, and community pharma-cies are often locally well-established and well-known, and they may be successful in luring manyinfusion patients-and the physicians who referthem-away from the larger national companies.Some companies have capitalized on this localadvantage. Vital Care and O. P.T.I.O.N. Care, forexample, concentrate on marketing their franchiseoperations to community pharmacies in small- tomedium-sized towns, where patients and physiciansoften have strong loyalties to the familiar localpharmacies and where the advantages of the larger,more centralized national companies are lessened(158,272).

8 As of January 1990, 170 of these branches offered full-service home infusion therapy services (333).g Excludes ent~ nutrition patkslts.


Providers’ Scale and Scope of Services

Although small providers often have the advan-tage of local reputation, the large national homeinfusion providers have the advantages that accom-pany economies of scale. Large companies with highpatient volume can afford to invest in specializedpersonnel, so that nurses with particular expertise(e.g., in antineoplastic therapy) can be assigned topatients with relevant problems. In addition, largecompanies can recruit young pharmaceutical andnursing staff with recent clinical and infusionexperience, eliminating much of the need for re-education that some retail pharmacists and homecare nurses must undergo before entering the infu-sion therapy field (364).

The centralized billing capability of many largeproviders also has distinct advantages; since homeinfusion therapy is still a relatively young field,many insurers do not have clear rules regarding howand what to pay for, and those that do differ in theirguidelines and billing requirements (364). Personnelwho can devote their full time to learning theintricacies of different payers’ policies are probablymuch more successful in getting the claims paid.

The advantages that attend some of these econo-mies of scale explain the popularity in the industryof organizations that fulfill some of these functions.Pharmacy franchises and purchasing associations inparticular example the match between local busi-nesses and access to central billing, educational, andmarketing expertise.

The home infusion industry may also have someeconomies of scope. Few providers offer only homeinfusion services. The great majority branched intohome infusion services or products as an extensionof previous business in pharmaceuticals, medicalsupplies, home nursing, or other health care services.For large providers, such as Caremark, the otherbusiness of the parent company-in this case, supplymanufacturing-can provide low-cost inputs intothe infi.mien business, while the experience in homeinfusion can in turn provide ready feedback ontechnological innovations in supplies. For smallproviders, such as HHAs and community pharma-cies, the basic business of home nursing, retailpharmacy, or medical equipment supply also pro-vides the stable source of revenue that could beendangered by low and volatile patient volume in theinfusion business.

The advantages of providing complementaryservices are often great enough to encourage infusion-only providers to branch into related areas. Forexample, Abel Health Management Services, Inc., aprivately owned firm in New York, began as a smallhome infusion company in 1985. Its separate divi-sions now include not only a pharmacy and aninfusion nursing service but also a medical equip-ment supply company, a long-term nursing careservice, and a diagnostic laboratory (3).

Ease of Entry Into the Market

During the 1980s home infusion was a fast-growing industry, and the prospect of profits hasdrawn a multitude of new providers. In hardimmediate dollars, the costs of starting up a homeinfusion business have been relatively low for manysmall providers; some companies have reportedstartup costs of as little as $100,000 (153). Contract-ing for or cooperatively providing services notprovided in-house (e.g., pharmacy or nursing serv-ices) lowers fixed startup costs and is undoubtedlywhy such arrangements are common among smallerproviders. (Because of the travel costs associatedwith home delivery and nursing, however, evenlarge companies often contract for some services inareas distant from their central facilities.)

The greatest startup costs for most new providersare probably the acquisition of resources (i.e.,personnel and equipment) and the costs of marketingthe service to get referrals (364). Relevant phar-macy, nursing, and management expertise in homeinfusion therapy differs from that in other areas ofhealth care, and it must be acquired either by hiring(or consulting with) personnel who already have it orby spending the money to train those who do not.Marketing costs can be high, especially if thegroundwork has not been laid by existing homeinfusion providers and the new entrant must take onthe task of educating the physicians and hospitalpersonnel regarding the possibilities and advantagesof home therapy. The importance of expertise andmarketing as components of startup costs mean thatways to reduce these costs-e. g., through purchas-ing marketing and expertise through a franchisearrangement-are a mechanism to ease entry intothe market.

The prospect of profits to be made in the industryhave attracted new entrants despite some of thesestartup costs. Because home infusion is still largely


Box 4-H—Alternatives to Service-Intensive Infusion Therapy

The traditional alternatives to infused drugs are oral drugs, which when appropriate are usually both simplerand cheaper to administer. When parenteral drugs are preferred, the reason is usually greater drug effectiveness; theusual reason for prescribing intravenous antibiotics, for example, is that oral antibiotics have proven (or are expectedto be) insufficient to get rid of the infection (see ch. 2).

New, more potent forms of oral drugs, however, can sometimes compete with intravenous (IV) drugs. Forexample, oral ciprofloxin, one of the recently developed fluoroquinolone antibiotics, is often effective in treatingosteomyelitis caused by certain ● organisms (126). The drug is, with good reason, regarded by the home infusionindustry as a competitor to IV antibiotics for this use (289).

Changes in equipment technologies have broadened the range of drug infusion alternatives available for someconditions, HDIT, as described in this report, uses external infusion devices and is often service-intensive. Forantineoplastic therapies, in which total liquid drug volume is small, tiny infusion pumps that are surgicallyimplanted in the body, and replenished with the drug at the physician’s office, are an alternative to similar drugsadministered by an external infusion pump that the patient must operate.

Other technological advances may result in alternatives to HDIT in the future. Medicated patches that graduallyrelease a drug absorbed through the skin, for example, could replace other forms of administration for some drugs.A transdermal patch for an analgesic, fentanyl, was recently introduced in the United States for management of painin cancer patients, offering an alternative to IV analgesics for some patients (275). Slow-release implanted drugs(e.g., the recently approved contraceptive Norplant) could offer another, similar “infusion” alternative to theservice-intensive kind of HDIT described here.

viewed as an alternative to hospital care, and associated revenues—within the hospital’s domain.because hospital charges are relatively high, homeinfusion providers have probably often been able tocharge prices considerably higher than their actualcosts (see ch. 6). Payers have apparently beenrelatively insensitive to differences in prices amonghome providers as long as these providers canconvince payers that total home charges will be lessthan total hospital charges. Lower profit margins, aspayers become more discriminating, may discour-age some new entrants.

Alternatives to HDITThe demand for HDIT and the growth of the

industry depend in part on the existence of alterna-tives. Some alternatives take the form of new, lessservice-intensive ways administering the therapy(box 4-H). When service-intensive infusion therapyis necessary, however, there are four basic alterna-tives to home care as the site of therapy: hospitals,outpatient clinics, physicians’ offices, and nursinghomes.

At present, the home infusion industry still viewsits main “competitors” as hospitals and has devotedmost of its efforts to wooing patients away fromthese institutions. One result has been to encouragesome hospitals to enter the home infusion marketthemselves in order to keep their patients-and the

Despite this incentive, and despite the relativeadvantages of having in-house trained clinical phar-macy and infusion nursing staff, hospitals appear tobe less successful than some other types of providersin making the transition to providing HDIT unlessthey have previous experience with home care (e.g.,an in-house HHA), or they can successfully combineHDIT with hospital outpatient-based nursing serv-ices (15,177,307).

Other sites of care, however, may develop asfuture competitors. Physicians’ unwillingness torefer patients away may result in increasing amountsof infusion care being provided in physicians’offices and outpatient clinics, where concomitantbillable physician visits can also take place (see box4-F). These sites have the advantage of greaterprofessional oversight of infusion and lower pro-vider costs associated with travel. Because physi-cians control referrals, however, these arrangements-and others where physicians are co-owners of theHDIT providers-can result in market monopoly, asmentioned above.

In a typical outpatient HDIT setting (either ahospital outpatient center or a physician’s office),patients come to the center for the professionalservices they require (e.g., peripheral catheter rota-tion, laboratory work) and perform the remainder of

Chapter4—The Home Drug Infusion Industry .83

tasks (drug administration, catheter flushing) bythemselves at home (15,335) (see box 4-F). Anadvantage to this type of arrangement is thatoutpatient settings provide greater access to theprofessional resources required to address specifictherapy-related problems than in the home setting.For example, if a nurse in an outpatient centernotices site imitation in a patient, he or she canimmediately involve other health professionals (e.g.,a physician or clinical pharmacist) in determining anappropriate course of action to treat the problem andavoid serious infection.

Another advantage to the outpatient clinic as thesetting for routine professional services for HDIT ishealth system cost. For patients who are ambulatory,who only need to be seen professionally everyseveral days, and who live reasonably near anoutpatient center, extra professional costs associatedwith home visits (transportation, reimbursement fortravel time, additional paperwork, and interprofes-sional communication) can be avoided.10

Nursing homes may also become more significantplayers in providing infusion therapy if cost con-straints imposed by health insurers make this settingrelatively attractive. Some health maintenance or-ganizations, for example, refer infusion patients tonursing homes if they expect the costs in this settingto be less than home care costs (389).

Some nursing homes may be better equipped toprovide the required services than others. Currently,nursing home patients who require infusion therapyusually have to be transferred back to an acute-carehospital because the nursing facility lacks theresources to provide skilled infusion therapy serv-ices. A 1985 study of one nursing home found that17 percent of its patients had to be admitted to thehospital during a l-year period (344). The studyestimated that one-third of these transfers could havebeen avoided if the nursing home had had the staffand other resources required to administer infusiontherapy (344).

Some skilled nursing facilities (SNFs) have re-sponded by implementing infusion therapy trainingprograms for their staff and establishing specialinfusion therapy units to handle the needs of patientswho would otherwise have to be readmitted (62).Other SNFs purchase the specialized services ofhome infusion companies, who send nurses and/orpharmacists to the facility as much as they would ifit were the patient’s own home (see ch. 4). In somecases, home infusion companies themselves trainstaff at the nursing facility to perform skilled tasksassociated with infusion therapy (364). Home infu-sion companies may even operate SNFs (158).

10 ~ ~t ~o~ ~ be fo~d in r~~t c-es in Medicare policy regarding mode of service delivery for home dialysis patients. h 1990, H@Astopped paying for home health aide services for home dialysis patients after Congress agreed that dialysis scxvices were more cost-effective wheudelivered in an outpatient center (Public Law 101-239).

Chapter 5

QUALITY ASSURANCE INHOME DRUG INFUSION THERAPY

ContentsPage

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87

Summary of Conclusions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87Quality Issues in HDIT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88

Patient Screening and Assessment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88’Patient and Family Caregiver Training . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88Patient Rights and Responsibilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89Clinical Considerations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90Staff Qualifcations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90The Role of the Physician ● . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91Service Coordination . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 92

Existing Standards for HDIT Providers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 92Standards Issued by National Organizations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 92Standards Issued by Health Insurers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93Developing Quality Indicators for HDIT Providers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93State Regulation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95

The Federal Role in HDIT Quality Assurance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 96Current Medicare Quality Assurance Efforts Relevant to HDIT . . . . . . . . . . . . . . . . . . . 96Proposed Requirements Under the MCCA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97Determining Provider Compliance With Conditions of Participation . . . . . . . . . . . . . . . 101Case Review: Role of Medicare Peer Review Organizations and Fiscal

Intermediaries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103Quality Assurance for Beneficiaries Who Receive Care Through Risk-Based

Contracts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107

BoxesBox Page5-A. Blue Cross and Blue Shield of the National Capital Area Standards

for Participating Home Care Providers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 945-B. Quality Assurance in Home Care . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 955-C. The Medicare Peer Review Organization (PRO) Review Process . . . . . . . . . . . . . . . . 1045-D. Proposed Scope of PRO Review for Home IV Drug Therapy Services Under

the Medicare Catastrophic Coverage Act of 1988 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 106

TablesTable Page5-1. Factors Affecting Compliance in Home Intravenous (IV) Antibiotic Therapy

Patients . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 895-2. Examples of Home Infusion Nurse and Pharmacist Skills . . . . . . . . . . . . . . . . . . . . . . . 91

Chapter 5

QUALITY ASSURANCE IN HOME DRUG INFUSION THERAPY


As described in previous chapters, home druginfusion therapy (HDIT) is a high-technology,invasive service that can pose considerable risk topatients. Complications of therapy are potentiallymore serious in the home than in the hospital,because health personnel are not be immediatelyavailable to recognize and treat them. HDIT isfurther complicated in that it requires the coordina-tion of multiple services (medical, pharmacy, nurs-ing, laboratory, and supply) that are often providedby separate entities. If Medicare were to providecoverage for HDIT services, it would want toimplement some measures to protect beneficiariesfrom inappropriate and substandard care. This chap-ter examines what measures might be possible.

The chapter first discusses key issues in HDITquality assurance at the provider level and reviewsexisting standards for HDIT Next, it reviews pastand present Federal quality assurance efforts inhome care generally and in home infusion therapyspecifically. Finally, the chapter examines the po-tential Federal role in assuring the quality of HDITservices provided to Medicare beneficiaries.1 In thislast task, the chapter reviews and critiques some ofthe requirements that might have been imposed uponproviders in the wake of the Medicare CatastrophicCoverage Act of 1988 (MCCA)2 (which was re-pealed before proposed regulations could be madefinal). It also examines potential roles for Medicinepeer

●

review organizations (PROS).

Summary of Conclusions

The complicated and invasive nature of HDIT,the limited knowledge about the safety andeffectiveness of some therapies in the homesetting, and the comparatively frail healthstatus of some Medicare beneficiaries warrantrigorous Federal oversight of HDIT quality

assurance at least at the outset of a Medicarebenefit, if not on a continuing basis.

The degree to which Medicare can rely on Statelicensure and certification as a means ofassuring HDIT quality is extremely limited.State regulation of HDIT providers is stillabsent in most States and inconsistent amongStates where it does exist. Federal policy couldhelp to focus and standardize State HDITregulatory efforts.

The most consistent measures of HDIT pro-vider quality currently available are standardspublished by the Joint Commission on theAccreditation of Healthcare Organizations(JCAHO) and the National League for Nurs-ing’s Community Health Accreditation Pro-gram (NLN/CHAP). However, accreditationthrough these channels can be costly to obtain,and many existing providers have not sought it.Thus, Medicare should rely on State agencies,acting under explicit and consistent guidelines,to determine initial and continuing compliancewith any conditions of participation (COPS)that Medicare develops. This will undoubtedlymean that some providers will need to seekmultiple certification (e.g., compliance withJCAHO standards for private insurer reim-bursement, State licensure requirements forfacility operation, and an additional set ofCOPS for Medicare reimbursement), whichmany will find burdensome. Eventually, JCAHO-and NLN/CHAP-accredited HDIT providerscould be granted “deemed status” if accredita-tion standards were commensurate with Medi-care’s COPS.

Individual case review at some level is criticalto assuring safety, appropriateness, and consis-tency in HDIT PROS could conduct at leastretrospective review of a random sample ofHDIT cases. Prior authorization by PROS for100 percent of HDIT claims would be administ-ratively costly and may not be necessary. As an

10TA defines “quality of health care” as the evaluation of the performancee of health care providers according to the degree to which the processof care increases the probability of outcomes desired by patients and reduces the probability of undesired outcomes, given the state of medical knowledge.Which elements of patient outcomes predominate depends on the patient condition (363).

2 fib~c ~w l(_)&360.

-87-


●

●

●

●

alternative, prior authorization, performed byeither PROS or fiscal intermediaries (FIs),3

could be reserved for certain therapies orcertain patients who are determined to be atincreased risk.

Physician involvement is key to safe andeffective delivery of HDIT services. To ensureappropriate physician oversight in the event ofa Medicare benefit, HCFA could developspecific requirements or incentives and couldcharge PROS with reviewing compliance at thecase level.Although many patient care services may beperformed under contract rather than directlyby an HDIT provider, certain functions shouldremain the primary responsibility of the pro-vider. These functions include: initial patientassessment; quality assurance; maintaining clin-

ical records; periodic drug regimen review;coordinating all HDIT services; guaranteeing24-hour a day, 7-day a week availability ofemergency services; and serving as the initialpoint of contact for patients in the event ofquestions, concerns, requests for supplies, andany emergencies.Because many of these functions require theexpertise of a professional nurse well-versed inHDIT practice, an HDIT provider should em-ploy directly at least one registered nurse (RN)whose training and prior experience qualifyhim or her to assume these responsibilities. Inaddition, an HDIT provider should have aqualified pharmacist either on staff or hired ona consulting basis.In the event of an HDIT benefit, Federalpolicies could help both patients and providersprotect themselves from adverse outcomes andpotential legal consequences of those out-comes. For example, providers could be re-quired to ensure that patients understood theirresponsibilities for HDIT and consented tothem in writing. Providers could also berequired to give patients a single telephonenumber they can call in the event of anycomplication or emergency and be assured animmediate personal response.

Quality Issues in HDITOnly the provider can ensure that good quality

HDIT is provided on a day-to-day basis for eachindividual patient. As discussed later, many externalstandards are aimed at ensuring that providers haveinternal procedures for addressing quality-of-careissues. This section discusses some of the areaswhere provider procedures for quality assurance areespecially critical.

Patient Screening and AssessmentAppropriate patient screening is the first and most

important step in HDIT quality assurance theprovider takes. For Medicare beneficiaries, who aremore likely than other individuals to have fragilehealth conditions and limited functional capacity,careful assessment is crucial. As discussed inchapter 3, screening requires a thorough assessmentof medical and nonmedical characteristics thatrender a patient appropriate or inappropriate forHDIT. These characteristics include stability of thepatient’s medical condition, willingness of thepatient to undergo home therapy, knowledge andability of patient (or caregiver) to perform self-care,equipment used, type and toxicity of drug, andenvironmental characteristics of the home setting(25).

But a thorough initial assessment also requiresthat the provider consider what types of services it iscapable of delivering in a safe and efficient manner.If a patient requires services that a provider cannotdeliver directly, the provider must either refer thepatient elsewhere or make contractual arrangementsto provide those services. The complicated nature ofHDIT and the variety of factors that can influenceultimate patient outcome demand that patient screen-ing be a multidisciplinary effort involving physi-cians, nurses, pharmacists, and other health profes-sionals as necessary (e.g., a social worker) (131,270).

Patient and Family Caregiver4 TrainingHome care in general poses challenges for quality

assurance because many patient care factors are notunder the direct control of the provider. Proceduresas critical as catheter flushing and intravenous (IV)

3 M~c~e fiw~ h~mfi= include FM B carriers and Part A intermediaries who contract with the Health tie FtiCiIIS ~“ - tration toprocess claims and perform other administrative tasks associated with the Medicare program.

4 “Family caregiver” refers hereto a family memba or friend who assists the patient in self-care responsibilities on an unpaid basis. It does notinclude paid caregivers such as home health aides, for whose actions the employing agency is legally responsible.

Chapter 5-Quality Assurance in Home Drug Infusion Therapy .89

drug administration are often performed by thepatient without any supervision. A broad range offactors can affect the degree to which a patient is ableor willing to comply with self-care instructions(table 5-l).

Providers exercise control over the quality ofself-care techniques through comprehensive trainingof the patient and family caregiver. These techniquesare not trivial to learn. In a recent survey, 92 percentof primary care physicians felt that patients andfamily members could be taught general self-care,but only 47 percent felt their patients could be taughtthe complex level of self-care required for HDIT(342). Medicare beneficiaries with fictional orcognitive limitations may find it especially difficultto perform certain procedures safely (134). In thesecases, additional skilled nursing services may benecessary to ensure good-quality care (134) (see ch.3).

Providers can undertake some specific measuresto assure the quality of patient education. Theseinclude:

●

●

●

●

The use of standardized teaching and referencematerials (210,296). Patient instruction manu-als should be written on a level that patients canunderstand (90,240,296).Continuity in training with equipment andsupplies. If a patient is trained on one infusionpump and sent home with another, for example,he or she might not know how to start or stopthe pump (390).Continuity among instructors in patient in-struction (e.g., dressing changes and aseptictechnique). Teaching different ways of under-taking self-care techniques can cause confu-sion, leading to poor performance of self-caretasks (210).Beginning patient training before hospitaldischarge (for patients whose therapy is initi-ated in the hospital) (240,296,364). Ideally, toensure that the patient can transfer what he orshe has learned to the home setting, a nurse orpharmacist would visit the home to observe thatpatient or family caregiver administer the frosthome dose (240,364).

Patient Rights and ResponsibilitiesExisting standards for HDIT providers all require

that the primary provider assume legal responsibilityfor the quality of any services provided to its patients

297-913 0 - 92 - 7

Table 5-l-Factors Affecting Compliance in HomeIntravenous (IV) Antibiotic Therapy Patients

Physiologlcal factorsAgePhysical disabilities

ArthritisParalysisAmputationDecreased or poor visionCast requiring crutches, walker, or wheelchairNeuromuscular dysfunction, multiple sclerosis, Parkinson’s

diseaseNeuropathy secondary to diabetes mellitusDiagnosis: duration and severity of diseaseDosing frequency and length of therapyPainLack of fine motor skillsDecreased strength and dexteritySide effects of medicationsPoor venous access requiring central line placement

Psychosocial factorsEducationLack of care partnerDesire to go homeExternal locus of controlSocioeconomic statusHome environmentCommunity resourcesStorage/refrigeration spaceFear/isolationDecreased socialization (especially with multiple IV antibiotics

and frequent dosing)Cost/Insurance coverageSleep deprivation from frequent dosingOther family responsibilities (e.g., mother with small children, ill

spouse or parent, work, school)Altered body image due to heparin Iock/central lineDenial of diagnosis requiring IV antibiotic therapyInaccessible floor plan in home

Nursing/rnaditxl supportLack of adequate patient education programUnclear understanding of rationale of therapyInaccessibility to nursing personnel on a 24-hour basisPoor home followup by home care agency

SOURCE: Adapted from M.S. Neiderpruem, “Factors Affecting Compli-ance in the Home IV Antibiotic Therapy Client,” Journal of/intravenous Nursing 12(3):136-142, May/June 1989.

on a contractual basis. They also require that theprovider have written policies describing whatspecific services it is capable of providing and underwhat types of arrangements it provides them (178,230,237). Most standards require nurses or otherhealth personnel to document that patient training inself-care techniques has been completed satisfacto-rily (42,178,237).

The nurse’s documentation does not itself consti-tute a patient’s assertion of shared risk-i.e., that thepatient understands his or her responsibility forself-care to reduce the risk of adverse health events.To effect such an assertion, the HDITprovider could


be required to detail in writing those aspects of carefor which the patient is responsible and have thepatient acknowledge that responsibility by readingand signing an agreement.

Cost to the patient has been cited as a factor thatcan affect patient compliance in HDIT (240) (seetable 5-l). To minimize patient concern aboutunexpected costs associated with therapy, providerscould be required to inform patients before therapystarts about which specific items and services arecovered, which are not, and what the patient’s costshare will be.

Clinical ConsiderationsOne of the greatest risks of infusion therapy is risk

of secondary infection. Strategies for minimizingthis risk in the home include:

careful aseptic preparation of drugs and fluidsto be infused;using the aseptic technique (see ch. 3, box 3-A)each time the line is accessed or the catheterexit site is exposed (e.g., during drug adminis-tration, dressing changes, catheter care);minimizing the number of times the patient’scatheter, the administration set, or the containerof infusate are exposed or changed (since eachexposure increases the potential for contamina-tion);periodically replacing devices or parts of theequipment that are subject to contamination(e.g., peripheral catheters, administration sets,falters, injection caps); andutilizing in-line antimicrobial filters (unlesstheir use is contraindicated-see ch. 3) toeliminate possible contaminants from the in-fusate before it enters the vascular system.

To ensure that all these steps are followed, allpatients, family caregivers, and patient care staffmust be instructed in and be able to demonstrate therequisite techniques and precautionary measures.

Although patients may be expected to performroutine tasks associated with their therapy, theymust have access to emergency assistance shouldany complications arise. The invasive nature andpotential risks of HDIT demand that emergencyservices be available on a 24-hour a day, 7-day aweek basis (174,178,230,240,248). This means thatinfusion provider staff (e.g., nurses and pharmacists)and the patient’s physician must always be within

reach by phone and able, if necessary, to see thepatient personally or deliver emergency suppliesimmediately. To avoid patient confusion, providersmay give the patient a single number to call in orderto report any kind of emergency or problem. Thestaff person who answers that call can then immedi-ately contact the appropriate staff, contract employ-ees, or, if necessary, the physician, to respond to thesituation.

Staff QualificationsRegardless of how well organized and coordi-

nated the services of an HDIT provider are, thequality of patient care will suffer if the individualstaff members who provide those services are notadequately qualified to do so. HDIT involves avariety of skilled techniques with which the averagenurse and pharmacist are not likely to be familiar(see table 5-2).

As discussed in chapter 3, formal training andcertification in certain areas of specialty practicemay be reasonably good indicators of staff capabil-ity and experience, but they do not guaranteeproficiency in any given skill area. For example, acertified advanced practice RN may have difficultyinserting traditional peripheral catheters, while abasic RN who has pursued special training may beproficient in a technique as advanced as PICC(peripherally inserted central catheter) line place-ment. State pharmacy regulations in some cases actas indirect controls over general pharmacist qualifi-cations, but they rarely offer a direct mechanism forassessing specific proficiencies (63). The burdentherefore falls upon the employer to determine staffproficiency through employment screens, educa-tional requirements, and on-the-job training inspecific techniques.

In addition to knowing certain requisite tech-niques, skilled staff must be receptive and adaptiveto the constant stream of new technologies thatquickly become state-of-the-art in HDIT Recenttechnological advancements in home care have ledhome health agencies HHAs) and other home careproviders to seek more highly skilled staff and tooffer more in-service training in the use of newtechniques and equipment (12,182). A 1987 study of287 HHAs, for example, found that venipuncture,physical assessment, patient teaching, and IV ther-apy management skills were among the most highlyranked qualifications sought in agency nursing staff

Chapter 5-Quality Assurance in Home Drug Infusion Therapy .91

Table 5-2—Examples of Home Infusion Nurseand Pharmacist Skillsa

Nurse skills●

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●

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●

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●

Traditional peripheral catheter insertionPeripherally inserted central catheter (“PICC line”)placementCatheter maintenance and repairFamiliarity with equipment and supplies used in drugadministrationAwareness of potential side effects of specific therapeuticregimensAbility to recognize and treat infusion therapy-relatedcomplicationsAbility to practice autonomouslyPatient trainingAbility to communicate effectively with the patient,pharmacist, and other staffAbility to assess infusion-associated emergencies andundertake appropriate steps

Pharmacist skills● Compounding drugs for infusion. Thorough knowledge of infusion drug stability and

compatibility● Thorough knowledge of potential infusion drug side effects. Knowledge of therapeutic alternatives in the event of

complications. Familiarity with equipment and supplies used in drug

administration● Ability to communicate effectively with physicians, nurses,

and other staff. Ability to communicate effectively with patients directly. Ability to assess infusion-associated emergencies and

undertake appropriate stepsaSki119 ty@=l& bated with home infusion therapy provision. Not all

home infusion nurses and pharmacists need to be profident in all skillslisted. Larger home infusion providers maydivideresponsibilities betweenstaff who specialize in one or more skill.


(182). Similarly, pharmacists must be up to date onnewly emerging home therapies in order to advisephysicians, nurses, and patients of therapeutic risksand alternatives.

The HDIT provider can help to maintain theproficiency of its staff by encouraging, mandating,and even providing ongoing education in newtherapies, technologies, and techniques. The FederalGovernment can help ensure staff quality by requir-ing providers to offeror facilitate staff access to suchtraining and by requiring that providers evaluate anddocument staff proficiency on a regular basis. Aprecedent under Medicare is the requirement thatcertified HHAs provide in-service education andcompetency evaluations for home health aides (SSAsec. 1891(a)(3)). Regulations issued by HCFAspecify requirements for the curricular content ofhome health aide training programs (54 F.R. 155).

The Role of the PhysicianThe referring physician is the critical gatekeeper

in HDIT. It is the physician who is responsible forprescribing the therapy, ordering all services pro-vided to a patient, and consulting with HDIT staff inthe event of any complications (121,178,237). Thepatient’s physician must also be readily available forboth emergency and routine consultation (e.g., todiscuss lab results or changes to the therapy).

Because the physician bears responsibility for theplan of care, safe and effective delivery of HDITservices by the provider depends on the physician’sunderstanding of the services and willingness toparticipate in care. However, the Office of Technol-ogy Assessment’s (OTA’s) discussions with physi-cians and HDIT providers suggest that physiciansvary in their understanding of HDIT services andtheir willingness to play an active role in patientmonitoring. Ideally, physician abilities should in-clude home health care patient assessment skills;knowledge of home care therapies and technologies;knowledge of when to recommend specific non-physician home health services; ability to play anactive and effective role in home health care; andability to evaluate the efficacy of home health careservices and contribute to home health care qualityassurance efforts (12).

Legal, financial, and professional concerns canimpede physician involvement in home care (12).Physicians cite fear of malpractice, lack of compen-sation, and lack of faith in the quality and supervi-sion of home care personnel as deterrents to referringtheir patients to home care (203,342). To date, legalconcerns of physicians regarding home care havebeen largely theoretical, since few if any legalactions have been taken by home patients (12).Because HDIT services are generally delivered bylicensed nonphysician health professionals who,along with their employers, assume legal liability forthe care they provide, a physician’s legal risks fromreferring a patient to HDIT may be no greater thanthose associated with referral to an acute-carehospital (248). However, the potential for physicianliability-particularly where high-technology homecare is involved-continues to be of concern,particularly where the physician feels he or she haslittle control over the conduct of the patient carereceived in the home (12,108,248). In a recentnational survey of 1,100 primary care physicians,


over 60 percent felt there were significant differ-ences in quality of care offered by different HDITproviders (342). Sixty-four percent of the physicianssurveyed preferred providers who could offer bothHDIT and general, comprehensive home health careservices (342).

In the event of an HDIT benefit under Medicare,several strategies would be available to encourageadequate physician involvement in HDIT. For ex-ample:

●

●

●

Regulations could require a minimum fre-quency of physician-patient and physician-provider contact. The appropriate frequencywould probably vary depending on the type oftherapy and the patient’s overall medical condi-tion.Medicare could provide financial reimburse-ment for the time physicians spend monitoringtheir HDIT patients (see ch. 7).Physicians could be involved in the develop-ment and periodic review of providers’ intro-dquality assurance programs. This activity mightincrease physicians’ sense of control over thequality of home services they prescribe for theirpatients.

Service CoordinationThe decentralized nature of HDIT services poses

an additional challenge for quality assurance. OTA’sdiscussions with HDIT providers and patients stronglysuggest that communication between the patient,referring physician, all HDIT staff, and any otherparties either directly or indirectly involved in thepatient’s care are key to goodquality care andfavorable outcome of therapy. Communication andcoordination may be of particular concern to provid-ers who subcontract pharmacy or nursing services.

Furthermore, some elderly patients require homecare services beyond those generally required byyounger, healthier patients on HDIT (e.g., homehealth aide services) (see ch. 3). Coordinating HDITwith general home health services (e.g., making surehome health aide staff are aware of the patient’sHDIT regimen) can improve quality of care, reduceconfusion for the patient, and cut overall costs ofcare by eliminating unnecessary duplication ofservices.

Many existing specialized HDIT providers havelimited experience with elderly patients who requireadditional home services (see ch. 4). Of the varioustypes of HDIT providers, Medicare-certified HHAsare probably the most likely to have had experiencein coordinating these services because they providethe full range of Medicare-covered home care.Under anew Medicare benefit, Federal policy couldaddress these issues by establishing explicit require-ments for coordination of services between allagencies or individuals involved in patient care.

Existing Standards for HDIT Providers

Standards Issued by National OrganizationsStandards developed by national organizations

often serve as models for Medicare provider require-ments. Existing published standards for HDIT pro-viders or services, which vary in scope and detail,address areas such as:

● protocols and procedures for patient assess-ment and care,

● equipment and facility standards,. staffing requirements and qualifications,. the physician’s role, and. internal quality assurance program require-

ments.

Some of these standards are issued as guidelinesfor voluntary accreditation; others, for purposes ofgeneral reference and guidance. The two organiza-tions currently offering accreditation for HDITproviders are JCAHO and NLN/CHAP (237). Otherorganizations that have issued advisory or modelstandards applicable to HDIT include the NationalAlliance for Infusion Therapy (NAIT)5 (230), theIntravenous Nurses Society (INS) (174), and theNational Association of Boards of Pharmacy (231).Most of these standards have been developed duringthe past few years and have undergone frequentrevisions.

Although an increasing number of HDIT provid-ers are obtaining accreditation, others have notpursued it. As of September 1991, JCAHO hadaccredited approximately 920 home infusion provid-ers, including freestanding infusion companies,hospital-based providers, and visiting nurses associ-ations that provide HDIT under contract (33).NLN/CHAP, which began offering accreditation for

5 Fo~erly he i+lj.i~~ for Medical Nutrition.

Chapter 5-Quaility Assurance in Home Drug Infusion Therapy .93

HDIT in late 1989, had accredited a total of 38providers as of November 1991 (95).

It is impossible to determine the actual proportionof existing home infusion providers that are accred-ited because of differences in the way providers arecounted. Depending on the organization of a multi-site provider and the way in which it seeks accredita-tion, JCAHO and NLN may accredit the parentorganization as a whole or each individual branch orfranchise separately (95). Furthermore, because bothNLN and JCAHO have a 3-year accreditation cycle,some providers accredited only for noninfusion-related home health care may have begun to offerinfusion therapy services in the interim. Theseproviders, although accredited, are not accreditedspecifically for HDIT.

Standards Issued by Health Insurers

Some private third-party payers that cover HDITservices have developed specific standards or guide-lines for providers that wish to obtain reimburse-ment. The purpose of these guidelines is both toassure quality and to contain costs.

Blue Cross and Blue Shield of the NationalCapital Area (BCBS/NCA), for example, has issuedparticipation guidelines for home health care provid-ers that specifically address HDIT services delivery(see box 5-A). Although the BCBS/NCA guidelinesdo not specify core staffing requirements, they dorequire that a single provider assume responsibilityfor the provision of all services. They also requirethat the primary provider hire, on at least a consult-ing basis, a licensed pharmacist proficient in infu-sion therapy practice. Under the guidelines, HDITproviders must have written policies and proceduresregarding frequency of physician and staff contact,patient selection criteria, and monitoring require-ments for each type of therapy they provide.Providers who deliver infusion antineoplastic ther-apy and total parenteral nutrition services must meetsome additional requirements (42).

While many standard-both national standardsand those issued by health insurers-require provid-ers to implement an ongoing internal quality assur-ance program (178,230,237), few offer specificguidelines for structuring such a program. BCBS/NCA is an exception (see box 5-A) (42).

Developing Quality Indicatorsfor HDIT Providers

Most HDIT providers operating today have someform of internal quality assurance program, althoughthe degree of effort varies considerably (364). Mostproviders focus on structural and process measuresof quality (see box 5-B). These include suchmeasures as reading and recording of patient vitalsigns during each nursing visit, completion ofrequired continuing education by provider staff, anddocumentation of patient training activities.

Although structure and process measures canprovide a strong quality assurance framework for theoperations of an HDIT provider, specific quality ofcare problems may go unnoticed if patient outcome

regularly (96). Poten-criteria are not also examinedtial criteria that can be examined in an ongoinginternal quality assurance program are as numerousas the provider’s list of written protocols for patientcare. If performance of every protocol is docu-mented in the patient records, then those records canbe examined for compliance in every aspect ofpatient care. Depending on the number of patientsserved by a provider, review can be performed on allor on a sample of patient records. Specific outcomecriteria that might be helpful to monitor include:

rate of equipment malfunction (103);rate of nonroutine infusion restarts and reasonsfor these restarts (81);level of patient satisfaction with HDIT servicesand specific reasons for dissatisfaction (thiscould be accomplished through periodic retro-spective patient satisfaction questionnaires)(219);specific patient complaints (e.g., request for adifferent professional caregiver) (219);rate of infusion therapy-related complications(e.g., phlebitis, infection, catheter occlusion, airembolism, infiltration) (96);rate of early detection and treatment of drugside effects (e.g., laboratory testing performedand results reported according to protocols,appropriate followup by physicians and nurses)(96); andeffectiveness of HDIT (therapeutic goals achieved;no recurrence of condition noted 6 months afterlast treatment) (96).

Studying outcomes of HDIT is useful not only forthe identification of noncompliance with specific


Box 5-A—Blue Cross and Blue Shield of the National Capital Area Standardsfor Participating Home Care Providers

Blue Cross and Blue Shield of the National Capital Area has published standards for home infusion providerswho wish to obtain reimbursement from the plan. These standards address areas such as:

. licensure, organization, governance, and management; development of written policies and procedures for all treatment modalities;● monitoring frequency of physician contact;. professional training and continuing education for nurses and pharmacists; coordination of services;● 24-hour availability of services;. testing and maintenance of equipment;* patient assessment and training;● arrangements for collection, analysis, and reporting of laboratory test results; and. availability of social work services to patients as needed.

In addition, the standards set the following specifications for an ongoing internal quality assurance program:1. There is evidence of an ongoing quality assurance program supported by the provider to monitor the quality

and appropriateness of patient care and services provided. The program includes, but is not limited to: assessment of the competency of personnel providing services, including the appropriateness of

responsibilities assigned to each individual;. appropriate execution of physician orders;* effective emergency response to patient or caregiver problems;● evaluation of services including review of provider policies and procedures;* ongoing, concurrent review of any infections, complications, adverse reactions, and therapeutic failures;* review of the records of maintenance, repairs, and faulty supplies for all equipment;* evaluation of the effectiveness of the patient and caregiver training and education program; and● hiring a fully licensed pharmacist as a consultant to the staff of the infusion therapy program to participate

in the development of educational programs, policies and procedures, and ongoing quality assuranceactivities.

2. Assessment of documentation within the medical record includes, but is not limited to: designation of the attending physician primarily responsible for the patient’s therapy at home;* initial and ongoing physical and psychosocial assessments;● evidence that the patient and/or caregiver has completed training; presence of a plan of treatment; signed and dated progress notes for each home visit and telephone contact noting: treatment administration,

response to therapy, complications or adverse reactions, modification in prescription, patient/caregivercompliance, condition of infusion site, and catheter site changes.

appropriate and complete diagnostic and therapeutic orders signed by the attending physician;● relevant laboratory test determinations and procedure findings;* pharmacy dispensing record including date and time; solution type, volume, and lot number, medication

additives; and dose and infusion rate; documentation of ongoing contact with the attending physician and other agencies/vendors providing

patient services;● supplies and equipment used; and a summary statement at termination of therapy which includes results of therapy, complications, outcomes,

and disposition or status of the patient upon discharge from care.SOURCE: Blue Cross and Blue Shield of the National Capital ~‘ ‘Guidelines for Participation of Home Care Providers,” Washingtotq DC,

Fdxuary 1989.

protocols, but also for gaining a general base of rational coverage and delivery policies. Some pro-knowledge about the problems associated with viders have already begun to incorporate specificHDIT and how to resolve them. As HDIT evolves, outcome measures into their quality assurancecareful documentation of patient problems and programs. NLN/CHAP accreditation surveys foroutcomes will be crucial to the development of home infusion providers also incorporate outcome

Chapter 5—Quality Assurance in Home Drug Infusion Therapy .95

Box 5-B-Quality Assurance in Home Care

Quality assessment is the measurement and evaluation of the quality of health care provided to individuals orto groups of patients. Quality assurance is the conduct of activities that safeguard or improve the quality of healthcare by correcting deficiencies found through quality assessment (363).

Quality assessment involves the application of structural, process, and outcome measures (98). Structuralmeasures assess whether the availability and organization of resources (e.g., quality of personnel, equipment,facilities, and coordination of services) are adequate to assure a certain standard of quality. Process measuresexamine the amount of careprovided and the performance of health professionals who deliver it by comparing actualcare delivered with accepted standards. Outcome measures assess the relative effectiveness of structure and processin determining quality of care by looking at specific patient outcomes (e.g., health status, incidence ofcomplications, satisfaction with care). While structural and process standards can measure the capacity to deliverquality care, only outcome measures can determine whether providers are in fact meeting that capacity (292,293).

Quality assessment and assurance methods for ambulatory and home care are less developed than those forinpatient care (48,192,252,253,292,395). Quality assurance efforts in home care to date have focused on structuraland process measures rather than patient outcomes, which are less well-researched and designed. State licensure,accreditation, and Medicare certification are the three primary quality assurance mechanisms used in home healthcare today (292).

However, sophisticated and more narrowly defined home services such as infusion therapy may be conduciveto outcomes assessment in a way that other home health services are not. For example, IV antibiotic therapy outcomecan be measured by resolution of the infection within a given time period and by nonrecurrence of that infectionfor a specific time period following completion of therapy. In contrast, “outcomes” of ongoing home healthservices for a chronic arthritis patient are less tangible.

Even the most sophisticated and comprehensive quality assurance program cannot guarantee successful patientoutcomes, because factors other than quality of care can affect these outcomes (25,47,293). This maybe particularlytrue in the home setting where many of the factors that can affect patient outcomes are beyond the provider’ control(25). Thus, screening patients for some of these potentially problematic factors (e.g., ability to perform self-caretasks adequately) becomes key in HDIT quality assurance.

and consumer-oriented measures of quality (237), settings, however, is limited (352). The require-and JCAHO has put together a task force to examine ments set forth by States vary considerably in depthoutcome-oriented quality indicators for HDIT (229). and scope, and some States have no regulations at all

State Regulationfor certain types of providers (e.g., HHAs andhospices) (352). As of March 1991, for example, 11

Medicare sometimes looks to State regulatory States still had no licensure requirements for Medi-mechanisms as one means of assuring the level and care-certified HHAs, and 20 States had no licen-quality of services offered by participating provid- sure requirements for non-Medicare-certified HHAsers. Generally, if a State has applicable licensure or (233). 7

certification laws, Medicare requires that a provider— To the extent that HHAs are involved in anywhether it be a physician, a hospital, or an HHA-belicensed or certified according to those laws in order aspect of HDIT, Medicare regulation and existing

State regulation of HHAs could serve as an indirectto qualify for reimbursement from the program(74). 6 means of assuring the quality of those HDIT

services. At present, however, Federal regulation ofThe extent to which State licensure and certifica- Medicare-certified HHAs does not directly address

tion laws can serve as reliable and consistent quality assurance issues unique to HDIT or othermeasures of quality for nonhospital health care high-technology home services (352). The extent to

G The same rule was to apply under the proposed regulations for home IV drug therapy providers issued pursuant to the MCCA (54 F.R. 172—seeappendix C).

7 Medicare began covering services provided by HHAs that met its conditions of participation in 1966. Initially, private HHAs were allowed toparticipate inthe Medicare program only if they were licensed pursuant to State law (74). In 1981, requirements were relaxed to allow for the participationof private agencies in States with no licensing mechanism (74).


which State HHA regulations specifically addressHDIT services is unknown, but since many Stateshave used Medicare COPS as a model for their ownHHA regulations (232,233,292,352), it may bepresumed that it is very limited. For new servicessuch as HDIT, it may be years before States developspecific licensure or certification mechanisms, ifthey develop them at all.

Most of the existing State regulations for HDITproviders have been developed and implemented byState boards of pharmacy. A May 1989 survey of all50 State boards of pharmacy found that 15 States hadpublished some relevant regulations and an addi-tional 18 States were planning to do so (210). Thescope of these regulations varies considerably fromState to State, however. Some apply only to prepara-tion of parenteral drugs, while other States defineand regulate a broader role for pharmacies in HDITprovision:

● At least two States require separate licensurefor home infusion therapy pharmacy providers(366). Regulations in Washington State addressthe full scope of home infusion therapy serv-ices, including nursing, pharmacy, delivery,coordination, and physician involvement. Wash-ington has even designed and implementedspecial training programs for inspectors ofhome infusion pharmacies/providers (210). Reg-ulations in New Jersey are more limited inscope (295).

. An additional 20 States claim to have someform of home infusion therapy regulations inplace, but OTA found that most of theseregulations address only the preparation andlabeling of parenteral solutions rather than thebroader range of home infusion therapy serv-ices (366). Regulations typically address areassuch as physical plant, staffing, procedures,internal quality assurance, and recordkeeping(63,366). Most States have specific regulationsfor the handling and preparation of cytotoxicdrugs (e.g., antineoplalstic drugs) (63,366).Regulations vary, however, in their descriptionof the scope of pharmacist responsibilities forpatient care (63).

● AS many as 28 States claim they do notcurrently regulate home infusion pharmacies.Of these, eight claim that such regulations are

currently under development (210,366). How-ever, some of these States may actually regulateparenteral drug preparation at a level commen-surate with that of States that claimed they doregulate home infusion pharmacy (366).

The Federal Role in HDITQuality Assurance

The high level of coordination and skill involvedin the provision of HDIT services raises concernsthat, under Medicare, all providers might not offer aconsistent acceptable level of quality services.Under a separate HDIT benefit, Medicare couldexercise control over the quality of HDIT servicesby:

1.

2.

3.

4.

establishing COPS for providers, implement-ing survey and certification procedures toensure compliance with those COPS, andapplying penalties for noncompliance;conducting case-by-case review (both priorand retrospective), either through FIs or PROS;developing a list of covered drugs that aregenerally safe and appropriate for home deliv-ery; andcreating a system of payment that providesappropriate incentives for the referral of pa-tients to HDIT and for the participation ofqualified health professionals (nurses, phar-macists, and physicians) in the conduct of thatcare.

The following section focuses on the first twomechanisms. Coverage and payment considerationsare discussed in chapters 6 and 7 of this report,respectively.

Current Medicare Quality Assurance EffortsRelevant to HDIT

Under Medicare, all qualifying providers8 mustcomply with certain conditions set forth by theSecretary of the Department of Health and HumanServices in order to obtain reimbursement for theirservices (42 CFR 417). These conditions are Medi-care’s most systematic method of assuring quality ofcare at the provider level.

Existing Medicare coverage for HDIT is limitedand fragmented. The key sources of coverage are the

a ~~hovidms~~ ~der M~~ me defm~ to include the following: hospi~, skilled nursing f-ties, comprehensive Outpatient rehabfitationfacilities, home health agencies, hospices, and providers of outpatient physical therapy or speech pathology services (42 CFR 417,416).

Chapter 5-Quality Assurance Home Drug Infusion Therapy ● 97

Part A home health care benefit and the Part Bdurable medical equipment (DME) benefit (see ch.6). Existing COPS for HHAs are broad and do notaddress many of the quality assurance concernsspecific to HDIT. DME suppliers, because they aresuppliers of equipment rather than providers ofservices, are not subject to any direct Medicarequality control measures in spite of the fact that theyare another major source of Medicare-coveredHDIT.9

Under Part A, certified HHAs are required tocomply with specific COPS that include staff qualifi-cations and annual program evaluation by a groupcomposed of HHA staff and consumers (42 CFR484). These COPS, discussed in more detail later inthis chapter, are for home health services generallyand do not specifically address HDIT quality con-cerns. Medicare PRO oversight of home healthservices, also discussed later in the chapter, has beenlimited and indirect.

Drugs and other fluids administered via aninfusion pump are occasionally covered under thePart B DME benefit along with the pump (see ch. 6)(365). Direct Medicare quality assurance efforts are.virtually nonexistent, however, because DME sup-pliers who bill Medicare are not subject to anyspecific COPS or conditions of coverage (74). Theyare required by law to provide instruction in theoperation of DME, but the degree to which they doso is currently not documented or regulated, and insome cases it may consist merely of includingwritten manufacturers’ instructions in an equipmentdelivery (156).

The Safe Medical Devices Act of 1990 requiresthat device user facilities10 report medical devicemalfunction events that contributed to the death orserious illness or injury of a patient to either themanufacturer or the Secretary of the Department ofHealth and Human Services within 10 days of theiroccurrence (Public Law 101-629).11 Such reportscould be useful for identifying and monitoring the

use of potentially harmful HDIT devices (e.g., aninfusion pump prone to malfunction).

Because current Medicare coverage for the com-ponents of HDIT is very fragmented, a compre-hensive HDIT quality assurance program is notpossible at present. The responsibility for qualityassurance is therefore implicitly relegated to theprescribing physician, who often has little controlover the services provided to HDIT patients. Somecarriers (the Part B FIs) have been reluctant to coverdrugs under the DME benefit because they perceivethe lack of a defined ‘infusion provider’ ‘—and thequalifications that such a designation might require-as a quality problem (365). Some carriers go so faras to require preauthorization of all claims involvingpayment for drugs under the DME benefit (365).

Proposed Requirements Under the MCCAIf a Medicare HDIT benefit were created, COPS

would probably need to be established specificallyfor providers of this service. Fortunately, HCFA hasalready given considerable thought to developingCOPS for HDIT providers, because the now-repealed MCCA was to have included home IV drugtherapy .12 Proposed regulations issued pursuant tothe MCCA specified detailed COPS for qualifiedproviders (see app. C). The proposed COPS ad-dressed:

●

●

●

●

●

●

●

●

●

●

●

●

compliance with Federal, State, and local laws,governing body and administration,patient selection,plan of care and physician review,maintenance and handling of central clinicalrecords,core staff and services,nursing services,pharmacy services,patient and family caregiver evaluation andinstructions,written protocols and policies,provider quality assurance activities, andinfection control (54 F.R. 172).

g Medicare also covers total parenteral nutritio~ another form of home infusion therapy, under the Part B prosthetic devices benefit (see ch. 6).Coverage is limited to nutrients, equipmen~ and supplies. Medicare has no structural quality assuran ce requirements for total parented nutrition (TPN)providers.

10 Devi~userf~ilities ~clude hospi~, ~b~atory ,su@calfacilities, nursing homes, or outpatient treatmentfacilities that arenotphysicians offices(e.g., HHAs, DME suppliers) (Public Law 101-629).

11 Repo~ ~ovisiom of tie Stie Mdicd Devices Act of 1990 were eff~tive as of NOV. 2% 191.12 ~ dwelop tie cops, Ha’ sought gui~ce ~m in&@y represen~tives, h~~ pmfessio~s, pmfessio~ ~soc~tions, orgtitions tit

currently aamxlit or publish standards for home IV drug therapy providers, and other knowledgeable parties (54 F.R. 172).


Although the proposed rules were never madefinal, they generated mostly positive comments fromresponding organizations (167). The remainder ofthis section focuses on specific areas of the proposedCOPS that deserve additional attention if a newbenefit were to be implemented.

Routes of Drug Administration

The MCCA benefit was to cover IV therapy alone.If Congress were to develop an HDIT benefit thatalso covered other routes of administration (e.g.,subcutaneous, intraspinal), relevant COPS and otherregulations would need to address the attendantdifferences in intensity of services, required equip-ment and supplies, and specific techniques used. Forexample, the proposed conditions issued pursuant tothe MCCA required that peripheral catheters bechanged at least every 3 days (54 F.R. 172).Although existing standards support the 3-dayrotation of peripheral venous catheters, peripheralarterial catheters are generally changed less fre-quently, and subcutaneous infusion needles arechanged every 48 hours (see ch. 3) (174).

Patient Care Policies and Physician Review

The proposed regulations specified that it wouldbe the referring physician’s responsibility to initiallydetermine whether home IV therapy is appropriatefor the patient and to prescribe the drug regimen forthat patient. In addition, they required the referringphysician to review the plan of care at least every 30days (54 F.R. 172).

The proposed rules made no specific requirementsfor frequency of contact between patient and physi-cian during the course of therapy, however. For asubstantial proportion of HDIT patients, a 30-dayminimum review requirement might mean that theirplan of care would undergo only initial review,leaving the possibility that some complications orside effects of therapy would go unnoticed. Morefrequent physician contact during therapy may beespecially appropriate for elderly patients withmultiple health problems. Specific requirements forpatient-physician or provider-physician contact couldeven be established by type of therapy or type ofcondition. For example, some programs recommendweekly physician visits for patients on antibiotictherapy (91). In addition, HCFA could require morefrequent comprehensive review of the plan of careby the referring physician.

Patient Selection

The proposed rule required that a provider screeneach patient before acceptance, and that this screen-ing be performed by a multidisciplinary team ofexperts in home IV therapy. Both medical criteria(e.g., the patient’s clinical status) and nonmedicalcriteria (e.g., patient’s ability to undertake self-care)were to be considered in patient selection (54 F.R.172).

The proposed conditions did not provide specificscreening criteria to use in determiningg that patients“have a clinical status that allows IV drugs to besafely administered at home. ” Although it is ulti-mately the physician’s responsibility to determinewhether a patient’s medical condition is sufficientlystable for HDIT, additional requirements might aidproviders or other parties involved in initial determi-nation of appropriateness of HDIT (e.g., PROS orFIs). As discussed below, the MCCA mandatedPROS to perform prior authorization on all home IVtherapy claims. Presumably, each PRO would de-velop its own screening criteria to determine safetyand appropriateness. Separate criteria in each PROjurisdiction, however, could lead to inconsistency incoverage and quality of care.

In addition, if a new Medicare benefit were tocover HDIT for patients not capable of self-care,more explicit patient selection and provider servicesrequirements would need to be developed.

Staffing and Services

The Health Care Financing Adminis tration(HCFA)proposed that home IV therapy providers meetcertain staffing and service requirements. Specifi-cally, the proposed regulations stated that:

. Home IV providers must directly employ atleast one full-time-equivalent (FTE) nurse orpharmacist.

. The home IV provider must perform the follow-ing services directly:-developing, supervising, and coordinating

all nursing and pharmacy services;—assuring that only qualified personnel pro-

vide home IV services;-consulting with pharmacists involved in

patient care to coordinate the plan of carewith the physician; and

—performing quality assessment activities in-cluding drug regimen review.

Chapter 5-Quality Assurance in Home Drug Infusion Therapy ● 99

There was extensive debate both before and afterpublication of the proposed rule regarding corestaffing requirements (167) (52 F.R. 172). Therationale behind the proposed requirement for eithera full-time nurse or a full-time pharmacist was thatHDIT involves both nursing and pharmacy services,and that a provider should therefore have at least oneof either of these professionals within its directemploy. A nurse or a pharmacist alone, however,would not have been able to provide all of theproposed core services. For example, a nurse wouldnot be capable of drug regimen review, and apharmacist would not be capable of developing andsupervising nursing services. HCFA had initiallyconsidered requiring that both a nurse and a pharma-cist be employed directly, but professional providerorganizations objected on the grounds that thiswould disenfranchise many existing providers (e.g.,HHAs with no in-house pharmacy) (54 F.R. 172)(167).

A possible solution to this problem would be torequire that providers who have only an RN underdirect employ maintain a consulting contract with apharmacist who is experienced in HDIT. Thispharmacist would assist the HDIT provider on anongoing basis with development, coordination, andevaluation of pharmacy services and with periodicdrug regimen review. (This model is similar to thatused by BCBS/NCA (42)).

Nursing Service-The proposed rule requiredthat all nurses providing home IV services be RNswho had at least 2 years’ experience in patientassessment and infusion therapy. Nurses were re-quired to be proficient in all procedures directlyrelated to IV therapy and the insertion of all types ofneedles and catheters commercially available (52F.R. 172).

The comprehensiveness of these proposed skillrequirements may be unrealistic in the existingspecialized HDIT market. HDIT providers—especially those with numerous staff-tend to dividepatient care responsibilities among nursing staffaccording to individual nurses’ skill levels (see ch.3, box 3-C). For example, one nurse may specializein PICC line placement, performing it on all of theproviders’ patients, while another may be responsi-ble for placement, maintenance, and repair of

standard peripheral catheters. Still other nurses mayspecialize in the care of patients with central accessdevices.

In addition, although some HDIT-related proce-dures are skilled procedures that mu@ be performedby an RN (e.g., venipuncture), other tasks (e.g.,dressing changes and central catheter care) may beperformed by other staff who have been trainedproperly and who work under the supervision of anRN. Some providers use licensed practical nurses toperform noninvasive catheter care and drug adminis-tration procedures (3).13 Greater flexibility in staffskill requirements could improve the ability ofproviders to recruit qualified staff. For example,most home infusion provider nursing staff today arenot proficient in inserting PICC lines, a type of“commercially available” catheter (see ch. 3).Although the level of proficiency and experiencedescribed in the proposed conditions is not reasona-ble to require of each individual nurse involved inHDIT, it is reasonable to require it of at least onenurse who is employed directly by the provider.

Pharmacy Services-HCFA did not address thequalifications pharmacists, despite the fact thathome infusion pharmacy requires expertise andknowledge as specific as that in infusion nursing. Inthe future, specific experience in relevant aspects ofHDIT phamacy (e.g., drug compounding, patienteducation, drug therapy monitoring, drug regimenreview) could be required of pharmacists whoseresponsibilities included such activities.

HCFA’s proposed standards for drug preparationwere also inconsistent in some areas with existingprivate standards for home infusion pharmacies. Forexample, the proposed regulations would haveallowed either clean work benches or laminar flowhoods for the preparation of IV drugs (54 F.R. 172).In contrast, JCAHO, NLN/CHAP, NAIT, and Amer-ican Society of Hospital Pharmacists (ASHP) stand-ards all require the use of laminar flow hoods toprotect against microbial and particulate contaminat-ion (178,199,230,237).

Patient and Family CaregiverAssessment and Training

Proposed COPs required that an RN performpatient and family caregiver evaluation and educa-

13 HCFA*S exp~ence that “none of the entities [it] contict~ allowed anyone but a registered nurse to furnish nursing services connattd with Ndrug therapy” (54 F.R. 172) may have been influenced by the fact tba~ at the time the proposed rule was published, it had contacted mostly proprietaryhome IV drug therapy providers (167).


tion. This requirement would have been problema-tic, for two reasons. First, patient and familycaregiver evaluation is often a multidisciplinaryeffort that involves not only the nurse but thereferring physician, pharmacist, and other healthprofessionals such as a nutritionist or social worker.Second, some aspects of patient/family caregiverinstruction (e.g., discussion of side effects of ther-apy, use of infusion devices, self-care techniques)may sometimes be appropriately given by pharma-cists or other types of health personnel, such asspecially trained pharmacy technicians (see box3-C) (15). Future COPS for HDIT providers couldreflect this practice by allowing a broader range ofhealth professionals to perform some of thesefunctions, perhaps under the supervision and coordi-nation of a qualified RN. Also, any future COPsmight want to specifically address patient responsi-bilities in HDIT.14

Protocols and Policies

First-Dose of Medication—Proposed COPS re-quired that the first dose of any IV therapy be givenunder the direct supervision of a physician or nursewho is equipped with resuscitation medication andequipment to treat anaphylaxis (54 F.R. 172).Alternatively, under a new benefit, HCFA mightrequire that the first dose of infused drugs with aknown potential for allergic reaction or other com-plications always be delivered under a physician’ssupervision.

The nature of the supervision could vary depend-ing on the setting in which the initial dose is given.For example, patients who are discharged to HDITfrom the hospital could be required to receive theirfirst dose in the hospital where physicians are readilyavailable. For outpatient-initiated therapy, patientscould be required to receive the first dose in aphysician’s office or hospital outpatient setting. Foroutpatients who are homebound, special exceptionscould be made or, alternatively, a physician homevisit could be required for the initial dose.

Catheter Care-Catheter care requirements inthe proposed rule were generally consistent withrecognized standards of infusion nursing practice(174,199,237). In light of the rapid pace of techno-logical innovation and change in HDIT, however,

rigid standards such as those proposed might haverequired frequent updating to stay abreast of currentpractice. For example:

●

●

The proposed rule required that the sites of allperipheral catheters be rotated by a nurse atleast every 3 days (54 F.R. 172). Some newercatheters can remain in place longer than 3 days(see ch. 3) (364). Alternatively, HCFA couldrequire that the catheter site be inspected by anurse at least every 3 days and changed asnecessary.The proposed rule required that IV administra-tion sets be changed at least every 24 hours (54F.R. 172). Although support for this require-ment may be found in existing standards orprofessional literature, the appropriate fre-quency of administration set change varies withthe particular therapy and dosing fiquency.For example, patients on continuous infusionmay only change their administration set every5 to 7 days, while patients using disposableinfusion devices may change their administra-tion sets up to 4 times a day by default, becausethe administration set is integral to the device.A less rigid requirement for administration setchange could thus be appropriate.

Air-Elimination Filter and Catheter Testing—As an additional measure of quality control, HCFAproposed that nurses routinely collect a randomsample of discarded catheters and air-eliminationfalters and send them to a laboratory for analysis ofparticulate and microbial contamination (54 F.R.172). Both ASHP and the Association for Practition-ers in Infection Control objected to this condition onthe grounds that the catheters and falters could easilybecome contaminated between the time they wereremoved from the patient and the time they wereexamined in the laboratory (1,199). Both thesegroups recommended culturing the catheter or filteronly when there were clinical signs of possibleinfection (1,199).

Drug Therapy Review—The proposed rule re-quired that the pharmacist review the prescribedcombination of IV drugs and equipment for appro-priateness before therapy began. In addition, thepharmacist was to be required to review the appro-priateness of drug therapy at least every 3 days and

M For emple, the patien~f~y c~egivm might be instructed and required to document on a chart each drug and 501Ution admiIIi5t@i0n Or d.bHDIT-related procedure (e.g., catheter flushing, administration set change, dressing change) and note any attendant difficulties they experienced. Thesecharts could be incorporated into the central clinical record to complement nurse and physician notes.

Chapter 5—Quality Assurance in Home Drug Infusion Therapy . 101

report significant findings to the physician (54 F.R.172).

Review every 3 days may not be necessary in allcases, and it may sometimes be logistically difficultif the pharmacist must meet with the patient’s nursein order to review appropriateness. Some providershave most staff on site and can hold regular meetings(e.g., routine drug regimen review once a week)attended by all members of the provider staff.Providers who send staff to patients’ homes and/orsubcontract for pharmacy services, however, mayhave to resort to other modes of communication(e.g., telephone, facsimile, extensive patient encoun-ter notes) to accomplish the conferencing necessaryfor ongoing drug regimen review. HCFA mightinstead require pharmacists to review appropriate-ness of therapy at least once a week and wheneverrequested to do so by patient care staff.

Patient Rights and Responsibilities-The pro-posed conditions specified that treatment shouldbegin only if the provider is capable of furnishingcare at the level of intensity required by the patient.In addition, providers were to inform patients oftheir responsibilities and rights in writing uponinitiation of therapy. The proposed rule also requiredproviders to establish procedures for patient com-plaints (54 F.R. 172).

Under anew benefit, HCFA might want to furtherrequire that written consent be obtained frompatients before therapy begins. For instance, provid-ers could be required to obtain signed statementsfrom patients documenting that they fully under-stand and are able and willing to perform all aspectsof required self-care, that they are aware of the risksassociated with their therapy, and that they under-stand what their share of costs for the services areexpected to be.

Provider Quality Assurance Activities

The proposed conditions required home IV pro-viders to maintain ongoing, systematic qualityassurance programs to evaluate the quality andappropriateness of patient care, correct deficiencies,and improve patient care (54 F.R. 172). A writtenevaluation plan was to include scope and objectivesof quality assurance activities, specific activities tobe monitored, methods for evaluation and reportingof results, mechanisms for corrective action, andstaff responsibilities for each activity. Home IVproviders were to be required to collect and analyze

data at least annuully on the length of therapy bydiagnosis and treatment; patient complications andrehospitalizations; and the nutritional status ofpatients. In addition, providers would have beenrequired to determine that activities had been carriedout appropriately (e.g., that delivery of drugs andequipment was timely, that any peripheral catheterpatient had their catheter rotated by a nurse every 3days, etc.) (54 F.R. 172).

The proposed quality assurance standards lackedspecificity in some areas. For example, they failed tospecify whether the quality assurance activities (e.g.,collecting data on negative outcomes) should beapplied to all cases or to a sample of cases. Also,although the proposed COPS required the provider tospecify “staff responsibilities for each activity in thequality assurance program,” they did not specifywhere activities should involve both nursing andpharmacy Staff.

Nor did the rule specify a role for the patient in theongoing quality assurance program. Providers couldhave been required to conduct an exit interview witha sample of patients (or with all patients), forexample, to verify that care documented in theclinical record was in fact performed.

Determining Provider Compliance WithConditions of Participation

Activities of State Survey Contractors

To determine compliance with its COPS, HCFAgenerally relies on a State agency (usually a depart-ment of health or department of aging) with whomit contracts to conduct periodic surveys of allfacilities in the State (351). State surveyors are givenguidelines and, in some cases, specific assessmenttools, to use in the survey process for each type offacility.

Because the proposed COPS for home IV therapyproviders were never implemented, mechanisms fordetermin ing provider compliance were never tested.However, past experiences with HHAs can shedlight on potential problems in determiningg compli-ance with any future Medicare COPS for HDITproviders.

In order to qualify for reimbursement through theMedicare program, HHAs must comply with COPSthat address the following two general areas:


administration (acceptance of patients, plan ofcare, patient rights, medical supervision, dis-closure of information, organization and ad-ministration of services, policy review), andfurnishing of services (staff qualifications andtraining, maintenance of clinical records, pro-gram evaluation, survey and certification proc-ess) (42 CFR 484).

Compliance for both initial and continuing certifi-cation is determined by surveyors15 from a Stateagency who make an unannounced visit to the HHAat least once every 15 months. On each visit, a‘‘standard survey’ is conducted that assesses com-pliance with a specified subset of the COPS. Thesurvey visit can include review of a random sampleof medical records,16 review of written patient careprotocols, verification of staff qualifications and training, site visits to patients’ homes t. witnessthe direct provision of care and interview patientsregarding their satisfaction with the HHA services.Based on the standard survey, the surveyor makes ajudgment as to whether the HHA seems to beproviding standard or substandard care. If it isjudged substandard, the State conducts an extendedsurvey that assesses compliance with the exhaustivelist of COPS. If the HHA fails the extended survey,sanctions can be applied.

The Omnibus Budget Reconciliation Act of 1987(OBRA-87) 17 mandated that quality of care meas-ures based on patient outcomes be incorporated intothe HHA survey procedure. Measures such as deathor readmission to a hospital or nursing home duringor shortly after termination of treatment are amongthose to be used to detect problems (42 CFR 484).OBRA-87 also mandated that visits to the homes ofHHA patients be included in the survey process toenable direct observation of care currently beingprovided, and to ensure that procedures documentedin the patient record were actually performed (351).Accordingly, HCFA has published revised COPS forHHAs (42 CFR 484) and has issued instructions toState survey agencies on how to conduct outcomes-oriented surveys (370).

Because the outcomes-oriented survey and certi-fication mandates did not go into effect until March

1991 (132), it is too early to know whether they arein fact improving the quality of HHA care. However,a 1989 study by the U.S. General Accounting Oftlce(GAO) found numerous problems with the conductof HHA surveys by State agencies prior to imple-mentation of the new provisions. These included:

inadequate guidance and oversight by HCFAon conduct of surveys;inconsistent interpretation by State surveyorsof requirements for compliance with MedicareCOPS;inconsistency in scope of surveys and methodsused to select samples of records for review;lack of coordination between State surveyagencies, FIs, and Medicare PROS;18 andlack of personnel training standards for high-technology services such as infusion therapy(351).

Although some of these problems have been ad-dressed in the new instructions issued by HCFA(132), it remains to be seen whether they will beresolved.

If future HDIT coverage under Medicare entails anew class of certified providers, similar problemscould arise. Problems might be avoided by improvi-ng the clarity of the conditions themselves, offeringmore thorough and consistent guidance to the Stateagencies that conduct the surveys, and mandatingand facilitating cooperation between all organiza-tions involved in HDIT quality of care review (e.g.,PROS, FIs, and relevant State licensing agencies)(351).

Reliance on Standards Issued by NationalAccrediting Bodies

Section 1865 [a] of the Social Security Act permitsHCFA to grant “deemed status’ ’-i.e., to considercertain health facilities as meeting any or all ofMedicare’s COPS for that type of facility-tofacilities accredited by a national accreditationprogram (SSA, sees. 1864, 1865[a]). Deemingauthority is monitored through a validation reviewprocess in which a small sample (5 percent) ofproviders are surveyed directly by HCFA to test how

15 ~ ~eyors are always registered n~es.

16 smle She dewnds on he s~e of tie agency ~ k defm~ u a f~ed n~ber of r~ords mtier - a percentage (132).

17 Public Law 100-203.16 pROs me r~~ by law to coordinate their efforts with other levix bodies.


well the accrediting organization’s standards con-tinue to reflect Medicare’s COPS (55 F.R. 51434).

Until last year, HCFA had extended deemedstatus only to hospitals accredited by JCAHO(127).19 In October 1991, HCFA granted deemedstatus to HHAs accredited by NLN/CHAP. JCAHOhas also applied to HCFA for recognition as adeeming authority for HHAs, but authority has notyet been granted.

It is unlikely that Medicare could initially rely on“deeming authority” as a mechanism for certifica-tion of HDIT providers due to inherent limitations ofthe standards themselves and the accreditationprocesses. First, accreditation surveys performed bynational organizations may not be as good a measureof compliance with COPS as surveys by Stateagencies, because they tend to be conducted lessfrequently and are generally scheduled in advance,giving providers the forewarning they need to get“Up to speed.” To date, JCAHO has conducted fullsurveys once every 3 years and has given providersa minimum of 4 weeks’ formal notice (179).20

NLN/CHAP also operates on a 3-year accreditationcycle, but it conducts abbreviated annual surveys ininterim years and all of its site visits are unan-nounced (237).

Also, the cost of obtaining accreditation throughJCAHO or NLN/CHAP may deter some smallerproviders from seeking it. JCAHO’s average fee fora single-site HDIT provider is approximately $4,800for the full three-year accreditation period (33). The1992 NLN/CHAP fee for a medium-sized single-siteprovider whose net revenue was under $1 millionwould be roughly $13,000 over a 3-year period(95).21

Case Review; Role Of Medicare Peer ReviewOrganizations and Fiscal Intermediaries

While Medicare relies on State and nationalsurvey and certification processes to determinecompliance with specific COPs, it generally relieson PROS to assess the quality and appropriateness of

care at the individual case level. Mandated under theTax Equity and Fiscal Responsibility Act of 1982(Public Law 97-248), PROS have the authority todeny Medicare payment for inappropriate or unnec-essary services and to discipline and/or sanctionproviders and practitioners to correct any unaccepta-ble medical practices (363).

Because HDIT is a complicated service to deliver,and an HDIT benefit might be prone to overutiliza-tion if Medicare did not cover other outpatientprescription drugs (see ch. 6), some level of PROreview of claims would be warranted. A minimallevel of PRO review would be retrospective reviewof a random sample of claims within each PROjurisdiction. (Even this form of review is currentlynot required for Medicare home health servicesclaims.) The most rigorous level of review, whichwas to be required under the MCCA benefit until1993, would be prior review and authorization of allHDIT claims.

Current PRO Activities

To date, PROS have been involved primarily inreview of claims for hospital and physician services.Due to the large volume of Medicare claims, reviewis usually conducted retrospectively on a randomsample of claims. However, prior review is currentlyrequired for a few select procedures. (See box 5-Cfor a description of PRO prior and retrospectivereview processes.) PROS also review cases wherequality of care has been brought into question, butthis mechanism is limited by the ability and willing-ness of beneficiaries, providers, and health profes-sionals to recognize and report suspected deficien-cies or problems.

Because the initial PRO claims review is usuallyperformed by individuals (usually nurses) who arenot experts in the particular type of care provided, akey element to the prior review process is explicitreview criteria for the service in question (183). Atpresent, Medicare instructs each PRO to develop itsown criteria for care, diagnosis, and treatment based

19 Unti 19s4, ~owmcefor “deemed status” was limited to hospitals, skilled nursing facilities, and HHAs. Legislation in 1984 @blic hw 98-369)expanded the allowance to include rural health clinics; psychiatric hospitals; ambulatory surgical ~ters; clinical laboratories; hospices; comprehensiveoutpatient rehabilitation facilities; and clinic, rehabilitation agency, or public health agency providers of occupational therapy, speech pathology, orphysical therapy services. This expanded authority has not been us~ in part due to lack of relevant national accrediting bodies (127).

m J~O has a&eed to perfOrXII -qunannounced surveys as required under OBRA-87 if granted deemingauthority by HCFA for HHAcertification (287).

21 ~1~ f= ~o~ ~cludes ~~ fees ~~~ on net revenue wording to a sfi~ fee s~e), cost of the initial visit (2 Stdf On-Site fOr 3days), plus the cost of two additional survey visits (appro ximately half the cost of the initial visit) (95).


Box 5-C-The Medicare Peer Review Organization (PRO) Review Process

Prior ReviewThe physician or provider contacts the appropriate PRO for preauthorization, furnishing the plan of care and

any additional documentation required for the review process (183). The first level of review, generally conductedby nurses, involves the application of explicit review criteria that have been developed by the PRO for the particularprocedure or service. If the request for authorization fails to meet the initial explicit review criteria, it is referredto a physician reviewer who subjects it to implicit criteria based on his or her own clinical judgment and onprofessionally recognized standards of care. During this second level of review, the physician reviewer may requestadditional information from the referring physician. If the request fails second level review (after affording thephysician and/or provider an opportunity to discuss the case), authorization is denied (183).Retrospective Review

Each record identified for retrospective review undergoes five different basic reviews: generic quality screen,admission, discharge, invasive procedure and items/services coverage, and DRG (diagnosis-related group)validation. First-1evel reviewers (usually nurses) use explicit criteria to determine potential quality-related orutilization problems, If initial review uncovers a potential problem the records are referred to a PRO physicianadviser for further review (105). Potential quality problems not detected by one of the five reviews (e.g.,mismanagement of the case) maybe discovered by the initial nurse reviewer based on his or her medical judgement.In this case, the medical record would also be refereed to a physician adviser. If the initial reviewer can determinethat a case failing one of the generic quality screens is not actually a quality problem, the case is not referred to aphysician adviser (357).

A physician reviewer conducts a more in-depth examination of the medical record, based on his or her clinicaljudgment, to determine whether there actually is a problem. The review process also allows the attending physicianand hospital an opportunity to discuss the specifics of the case in question. These discussions often reveal uniquecharacteristics of the case that explain why it may have failed the initial screens. Most cases of potential problemsare resolved this way (92).

If the physician reviewer determines after the discussions that the care provided was not medically necessaryor that it should have been provided in another setting, a payment denial notice is sent by the PRC) tn the beneficiary,physician, provider, and fiscal intermediary. If the physician reviewer identifies a quality of care problem that isnot cleared up after discussing the case with the patient’s physician, the PRO will initiate appropriate interventions.These interventions may include physician education through a continuing medical education program, a correctiveaction plan, intensified review of the physician and hospital, or the initiation of a sanction review (357).

on typical patterns of practice within its geographic denials, mortality, and confirmed quality problems.area or, where appropriate, on national criteria (374).

The retrospective review process uses separatequality screens that focus on potential problem areasand the overall appropriateness of care provided.The quality screens used to review the interveningHHA care received by readmitted hospital patients,for example, address such issues as the adequacy ofpatient screening and education, the provider’sresponse to any changes in the patient’s healthcondition, whether any deaths occurred within 48hours of transfer to the hospital, and documentationof the plan for appropriate followup care (375).

Based on the information collected in medicalrecord reviews, PROS produce physician and hospi-tal “profiles” containing information on claims

The profiles are used to identify patterns of care thatdeviate from the norm for particular types ofproviders or deviate from established criteria andstandards (350). The identification of an aberrantpattern of care may trigger a PRO’s evaluation of alarger sampling of records from the physician orhospital in question. If PROS were to be involved inreviewing HDIT claims, the development and use ofsuch profiles for HDIT providers might be anadditional mechanism for safeguarding the qualityand appropriateness of HDIT services.

At present, PROS’ only involvement in qualityassurance for home health is through hospitalreadmission review and beneficiary complaints(Public Law 99-509).22 The PRO takes a 25 percent

~ They do not review intervening care rendered inaphysician ofllce setting, emergency room, or any other sett@, alt.houghemergency mom set-sare proposed to be included as an intervening care review setting in the fourth contract cycle for PROS (53).

Chapter 5—Quality Assurance in Home Drug Infusion Therapy ● 105

sample of all hospital readmission for a given year.From that sample, it reviews 20 percent of thosereadmission that received intervening care in ahospital outpatient clinic, HHA, or skilled nursingfacility, obtaining relevant clinical records from theintervening care setting to determine whether thecare provided was adequate and appropriate (53).The sampling method and small sampling size,however, limit the usefulness of these data inassessing quality at the individual provider level.Even the Keystone PRO in Pennsylvania, which wasthe first to review intervening care claims and hashad the most experience with the process, hadreviewed an average of only one patient per HHAper year in the State as of 1990 (53).

PROS also review HHA claims involving bene-ficiary complaints, but the flow of complaints to datehas been highly inconsistent among States (53). Thismay be due to lack of beneficiary awareness of theavailability of the PRO to investigate such com-plaints (44). Confidentiality provisions that preventthe PRO from informing the beneficiary of theresults of such an investigation may also serve as adisincentive for beneficiaries to lodge formal com-plaints (53).

Proposed PRO Activities Under the MCCA Benefit

The MCCA called for extensive PRO involve-ment in oversight of home IV drug therapy servicesto ensure that care was being provided safely to anappropriate set of patients. Regulations and instruc-tions issued pursuant to the MCCA articulated sixareas of direct PRO involvement (54 F.R. 173).

Prior authorization:1.

2.

3.

Prior review of 100 percent of home IV therapyclaims until 1993.23 PROS were to completereview prior to initiation of services forinpatient starts, and within 1 working day ofservice initiation for outpatient starts.Review of all requests for continuation ofhome IV therapy beyond the date or number ofdays specifed in the original request. Thesereviews were to be completed within 3 work-ing days of the original termination date.Review of all requests for changes of home IVdrug therapy during the specified course oftreatment, to be completed within 1 workingday of the prescribed therapy change.

Retrospective review:4.

5.

6.

Postpayment review of a random 5 percentsample of all paid home IV therapy claims todetermine provider and physician compliancewith professionally recognized standards ofcare.Periodic validation reviews of a random sam-ple of claims in which initial approval wasgranted after the PRO had reviewed medicalinformation via telephone but had not re-viewed actual medical records, to validate theaccuracy of information given verbally.Prepayment review of any cases where PROinitial authorization was required but had notbeen completed.

Universal prior authorization for HDIT may notbe necessary. The rationale for this requirementunder the MCCA was to ensure safety and appropri-ateness of a relatively new and complicated mode ofservice delivery through a front-end mechanism.However, as the range of therapies that can be safelyand effectively provided in the home setting expandsand the volume of claims increases, it may no longerbe practical for PROS to perform prior authorizationon all claims. Furthermore, some therapies (e.g.,certain antibiotic therapies) pose relatively littleserious risk to patients. Claims for these might behandled through retrospective review unless HCFAfelt there were a potential for mis- or overutilizationof home IV antibiotic therapy (e.g., if oral drugswere usually sufficient for the condition but were notcovered by Medicare).

Requiring PROS to perform prior authorizationfor all drug changes during the course of HDIT.services also may be unnecessary. As one alterna-tive, Medicare could implement more limited safe-guards, such as requiring additional patient instruc-tion as to potential complications and mandatingprofessional supervision during administration ofthe first dose of a new drug. Targeted retrospectivereview of drug changes by either a PRO or an FIcould identify problems with particular drugs (orparticular providers).

In some circumstances, there may be a need forongoing review of a patient’s HDIT to ensure thatthe course of treatment continues to be safe andeffective for that patient. In the event of futureMedicare coverage for HDIT, an appropriate regula-

~ PRO Pfior revi~ of w home IV claims was mandated under the MCCA until 1993 and left at HCFA’S discretion thereafter (~).

297-913 0 - 92 - 8


Box S-D—Proposed Scope of PRO Review for Home IV Drug Therapy ServicesUnder the Medicare Catastrophic Coverage Act of 1988

From the time it received a request for review of home IV drug therapy services from either a physician or ahealth care facility, a PRO was to have 8 working hours to determine whether the services were reasonable,appropriate, and necessary for treatment of the patient’s condition. Before approving home IV drug therapy service,the PRO was to have determined or to have been assured that:

* the patient’s condition was such that inpatient hospitalization was not justified either:1) as a continuation of an existing hospitalization, or2) as a medically necessary and appropriate admission;

the patient met the selection criteria specified in the regulations (see appendix C);● the patient and/or caregiver had been or would be sufficiently trained to administer the drugs safely and

effectively in the home;. the patient or caregiver would independently administer at least one dose of the drug under supervision;* the plan of care developed by the referring physician had enough information to support coverage of home

IV drug therapy services;. the covered drug was being used for one of the indications approved by the Secretary of the U.S. Department

of Health and Human Services; the drug was medically indicated for treatment of the patient’s condition; the prescribed dosage of the drug was correct for the patient’s height, body weight, and other considerations;● appropriate periodic monitoring had been or would be performed;● the drug was not contraindicated;● the home IV drug therapy services prescribed met professionally recognized standards of care; and. the intavenous route of administration was the only safe and effective route for the patient.

SOtXtC!ES: 1%0 Review of Home IV Drug Thwapy !%rviees, guidelines issued to PROS by the Health Standards and Qwdity B- HealthCare Fkumcing Adm.inistratio& September 1989; 54F.R. 173, Sept. 8, 1989.

I

tory body might want to identify specific drugs or tively, prior review could be made the responsibilityconditions that warrant a more intense level ofongoing review and require that PROS or FIsperform such reviews.

Finallly, prior authorization of HDIT cases re-quires the ability for rapid response, since lack ofresponsiveness can delay hospital discharge or theinitiation of therapy. Prior authorization of all HDITclaims within 1 working day might present seriousadministrative challenges to PROS. FIs might be analternative body that could evaluate the appropriate-ness of HDIT on a prior, case-by-case basis. FIs havesome experience with current HDIT coverage underthe Part B DME benefit and the Part A home healthbenefit (365) (see ch. 6). Prior review might even bedivided between PROS and FIs depending on type oftherapy and the potential for its overuse. Forexample, prior review for therapies with which FIshave limited experience might be placed initiallywithin the domain of PROS until a sufficient base ofexperience has been obtained to develop explicitreview criteria. At that point, responsibility could betransferred to the FI, who could either continue priorreview or resort to retrospective review. Alterna-

of FIs from the start, with PROS reviewing only arandom sample of claims retrospectively. FIs mightalso be a more appropriate choice than PROS forconducting change-of-therapy review in cases whereHCFA deems this necessary.

Before the MCCA was repealed, HCFA hadproposed generic quality screens to be used by PROSin prior review of home IV therapy claims (see box5-D), as well as retrospective quality of care screens(53,167,376). HCFA had also developed diagnostictesting and other special criteria specific to the typeof therapy and diagnosis to be used by PROS forreview purposes (376).

If Congress were to create a new HDIT benefit,the work begun by HCFA in developing guidelinesand screening criteria for prior and retrospectivereview of home IV therapy could serve as a startingpoint for the development of final screening criteria.New criteria would be needed, however, if thebenefit were to cover alternative routes of parenteraladministration, additional drugs, and/or benefici-aries who were not capable of self-care procedures.


Quality Assurance for Beneficiaries WhoReceive Care Through Risk-Based ContractsUnder the proposed regulation, HCFA intended

not to extend PRO review (either prior or retrospec-tive) to home IV drug therapy services delivered tobeneficiaries in risk-based health maintenance or-ganizations (HMOs) or competitive medical plans(CMPs) (54 F.R. 173).24 HCFA reasoned that:

[B]ecause risk-based HMOs/CMPs already havethe clear incentive to prevent unnecessary utilizationof covered health care services, it would be largelyduplicative and, therefore, wasteful to have PROSuse their limited resources to make the samedeterminations (54 F.R. 173).

Although PRO utilization review activities mayhave been duplicative of existing HMO/CMP initia-tives, it is not clear that PRO quality review wouldhave been duplicative. Because HMOs and CMPsare paid on a per capita basis for the services theyrender to Medicare beneficiaries, they have incen-tives to control the utilization of potentially costly

services such as HDIT. They do not have as direct anincentive to control the quality of services delivered.

In 1985, Congress mandated PRO review ofquality of inpatient and outpatient services providedto these beneficiaries after January 1987 (PublicLaw 99-272).25 A recent study by GAO foundserious deficiencies in PRO external review ofquality of care provided in risk-based HMOs, citingdata collection and sampling problems as the majorbarriers to adequate oversight (355). The GAO studyalso found that HCFA does not adequately assess theeffectiveness of HMO internal quality assuranceprograms. Although PRO case-by-case review ofHMO quality of care is mandated, PRO review ofHMOs’ internal quality assurance programs is op-tional and most HMOs have chosen not to subjecttheir programs to PRO review (355). The increasingenrollment of Medicare beneficiaries in risk-basedHMOs in recent years (355) makes it all the moreimportant to extend any Medicare HDIT qualityassurance efforts (including PRO review) to theseplans.26

u ~enm~ of M~cme&neficfies ~11~ inrisk-wHM@ more than doubled between 1985 ~d 1990 (from 383,480 to 1,238,479) (355).See 42 CFR part 417 for a description of Medicare contmcts with risk-based HMOs/CMPs.

~ ~blic IAW 99-509 arnend~ this Provisioxq a.llowing HMOS to contract with organizations other than PROS for quality review and _ theeffective date of mandated PRO review to April 1,1987. As of Septemba 1990, despite the allowance of Public Law 99-509, all risk-based HMO qualityof care review was being conducted by 30 Me&are PROS (355).

~ H@A has r=nfly propo~ mjor c~es in the PRO review process for HMO/CMP enrollees. The changes, which would bC implementedsometime during 1992 or 1993 if approved, include a move away from inpatient hospital claims review toward a more comprehensive review of all caredelivered over a 12-month period for a random sample of enrollees (46). HCFA has also proposed tbat PROS conduct a more focused review of recordsof deceased beneficiaries (46).

Chapter 6

COVERING HOME DRUG INFUSIONTHERAPY: IMPLICATIONS

FOR MEDICARE

ContentsPage

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Summary of Conclusions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .The Costs of Home Drug Infusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Provider Costs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Payer Costs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Patient Costs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Costs to the Health Care System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

HDIT Coverage by Non-Medicare Payers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Private Insurers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Medicaid . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .CHAMPUS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Current Medicare Coverage of HDIT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Applicable Existing Benefits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .The Extent of Current Medicare Coverage of Home-Infused Drugs . . . . . . . . . . . . . . . .

Impact of Extending Coverage for HDIT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Implications for Medicare Expenditures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Implications for Hospitals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Implications for Technological Change . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Issues in Extending Coverage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Making Drug Coverage Decisions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .HDIT Eligibility and Home Health Services . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

111111111112112113114115116116117117118118122123123124125126126129

BoxesBox Page6-A. The NAIT Survey . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1166-B. Home Infusion Therapy in the Colorado Medicaid Program . . . . . . . . . . . . . . . . . . . . 1176-C. Defining “Homebound” Under the Medicare Home Health Benefit . . . . . . . . . . . . . 1196-D. Services and Supplies Covered Under the Medicare Hospice Benefit . . . . . . . . . . . . 121

TableTable Page6-1. Prices for Ambulatory Infusion Pumps: Examples From Two Manufacturers,

1991 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 113

Chapter 6

COVERING HOME DRUG INFUSION THERAPY:IMPLICATIONS FOR MEDICARE


Medicare, the Federal Government’s insuranceprogram for the elderly and disabled, does not havea home drug infusion therapy (HDIT) benefit. Nopart of the Medicare insurance plan states thatMedicare will pay for the prolonged administrationof drugs in the home. Yet Medicare does indeed payfor many of the components of HDIT some of thetime, and during the brief period when the MedicareCatastrophic Coverage Act (MCCA) was law, it wasexplicit Federal policy to extend coverage to HDITmore generally. The repeal of that act has permitteda second look at the implications of such a benefit.

As with most other aspects of HDIT, there is littledirect and unambiguous evidence to shed light onwhat would happen if Medicare covered the therapy.This chapter draws on small studies, the healtheconomics literature, the experiences of privatepayers and Medicare carriers, the experiences andstatements of providers, and the findings of previouschapters of this report to examine the scenario ofMedicare coverage and the various ways it mightplay out.

To do so, the chapter first examines the costs (andbenefits) of HDIT from the perspective of thedifferent actors involved-patients, providers, third-party payers, and the health care system as awhole-and discusses some of the factors that affectthose costs. It then describes the extent to whichMedicare currently covers components of HDIT andrelated services. Finally, the chapter discusses someof the issues and implications of extending Medicarecoverage for the program, its beneficiaries, provid-ers, and technological change.

Summary of Conclusions. Most patients who have been treated with

HDIT find it preferable to hospital inpatienttreatment. For them, any additional patient-related burdens of home treatment (in time,travel, etc.) are more than offset by the advan-tages of a more normal home and work life.

HDIT can be expensive to provide. Nonethe-less, it is widely believed to be cost-saving topatients, third-party payers, and the health caresystem alike. For the kind of patient most likelyto be on such therapy in the past-typically, arelatively young patient on antibiotic therapywho has no need of medical or assistive careother than the infusion-related care-this beliefprobably holds true much of the time.

Under other circumstances, however, HDIT isprobably often not less costly to the health caresystem than institutional alternatives. Thesecircumstances are more likely to occur if thepatient is unwilling to bear the responsibilitiesof home therapy; if the patient has additionalmedical problems or disabilities besides thosethat necessitate the infusion therapy; if there isno unpaid caregiver able to assist the patient athome; or if the patient’s discharge forces ahospital bed to lie empty.

Despite the lack of a benefit for HDIT, asubstantial amount of it appears already to bepaid for in some way by Medicare, but thisindirect coverage is neither coordinated norequitably applied. Existing coverage is sofragmented and variable that its extent isimpossible to describe with any accuracy.Nonetheless, under current rules, the actualcoverage is increasing and will probably con-tinue to do so in the near future, as Medicare’sadministrative contractors use their discretionto cover drugs as well as the associatedequipment, supplies, and nursing care.

The absence of a coordinated benefit for HDITlimits the extent of the services that areprovided. It also limits the ability of Medicareto assess, monitor, or influence the safety,quality, and effectiveness with which HDITservices are delivered.

Medicare patients are much more likely thanother patients to have social or medical circum-stances that would require a paid caregiver toadminister HDIT. They are also more likely toneed additional assistance with daily livingactivities. Thus, while some Medicare patients

-111-


are ideal and self-sufficient candidates forHDIT, many would probably have total homecare costs that exceed institutional costs.

Medicare coverage of HDIT would offer oppor-tunities for enhanced quality of life duringtreatment for many beneficiaries. It is possible(though by no means certain) that in the longrun such a benefit might also be cost-saving tothe program. In the short run, however, theaddition of this benefit would raise programcosts significantly, because Medicare cannotimmediately recoup the financial benefits ofshorter hospital stays. The extent of the addedshort-run costs, and the likelihood of long-termcost savings, would depend on the breadth ofthe benefit and its administration.

Decisions regarding the exact drugs and condi-tions to be covered under an HDIT benefitcould be made at the statutory, regulatory,fiscal intermediary (FI),1 or individual physi-cian level. Of these, decisionmaking placed atthe regulatory or FI level are the most consist-ent with existing Medicare coverage decisions.Compared with FI decisionmaking, coveragedecisio nmaking at the regulatory level permitsmore consistency but less rapid accommoda-tion of new drugs and drug protocols that mightbe appropriate for home use.

The Costs of Home Drug InfusionThe costs of HDIT depend on the perspective of

those paying them. For the provider, costs are thecosts of inputs-supplies, services, equipment, drugs,and administrative overhead. For payers, costs arepayments for the service and administrative time forthe benefit. For patients, costs—and benefits-are indollars, time, and ability to participate in otheractivities. For the health care system as a whole,costs are overall resource and opportunity costs.HDIT is frequently cited as being cost-saving (seebelow), but the extent to which it is so depends verymuch on the context in which it takes place and theperspective from which cost savings are analyzed.

On its face, the literature regarding the costs andcost-effectiveness of HDIT is extremely positive.With very few exceptions, published studies con-clude that HDIT is less expensive than institutional

therapy for presumably equivalent benefit. Since1978, when the first two reports appeared, at least 17studies have reported that charges for antibioticinfusion patients treated at home were less thanthose for hospital-treated patients (16,78,101,106,106a,119,136,148,182a,187,188,267,268,278,324,325,335). The average reported savings per home patientin these studies ranged from $510 to $22,232 (22).

A problem in using these studies to infer cost-effectiveness of HDIT is that most use only providercharges, rather than resource costs, for their compar-isons of home and hospital therapy. In addition, inmany of the studies, hospital and home patients wereapparently unmatched except for the general type oftherapy. Hospital charges often included surgery andother inpatient procedures that had no home equiva-lents, and in some cases, hospital charges weresimply rough estimates.

A more rigorous study of once-a-day intravenous(IV) antibiotic administration for osteomyelitis waspublished in 1986 (101). It, too, found that HDITresulted in lower per-patient expenditures. Patientsin the study were assumed to be entirely self-administering; no allowance was made for outpa-tient nursing. Collectively, then, the existing litera-ture shows that, for carefully selected patients,charges for home care can average considerably lessthan charges for hospital care.

The actual resource costs of care, however, do notnecessarily bear any relationship to charges. In fact,it is the difference in the perception of what costs arerelevant, and changes in who is receiving home care,that explains why HDIT has not diffused even morerapidly despite the extensive literature on its savingspotential. Thefactors.

HDIT is not

following section discusses these

Provider Costsinexpensive to provide. It requires

special expertise on-the part of nurses; it requiressubstantial amounts of pharmaceuticals and clinicalpharmacy services; and it may require equipmentrental as well as a multiplicity of supplies. Oncebegun, it cannot be abandoned without institutional-izing the recipient or endangering the patient’shealth. Thus, placing a patient on HDIT requires asubstantial financial commitment on the part of theprovider. There are no studies of actual provider

1 Fiscal intermediaries (part A intermediaries or Part B carriers) are Medicare’s local administrative agents.

Chapter 6-Covering Home Drug Infusion Therapy: Implications for Medicare ● 113

costs of finishing this service; only anecdotalinformation is available. One HDIT provider, forinstance, believes its average costs of providing alldrugs, services, and supplies for IV antibiotictherapy to be roughly $4,000 per month (367).

Costs probably vary considerably among provid-ers. Health care worker wages, for example, areusually higher in urban than in rural areas (48 F.R.39752). Wages for nursing services also vary amongproviders depending on the qualifications the pro-vider requires of the nurses. The exclusive use ofregistered nurses (RNs) with extensive IV therapyexperience, for example, is more costly (and possi-bly of higher quality) than the use of RNs withlimited experience who perform both IV and otherhome health nursing services, because the morehighly skilled nurses command higher salaries(364). One survey of infusion specialty companiesfound that their specialist nurses earned an averageof $17.44 to $20.15 per hour, depending on experi-ence (256).

Costs of supplies and equipment can also varyconsiderably among providers for any given ther-apy. Some providers, for example, use infusionpumps for almost all the therapies they provide(364). Others use less expensive gravity drip sys-tems to deliver many antibiotics (364). Even amongpumps, there can be great variation in costs (table6-l), with the choice of which pump to usedependent on type of therapy, provider experience,purchasing arrangements, physician and patientpreference, and patient characteristics.

Providers’ drug costs vary tremendously as well,even within a single category of drugs such asantibiotics. Different antibiotics can have dramati-cally different average prices. Even for a single drug,providers’ costs of acquiring the drug vary depend-ing on their purchasing power (60,331).

The kinds of patients seen will affect both supplyand nursing costs. Providers with a high cancer orAIDS2 caseload, for example, may spend more perpatient than other providers because these patientsoften require multiple therapies and the administra-tion of highly toxic drugs that require pumps to beadministered safely (see chs. 2 and 3). Similarly,providers who serve large numbers of elderly or

Table 6-l—Prices for Ambulatory Infusion Pumps:Examples From Two Manufacturers, 1991

Manufacturer/pump Pump pricea

Pharmacia DeltecCADD-HFX . . . . . . . . . . . . . . . . . . . . . . . . . .CADD-PlUS . . . . . . . . . . . . . . . . . . . . . . . . . .CADD PCA2 . . . . . . . . . . . . . . . . . . . . . . . . .CADD-TPN pump . . . . . . . . . . . . . . . . . . . . .CADD-TPN system . . . . . . . . . . . . . . . . . . .

lvion Corp.Walkmed 300 . . . . . . . . . . . . . . . . . . . . . . . .Walkmed 410 . . . . . . . . . . . . . . . . . . . . . . . .Walkmed 420 . . . . . . . . . . . . . . . . . . . . . . . .Walkmed 430 . . . . . . . . . . . . . . . . . . . . . . . .Walkmed 440 . . . . . . . . . . . . . . . . . . . . . . . .lntelliJect@ . . . . . . . . . . . . . . . . . . . . . . . . . .

$2,5953,3953,4953,5953,995

1,8602,0952,6952,6953,0955,400

apri~9 are those quoted to the Office of T=hnology Assessment by themanufacturers in October 1991. It ispossibtethatthe actual prfees ptdd bysome providers are Iowerthan the prices listed here (e.g., if the providersobtained discounts from the manufacturers).

SOURCES: M. Moraezewski, Pharmaeia Deltee, St. Paul MN, personaleommunieation, Oct. 7, 1991; R.P. Nelson, Ivion Corp.,Broomfield, CO, personal eommunieation, Oct. 7, 1991.

disabled patients are likely to have higher nursingcosts per patient than other providers, because theseindividuals may need more assistance with theirtherapies and other health and personal care needs(see ch. 3).

There may be some tradeoff between nursing andsupply costs. The use of a preprogrammed pump, forexample, may allow an elderly patient to go home ontherapy without the need for a paid nurse toadminister each dose. The actual extent to whichmore sophisticated drug delivery systems mayreduce nursing costs, and for which patients, isundocumented and apparently unknown.

Payer CostsThe costs of HDIT to a third-party payer-e.g.,

Medicare, Medicaid, or private insurance-are theamount that the insurer pays for the therapy and anyassociated health care services necessary to provideit.3 This amount may simply be the providers’charges for the therapy and associated services,minus any coinsurance or deductible paid by thepatient. Alternatively, the insurer may pay on someother basis, such as a fee schedule or a ratenegotiated beforehand with the provider.

Much of HDIT’s early success and rapid diffusioninto the health care system has derived from

2 Acquired immunodeficiency syndrome.s In some case~.g., in some health maintenance orgsnizstions-the provider and the insurer maybe the same entity. In this case, the insurer’s

costs are simply the costs of providing the service.


providers’ ability to convince insurers their pay-ments will be less for home than for hospital therapy.But in 1992 this is not always the case, despite theevidence that home care charges have historicallybeen lower.

Insurers’ home care payments are sometimeshigher than hospital payments for two reasons. First,the most important contributor to the lower histori-cal charges for home infusion is the replacement ofpaid room, board, and labor in the hospital with theirunpaid equivalents in the home. All of the studiesthat reported lower charges for HDIT required thathome patients be able and willing to carry out theirinfusions with the help of a family caregiver. ButHDIT in the 1990s is by no means limited toself-infusing patients (250,364), and total homecharges for patients who require paid assistance mayexceed hospital charges for equivalent care (204).This may be particularly true if, in order to substitutehome for hospital care, the patient needs not onlyassistance with the infusion but help with otheractivities as well (e.g., dressing and bathing).

Second, the relationship between payments andcharges differs for hospital and home therapy.Medicare, Medicaid, and private insurers now oftenpay hospitals much less than actual charges.4 Butinsurers that pay directly for HDIT often still do soon the basis of home provider charges, because theyhave little other basis for establishing payment rates(55). Consequently, according to insurers, paymentfor HDIT can sometimes exceed payment forequivalent hospital care even for the most self-sufficient patients.

For example, one insurer told the Office ofTechnology Assessment (OTA) that it had receivedclaims for a patient with Lyme disease in which thecharge for self-administered home IV antibiotictherapy was over $650 per day. Based on its hospitalpayment experience, the insurer believed that hospi-tal care for this patient would have been consider-ably cheaper than home care at the charged rate(367).

The difficulty in realizing cost savings to thepayer is particularly acute for third-party payers thatreimburse for hospital inpatient care at a fixed rateper patient discharged. In this case, the hospital

payment remains the same regardless of whether thepatient is discharged home after a few days orremains hospitalized for several weeks. From thepayer’s perspective, home care payments simply addto, rather than substitute for, hospital paymentsunder such a system (243). Only when hospital careis averted altogether can the payer reduce its costs.

Patient CostsPatient-associated costs of HDIT fall into three

categories. First, and most obvious, are directmedical costs. In the extreme, when no third-partycoverage applies, these costs include the purchaseprices for all of the products and services directlyrelated to the therapy. Because these costs are veryhigh for most patients, HDIT is probably rarelyprovided to such patients except as charity care.When the patient’s insurer does cover home therapy,the patient’s direct medical costs include any insur-ance copayments (i.e., coinsurance and deductibles)and any provider charges uncovered by the insurer(e.g., charges greater than the payer’s allowedcharge and charges for any luxury or nonprescribeditems).

Nonmedical costs (e.g., food, electricity, andtransportation costs) can be equally important tohome patients. Some of these, such as food, become“medical costs” and are covered by insurance whenprovided in a hospital. Finally, patients on prolongedinfusion therapy also bear indirect costs associatedwith the therapy, such as time lost from familyresponsibilities and leisure activities, lost income,family stress, and psychological discomfort.

It is the lessened indirect costs often associatedwith HDIT that account for its popularity withpatients. Patients with strict school, work, or homeresponsibilities (e.g., caring for another familymember) can be very vocal and articulate in theirpreference for HDIT (364). In studies reporting onpatient satisfaction and activities during HDIT, mosthome patients were able to resume their normalactivities while on treatment (106,188). Even thosewithout employment or other outside commitmentsmay find home infusion attractive because it permitsthe patient to engage in outside recreational activi-ties and a normal social life (364). No studies have

4 Medicare and Medicaid have paid less than actual charges for many years. More recently, the increase in managed-care programs such as preferredprovider and health maintenance organimations (which together make up over one-fourth of the group insurance market) (150) means that many privateinsurem also receive substantial discounts off of hospitals full charges.

Chapter 6-Covering Home Drug Infusion Therapy: Implications for Medicare . 115

been performed on the extent to which elderlypatients requiring infusion therapy prefer one site ofcare over another, but there is no reason to think theywould value the relative freedom of home care lessthan most other patients.

Costs to the Health Care SystemWhether paying for HDIT costs more or less to the

overall health care system than not paying for thisservice cannot be answered by examining eitherprovider, payer, or patient costs in isolation. HDITis cost-saving to the system if (and only if) the nethealth care resources required to provide this serv-ice, and any adjunct services needed at home, arefewer than those required to provide equivalenttherapy and services in alternative settings.

The comprehensiveness of this requirement iscritical. It is the total package of care required by apatient in order to be treated at home just theinfusion therapy-that must be compared with carein alternative settings in an evaluation of relativehealth system costs. If a patient needs help withbathing and N site dressing (bandage) changes inorder to be treated at home, the costs of providingthose home services must be counted as part of thecosts of being able to receive HDIT. Depending onthe way benefits are defined and paid, HDIT can becost-saving to any individual payer without neces-sarily saving health system resources overall, andvice versa.

The three basic settings for drug infusion therapythat are alternatives to the home are hospitals, whilethe patient is an inpatient; ambulatory care settings,such as outpatient clinics and physician offices; andskilled nursing facilities (SNFs) (including self-defined subacute care facilities). There are nostudies of the resource costs of providing druginfusion therapies in any of these settings. However,it is possible to explore some of the factors thatinfluence relative costs under different circum-stance.

Need for Professional Services

In the extreme, if a patient needs 24-hour skillednursing in order to be able to receive drug infusiontherapy at home, the home is highly unlikely to be acost-saving setting for treatment. In this instance, thenurse can care for only a single patient, a situationthat is very resource-intensive and that can be moreexpensive than most hospital care (204,362a).

In contrast, the home is likely to be a relativelyefficient setting for a patient who requires noprofessional care at all except for the initial training.Since the training itself is a resource cost notincurred by institutionalized patients, the relativecost savings for such patients increases with thelength of time on therapy. This potential for greatsavings over time for independent and relativelyhealthy patients was one of the spurs behind thedecision by Medicare in 1977 to pay for hometherapy for patients requiring long-term total paren-teral nutrition (TPN) (359).

Cost of Travel and Care Coordination

Home therapy, in contrast to inpatient- or clinic-based therapy, requires a considerable amount ofprovider time spent in activities other than directpatient care, such as travel between patients andcoordination among relevant providers (physician,pharmacist, nurse, etc.). Where the costs of conduct-ing these activities are high, home care may berelatively more resource-intensive. For example, ifa patient needs professional supervision for a4-times-a-day infusion regimen, requiring multipledaily trips by the nurse, home care may be morecostly to the health care system than equivalent careprovided in an SNF. Patients with many complexhealth care needs, of which infusion therapy is onlyone, may be similarly less expensive to care for in ahealth care setting that can offer the array of neededservices on-site.

Providers of clinic-based outpatient infusion ther-apy maintain that this setting is more efficient thanhome care for treating many patients (340,340a).The ability of outpatient clinics to maintain allneeded services on site, with personnel in constantcommunication, suggest that this assertion may wellbe true for at least some patients.

Institutional Occupancy Rates

Treating patients at home rather than in thehospital cannot be cost-saving to the health caresystem if hospitals are unable to either eliminatebeds and associated services or put the beds andservices to better use (e.g., by transferring into thenow-open bed a patient previously being treated inthe intensive care unit). Where hospitals haveunoccupied beds and underutilized staff, continuingtreatment in the hospital may well be less expensive


Box 6-A—The NAIT Survey

The National Alliance for Infusion Therapy (NAIT), an association of “providers and manufacturers of homeinfusion services, equipment, and products,” sponsored a survey of data from nine of its members in 1990. Thesurvey’ goal was to "identify types of available data and obtain preliminary information about industry and patientcharacteristics.’ It included the following components:

1. National patient census. The contractor performing the survey (Coopers & Lybrand) collectedcross-sectional data for March and September 1990 to obtain a complete census of all home infusion therapypatients considered “on service” at that time in eight participating companies. This census (42,700 patientson Sept. 30, 1990) was then analyzed according to variables of interest (e.g., geographic location).

2. Patient-specific data sample. From a stratified sample of 86 branch offices of companies participating inthe survey, the contractor then sampled 2,506 patient records to identify patient-specific demographic,clinical, service, and therapy information. Patients were selected for the sample only if they received oneor more of the following infusion therapies during the 2-week sample period: antibiotics, antineoplastics,pain management, total parenteral nutrition, and enteral nutrition.

3. Patient education survey. The contractor separately surveyed a small sample of previously hospitalizedpatients who were receiving services from participating companies regarding the infusion-related educationand training they received in the hospital before discharge.

4. Site visits to four branches of three companies and one corporate office to obtain operation and servicedelivery information.

5. A review of the published literature regarding home infusion therapy services, costs, and wages for skilledemployees.

6. Longitudinal data for a subset of all previously surveyed patients who were discharged from home infusionservice during the period Sept. 9, 1990 through May 31, 1991. (Late reporting and incompleteness madethese data of questionable reliability.)

SOURCE: A.K. Parwx and K. Lir@ National A1.lianeefor IofusionTherapy, WasbingtoQ DC, memorandum to E. Power, Off3ce of ‘IkdmologyAssessment oet. 30,1991.

to the health care system than treating that patient at Private Insurershome (at least in the short run). Conversely, ifinstitutional beds are fully occupied, home care Most HDIT is paid for through private insurance.becomes a relatively more efficient setting, because Several providers who specialize in home drugthe alternative is to build more institutional beds. infusion (as opposed to TPN) report anecdotally that

over three-fourths of their patients have privatethird-party coverage (83,343).5 The NAIT survey

HDIT Coverage by Non-Medicare Payers found that almost 64 percent of patient recordssampled listed private insurance as the payer and an

Most health care third-party payers cover HDIT atadditional 14 percent had a combination of privateinsurance and Medicare (256).

least some of the time. Coverage increased substan-tially during the 1980s, as the technology became Similarly, most private insurers cover HDIT to atmore developed, providers became more adept at least some extent. A 1987 survey of coverage forconvincing payers of its worthiness, and payers home IV antibiotic therapy found that of 50 Bluebecame more familiar with it. In a 1990 survey of Cross/Blue Shield programs, 47 covered this serv-records of some infusion companies that are mem- ice, although 34 required that it receive priorbers of the National Alliance for Infusion Therapy authorization before coverage commenced (21).(NAIT), less than 4 percent of patients had no This survey likewise found that most commercialthird-party coverage of any kind for their therapy insurers and all of the 19 responding health mainte-(257). (Box 6-A describes the NAIT survey.) nance organizations covered this therapy, with about

5 Because Medicare covers TPN, providers specializing in this form of infusion therapy would be expected to have a higher proportion of Medicarepatients (and a lower proportion of privately insured patients) than those specializing in HDIT


half of each group requiring prior authorization (21).These results, now 4 years old, probably understatecurrent coverage; the continued expansion andfinancial well-being of the HDIT industry suggeststhat coverage for the therapy is widespread.6

MedicaidMedicaid is a federally aided, State-administered

program that provides medical assistance to roughly26 million low-income people (114). Although theFederal Government sets some minimum standards,the actual services offered by individual StateMedicaid programs vary widely among the pro-grams.

All State Medicaid programs cover the basiccomponents of HDIT in some fashion (although theydo not necessarily pay generously). Durable medicalequipment (DME) and home care services for adults,for example, are federally mandated benefits underthe program. Prescription drugs are optional, but asof 1990 all 50 States and the District of Columbiacovered them (373).

More comprehensive coverage of HDIT, how-ever, is not so universal. A 1987 survey of the 50State Medicaid programs, sponsored by Hoffmann-La Roche, found that 48 of the 50 States paid forhome IV antibiotic therapy (21). Of these 48programs, 29 required that the service receive priorapproval before it would be covered. At least oneMedicaid program has documented that HDIT hasbeen cost-saving to the program (box 6-B).

CHAMPUSThe Civilian Health and Medical program of the

Uniformed Services (CHAMPUS), operated by theDepartment of Defense, is an example of anothergovernment health care program that covers HDITin at least some cases. CHAMPUS pays for themedical care needed by dependents of active andretired military personnel when that care cannot beobtained from a military hospital. The programcovers home infusion therapy both under its basicbenefit package and through two ongoing homehealth care demonstration projects. Coverage isgenerally broad, but it is probably somewhat erratic

Box 6-B—Home Infusion Therapy in theColorado Medicaid Program

A review of claims for home infusion therapysubmitted to Colorado’s Medicaid program foundsatisfactory results of this coverage for that pro-gram. Researchers found that 61 patients weretreated at home, based on claims submitted over a26-month period. Most of these patients weretreated with anti-infective drugs. The remainderreceived either other infused drugs or total paren-teral nutrition (TPN) (85).

program savings for the period were estimated tobe at least $125,000 (1988 dollars). The programresulted in a significant shift of Medicaid resources,from hospital spending (which decreased by auestimated $430,000 due to the program) to expendi-tures for nonhospital pharmacy services (whichincreased by nearly $100,000). Anti-infective ther-apy was the greatest overall contributor to savings,due to its large share of patients, while painmanagement resulted in the greatest per-patientsavings. In this study, home TPN was found toresult in little or no program cost savings (i.e., it didnot reduce Medicaid expenditures) (85).

in its implementation due to the individualizednature of many coverage decisions.

CHAMPUS basic home health benefits includemedical equipment, skilled nursing care, drugs andmedical supplies, and physician visits. The programhas little formal policy regarding what types of homeinfusion therapies are covered; all decisions aremade on a case-by-case basis, and informal coveragepolicies (mostly in the form of specific exclusions)are based on accumulated claims experience (20).However, coverage for HDIT appears fairly broad.Except for beneficiaries requiring custodial care (towhom limits on nursing services apply), unlimitedhome health visits to CHAMPUS beneficiaries arecovered if they are medically necessary and if thepatient is either “homebound” or services areotherwise determined to be needed in the home.7

Infused drugs are covered, but only if they areapproved by the Food and Drug Administration

G The f~cid well-being of the ~~ market is suggested by the fact tha~ according to market analyst estimates, industry revenues grew by over30percentper year between 1986 and 1988 and were predicted to continue to grow by over 25 percent per year through IW1 (275). Companies likewisecontinue to perceive the HDIT industry as a growing one, and of the top 10 companies in the home care industry (defined by total revenue), 7 deriveat least a quarter of their revenue fium home infusion therapy, including HDIT (392).

7 CHAMPUS has no working deftition of “homebound,’ and fiscal intermediaries may be applying the restriction rather liberally (20).


(FDA) for both the particular route of administrationand the particular condition (19).8

In contrast, under the ongoing demonstrationprojects, drugs may (on a case-by-case basis) becovered for unapproved uses if they are widely usedfor those purposes (269).9 In general, the demonstra-tion projects require that a patient have an alternatecaregiver in order to receive home infusion therapy.However, CHAMPUS has paid for additional assis-tive services on occasion (269).

Current Medicare Coverage of HDITApplicable Existing Benefits

Medicare, the Federal Government’s health insur-ance program for aged and disabled individuals, hasno defined benefit that covers HDIT. Infusiontherapy of any kind has been considered in the pastto be an institutional rather than a home service.Even TPN, which has been covered by Medicaresince 1977, is covered under the prosthetic devicebenefit (as a replacement for the digestive system)rather than as a home infusion therapy benefit.

Nonetheless, there are a number of existingbenefits under which patients can get certain compo-nents of drug infusion therapy covered at home. Thetotal number of Medicare patients who receive somecoverage for home infusion therapy is unknown butprobably extensive. However, the coverage thatexists is also highly fragmented, nearly alwaysincomplete, and varies enormously depending on thelocation and circumstances of the patient.

Medicare is separated into two parts: Part A,which covers hospital, skilled nursing facility, homehealth, and hospice care; and Part B, which coversphysician and related services, hospital outpatientservices, nonhospital laboratory services, and medi-cal equipment and supplies.10 Existing benefits thatcurrently serve as “back door” mechanisms forHDIT coverage include:

1. Part B DME benefit,2. Part A home health benefit,

3. Part B diagnostic laboratory services benefit,4. Part B physician services benefit,5. Part B hospital outpatient benefit, and6. Part A hospice benefit.

Each of these benefits and its relation to HDIT isdescribed below.

Part B Durable Medical Equipment

The Medicare DME benefit is the most broadlyavailable mechanism through which Medicare cov-ers some of the components of HDIT. To be eligiblefor this benefit, a beneficiary usually need only havea physician certify that the equipment: 1) is fur-nished to that person in his or her home,11 and 2) ismedically necessary to ameliorate illness or injury orto improve functioning of a malformed body part.Infusion pumps and IV poles qualify as DME.

Medicare also covers medical supplies and acces-sories necessary for the proper functioning of theequipment (74). Thus, supplies such as tubing,needles, and alcohol swabs would be covered whena pump is covered.

Equipment must be capable of withstandingrepeated use to qualify as DME. Single-use infusioncontrol devices (e.g., elastomeric infusers-see ch.3) do not qualify. Also, equipment with certainconvenience or luxury features are covered in fullonly if those features are deemed medically neces-sary for the patient’s condition (74). Thus, Medicarepresumably would not cover a sophisticated infusionpump if the drug to be infused could be deliveredsafely and effectively through a less expensivegravity drip system. Furthermore, because a gravitydrip system (with the exception of the IV pole) is notconsidered DME, related medical supplies wouldusually also be excluded from coverage in thisinstance.

The coverage of supplies and accessories relatedto the DME explicitly includes “drugs and biologi-cals that must be put directly into the equipment toassure proper functioning of the equipment” (74).

8 CHAMPUS does not cover dregs for unapproved uses; for example, the FDA has not approved terbutaline for use in preventing preterm labor, soit is excluded from CHAMPUS coverage (20). The only exception to this general policy is tbat, under a proposed and soon to be final rule, CHAMPUSwill cover class III investigational cancer drugs listed by the NationaJ Cancer Institute (20).

9 For example, CHAMPUS does cover home-”mi%sed terbutaline for high-risk obstetric patients under the demonstration program. They haveexperience with about 60 patients, and staff believe the therapy to be effective in prolonging pregnancy (269).

10 Home he~th stims can alSO be covered under Part B for beneficiaries who are ineligible for ~ A bntilts.11 For the Pvsm of ~s &#lt, a “home” is def~~ ~ tie patient’s pl~ of residence, but tie definition excludes iIIStit’UtiOIIS Or diSbCt p-

of institutions that meet the basic defiition of a hospital or a skilled nursing facility.


Box 6-C—Defining “Homebound” Under the Medicare Home Health Benefit

For much of Medicare’s history, “homebound” was written in the statute as “confined to the home” andappeared at only two places in the Social Security Act (sections 1814(a) and 1835(a)). Over the years, the HealthCare Financing Administration (HCFA) attempted to clarify the definition through guidelines and examples in theMedicare Intermediaries’ Manual. The guidelines essentially restricted qualifying beneficiaries to those unable toleave the house by any means to get medical care, although the manual specified a few exceptions (e.g., trips tochurch, trips to the doctor for medical care that couldn’t be delivered at home) (379). Still, intermediaries’interpretations of “homebound” were apparently highly varied (167).

The omnibus Budget Reconciliation Act of 1987 (Public Law 100-203) attempted to further clarify themeaning of “homebound” by specifying in statute that:

. . . an individual shall be considered to be ‘confined to his home’ if the individual has a condition, due to an illnessor in., that restricts the ability of the individual to leave his or her home except with the assistance of anotherindividual or the aid of a supportive device (such as crutches, a cane, a wheelchair, or a walker), or if the individualhas a condition such that leaving his or her home is medically contraindicated. While an individual does not have tobe bedridden to be considered ‘confined to his home,’ the condition of the individual should be such that there existsa normal inability to leave the home, that leaving home requires a considerable and taxing effort by the individual,and that absences of the individual from home are infrequent or of relatively short duration, or are attributable to theneed to receive medical treatment” (SSA secs. 1814(a), 1835(a)).

Despite this effort to bring some uniformity to the application of the “homebound” restriction, continuedambiguity in the definition of “confined to his home’ will most likely lead to continued differences in intermediaryinterpretation and practice. HCFA intends to publish regulations that attempt to explain the new statutory languagein more detail (167).

The interpretation of this clause, however, is left to Part A Home Health Services13

the discretion of the FI (i.e., the Part B carrier) (155).To clarify what drugs might be appropriately cov- The Medicare home health benefit is a source ofered through this provision, the Health Care Financ- coverage for skilled nursing services associated withing Administration (HCFA) inserted language in the home infusion for Medicare beneficiaries. To beMedicare Carriers Manual that instructs carriers to eligible for Medicare-covered home health services,cover the cost of external infusion pumps and however, a beneficiary must be “confined to hisassociated drugs when used for the administration home’—i.e., unable to leave his home without theof:

●

●

●

●

deferoxamine to treat acute iron poisoning oriron overload;heparin to treat thromboembolic disease and/orpulmonary embolism (in institutional settingsonly);antineoplastic therapy to treat liver cancerpatients who cannot or will not undergo surgic-al treatment; andmorphine to treat cancer patients for intractablepain (378).

assistance of another person or a supportive device(379). The legislative definition of “confined to hishome’ has been broadened in recent years (see box6-C). However, it is still both fairly restrictive andsomewhat ambiguous, and there is still variationamong Medicare intermediaries in interpretation ofthe rule (167).

The homebound requirement effectively elimi-nates a large number of the least disabled patients ondrug infusion therapy from any nursing coverageoffered under the home health benefit. For example,

–

patients who are otherwise healthy and nondisabledThis language neither requires nor prohibits carriers but require continuation of an 8-week course offrom covering other drugs under this same general antibiotic therapy would not qualify for any homerubric .12 health services because they are not homebound.

12 HCFA does explicitly prohibit cove~e of extew infusion pumps for the subcutaneous administration of insulin to diabetic patients (378).13 6’Homeh~thsewices~ * ~cova~~erpm A ~ess the ~nefici~ has exhausted his or her Part A coverage, in which case coverage is ~der

Part B (74).


Beneficiaries eligible for home health benefitsalso must be under a physician’s written plan of careand must be in need of either part-time or intermit-tent skilled nursing care or skilled physical or speechtherapy services (379). Nearly all patients requiringhome infusion would meet this qualification. Thus,most infusion patients who were also homeboundwould be eligible for other home health benefits notrelated to the infusion therapy as well.14

Two home health benefits are especially relevantto HDIT patients. These are:

Part-time or intermittent skilled nursing serv-ices provided by or under the supervision of aregistered nurse (RN) (379). Patients qualify ifthey need up to 28 hours per week of skillednursing and home health aide services com-bined at less than 8 hours per day, or up tofull-time (8 hours per day) on a temporary basis(up to 3 weeks). The need for services up to 35hours per week of skilled nursing and homehealth aide services combined at less than 8hours per day (or on less than a daily basis) maybe approved on a case-by-case basis (379).Through this benefit, most skilled nursingservices required for HDIT would be covered.DME and medical supplies. Covered suppliesinclude presumptively medical supplies (e.g.,needles, wound dressing supplies) as well asordinarily nonmedical supplies that are deemednecessary for the patient’s medical condition(e.g., lotions or soaps that serve a particulartherapeutic purpose). Unlike the part B DMEbenefit, drugs and biological are specificallyexcluded from DME provided under the homehealth benefit (379). Nonetheless, this benefitpermits the rental or purchase cost of aninfusion pump and all HDIT-related medicalsupplies except the drugs (e.g., tubing, catheter

The

●

●

●

●

replacements, dressing supplies, alcohol swabs)to be covered.

home health benefit also covers:

skilled physical, speech, and occupational ther-apy services,part-time or intermittent services of a qualifedhome health aide,15

medical social services,16 andhome medical services of residents and internsin approved teaching programs with which thehome health agency is affiliated (74).

All covered services must be furnished by or underarrangement with a Medicare-certified home healthagency (HHA) (74).

Part B Diagnostic Laboratory Services

Medicare’s Part B diagnostic laboratory servicesbenefit covers nonhospital diagnostic laboratoryservices that are ordered by a physician, includinglaboratory tests to monitor the status of an HDITpatient (74,378).17 Skilled health professional serv-ices required to obtain laboratory specimens (e.g., alab technician to draw blood) and travel costs oflaboratory personnel for the purpose of collectingspecimens from homebound persons are also cov-ered (378).

Part B Services Incident to a Physician’s Services

Services and supplies (including drugs and bio-logicals that cannot be self-administered18) fur-nished incident to a physician’s professional serv-ices are covered under Part B of Medicare. Nonphys-ician services (e.g., nursing services) covered underthis provision usually must be performed under thedirect supervision of the physician by individualsunder that physician’s employ (378).

M me N~T -w fo~ ~ 12 ~xmt of w p~ents ~ its -le Wme no~~ato~ (~d thUS mi@ qualify x homebound) (256). Theproportion of elderly patients on HDIT who might quali@ is probably considerably higher, since most patients in the NAIT sample were under age 65.

15‘rhepww of h~meh~th~defiits must~ toprovide~ds-on~rso~ c~e or ~~icesn~es~for the health or fI~tment Of ~ehefiCi~(e.g., simple dressing changes, assistance with orid medications). !kxvices of a home health aide are not considered reasonable and necessary if thereis a family member or other caregiver available and willing to perform thexw however, it is customary to presume that no caregiver is available unlessthe beneficiary or a family member indicates otherwise or the home health agency has knowledge to the contrary (379).

16 ~wples of m~~ SWM s~ims include: counseling services, community resource identiilcatiou assessment of resource COOrdiMtiOU mdassessment of social and emotional factors related to the beneficiary’s condition and treatment (379).

17A ctic~ ~hmtow tit is part of a hospiti is comidti an independent laboratory when it provides services to nonpatients (378). If the samehospital laboratory provides services to the hospital’s outpatients, such services are covered under the Part B outpatient hospital services benefit (74).

1s ~~venomly administer~ drugs are generally not considered by HCFA to b @f-~“ “ tered drugs (378).


In certain unusual circumstances, however, Medi-care can waive the direct supervision requirement.19

Specifically, for homebound patients who live inareas not served by any Medicare-certified HHA,Medicare will cover a number of skilled serviceswhen provided by nonphysicians, including injec-tions, venipuncture, dressing changes, and patienttraining activities (378). HCFA has no informationregarding the extent to which services are billedunder this waiver (76,143). The increase in thenumber of certified HHAs (from 2,212 in 1972 to5,673 in 1990) (353), however, suggests at least thatthe need for such a provision has decreased.

Medicare coverage of services furnished incidentto a physician’s services are more commonlyrelevant to infusion services in the context ofoutpatient infusion. Through this coverage rule,Medicare covers the nursing services and suppliesfor infusions performed in physicians’ offices. Somecarriers apparently restrict such outpatient infusioncoverage, however. For example, an IV antibioticprovider in the State of Washington reports that itscarrier will cover office-based infusion only forcertain medical conditions (146).

Part B Hospital Outpatient Services

As with physicians’ offices, hospital outpatientdepartments already qualify for payment for theirvarious nursing activities and medical supplies, andoutpatient infusion provided in this setting is reim-bursable. Medicare covers laboratory services, dura-ble medical equipment, visits, medications, andmedical supplies provided in hospital outpatientdepartments (273). Furthermore, payment for mostservices in this setting is on the basis of reasonablecosts, making it potentially financially attractive tohospitals able to organize and maintain an outpatientclinic.

Through this mechanism, Medicare may covernot only infusions performed in the clinic itself butthe costs of visits for skilled nursing services (e.g.,catheter site changes) when a patient is performingthe daily infusions at home. The extent to which thebenefit is used for either purpose is unknown.

Box 6-D—Services and Supplies CoveredUnder the Medicare Hospice Benefit

Supplies and services covered under the Medi-care hospice benefit include:

. nursing care;

. medical social services;● physicians’ services;. counseling services for the patient and familly

members;● short-term inpatient hospice care;. drugs and biological that are used primarily

for pain and symptom control;. medical equipment and supplies related to pain

and symptom management;. physical, occupational, and speech therapy;

and home health aide and personal care services

(including personal comfort and custodial careitems as necessary).

Nursing and home health aide services are coveredon a 24-hour basis only during periods of crisis.

SOUR~: Commerce Clearing House, Inc., A4edicum undMedz”ca&.iGzddk (chiC~O, ~: ~~, k., 1990).

Part A Hospice Care

Terminally ill patients (those with a life expec-tancy of 6 months or less) are eligible for theMedicare hospice benefit. This benefit focuses onpalliative treatment, symptom control, and homecare rather than on curative treatment. When abeneficiary elects hospice care, he or she becomesineligible for most other Medicare benefits.20

Hospice care must be provided by a Medicare-certified hospice program. Hospice care services andsupplies (see box 6-D) are covered by Medicare ifthey are reasonable and necessary for the palliationor management of the patient’s terminal illness andare included in a written plan of care that is reviewedperiodically by the patient’s physician. The hospiceprogram must provide all these services directly orthrough arrangements with other approved entities.

Any home infusion services provided by thehospice are covered under a daily rate. Hospices may

19 me s~ic~ must still be provided under general physician supcmision. “General supervision” requires that the service(s) be ordered by thephysiciq that thephysicianmaintain contact with the professionals performing the service(s), and that the physician maintain professional responsibilityfor the service(s) (378). (In contras~ “direct supervision” requires that the physician be on site.)

~ Semices of such aphysici~ the patient’s attending physiciam who is not an employee of the hospice continue to be reimbursable wdm MediaePart B (74).

297-913 0 - 92 - 9


be discouraged from providing such services eitherbecause they are too costly, too complicated toprovide, or both (26). Some hospices, for example,do not accept patients who are on TPN (30).(Although TPN is covered under the Part B pros-thetic device benefit, beneficiaries who have electedthe hospice benefit are no longer eligible for suchcoverage.) The bulk of home infusion therapyprovided under the hospice benefit is believed to befor pain management (26). Pain management admin-istered by infusion pump is considered a “high-cost” service by providers, and although hospicesgenerally prefer less costly alternatives, they willgenerally pay for a pump system if it is requested bythe physician (26).21

The Extent of Current Medicare Coverageof Home-Infused Drugs

The primary means by which Medicare currentlycovers HDIT are the home health benefit, whichenables homebound persons to receive coverage forinfusion-related nursing, and the DME benefit,which permits Medicare beneficiaries who needthem to receive infusion pumps and related supplies.It is the latter benefit that allows patients to receivesome drugs, with the extent of drug coveragedependent on the Medicare carrier’s discretion.These two complementary benefits can, at times,enable a Medicare patient to receive reasonablycomprehensive (but uncoordinated) home infusionbenefits. The patient, if homebound, may qualify forthe home health benefit through the need forintermittent infusion-related nursing, while billingfor drugs, equipment, and supplies through the PartB DME benefit.

To assess the extent to which carriers actuallycover home-infused drugs through the DME benefit,OTA conducted a survey of all 43 carriers in theUnited States.22

As of February 1991, all of these carriers hadpolicies to cover at least the three drugs explicitlypermitted by HCFA for home treatment of specifiedconditions: morphine for intractable cancer pain,antineoplastic therapies for certain cancers, and

deferoxamin e for iron overload. Seventeen carrierscovered only the drugs and conditions specified byHCFA, and some placed additional explicit restric-tions on coverage (e.g., treatment was covered onlyit begun in a health care setting). At the oppositeextreme, however, many carriers covered not onlythe drugs permitted by HCFA but a wide variety ofother drugs as well. For example, 24 carriersreported that they at least sometimes cover analge-sics other than morphine; 18 at least sometimescovered antibiotics; and 3 carriers covered dobutam-ine (365).

A few carriers even reported covering, through theDME benefit, certain drugs that are not administeredvia infusion pumps. One carrier covered antibioticswhen administered through a gravity drip system,and one covered hydration therapy in terminally illpatients when the therapy was administered bygravity drip (365).23

The results of this survey prompt two conclusions.First, there is clearly great variability in DMEcoverage policy among carriers, from carriers whocover only the HCFA-listed drugs under the moststringent conditions to carriers who cover even drugsnot administered through a pump. Second, theamount of HDIT that is already being covered byMedicare is significant and is increasing rapidly.Both the categories of drugs that carriers are willingto cover and the number of claims for drugs in thosecategories appear to be rising.

Antibiotics and dobutamine coverage policiespresent striking examples of the rapidity with whichcoverage-and claims-are increasing:

●

●

●

Three of the 18 carriers that covered at leastsome antibiotics had begun doing so only veryrecently, and one noncovering carrier wasconsidering extending coverage to antibioticsat the time of the survey.Seven carriers said that claims for antibioticswere frequent and submitted in increasingnumbers.Of the three carriers that said they would coverdobutarnine at home, one had yet to see a claim

21 me issue of hi~-cost services provided by hospices is currently Waler eJK* tion at Project HOPE as part of a congressionally requested study(26).

~ ~ese ~~ti~te w of tie carriers covering the United States and the District of Columbia. Attempts to include Puerto Rko’s her ~ tie ~eYwere unsuccessful.

?.3 W. ~emrepfi~~t~eyevacover~ a~oso~Pn~~e under the DMEbenefit. OTAdid not follow up s~eYresPo~es~d so c~otconfii this.


for it. The other two had both institutedcoverage only very recently; one had seen onlya single claim so far, while the other carrierestimated that dobutamine already accountedfor 10 percent of its drug claims under the DMEbenefit (365).

An interesting characteristic of current coverageof home-infused drugs is that because changes aremade incrementally at the local level, and becausetwo of the three drugs sanctioned by HCFA are forcancer therapy, patients with severe cancer have thegreatest coverage. In the survey, all carriers coveredmorphine and some antineoplastics, and most alsocovered some other related drugs (e.g., other analge-sics). Furthermore, where carriers covered addi-tional categories of drugs, coverage was sometimeslimited to patients already receiving other therapies.For example, four carriers covered adjunct therapies(e.g., hormonal therapies) for patients currentlyreceiving home antineoplastic infusion; two carrierscovered antibiotics only as adjuncts to antineoplas-tic therapy; and the two carriers that coveredhydration did so only for patients already receivinginfusion therapies (365).

The logic behind such coverage is that patientswho are receiving home antineoplastic therapyshould not be forced back into the hospital simplybecause of the need for additional related therapies.The result, however, is that under the presentsystem, the sickest patients have the greatestcoverage for HDIT, while the healthiest patients(e.g., needing only simple antibiotic therapyadministered through a gravity drip) usuallymust remain hospitalized for the duration of theirtherapy.

Impact of Extending Coverage for HDIT

Extending Medicare coverage to include HDITwould increase the treatment options available toMedicare beneficiaries and the market possibilitiesfor HDIT providers. It would also have morecomplex potential implications for Medicare expen-ditures, hospitals who provide inpatient infusiontherapy, and the development of new health caretechnologies. These three issues are described below.

Implications for Medicare ExpendituresWhatever its advantages, an HDIT benefit would

almost certainly raise Medicare expenditures in thefirst few years of its implementation. The majorreason for this is that Medicare currently pays forhospital inpatient services on a per-case basis,according to a patient’s diagnosis-related group(DRG). This payment system, as it currently stands,does not permit hospital payments to decrease in agiven year even if more patients are discharged earlyto HDIT. In the longer run some offsetting inpatientsavings might occur, as the hospital inpatientpayment rate schedule is recalibrated to account forthe lower hospital costs of serving these patients andhospital payments are reduced accordingly.

A 1987 study examined some of the potentialeffects on Medicare of extending coverage to homeIV antibiotic therapy. This study included 150 homepatients and 144 hospital patients who met theclinical criteria for home therapy but were treated inthe hospital.24 All home patients had to be able toself-infuse and had to be well enough to return homeexcept for the need for continued therapy (e.g., nofever) (285).

The study found little difference in outcomebetween home and hospital therapy. Therapy wasjudged successful in 83 percent of home patients and88 percent of hospital patients. Of patients for whomdata from laboratory and other tests were available,results were nearly identical for the two settings(285).

To estimate potential Medicare expenditures, thestudy examined 1984 Medicare data on hospitalizedpatients in five DRGs that include an estimatedtwo-thirds of the Medicare patients on long-termantibiotic therapy.

25 The researchers then simulatedMedicare expenditures under various assumptionsof the extent of home therapy and the ability ofMedicare to adjust hospital inpatient rates.

In the base model, the researchers assumed that atequilibrium (i.e., several years after implementationof home IV antibiotic coverage), only 78 percent ofpatients would be hospitalized for their entire courseof therapy. Of the remaining 22 percent, 12 percentwould receive some hospitalization (e.g., for theinitiation of therapy), and 10 percent would avoid

24 B~u~e of me ~lc~~ id@@@ eldmly home patients, some patients in the home poup wme under age 65.

n The DRGs examined were those forendocarditis, cdhditis, celhditis with eomorbidities, osteomyelitis, and osteomyelitis with wound debridement.


hospitalization entirely. The researchers also as-sumed that “treatment shifts” from oral to infusedantibiotics would be minimal. Net savings (includ-ing savings from fewer physician visits in the home)were projected to be $16.9 million under baselineconditions. Changing baseline assumptions to re-flect fewer home patients and fewer patients whocould avoid hospitalization entirely reduced, but didnot eliminate, the projected savings (285).

The results of this study imply that, for relativelyindependent Medicare patients on antibiotic therapy,Medicare expenditures would be equal or lower inthe long run if infusion therapy were covered. Toachieve this outcome, however, Medicare must firstwithstand greater expenditures in early years (untilhospital payment rates can be readjusted to reflectthe shorter inpatient stays). In addition, there mustbe no extra program costs incurred as a result ofinequities among hospitals with differing abilities todischarge patients early (see below).

One factor not included in this study was dualcoverage-i.e., Medicare beneficiaries who alsohave extensive private insurance benefits. Approxi-mately 35 percent of elderly persons26 are coveredby private employer-based health insurance (242).Although the extent to which these Medicare bene-ficiaries are currently receiving privately coveredHDIT is unknown, it may be substantial; oneprovider, for example, reports that 20 percent of itsprivately insured patients (who are 85 percent oftheir caseload) are also eligible for Medicare (83).Any Medicare coverage expansion for HDIT wouldprobably result in some shift in spending fromprivate payers to Medicare.

implications for HospitalsAll else equal, implementing an HDIT benefit

should result in reduced average lengths of hospitalstay (ALOS) in the DRGs that include home-treatedpatients. The reductions would not apply equally toall people in those DRGs, however, nor would theybe distributed equally among all hospitals.

Within any individual DRG, the advent of anHDIT benefit would result in some proportion ofpatients being discharged home after a short stay,while the remaining patients’ stays are unchanged.Those patients in the first group will have lengths of

stay lower than the average, generally leading tohigher profits for the hospital. Patients in the secondgroup, however, will often have longer lengths ofstay than the average, and hospitals will lose moneyon most of them. Implementing an HDIT benefitthus would have a natural spiraling effect; as morepatients were discharged early, ALOS in the DRGwould decline, and the remaining sicker patientswould come under ever-increasing pressure to leavethe hospital early.

If there were no counterbalancing pressures orrestrictions, the tendencies of the system couldlogically continue the spiral until even the sickestpatients needing continuous care were discharged tohome treatment. Counterbalancing pressures doexist, of course; they include Medicare paymentrestrictions for home care, physician disincentives toprovide home care, home providers’ unwillingnessto accept severely ill patients, and hospitals’ fear oflegal liability for adverse outcomes in severely illhome patients.

Variability among hospitals’ abilities to dischargepatients to HDIT would prove to be a more seriousand difficult problem to solve. Some hospitals—those with their own home infusion therapy compa-nies, or with established arrangements with otherproviders of such care-are already well-positionedto take advantage of an HDIT benefit by dischargingas many patients home as possible. Other hospitalsdo not yet have such arrangements but can makethem reasonably quickly once a benefit is estab-lished. It is likely, however, that a third group ofhospitals also exists: those that cannot dischargepatients home because of the absence of an HDITprovider in the area they serve, or because thepatients live in homes that are inadequate settings forsuch therapy. Furthermore, if these hospitals arelocated in very low-income or low-density areas,there may be little hope of home infusion providersbeing established in the future.

Where this is the case, hospitals will be forced totreat home-eligible patients as inpatients. The moresuccessful other hospitals are at discharging patientshome, the greater the financial losses of thesehospitals in whom the ALOS remains unchangedthrough no fault of their own. The hospitals likely tosuffer the most are those already facing fiscal

M Appro~tely 95 percent of the elderly (age 65 and over) are covered by Mfim.


difficulties: those that serve primarily rural or poorpopulations. 27

For rural hospitals, swing beds may be a solutionfor some discharge difficulties related to HDIT.Medicare permits small rural hospitals to designatea proportion of their acute-care beds as ‘‘swingbeds” and to receive reimbursement for eitheracute-or skilled-nursing-level care provided to pa-tients in those beds. As of 1987, about 1,000hospitals-roughly half of all eligible hospitals—had Medicare-certified swing beds (310). In thesehospitals, patients needing only drug infusion ther-apy could be “discharged’ to long-term care withinthe hospital itself and without changing the infusion-related services provided to the patient. This strategymight require some guidelines regarding at whatpoint patients could be “discharged” from acutecare, and it might require some changes in swing-bed payment rates, but it would probably relievemost rural hospitals from the most extreme effects ofhaving no HDIT provider in their areas.

Urban hospitals serving large numbers of poorbeneficiaries with inadequate homes do not have theswing-bed option. These hospitals will requireadditional payments (e.g., through the dispropor-tionate share adjustment) or other alternative set-tings to discharge patients (e.g., nursing homeswilling to accept infusion patients) if they are not tosuffer undue losses.

Implications for Technological ChangeUnless it is limited to a very few patients,

Medicare coverage of HDIT would affect virtuallyevery aspect of the home infusion industry. Medi-care not only represents an enormous segment of theuser market, but its benefit policies often serve as theboilerplate for other public and private insuranceprograms. In addition, Medicare’s other policies andthe special needs of its population may drive themarket to respond to its own unique characteristics.Some of the possible areas for technological changeare outlined below.

Development of Drugs and Drug Protocols

Most employer-based insurance policies pay fororal outpatient prescription drugs (19). At present,drug development favors oral drugs over other formsof administration because of their broad patient

acceptance and large market. Developers go to somelengths to manufacture oral formulations; for exam-ple, despite the proven effectiveness of subcutane-ous insulin, manufacturers continue to strive for aneffective noninjectable form of the drug (301,303,304).

Medicare, however, does not presently cover mostoral outpatient drugs. If Medicare does begin to payfor HDIT, it would add substantially to the alreadygrowing demand for parenteral drugs, while the oraldrug market would remain the same. This disparityin demand by drug type would probably not causedevelopers to ignore oral formulations where theseappear easily feasible, but it would make it lessworthwhile to undertake additional research once asatisfactory parenteral form has been developed.One possible consequence of this incentive is todecrease investment in research aimed at oral drugdelivery-the method that is ultimately least expen-sive for the health care system to deliver.

Medicare HDIT coverage would also probablyfuel the existing trend toward longer, continuous orintermittent infusions rather than the short, intensivedrug administration that is more suitable to thehospital. The greater potential market could lead notonly to different protocols for newly developedparenteral drugs but to new uses of existing drugs(e.g., broader use of IV immune globulin) (see ch. 2).

Technological Change in Equipment and Supplies

Once a technology of drip bags and simpleperipheral catheters, HDIT now can boast of anever-expanding array of medical supplies and de-vices. Any Medicare coverage expansion is likely toadd to the general incentives to develop newtechnologies for the HDIT market. In addition, itcould stimulate technologies aimed more specifi-cally at the special needs of the Medicare population,within the constraints of Medicare coverage policy.

Many Medicare patients, for example, may not beable to master or manipulate sophisticated infusionpumps. The need for simple, easily mastered equip-ment and supplies among this population is likely todirect device manufacturers’ resources toward suchareas as one-time, disposable infusion “pumps”;catheters pretreated with antibiotics to reduce infec-tion; prepackaged and premeasured supplies thatminimize handling needs; and other developments

27 k 1989, sm m~ hospi~ (wi~ fewer k 50 beds) and large urban hospitals with a disproportionate number Of pOOr patients had lower totihospital fwcial margins than any other hospital types (274).


that increase supply costs but might reduce the needfor detailed patient training and professional assist-ance. Alternatively, if Medicare coverage incentivestended to encourage outpatient rather than homeinfusion, manufacturers would probably respond bydeveloping more devices that could deliver a sophis-ticated variety of drugs in the home unaided but thatmight require intensive nursing attention as often asonce a day.

Issues in Extending CoverageMaking Drug Coverage Decisions

As discussed in chapter 2, many drugs are beingadministered safely and effectively at home. How-ever, some drugs are being used for which theevidence on effectiveness is ambiguous (e.g., dobu-tamine). Others are effective but may be dangerousin the home if not closely monitored and adminis-tered with proper precautions (e.g., many antineo-plastics). Even within categories of relatively safedrugs there can be drugs that require especially strictprecautions to be administered safely (e.g., theanti-infective amphotericin B), and drugs that areextremely costly for the benefit they confer to somepatients (e.g., immune globulin).

Under an HDIT benefit, two basic questionsregarding drug coverage decisionmaking wouldarise:

1.

2.

Who should decide what drugs to cover? Andwho should decide what limitations to place onthe drugs that are covered?How should the drug coverage decisions bemade? HOW should the initial set of covereddrugs be determined, and how should futuredrugs (or indications for existing drugs) beincorporated into those decisions?

Policy Under the Medicare CatastrophicCoverage Act

The MCCA (Public Law 100-360), passed in1988, would have allowed Medicare to cover drugsthat were safe and effective for IV administration inthe home. The law required coverage for all antibiot-ics unless the Secretary of Health determined that aspecific antibiotic could not be administered in thehome setting in a safe and effective manner. Drugswhich are not antibiotics were covered only if the

Secretary did determine them to be safe and effectivein the home. The drugs and accompanying diagnosesfor which they were to be covered were published inthe Federal Register in September 1989, just beforethe act was repealed. (This notice is reproduced inappendix C.)

Under the MCCA, Congress took on the responsi-bility for setting the categories of drugs to becovered, while delegating the responsibility fordeciding on specific drugs and indications to HCFA.To produce the list of covered drugs and accompany-ing indications, HCFA obtained a list of drugs thatwere currently approved by the FDA for IV use. Thislist was then examined by individuals from HCFA,with advise from various professional groups andother sources, to determine the appropriateness ofeach particular drug for home infusion (368). Eachdrug was evaluated ad hoc and included or excludedon its own merits; no standardized process forreview was used. Because HCFA has few physiciansor pharmacists on staff, and received little assistancefrom FDA clinicians, the evaluators had littleclinical expertise at their disposal.

This system produced a list that was plagued withseeming inconsistencies. For example, dilantin, ananticonvulsant agent used to control seizures, wasincluded on the list of approved drugs despite thepossibility of fatal adverse effects of this drug whengiven intravenously (216).28 In contrast, erythromy-cin, an antibiotic with comparatively minor sideeffects, was not included.

The list of conditions for which approved drugscould be covered showed similar potential inconsis-tencies. HCFA omitted pulmonary infections fromthe list of approved conditions treatable with homeantibiotics, for example, despite the fact that recur-rent pulmonary infection related to underlying cysticfibrosis was one of the first indications for whichhome IV drugs were successfully administered(290).

The list of approved drugs and conditions was tobe updated through a periodic review, with thetimeframe for review unspecified in legislation.HCFA was prepared to update the list on an annualor semi-annual basis using a format that was not yetdetermined (368). FIs had very little discretionregarding drug coverage; their main function in this

M ne ~ten~ for the= adve~e effwts me so great that the manufacturer stresses that ‘ ‘continuous monitoring of the electrocardiogram ~d bloodpressure is essential” (216). Practically, this usually means administration of the drag in a hospital intensive care unit.


regard was to bring new drugs or indications to theattention of HCFA in order that they be incorporatedto the next update.

Future Policies: Who Should Decide onAppropriate Drugs?

The final decision of which drugs are approved forhome infusion could theoretically be made at anypoint on the regulatory spectrum, from Congress(through statute) to the individual physician (basedon personal experience and opinion).

Congress could potentially not only establishcategories of drugs to be covered but directlyauthorize which drugs and which conditions wereappropriate for HDIT. Setting the drugs to becovered in statute eliminates ambiguity but makesupdating the list extremely cumbersome. Such alevel of legislative involvement in Medicare cover-age decisions is unusual and, given the quantity ofdrugs to be considered and the rapidity of technolog-ical change in the pharmaceutical industry, probablyundesirable. Congress could, however, set somegeneral guidelines regarding the relative risks andbenefits that are appropriate for Medicare to under-write in the home.

HCFA has traditionally undertaken coverage taskssimilar to those involved in HDIT. The list ofprocedures that are reimbursable if performed in anambulatory surgical center, for example, is estab-lished in regulation and has been updated once sinceestablished in 1983 (see 53 F.R. 31468). Under theMCCA, however, HCFA’s attempt to fill this rolewas troubled by a relatively short deadline and a lackof qualified clinical personnel. HCFA has littleexperience in drug evaluation and is not currentlyinvolved in any drug approval process. RequiringHCFA to approve drugs for home infusion usemeans that either HCFA must retain additionalpersonnel who have detailed knowledge of the risksand benefits associated with drugs, or that HCFAmust receive assistance from another agency withsuch expertise, such as the FDA.

Alternatively, the FDA itself could stipulate whatconstitutes safe and effective therapy in the home,using a similar process to its current approvalprocess. In effect, this would amount to approval forlabelling the drug for that use. The many drugs notspecifically approved for home use thus could not becovered.

Fiscal intermediaries could decide what is properinfusion therapy for home use, making not onlypatient-specific decisions on appropriateness butestablishing the general drug coverage categories aswell. Many local medical carriers have already beeninvolved in this activity to some extent throughmaking drug decisions as part of the DME benefit,and some also may perform similar functions fortheir private insurance business.

FI-level drug coverage decisions permit relativelyrapid updates to accommodate new therapies. Thisflexibility, however, would be purchased at theexpense of some consistency; in contrast to a singleHCFA list, the covered drugs and indications wouldprobably differ somewhat among carriers dependingon the expertise and practices of providers in theirareas. Some of these differences might be justified;what can be safely provided at home may well oftendepend on provider experience with that drug. Otherdifference might be minimized with HCFA-mediated communication among carriers.

Finally, coverage could simply be made univer-sally applicable for any drugs that individual physi-cian providers prescribed for use in the home. Thisalternative is the most flexible and allows for rapidincorporation of new drugs and new procedures. Onthe other hand, individual provider responsibility forhome infusion would probably result in a tremen-dous variation of practice which mayor may not beappropriate to the home setting. This level ofdecisionmaking also directly permits payment forexperimental and untested drugs (or existing drugsbeing used in novel ways), without making anyprovisions that these experimental therapies beadministered as part of an established protocol.

How Should Drug Coverage Decisions Be Made?

The ad hoc decisionmaking under the MCCAresulted in an irreproducible process that washeavily susceptible to criticism, and which HCFAmight have been hard-pressed to defend in any legalchallenge. To avoid this problem in the event of anew benefit, guidelines could be established (e.g., byCongress or HCFA) that would outline the approvalprocess and the standard of evidence that a drugwould have to meet to be approved.

Levels of Evidence-Achieving consistency indrug coverage decisionmaking requires adherence toan agreed-upon standard of evidence for establishingthe safety and effectiveness of an infused drug in the


home. This standard would apply regardless of whoactually made the drug-specific coverage decisions.

The most stringent standard would be that re-quired by the FDA for approving the label of anydrugs for marketing. In essence, this standard wouldbe equivalent to saying that Medicare would payonly for drugs whose label specified that they weresafe and effective when administration in that form,for that condition, in the home.

A second level of evidence could require that thedrug be FDA-approved for the condition and thatsome data on its use at home be presented. Thisapproach is entirely feasible, but it prohibits pay-ment for “off-label” use-i.e., use of an FDA-approved drug for an indication not specificallyapproved by the FDA for the label. Off-label use isimplicitly reimbursed in hospitalized patients, and asubstantial proportion of the actual use of manydrugs is for off-label use. A recent survey by theGeneral Accounting Office, for example, found thatnearly half of all cancer patients treated by oncolo-gists receive, as part of their therapy, at least onedrug whose label does not include that particulartype of cancer (354). In the same survey, a numberof oncologists reported having admitted patients tohospitals solely to have an off-label drug reimbursed(354). Thus, requiring this level of evidence wouldprobably affect the actual therapies that physiciansprescribed, and it would probably also result infewer patients being treated at home than wouldotherwise be the case.

A third level of evidence could be to require thatthe drug be FDA-approved and that the particularindication be listed for that drug in commonreference sources of drug information in order to bereimbursed. This standard would require less rigor-ous documentation in supporting the “possible”effectiveness of a drug and would probably have lesseffect on actual prescribing practices than morestringent standards. There might, however, be somepressure on the organizations that publish suchreference books to make accommodations to manu-facturers in order for a drug to qualify for Medicarereimbursement.

Finally, the level of evidence required could beone of a consensus of clinical experts, based on theirpersonal judgment and knowledge of the literature.This is a formalized version of the practice of manylocal carriers, which use local clinical consultants toadvise them regarding whether a particular proce-

dure, for example, is generally considered safe andeffective (i.e., nonexperimental) (359). This stand-ard would have the least impact on actual prescrib-ing practices but holds the greatest potential forleading to great variations in coverage decisionsacross geographic regions.

Applying Consistent Judgment—Whatever thestated standard of evidence to which decisionmakerswould adhere, drug coverage decisions would inevi-tably require judgment on the part of those involvedin the decision. For any given drug, they must decidewhether the risk to patients of delivering a specificdrug in the home is worth the potential benefit. Thefact that a drug is risky does not itself eliminate theneed to make this decision. Even drugs withunpleasant and sometimes severe side effects (e.g.,most antineoplastics) are often considered worthusing if the untreated disease is often fatal and thereare few more benign alternatives.

The degree to which an evaluator considers thelevel of risk in a drug “acceptable’ is likely to varyamong individuals. Given this, one way to adhere toa consistent standard of tolerable risk would be toensure that the same set of decisionmakers isresponsible for each separate drug coverage deci-sion. Within this group, decisionmakers could makea conscious attempt to apply individual and groupjudgments consistently. Thus, if HCFA were mak-ing the coverage decision, applying a consistentprocess might mean appointing an outside board ofadvisory experts to judge the relative risks andbenefits of various drugs for various indications inthe home. Alternatively, the advisory group mightcomprise FDA clinicians, or clinical and otheremployees of the Agency for Health Care Policy andResearch. If FIs were to be the decisionmakers, theclinical advisors to the coverage decision might beadvisory panels composed of local communityphysicians, pharmacists, and nurses.

Although clinical experience is not the onlynecessary skill to be represented in the group makingthe coverage decisions, it is a vital one. Deciding onan acceptable tolerance of risk requires clinicalinput, because it depends on a knowledge of thealternative treatments for that medical condition.Since the Medicare population is hugely elderly,knowledge of the drug’s likely effects in the elderlypopulation is also a valuable input that requiresclinical experience.


HDIT Eligibility and Home Health ServicesMany Medicare beneficiaries who might qualify

medically for HDIT might also need assistiveservices-i.e., help with the infusion and any otherneeded care-if they were treated at home ratherthan in a health care setting. An estimated 40 percentof elderly persons need assistance with at least onebasic activity of daily living (e.g., eating, dressing)(see ch. 3). Family caregivers would not necessarilybe available or able to shoulder the burden ofproviding assistive health services; of the noninstitu-tionalized elderly, one-third live alone (386).

Because providing paid assistive health servicesincreases the payer’s costs of care for a patient onHDIT, the extent to which Medicare covers theseservices for HDIT beneficiaries would greatly affectMedicare expenditures. One way to affect thedemand for assistive care by HDIT beneficiarieswould be to institute payment mechanisms thatdiscourage (or encourage) the provision of theseservices. Another, more direct alternative would beto design eligibility and coverage policies for theHDIT and the home health benefits to affect the useof such services (or the discharge of patients whowould need such services). Some possible policies,and their potential implications, are described here.

Atone end of the spectrum, Medicare could coverHDIT only for patients who can demonstrate thecapacity to administer the infusion without theassistance of a paid caregiver.29 This alternativewould restrict the benefit to a small number ofpatients who were alert and relatively healthy or whohad family or fiends able to perform the administra-tion. In the absence of more information about therelative costs of home and institutional care, thisalternative offers the surest opportunity to achieveprogram cost savings. However, it restricts theability of homebound patients, or those who mightbe able to avoid hospitalization altogether, to receiveHDIT from a professional caregiver. It would alsoeliminate from eligibility for the benefit a largenumber of Medicare patients who would prefer to betreated at home but are unable to take responsibilityfor their own care.

At the opposite extreme, Medicare could extendeligibility for an HDIT benefit to any patientmeeting some basic medical appropriateness criteria

(e.g., the patient requires a parenteral drug and ismedically stable). This criterion would permit themaximum number of beneficiaries to make use ofthe benefit. However, it would permit unlimited useof assistive home services, no matter how expensive,unless adjunct policies were also in place to limitthese services.

Policies intermediate to these two extremes alsoexist, in which the covered benefits rather than theeligibility criteria would be restricted. These poli-cies take the form of restricting both the assistiveservices covered under the HDIT benefit itself andthe home health care benefits for which the patientmight be concurrently eligible. For example, theHDIT benefit might include coverage of dailynursing to accommodate patients with needs foroccasional nurse-administered infusions (e.g., up to10 visits or 20 hours of home skilled nursing perweek).

This alternative assumes that at some low level ofprofessional assistance, home care is still less costlythan institutional care. It might be particularlyrelevant if relatively low-cost outpatient care orinstitutional care in SNFs were not available,making hospital inpatient care the only real altern-ative to the home. However, this alternative alsoleaves open the possibility that program expendi-tures may actually increase under this alternative ifthe coverage is generous.

To avoid unwittingly paying for assistive servicesthrough the home health benefit in this example,HDIT patients could be disqualified from concurrenteligibility for that benefit. Thus, any infusion patientwho also required unrelated skilled nursing care orother professional therapy or assistive services (e.g.,physical therapy) could not be discharged home.This restriction would eliminate the possibility ofpaying for home care for patients who need veryextensive services, but it raises the possibility thatmany patients might be discharged home and thenrehospitalized (at Medicare’s additional expense) ifthey developed a need for occasional additional care.It might also prevent many terminal or homeboundpatients, who currently qualify for home careservices, from receiving their infusion at home aswell. This policy might require that the homeinfusion and home health benefits be administered

29 For e=ple, ~ p&&c~mi@t & q~ to ce@ tit ~C patient or family member could perform me infusion as a prerequisite for eligibilityfor the benefit.


by the same FI so that concurrent benefit eligibilitycould be detected.

Alternatively, the HDIT benefit could be verylimited in its coverage of assistive services butbeneficiaries could be permitted (if they qualified) toretain home health benefit eligibility at the sametime. Under this scenario, coverage for concurrenthome health benefits could itself be limited torestrain utilization of assistive services. For exam-ple, HDIT patients who were homebound could be

covered for home health services up to a statedmaximum limit (e.g., 50 percent of the averageper-patient home health payment in that area). Thisalternative would allow for some assistance whileproviding an incentive for home providers to acceptpatients only if their anticipated assistive needs werefew. However, it might also result in some under-service or rehospitalization of patients whose assis-tive needs were eventually greater than originallyanticipated.

Chapter 7

PAYING FOR HOME DRUG INFUSIONTHERAPY UNDER MEDICARE

ContentsPage

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 133Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 133Summary of Conclusions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 133

Potential Payment Methods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 134Background ..*. *.*. .*. ..*. ... ... o.. ... ..*. . .**. .*** *o*. . **do.....**...**.. 134Existing Methods of Paying for Drug Infusion Under Medicare . . . . . . . . . . . . . . . . . . . 135Examples of Potential Payment Models for HDIT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 138

Goals and Tradeoffs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 141Access . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 142Quality Assurance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 143Equity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 144Cost Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 144Administrative Feasibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 145

Evaluating Payment Alternatives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 146Retrospective Charge- or Cost-Based Reimbursement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 146Competitive Payment Methods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 147Noncompetitive Prospectively Set Rates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 147

Other Issues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 148Paying for Drug Infusion Therapy in Skilled Nursing Facilities . . . . . . . . . . . . . . . . . . . . 148Physician Compensation and Ownership . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 149

BoxBox Page

7-A. HDIT Under Prospective Per Capita Payment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 141

TablesTable Page

7-1. Medicare Payment Methods for Durable Medical Equipment . . . . . . . . . . . . . . . . . . . 1377-2. Example of One Insurer’s Prospective Per-Diem Fee Schedule . . . . . . . . . . . . . . . . . . 1407-3. Presumed Quality Incentives Under Alternative Payment Methods . . . . . . . . . . . . . . . 143

Chapter 7

PAYING FOR HOME DRUG INFUSION THERAPY UNDER MEDICARE

Overviewintroduction

The sheer size of Medicare as a purchaser ofhealth care means that the consequences of itspayment decisions will permeate every aspect ofhome drug infusion therapy (HDIT). How theservice is reimbursed will affect the willingness ofproviders to offer it, the willingness of physiciansand patients to use it, the content of the careprovided, the setting in which it is offered, the futurestructure of the industry, Medicare expenditures,and, ultimately, health care system costs. Thepurpose of this chapter is to briefly describe thedifferent methods of payment that are possible anddiscuss their potential implications if applied toHDIT.

Summary of ConclusionsThere is no single obviously best method bywhich to pay for HDIT Three methods, all ofwhich are currently in use in some form, couldbe implemented almost immediately: cost-/charge-based reimbursement (amplifying onexisting Medicare home benefits and paymentmethods); all-cost-based reimbursement; andprospective, government-set rates per item, perdiem, or possibly per episode of infusion. Twoother possibilities-competitively set rates andbundling home infusion into hospital inpatientrates-could be implemented but involve muchgreater administrative effort or would requiremuch more information before implementat-ion.

Of the three payment methods that could beimplemented immediately, cost-/charge-basedreimbursement would be the simplest to implem-ent but offers strong incentives to overpro-vide care and the fewest possibilities for costcontrol. All-cost-based reimbursement offersincentives to provide high-quality, accessiblecare to Medicare beneficiaries, but it alsoencourages the provision of costly services andmay be somewhat inflationary. (Placing a capon allowable costs might reduce cost increasesto some extent.) Prospectively set rates offerthe greatest possibility for cost control. Pro-

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spective rates for HDIT have been used suc-cessfully by private insurers, and more infor-mation is available to set rates than was true atthe time the Medicare Catastrophic CoverageAct (MCCA) was passed. However, this methodcould endanger patient access and quality ofcare if rates were low and quality of care couldnot be monitored adequately.

If prospectively set rates are chosen as themethod of payment for HDIT, bundling at leastnursing and pharmacy services, supplies, andequipment into a single rate (or set of rates)might reduce paperwork burdens and system“gaming.’ ‘ Continual advances in new tech-nology and potential tradeoffs between nursingneeds and equipment costs for some technolo-gies means that, if payment were according toan itemized fee schedule, Medicare might findit difficult to keep up with changes in thetherapy and still keep costs under control.

Some private insurers have successfully imple-mented HDIT “preferred provider’ programs,under which providers agree to meet qualitystandards and accept the insurer’s payment rateas payment in full, in exchange for the likeli-hood that more of that insurer’s patients willuse the provider’s services. A similar programrequiring mandatory assignment for HDITproviders serving Medicare patients wouldreduce patients’ risk of being billed for chargesin excess of the Medicare payment rate. A lackof providers willing to participate would be oneindicator that Medicare payment rates were settoo low.

Good-quality HDIT requires intimate physi-cian involvement. Paying physicians for thisinvolvement would enhance quality of care andremove existing physician incentives to eitheravoid HDIT or receive “consulting fees’ andother remuneration from HDIT providers. Tocontrol costs and prevent physician “unbundling’of services for billing purposes, Medicare couldpay a single rate for physician services relatedto a single specified period of time (e.g., perday, per week, or per episode of infusiontherapy). Separate provisions could be made forpatients on indefinite or multiple therapies.


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Many patients who could be served with HDITmight be equally well or better served byinfusion therapy provided in a skilled nursingfacility (SNF) or an outpatient facility. Pay-ment for infusion therapy in these settingsdeserves study and possible revision concomi-tantly with consideration of payment for HDIT.In particular, higher payment for infusionprovided in SNFs may be warranted where itcan be provided with good quality in thissetting. Similarly, rural swing-bed patients ondrug infusion therapy should receive adequatereimbursement, particularly when the hospitalsare unable to discharge patients due to a lack ofquali.tied HDIT providers.

Physician ownership of drug infusion facilitiespresents some troubling issues. Physicians arethe critical source of referrals for HDIT provid-ers, and physician ownership of a provider mayinhibit referrals to other providers even if thoseproviders offer care of equally high quality andlower cost. For some physicians, office-basedinfusion-in which the actual drug infusion isperformed in the physician’s office-is a directextension of the physician’s usual practice.Although this also represents a “captured”referral, it raises slightly different issues thanphysician co-ownership of other outpatient andhome infusion companies.

Potential Payment MethodsBackground

Two basic payment methods are used to pay forhealth care services: retrospective methods, inwhich the amount of payment is determined after theservices have been provided; and prospective meth-ods, in which the rate is set before the visitor serviceactually takes place.

Retrospective Methods

Retrospective cost- and charge-based paymentmethods were the original mainstays of Medicarepayment to health care providers. Hospitals, forexample, were originally reimbursed based on theiractual allowable costs of serving Medicare patients(359). Most home health services continue to bereimbursed by Medicare in this way (although thereare limits on the amount paid). Charges (rather than

costs) were the historical basis for paying physiciansand for reimbursing for such items as laboratory testsand home durable medical equipment (DME) (359,360).

Retrospective cost-based payment creates somestrong financial incentives for providers. First, sincesuch methods usually allow for recovery of fullaverage costs, including a return on capital invest-ment, providers with marginal costs that are lowerthan average costs make a profit on each serviceprovided. 1 Thus, they have an incentive to serve asmany patients as possible. Second, for each individ-ual patient, providers have an incentive to offer asmany services as possible (including services thatprovide little real benefit to the patient). Third, thereis little incentive for providers to produce servicesefficiently, since they can recover any expensesrelated to production. And fourth, where cost-basedpayment exists side-by-side with other paymentmethods, providers are encouraged to use whateveraccounting flexibility they have available to attrib-ute costs to the cost-reimbursed service.

Cost-based payment can lead to poor-quality careif unneeded services (with their attendant risks,however minor) are provided. However, it can alsolead to high-quality care if providers choose tocompete on the basis of quality (since competing onthe basis of cost confers no advantage under thismethod).

Where actual costs are difficult to determine,historically Medicare has paid on the basis ofcharges. Like cost-based payment, retrospectivecharge-based payment contains incentives to in-crease the number of services as long as the chargesfor the service are higher than the costs of providingthe service (as, presumably, they usually are). And,like costs, charges as the basis of payment tend to beinherently inflationary, since there are few incen-tives for providers to reduce them. Because chargesare limited only by the competitiveness of themarketplace and what providers deem appropriate tobill, Medicare now pays for few services at theiractual or average charge. However, many items andservices are currently reimbursed at set rates accord-ing to a fee schedule, and the level of (and variationamong) rates can often be traced to the averagecharges that served as the original basis for the feeschedule.

1 See p. 196 for deftitions and a discussion of marginal and average costs.

Chapter 7—Paying for Home Drug Infusion Therapy Under Medicare . 135

Prospective Methods

In contrast to retrospective methods, prospectivepayment involves determiningg payment rates inadvance of service delivery. Because payment isunchanged by the actual costs of producing thatparticular service, providers have an incentive toreduce costs. Providers may also have an incentiveto reduce service quality as a way to reduce costsunless there are counterbalancing forces (e.g., com-petition for referrals or regulatory penalties). Thus,use of such methods may require enhanced levels ofquality monitoring and assurance. Difficulties inupdating prospective rates can also present prob-lems. Fixed-rate schedules may be less responsivethan competitive approaches to changes overtime intechnology and production processes.

The effect of a given prospectively fried rateschedule depends on such factors as the level of therates and the base units to which the rates apply.Very high rates encourage inefficient production ofservices; very low rates may discourage providersfrom participating in Medicare or offering theservice at all. Rates applied to a very detailed levelof service (e.g., a single visitor piece of equipment)may offer different incentives to under- or overpro-vide these services than rates that apply to a bundleof services (e.g., all services provided on a givenday).

Prospective rates may be freed in advance by thepayer and applied equally to all providers with littledirect provider input (e.g., fee schedules determinedby past charges). Alternatively, they can be setthrough competitive bidding or negotiation withproviders. For example, the payer may advertise acontract for providing a certain service to patientsand contract with the provider(s) offering the lowestprice for that service. Or, the payer may enter intodirect negotiations with providers, with differentproviders receiving different rates. Such paymentmethods have been employed by the Department ofVeterans Affairs and some Medicaid programs forpurchasing home oxygen and other home medicalequipment items (82).

These options avoid some of the difficulty thepayer may otherwise face in determiningg what anappropriate rate should be, since in this case marketforces determine the payment rate. In order for acompetitive bidding-based system to be effective,however, there must be sufficient market competi-tion to ensure that all the bids will not be artificially

high. The service must also be sufficiently well-defined to enable it to be specified exactly in thecontract or negotiation process.

Establishing market-based prospective rates maybe a time-consuming and expensive process, partic-ularly if it requires individual negotiation with manyproviders. In addition, this method raises the sameneed for quality assurance activities as other pro-spective freed-rate methods.

Existing Methods of Paying for Drug InfusionUnder Medicare

Hospital Inpatient Infusion

Drug infusion therapy provided to hospital inpa-tients is reimbursed through Medicare’s hospitalprospective payment system, in which rates for thecoming year are set prospectively for each diagnosis-related group (DRG). Hospitals do not receivepayment specifically for the infusion supplies andservices or associated laboratory tests. Rather, thosecosts are lumped with all other costs of treatingpatients in each DRG, and the payment for that DRGis assumed to cover the average costs of all patientsit comprises. Hospitals that can reduce the costs oftreating any one individual (e.g., by using a lessexpensive drug, reducing the nursing visits neces-sary, or discharging a patient early) will maximizetheir profit (or minimize their loss) on that individ-ual.

In certain DRGs (e.g., the one that includesosteomyelitis), patients receiving long-term druginfusion make up a substantial proportion of allpatients (285). The costs of infusion therapy in theseDRGs is thus a signifcant proportion of total costs,and changes in the amount of inpatient infusionwould have a major effect on the future reimburse-ment for all patients in these DRGs. In contrast, inDRGs for which drug infusion is an infrequenttreatment, or limited to patients with very short-termneeds, discharging patients who are on long-terminfusion would have little effect on future inpatientpayment rates.

Nonetheless, because hospitals receive the sameper-patient payment regardless of whether the pa-tient is discharged early or remains in the hospital,hospitals have a strong incentive to transfer long-term infusion patients to other settings as rapidly aspossible. This incentive is unchanged by futurelower payment rates in high-infusion DRGs; hospi-


tals still reduce their costs by discharging infusionpatients as early as they can.

Infusion in Other Facilities

Outpatient Facilities--Medicare payment foroutpatient drug infusion depends on the setting inwhich it takes place. If the setting is a hospitaloutpatient department, infusion is reimbursed retro-spectively on a cost basis (i.e., based on Medicare’sshare of hospital costs actually incurred) for drugs,services, and most supplies and equipment. If thesetting is a physician’s office, reimbursement isretrospective and based on the physician’s charges,within the limits of what Medicare allows. (Begin-ning in 1992, Medicare is phasing a fee schedule forphysician services, but it is not yet clear how thiswill affect office-based infusion services.) In bothcases, providing more infusion results in morereimbursement to the facility (or physician).

Skilled Nursing Facilities--Drug infusion inSNFs is covered under the usual prospectively setdaily SNF rate and paid under Medicare Part A.Hence, these facilities incur costs but receive nomore reimbursement in the short run when infusiontherapy is provided. (In the long run, as withhospitals, incurring infusion costs in one year mayraise reimbursements in future years, but the returnis not directly related to the service provision for thatindividual patient.)

Ancillary Services-For all nonhospital infu-sion, related laboratory tests are reimbursed sepa-rately. Medicare pays the clinical laboratory directlyon the basis of a fee schedule that is limited by anational cap on maximum fees for specific services.Medicare pays a separate nominal fee (up to $5) tocover the costs of specimen collection when skilledpersonnel are necessary (e.g., to perform a venipunc-ture). For beneficiaries who are homebound or whoare inpatients of a nonhospital inpatient facility,Medicare also pays the transportation costs ofskilled personnel who travel to the patient’s resi-dence to collect such specimens (SSA sec. 1833(h)).

Home Infusion

In the home, unlike other settings, the suppliesand services that make up drug infusion therapy aregenerally reimbursed independently in differentways. In addition, drugs are only occasionallydirectly reimbursed by Medicare. (Physician serv-ices and laboratory tests are separately reimbursed,as they would be for any other nonhospital service.)

Equipment-Medicare payment for medical equip-ment (e.g., infusion pumps, IV poles) and relatedsupplies under the Part B DME benefit is retrospec-tive, based on the lower of the actual charge or alocal fee schedule amount (SSA sec. 1834). Aseparate fee schedule is established for each of sixcategories of DME (table 7-l).

Fee schedule amounts were initially determinedby carriers (the Part B fiscal intermediaries, or FIs)based on local charges for the equipment and havebeen updated by inflation. The Omnibus BudgetReconciliation Act of 1990 (Public Law 101-509)mandated a transition to a national rather than localfee schedules for DME, to be fully implemented by1993.

Home Health Services-Services provided by ahome health agency (ID-IA) are reimbursed on thebasis of retrospective costs. The computed reasona-ble cost per visit is subject to nationally appliedlimits for each type of service2 for freestandingHHAs.3 Hospital-based HHAs are permitted higherlimits to account for presumed higher administrativeand general costs.

For the purposes of reimbursement, the provisionof any of the covered home health services by aparticular skilled nurse, skilled therapist, or homehealth aide on a particular day or at a particular timeof day is considered a visit. For example, a registerednurse and a physical therapist providing services onthe same day would be considered two visits. Twoseparate visits by a nurse on the same day would alsobe considered two visits, but if a nurse performs twoseparate services during the same visit (e.g., skillednursing services and home health aide services) it iscovered only as a single visit.

2‘IjqMs of services are skilled nursing care, physical therapy, speech pathology, occupational therapy, medical social services, and home health aideservices.

s Although calculated by service, limits are actually applied in the aggregate, permitting HHAs to offset high-cost services with low-cost services(353). A recent study by the General Accounting OffIce concluded that cost savings are greater when limits are applied by type of visit rather thaQ inthe aggregate, and that the impact on beneficiary access and quality of care would be minimal if HCFA applied limits by type of visit (353).


Table 7-l—Medicare Payment Methods for Durable Medical Equipment (DME)

Category Payment method

Inexpensive rental payments or routinelypurchased DME . . . . . . . . . . . . . . . . . . . . . . . Lump-sum purchase amount or monthly rental payments whose total may not exceed

the lump-sum amount.Items requiring frequent or substantial

servicing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Monthly rental until the period of medical necessity ends.

Customized items adapted for a particularpatient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Lump-sum purchase amount determined by the carrier with consideration as to the

equipment’s maintenance and servicing needs.Prosthetic and orthotic devices. . . . . . . . . . . . . Lump-sum purchase amount for most prosthetic and orthotic devices. Intraocular

lenses; parenteral and enteral nutrition nutrients, supplies, and equipment; andprosthetic devices that fall into other Medicare coverage categories (e.g., artificiallimbs) are exceptions that are subject to different rules.

Capped rental items . . . . . . . . . . . . . . . . . . . . . . Monthly rental amount that is at the lesser of the actual charge or 10 percent of the feeschedule amount for the equipment. Payment may not exceed 15 continuousmonths of equipment rental. Suppliers must continue supplying rented DME at noadditional charge to the beneficiary after Medicare payments have stopped,provided that such rental continues to be medically necessary. Maintenance andservicing fees are calculated separately on a reasonable charge basis for eachitem.

Oxygen and oxygen equipment . . . . . . . . . . . . Monthly rental according to a fee schedule specific to the type of equipment.

SOURCE: Office of Technology Assessment. Information from Social Security Act, section 1324 (a).

Drugs-Drugs are rarely explicitly covered in thehome. The single exception is for certain drugs thatare covered under the DME benefit (as part of anfusion pump; see ch. 6). In these cases, Medicareusually pays for the drug based on either historicalcharges for that drug code for a given carrier or thelisted average wholesale price (AWP) of the drug.Occasionally, the drug is simply included in thepayment for the infusion pump (365).

With exception of DME-basedpayment, paymentfor the drug to be infused must come either directlyfrom the patient, from the providing pharmacy (ascharity care), or from another interested provider.Specifically, a hospital may choose to pay for thedrug (or donate the drug) in order to discharge aMedicare patient from the hospital and reduceinpatient costs while retaining the full inpatientpayment. Anecdotal accounts of this practice arewidespread, but there are no data on the frequencywith which it occurs.

Hospice Services

Medicare pays for hospice-related infusion serv-ices under the prospective fee schedule for hospiceservices. Each day of hospice care is classified into

one of four ‘levels of care. ’ Medicare pays hospiceprograms at a per diem or an hourly rate, dependingon the level of care to which that day is assigned.Including infusion services does not change thedaily payment. The four levels of care are:

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routine (periodic) home care;

continuous home care (at least 8 hours of homehospice care per day);

general inpatient care (for symptom manage-ment or pain control that cannot be provided inthe home setting); and

inpatient respite care for up to 5 days (toprovide respite for family caregivers) (74).

Payment for all hospice services is subject to a capon total payment per patient (74). The only coveredservices not included in the prospective rates are thedirect patient care services of physicians. Forphysicians employed or paid by the hospice, directpatient care services are reimbursed on the basis ofcharges for those services. The services of otherphysicians are paid through Part B in the same wayas nonhospice physician services.4

A pa~ents to hospice physici~ are made in addition to the daily rates but are counted toward the overall cap on per patient hospice payment. pmB payment for physician services is not counted toward the overall cap (74).

297-913 0 - 92 - 10


Examples of Potential Payment Modelsfor HDIT

Unbundled Retrospective Payment: The ExistingMedicare Home Benefit Model

Medicare’s existing payment methods for homenursing and equipment offer the most basic modelfor an HDIT payment method. Under this model, thedifferent components of HDIT would be paidseparately in the same way they are under existingbenefits. Equipment and supplies would be reim-bursed according to the present method of paying forDME and related supplies; payment could be madeeither to an HHA or directly to the DME supplier.Infusion-related nursing services would be paid onthe basis of visit costs under the HHA methodology.Physician services and laboratory services would bereimbursed in the same manner as at present.

Drug payment has less precedent under thecurrent system. Most carriers pay based on their owncharge experience, but the drug codes in theMedicare coding system are crude and often inade-quate (365). Pharmacy services are not explicitlyrecognized.

At present, the only well-developed paymentmodel for home-infused products and related phar-macy services is the existing method of paying forhome total parenteral nutrition (TPN).5 Under thePart B prosthetic device benefit, payment for nutri-ents administered in the patient’s home is based onthe reasonable charge for the various solutioncomponents provided to the patient (379). Thecharge for the nutrients implicitly includes paymentfor related pharmacy services, since these servicesare not recognized separately. All TPN bills areprocessed and paid by two regional carriers to ensureconsistency in coverage and payment policies. Atthe least, extending the TPN payment model (oralmost any other payment model) to drugs requiresthe development of much more detailed drug codes.

Prospective Payment for Bundled Services:The ESRD Model

Like drug infusion therapy, dialysis for patientswith end-stage renal disease (ESRD) can be pro-vided at home and involves a sophisticated mix ofmedical equipment, supplies, and services. Existing

payment methods for chronic dialysis thus arepotentially applicable to HDIT as well.

Medicare pays for medical care associated withhome dialysis in one of two ways:

Method l—If a home dialysis patient receivescare from an approved dialysis facility, Medi-care pays that facility a monthly rate thatincludes all services, supplies, equipment, andcertain laboratory tests associated with dialy-sis. Separate monthly rates apply to continuouscycling peritoneal dialysis and intermittentdialysis (379). Claims are processed by theMedicare Part A intermediary.Method 2—If a home dialysis patient obtainssupplies, equipment, and services directly fromthe supplier, Medicare pays the beneficiary (orthe supplier) its share of the reasonable cost ofthese items. Payment is per item, but totalmonthly payments for all items may not exceedthe applicable composite rates under method 1(Public Law 100-239). Claims are processed bythe Medicare Part B carrier.

The vast majority of Medicare home dialysispatients are covered under the method 1 compositerate (74). The new cap on method 2 payments hasbeen difficult to implement in some areas becausesupplies are not billed locally (e.g., a patient onhome dialysis in South Carolina may receive equip-ment from a supplier in Georgia) (45).

Laboratory tests not included in the method 1composite rate are paid as any other Part Bdiagnostic laboratory services under fee schedule forthose services (379).

All physician’s services that are related to thecontinued management of a home dialysis patientare reimbursed by the carrier under a separatemonthly cavitation payment (MCP). The amount ofthe MCP is based on local prevailing charges formedical specialists’ followup office visits in 1981,as periodically updated since. In 1988, the MCP forany given locality was subject to a minimum of $132and a maximum of $203. Services unrelated todialysis management may be billed separately fromthe MCP. Payment for self-dialysis training servicesprovided by a physician is also made separately from

5 There is currently no written policy for TPN paymen~ although the carriers have special instructions from the Health Care Financing Adnums“ “ tration(HCFA). The OffIce of ‘Ib&nology Assessment (OTA) obtained information about coverage and payment directly from HCl?A’s Bureau of Programoperations.


the MCP amount (at a flat rate of $500 per patient)(379).

Were infusion drug therapy to be paid accordingto the ESRD model, reimbursement would be madeat one or more flat rates per patient, with the ratesincluding equipment, supplies, and services. Thedrugs themselves could be either included or ex-cluded in the composite rate, as could laboratory andphysician services. The ESRD program also pro-vides a possible model for paying for infusion-related physician services.

Prospective Rates With Participation:The Blue Cross/Blue Shield Model

A number of private insurance companies haveinstituted HDIT benefits (55), and models fromthese companies may be applicable to Medicare.Some insurers have instituted benefits paid in amanner similar to the “existing home benefit”model described above; each component is paidbased on costs or charges according to preexistingbenefit policies (55). Other insurers, however, reportsatisfaction with a payment model that combines aprospectively set per-service or per-diem rate with aprocess under which eligible providers agree tobecome preferred providers if they accept that rate.

In the preferred provider model (used by at leastthree Blue Cross/Blue Shield plans), the insurerdefines some provider conditions of participationand offers a set of rates for a defined set of HDITservices. Area providers that meet the conditions ofparticipation can agree to serve the insurer’s patientsat the set rates. In doing so, they agree to “acceptassignment’ and accept the rate as payment in full.Providers who agree to participate are “preferredproviders ‘‘ in the program; physicians are encour-aged to refer patients to them, and patients areencouraged to use them to avoid extra billing.Nonparticipating providers may also serve patients,but they are paid only the set rate and the patient isliable for any additional billed amount (43,243).

To be successful, the preferred provider model forHDIT requires four elements:

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a well-defined set of services to be provided,minimum quality standards for chosen provid-ers,a rate that is high enough to cover necessaryprovider costs but lower than at least somebilled charges on the market, and

. enough providers in the market to invite com-petition for patients.

The rate is especially critical. If it is too high, thepayer loses the advantage of market leverage andmakes unnecessary payments. If the rate is too low,providers will be unwilling to participate becausethey cannot cover their costs; too few providersmean impaired access for patients.

Two insurers in Arizona and Washington, DC thatuse this model set rates and pay in slightly differentways. In Washington, DC, infused drugs are paid ata set amount over the listed AWP, based onpharmacist input regarding the preparation timeneeded for different drugs (43). Equipment is paidaccording to a rental fee schedule. All other suppliesand services (except laboratory and physician serv-ices) are “bundled” and paid at a daily rate thatvaries depending on the amount of nursing servicesneeded that day (table 7-2). The daily rates werecalculated from an amalgam of historical charges,manufacturers’ list prices, and professional input(43).

In Arizona, in contrast, rates are establishedseparately for each individual item, whether it beequipment, supplies, or services. Drugs are paid atAWP plus an administrative markup; pharmacyservices are paid per dose, based on judgments of apharmacist panel (243).

Both of these insurers report lower costs thanbefore instituting their respective programs, whenthey were paying much higher billed charges. Bothalso report substantial participation rates among areaproviders, at least in the brief time they haveoperated thus far (43,243).

The Medicare Catastrophic Coverage Act Model

After the MCCA was passed, the Health CareFinancing Administration (HCFA) published pro-posed regulations that outlined in detail how thehome intravenous (IV) drug therapy benefit underthat act was to be paid (see app. C for a summary ofthe proposed regulations). Although they were nevermade final due to the repeal of the act, theseproposed regulations offer a detailed potential modelfor any future similar benefit. In them, HCFAproposed to pay for home IV drug therapy in twoparts: 1) the drugs, and 2) all other supplies,equipment, and administrative, pharmacy, and nurs-ing services.


Table 7-2—Example of One Insurer’s ProspectivePer-Diem Fee Schedulea

PaymentDescription per day

Medical suppliesb and nurslng services

Initial home nursing visit for instruction andassessment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Supplies only (no professional nursing intervention);patient is self-administering medication. . . . . . . . .

Supplies and brief (O to 1 hour) professional nursingintervention . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Supplies and intermediate (more than 1 to 2 hours)professional nursing intervention . . . . . . . . . . . . . .

Supplies and comprehensive professional nursingintervention (more than 2 hours) . . . . . . . . . . . . . . .

Additional medical supplies for multiple therapies(billed in addition to one of above services) . . . . . .

Noninfusion maintenance of central line catheter(implantable device) . . . . . . . . . . . . . . . . . . . . . . . .

Noninfusion maintenance of central line catheter(nonimplantable device) . . . . . . . . . . . . . . . . . . . . . .

Blood transfusion and associated nursing visits(per episode) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Equipment rentalIV pole . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

External ambulatory infusion pump andadministration equipment. . . . . . . . . . . . . . . . . . . .

Stationary infusion pump. . . . . . . . . . . . . . . . . . . . . . .Patient-controlled analgesia infusion pump . . . . . . . .Elastomeric infuser . . . . . . . . . . . . . . . . . . . . . . . . . . . .

$200.00

35.00

110.00

160.00

345.00

25.00

30.00

5.00

475.00

1.00

19.0012.0016.0030.00

~his table represents only part of the fee schedule. It does not includeitems on the fee schedule that relate to nutritional therapy, aerosolizedtherapy, or other services.

bFee a=um= supplies are distributed by the home care protider.SOURCE: L. Bodenheimer, Blue Cross and Blue Shield of the Nationai

Capital Area, Washington, DC, personal communication, June28, 1991.

The drugs themselves were to be subject to apayment rate that depended on the exact drug anddosage. The rate for a given drug was the lesser of theactual charge or the calculated payment limit. Thepayment limit, in turn, was based on a per-doseaverage price for the drug, derived from publishedAWPs or HCFA-conducted surveys of drug prices.The payment limit also included a small administra-tive allowance for each dose (54 F.R. 37208).

All other supplies, equipment, and services wereto be included in two per diem rates, one for eachgeneral type of covered therapy (i.e., antibiotics andanalgesics). Rates were built up through estimates ofthe cost of providing each of the components of thepharmacy and nursing services and supplies re-quired. Establishing these rates required not onlyinformation on per-unit costs but on assumptions

regarding the services required. A patient on antibi-otic therapy, for example, was assumed (on average)to require a nursing visit and associated cathetersupplies every 3 days, drug delivery every 5 days,and self-administration of one dose (with associatedper-dose pharmacy preparation time) 2.5 times eachday. Only 10 percent of antibiotic patients wereassumed to require pumps (54 F.R. 46938).

The proposed basic fee for pain managementtherapy (not including the drug) was $31.63 per day,and the basic daily fee for antibiotic drug therapywas to be $45.44. These amounts would be adjustedfor geographic variation in a wage index and wouldbe reviewed for updating overtime (54 F.R. 46938).In addition, providers would receive one-time orpatient-specific allowances for initial patient educa-tion and treatment and for patients on multiple drugregimens. Physician and laboratory services wereoutside the fee schedule and would be paid as anyother such services.

Bundling With Hospital Services:A Hypothetical Model

Linking post-hospital and hospital treatments intoa single payment for all nonphysician services hasnever been implemented under the Medicare pro-gram, but the idea is not entirely new. In fact,combining hospital and post-hospital home healthservices was one of the potential payment methodsthat HCFA considered testing in a demonstrationproject in the 1980s (381).

In the context of HDIT, bundling with hospitalinpatient payment could take two forms. First, thecosts of paying for HDIT could actually be includedin the prospective payment rate to hospitals forrelevant DRGs. In essence, the costs of post-hospitalinfusion therapy would become for Medicare pur-poses part of hospital costs, and the calculations ofDRG payment rates would simply be adjusted toaccount for them. All hospitals would receive thenew DRG rate, regardless of their actual institution-specific patient experience.

Alternatively, all hospitals could receive the basicDRG payment (which might be lower than atpresent), and hospitals would receive an additionaladd-on payment for each patient discharged toHDIT. The add-on would be assumed to cover allcosts of the home therapy (except physician serv-ices).


In either case, the essential feature is that thehospital receives the payment for the home therapy.Thus, the hospital must either provide the therapyitself (e.g., through its own HDIT service), or pay inturn the outside provider who does so. BundlingHDIT and hospital payment would have the greatadvantages of reducing hospital incentives for overlyearly discharge of patients requiring detailed care,while encouraging hospitals to use the most cost-effective setting for patients appropriately dis-charged to nonhospital infusion. There would bestrong incentives to control costs, including limitingthe duration of treatment, as payment would essen-tially be on a per-episode basis.

However, this method would also face substantialimplementation difficulties. To correctly update thehospital payment rate, or calculate the add-on rate,the average costs of home infusion patients associ-ated with each DRG would have to be determined.Doing so would be very difficult, since outsideproviders have little incentive to make their per-DRG costs known even if they know them them-selves. Also, this payment method requires thathospitals have sophisticated and ongoing relation-ships with outside home providers, which wouldtake some time to develop. Fewer than 20 percent ofcurrent HDIT providers are hospitals (193). Hospi-tals unable to provide such services directly wouldneed to solicit bids for such services, much as wouldbe the case with a public-sector agency responsiblefor a competitive-bidding-based payment system.

Furthermore, a significant and probably increas-ing proportion of HDIT patients are not hospitalinpatients at the time they begin therapy. IndividualHDIT providers report that anywhere between O and23 percent of their patients begin their homeinfusions in outpatient settings (195,250,332), andone provider reports that the proportion increasedfrom O in 1986 to 20 percent in 1989 (83). Separatepayment methods would still be required for thesepatients.

Another “bundled service” model would be topay for all HDIT services through HHAs. Under thismodel, an HHA providing home health services to aMedicare patient who also required HDIT wouldreceive an add-on for supplies and services directlyrelated to the infusion. Services and supplies bypatients needing only infusion, and no other, homehealth services would be paid to the HHA at someprospective rate slightly higher than the add-on rate.

Box 7-A—HDIT Under ProspectivePer Capita Payment

The most comprehensive “bundle” of servicesto which a prospective rate may be applied is theuniverse of health care services an individual needsduring a given time period--"per capita” payment.Here, a provider receives a predetermined fee peryear for every beneficiary enrolled with that pro-vider, regardless of whether the beneficiary actuallyuses any services. Payment includes not onlyinfusion therapy but all other acute and primary care(and, sometimes, some long-term care as well).

This model is already in place for Medicarebeneficiaries enrolled in health maintenance organi-zations (HMOs), which receive a capitated rate thatincludes all the Medicare benefits to which a patientis entitled. In essence, for HMOs, payment forHDIT is “bundled” with payment for all otherhealth care services.

Some HMOs provide HDIT themselves for thosebeneficiaries they deem eligible (389); others con-tract with outside providers who offer the service.The outside providers, in turn, may accept eitherfees-for-service or a capitated rate for the patientpool, with the exact number of patients they willserve unknown at the time the rate is set (186). Incontrast to per capita payment for all basic healthservices, there is very little experience yet with percapita payment to HDIT providers to cover only thistherapy.

The advantages of this model relate less tocost-effectiveness incentives than to care coordina-tion incentives; patients needing both infusion andother home health services would have care coordi-nated within a single provider. Like the hospitalbundling model, this model has the disadvantagethat it requires agencies that do not provide infusionin-house to have arrangements with other providers.This disadvantage is not be trivial; at present, itappears that many HHAs have little direct experi-ence with HDIT.

Goals and TradeoffsAny payment method is a compromise to achieve

the best result given a number of competing goals.Among the major goals of the Medicare system are:

● Access to necessary medical care for Medicarebeneficiaries. This goal can be achieved only ifpayments to providers are adequate to induce


●

●

●

sufficient supply to serve Medicare benefici-aries.Care of acceptable quality for beneficiaries. Toensure care of at least minimum quality,Medicare may provide incentives for providersto produce care of high quality (e.g., by givinghigher payments or conferring a market advan-tage to high-quality providers). Alternatively,Medicare may implement quality monitoringand assurance systems, under which payment isdenied when certain indicators fall belowacceptable standards.Equitable treatment of beneficiaries, providers,and other participants in the health care system.For beneficiaries, the goal is equity of accessand cost burdens; for providers, the goal is fairpayment and participation rules.Cost controls that keep program, beneficiary,and health system costs as low as possible.Because cost control competes directly withother objectives, payment systems are usuallydesigned to achieve appropriate levels of cost,

consistent with other goals, rather than to

achieve the minimum possible costs.An administratively feasible program that can

be implemented. To be successful a paymentmethod must be workable for both governmentadministrators and for providers. Some pro-grams may be very complex and costly toadminister; for others, the information baseneeded to implement the program (e.g., todetermine appropriate payment rates) may belacking. Programs may also differ in theiracceptability to providers and the costs ofovercoming poor provider participation.

These policy goals are not entirely distinct fromone another. Administrative feasibility, for example,could be considered a subset of program costs.Focusing on each separately, however, highlightsthe tradeoffs between goals that are inherent to thedifferent basic payment methods.

Access

Access to care for beneficiaries requires providerswho are willing and able to provide care. Sometimes,access is endangered because no providers exist—for example, in a rural area with insufficientpopulation density to support a home infusionprovider. In other cases, providers may exist but may

be unwilling to serve Medicare patients. Becausewillingness to serve patients is often related toreimbursement for services, Medicare must trade offthe desire for program cost control with the need toensure the participation of adequate numbers ofproviders in every service area.

For Medicare home health services, which arereimbursed on a cost basis, provider participationhas not been a problem. Nonetheless, providerparticipation could become an important issue ifMedicare adopted a fee schedule that providersfound inadequate. It has been documented that

physician participation in the Medicaid program isdirectly related to rates paid (143,152,313). In someareas, physician willingness to accept assignment(which implies acceptance of Medicare’s paymentrate) for Medicare patients has also been an issue(56,180,214). The consensus of research in the pasthas been that an increase in payment rates (relativeto physician charges) would increase physicianwillingness to accept Medicare assignment (56,221,255).

If providers cannot control the payment theyreceive for services, they can still to some degreecontrol the types of patients they serve. Nursinghomes, for example, have been thought to selectpatients requiring the least costly care in order tomaximize profits under a fixed-rate payment system(173). HHAs, currently reimbursed for their costs,have little reason to be selective in serving patients(though they may try to avoid or terminate particu-larly troublesome patients who exact an emotionalcost on staff that is not reimbursable). A freed-ratepayment scheme, however, could create incentivesfor HHAs to find ways to serve the less costlypatients. This might be accomplished through estab-lishing outreach and referral networks directedtoward low-cost patients, or by encouraging thetransfer of costly patients to other providers.

The payment rate necessary to induce a sufficientnumber of providers to offer their services toMedicare patients may vary among geographiclocations and according to local market conditions.If access is to be ensured for all, it may be necessaryto tailor rates to market area characteristics. Or, ifuniform rates were to be used, Medicare could allowrates that are higher than necessary in low-cost areasto ensure adequate supply in high-cost areas.

Chapter 7—Paying for Home Drug Infusion Therapy Under Medicare ● 143

Table 7-3-Presumed Quality Incentives Under Alternative Payment Methods (relative to cost-based reimbursement)

Provider incentives relating to:

VisitsCost per per time Length of Potential impacts on

Payment method visit period episode quality of care

Rate per visit. . . . . . . . . . . . . . . . . . .

Comprehensive monthly rate . . . . . .

Comprehensive per-episode rate. . .

Bundling payment for hospital andposthospital services . . . . . . . . . .

Competitive bidding . . . . . . . . . . . . .

Reduce Reduce increase ●

Reduce Reduce increase ●

●

Reduce Reduce Reduce ●

●

●

Reduce Reduce Provide cost-efficient ●

balance of hospital and ●

posthospital services●

Reduce length of visitor quality of staff

Reduce length of visit or quality of staffProvide service too infrequently

Reduce length of visit or quality of staffProvide too few home health servicesDischarge prematurely

Reduce length of visit or quality of staffProvide too few hospital/posthospitalservicesDischarge prematurely

Same as above units of payment for any given type of rate, but incentives maybe intensified if ratesbased on bidding are lower than rates based on historical costs. Also, possible reduction in accessto services if winning bidders have insufficient capacity and/or losing bidders serve areas not reachedby winning bidders.

SOURCE: U.S. Department of Health and Human Serviees, Health Care Financing Administration, Office of Research and Demonstrations, Demonstrationsand Designs of A/temative F?eimbursement Methods for Home Hea/th Sem”ces, HCFA Pub. No. 03290 (Baltimore, MD: HCFA, September 1989),table 3-2.

Quality AssuranceThe quality and quantity of care provided to

patients receiving home health services can beaffected by the incentives inherent in the wayMedicare pays providers. Incentives can take theform of higher payments for high quality care.Where quantity is one measure of quality (e.g.,frequency of visits), then per-unit payment mayprovide good incentives. In other cases, workablemeasures of quality must be developed so that highquality can be rewarded (or low quality censured) bythe payment system.

Competition can also be used to ensure quality.Even when Medicare payments are uniform acrossproviders, providers in competitive markets mayhave to offer services of acceptable quality to attractMedicare patients and their physicians.

A 1989 study of alternative payment methods forhome health services under Medicare examinedthese issues at the theoretical level (381) .6This studysuggested that, while smaller units of payment (e.g.,per visit) might result in increased utilization, largerunits of payment (e.g., per episode) could result inreduced quality of services as providers attempted tocut costs of service (table 7-3) (381). Competitivebidding models, because they can have considerable

impact on the caseload, market share, and revenuesof both losing and Winning bidders, also presentserious quality and access concerns (381). Theseconcerns might be exaggerated for a market as newand diffuse as HDIT. Nonetheless, these findingssuggest that payment methods that create incentivesfor providers to cut costs (e.g., per episode, per diem,monthly rate, competitive bidding) should be bal-anced by more vigorous quality assurance andutilization review efforts (381).

When it is too difficult or costly to includeappropriate incentives in the payment system, it maybe necessary to develop a separate quality monitor-ing and assurance system. Payment can then bedenied when quality measures fall below acceptedstandards. (LOW quality of care can result from toomuch service as well as too little service. It isimportant to ensure that the system does not induceuse of unnecessary care.)

HDIT services, because they can be more nar-rowly and specifically defined than home healthservices in general, may be more conducive tofocused quality assurance measures. These mightinclude Federal, State, and provider-level qualityassurance initiatives and controls, implementedthrough survey and certification of providers, on anongoing and systematic basis through providers’

G Impact could not be examined direetly because the intended projeets to demonstrate them were never implemented.


internal quality assurance programs, and on anindividual case basis (i.e., through preauthorizationand retrospective review by an outside party).

EquityInequity among Medicare beneficiaries could

arise if the payment system failed to ensure access toservices in some geographic areas. It could also ariseif patient cost sharing provisions fell disproportion-ately on one group or another, or if limits oncoverage duration or scope served to deny benefitsto certain groups of patients.

Inequity among providers may result from pay-ment rates that do not account for differences in costoutside the provider’s control, or from differences inthe way services are reimbursed that may affectproviders differently. For example, a single paymentrate for all HDIT that was based on average costsover all types of therapy might disadvantage provid-ers who specialize in a particular type of therapy thatis more expensive than average.

Even if payment is equitable across all HDIT.providers, equity across different settings of caremay be difficult to achieve. There is little a priorireason to believe that home care is preferable tooutpatient infusion for mobile patients with access toan outpatient provider, for instance. The method(and level) of payment chosen for HDIT, however,could easily cause an inequity between home andoutpatient providers, resulting in possible unin-tended incentives to use one rather than the other.

Cost ControlSetting Payment Rates:Marginal Versus Average Costs

Cost control for the Medicare program, benefici-aries, and the health care system overall requires thatpayment is not excessive relative to productioncosts. Thus, regardless of the payment methodchosen, the payment rate—i.e., the actual amountpaid, regardless of the method in which it iscalculated-is extremely important. From Medi-care’s perspective, the best payment rate is thelowest one that can be obtained without inducingundesirable changes in provider behavior (e.g.,refusing to accept Medicare patients). For anyindividual provider, the response to a given payment

rate will depend heavily on whether that rate isabove or below the provider’s marginal cost (theprovider’s own production cost of serving one morepatient) and the provider’s average cost of servingall patients (i.e., total costs divided by total patientsserved). 7

For the great majority of providers, setting ratesbelow marginal costs would probably lead them toavoid serving Medicare patients (since they wouldtake a financial loss on every patient). Exceptionsmight be publicly subsidized providers (e.g., publichealth departments) or providers that could treat theservice as a “loss leader” to induce patients to alsouse other, more lucrative services. (Note that anygiven payment rate might be below the marginal costfor most providers but above marginal cost forothers. The latter providers might still be willing toserve patients.)

If rates were set above marginal cost but belowaverage cost, most providers would probably con-tinue to serve Medicare beneficiaries. In this case,even though the rate fails to cover average cost, thepayment received for each Medicare patient coversthe extra cost that the patient generates and makessome contribution to the provider’s fixed costs.

If payment just covers marginal costs, providersmay be willing to serve Medicare patients if they areable to charge other payers more than average costs.Such cost shilling might raise concerns about theequitable distribution of cost among payers. A verysimple model of home infusion provider behavior(app. D), however, suggests that rates betweenaverage and marginal cost would result in lowerprofits for providers rather than higher rates for otherpayers, so cost-shifting and interpayer equity is nota major issue.

Interprovider equity may be of somewhat moreconcern. In some cases, Medicare rates belowaverage cost might endanger the financial viabilityof providers heavily dependent on Medicare pa-tients. So, rates at this level could have an impact onaccess to services in some areas and for some typesof providers.

Rates at or above average cost should besufficient to induce providers to serve Medicarebeneficiaries where such service can be efficiently

7 Note that neither marginal nor average costs bear any necessary relation to charges. In fac~ in order for a provider to make a profit in the long ~charges must be higher than average costs. Payments can be less than charges but still higher than average costs.


provided. They could also be viewed as coveringMedicare’s fair share of provider costs. Althoughrates above average costs (including a normal profitor return to invested capital) might be consideredexcessive in a world where all providers facedsimilar constraints and similar patients, there aresome circumstances in which rates above measuredaverage cost might be appropriate.

For example, it maybe necessary to pay more thanthe average cost of an efficient-size operation toensure that services are provided in areas that cannotsupport a provider of efficient size. Also, if theadministrative costs of serving Medicare patients aresignificantly greater than such costs for otherpatients, then it may be desirable or necessary forMedicare to pay more than the average cost ofserving all the provider’s patients. Third, coststructures could differ from those postulated inappendix D. If marginal cost exceeds average cost(e.g., due to a limited supply of potential staff) andparticularly if there are barriers to entry of newproviders at an efficient size (e.g., startup costs),then it maybe necessary to pay marginal costs (morethan average cost) to induce supplyminimum of the average cost curve.

Other Cost Containment Mechanisms

Because Medicare pays hospitalsdischarge basis, discharging a patient

beyond the

on a per-home early

would result in temporary double-payment for thatpatient if the HDIT were covered. One privateinsurer with a payment method similar to Medicare’sauthorizes home infusion only for patients whoseposthospital course of therapy is expected to be atleast 7 days (243). This policy reduces the payer’sshort-term costs, but at the expense of also reducinghospital cost savings that might be reflected in futurelower hospital payment rates.

Reducing hospital payments by some prescribedamount at the time an HDIT benefit is implementedwould be another way to reduce the program costs ofshort-term double-payment. For example, patientsdischarged to HDIT could be treated in the same wayas inter-hospital transfers, with the “transferring”hospital receiving a proportion of the full DRG rate,based on the number of days the patient washospitalized. As yet, however, Medicare has littlesolid information on which to base such a policy.Unknown factors include the extent to which pa-tients could be discharged sooner in the face of an

HDIT benefit; whether the ability to discharge variesamong hospitals; and how hospitals would behave inthe face of such a policy. The concept also violatesone of the basic premises of Medicare’s inpatientprospective payment system, which is intended toreward efficiency (and, where appropriate, shortstays) and penalize inefficiency. A demonstrationproject could address the former issues, but the latterones require a more fundamental policy change.

Administrative Feasibility

Cost and Complexity of Administration

It is not clear whether prospective payment orretrospective reimbursement methods are generallymost easily administered. It is likely that the manyHDIT providers who have not used Medicare costreports (i.e., most providers that are not hospitals orHHAs) would find prospective rates easier to adoptthan full cost reporting. On the other hand, adminis-tering the geographic and annual adjustments toprospective rates could be difficult and possiblycostly for the Medicare program to do well.

Competitive processes may be the most administ-ratively costly payment methods, because theyrequire soliciting bids, making awards, and monitor-ing quality in every market area. Arizona’s competitive-bidding-based Medicaid demonstration program, forexample, has administrative costs equal to 12percent of medical costs, compared with 4 to 7percent for most other State Medicaid programs(212). Since the program showed a modest netsavings overall, however, there may well be somesubstitution of administrative costs for medical costsin competitive bidding systems (212).

Government-set prospective rates may require thegreatest difficulty obtaining accurate information toestablish rates. In contrast to cost reimbursementmethods (where the provider’s actual cost is the ratepaid) and competitive payment methods (where thecompetitive process effectively generates its owninformation through bidding or negotiation), gov-ernment-set prospective rates require detailed infor-mation, of two types. First, the relevant costs used asthe basis for the rates (e.g., average cost) must bemeasured or estimated reasonably accurately. Sec-ond, legitimate and acceptable variation in costsmust be accounted for. Developing detailed infor-mation on variations and methods to account fordifferences, if found, could be complex.


Administrative burdens (e.g., learning Medicarecost reporting rules) can also affect provider partici-pation. A generous payment rate may overcomeresistance to paperwork burdens, but it may bepreferable and less costly for the program to findways to minimize the required provider documenta-tion. Provider complaints about payment systemsoften mention payment delays, the need for multipletypes of claims forms and procedures, unanticipatedclaim denials, and unreasonably low payment rates.To the extent that a payment system can limit thesetypes of problems, provider participation is likely tobe better.

One possible way to reduce administrative bur-dens for both Medicare and providers, whatever thepayment method chosen, is to consolidate claimsreview and payment for HDIT within a few regionalFls. Precedents for such consolidation exist. TPNbenefits are administered through only two nationalFIs. More recently, home health benefit administra-tion has been consolidated among nine regional FIs.HCFA appears to be satisfied with the benefits ofadministrative consistency that have attended con-solidation (399).

A final administrative consideration for Medicareis whether an HDIT benefit should be administeredunder Part A or Part B of Medicare. The question isnot trivial, nor the answer obvious, because thecomponents of HDIT as they are now covered underMedicare fall in both. DME and associated drugbenefits are usually administered through Part B,and the Part B carriers currently have the greatestexperience administering a home drug benefit as aconsequence. On the other hand, home healthservices are usually administered through Part Aintermediaries. Thus, if one objective is to ensurecoordination of HDIT and other home health bene-fits, administration through Part A, or through FIsthat administer both Parts A and B, may beindicated. Conversely, if HDIT patients were ex-cluded from receiving concurrent home healthbenefits, it might make more sense to administer anHDIT benefit through Part B carriers.

Evaluating Payment AlternativesThe possible choices for HDIT payment are many

and could include any of a number of variations onthe payment models described above. This sectionassesses basic methods of payment according to the

tradeoffs they entail in the goals of a paymentsystem.

Retrospective Charge- or Cost-BasedReimbursement

Cost- or charge-based reimbursement as a methodof payment for HDIT (e.g., as in the existingMedicare home services model described above)offers the advantage of promoting provider partici-pation and providing incentives for high qualitycare. This method would be easy to implement, sinceit fits with existing methods of payment for homeequipment and services. Restricting payment tocost-based only would be slightly harder to imple-ment, since many HDIT providers do not haveexperience with Medicare’s cost reporting system.

The primary disadvantage of cost- and charge-based reimbursement is the lack of incentives forcost control. Both have inherently inflationarytendencies, because providers can recoup full costs(or, for charge-based reimbursement, greater thanfull costs) and thus have little reason to seek the bestpossible prices from their suppliers. Provider effortsto constrain their own costs are likely to occur onlyif they have a significant fraction of their businesspaid on some other basis. Since it appears that many(if not most) private insurers currently use someform of charge-based reimbursement for HDIT, thisis not likely to be the case in the immediate future.

Despite its inflationary nature, cost-based reim-bursement would not necessarily be more expensiveto the Medicare program than prospective paymentmethods. If HDIT is provided with a commontechnology in accordance with well-establishedprofessional standards (for frequency of visits,necessary equipment, credentials of caregivers, cri-teria for termination of care, etc.) then there maybelittle room for providers to inflate costs or provideextra services. If home care costs increased onlyslowly, and if prospective rates had to be set high(e.g., to ensure access in all areas, or because theratesetting process was ‘captured’ by the industry),cost-based rates could be lower than prospectivelyset rates. Cost-based reimbursement would alsohave relatively low startup administrative costscompared with most other payment methods. Also,less quality assurance monitoring would be neededthan with other payment methods.


Competitive Payment Methods

Competitive bidding approaches could be appliedto HDIT. Services are fairly well defined and inmany markets there are sufficient numbers ofpotential providers to allow for a truly competitiveprocess. It would be possible to contract competi-tively for delivery of HDIT services to Medicarebeneficiaries in individual markets across the coun-Q .

The principal advantage of competitive approachesare that market mechanisms are used to set rates. Itwould not be necessary to set rates uniformly high toensure access in areas with high costs. Throughcompetition, rates could be established well belowaverage cost, probably close to marginal cost,without impairing the access of Medicare benefici-aries to service. Rates could be revised routinely toreflect changes in cost and technology.

The principal disadvantage of a competitivepayment method is that the costs of administeringsuch a system could exceed those for a prospectivepayment or cost reimbursement system. Althoughsome competitive systems (e.g., Arizona’s Medicaidprogram) have found that savings from low ratesmore than balanced the extra administrative costs ina comprehensive health care plan, Medicare mightbe hard-pressed to meet this standard due to thesmall market for HDIT. Competition would proba-bly involve multiple bidding processes to cover theentire country. Also, as this method would giveproviders strong incentives to control costs, the sameapproaches to quality assurance would be requiredthat are necessary with prospective government-setrates. Studies of existing competitive bidding pro-grams have found that excluding quality as acriterion for award selection and inadequate moni-toring of quality have been problems in some ofthese programs (380).

To be successful, this payment method requiresthat several providers be available in an area tocompete. This may be a problem in sparselypopulated areas with few providers. In addition, ifthe initial ‘winners” in a bid gain sufficient marketadvantage, the long-term competitiveness of themarket could be endangered. In particular, winner-take-all bidding may promote market concentration and

make future bidding harder to conduct (380). Long-term program costs could rise as a consequence.

Noncompetitive Prospectively Set RatesProspective rate setting offers greater direct gov-

ernment control over rates than is possible with costreimbursement or competitive methods. This wouldpromote efficient operations, but it might also leadto reduced quality of service (e.g., less reliability,less qualified staff, lower quality supplies, lessinternal quality assurance). The extent to which anycost saving would accrue to Medicare, rather than toprovider profits, would depend on whether futurerates were adjusted downward to reflect the savings.Inefficient providers and providers with high costsnot fully adjusted for by a geographic wage index(e.g., those serving high-crime or low-volume areas)might find it difficult to continue serving Medicarepatients.

As demonstrated by the proposed regulationspursuant to the MCCA, data limitations may restrictthe exact form of prospective ratesetting that isimmediately possible. In the proposed regulations,HCFA acknowledged some of the limitations of thedata used to develop the rates and identified areaswhere better data may be needed. Data are mostreadily available on average costs (in HHAs) andcharges. Little information is available on truemarginal costs, or even average costs of freestandingHDIT specialty companies. However, estimates ofaverage variable costs, which were the focus of theHCFA rates, may closely approximate marginalCosts.*

Updating Prospective Rates

Adjusting rates for changes over time may be evenmore difficult. Changes in the method of delivery inresponse to the new financial incentives or technol-ogy may make initial rates obsolete rather quickly.Much of the data used to establish rates comes fromindustry surveys. Once it is known that the surveysare used to set rates, providers may inflate thereported costs of providing services.

Under the MCCA, HCFA proposed to adjust ratesamong geographic areas using a wage index and toconsider annual inflation adjustments. The adequacyof such a geographic adjustment depends on theextent to which the wage index reflects true cost

g Wriable costs are those costs that change as output changes. (In the long m most costs are variable, but in the short run variable costs are thosesuch as supplies, transportation etc. that change as patient caseload increases or decreases.)


variations among HDIT. Cost of providing HDITmay vary with local costs of office space, transporta-tion, and liability insurance as well as wages. Thereis no good information on the variation of such costs,so it is not clear whether the geographic wageadjustments would have been sufficient to ensureaccess of Medicare beneficiaries in all areas. If rateswere based on average total costs, they would be atleast as high as marginal cost even in the high-costareas. In this case, the adequacy of an adjustmentmay be more of an issue of equity among providersthan one of access.

Prospectively set rates are the basis for four verydifferent models discussed earlier: the all-serviceper-month ESRD model, the per-diem MCCA andprivate sector models, the per-item private sectormodel, and the per-episode models that bundle homeinfusion with hospital or home health services.These models differ in two basic aspects: how theybundle services across time (e.g., per diem, perepisode of care), and how extensively they bundlethe various components of therapy (e.g., nursing andpharmacy services, equipment and supplies, drugsand ancillary services).

Bundling Across Components of Therapy

Bundling services together for payment, as HCFAproposed to do (under the MCCA) for HDIT nursingand pharmacy services, supplies, and equipment,reduces the incentive to provide extra services in thecourse of a visit. Bundling services, supplies, andequipment also encourages use of the most efficientcombination of services. Its drawback is that it couldalso lead providers to skimp on provision of servicesif competitive forces or quality assurance proceduresare not effective in ensuring provision of neededservice components.

Bundling other components of therapy (e.g.,drugs, routine laboratory services) into a singlepayment rate is also possible, although the Office ofTechnology Assessment (OTA) is not aware of anypayers that currently do so for HDIT. The paymentadjustments that might be necessary to accommod-ate different drug dosages and patient monitoringneeds could be administratively taxing, at least untilpayers gain more experience with this therapy.

Alternatively, payments could be made separatelyfor nursing care, supplies, equipment, pharmacyservices, and all other components of care. As notedabove, however, this is likely to lead providers to

supply as many such services as possible in order tomaximize payments. Providers might also have anincentive to use expensive equipment, even if it wasof little additional benefit to the patient. Monitoringthe detailed itemization of supplies and equipment topreclude paying for unnecessary items could beadministratively costly.

If unbundling was coupled with a diffusion ofprovider responsibility (from a single agency tomultiple providers), then the quality of patient carecould suffer from lack of coordination. In suchcircumstances it might be necessary to add (and payfor) a case management role to ensure coordination.An independent case manager could act to preventuse of unnecessary or unduly expensive services, butwould probably be more costly than if the casemanagement function was assumed by a provider.

Bundling Across Time

Any prospective payment method that bundlesservices across time creates incentives to cut costsand quality (e.g., by reducing the number of nursingvisits) unless rates are high and there is strongcompetition to provide quality services to attractMedicare patient referrals. Per-diem rates mayinclude a mild incentive to overuse services towardthe end of therapy, if rates are higher than the dailycosts of serving the patient, though such actionwould require the inattention of the patient’s physi-cian. Compared with per-episode rates, per-diemrates present less risk to the provider-persons withunusually long episodes of care will produce greaterpayments.

Bundling services across time for the purposes ofpayment may encounter information problems. Inthe hypothetical model described above, for exam-ple, in which HDIT would be “bundled” withhospital care, the lack of information regarding howto estimate per-DRG costs associated with HDITmight delay implementation of this method.

Other Issues

Paying for Drug Infusion Therapyin Skilled Nursing Facilities

For patients who require substantial professionalnursing assistance and who cannot be treated asoutpatients, treatment in SNFs is a potential alterna-tive to hospital inpatient care. Medicare alreadycovers drug infusion therapy in this setting. Despite


this apparent coverage, SNF-based infusion therapymay often be discouraged as unavailable, for fourreasons.

First, most SNFs operate at close to capacity. In1986, the average occupancy rate for SNFs in theUnited States was 92 percent (384). In 11 States, theaverage occupancy was over 95 percent (384).Consequently, admitting a patient to an SNF forextended drug infusion may often be much moredifficult than prescribing home care for that patient.

Second, Medicare reimbursement for SNFs dis-courages the provision of most expensive therapies.Current reimbursement policy is to pay SNFs theircosts, but these payment amounts are subject to alimit of 112 percent of the median costs for similarSNFs (74). Thus, any individual SNF is heavilydiscouraged from specializing in drug infusiontherapy, which increases both supply and nursingcosts.

Parenteral nutrition products provided to SNFpatients are an exception to this reimbursement rule.When these products are provided by an outsidesupplier, who bills Medicare directly, their costs arenot borne by the SNF. SNFs who likewise succeedin billing some drug infusion costs separately underPart B may be able to mitigate some of thedisincentives for providing this therapy under Part ASNF payment.

Third, most SNFs do not have staff qualified toadminister infusion therapy, and if most of a SNF’spatients require less medically intensive care it haslittle incentive to recruit (and pay for) such person-nel. Staffing issues may be a greater barrier thanreimbursement to providing infusion therapy inmany SNFs (133).

And fourth, Medicare coverage rules encourageSNF residents who develop a need for drug infusionto be rehospitalized for the therapy. By doing so, thebeneficiary can often become re-eligible for Medi-care’s limited SNF benefits (133).

If Medicare covers HDIT, it may also wish toprovide more balanced incentives to provide thetherapy in SNFs for patients whose need levels makethem expensive to Medicare to treat at home. Druginfusion therapy could, like parenteral nutrition, berecognized as a separate component and either billeddirectly by the provider or treated as a SNF“pass-through,” not subject to the limits. Altern-

atively, SNFs could be reimbursed in a manner thatwas more directly related to the level of careprovided. SNF reimbursement systems that linkpayment to patient resource needs are currentlyunder development (300).

Higher extended-care payments for patients ondrug infusion therapy would also benefit ruralhospitals who must discharge such patients to swingbeds for lack of other nonhospital providers (see ch.6). Swing-bed care is reimbursed by Medicare at theaverage rate that Medicaid pays for SNF-level carein the different States (298). Swing-bed units mightneed higher payments to accommodate the higherservice levels presumably needed to administer druginfusion therapy safely.

Physician Compensation and OwnershipHDIT requires substantial physician involvement.

Physicians must assess the patient’s medical condi-tion, order the appropriate therapy, monitor thepatient’s ongoing health status at home, managecomplications or changes in prescription needs,document all medical management, and respond toany emergencies. Furthermore, greater physicianinvolvement and cooperation with other HDITprofessionals probably leads to higher quality care(see ch. 5).

Except for reimbursement related to predischargehospital visits and office visits during the course oftherapy, however, physicians generally receive nocompensation for performing these activities. Thelack of direct payment for services that take placeover the telephone or require substantial paperworkis a disincentive for some physicians to refer patientsto home care generally (6,203). This may be onecause of the finding that, although the role of homehealth services has increased, physicians’ involve-ment in home health care has decreased (12). Theproblem is exacerbated in the case of HDIT by theextensive and ongoing need for medical advice anddecisionmaking during therapy.

At present, one way for physicians to receivegreater financial rewards for the patients they referto HDIT is by receiving some form of compensationfrom the home providers themselves. Compensationmay take any of a number of forms. For example,according to some individuals interviewed by OTAstaff, a physician may receive a “consulting fee”from the home provider, with the amount of the fee


linked to the number of patients referred by thephysician.9 Alternatively, the physician may actu-ally share ownership of the home provider itself,thus receiving a share of the profits of that provider,which result in part from the number of patientsreferred.

Physician ownership of health facilities is acommon phenomenon. Over 8 percent of physicianswho are members of the American Medical Associa-tion (AMA) report ownership interest in at least onehealth facility, and 6 percent refer patients to thatfacility (66). A study by the Office of InspectorGeneral (OIG) found that 15 percent of physicianswho bill Medicare have some kind of financialarrangement with a health care entity to which thosephysicians refer patients (383). Physician ownershipis similarly common in the home infusion industry.For example, T2, a home drug infusion companybased in Georgia, is owned primarily by physicianswho own stock in the company. As of 1990, thecompany owned 42 centers and managed another51centers (222). Furthermore, the independently ownedcenters managed by the company are themselvesowned by physicians.

Financial inducements are not the only mecha-nisms by which providers may stimulate referrals.Hospitals, for instance, may offer physicians gratui-ties such as free office space in exchange for therelocation of the physician’s practice to that hospital(383). The OIG study found that 8 percent ofphysicians billing Medicare receive nonfinancialcompensation in exchange for patient referrals, suchas office space rental agreements, employee arrange-ments, and management service contracts (383).

Inducements can be negative as well as positive.Hospitals that own HHAs, for example, may pres-sure physicians with hospital admitting privileges torefer their patients to the hospital’s agency ratherthan to alternative sources of care.

Any business arrangement by which the physicianreceives financial compensation for the patients heor she refers to another provider raises both ethicaland legal issues. Opponents to such arrangementshave argued that they involve an inherent andunnecessary conflict between the physician’s re-sponsibility for the patient’s well-being and his orher interest in financial reward (279,280). The

conflicts of interest may be especially strong if thephysician’s financial interest in the referral is notdisclosed to the patient (279,280).

There is some evidence that physician ownershipof health facilities is related to higher use of thosefacilities’ services. Government studies of diagnos-tic imaging centers and clinical laboratories ownedby referring physicians have reported that thesefacilities performed more tests, and the referringphysicians ordered more tests, than comparablephysicians and independently owned facilities (356,383). A study of primary care physicians who ownedtheir own radiology equipment likewise found thatpatients were at least four times as likely to havediagnostic imaging done if the patient’s prescribingphysician was self-referring, and charges for theseprocedures were often relatively high as well (157).

A recent study of physician-owned facilities inFlorida found that results varied somewhat depend-ing on the type of facility (321). This study found themost problems with clinical laboratories, diagnosticimaging centers, and physical therapy/rehabilitationcenters. Physician-owned facilities in these catego-ries had clearly increased costs, charges, and/orutilization, or were associated with greater access orquality problems, compared with comparable facilit-ies. The report was not able to draw clear conclu-sions regarding problems with the other four types offacilities studied (ambulatory surgical centers, DMEsuppliers, HHAs, and radiation therapy centers).HDIT providers were not specifically examined inthiS study.

There is little consensus among physician associ-ations regarding the acceptability of different owner-ship and other financial arrangements. The AMA,for example, holds that physician ownership ofhealth facilities is both ethical and acceptable (13).The American College of Surgeons and the Ameri-can College of Radiology takes the position thatself-referrals are potentially unethical and generallynot in the best interest of the patients (9). Thestrongest position on physician ownership has beentaken by the Committee on Implications of For-Profit Enterprise in Health Care (drawn from thecouncils of the National Academy of Sciences, theNational Academy of Engineering, and the Instituteof Medicine), which regarded it as unethical and

g Such armngements are not limited to home infusion therapy; for example, hospitals suffering great f~cial losses have offered physicianscompensation disguised as “consulting fees” in order to reeruit staff physicirms (383).


unacceptable for physicians to have ownershipinterests in health care facilities to which they makereferrals or to receive payments for making referrals(137). The committee recommended the use ofphysician compensation systems that break the linkbetween the decisions physicians make in treatingtheir patients and the rate of return they earn oninvestments in their medical practice.

In some circumstances, compensation for refer-rals is illegal. The Medicare and Medicaid Antikick-back regulations prohibit offering, soliciting, pay-ing, or receiving any remuneration, whether directorindirect, for:

● referring an individual to a provider for thereceipt of an item or service that is covered byMedicare or Medicaid; or

. purchasing, leasing, or ordering any item orservice that is covered by Medicare or Medic-aid.

Under the antikickback law, it is not only unethi-cal but illegal for physicians to refer Medicare orMedicaid patients to a health care facility inexchange for remuneration. This provision has beenupheld stringently by the courts. In a 1989 appealscourt decision, the court found that the antikickbackstatute is violated unless payments are ‘‘wholly andnot incidently attributable to the delivery of goodsand services. ” (U.S. v. Kats [871 F.2d 105, 9th Cir.1989]).

In contrast, it is not illegal under present statutes10

for physicians to invest in most kinds of health care

centers and refer their patients to those centers.Certain types of facilities have been singled out,however. The Omnibus Budget Reconciliation Actof 1989 (public Law 101-239) prohibits physicianswho own or invest in clinical laboratories fromreferring Medicare patients to these facilities forlaboratory testing.

11 The repealed MCCA wouldhave prohibited payment for HDIT services pro-vided by a company in which the physician orderingthe services had a financial interest. (This prohibi-tion was repealed along with the act.)

Despite its potential for abuse, physician owner-ship of health facilities may sometimes be not onlyacceptable but desirable. In some places, for exam-ple, a physician-owned health care unit maybe theonly such unit available; prohibiting payment forthese services could be a barrier to basic access ofhealth care.

Although ownership of HDIT providers was thefocus of concern under the MCCA, drug infusiontherapy services provided through a physician’s ownoffice may be at least as widespread a phenomenon.Banning this practice is tantamount to banning thedispensing of drugs in a physician’s office andaffects not only the physician’s freedom to invest atwill but his or her freedom to enter into certain kindsof personal practice. Ownership in both HDITcompanies and office-based provision of HDIT raisesimilar concerns regarding referrals. Office-basedinfusion therapy raises a broad range of other issuesas well, however, and policymakers may wish todistinguish between the two.

1° 42 U.S.C. 1395nn(b)11 ~ ~mvision took effect on JZUI~ 1* 1992.

APPENDlXES

Appendix A

METHOD OF THE STUDY

History of the ProjectThe origins of this study lie in the passage of the

Medicare Catastrophic Coverage Act of 1988 and itssubsequent repeal in 1989. As part of a broad coverageexpansion that would have extended Medicare coverageto outpatient prescription drugs, that act would haveresulted in greater coverage of outpatient immunosup-pressive drugs (now limited to coverage for only 1 year),and it would have established a home intravenous drugtherapy benefit. With the repeal of that act, these two morespecific coverage expansions once again became issuesbefore Congress.

In April of 1990, the Senate Committee on Financeasked the Office of Technology Assessment (OTA) torevisit these two topics and the relevant coverage andpayment issues they involve. The proposed assessmentwas approved by OTA's congressional TechnologyAssessment Board in June 1990 and begun the followingmonth. The assessment was conducted in two partsleading to two separate reports, one on immunosuppres-sive drugs and one on home intravenous drugs and otherdrugs infused at home.

Conduct of the Home Drug Infusion Therapy(HDIT) Study

During the fall of 1990 and the frost 6 months of 1991,OTA staff reviewed the literature on HDIT and inter-viewed experts in home care, medicine, intravenousnursing, clinical pharmacy, and infusion equipmentmanufacturing. Project staff also met several times withindividuals at the Health Care Financing Administrationto learn from their experience with HDIT coverage afterthe Medicare Catastrophic Coverage Act, and withseveral private insurance company representatives re-garding the experiences of private payers with HDIT.

In the course of the interviews and literature review, itbecame clear that objective and detailed information onmany aspects of HDIT was incomplete or lacking entirely.To gain a more comprehensive understanding of thetherapy and the industry that provides it, OTA made anumber of site visits to providers. The organizationsvisited included a spectrum of hospital-, pharmacy-, homehealth agency-, and specialty-company-basecl HDIT pro-grams. A list of these organizations appears at the end ofthis appendix. In addition, staff met with providerrepresentatives at OTA and held extensive telephoneinterviews. OTA staff also met with individuals from

organizations that include HDIT providers among theirmembers.

OTA also requested detailed data on such aspects asprovider structure and summary patient information fromthe providers contacted. Few providers were able tosupply these data, lending insights into the informationdifficulties a Medicare policy might face.

Most major OTA studies have a panel of outsideexperts chosen to advise OTA staff on the study andensure that all significant points of view are represented.This study was originally intended to be performed incoordination with an ongoing study of drug research anddevelopment, with the same advisory panel. It transpired,however, that the two studies had little directly incommon, and the advisory panel for the earlier studyproved inappropriate for the existing study. Because ofthe short timeframe anticipated for this study, it alsoproved infeasible to appoint a separate advisory panel atthe point for the current study.

To ensure that sufficient expert advise was obtainedand that all viewpoints were represented, OTA staff tookgreat care to involve a variety of outside persons in thereview of the draft material. A preliminary draft was sentto nearly 100 experts in the field, including HDITproviders, manufacturers, health professional and patientorganizations, health care payers, researchers, and otherswith interest and knowledge in the area of HDIT for theirreview and comment. Fifteen representatives of the majororganizations concerned with HDIT met at OTA for apublic discussion of the draft on September 10, 1991 (seep. v of this report). The final draft, incorporating revisionsbased on reviewers’ comments and discussion at thepublic meeting, was transmitted to the TechnologyAssessment Board in October 1991.

Contractors providing material to OTA for this studywere:

Julia T. Ostrowsky, Chicago, IL, survey of MedicarePart B carriers regarding coverage of and payment fordrugs used in infusion pumps under the durable medicalequipment (DME) benefit, conducted February 1991.

Thomas W. Grannemann, Lexington, MA, “Incentivesand Behavioral Responses to Alternative Payment Meth-ods for Home Intravenous and Immunosuppressive DrugTherapies Under the Medicare Program,” prepared undercontract to the Office of Technology Assessment, Febru-ary 1991.

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OTA Site Visits to HDIT ProvidersAnne Arundel General Hospital Outpatient IV Therapy

Services ProgramAnnapolis, MDNovember 1990

CaremarkColumbia, MDAugust 21, 1990

Handmaker Home Health Services, Inc.Tucson, AZMay 2, 1991

Infusion CareColumbia, MDAugust 2,1990

Jefferson County Department of HealthBirmingham, ALNovember 1, 1990

HMSS, Inc..Phoenix, AZMay 3, 1991

New England Critical CareColumbia, MDAugust 21, 1990

Jefferson (Hospital) Home Infusion ServicePhiladelphia, PASeptember 20, 1990

University Medical Center Home Health Services, Inc.Tucson, AZMay 2, 1991

Vital Care, Inc.Livingston, ALNovember 2, 1990

Visiting Nurses Association of WashingtonWashington, DCFebruary 4, 1991

Provider Visits to OTA

ABEL Health Management Services, Inc.November 9, 1990

Arlington Cancer CenterApril 25, 1991

Kimberly Quality CareJanuary 23, 1991

Appendix B

ACKNOWLEDGMENTS

This report was greatly aided by the assistance of many individuals who provided OTA staff with information andadvice over the course of the study. OTA extends particular thanks to those persons who participated in the workshopdiscussion of the draft report (see inside front cover) and to the following individuals. (These individuals do notnecessarily either agree or disagree with the findings and conclusions of this report. OTA assumes full responsibility forthe report and the accuracy of its contents.)

Ed AbelABEL Health Management Services, Inc.Great Neck, NY

Carol AndersonAmerican Association of Blood BanksArlington, VA

Tess AngelesPerivascular Nurse ConsultantsRockledge, PA

Teri BairJohnson & GibbsDallas, TX

Joseph BakerCHAMPUSAurora, CO

Paul BarberAmerican Association of Blood BanksArlington, VA

Ira BatesNational Hospice OrganizationAlexandria, VA

Katherine BennettAdvanced Metabolic Systems, Inc.Washington, DC

Dale BenzineT2 Medical, Inc.Alpharetta, GA

Douglas BerchardUniversity of TennesseeChattanooga, TN

Beverly BlackAmerican Society of Hospital PharmacistsBethesda, MD

Flora BlackledgeJefferson County Department of HealthBirmingham, AL

Donald BlairState University of New YorkSyracuse, NY

Marvin BlitzEmpire Blue Cross Blue ShieldNew York, NY

Lori BodenheimerNational Capitol Area Blue Cross and Blue ShieldWashington, DC

Patricia BoothChevy Chase, MD

Diane BoyerVNA of WashingtonWashington, DC

Lisanne BradleyHealth Care Financing AdministrationRockville, MD

Anne BurdenVNA of WashingtonWashington, DC

Bart ClarkNational Association of Boards of PharmacyPark Ridge, IL

Brian CrawfordVital Care, Inc.Livingston, AL

Sam DellavecchiaHealth Care Financing AdministrationBaltimore, MD

Joanna DixonNational League for NursingNew York, NY

Bill DombiNational Association of Home CareWashington, DC

Burton DunlopProject HOPEChevy Chase, MD

Robert ErnstHome Infusion ServicesPittsburgh, PA

- 1 5 7 -


Chuck FaxonSun Belt PharmacareSan Antonio, Tx

Lorraine FerryUniversal Management Systems, Inc.Newton Square, PA

Ruth GaltenNational Association for Home CareWashington, DC

John GansAmerican Pharmaceutical AssociationWashington, DC

Irene GibsonHealth Care Financing AdministrationBaltimore, MD

Jade GongAmerican Health Care AssociationWashington, DC

Sarah GreggBaxter Healthcare Corp.Washington, DC

Stuart GutermanProspective Payment Assessment CommissionWashington, DC

Lynn HadawayMenlo Care, Inc.Menlo Park, CA

Susanne HardingInfections Limited, P.S.Tacoma, WA

David HigbeeHealth Care Financing AdministrationBaltimore, MD

Jimmy HindmanVital CareLivingston, AL

Tom HoyerHealth Care Financing AdministrationBaltimore, MD

Charlotte HughesOlsten Health CareTampa, FL

Brian HypsAmerican Pharmaceutical AssociationWashington, DC

Sam JamopolisArlington Cancer CenterArlington, TX

Craig JeffriesHealth Industry Distributors AssociationAlexandria, VA

Christian KhungBlue Cross Blue Shield of MassachusettsNorth Quincy, MA

Chris KozmaUniversity of South CarolinaColumbia, SC

Milt LehmanParenteral Alimentation Providers Association, Inc.Larkspur, CA

Keith LindNational Alliance for Infusion TherapyWashington, DC

Sue MasoorliPerivascular Nurse ConsultantsGaithersburg, MD

Mary MonkUniversity of MississippiUniversity, MS

W. Steven MurrayHealthcare Solutions, Inc.Torrance, CA

Donna NemerArizona Blue Cross and Blue ShieldPhoenix, AZ

Marsha NusgartHealth Industry Manufacturers AssociationWashington, DC

Helayne O’KeiffBarnes Home Health AgencySt. Louis, MO

Karen PaceNational Association for Home CareWashington, DC

Alan ParverNational Alliance for Infusion TherapyWashington, DC

Jere PaulmenoIVION Corp.Denver, CO

Daniel PaxtonCystic Fibrosis FoundationBethesda, MD

Raymond PontzerHome Infusion ServicesPittsburgh, PA

Appendix B-Acknowledgments . 159

Lt. Col. Maureen Potter John SwensonCHAMPUS Valley Medical CenterAurora, CO Renton, WA

Michael Prime Brian SwiftO.P.T.I.O.N. Care, Inc. Jefferson Home Infusion ServiceChico, CA Philadelphia, PATimothy Redmon Keven ThompsonNational Association of Retail Druggist National Capitol Area Blue Cross and Blue ShieldAlexandria, VA Washington, DCSteve RichardsMinnesota Blue ShieldSt. Paul, MN

Sharon RiserPerivascular Nurse ConsultantsGaithersburg, MD

Karen Snow RizzoUMC Home Health Services, Inc.Tucson, Arizona

Anne RooneyJoint Commission on Accreditation of Healthcare

OrganizationsOakbrook Terrace, IL

James ToddAmerican Medical AssociationChicago, IL

Tim Vanderveen

San Diego, CA

Jolee VerbekePharmacia Deltec, Inc.St. Paul, MN

Paul VitaleAnne Arundel Medical CenterAnnapolis, MD

William Saunders Mary WeickHealth Care Financing Administration Food and Drug AdministrationBaltimore, MD Rockville, MDJane SiskDobbs Ferry, NY

Stan WyremskiABEL Health Management Services, Inc.

William Slattery Great Neck, NYABEL Health Management Services, Inc.New York, NY

Robert ZoneEquicor

Susan Slaughter Nashville, TN

San Diego, CA

OTA also acknowledges the assistance of individuals from the following organizations, without whom the surveyof carrier policy would not have been possible:

Aetna-Arizona and Nevada Arkansas Blue Cross and Blue ShieldPhoenix, AZ Little Rock, AR

Aetna Georgia Indiana Blue ShieldDowner’s Grove, IL Indianapolis, IN

Aetna—Hawaii Blue Cross and Blue Shield of Arkansas-LouisianaHonolulu, HI Baton Rouge, LA

Aetna-New Mexico/Oklahoma Blue Cross and Blue Shield of ColoradoAlbuquerque, NM Denver, CO

Aetna-Oregon and Alaska Blue Cross and Blue Shield of IllinoisPortland, OR Chicago, IL

Alabama Blue Shield Blue Cross and Blue Shield of Kansas CityBirmin gham, AL Kansas City, MO


Blue Cross and Blue Shield of MichiganDetroit, MI

Blue Cross and Blue Shield of MontanaHelena, MT

Blue Cross and Blue Shield of North Dakota/WyomingFargo, ND

Blue Shield of Rhode IslandProvidence, RI

Blue Shield of Western New YorkBinghamton, NY

California Blue ShieldSan Francisco, CA

Empire Blue ShieldNew York, NY

Equicor-MahoBoise, ID

Equicor North CarolinaGreensboro, NC

Equicor TennesseeNashville, TN

Florida Blue ShieldJacksonville, FL

General American Life Insurance Co.St. Louis, MO

Group Health IncorporatedNew York, NY

Iowa Blue ShieldDes Moines, IA

Kansas/Nebraska Blue ShieldTopeka, KS

Kentucky Blue ShieldLexington, KY

King County Medical Blue ShieldSeattle, WA

Maryland Blue Cross and Blue ShieldTimonium, MD

Massachusetts Blue Cross and Blue ShieldBoston, MA

Minnesota Blue ShieldSt. Paul, MN

Nationwide Insurance Co.Columbus, OH

Pennsylvania Blue Shield—New JerseyLawrenceville, NJ

South Carolina Blue ShieldColumbia, SC

Texas Blue ShieldDallas, TX

Transamerica Occidental Life Insurance Co.Los Angeles, CA

Travelers of ConnecticutHartford, CT

Travelers of MinnesotaBloomington, MN

Travelers of MississippiJackson, MS

Travelers of VirginiaRichmond, VA

Utah Blue ShieldSalt Lake City, UT

Wisconsin Physicians’ ServiceMadison, WI

Appendix C

HOME INTRAVENOUS DRUG THERAPY: PROPOSED REGULATIONSUNDER THE MEDICARE CATASTROPHIC COVERAGE ACT

The Medicare Catastrophic Coverage Act of 1988(Public Law 100-360) included a new Medicare benefitthat would have covered home intravenous drug therapy.The act, and the benefit, were repealed the following year.Shortly before the repeal, however, the Health CareFinancing Administration (HCFA) had published pro-posed regulations to implement this new benefit. Al-though the proposed rules were never made final, theygenerated considerable comment from the industry, andthey represent a potential baseline against which anyfuture related policies can be compared.

The remainder of this appendix presents exerpts fromthe Federal Register that relate to coverage and paymentfor home intravenous drug therapy. Exerpts are ordered asfollows:

●

●

●

●

●

list of covered home intravenous drugs (54 F.R.37239, Sept. 7, 1989);payment for covered outpatient drugs (54 F.R.37208, Sept. 7, 1989);coverage of home intravenous drug therapy services(54 F.R. 37422, Sept. 8, 1989);payment for home intravenous drug therapy services(54 F.R. 46938, NOV. 8, 1989); andconditions of participation for home intravenousdrug therapy providers (54 F.R. 37220, Sept. 7,1989).

Specific relevant sections and paragraphs are exerptedverbatim (including abbreviations), but sections omittedare not explicitly indicated. Headings and some sectionshave been reformatted for publication purposes in thisreport.

List of Covered Home IV Drugs (54 F.R. 37239)This notice sets forth a list of intravenous drugs that we

[HCFA] propose to cover on the basis that they can besafely and effectively administered in the home. Thenotice would implement section 1861(t)(4) of the SocialSecurity Act as added by section 202(a) of the MedicareCatastrophic Coverage act of 1988.

Home IV CoverageSection 202(a) of Pub. L. [Public Law] 100-360

amended sections 1861(s)(2)(J) and (t) of the Act toprovide general coverage for outpatient prescriptiondrugs under Part B and to authorize Part B coverage ofhome IV drugs. In addition, section 203 of Pub. L.100-360 added sections 1861(jj), 1834(d) and 1835(a)(2)(G)to the Act and amended other related sections to authorize

coverage of home IV therapy services. For purposes ofthis new home IV benefit, under new section 1861(t)(4)(B)of the Act, we are required to publish, by January 1, 1990and periodically thereafter, a list of covered home IVdrugs, and their indications, that can be safely andeffectively administered in the home.

It is this list of drugs that we are addressing in thisproposed notice. Proposed rules setting forth regulationsto implement the various other provisions of Pub. L.100-360 dealing with the outpatient prescription andhome IV drug benefits will be published in separatedocuments as follows:

●

●

●

Overall coverage of outpatient prescription drugs(including drugs used in immunusuppressive ther-apy and home IV drugs).Payment methodology for covered outpatient pre-scription drugs (which will apply also to coveredhome IV drugs).Coverage of home IV drug therapy services.Conditions of participation for home TV drug therapyproviders.Fee schedule for home IV drug therapy services.Deductible and coinsurance amounts and the Part Bcap on out-of-pocket expenses.Participating pharmacies.Drug bill processors.Coverage of catastrophic Part B expenses, outpatientdrug expenses, and respite care benefits for benefici-aries enrolled in pre-pay health plans, such as healthmaintenance organizations.

The statute provides specific definitions of “coveredoutpatient prescription drugs” and of what constitutes‘‘covered home IV drugs. In order to be a covered homeIV drug, the drug must first qualify as a covered outpatientprescription drug as described below.

Section 202(a) of Pub. L. 100-360 amended sections1861(s)(2)(J) and (t) of the Act by establishing thefollowing definition of a “covered outpatient drug,”which includes drugs, biological products, and insulin.

Drugs-A drug that may be dispensed only uponprescription and that meets one of the following require-ments:

The drug is approved for safety and effectiveness asa prescription drug under sections 505 or 507 of theFFDCA [Federal Food, Drug, and Cosmetic Act], orapproved under section 505(j) of the FFDCA.

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. The drug was commercially used or sold in theUnited States before the date of enactment of theDrug Amendments of 1%2 (October 10, 1%2) or itis identical, similar or related to such a drug, asdefined by 21 CFR 310.6(b)(l). Nevertheless, sucha drug will not be covered if the Secretary has madea final determination that it is a “new drug’ and hasnot been approved under sections 505 or 507 of theFFDCA, or if it is subject to certain actions broughtby the Secretary to enforce provisions of sections502(f), or 505(a) of the FFDCA (21 U.S.C. 352(f), or355(a)).

. The drug is described in section 107(c)(3) of theDrug Amendments of 1962 and is one for which theSecretary has determined there is compelling justifi-cation for its medical need, or it is identical, similar,or related to such a drug. Also, the drug must be onefor which the Secretary has not issued a notice towithdraw approval for marketing, because the Secre-tary has determined that the drug is less thaneffective for all conditions of use represented,recommended, or suggested on its labeling. Theseare the ‘‘DESI’ [Drug Efficacy Study Implementa-tion] drugs.

Biological products—A biological product is consid-ered a “covered outpatient drug” if it is one that may bedispensed only upon prescription, is licensed undersection 351 of the PHS [Public Health Service] Act (42U.S.C. 262), and is produced at an establishment licensedunder that Act to produce that product.

Insulin—Insulin is covered if it is certified undersection 506 of the FFDCA (21 U.S.C. 356) for thestrength, quality, and purity necessary to ensure adequatesafety and efficacy of use. In accordance with section1861(t)(2)(C) of the Act, as amended by Pub. L. 100-360,insulin would be considered a “covered outpatient drug”whether or not it is dispensed under a prescription.

In addition, section 202(a)(2)(C) of Pub. L. 100-360added sections 1861(t)(4)(A) and (B) to the Act to define“covered home IV drugs” as covered outpatient drugsthat are intravenously administered to individuals inplaces of residence that are used as the individuals’homes. The definition includes:

Antibiotic drugs unless the Secretary has deter-mined, for a specific drug or for the indication forwhich it is applied, that the drug cannot generally beadministered safely and effectively in a homesetting; andDrugs that are not antibiotics, but only if theSecretary has determined that for a specific drug andthe indications for which the drug is being appliedthat it can generally be administered safely andeffectively in a home setting.

Process Followed in Compiling the Drug List

Description of the Process-As noted above, section202(a)(2)(C) of Pub.L. 100-360 added section 1861(t)(4)(B)to the Act to require us to develop a list of covered homeIV drugs by January 1, 1990. These drugs must meetdefinitions of a “covered outpatient drug” set forth innew sections 18 61(t)(2) and (2) or the Act and of a“covered home IV drug” set forth in new section1861(t)(4)(A) of the Act.

Our task with respect to putting together a proposed listof covered home IV drugs has been twofold. First, we hadto compile a list of IV drugs (both antibiotics andnon-antibiotics) and their indications. Second, in accor-dance with section 1861(t)(4) of the Act, we had toidentify from that list those IV drugs that are safe andeffective for use in the home. In accordance with section1861(t)(4)(A)(ii) of the Act, our rules for includingantibiotics and non-antibiotics differed. We obtainedinformation about IV drugs based on the followingcategories:

. Antibiotic IV drugs, and indications for which eachdrug is applied, that can generally be safely andeffectively administered in the home.

. Non-antibiotic IV drugs, and indications for whicheach drug is applied, that can generally be safely andeffectively administered in the home. We separatedthis category into the following groups:—Anti-infectives (other than antibiotics);—Hydration therapy;—Pain management drugs;—Antineoplastic drugs; and-Other drugs.

In determining which drugs may be administeredintravenously, we obtained the following lists from theFDA:

●

●

●

All IV drugs that are currently approved by the FDAfor marketing,DESI drugs, [and]“Compliance Report for DESI-2,” also referred toas the “B List” of unapproved drugs that arecurrently marketed.

The drugs that we considered for our proposed list hadto meet the statutory definition of “covered outpatientdrug” and can be found on one of these FDA generatedlists. Before we reviewed a specific drug for possibleinclusion as a “covered home IV drug,” the drug had tomeet this initial requirement, as set forth in section1861(t) of the Act.

In listing the drugs, we decided to place together in onelist all those drugs, both antibiotics and non-antibiotics,that we initially propose as being covered. We believesetting forth a comprehensive list of covered drugs for

Appendix C-Home lntravenous Drug Therapy:Proposed Regulations Under the Medicare Catastrophic CoverageAct ● 163

purposes of rulemaking will make it easier for the publicto direct their comments appropriately to a specificallynamed drug or indication, as opposed to our solicitingcomments on those antibiotics and their indications thatwe propose not to cover. As discussed below, weencountered special problems with unlabeled indicationsfor antibiotics in this regard. Therefore, [Table C-1] to thisnotice contains a list of drugs and indications that wepropose to cover. [Table C-2] contains a list of antibioticsand indications that we propose not to cover.

We want to emphasize that we do not have thediscretion under the home IV drug benefit to pay for adrug or an indication that is not on the final list. Section1861(t)(4)(A) of the Act, as added be section 202(a) ofPub. L. 100-360, limits coverage of home IV drugs tothose drugs that the Secretary has determined are safe andeffective for use in the home. Any drug or indication notaddressed on the final list to be published after weconsider and evaluate public comments on the attachedproposed list, or any drug or indication not included in asubsequent update, would not meet this requirement andpayment would not be made for that drug or indication.

To obtain advice in determining whether an IV drugshould be included in our proposed list of IV drugs asbeing safe and effective for use in the home, we contactedthe following organizations:

. The U.S. Pharmacopoeia (UPS).

. The American Society of Hospital Pharmacists(ASHP).

. The American Medical Association (AMA).● Various home IV providers (recognized in he field of

home IV therapy).● The pharmaceutical Manufacturers Association.● Various drug manufacturers.

We requested that these sources submit a list of IVdrugs that, in their opinion, could generally be safely andeffectively administered in the home, and, in addition, anyother information they thought pertinent. Although all ofthe organizations we contacted did not respond withrecommendations about drugs suitable for home use, wedid receive specific recommendations based on reviewsby advisory panels, medical and clinical evidence tosupport inclusion of certain drugs, lists of IV drugs thatare currently being administered in the home setting, andrecommendations for exclusions.

In addition, we contacted the publishers of the follow-ing compendia:

United States Pharmacopoeia Dispensing Informa-tion, Volume 1 (Drug Information for the HealthCare Professional)(USP DI);American Medical Association’s Drug Evaluations(AMADE): and

. American Hospital Formulary Service Drug Infor-mation (AHFS DI).

Based on the information we received from all of thesesources, we constructed an initial list of IV drugs that weconsidered for inclusion on the proposed list as being safeand effective for home use. (At this point, the list includedcertain antineoplastic drugs but did not include 12 of theantibiotic drugs that were included on the master list of IVdrugs submitted to us by the FDA. For reasons discussedbelow, neither of these groups of drugs is included in[table C-l].) We then obtained form the FDA the labeledindications for these drugs.

For the purpose of determining unlabeled uses ofapproved drugs, we relied on the information provided bythe three compendia and the suggestions of the varioushome IV providers.

Having put together the list of IV drugs and indications,we then submitted it to health care professionals recom-mended to us by the Intravenous Nurses Society and theAMA [American Medical Association]. We requestedthat these individuals examine the list from a clinicalperspective and we received several clinical recommen-dations.

As noted earlier, our rules for including antibiotic andnon-antibiotic drugs on the proposed list have differed.The law requires the Secretary to coverall antibiotic drugsunless the Secretary makes the determination that aspecific antibiotic cannot generally be administeredsafely and effectively in the home. The list of IV drugs weinitially obtained from the FDA included identification ofall IV antibiotic drugs that are currently available on themarket. Of those antibiotic drugs, there were 12 antibiot-ics that we are proposing as not generally being safe andeffective for use in the home.

It is our understanding that the following factors mayprevent these 12 drugs that we propose for exclusion frombeing safe or effective when administered in the homesetting:

. Potential serious or life-threatening side effects;● Stringent monitoring requirements that could not

effectively be performed in the home setting; and. Stability limitations.

We list these 12 antibiotics below and specificallysolicit comments and information about these drugs andtheir indications that might be relevant to a finaldetermination about their suitability for use in the home.The drugs are:

1. Chloramphenicol sodium succinate2. Colistimethate sodium3. Doxycycline hyclate4. Erythromycin gluceptate5. Ervthromvcin lactobionate


Table C-l—Proposed List of Covered Home IV Drugs and Indications

Approved drug/Approved conditions

AntibioticsAmdinocillin

Urinary tract infections,bacterial

Amikacin sulfateBone and joint infectionsEndocarditis, bacteriaGenitourinary tract infectionsSkin and soft-tissue infectionUrinary tract infections, bacterial

Ampicillin sodiumArthritis, gonococcalBone and joint infectionsEndocarditis, bacterialEntercolitis, “Shigella”Genitourinary tract infectionsGonorrhea“Hemophilus” infectionsListeriosisParatyphoid feverSkin and soft-tissue infectionsUrethritis, gonococcal

Ampicillin sodium and sulbactam sodiumBone and joint infectionsEndocarditis, bacterialGenitourinary tract injectionsSkin and skin structure infections

Azlocillin sodiumBone and joint infectionsEndocarditis, bacterialSkin and skin structure infectionsUrinary tract infections, bacterial

AztreonamBone and joint infectionsEndocarditis, bacterialGenitourinary tract infectionsSkin and skin structure infectionsUrinary tract infections, bacterialCarbenicillin DisodiumGenitourinary tract infectionsSkin and soft-tissue infectionsUrinary tract infections, bacterial

Cafamandole nafateBone and joint infectionsEndocarditis, bacterialGenitourinary tract infectionsSkin and skin structure infectionsUrinary tract infections, bacterial

Cefonicid sodiumBone and joint infectionsEndocarditis, bacterialGenitourinary tract infectionsSkin and skin structure infectionsUrinary tract infections, bacterial

Cefoperazone sodiumBone and joint infectionsEndocarditis, bacterialGenitourinary tract infectionsSkin and skin structure infectionsUrinary tract infections, bacterial

CeforanideBone and joint infectionsEndocarditis, bacterialGenitourinary tract infections

Approved drug/Approved conditions

Skin and skin structure infectionsUrinary tract infections, bacterial

Cefotaxime sodiumBone and joint infectionsEndocarditis, bacterialGenitourinary tract infectionsSkin and skin structure infectionsUrinary tract infections, bacterial

Cefotetan disodiumBone and joint infectionsEndocarditis, bacterialGenitourinary tract infectionsSkin and skin structure infectionsUrinary tract infections, bacterial

Cefoxitin sodiumBone and joint infectionsEndocarditis, bacterialGenitourinary tract infectionsSkin and skin structure infectionsUrinary tract infections, bacterial

CeftazidimeBone and joint infectionsEndocarditis, bacterialGenitourinary tract infectionsSkin and skin structure infectionsUrinary tract infections, bacterial

Ceftizoxime sodiumBone and joint infectionsEndocarditis, bacterialGenitourinary tract infectionsSkin and skin structure infectionsUrinary tract infections, bacterial

Ceftriaxone sodiumBone and joint infectionsEndocarditis, bacterialGenitourinary tract infectionsSkin and skin structure infectionsUrinary tract infections, bacterialLyme Disease, joint and Central Nervous System (CNS)

Cefuroxime sodiumBone and joint infectionsEndocarditis, bacterialGenitourinary tract infectionsSkin and skin structure infectionsUrinary tract infections, bacterialGonorrhea

Cephalothin sodiumBone and joint infectionsEndocarditis, bacterialGenitourinary tract infectionsSkin and soft tissue infectionsUrinary tract infections, bacterial

Cephapirin sodiumBone and joint infectionsEndocarditis, bacterialGenitourinary tract infectionsSkin and skin structure infectionsUrinary tract infections, bacterial

CephradineBone and joint infectionsEndocarditis, bacterialGenitourinary tract infectionsSkin and skin structure infectionsUrinary tract infections, bacterial

Appendix C-Home lntravenous DrugTherapy: Proposed Regulations Under the Medicare Catastrophic Coverage Act . 165

Table C-l—Proposed List of Covered Home IV Drugs and Indications-Continued

Approved drug/Approved renditions Approved drug/Approved conditions

Clindarnycin phosphateBone and joint infectionsGenitourinary tract infectionsSkin and soft tissue infectionsGentamicin sulfateBone and joint infectionsEndocarditis, bacterialGenitourinary tract infectionsSkin and skin structure infectionsUrinary tract infections, bacterialListeriosisImipenem and Cilastatin SodiumBone and joint infectionsGenitourinary tract infectionsSkin and skin structure infectionsUrinary tract infections, bacterial

Methicilin sodiumEndocarditis, bacterialSkin and soft tissue infections

Mezlocillin sodiumBone and joint infectionsEndocarditis, bacterialGenitourinary tract infectionsSkin and skin structure infectionsUrinary tract infections, bacterial

MiconazoleCandidiasis, disseminatedCandidiasis, mucocutaneous, chronicPetriellidiosisUrinary bladder infections, fungal

Nafcillin sodiumEndocarditis, bacterialSkin and soft tissue infectionsNetilmicin SulfateBone and joint infectionsEndocarditis, bacterialGenitourinary tract infectionsSkin and skin structure infectionsUrinary tract infections, bacterial

Oxacillin sodiumEndocarditis, bacterialSkin and soft tissue infectionsPenicillin G PotassiumArthritis, gonococcalDiphtheria, prophylaxisEndocarditis, bacterialGenitourinary tract infectionsGingivostornatitis, necrotizingulcerativeListeriosisLyme disease, joint and CNSSyphilis

Penicillin G sodiumArthritis, gonococcalDiphtheria prophylaxisEndocarditis, bacterialGenitourinary tract infectionsGingivostomatitis, necrotizing ulcerativeListenosisLyme disease, joint and CNSSyphilis

Piperacillin sodiumBone and joint infectionsEndocarditis, bacterial

Genitourinary tract infectionsSkin and skin structure infectionsUrinary tract infections, bacterialUrethritis, gonococcal

Ticarcillin disodiumBone and joint infectionsEndocarditis, bacterialGenitourinary tract infectionsSkin and soft tissue infectionsUrinary tract infections, bacterial

Ticarcillin disodium andclavulanate potassium

Bone and joint infectionsEndocarditis, bacterialGenitourinary tract infectionsSkin and skin structure infectionsUrinary tract infections, bacterial

Tobramycin sulfateBone and joint infectionsEndocarditis, bacterialGenitourinary tract infectionsSkin and skin structure infectionsUrinary tract infections, bacterialListenosis

Vancomycin hydrochlorideBone and joint infectionsEndocarditis, bacterial

Non-antibiotic drugsAnti-in fectives (other than antibiotics)Acyclovir sodium

Herpes zosterHerpes simplex

Pentamidine isethionatePneumonia, “Pneumocystis carinii”Leishmaniasis, visceralTryponosomiasis, African

Sulfamethoxazole and trimethoprimBone and joint infectionsChancroidChlamydial infectionsEnterocolitis “Shigella”Genitourinary tract infectionsGonorrhea“Hemophils” infectionsLymphogranuloma venereumParatyphoid feverPneumonia, “Pneumocystis carinii”Rheumatic feverUrinary tract infections, bacterial

Hydration TherapyIntravenous solutions1. Dextrose in water solutions2. Sodium chloride solutions3. Dextrose/sodium chloride solutions4. Premixed potassium chloride solutions up to concentrations of

40 mEq/Lip

The following limitations apply for all of the above solutions:a concentration of dextrose in any solution is not to exceed

10%.b. concentration of sodium chioride in any solution is not to

exceed 0.9°/0.(continued on next page)


Table C-l—Proposed List of Covered Home IV Drugs and Indications-Continued

Approved drug/Approved conditions Approved drug/Approved conditions

5. premixed electrolyte solutions, containing any combination ofthe following electrolytes in their various salt forms, which arenot intended for parenteral nutrition:

SodiumPotassiumCalciumMagnesiumChloridePhosphate

The caloric content of these solutions is limited to 340 calories.

Electrolytes1. Calcium chloride2. Calcium glumnate3. Calcium glucepate4. Magnesium chloride5. Magnesium sulfate6. Potassium acetate7. Potassium chloride8. Potassium phosphate9. Sodium acetate

10. Sodium bicarbonate11. Sodium chloride12. Sodium phosphate

The indications for drugs in this category are less specific thanfor other drugs. After referring to various clinical tests, we havedetermined that water depletion, and combined water andelectrolyte depletion, can be the result of many disease andnon-disease states, including but not limited to the following:Extrarenal losses1. Gastrointestinal (vomiting, diarrhea, ostomy drainage)2. Skin losses (sweating, burns)3. Lung losses (bronchorrhea)

Renal losses1. Renal disease (chronic renal failure, diuretic phase of acute

renal failure)2. Diuretic excess3. Osmotic diuresis (diabetic glycosuria)4. Mineralcorticoid deficiency (Addison’ s disease, hypoaldoster-

onism)

There may be other instances when a patient needs hydrationtherapy. Patients taking antineoplastic drugs must often behydrated to increase urine output to insure the timely excretion ofthe drug because of its toxic side effects.Pain Management DrugsIndication: for treatment of chronic intractable pain.

Butorphanol tartrateHydromorphone hydrochlorideMeperidine hydrochlorideMorphine sulfate

OtherAminophylline

Asthma, bronchilaBumetanide

EdemaCimetidine hydrochloride

Adenoma, multiple endocrineBleeding, upper gastrointestinalHypersecretory conditions, gastricMastocytosis, systeicPancreatic insufficiencyReflux, gastroesophagelStress-related mucosal damage

Ulcer, duodenalUlcer, gastricZollinger-Ellison syndrome

Deferoxamine mesylateToxicity, iron chronicToxicity, aluminum

Dexamethasone sodium phosphateAdrenocortical insufficiency, chronic primary (Addison’s)Adrenomrtical insufficiency, secondaryAdronogenital syndrome (adrenal hyperplasia, congenital)Anemia, hemolytic, acquired (autoimmune)Anemia, hypoplastic, congenital (erythroid)Anemia, red blood cell (erythroblastopenia)Arthritis, psoriaticArthritis, rheumatoidBowel disease, inflammatory, including colitis, ulcerativeBronchitis, asthmatic, acute or chronicCalcium pyrophosphate deposition disease, acute (pseudogout,

chondrocalcinosis articularis, synovitis, crystal-induced)Carcinoma, breastCarcinoma, prostaticConnective tissue disease, mixedDermatitis, exfoliativeDermitis herpetiformis bullousDermatitis, seborrheic, severeDermatomyositis, systemicDermatoses, inflammatory, severe (Stevens-Johnson

syndrome)Fever, due to malignancyGouty arthritis, acuteHemolysisHypercalcemia associated with neoplasms (or sarcoidosis)Increased cranial pressure due to malignancyLeukemia acute or chronicLupus erythematosus, systemicLymphomas, Hodgkins, or non-HodgkinsMultiple myelomeMycosis fungoidesNausea and vomiting, cancer-chemotherapy inducedPenphigoidPemphigusPolychondritis, relapsingPolymyalgia, rheumaticPolyps, nasalPulmonary disease, chronic obstructive (not controlled with

theophylline and beta-adrenergic agonists)Reiter’s diseaseRheumatic feverRhinitis, allergic, perennial, or seasonal, severeThrombocytopenia secondary in adultsThrombocytopenia purpura, idiopathic, in adultsTrichinosis

Diphenhydramine hydrochlorideNausea and vomitingFamoticineAdenoma, multiple endocrineBleeding, upper gastrointestinalHypersecretory conditions, gastricMastocytosis, systemicPancreatic insufficiencyReflux, gastroesophagealStress-related mucosal damage

Ulcer, duodenalUlcer, gastricZollinger-Ellison syndrome

Appendix C—Home Intravenous Drug Therapy: Proposed Regulations Under the Medicare Catastrophic Coverage Act . 167

Table C-l—Proposed List of Covered Home IV Drugs and indications-Continued

Approved drug/Approved conditions Approved drug/Approved conditions

FurosemideEdemaHeparin Calcium

Heparin sodiumThromboembolism

Hydrocortisone sodium phosphateHydrocortisone sodium succinate

Adrenocortical insufficiency, chronic primary (Addison’s)Adrenocortical insufficiency, secondaryAdrenogenital syndrome (adrenal hyperplasia congenital)Anemia, hemolytic, acquired (autoimmune)Anemia, hypoplastic, congenital (erythroid)Anemia, red blood cell (erythroblastopenia)Arthritis, psoriaticArthritis, rhematoidBowel disease, inflammatory, including colitis, ulcerativeBronchitis, asthmatic, acute or chronicCalcium pyrophosphate deposition disease, acute (pseudogout,

chondrocalcinosis articularis, synovitis, crystal-induced)Carcinoma, breastCarcinoma, prostaticConnective tissue disease, mixedDermatitis, exfoliativeDermatitis, herpetiformus, bulloussDermatitis, seborrheic, severeDermatomyositis, systemicDermatoses, inflammatory, severeEnteritis, regional (Crohn’s disease)Erythema multiform, severeFever, due to malignancyGouty arthritis, acuteHemolysisHypercalcemia associated with neoplasms (or sarcoidosis)Increased cranial pressure, due to malignancyLeukemia, acute or chronicLupus erythematosus, systemicLymphomas, Hodgkin’s or non-Hodgkin’sMultiple myelomaMycosis fungoidesNausea and vomiting, cancer chemotherapy inducedPemphigoidPenphigusPolychondritis, relapsingPolymyalgia, rheumaticPolyps, nasalPulmonary disease, chronic obstructiveReiter’s diseaseRheumatic feverRhinitis, allergic, perennial or seasonal, severeThrombocytopena, secondary, in adultsThrombocytopenia purpura, idiopathic, in adultsTrichinosis

Iron dextranIron deficiency anemia

Leucovorin calciumMethotresate toxicity (antidote to folic acid antagonist)

MannitolPremeditation, cancer chemotherapy

Methylprednisolone sodium succinateAdrenocortical insufficiency, chronic primary (Addison’s)Adrenocortical insufficiency, secondaryAdrenogenital syndrome (adrenal hyperplasia, congenital)Anemia, hemolytic, acquired (autoimmune)Anemia, hypoplastic, congenital (erythroid)Anemia, red blood cell (erythroblastopenia)

Arthritis, psoriaticArthritis, rhematoidBowel disease, inflammatory, including colitis, ulcerativeBronchitis, asthmatic, acute or chronicCalcium pyrophosphate deposition disease, acute (pseudogout,

chondrocalcinosis articularis, synovitis, crystal-induced)Carcinoma, breastCarcinoma, prostaticConnective tissue disease, mixedDermatitis, exfoliativeDermatitis, herpetiformus, bulloussDermatitis, seborrheic, severeDermatomyositis, systemicDermatoses, inflammatory, severeEnteritis, regional (Crohn’s disease)Erythema multiform, severeFever, due to malignancyGouty arthritis, acuteHemolysisHepatitis, chronic activeHepatitis, nonalcoholic, in womenHypercalcemia associated with neoplasms (or sarcoidosis)Increased cranial pressure, due to malignancyLeukemia, acute or chronicLupus erythematosus, systemicLymphomas, Hodgkin’s or non-Hodgkin’sMultiple myelomaMycosis fungoidesNecrosis, hepatic, subacutePemphigoidPenphigusPolychondritis, relapsingPolymyalgia, rheumaticPolyps, nasalPulmonary disease, chronic obstructiveReiter’s diseaseRheumatic feverRhinitis, allergic, perennial or seasonal, severeThrombocytopenia secondary, in adultsThrombocytopenia purpura, idiopathic, in adultsTrichinosis

MetoclopramideGastroparesisNausea and vomiting, cancer chemotherapy inducedPhenytoin SodiumEpilepsyProchlorperazine EdisylateNausea and vomiting

Ranitidine hydrochlorideAdenoma, multiple endocrineBleeding, upper gastrointestinalHypersecretory conditions, gastricMastocytosis, systemicPancreatic insufficiencyReflux, gastroesophagealStress-related mucosal damageUlcer, duodenalUlcer, gastricZollinger-Ellison syndrome

Biologlcals and IndicationsImmune globulin

Immunodeficiency syndromeThrombocytopenic purpur~ idiopathicAlpha-proteinase inhibitor, humanEmphysema panacinar, due to alpha-antitrypsin deficiency


Table C-2—Proposed List of Non-Covered Home IVAntibiotic Drugs and Indications

Antibiotic Drugs NotProposed for Coverage Conditions

Chloramphenicol sodium Biliary tract infectionssuccinate Central nervous system

Colistimethate sodium infectionsDoxycycline hyclate Intra-abdominal infectionsErythromycin glucepate Respiratory tract infectionsErythromycin Iactobionate SepticemiaKanamycin sulfateLincomycin hydrochlorideMinocycline hydrochlorideMoxalactum disodiumOxytetracycline hydrochloridePolymyxin B sulfateTetracycline hydrochloride

6. Kanamycin sulfate7. Lincomycin hydrochloride8. Minocycline hydrochloride9. Moxalactum disodium

10. Oxytetracycline hydrochloride11. Polymyxin B sulfate12. Tetracycline hydrochloride.

In addition, we want to note that, in our administrativeprocess of assembling the list of antibiotic drugs (coveredand noncovered), we believe that we have addressed allantibiotic drugs currently on the market. However, theintroduction of new drugs into the marketplace is anongoing occurrence. In addition, it is not inconceivablethat in our process, we may have inadvertently missed anantibiotic drug. Therefore, we also invite public commentconcerning antibiotics that do not appear in eitherappendix.

For non-antibiotic drugs, the Secretary has to make adetermination that a drug can generally be safely andeffectively administered in the home. Therefore, beforeand IV drug could be placed on Appendix I, we had todevelop evidence from which that determination could bemade. We derived this list based on consultations with theUSP DI and the AHFS DI, providers of home IV therapy,and a review of available medical and scientific informa-tion.

With respect to the antineoplastic drug subcategory, weinitially considered the following drugs for inclusion onthe list:

1.2.3.4.5.6.7.8.

Bleomycin sulfateCyclophosphamideCytarabineDaunorubicin hydrochlorideDiethylstilbestrol diphosphateDoxorubicin hydrochlorideEtoposideFluorouracil

9. Methotrexate sodium10. Mitomycin11. Mitoxantrone hydrochloride12. Streptozocin13. Vinblastine sulfate14. Vincristine sulfate.

Concerns were raised throughout the process of devel-oping and clearing the list about the general safety of thisgroup of drugs when administered intravenously in thehome setting. A review of the drug labels revealed that ofthe 14 drugs in this category, 12 of them had warnings thatspecified that the drug should be administered by or underthe supervision of a qualified physician who is experi-enced in cancer therapy. In addition, several drugs hadadditional warnings that patients should have access to orbe treated in a facility with laboratory and supportiveresources sufficient to monitor drug tolerance. We alsoreviewed the National Institutes of Health (NH) recom-mended guidelines for the ‘‘Handling of ParenteralAntineoplastic Drugs” prepared in collaboration withoncologists, the clinical center pharmacy (within NIH),oncology nurses, and National Cancer Institute staff. Withthese factors to consider, and mindful also of the extensivesafety requirements these factors could necessitate in theconditions of participation for home IV drug providers,we concluded that we are not able to propose, at this time,that these drugs could be safely and effectively adminis-tered intravenously in the home. In order to be consistentwith the approved FDA labeling, we made the decision toremove these drugs from [table C-l]. Because of theconcern about whether antineoplastics are safe for use inthe home, we have decided to seek further advice form thePublic Health Service on this matter. Coverage ofantineoplastic drugs under the home IV therapy benefitwill accordingly be deferred pending receipt of suchadvice.

Use of Compendia—We selected the three compendialisted above as reliable sources for some of the advice andinformation we needed based on the recommendationscontained in the Conference Report accompanying Pub.L. 100-360 (H.R. Report No. 661, 100th Congress, 2dSession 192 (1988)). In the report, the three compendiaare suggested for consideration as references for a relatedpurpose under the new drug benefit, that is, for purposesof the establishment of standards for covered outpatientprescription drugs, as required under the new section1834(c)(5)(B) of the Act (as added by section 202(b)(4)of Pub. L. 100-360). Since Congress recognized thesecompendia as authoritative for one purpose under the newdrug benefit, we believe it is appropriate to rely on themfor a related similar purpose under that benefit.

In addition, the USP DI is sponsored by the USP, andorganization that includes members of schools of medi-cine and pharmacy, State medical and pharmacy associa-tions, national medicine and pharmacy associations. Its


listing of drugs includes virtually all drugs approved inthe United States. The USP DI staff prepare monographsafter a literature search and review of FDA approvedlabeling. (A monograph is an essay or treatise on theavailable data for a specified drug.) These monographsare reviewed by over 300 additional experts, plus manyschools, associations, pharmaceutical companies, andgovernment agencies. They are again reviewed by advi-sory panels until a consensus is developed. Proposedmonographs are then published in the USP DI Review forgeneral public comment before being published in theUSP DI. The USP DI is republished annually with sixsupplements per year and contains individual mono-graphs, most information from the FDA-approved label,and unlabeled uses of approved drugs.

The AHFS DI is sponsored by the American Society ofHospital Pharmacists, which represents 22,000 pharmac-ists. AHFS DI staff prepare monographs after a literaturesearch and review of FDA labeling. These monographsare reviewed by over 300 specialists at the doctoral level,including physicians, pharmacologists, and biochemistsselected form among experts in drug therapy. This reviewprocess continues until a consensus is developed. TheAHFS DI includes individual drug monographs withsome general category statements, full FDA label disclo-sure, and unlabeled uses of approved drugs. The AHFS DIis republished annually with three to four supplements peryear.

The ANA DE is sponsored by the AMA, whichrepresents over 293,000 physicians. The listed drugsinclude all drugs approved by the FDA for use in theUnited States. AMA staff prepare monographs after aliterature search and review of FDA approved labeling.These monographs are reviewed by about 400 consultantsfollowed by approximately 100 designees or members ofthe American Society for Clinical Pharmacology andTherapeutics. The review process continues until aconsensus is developed. The AMA DE includes mostlygeneral statements with truncated drug monographsincluding unlabeled uses of approved drugs. The AMADE has been published every 3 years with updates.However, beginning in late 1989, the AMA plans topublish this copendium annually with quarterly updates.

Description of the List

[Table C-1] consists of IV drugs and their indicationsdivided into three main categories. The categories are:biological, antibiotics and non antibiotics (which isfurther broken down as indicated above into the foursubcategories of drugs, excluding for reasons discussedabove antineoplastic drugs). The list is based on ouranalysis and evaluation of the recommendations andinformation received from the various professional organ-izations that we contacted. [Table C-2 contains a list] of

the antibiotic drugs and indications not proposed forcoverage.

We recognize that there is wide variation in both thetype of drugs included in [table C-1] as well as theindications for these drugs. This is due in part to the factthat the concept of home IV therapy has evolved to treatdiverse types of patients:

Patients who began a course of IV therapy in thehospital that has not been completed, but who arestable enough to no longer require hospitalization.Patients who are terminally ill and require IVtherapy, but whose condition does not warranthospitalization.Other types of patients who require IV therapy but donot require hospitalization.

We are proposing that all candidates for home IVtherapy meet specific selection criteria as outlined in theregulations referred to earlier that deal with coverage ofhome IV drug therapy services and conditions of partici-pation for home IV drug therapy providers.

While many of the drugs on the proposed list can besafely and effectively administered in the home settingand would be covered, such medications are sometimestaken orally. Payment may be denied if a more appropriateroute of administration is available. When deciding thatthe route of administration is appropriate, the Peer ReviewOrganization (PRO) will carefully review to determine ifanother route of administration would be effective (forexample, oral, subcutaneous, etc.). If the PRO makes adetermination that another route would be effective, thePRO would deny payment. (An example might be: aphysician seeking prior approval for the administration ofintravenous Aminophylline.) Payment is made for homeIV therapy only when it is reasonable and necessary andthere is medical justification for its use.

The proposed list includes some very toxic drugs whileother less toxic drugs are excluded. We note, however,that in urging us to include virtually all IV drugs on thelist, some organizations we contacted took the positionthat “a drug is a drug, and a cell is a cell.” Theseorganizations believe a drug that can be administered ina hospital setting can also be administered in the homesetting. We take a different view. There are a variety offactors that we have considered that play a role in thedetermination of whether a drug is safe and effective foruse in the home. These factors include, in addition to theobvious factor of potential serious or life-threatening sideeffects, drug product stability and compatibility charac-teristics, and the need for close patient monitoring.

The variation of indications for each specific drug is areflection of the varying degrees and stages of illnessesthat will be treated in the home setting. We believe that wemust allow flexibility to enable the physician to develop

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a plan of treatment appropriate for the specific medicalcondition of the patient. Nevertheless, we wish to makeclear that the appearance of an indication for a covereddrug on the listing is not intended to imply that theindication is approved under the provisions of theFFDCA.

With respect to the specific working of the indications,because there are different phrases to describe the samedisease states and conditions, there may appear to beinconsistencies in our use of medical terminology whenlisting indications. According to medical professionalsand medical texts, the following terms are examples ofterms that may be used interchangeably:

. Genitourinary infections with gynecological infec-tions; and

. Skin and soft-tissue infections with skin and skinstructure infections.

Also, there may be times when a specific indicationcould be considered as a subset of a larger classification.Examples of these would include:

● Cystitis as part of urinary tract infections; and. Gonorrhea as part of genitourinary infections.

Such indications may have been listed separately inAppendix I because that is the way they appeared in therecommendations that we received. In addition, becausethe practice of medicine is dynamic, it would not befeasible to list all indications, either labeled or unlabeled,that are not suitable for treatment in the home. For thisreason, we have listed the indications for each drug thatcan generally be treated safely and effectively in thehome. The following indications are proposed for exclu-sion for all intravenous antibiotics because it is ourunderstanding that the seriousness of the conditionrequires hospitalization.

1.2.3.4.5.

Biliary tract infections.Central nervous system infections.Intra-abdominal infections.Respiratory tract infections.Septicemia.

Furthermore, specific labeled indications for certaindrugs have been excluded because it is our understandingthat they could not be safely and effectively treatedintravenously in the home.

One of our proposed subcategories is “hydrationtherapy.’ For our purposes and purposes of home IVtherapy, the term is defined as the replacement of fluidsor electrolytes, or both, in the human body when thephysiologic and homeostatic mechanisms, which nor-mally preserve their balance, fail as a result of illness ordisease.

Most of the drugs that appear on the proposed list havespecific dosages or dose ranges and are given at specifictime intervals. For example, Cimetidine, used for hy-persecretory conditions has a recommended dosing sched-ule of 300 mg administered intravenously every 6-8hours. In comparison, for hydration therapy purposes, aphysician can prescribe any of numerous availablesolutions used for this purpose, with the addition of oneor more of the listed electrolytes, in a dose he or she hasdetermined to be appropriate (for example, dextrose 5percent in sodium chloride 0.45 percent, 1000 ml with 7mEq of calcium as the chloride, gluconate or glucepatesalt).

The magnitude of different combinations of ingredientsin this subcategory requires our format for listing drugs inhydration therapy to differ from the other categories. Thismeans that the options available to a physician prescribinga course of hydration therapy for a Medicare beneficiarywould not be limited. The only restrictions on amounts ofingredients are those placed on solutions. These limita-tions have been determined to be the upper limits ofcommercially available products that would normally beused for hydration therapy (versus parenteral nutrition).

We are aware that our list will need periodic revisionas new drugs are approved by FDA for entry in themarketplace. The FDA has informed us that 10-20 new IVdrugs are approved over the course of each year that wewould have to consider for entry on the list. In addition,if a drug already on the list is removed from the market orif a drug is no longer considered to be appropriate forhome use, we would delete the drug from the list. We willupdate the list at least annually through a notice in theFederal Register. Updates may occur more frequently,possible as often as semi-annually.

Regulatory Impact StatementExecutive Order 12291 (E.O. 12291) requires us to

prepare and publish a regulatory impact analysis for anyproposed notice that meets one of the E.O. criteria for a“major rule”; that is, that would be likely to result in:

●

●

●

An annual effect on the economy of $100 million ormore;A major increase in costs or prices for consumers,individual industries, Federal, State, or local gover-nment agencies, or geographic regions; orSignificant adverse effects on competition, employ-ment, investment, productivity, innovation, or on theability of United States-based enterprises to competewith foreign-based enterprises in domestic or exportmarkets.

Also, we generally prepare a regulatory flexibilityanalysis that is consistent with the Regulatory FlexibilityAct (REA) (5U.S.C. 601 through 612) unless the Secre-tary certifies that a proposed notice would not have a

Appendix C-Home lntmvenous Drug Therapy:Proposed Regulations Under the Medicare Catastrophic Coverage Act ● 171

significant economic impact on a substantial number ofsmall entities. For purposes of the RFA, pharmaceuticalmanufacturers and physicians are considered small enti-ties.

As noted earlier in this preamble, this notice addressesthe issues of:

1.

2.

Identifying IV drugs (both antibiotics and non-antibiotics) and their indications that are approvedfor marketing by FDA; andIdentifying those IV drugs that are safe and effectivefor use in the home. There maybe some economicor other effects of the proposed list of drugs that maytouch upon other proposed rules implementingother home IV provisions of the catastrophiclegislation, and some of these effects are addressedhere as well as in the other rules. The purpose of thisduplication is to ensure that the reader may deter-mine the effects of each document without referringto the other proposed documents.

In addressing the first issue discussed above, all of theIV drugs listed in this notice may be covered underMedicare as covered outpatient drugs because they meetthe criteria defined in section 1861(t)(2) of the Act. Thus,HCFA has exercised no administrative discretion in thisarea.

Administrative discretion, however, was required toidentify those IV drugs that are safe and effective for usein the home. As discussed earlier in this preamble, wecontacted the USP, ASHP, AMA, various home IVproviders, the Pharmaceutical Manufacturers Associa-tion, various drug manufacturers and the IntravenousNurses Society in making our initial determination as towhether a certain IV drug could be proposed as safe andeffective for use in the home. We believe that theinformation solicited from the compendia along with theadvice of the other organizations constitutes a valid basison which to conclude with reasonable assurance that aparticular drug can generally be administered safely andeffectively in a home setting. Furthermore, we believe thatthe identification of IV drugs that are safe and effective foruse in the home would not result in any significant effectson the economy or on small businesses. Our reasonsfollow:

Effects on Drug Manufacturers-Drug manufactur-ers producing IV drugs that are included in this proposedlist would be advantaged in competing for the Medicaremarket because their drugs would be covered underMedicare as home IV drugs. We recognize that manufac-turers producing IV drugs that are not included in ourproposed list would be adversely affected in competingfor the Medicare share of the IV drug market. Althoughwe do not have data available that allow us to determinethe degree to which drug manufacturers would be

affected, we do not believe that will be significantlyaffected. This is because IV drugs (except antineoplastics)currently being prescribed for home use would likely beincluded on the proposed list based on the methodologyused in developing this list.

Effects on Beneficiaries-Medicare beneficiaries whoare prescribed an IV drug for home use that is on theproposed list would benefit by being eligible for Medicarecoverage of that drug. Conversely, beneficiaries for whoma drug has been prescribed that is not covered by Medicarefor home IV use may have to remain in the hospital toreceive covered IV therapy or may have to incur expensesfor home IV therapy themselves. Since we believe thatmost drugs currently prescribed for home IV use areincluded on the list, we do not believe beneficiaries wouldbe significantly affected adversely.

Effects on Physician-If drugs commonly prescribedby a physician for use in the home are not on the list, thephysician could be influenced to change his or herprescribing patterns for Medicare patients to ensure thatthe patient is prescribed a Medicare covered home IVdrug. However, given that we have consulted with variousprofessional organizations and compendia in developingthis list, we believe that the list, with the exception ofantineoplastices, contains the most frequently prescribedhome IV therapy drugs. Thus, we believe it unlikely thatphysicians’ prescribing patterns would change signifi-cantly as a result of this list.

For the reasons discussed above, we believe that thisnotice would not meet the $100 million criterion nor dowe believe that it meets the other E.O. 12291 criteria.Therefore, we have determined that this notice is not amajor rulemaking document under E.O. 12291, and aregulatory impact analysis is not required. Also, for thereasons discussed, we have determined, and the Secretarycertifies, that this notice would not have a significanteconomic impact on a substantial number of smallentities. Therefore, a regulatory flexibility analysis wouldnot be required under RFA.

Payment for Covered Outpatient Drugs(54 F.R. 37208)

This proposed rule sets forth the methodology fordetermin ing payment for covered outpatient drugs underthe new catastrophic drug benefit. This proposal wouldimplement sections 1834 (c)(2), (3), and (4) of the SocialSecurity Act as added by section 202(b) of the MedicareCatastrophic Coverage Act of 1988. Coverage of andpayment for these covered outpatient drugs under Part Bof Medicare would be implemented on January 1, 1990for drugs used in immunosuppressive therapy and cov-ered home intravenous (IV) drugs and on January 1, 1991for all other drugs.


Purpose

This subpart implements section 1834(c) of the Act inpart by specifying how payments are made for coveredoutpatient drugs under the catastrophic drug benefit.

Definitions

For purposes of this subpart, the following definitionsapply: Average price means the price that is determinedthrough the use of either published or survey dataconcerning amounts pharmacies pay for drug products.Multiple source drug means a covered outpatient drug forwhich there are two or more drug products that meet allof the following conditions during payment calculationperiod:

(a) Therapeutically equivalent. The drug productsare rated as therapeutically equivalent by the Foodand Drug Administration (FDA) in its most recentpublication of “Approved Drug Products withTherapeutic Equivalence Evaluations. ”

(b) Pharmaceutically equivalent and bioequivalent(1) Except as provided in paragraph (b)(2) of this

section, the drug products have been deter-mined by FDA to be pharmaceutically equiva-lent and bioequivalent.

(2) The drug products are not required to meet thecondition concerning pharmaceutically equiv-alency and bioequivalency as set forth inparagraph (b)(l) of this section if FDA changesby regulation (after an opportunity for publiccomment of 90 days) the requirement that, forPurposes of the Approved Drug Productswith Therapeutic Equivalence Evaluations,”in order for drug products to be rated astherapeutically equivalent, they must be phar-maceutically equivalent and bioequivalent.

(c) Available for sale or marketing. The drugproducts are considered to be available for sale ormarketing. Drug products meet this condition ifthey are listed by FDA in its most recent publica-tion of ‘Approved Drug Products with Therapeu-tic Equivalence Evaluations” (other than in theDiscontinued Drug Product List in the publication)unless HCFA determines that sale or marketing isnot actually occurring.

Nonmultiple-source drug means a covered outpatientdrug that does not meet the definition of a “multiple-source drug.” Payment calculation period means the6-month period beginning January 1st of each year or the6-month period beginning July 1st of each year.

Determination of Amount Payable

(a) General. The amount payable for a coveredoutpatient drug under the catastrophic drug benefit

(b)

as described in 410.29 of this chapter is theapplicable payment percent for the drug as deter-mined under 414.514 multiplied by the lesser of:(1) The actual charge; or(2) The payment limit determined under 414.506.

Effective date. Payment is determined under thecriteria described in paragraph (a) of this sectionfor:(1)

(2)

Drugs dispensed for immunosuppressive ther-apy after a transplant or covered home IVdrugs on or after January 1, 1990; andAll other covered outpatient drugs dispensedon or after January 1, 1991.

Determination of the Payment Limit

(a)

(b)

General. To determine the payment limit for adrug, HCFA uses the procedures set forth inparagraph (b) or (c) or this section.

Nonmultiple-source drug and multiple-sourcedrug with a restrictive prescription. For anonmultiple-source drug and multiple-source drugwith a restrictive prescription as described in414.508, the payment limit is determined asfollows:

(1) For drugs dispensed on or after January 1,1990 and before January 1, 1992, the paymentlimit is equal to the sum of:(i) The amount of the administrative allow-

ance as set forth in 414.512; and(ii) The product of the number of tablets or

other dosage units dispensed and thedosage unit average price as determined in414.510 for the payment calculation pe-riod in which the drug is dispensed.

(2) For drugs dispensed on or after January 1,1992, the payment limit is equal to the lesserof:(i)

(ii)

(c) Multiple-source drug without a restrictive pre-

The amount of the administrative allow-ance plus the product of number of tabletsor other dosage units dispensed and theaverage price per dosage unit determinedunder 414.510 for the payment calcula-tion period in which the drug is dispensed;orThe 90th percentile of actual charges fora drug for the second previous paymentcalculation period or other dosage unitsdispensed.

scription. For a multiple-source drug without arestrictive prescription, the payment limit is equalto the sum of:

Appendix C—Home Intravenous Drug Therapy:Proposed Regu/ations Under t he Mediicare Catastrophic Coverage Act . 173

(1) The administrative allowance; and(2) The product of the number of tablets or other

dosage units dispensed and the dosage unitaverage price based on the unweighed mediandetermined under 414.510 for the paymentcalculation period in which the drug is dis-pensed.

Determining Whether a Prescription Is Restrictive:

(a)

(b)

(c)

General. A drug has a restrictive prescription if itmeets the conditions set forth in either paragraph(b) or paragraph (c)of this section.

Handwritten prescription. In the case of awritten prescription for a drug, only if the prescrib-ing physician (or other person prescribing thedrug) includes in his or her handwriting the phrase“brand medically necessary.’

Telephoned prescription. In the case of a pre-scription for a drug that is telephoned to-thepharmacy, the prescribing physician (or otherlegally authorized person who is prescribing thedrug) indicates that the particular drug must bedispensed by stating the phrase “brand medicallynecessary” both:(1) During the telephone call; and(2) Within 30 days after the telephone call, in a

written and signed confirmation, in his or herhandwriting to the pharmacy.

Determination of Dosage Unit Average Price

(a)

(b)

(c)

General. HCFA determines the average price ona per dosage unit basis for purchases in reasonablequantities, as appropriate, based on prices in effecton the first day of the previous payment calculationperiod. The average price is based on dosage formand strength for each drug product.

Sources for dosage unit average price. HCFAobtains the information described in paragraph (a)of this section from the lower of:(1) When available, a biannual survey of a

representative sample of direct sellers, whole-salers, or pharmacies as appropriate; or

(2) Prices published in commonly recognized,comprehensive listings of drug prices.

Performance of surveys.(1) Nonmultiple-source drugs.

(i) HCFA performs the biannual survey de-scribed in paragraph (b)(1) of this sectionfor those nonmultiple-source drugs thatare commonly prescribed to Medicarebeneficiaries except that this survey doesnot have to be performed in:(A) Any year in which HCFA determines

that a survey is not appropriate for a

(d)

(e)

(f)

specific covered outpatient drug; or(B) In years subsequent to 1990, any year

in which HCFA determines that thereis a low volume of sales for a drug.

(ii) The dosage unit average price is based onthe median of the surveyed prices.

(2) Multiple-source drugs. HCFA performs thebiannual survey described in paragraph (b)(1)of this section for multiple-source drugs, butonly if HCFA determines a survey to beappropriate. The dosage unit average price isbased on the unweighed median of thesurveyed prices.

Use of published prices.(1)

(2)

Nonmultiple-source drugs and multiple-source drugs with restrictive prescriptions.The dosage unit average price for nonmultiple-source drugs and multiple-source drugs withrestrictive prescriptions is based on the lowestpublished price.Multiple-source drugs without restrictive pre-scriptions. The dosage unit average price formultiple-source drugs without restrictive pre-scriptions is based on the unweighed medianof published prices.

National determination. The determination ofthe dosage unit average price is made on a nationalbasis unless HCFA makes the determination on aregional basis to take into account limitations onthe availability of drugs and variations on theprices among different areas.

Discounts. In determiningg the dosage unit averageprice, HCFA does not consider discounts.

Administrative Allowance

(a) For 1990 and 1991. For a drug dispensed on orafter January 1, 1990 and before January 1, 1992,the administrative allowance for dispensing thedrug is:(1) $4.50 per prescription for a pharmacy that

meets the requirements under subpart B of part490 of this chapter for a participating phar-macy; or

(2) $2.50 per prescription for a pharmacy that isnot a participating pharmacy.

(b) For years subsequent to 1991. For each yearsubsequent to 1991, the administrative allowanceis the allowance applicable to the previous yearincreased by the percentage increase in the im-plicit price deflator for gross national product overthe 12 month period ending with August of thepreceding year as published by the Department ofCommerce rounded to the nearest penny.


(c) Limitation on administrative allowance fordispensing insulin.(1)

(2)

Purchase of a 30 day supply. For insulin thatis available without a prescription, the admin-istrative allowance is made for each purchaseof a reasonable quantity, that is, a 30 daysupply.Exceptions. An administrative allowance ismade for a purchase of a supply of insulin forfewer than 30 days in the following circum-stances (or if other extenuating conditionsexist):(i) There is a change in the type of insulin the

beneficiary uses or the insulin regimen isotherwise modifies; or

(ii) If, because of travel plans, the beneficiaryneeds to make smaller purchases or for-gets to bring along enough insulin forduration of the trip.

(d) Exception for drugs dispensed for home IVdrug therapy. No administrative allowance ispaid for dispensing a drug that is to be used inhome IV drug therapy. An allowance for dis-pensing IV drugs is made under the fee schedulefor payment for services related to home IV drugtherapy under subpart J of part 414.

Amount of the Payment Percent(a)

(b)

Immunosuppressive and home IV drugs. Fordrugs related to immunosuppressive drug therapydispensed during the first year after a coveredorgan transplant and for home IV drugs, thepayment percent equals 80 percent.

Other drugs. The payment percent for coveredoutpatient drugs other than the drugs described inparagraph (a) of this section equals the following:(1) In 1990 and 1991,50 percent.(2) In 1992,60 percent.(3) In 1993 and subsequent years, 80 percent.

Coverage of Home Intravenous Drug TherapyServices (54 F.R. 37422)

These proposed regulations would expand coverageunder Medicare Part B to include coverage of home IVdrug therapy services as authorized by section 203 of theMedicare Catastrophic Coverage Act of 1988. Theyinclude requirements for certification and for review andapproval of the need for the covered services by a peerreview organization, and they place limits on acceptanceof and payments for certain patient referrals for coveredhome IV drug therapy services as specified in the statute.Home IV drug therapy services are covered by Medicarebeginning January 1, 1990.

Basic RuleUnder sections 1834(d) and 1861(jj), Medicare Part B

pays for home intravenous drug therapy services fur-nished by a qualified home intravenous drug therapyprovider (see part 485, subpart C of this chapter) or byothers under arrangements made by the qualified home IVdrug therapy provider with them, to a patient who is underthe care of a physician, in a place of residence used as thebeneficiary’s home and under a plan of care establishedand periodically reviewed by the beneficiary’s referringphysician.

DefinitionsFor purposes of this subpart:

Home intravenous drug therapy provider or “homeIV provider” means an entity that provides home IV drugtherapy services, has been certified as meeting theconditions of participation of part 485, subpart C of thischapter, and has a provider agreement with HCFA.

Home intravenous drug therapy services or “homeIV services” means nursing, pharmacy and relatedservices (including medical supplies, equipment, intrave-nous fluids only when used as diluents for covered homeIV drugs, and delivery services) necessary to conduct anintravenously administered regimen safely and effec-tively in conjunction with the use of a covered homeintravenous drug. These services are furnished to anindividual who is under the care of a physician, in a placeof residence used as the individual’s home, by a qualifiedhome IV provider (or by others under arrangements), andunder a plan established and periodically reviewed by thereferring physician.

IV stands for intravenous.

Place of residence used as the individual’s home isa place in which the beneficiary normally resides and isnot an institution or facility that is defined in section1861(e)(l), 1819(a) or 1919(a) of the Act.

Referring physician means the physician who pre-scribed the covered home intravenous drug for which theservices are to be provided or who established the plan ofcare for the services or both.

Home IV Drug Therapy Services(a) Individual services. Particular services included

in the term “home intravenous drug therapyservices’ that are covered under this subpart arelimited to the nursing services and pharmacyservices described in 485.135 and 485.140, respec-tively, of this chapter and related services de-scribed in paragraph (b) of this section that arenecessary for the safe and effective administrationof a covered home IV drug. Separate payment maynot be made for any of these services furnished to

Appendix C-Home lntravenous Drug Therapy:ProposedRegulations Under the Medicare Catastrophic Coverage Act . 175

(b)

(c)

a patient receiving covered home intravenous drugtherapy services.

Related services and supplies. The home IVprovider must furnish the following if they arenecessary for the safe and effective administrationof a covered home IV drug:(1)(2)

(3)

(4)

(5)

Medical supplies;Intravenous fluids for use as diluents forcovered home IV chug;Training of the patient or his or her caregiverin the techniques of IV drug therapy;Equipment such as IV poles and infusionpumps; andDelivery of medical items and supplies.

Prohibited payment. Payment may not by madeto a home IV provider for covered home IV drugtherapy services unless the home IV providerfurnishes the covered home IV drug either directlyor under arrangements.

Payment Limitations Concerning CertainPatient Referrals

(a) Ownership and compensation rules. Paymentmay not be made to a home IV therapy provider forthe home IV drug therapy services furnished to abeneficiary if that beneficiary’s referring physicianor an immediate member of the referring physi-cian’s family has an ownership interest in theprovider or receives compensation from the pro-vider unless an exception under paragraph (b)through (e) of this section applies. For purposes ofthis paragraph, an immediate member of thefamily includes the physician’s spouse; naturaland adoptive parents, natural and adopted chil-dren; natural, adopted, and adoptive siblings;stepparents, stepchildren, and step siblings; fathers-in-law, mothers-in-law, brothers-in-law, sisters-in-law, sons-in-law, and daughters-in-law; and grand-parents and grandchildren.

(b) Exception applying to limitation on ownership.(1)

(2)

(3)

Payments may be made if the ownershipinterest is the ownership of stock in the homeIV provider that is traded over a publiclyregulated exchange and purchased on termsgenerally available to the public.Payments may be made if the provider is thesole home IV drug therapy provider in a ruralarea.For purposes of paragraph (b)(2) of thissection, a rural area is one that is not anurbanized area (as defined by the Bureau of theCensus) and that is designated by the Secre-tary either:(i) As an area with a shortage of personal

(c)

(d)

(e)

health services under section 1302(7) ofthe Public Health Service Act, or

(ii) As a health manpower shortage areadescribed in section 332(a)(l)(A) of theAct because of its shortage of primarymedical care manpower.

(4) For purposes of paragraph (b)(2) of thissection, a sole home IV drug therapy providerin a rural area is one that is approved as suchby HCFA after the provider:

(i) Designates a particular area;(ii) Shows that no other home IV provider

furnishes services within that area [and](iii) Shows that there are no physicians with-

out an ownership interest in the provideravailable to perform certification andrecertification and to write plans of care.

Exception applying to limitation on compensa-tion. Payment may be made under this section ifthe compensation is reasonably related to items orservices actually provided by the physician anddoes not vary in proportion to the number ofreferrals made by the referring physician. Thisexception does not apply if the compensation is fordirect patient care services.

Exception applying to uncompensated officeror director. Payment maybe made if the referringphysician’s or immediate family member’s own-ership or financial relationship with the provider isas an uncompensated officer or director of theprovider.

Exceptions applying to instances in which thereis not substantial risk of program abuse. Pay-ment may be made under this part in those cases inwhich the Secretary has specifically determinedthat the nature of the ownership or compensationdoes not pose a substantial risk of program abuseinvolving the following:(1) Space rental. For purposes of this paragraph,

the term ‘‘fair market value” means the valueof the rental property for general commercialPurpose (not taking account of its intendeduse), but it is not adjusted to reflect theadditional value the prospective lessee orlessor value would attribute to the property asa result of its proximity or convenience to thelessor where the lessor is a potential source ofpatient referrals to the lessee. As used insection 1834(d) of the Act, neither “owner-ship” nor “compensation” includes pay-ments made by a lessee to a lessor for the useof premises, as long as:

(i) The lease agreement is set out in writingand signed by the parties;

(ii) The lease specifies the premises covered


by the lease;(iii) If the lease is intended to provide the

lessee with access to the premises forperiodic intervals of time, rather than ona full-time basis for the term of the lease,the lease specifies exactly the schedule ofsuch intervals, their precise length, theirperiodicity, and the exact rent for suchintervals;

(iv) The term of the lease is for not less than1 year; and

(v) The rental charge is consistent with fairmarket value in arms-length transactionsand is not determined in a manner thattakes into account the volume or value ofany referrals of business between theparties for whom the services would bepaid by Medicare or Medicaid.

(2) Equipment rental. For purposes of this para-graph, the term “fair market value” means thevalue of the equipment when obtained from amanufacturer or professional distributor, but itis not adjusted to reflect the additional valuethe prospective lessee or lessor would attributeto the equipment as a result of its proximity orconvenience to the lessor where the lessor is apotential source of patient referrals to thelessee. As used in section 1834(d) of the Act,neither “ownership” nor “compensation”includes payments made by a lessee of equip-ment to the owner (’ ‘lessor’ of the equipmentfor the use of the equipment, as long as:

(i) The lease agreement is set out in writingand signed by the parties;

(ii) The lease specifies the equipment cov-ered by the lease;

(iii) If the lease is intended to provide thelessee with use of the equipment forperiodic intervals of time rather than ona full-time basis for the term of the lease,the lease specifies exactly the schedule ofsuch intervals, their precise length, theirperiodicity, and the exact rent for suchintervals;

(iv) The term of the lease is for not less than1 year; and

(v) The rental charge is consistent with fairmarket value in arms-length transactionsand is not determined in a manner thattakes into account the volume or value ofany referrals of business between theparties reimbursed under Medicare.

(3) Personal services and management con-tracts. For purposes of this paragraph, an agentof a principal is any person, other than a bona

fide employee, who has an agreement toperform services for, or on behalf of, theprincipal. As used in section 1834(d) of theAct, neither “ownership” nor “compensa-tion” includes payments made by a principalto an agent as compensation for the services ofthe agent, as long as:

(i) The agency agreement is set out inwriting and signed by the parties:

(ii) The agency agreement specifies the serv-ices to be provided by the agent;

(iii) If the agency agreement is intended toprovide for the services of the agent onperiodic, sporadic or part-time basis,rather than on a full-time basis for theterm of the agreement, the agreementspecifies exactly the schedule of suchintervals, their precise length, the perio-dicity, and the exact charge for suchintervals;

(iv) The term of the agreement is for not lessthan 1 year; and

(v) The aggregate compensation paid to theagent over the term of the agreement is setin advance, is consistent with fair marketvalue in arms-length transactions and isnot determined in manner that takes intoaccount the volume or value of anyreferrals of business between the partiesthat is reimbursed under Medicare or anyState health care program.

(4) Employees. As used in section 1834(d) of theAct, neither “ownership” nor “compensa-tion” includes any amount paid by an em-ployer to an employee who has a bona fideemployment relationship with the employer,for employment in the provision of covereditems or services. For purposes of this para-graph (f)(4), the term “employee” has thesame meaning as it does for purposes of 42U.S.C. 410(j)(2), part of the statutory defini-tion of “employee‘‘ in the Federal InsuranceContributions Act; that is, the common lawemployment test.

Physician Certification and Plan ofTreatment Requirements

Medicare Part B pays for home intravenous drugtherapy services only if the referring physician certifies,and recertifies as required under paragraph (b) of thissection, that the requirements described in paragraphs(a)(1) through (a)(5) of this section are being met.

(a) Certification: Content. The referring physicianmust certify, or recertify if applicable, that:(1) The home intravenous drug therapy services

Appendix C-Home lntravenous DrugTherapy:Proposed Regulations Under the Medicare Catastrophic Coverage Act . 177

(b)

(c)

(2)

(3)

(4)

(5)

are or were required because the individualneeds or needed the services for the adminis-tration of a covered home intravenous drug;A plan for furnishing the services has beenestablished by the referring physician and isreviewed periodically by that physician;The services are or were furnished while theindividual is or was under the care of aphysician;The services are furnished in a place ofresidence used as the patient’s home; andFor services initiated before January 1, 1993,a PRO has approved the services in accordancewith part 466, subpart E, of this chapter.

Recertification. The referring physician mustrecertify that the requirements in paragraph (a) ofthis section are still met at least every 30 days.

Plan of care requirements.(1)

(2)

(3)

Establishment. The referring physician mustestablish and sign the plan of care and consultas necessary with the home IV provider nurseor pharmacist before the home IV Therapybegins in accordance with sections 485.135and 485.140 of this chapter.Content. The plan of care must contain at leastthe information required in section 485.120 ofthis chapter.Review. The physician must review and signthe plan of care at least every 30 days.

PRO Review of Home IV Drug Therapy Services

(a)

(b)

Statutory basis. Sections l154(a)(16) and1835(a)(2)(G) of the Act require PROS to reviewall home intravenous (IV) drug therapy servicesbefore these services begin; or, in the case ofservices first initiated on an outpatient basis,within one working day (other than in exceptionalcircumstances) of the date of initiation of theservices.

Applicability. The regulations in this subpartapply to reviews, conducted by a PRO and itssubcontractors, of home IV drug therapy servicesfurnished, or proposed to be furnished to allMedicare beneficiaries other than those benefici-aries enrolled in HMOs [health maintenanceorganizations] or CMPs [competitive medicalplans] that contract with HCFA on a risk-basis asdescribed in subpart C of 42 CFR part 417.

Effective Dates-All home IV drug therapy servicesintended to be furnished to Medicare beneficiaries on orafter January 1, 1990 are subject to the PRO reviewrequirements of this subpart.

Definitions-As used in this subpart:

Outpatient basis means the patient receives servicesother than as an inpatient of a hospital.

Scope of PRO Review—

(a)

(b)

General rule. After a PRO receives a request forreview of home IV drug therapy services fromeither the referring physician or the health carefacility, the PRO must determine (in accordancewith the terms of its contract) whether the home IVdrug therapy is reasonable, appropriate, and neces-sary for the treatment of the illness or injury. Thisreview includes a determination that the intrave-nous route of administration is the correct route ofadministration and that the home IV drug therapyservices meet professionally recognized standardsof care.

Coordination of sanction activities. In imple-menting review of home IV drug therapy services,PROS must carry out the responsibilities specifiedin subpart C, part 1004, chapter V of this title,regarding imposition of sanctions on health carefacilities and practitioners who violate their statu-tory obligations under Section 1156 of the Act. Forexample, a PRO is to refer to the HHS [U.S.Department of Health and Human Services] Officeof Inspector General a case involving a physicianwho exhibits a pattern of not correctly monitoring,by appropriate laboratory tests, the administrationof a drug.

Notification of PRO Review Procedures-

(a)

(b)

Criteria. The PRO must distribute, at no charge,the criteria/quality screening guidelines to be usedin screening cases, at a minimum, to all affectedhealth care facilities and medical societies in theState.

Information required. Each PRO must givetimely written notification to health care facilitiesand physicians in its State the following informa-tion:(1)

(2)

(3)

(4)

(5)

Date. The date upon which the PRO plans tobegin review of home IV drug therapy serv-ices.Manner. The manner in which the referringphysician or health care facility is to seek PROreview.Required information. The information to befurnished to the PRO by the physician and/orhealth care facility and the need for expedi-ency in responding to PRO questions.Validation and quality review. The valida-tion and quality review that the PRO mayconduct on a sample of the cases after theservices are furnished in the home.Financial liability. A general statement about


financial liability for charges related to homeIV drug therapy services that are found to benot reasonable or medically necessary and astatement that no claims will be paid withoutPRO approval.

Responsibilities of Physicians and Health CareFacilities—

(a)

(b)

Physicians. The referring physician must coop-erate (in addition to the requirements in 466.78) inthe(1)

(2)

conduct of PRO review as follows:The physician must, in accordance with PRO-issued procedures, either seek PRO priorauthorization for the drug he or she proposesto have administered intravenously at home orassist in providing necessary information insupport of a health care facility that seeks PROapproval.The physician must furnish relevant medicalrecords, upon request, to the PRO for any ofthe reviews described in this subpart.

Health care facilities.(1)

(2)

(3)

(4)

In addition to the general requirements forhealth care facilities set forth in 466.78, thehealth care facility must cooperate in theconduct of PRO review (in accordance withthe regulations in this part and PRO-issuedprocedures) by obtaining the authorizationnumber provided by the PRO:(i) Before beginning the administration of an

IV drug in the patient’s home, except incases where the drug is to be started on anoutpatient basis on a weekend (i.e., anon-workday), the authorization must beobtained the first working day thereafter;and

(ii) In certain cases, before continuation ofhome IV drug therapy that the PRO haspreviously approved as described in 466.216(C) and (d).

Health care facilities must maintain a writtenagreement with the appropriate PRO.The health care facility must, in accordancewith PRO-issued procedures, either seek PROapproval of the IV drug therapy servicesproposed to be administered at home or assistin providing necessary information in supportof a referring physician that seeks PROapproval.The health care facility must transfer relevantmedical records (including the plan of caredescribed in 424.28(c)), upon request, to thePRO for any of the reviews described in thissubpart.

Lack of Cooperation by a Health Care Facility orPhysician—If a health care facility or physician fails tocomply with the requirements for review set forth in thissubpart, the PRO may determine that the health carefacility or physician has failed to comply with therequirements of subpart C, part 1004, chapter V of thistitle concerning failure by providers or practitioners tomeet statutory obligations under section 1156 of the Actand may report the matter to the Office of InspectorGeneral.

PRO Designation—(a)

(b)

(c)

When-home IV drug therapy is proposed for acurrently hospitalized inpatient, the referring phy-sician or health care facility must contact, for priorauthorization, the PRO with whom the hospital hasan agreement.

When home IV drug therapy is proposed for apatient who has had the drug started on anoutpatient basis, the physician or health carefacility must contact, for authorization, the PROfor the State in which the home IV drug therapyprovider is located.

For all other reviews, the PRO for the State inwhich the home IV drug therapy provider islocated will conduct the review.

PRO Approval—(a) Before approving the home IV drug therapy

services, the PRO must assured:(1)

(2)

(3)

(4)

That the patient’s condition is such thatinpatient hospitalization is not justified either

(i) As a continuation of an existing hospital-ization; or

(ii) As a medically necessary and appropriateadmission;

Orally, in writing, or from documentation (orany combination of these three), that thepatient meets the selection criteria outlined in485.115 of this subpart;That the patient or caregiver has been or willbe sufficiently trained as to how to administerthe drugs safely and effectively in the home;andThat the patient or caregiver has or willindependently administer(e-d) intravenously atleast one dose of the drug under supervision.

(b) The PRO must determine that:(1)

(2)

The plan of care, executed by the referringphysician, has enough information to supportthe coverage of home IV drug therapy serv-ices;The drug is being used for one of the statedindications listed in a Federal Register noticeissued by the Secretary;


(c)

(d)

(3)

(4)

(5)

(6)

(7)

(8)

The drug is medically indicated for the treat-ment of the patient’s condition;The dosage is correct (e.g., adjusted for heightand body weight);Appropriate diagnostic studies (e.g., cultureand sensitivities, kidney function tests) havebeen performed and will be performed asappropriate while the patient is receiving thetherapy;Other appropriate periodic monitoring hasbeen and will be performed;The drug is not contraindicated (e.g., basedupon abnormal laboratory findings, or druginteractions); andThe home IV drug therapy services meetprofessionally recognized standards of care.

The PRO must also determine that the intravenousroute of administration is the only route ofadministration that will be effective.

In performing review, the PRO uses reviewcoordinators to compare the facts about theindividual case to the criteria/screening guidelinesdeveloped by HCFA, the PRO, or both.(1)

(2)

(3)

(4)

If the case meets the criteria/guidelines, thereview coordinator issues a PRO approvalnumber.If the case does not meet the criteria/guidelines, the review coordinator refers thecase to a PRO physician.The PRO physician review either approves thecase (using a PRO approval number) orquestions the case.If the case is questioned by the PRO physician,the physician who prescribed the home IVdrug therapy and the health care facility areimmediately given an opportunity to discussthe case.

(i)

(ii)

(iii)

(iv)

The PRO attempts to contact either thereferring physician or health care facility.The referring physician may discuss thecase with a PRO physician.The health care facility may discuss thecase with a PRO representative. If, how-ever, the health care facility designates aphysician representative, the physicianmay also discuss the case with a PROphysician.For potential quality problems, the PROfollows the timeframes outlined in itscontract with HCFA.

Timing of Review—

(a) Prior review of continuation of inpatient hospi-tal therapy.(1) The PRO is required, for all IV drug therapy

(2)

(3)

(4)

continued at home after a hospital stay, toauthorize such use before hospital discharge.The review must be requested by the referringphysician or the health care facility in accor-dance with PRO-issued instructions.The PRO will follow the review processoutlined in 466.214(c).The PRO must complete the review within oneworking day of receipt of a request for review.

(i)

(ii)

(iii)

The date of the request for review isconsidered to be the date upon which thePRO receives all of the information itneeds to complete the review.In this timeframe, the PRO must give thehealth care facility and referring physi-cian an opportunity to discuss the case asdescribed in 466.214.Failure of the health care facility andreferring physician to discuss the casewithin the time allowed is not a basis thatwill prevent the PRO form making itsdetermination base upon the informationin its possession.

(b) Initial review of IV drugs started on an outpa-tient basis. In the case of a patient whose IV drugtherapy services are initiated on an outpatientbasis, the referring physician or health care facilitywill request PRO approval no later than the firstworking day on which the home IV drug therapyservices are prescribed.(1)

(2)

(3)

(4)

(5)

The PRO has 8 working hours in which tocomplete its review after receipt of a requestfor review from the referring physician orhealth care facility.The date the PRO receives the request forreview is the date on which the PRO receivesall the information it needs to complete thereview.PRO review follows a request from thereferring physician or health care facility thatis made in accordance with PRO-issued instruc-tions.The PRO will follow the review processoutlined in 466.214(c).The PRO must complete its review within 1working day of initiation for the home IV drugservices.(i)

(ii)

This timeframe includes the time the PROmust give the health care facility andphysician to discuss the case as describedin 466.214.If the health care facility and physician donot take advantage of the opportunity todiscuss the review within the time allowedthe PRO may make its determination


(c)

(d)

based upon the information in its posses-sion.

Subsequent reviews for continuation of drugs.In accordance with the PRO’s prior approval,when drugs are to be continued for a period of timebeyond the date or number of days approved by thePRO, the PRO will periodically review to deter-mine that coverage of the home IV drug therapyservices continues to be appropriate in accordancewith the requirements set forth in 466.214(a) and(b) of this subpart.(1)

(2)

(3)

If home IV drug therapy is planned to continuefor a time past the date the PRO has indicated,the physician or health care facility mustrequest PRO review no less than 3 workingdays before the expiration of the current PROapproval.The PRO follows the process outline in466.214(c).The PRO must complete subsequent reviewswithin 3 working days for the request.(i) In this timeframe, the PRO must give the

health care facility, if applicable, andphysician an opportunity to discuss thecase as described in 466.214.

(ii) If the health care facility and physician donot take advantage of the opportunity todiscuss with the tie allowed, the PRO maymake its determination based upon theinformation in its possession.

Prior review of change in drug. When thereferring physician proposes a change to the IVdrug therapy, the referring physician or the healthcare facility will request PRO approval of therevision in therapy within one working day ofinitiation of the change.(1)

(2)

(3)

The referring physician or health care facilitymust request PRO review in accordance withPRO-issued instruction.The PRO will follow the review processoutlined in 466.214(c).The PRO will complete its review within threeworking days of the request.(i) In this timeframe, the PRO must afford

the health care facility and referring phy-sician an opportunity to discuss the caseas described in 466.214.

(ii) If the health care facility and referringphysician do not take advantage of theopportunity to discuss the case within thetime allowed, the PRO will make itsdetermination based upon the informationin its possession.

(e) Retrospective reviews. For retrospective reviews,the PRO must adhere to the timing of review

requirements found in its contract with HCFA.

Notification—(a) The PRO must, within the timeframes given in

466.216, provide notification if its determinationas follows:(1) The PRO notifies the health care facility and

referring physician by telephone as to whetherit has determined that:

(i)

(ii)

(iii)

(iv)

Services are reasonable, appropriate, andmedically necessary. The PRO issues anapproval number and informs the healthcare facility, if applicable, and referringphysician of the date by which reviewand subsequent approval must be re-quested for continuation of the IV drugtherapy;Services are not reasonable, appropriate,or medically necessary;Services are medically necessary butneither the patient nor caregiver meetsthe selection criteria; orThe patient should receive the services if

(b)

another setting.(2) If the PRO does not authorize the services

because they are not reasonable, appropriateand medically necessary in the home setting,within 1 working day of the determination itmust, in accordance with the requirements ofsection 466.94(c), notify in writing:

(i) The beneficiary;(ii) The referring physician;

(iii) The health care facility, and(iv) The fiscal intermediary.

If the PRO determines that the services do not meetprofessionally recognized standards of care, thePRO will notify the referring physician and healthcare facility in accordance with the quality inter-vention plan in the PRO’s contract.

Retrospective Reviews-(a)

(b)

(c)

Random sampling. The PRO must periodicallyreview a sample of cases to determine that thehome IV therapy services meet professionallyrecognized standards of care and that the condi-tions in 466.214 are met.

Retrospective review of unapproved cases. Ona retrospective, prepayment (and on an exceptionbasis, postpayment) basis, the PRO reviews (uponthe request of the physician or health care facility)any claims for the home IV drug therapy servicesfor which PRO review was required but nevercompleted and makes a determination in accor-dance with 466.214.

Validation reviews. The PRO in the State wherethe home IV drug therapy provider is located must

Appendix C-Home lntravenous Drug Therapy:ProposedRegulations UndertheMedicareCatastrophicCoverage Act ● 181

conduct a validation review of a sample of cases inwhich approval for home IV drug therapy servicesunder this subpart was granted by telephone tierthe PRO considered medical information by tele-phone but did not review actual medical records.(1)

(2)

(3)

The PRO must be assured that informationprovided to the PRO was accurate and that thehome IV drug therapy services met profes-sionally recognized standards of care.If inaccurate information was given to thePRO, the PRO must deny payment for theservices if they are found to be uncoveredbased upon the correct information.As a result of this review, the PRO may decidethat future medical information must be sub-mitted in writing.

Liability and Sanctions for Unreviewed Cases—(a)

(b)

(c)

(d)

Payment contingent upon approval. No pay-ment will be paid for any claim where the PRO hasnot approved the services for payment.

Failure of PRO to complete review. If, becauseof a PRO administrative error, the review is notcompleted within the timeframes outlined in466.216, the PRO still must complete the reviewand issue an approval number or a notice denyingthe services.

Financial liability. Financial liability is deter-mined in accordance with provisions of sections1842(1) and 1879 of the Act and 405.330 through405.336 of this chapter.

Corrective action.(1)

(2)

If the review is not completed timely, whetheror not the PRO determines that the home IVdrug therapy is appropriate and the physicianor health care facility (or both) are the causeof the problem (including failure to make therequest on a timely basis), the PRO must takewhatever corrective actions are necessary toensure that future cases are reported to thePRO for review within the outlined timefra-mes.If the information given over the telephone isfound to be inaccurate or misleading, the PROmay take appropriate corrective actions.

Reconsiderations and Appeals Reconsiderations andappeals are available under part 473 of this chapter for allPRO initial denial determinations.

Location for Submitting Requests for Reconsidera-tion—

(c) Expedited reconsideration. A request for anexpedited reconsideration must be submitted di-rectly to the PRO if the denial is a result of:(1) Preadmission/preprocedure review; or

(2) Review of home intravenous drug therapyservices before the initiation of or during theperiod in which the beneficiary is still receiv-ing the services.

Time Limits for Issuance of the ReconsideredDetermination—

(a) Beneficiaries. If a beneficiary files a timelyrequest for reconsideration of an initial denialdetermination, the PRO must complete its recon-sidered determination and send written notice tothe beneficiary within the following time limits:

(1) Within 3 working days after the PRO receivesthe request for reconsideration if:(i)

(ii)

The beneficiary is still An inpatient in ahospital for the stay in question when thePRO receives the request for reconsideration;orThe initial determination relates to homeintravenous drug therapy services forwhich approval was denied and a requestwas submitted timely for an expeditedreconsideration.

(3) Within 30 working days after the PRO re-ceives the request for reconsideration if:

(i)

(ii)

(iii)

The initial determination concerns ambul-atory or noninstitutional services;The beneficiary is no longer an inpatientin a hospital or SNF [skilled nursingfacility] for the stay in question or nolonger receives home intravenous drugtherapy services for which the PROissued a denial determination; orThe beneficiary does not submit a requestfor expedited reconsideration timely [sic].

Payment for Home Intravenous Drug TherapyServices (54 F.R. 46938)

This proposed rule sets forth the methodology forpayment for home IV drug therapy services. This proposalwould implement the provisions of section 1834(d) of theSocial Security Act as added by section 203(c)(1) of theMedicare Catastrophic Coverage Act of 1988. Coverageof and payment for home IV drug therapy services underPart B of Medicare would be implemented on January 1,1990.

Basis and Scope

(a) Statutory basis. This subpart is based on sections1834(d)(l) and (2) of the Act which, respectively:(1) Provide that payment for home IV drug

therapy services is the lesser of the actualcharges or a fee schedule amount; and

(2) Require the Secretary to establish by regula-tion a per diem fee schedule for those services.


(b) Scope. This subpart sets forth the methodologyused to determine the per diem fee scheduleamount for home IV drug therapy services, whichare covered under Medicare beginning on January1, 1990.

Determination of Amount Payable

(a)

(b)

(c)

(d)

(e)

General rule. Medicare payment for home IVdrug therapy services, as defined in section 410.203of this chapter, is made at 100 percent of the lesserof:(1) The actual charge; or(2) The applicable per diem fee schedule amount

and any applicable additional allowances de-termined under this subpart.

Separate fee schedules. Two separate fee sched-ule amounts are calculated; one for pain manage-ment drug therapy and one for antibiotic and otherdrug therapies.

Basis for calculating fee schedule amounts. Theapplicable fee schedule amount for each type ofdrug therapy is the per diem allowance for each ofthe home IV drug therapy service componentsplus, as appropriate, additional allowances appli-cable in special circumstances.

Service components. HCFA calculates a per diemfee schedule allowance for each of the following:(1) Pharmacy services.(2) Pharmacy supplies.(3) Pharmacy delivery.(4) Nursing services and supplies.(5) Other equipment.

Special circumstances. HCFA calculates addi-tional allowances for each of the following:(1) Patient education and counseling at the time

IV drug therapy begins in the home(2) Multiple IV drug regimen.(3) New drug introduced into existing drug regi-

men.

Calculation of Per Diem Fee Schedule Allowancesfor Calendar Year 1990

(a) Pharmacy services.(1)

(2)

An average hourly pharmacy rate is calculatedby weighting an average hourly pharmacistrate based on direct and indirect costs and anaverage hourly pharmacy technician rate basedon direct and indirect costs by the estimatedtime spent by each in drug preparation.A per dose cost of preparation is calculated foreach type of drug by multiplying the averagetime spent in preparing the drug and evaluat-ing patient outcome by the average hourlypharmacy rate.

(3) A per diem cost of preparation is calculated foreach type of drug by multiplying the per dosecost for the drug by the average number ofdoses per day.

(4) The per diem allowance for pharmacy servicesfor each type of drug therapy is equal to the perdiem cost of preparing that type of drug.

(b) Pharmacy supplies.(1)

(2)

(3)

A per dose cost of pharmacy supplies for eachtype of drug therapy is calculated by addingthe cost of all supplies needed for that type oftherapy.A per diem cost of pharmacy supplies for eachtype of drug therapy is calculated by multiply-ing the per dose cost by the average number ofdoses per day.The per diem allowance for pharmacy suppliesfor each type of drug therapy is equal to the perdiem cost for supplies for that type of drugtherapy.

(c) Pharmacy delivery.

(d)

(1)

(2)

(3)

(4)

A per trip nonlabor cost of delivery of drugs iscalculated by multiplying the estimated aver-age mileage per trip by the Federal mileageallowance divided by the estimated averagenumber of deliveries per trip.A per trip labor cost of delivery of drug iscalculated by multiplying the estimated aver-age travel time for each delivery by an averagehourly salary rate for a delivery person basedon direct and indirect costs.A per diem cost of delivery for each type ofdrug is calculated by adding the per tripnonlabor and labor costs and multiplying theresult by the estimated number of trips per dayfor each type of drug.The per diem allowance for pharmacy deliveryfor each type of drug therapy is equal to the perdiem cost of delivery for that type of drugtherapy.

Nursing services and supplies.(1)

(2)

(3)

A per visit cost for patient care time iscalculated by multiplying the average numberof hours spent with a patient in each visit bythe average hourly salary for a nurse based ondirect and indirect costs.A per visit cost for travel time is calculated bymultiplying the average travel time per patientby the average hourly salary for a nurse basedon direct and indirect costs.The per visit costs calculated in paragraphs(d)(1) and (d)(2) of this section are adjusted forarea differences in wage levels by a factor(established by HCFA) reflecting the relativehome health agency wage level in the geo-

Appendix C-Home lntravenous Drug Therapy:Proposed Regulations Under the Medicare Catastrophic Coverage Act . 183

(e)

(4)

(5)

(6)

graphic area of the home IV drug therapyprovider compared to the nation average homehealth agency wage level.A per visit cost for travel is calculated bymultiplying the estimated average mileage pervisit by the Federal mileage allowance.A per visit cost of nursing supplies is calcu-lated by adding the cost of supplies used ineach visit.The per diem allowance for nursing services iscalculated by adding the separate adjusted pervisit cost for direct patient care time and traveltime and the per visit costs for travel andnursing supplies and dividing by the averagenumber of days between visits.

Other equipment. The per diem allowance forother equipment is the separate per diem cost of theequipment not related to either pharmacy ornursing services calculated for each type of drugtherapy by dividing the cost of the equipmentnecessary for the therapy by the average useful lifeof the equipment.

[Proposed actual amounts for all above services for1990 were $45.44 per day for antibiotic therapy and$31.63 per day for pain management therapy.]

Calculation of Additional Allowances forCalendar Year 1990

(a)

(b)

Patient education and counseling at the time IVdrug therapy begins in the home. The amount ofthe allowance depends on whether the patient hadbegun IV drug therapy as a hospital inpatient.(1)

(2)

Patient begins IV drug therapy while ahospital inpatient. If the patient begins IVdrug therapy as a hospital inpatient, theallowance is equal to two times the per visitcost for nursing services as a calculation byadding the per visit costs determined in414.588 (d)(1) through (d)(4).Patient begins IV drug therapy outside thehospital inpatient setting. If the patientbegins IV drug therapy in any setting otherthan that of a hospital inpatient, the allowanceis equal to three times the per visit cost fornursing services as calculated by adding theper visit costs determined in 414.558 (d)(1)through (d)(4).

Multiple IV drug regimen. A per diem allowanceis made for the additional pharmacy services andsupplies, nursing services, and other equipmentneeded for a patient who receives concurrentlymore than one IV drug. The per diem allowance isequal to the sum of the following:

(1)

(2)

(3)

50 percent of the applicable per diem allow-ance for pharmacy services as calculated in414.558(a).100 percent of the applicable per diem allow-ance for pharmacy supplies as calculated in414.558(b).100 percent of the applicable per diem allow-ance - for other equipment & calculated in414.558(e).

(c) Nursing services for initial dose of new drug—introduced into the drug regimen:(1)

(2)

Applicability. This allowance is made fornursing services related to one nursing visit forthe initial dose when a prescription changeintroduces an additional covered home IVdrug to the patient’s drug regimen or substi-tutes a new covered home IV drug for onealready being used.Amount. This allowance is equal to 50 percentof the per visit costs for nursing services ascalculated by adding the per visit costs deter-mined in section 414.558 (d)(1) through(d)(4).

Calculation of Per Diem Fee Scheduleand Additional Allowances for Calendar YearsAfter 1990

The per diem fee schedule and additional allowancesfor calendar years after 1990 are periodically recalculatedto take into account increases in costs of nursing andpharmacy services, supplies, and delivery, and otherequipment.

Conditions of Participation for HomeIntravenous Drug Therapy Providers

(54 F.R. 37220)This proposed rule sets forth the conditions of partici-

pation that an entity would be required to meet in order toqualify as a home intravenous drug therapy provider. Thisproposal would implement the provisions of section1861 (jj)(3) of the Social Security Act, which was addedby section 203(b) of the Medicare Catastrophic CoverageAct of 1988. An entity that meets these conditions ofparticipation would be eligible for payment from Medi-care for covered home IV drug therapy services furnishedto Medicare beneficiaries.

Basis and ScopeThis subpart sets forth the conditions that entities must

meet to be approved for participation in Medicare as homeIV drug therapy providers under section 1861(jj) of theAct and part 489 of this chapter.


Definitions

As used in this subpart unless the context indicatesotherwise, “home intravenous (IV) drug therapy pro-vider’ “home IV provider” or “provider” means anentity that:

(a) Incapable of providing covered home IV drugs,nursing and pharmacy services, and other servicesas are necessary for the administration of home IVdrug therapy; and

(b) Meets all the requirements of this subpart.

Condition of Participation; Compliance WithFederal, State, and Local Laws

The home IV provider and all personnel who furnishservices must be in compliance with applicable Federal,State, and local laws and regulations.

(a)

(b)

(c)

Standard: Compliance with Federal laws. Thehome IV provider must be in compliance withapplicable Federal laws related to the health andsafety of patients.

Standard: Licensure of home IV provider. IfState or local law requires licensing, the home IVprovider must be currently licensed or approved asmeeting the standards established for licensure.

Standard: Licensure of personnel. Personnelwho provide services, including individuals whoprovide services under arrangements with thehome IV provider, must be licensed, registered,certified, or meet other applicable standards inaccordance with applicable State and local laws.

Condition of Participation: Governing Body andAdministration

(a) Standard: Governing body. A home IV providermust have either:(1) A governing body that assumes full legal

(b)

(c)

responsibility for determining, implementing,and monitoring policies governing all opera-tions of the home IV provider; or

(2) Individuals who are legally responsible for theconduct of the home IV provider and whocarry out the governing body functions that arespecified in this section.

Standard: Disclosure of ownership. The homeIV provider must comply with the provisions ofsubpart C of part 420 of this chapter, which requirehealth care providers and fiscal agents to disclosecertain information about ownership and control.

Miscellaneous reporting. The home IV providermust furnish information relevant to, and partici-pate in, surveys and studies concerning cost-

(d)

(e)

(f)

findings or other issues relating to the efficientadministration of the home IV therapy benefit asrequested by the Secretary under section 1861(jj)(3)(x)of the Act.

Standard: Chief executive officer. The gover-ning body must appoint a chief executive officerwho meets the following conditions:(1) Assumes responsibility for the overall man-

agement of the facility under the authoritydelegated by the governing body.

(2) Assumes responsibility for the day-to-dayoperation of the home IV provider.

Standard: Patient care policies. The home IVprovider must have written patient care policiesthat govern the services it furnishes. The patientcare policies must include the following:(1)

(2)

(3)

(4)

(5)

(6)

A description of the services furnished by thehome IV provider’s employees and thosefurnished under arrangements.The diagnostic criteria that identify the pa-tients for whom the services are designed.Provisions for accepting only those patientswhose needs can be met by the services itfurnishes.Procedures for the acceptance of a referral,including the assignment of appropriate staffto conduct a timely assessment of the patient’smedical and psychological readiness for homeIV drug therapy services.Procedures for quickly notifying the referringphysician if the patient does not meet the homeIV provider’s admission criteria.Procedures for notifying the referring physi-cian of incidence of phlebitis, IV infiltration,or site infection that occurs after the providerbegins furnishing home IV drug therapyservices.

Standard: Contracted services and professionalmanagement responsibility.(1) The home IV provider must:

(2)

(i) Retain professional and administrativeresponsibility for and control and supervi-sion of contracted services; and

(ii) Ensure that the services are furnished:(A) In a safe and effective manner by

nurses or pharmacists meeting thequalifications of this subpart; and

(B) In accordance with the patient’s planof care and other applicable require-ments of this subpart.

With each contractor that provides arrangedservices, the home IV provider must have alegally binding written agreement that meetsat least the following requirements:

(i) Identifies the services to be provided.

Appendix C-Home lntravenous Drug Therapy: ProposedRegulations UndertheMedicareCatastrophic CoverageAct ● 185

(ii)

(iii)

(iv)

(v)

(vi)

(vii)

(viii)

Specifies that contracted services areprovided only if directly authorized bythe home IV provider.Describes the manner in which thecontracted services are coordinated, super-vised, and evaluated by the home IVprovider.Delineates the roles of the home IVprovider and the contractor in the pa-tient care process.Provides for the preparation of patientrecords with progress notes and observa-tions and for the prompt incorporationof the patient records into the clinicalrecord of the home IV provider.Provides that the requirements for theservices furnished under arrangementsand personnel who furnish them are thesame as for the services furnished di-rectly by the home IV provider and thepersonnel who furnish them.Specifies the financial arrangementsthat provide for payment to the contrac-tor by the home IV provider for theprovision of covered services.Specifies that a contractor that furnishesservices under arrangements may notbill the patient or Medicare for coveredservices.

Condition of Participation: Patient Selection

After a patient’s referring physician requests home IVdrug therapy, the home provider makes an assessment ofeach patient and his or her needs. For hospital inpatients,the home IV provider must make this assessment prior todischarge. The home IV provider furnishes services onlyto patients whose needs can be met by its services.

(a) Standard: Medical criteria. A patient must:(1)

(2)

(3)

(4)

Be under the care of a licensed referringphysician who either prescribed the home IVdrug or established the plan of care, or both,and who continually monitors the home IVdrug therapy;Have a clinical status that allows IV drugs tobe safely administered in the home;Have venous sites available for peripheral IVcatheter or needle placement or have a centralvenous catheter or other central venous accessdevice; andBe unable, for medical or therapeutic reasons,to take the provided medication orally or byother means less intrusive than IV.

(b) Standard: Nonmedical criteria. A patient must:(1) Be capable of performing safely self-

administration of drugs and self care after

297-913 0 - 92 - 13

(2)

(3)

(4)

adequate patient education (for example, beable to learn aseptic technique and heparinlock maintenance and read and understand thelabeling of the home IV drugs) or have aprimary care giver who can perform thesetasks;Be motivated to use home IV drug therapyservices;Be psychologically stable (that is, the prospectfor adherence to a disciplined medical regimenis realistic); andHave a home environment that is conducive tothe provision of home IV drug therapy serv-ices (that is, a clean home with electricity, atelephone, running water, refrigeration, andenough space to support home IV drug therapyservices).

Condition of Participation: Plan of Care

For each patient, the referring physician must establishand periodically review a plan of care.

(a) Standard: Development of the plan of care. Aplan of care must meet the following requirements:(1)

(2)

(3)

(4)

(5)

The plan of care is developed by the patient’sreferring physician.The plan of care is implemented by the homeIV provider.The plan of care is based on the referringphysician’s initial and ongoing individualpatient assessments.The plan of care is reviewed by the referringphysician as necessary, but at least once every30 days.The plan of care includes at least the followingcurrent information about the patient and thehome IV drug therapy services to be provided:

(i)

(ii)

(iii)

(iv)

(v)

(vi)

The patient’s name, gender, age, and leanbody weight.A narrative description of the appropriatediagnoses.The patient’s drug allergies or sensitivi-ties.The patient’s current drug therapy, in-cluding nonprescription drugs, and homeremedies.The goal of the provision of home IVdrug therapy services for the patient.The drugs and method of drug therapyadministration to be furnished by thehome IV provider including:(A)

(B)

(c)(D)

Amount of dosage and timing ofadministration;Route of administration, either pe-ripheral or central venous line.Frequency of IV site monitoring; andType of IV equipment, related sup-


plies and other equipment, and fluidsto be administered.

(vii) Identifying physician information, thephysician’s signature, and the date.

(b) Standard: Referring physician review of planor care. The referring physician review of the planof care must meet the following requirements:(1)

(2)

The referring physician reviews the patient’sprocess in attaining the objectives of the planof care at least every 30 days.The review is based upon appropriate informa-tion provided by health professionals, includ-ing information furnished by the registerednurse and pharmacist employed by the homeIV provider.

Condition of Participation: Central Clinical RecordsIn accordance with accepted principles of practice, the

home IV provider must establish and maintain a clinicalrecord for all individuals receiving care and servicesincluding those who are not entitled to Medicare. Eachclinical record must be completely, promptly, and accu-rately documented, readily accessible, and systematicallyorganized to ease retrieval and compilation of informa-tion.

(a) Standard: Content. Each clinical record is acomprehensive compilation of information ofmedical and other data that must contain sufficientinformation to identify the patient clearly and tojustify the diagnosis treatment. Entries in theclinical record must be made for all servicesprovided directly or under arrangements. Entriesmust be made for each treatment performed andmust be signed by the individual who performs theservices. Documentation on each patient must beconsolidated into one clinical record that mustcontain the following information:(1)(2)

(3)(4)(5)(8)

(7)

Patient identification data.The initial patient assessment and subsequentreassessments.Current plan of treatment.Consent and authorization forms.Past and present pertinent medical history.Complete documentation of all services pro-vided.Upon completion of treatment, a summary thatincludes a-description of patient status relativeto goal achievement, prognosis, and futuretreatment considerations.

(b) Standard: Retention and preservation. Thehome IV provider must retain-clinical records forthe appropriate time period as specified in thisparagraph. If the requirements of State law areused to define the time period for maintaining

clinical records, it must be the law of the State inwhich the services were provided to the patient.(1)

(2)

If the State where the services are furnishedhas a law that applies to the provider gover-ning the maintenance of clinical records, thehome IV provider must maintain its clinicalrecords for the time required by that law.In the absence of an applicable State law, the

(3)

(4)

home IV provider must maintain clinicalrecords for the time periods provided underthe appropriate statute of limitations concer-ning medical malpractice in the State.If there is no applicable State law or Statestatute of limitations concerning medical mal-practice, the home IV provider must maintainclinical records for at least 5 years.In addition, for services furnished to a minor,the home IV provider must maintain clinicalrecords for at least 3 years after the individualattains the age of majority under State law.

(c) Standard: Protection of information. The homeIV provider must-(l)-

(2)

Safeguard the clinical record against loss,destruction, or unauthorized use;Have procedures to govern the use and re-

(3)

(4)

moval-of records, to ensure release of informa-tion only to authorized individuals, and toensure that unauthorized individuals cannotgain access to, or alter, patient records;Obtain the patient’s written consent beforereleasing information not required to be re-leased by law; andRelease original records only in accordancewith Federal or State Laws, court orders, orsubpeoneas.

(d) Standard: Patient access. The home IV providermust permit each patient of his or her legalrepresentative to inspector obtain copies of his orher clinical records within 48 working hours afterthe provider receives a written request.

Condition of Participation Core Staff, Core Services,and Full-time Availability of Patient Core Services

A home IV provider must make all necessary nursingand pharmaceutical services available 24 hours a day, 7days a week to meet the reasonable needs of its patientswith respect to home IV drug therapy services.

(a)

(b)

Standard: Core staffing requirements. A homeIV provider must employ directly either a full-timeregistered nurse or a full-time register pharmacist.

Core services. A home IV provider must performthe following oversight and supervisory functionsitself (that is, these function may not be furnishedunder arrangements);

Appendix C—Home Intravenous Drug Therapy:ProposedRegulationsUndertheMedicareCatastrophic Coverage Act ● 187

(c)

(1)

(2)

(3)

(4)

Assurance that all patient care related nursingand pharmacy services, whether furnisheddirectly or under arrangements, are availableon a 24-hour-a-day, 7-day-a-week basis.Development and coordination of all activitiesof nurses and pharmacists including assuringthat only qualified, properly trained individu-als furnish these services.Necessary consultations and coordination con-cerning a patient’s plan of care with thepatient’s physician and provision of all patientlaboratory test results.Conduction a quality assessment and assur-ance program including drug regime review.

Standard: 24-hour availability of patient careservices.(1) To meet the needs of patients, a home IV

provider may contract for additional nursingor pharmacyservices to supplement the serv-ices directly furnished by the home IV pro-vider. If services directly furnished underarrangement [sic], the provider must maintainprofessional, financial: and administrative re-sponsibility for the services.

(2) A home IV provider must be able to meet thefollowing time requirements related to care ofa patient:

(i)

(ii)

(iii)

(iv)

The home IV provider must make routineor urgently needed nursing, pharmacy,and related services and home IV drugsand supplies available 24 hours a day, 7days a week.The home IV provider must be accessibleto patients at all times. If a patient orcaregiver telephones the home IV pro-vider with a problem concerning theadministration of a drug or malfunction-ing equipment, the provider must be ableto make telephone contact with the pa-tient or caregiver within 10 minutes, andthe provider must be able to resolve thatproblem as expeditiously as possiblegiven the nature of the problem.In an emergency, the provider must beable to deliver drugs to the patient at least30 minutes before the drugs are sched-uled for use.The home IV provider must furnishservices in a manner consistent withaccepted standards of medical practice.

Condition of Participation: Nursing Services

(a) General requirements. The home IV provider isresponsible for furnishing nursing services, di-rectly or under arrangements, that are necessary forthe provision of IV drug therapy services. Persons

furnishing the nursing services either as employeesof the home IV provider or of the organizationunder contract with the home IV provider must beeither registered nurses, or in States that permitsuch practice, physicians or physicians assistantsunder the supervision of a physician. (In suchStates, the references in this subpart to a “regis-tered nurse” or “nurse” are read to includephysician assistants.) In addition, the home IVprovider must:(1) Direct and staff nursing services to ensure that

the needs of its patients are met;(2) Specify the patient care responsibilities of the

nurses; and(3) Ensure that the requirements of paragraphs (b)

through (d) of this section are met.

(b) Education and experience.(1) The home IV provider must ensure that each

nurse who furnished home IV drug therapyservices meets the following requirements foreducation. experience, and proficiency:

(i)

(ii)

(iii)

(iv)

Education in the principles and practicesof infusion therapy and cardiopulmonaryresuscitation.Experience in patient assessment andinfusion therapy.Proficiency in all clinical aspects of IVtherapy with validated competency inclinical judgment and practice demon-strated by work experiences. For examp-le, each nurse must be able to accessperipheral veins and must be able torecognize medication and solution in-compatibilities.Ability to perform the following proce-dures:(A)

(B)

(c)

(D)

(E)

(F)

Interpret the physician’s order for IVtherapy and administer IV medica-tions as ordered.

Perform venipuncture and insertionof all types of needles and catheterscommercially available (excluding theinsertion of subclavian, jugular, andcut-down catheters).Prepare IV solutions with the addi-tion of medications in the absence ofadmixture services.Initiate, monitor, and terminate IVsolutions and additives.Evaluate the effectiveness of the dos-age, frequency, and route of adminis-tration of IV drugs and the patient’sadherence to the drug regimen.Set the flow rates established by thephysician for all IV solutions andmedications.


(c)

(d)

(e)

(G) Maintain and replace sites, tubing,and dressing in accordance with es-tablished policy.

(H) Draw blood.(v) Thorough knowledge of and proficient

technical ability in the use of the specifictype of IV equipment to be used by aparticular patient so that the nurse is ableto evaluate IV equipment and identifywhen maintenance would be necessary.

(vi) Ability to observe and assess all signifi-cant reactions related to IV therapy andinitiate appropriate nursing interventions.

Aseptic practices. Each nurse must follow estab-lished infection control and aseptic practices.

Physician notification. All significant findings ofthe nurse in the course of delivering home IVservices must be communicated to the physician.

Documentation. Each nurse must document in thepatient’s clinical record his or her action associatedwith the preparation, administration, and termina-tion of all aspects of IV therapy.

Condition of Participation: Pharmacy ServicesThe home IV provider must ensure that a registered

pharmacist is responsible for purchasing, preparation,safe administration, and clinical monitoring of drugs. Thehome IV provider may directly furnish necessary phar-macy services or it may enter into arrangements for theservices.

(a) Standard: Pharmacy services management. Thehome IV provider must ensure that necessarypharmacy services, furnished directly or underarrangements, are furnished in accordance with thefollowing requirements:(1)

(2)

(3)

The policies and procedures of the home IVprovider must ensure that pharmacy practice atall times is consistent with applicable law andregulations governing professional licensureand operation of pharmacies.The home IV provider must maintain andmake available an up-to-date copy of HCFA’slist of covered home IV drugs and pharmaceu-tical references that include official pharma-ceutical practice as it relates to patient care.The home IV provider must maintain patientprofiles that include: (i)

(ii)(iii)

(iv)

The patient’s name, age, and lean bodyweight;The patient’s diagnosis or diagnoses;Clinical information relating to the pa-tient’s initial and ongoing home IV drugtherapy;Current drug therapy provided to the

patient including nonprescription and homeremedy products; and

(v) A description of the patient’s drug aller-gies or sensitivities.

(4) A pharmacist reviews each prescription orderbefore dispensing a drug to ensure that thedrug is a covered home IV drug and that thecorrect drug is dispensed to the patient.

(5) A pharmacist assists the physician in deter-mining the appropriate schedule for monitor-ing the patient through laboratory testing. Thisschedule must include identification of tests tobe performed and the Medicare-approvedlaboratory that will perform the tests andfrequency of testing and obtaining the results.

(6) A pharmacist supervises support personnel toensure adequate quality of the drugs andpharmaceutical supplies.

(b) Standard: Storage, equipment, and prepara-tion area.(1) The IV provider must ensure that drugs,

supplies, and equipment are maintained in thepharmacy in accordance with the followingprocedures: (i)

(ii)

(iii)

(iv)

(v)

(vi)

Drugs must be stored separately underproper conditions of sanitation, tem-perature, light, moisture, ventilation, andsecurity.Areas used in the preparation of sterileproducts must be constructed to mini-mize opportunities for particulate andmicrobial contaminations and must beseparate from areas used in preparation ofnonsterile products.Work surfaces are kept free of equip-ment, supplies, records, and labels unre-lated to the preparation of a given pre-scription.Work surfaces and equipment must bedisinfected after the preparation of eachprescription.Clean work benches or laminar flowhoods must be used in the preparation ofIV drugs and must be inspected at leastannually in accordance with standardinspection practice.Both ingredients and final products mustbe inspected for the presence of inappro-priate particulate matter or signs of deteri-oration or microbial contamination. Theequipment necessary for such an inspec-tion must be maintained by the pharmacy.

(vii) Drugs must be kept in a locked storagearea.

(vii) Each dosage unit of both a cytotoxicdrug and a Schedule II controlled drug


(c)

(2)

(3)

(4)

must be accounted for in a distributionlog.

Unless contraindicated, an appropriate air-eliminating filter must be employed in thehome for delivery of IV fluids.Mislabeled or otherwise unusable drugs mustnot be made available for patient use.Outdated drugs must be destroyed.

Standard: Drug labeling. The label on any IVdrug or solution that has been dispensed to apatient must contain at least the following informa-tion:(1)

(2)

(3)

(4)

(5)

(6)

(7)(8)(9)

The name, address, and telephone number forthe pharmacy and the telephone number of thehome IV provider if the pharmacy services arefurnished under arrangements.The dates of both preparation and expiration ofthe drug.The pharmacy’s identifying serial number forthe drug order or prescription.The full name of both the patient and prescrib-ing physician.The name of the drug, its strength, and theamount dispensed.The directions for use including the scheduleddate, time, and rate of administration, andappropriate space for the patient or caregiverto add the date and time the solution is started.These directions must indicate that the IVfluids must be completely used or discardedwithin 24 hours of mixing or unfreezing amixture.The directions for storage.Cautionary or accessory labels if appropriate.The lot number or control number of the batchfrom which the drug was obtained.

Condition of Participation: Patient and CaregiverEvaluations and Instructions

To ensure safe home IV therapy for the patient, aregistered nurse who is proficient in the delivery of homeIV drug therapy services evaluates the patient to deter-mine suitability for the provision of home IV drug therapyservices. If the nurse determines that the patient is suitablefor this therapy and the home IV provider can furnish thenecessary therapy, the nurse trains the patient or caregiveror both, as appropriate, in providing the therapy and inproper maintenance of the equipment.

(a) Standard: Patient evaluation. The registerednurse performs the following activities:(1) Reviews the referring physician’s medical

orders before evaluating a patient for home IVdrug therapy.

(2) Before accepting the patient for care, evaluatesthe patient or caregiver for general compe-

(b)

(3)

(4)

tency and specific comprehension of theparticular IV drug therapeutic procedures to beused. In making this evaluation, the nurse:

(i)

(ii)

(iii)

Discusses possible complications of thetreatment with the patient or caregiver orboth as appropriate.Explains and demonstrates home IV drugtherapy procedures to the pat ient orcaregiver.After the patient or caregiver demon-strates IV drug therapy procedures, in-cluding aseptic techniques, evaluates anddocuments the competency and profi-ciency of the patient or caregiver.

May inspect the patient’s home prior tohospital discharge to ascertain that there is anarea in the home available for storage of drugsand supplies and an area available for use ofsterile supplies.Supervises the patient or caregiver when eitherstarts the first infusion therapy at home toverify his or her ability to transfer learningfrom the provider setting to the home setting.

Standard: Patient and caregiver education andinstructions. The nurse instructs the patient orcaregiver, as appropriate, in home IV drug therapyprocedures, including aseptic techniques and pro-vides written and illustrated instructions.(1) The written instructions that are prepared for

each different drug class and administrationroute must include the following information:

(i)

(ii)(iii)

(iv)

(2) The

A step-by-step description of the pro-cedures that the patient or caregiver mustfollow in administering an IV drug,including procedures for any probableemergency that might arise.Storage procedures.Procedures for disposal of drugs and IVequipment.A telephone number that would enable apatient to receive assistance at any time.nurse must instruct the patient or care-

giver about the following:“(i)

(ii)

(iii)

Methods of detecting early signs andsymptoms of IV-related sepsis and com-plications so that they may be reportedimmediately to the home IV provider’smedical personnel.When appropriate, use of electronic con-trolling devices (for example, an infusionpump) in delivery of home IV drugtherapy so that the patient or caregivercan recognize any malfunction thatshould be reported to the home IVprovider.Emergency interventions for possible IV


(iv)

(v)

complications that can be performed bythe patient or caregiver.Discarding IV needles in an appropriatereceptacle (such as a Sharp’s container)that is properly labeled and that is re-moved by the home IV provider staff orpersonnel at least every 3 days.Procedures for recording the administra-tion of IV solutions and drugs so theinformation can be given to the home IVprovider and attached to the patient’sclinical record.

(3) The nurse must discuss the range of physicalactivity that is appropriate for the patient.

Condition of Participation: Protocols and PoliciesThe home IV provider adheres to the following

procedures and has written protocols and policies consist-ent with respect to the provision of home IV drug therapyitems and services.

(a) Standard: First dose. The first dose of any drugnot previously administered intravenously is ad-ministered under the direct supervision of aphysician or nurse who must:(1) remain in attendance for a time period suffi-

cient to make sure that the patient is stable; and(2) Have resuscitation medication and equipment

to treat anaphylaxis readily available.

(b) Standard: Venipuncture and catheter care.(1)

(2)

(3)

(4)(5)

(6)

The site of a peripheral catheter is rotated bythe nurse at least every 3 days. A catheterwhose tip lies in a central vessel must berotated by a physician when appropriate.IV administration sets are changed at leastevery 24 hours by the patient or caregiver.IV dressings should be changed at least every48 hours or immediately upon becomingsoiled or wet.The air elimination filter is routinely changed.The central line catheter site is inspected by anurse at least once each weekAseptic techniques are practiced during allvenipuncture, dressing changes, catheter care,and assembly of IV infusion systems.

(c) Standard: Quality of the air elimination filterand sterility of the catheter.(1) On a sample of patients, the nurse packages air

(2)

elimination filters that have been removed bythe nurse from the IV tubing and immediatelysends then to an independent laboratory foranalysis of particulate matter and bacterial andfungal contamination.On a sample basis, the home IV providerpackages catheters that have been removed

(3)

from patients and immediately sends them toan independent laboratory for analysis ofsterility.The home IV provider keeps copies of labora-tory results on the testing of both air elimina-tion filters and catheters that are made avail-able for review upon request.

(d) Standard: Drug therapy review.(1) The pharmacist and nurse must review the

combination of IV drugs and equipment forappropriateness before drug therapy is initi-ated.

(2) The pharmacist must conduct ongoing review(at least once every 3 days) of the drug therapyand inform the physician of significant find-ings. As a minimum, this review must includethe appropriateness of the drug regimen andany instances of therapeutic duplication ofdrugs.

(e) Standard: Patient rights and responsibilities.The home IV provider must ensure that thefollowing requirements are met:(1)

(2)

(3)

(4)

(5)

Treatment of a patient begins only if the homeIV provider is capable of furnishing neededcare at the level of intensity required by thecondition of the patient.Each patient receives care appropriate to his orher needs in a timely manner.The patient is informed in a timely manner ofthe need for transfer to another medical entityor level of care and of any appropriatealternatives.If the home IV drug therapy is to end withouttransfer to another medical entity, the patientis informed in a timely manner of the impend-ing discharge, continuing care requirementsand other available services, if needed.Patients’ rights as set forth in this paragraph

(6)

are honored and patients are informed of theirresponsibilities, if any, in the care process. Therights and responsibilities are clearly stated indocuments distributed to patients upon admiss-ion to the home IV drug therapy program.Procedures are established to deal with patientgrievances and patient-recommended changeswithout coercion, discrimination, reprisal, orinterruption of services. A patient is informedat the beginning of home IV drug therapyabout these procedures for making, reviewing,and resolving complaints.

(f) Standard: Written protocols and policies. Thehome IV provider has written protocols andpolicies that are consistent with these procedures.

Appendix C—Home Intravenous Drug Therapy:ProposedRegulatjons Under the Medicare Catastrophic Coverage Act . 191

Condition of Participation: Quality Assurance

The home IV provider maintains an ongoing qualityassurance program designed to monitor patient careobjectively and systematically, evaluate the quality andappropriateness of patient care, resolve identified prob-lems, and pursue other opportunities to improve patientcare, resolve identified problems, and pursue otheropportunities to improve patient care.

(a) Standard: Program objectives. Through an on-going, planned, and systematic process, the homeIV provider monitors and evaluates the quality andappropriateness of patient care, including theperformance of employees and other personnelwho furnish services under arrangements with thehome IV provider. The home IV provider includesat least the following in a written evaluation plan:(1)

(2)

(3)

(4)(5)

Scope and objectives of the quality assuranceactivities.Activities identified for monitoring and evalu-ation.Methods for implementing the monitoring andevaluation activities and for reporting theresults.Mechanisms for taking follow-up action.Staff responsibilities for each activity in thequality assurance program.

(b) Standard: Patient care.(1)

(2)

The monitoring and evaluation of the qualityand appropriateness of patient care by thehome IV provider must include identificationof important aspects of care or service andfocus on high-risk high-volume, or problem-prone activities.The home IV provider collects data about thefollowing matters:

(i)

(ii)

(iii)

Length of home IV drug therapy bydiagnosis and treatment.Incidence and causes of patient rehospi-talization.Incidence of:(A) Phlebitis;

(c)

(3)

(B) Infiltration;(C) Site infection; and(D) Other infection.

(iv) Hydration and nutritional status.The home IV provider analyzes the data itcollects at least annually to determine thefrequency of negative outcomes and pre-scribes corrective action for negative out-comes.

Standard: Service delivery. The provider deter-mines the following:(1)

(2)

(3)

(4)

(5)

(6)

Drugs and IV equipment were delivered timelyto the patient.The patient could read the preparation andexpiration dates on the drug labels.A nurse visited a patient with a peripheral IVcatheter placement every 3 days and rotatedthe peripheral IV injection site.A nurse visited any patient with a central lineat appropriate intervals for monitoring.Procedures have been established to enablepatients to make complaints.The provider found acceptable solutions forcomplaints and kept a record of both.

Condition of Participation: Infection ControlThe home IV provider must develop infection control

procedures. These procedures must address at least staffpersonal hygiene and health status, isolation precautions,aseptic procedures, cleaning and sterilization of equip-ment, and methods to avoid transmitting infections. Thehome IV provider:

(a)

(b)

Advises staff, patients, and caregivers of anynecessary precautions, including infection controland personal hygiene and their responsibilities inthe infection control program; and

Develops a system for evaluating, reporting, andmaintaining records of infection related to the careof service provided among patients and as appro-priate, among staff.

Appendix D

A BASIC ECONOMIC MODELOF HOME DRUG INFUSION PROVIDER BEHAVIOR1

Basic economic models of health provider behaviorhave been applied to hospitals, physicians, nursinghomes, and home health agencies. The models are of twotypes: 1) those that assume that providers are profitmaximizing, and 2) models of behavior of not-for profitorganizations.

The first type of model has been applied to bothfor-profit and not-for-profit organizations, where it isassumed that not-for-profit providers face essentially thesame financial incentives as for-profit providers operatingin the same markets. Models of the second type (see, e.g.,references 89,175,244,258) incorporate some specificfactors thought to affect behavior of not-for-profit organi-zations. These include the possible desire of managers tomaximize size or prestige of their organization or tosatisfy the desires of special interest groups. Theseobjectives, in turn, may imply that not-for-profit organi-zations pay more attention to volume of services, quality,or their reputation for community service than for-profitorganizations.

The critical issue here, however, is whether there aredifferences in the way for-profit and not-for-profit organ-izations respond to incentives created by alternativepayment methods. This appendix will later discuss somepossible differences, but it assumes thereto be substantialsimilarities in the responses of for-profit and not-for-profit organizations; similar interests in the financialviability of the organization transcend differences in formof control. For both types of organizations the principaldeterminants of the quantity, cost, and quality of servicesinclude:

the cost of inputs,the technology of production,the demand for services by patients, andthe level and form of public and private payment forservices.

AssumptionsA model must be based on some assumptions about

provider behavior and the cost structure. This modelbegins with an assumption that providers are profitmaximizers, or behave much like profit maximizers

subject to some constraints to be specified. It later notesdifferences where they may be important.

The model presumes that providers incur some fixedcosts (e.g. administrative overhead) and have a constantor near-constant marginal cost for services (for equip-ment, supplies, and labor). These assumptions are reason-able for home drug infusion therapy providers since mostsuch providers can hire staff locally without significantlydriving up the market price. Most such providers probablyemploy a small share of the suitable employees locallyand represent a small share of the national market forsupplies. Limited short-run supply of staff in small marketareas may, nonetheless, lead to an upward-slopingmarginal cost curve for some providers.

The model presumes that providers serve both Medi-care and nonMedicare patients. It also presumes that,except in cases of patient cost sharing (deductibles andcopayments), the demand of Medicare patients is inde-pendent of prices charged, but that at least some otherpatients (self payers or those with insurance involvingcost sharing) are sensitive to prices. So the demand ofMedicare patients is perfectly price inelastic and provid-ers face a downward sloping demand curve for servicesprovided to other patients.

Provider Behavior Under DifferentForms of Reimbursement

Figure D-1 illustrates profit maximization under costreimbursement. The demand of private-pay patients is Dpand the associated marginal revenue curve is MRp. Theprovider’s average cost curve is AC. This cost curveshould be viewed as endogenous-costs could be higheror lower, depending on visit quality and provider effi-ciency. Pp and Pm represent payment levels from privatepatients and Medicare, respectively.

In this mode12the provider maximizes profits by settingmarginal revenue equal to marginal cost, where the

mined by the (horizontal)marginal revenue curve is detesum of the private patient marginal revenue curve and thedemand of Medicare beneficiaries (MRp + Din). At pointA in figure D-1 the provider supplies Q1 units of serviceto private-pay patients and Q2-Q1 units to Medicare

1 This appendix is based on T. Oranne_ ‘‘Incentives and Behavioral Response to Alternative Payment Methods for Home Intravenous andImmunosuppressive Drug Therapies Under the Medicare Program,’ paper prepared under contract to the OffIce of ‘lkchnology Assessment, WashingtonDC, February 1990.

2 See reference 111 for basic models of provider behavior, or reference 254 for a similar model of provider response to limited Medicaid paymentrates.

-192-

Appendix D-A Basic Economic Mode/of Home Drug Infusion Provider Behavior . 193

Figure D-l—Home Drug Infusion Therapy ProviderBehavior: Profit Maximization Under

Cost Reimbursement

cost M RP + Dm

\

Profit\ P

P m ,

\\\\\

ACMC

Q, MRP D Qp 2Quantity of visits

NOTE: See text for explanation.SOURCE: T. Grannemann, “Incentives and Behavioral Responses to

Alternative Payment Methods for Home Intravenous and im-munosuppressive Drug Therapies Under the Medicare Pro-gram,” paper prepared under contract to the Offioe of Technol-ogy Assessment, Washington, DC, February 1990.

patients. The profit (or surplus for not-for-profit provid-ers) is shown in the shaded area.

Prospective payment, that is, where providers receivea predetermined, fixed rate of payment, provides strongincentives to control costs. In figure D-2, under costreimbursement the only gain to the provider fromreducing average cost from AC1 to AC2 is the dark area.But under prospective payment, the provider could keepthe dotted area as profits as well, thus providing extraincentive to reduce costs. A shift from cost reimbursementto prospective payment in such circumstances could giveproviders a short-run windfall gain in profit or surplus andcould provide Medicare with an opportunity to lower perunit payments below the initial level of Pm. Profit-seeking providers might be the most responsive to suchincentives, while not-for-profit organizations may be lessinterested in additional surplus than in maintaining highquality at the higher cost. The choices for not-for-profitorganizations nonetheless are expanded by prospectivepayment, as they are given an opportunity to use anysavings derived from reduced costs for other purposes,such as covering care for the poor or providing otherservices needed in the community.

Figure D-2—Home Drug Infusion Therapy ProviderBehavior: Profit Maximization Under

Prospective Payment

P p

P m

MC

l\\

\! \\

\\\\\

\ \

Q, MR PD Qp 2

NOTE: See text for explanation.

SOURCE: T. Grannemann, “Incentives and Behavioral Responses toAlternative Payment Methods for Home Intravenous and lm-munosuppressive Drug Therapies Under the Medicare Pro-gram,” paper prepared under oontract to the Offioe of Technol-ogy Assessment, Washington, DC, February 1990.

Impacts on Quality of Care

Like quantity, the level of quality a provider chooses toproduce can be viewed as a product of supply anddemand. Fully insured patients who have no cost-sharingrequirements can be expected to demand the highest levelof quality, to the point where extra quality provides noadditional benefit (after accounting for any cost in termsof patient inconvenience). Cost-reimbursed providershave every reason to be accommodating to these patientdesires. Providers may, however, provide a uniformstandard of care to all their patients. So a provider’squality standards may reflect the best possible accommo-dation to all patients, insured and uninsured.

The provider’s choice of quantity and quality of visitsis illustrated in figure D-3. This figure shows possiblecombinations of quality and quantity. The iso-cost (IC)curves represent combinations of quality and quantity thatcan be attained at a given cost. The Engle curve (E)represents the patient’s preferred combinations of qualityand quantity, given the relative costs of producing each.This curve is determined by the point of tangency ofindifference curves with iso-cost curves.


Qua

Figure D-3—Provider Tradeoffs Between Quality andQuantity of Visits Under Alternative

Payment Methods

l i t y

‘o

%

P r i c e

D.

Q* Qo Q u a n t i t y

I

III

D\ !

III

Q Qo Q u a n t i t y

NOTE: See text for explanation.

SOURCE: T. Grannemann, “Incentives and Behavioral Responses toAlternative Payment Methods for Home Intravenous and lm-munosuppressive Drug Therapies Under the Medicare Pro-gram,” paper prepared under contract to the Office of Technol-ogy Assessment, Washington, DC, February 1990.

Point A represents cost reimbursement in which thepatient demands and receives Qo visits-the amountdemanded at zero out-of-pocket cost, shown in the lowerportion of the figure. The quality of visits, determined bythe provider’s standard of care, S, is directly related to thecost curve discussed above. Lower costs imply lowerquality, though more efficient providers may have lowercosts without sacrificing quality.

Point B in figure D-3 represents the likely result ofper-visit prospective payment that covers at least marginalcost. The provider has incentives to keep costs lower thanwith cost reimbursement and may provide services ofsomewhat lower quality. But the provider has no reasonto deviate from the patient’s desired quantity of care,

Qo-since the provider continues to make a profit on eachunit of service.

Point C represents the possible outcome of per-monthor per-episode prospective payment. Providers wouldmaximize profits by keeping costs as low as possiblesubject to the need to maintain patient satisfactionsufficient to maintain a suitable patient load. Professionalstandards, or quality assurance standards imposed byMedicare, must also be met. Profits can be expressed as:

Profit = N(quality, quantity) * payment - cost(quality,quantity)

First order conditions for profit maximization requirethat the marginal contribution of quality and quantity tonumber of patients (N) weighted by the payment rate justequals their respective marginal contribution to cost.

To maximize profits, then, providers must operatewhere the marginal cost due to increased quality (quant-ity) just equals the marginal benefit in terms of patientsadded due to a quality (quantity) increase. Providers thusmust be responsive to patient preferences regardingquality and quantity mix. It is likely, therefore, thatproviders under per-month or per-episode prospectivepayment will operate close to the Engle curve in figureD-3 and on an iso-cost curve lower than would be the caseunder cost reimbursement or per-visit prospective pay-ment. If, as shown by point C and the lower portion offigure D-3, competitive forces lead to a point on the Englecurve where the quantity equals what would be demandedby an uninsured patient, then an optimal quantity andquality would also be achieved in the sense that marginalcost equals marginal benefit to the patient. One wouldtherefore expect per-month or per-episode prospectivepayment to lead to lower quality and fewer visits per weekthan would be found under cost reimbursement.

While incentives would lead providers in this direction,competitive forces and quality assurance regulationscould counterbalance this effect. If policymakers desirehigher quality and frequency of visits than competitiveforces and professional standards can sustain, thenregulations or other quality assurance systems must beestablished.

To summarize the implications of this model:

●

●

●

Cost reimbursement promotes high quality care withincentives for providers to meet any patient demandsfor quantity (frequency) of service.Per-visit prospective rates promote cost control andlower quality, without any incentive to reducequantity (frequency) of visits.Per-month or per-episode prospective paymentsencourage both cost control and reduction in quan-tity or frequency of visits.

Appendix D—A Basic Economic Model of Home Drug Infusion Provider Behavior . 195

. Quality assurance mechanisms or regulatory con- quality but not frequency of visits. Under per-monthtrols may be used to counter some of the adverse or per-episode rates, controls maybe needed on botheffects of incentives under prospective payment. quality and frequency of visits.Under per-visit rates, controls may be needed on

Appendix E

GLOSSARY OF TERMS

Access: Potential and actual entry of a population into thehealth care delivery system.

Acute care: Services within a hospital setting intended tomaintain patients for medical and surgical episodiccare over a relatively short period of time.

Acute disorder: Characterized by a sudden onset,marked symptoms, and a short course.

Analgesic drug: A substance causing loss of sensitivityto pain without loss of consciousness.

Anaphylaxis: An unusual or exaggerated allergic reac-tion to foreign proteins or other substances.

Anemia: An abnormal decrease in the concentration oferythrocytes (red blood cells), concentration of hemo-globin, or hematocrit.

Antibiotic drug: Any of a number of substances pro-duced by one microorganism and inhibitory to anothermicroorganism.

Antineoplastic drug: Substance acting against the for-mation of a tumor.

Artery: A blood vessel that carries the blood away fromthe heart to the various parts of the body.

Aseptic: Free from infection.Average cost: For a home infusion provider, average

total cost per patient is the sum of all the provider’scosts of providing services, divided by the number ofpatients served. Of total costs, some costs are fixed inthe short run (e.g., capital equipment), while othersvary depending on the number of patients served (e.g.,dressing supplies). Average variable costs are the sumof these variable costs, divided by the number ofpatients served. In the long run, average variable costsmay approximate marginal costs.

Catheter: In infusion therapy, the tube that is insertedinto the body (e.g., into a vein) so that drugs or otherfluids can be administered.

Cellulitis: Infection of the skin and surrounding softtissue.

Central access device: An infusion device in which thecatheter is inserted directly into a large vein near theheart.

Chronic disorder: A disorder characterized by extendedduration and typically by slow development or apattern of recurrence.

Conditions of participation: Requirements that a hospi-tal or other health care facility must meet in order to beallowed to receive payments for Medicare patients. Anexample is the requirement that hospitals conductutilization review.

Cystic fibrosis: A genetic disorder that results inabnormal mucous secretions, including excess mucusin the lungs. Persons with cystic fibrosis are predis-posed to recurrent pulmonary infections.

Cytotoxic drug: A drug that has a specific toxic actionupon cells or special organs.

Diagnosis-related groups (DRGs): Groupings of diag-nostic categories drawn from the International Classi-fication of Diseases and modified by the presence of asurgical procedure, patient age, presence or absence ofsignificant comorbidities or complications, and otherrelevant criteria. DRGs are the case-mix measuremandated for Medicare’s prospective hospital pay-ment system by the Social Security Amendments of1983 (Public Law 98-21).

Dialysis: In persons with end-stage renal disease, aprocess that rids the body of liquid waste products,replacing the kidney’s normal function.

Drug regimen: A systematic plan for taking medicationthat is designed to improve or maintain the health of apatient.

Durable medical equipment: Medical equipment that iscapable of withstanding repeated use, generally notuseful to someone in the absence of injury or illness,and appropriate for home use. Examples includeintravenous poles and infusion pumps.

Elastomeric infuser: An infusion device that consists ofa disposable container with an inner elastic bladder thatcan be filled with medication.

Embolus: A detached blood clot, air bubble, or clump offoreign matter that blocks or occludes a blood vessel.

Enteral nutrition: The intake of nutrients that undergo atleast partial processing in the intestine. Strictly speak-ing, enteral nutrition includes normal food intakethrough the mouth. However, the term is often used toindicate more specifically the intake of nutrientsthrough a tube that leads directly to the stomach or thesmall intestine.

Epidural drug administration: Entrance of a drug intoepidural space surrounding the spinal cord, so that thedrug is absorbed directly into the spinal cord.

Extravasation: The forcing out of fluid (e.g., an infuseddrug) from a proper vessel into the surrounding tissue.

Family caregiver: A family member or friend whoassists the patient in self-care responsibilities on anunpaid basis.

Febrile: Of or pertaining to fever.Fiscal intermediary: An organization that acts as an

agent and purchaser of health care insurance or healthcare services for an insurer. Medicare’s fiscal interme-diaries include Part A intermediaries and Part Bcarriers (see Medicare intermediaries or carriers).

Granulocyte: A leukocyte (white blood cell) that con-tains granules in its cytoplasm.

Gravity drip system: A drug delivery system in which abag or bottle is hung on a hook or a pole above the level

-196-

Appendix E-Glossary of Terms . 197

of the patient, and fluid flows by gravity down the lineand into the catheter. The rate of flow in a simplegravity drip system is controlled primarily by a specialclamp or valve on the line that can be adjusted topermit the prescribed amount of fluid to flow through.

Health maintenance organization: A health care organ-ization that, in return for prospective per capitapayments, acts as both insurer and provider of compre-hensive but specified medical services.

Hemolytic reaction: A process by which erythrocytes(red blood cells) are destroyed.

Hemophilia: An inherited disease in which the bodylacks blood coagulation (clotting) factors.

Heparin: An anticoagulant drug.Homebound: Confined to the home.Home drug infusion therapy: Treatment that consists of

prolonged (or continuous) injections of drugs that areadministered in the home, usually repeatedly.

Home health agency: An organization that delivershealth services to patients in the home setting.

Hospice: A facility or program designed to provide acaring environment for supplying the physical andemotional needs of the terminally ill.

Immune globulin: A biological preparation that consistsof proteins from human blood plasma. These proteinsreact with foreign proteins to form antibodies that aidin the body’s defense against infections.

Immune system: The body’s defense method, character-ized by a high degree of resistance to specific foreignsubstances.

Infiltration: The accumulation in a tissue of substancesnot normal to it or in amounts in excess of the normal.

Infusion: In this report, the slow, prolonged injection ofa fluid into the body.

Infusion pump: A device that moves an infused fluid intothe body under positive pressure.

Inpatient services: Care that includes an overnight stayin a medical facility.

Intravenous drug administration: Entrance of a druginto the body by way of a vein.

Length of stay (LOS): The number of days a patientremains in the hospital from admission to discharge.

Licensed practical nurse: A nurse with usually 12months of practical nursing training and licensure, asopposed to a registered nurse with a four yearbaccalaureate degree and licensure.

Marginal cost: The incremental cost to the provider orsupplier of serving one more patient.

Medicaid: A Federal-State medical assistance programauthorized in 1965 to pay for health care services usedby people who meet income and other requirements.Eligibility requirements and benefits vary from Stateto State.

Medicare: A nationwide, federally administered healthinsurance program authorized in 1965 to cover the costof services for eligible persons over age 65, persons

receiving Social Security Disability Insurance pay-ments for 2 years, and persons with end-stage renaldisease. Medicare consists of two separate but coordi-nated programs-hospital insurance (Part A) andsupplementary medical insurance (Part B). Healthinsurance protection is available to insured personwithout regard to income.

Medicare beneficiary: One who receives coverage forhealth services under Medicare.

Medicare intermediaries or carriers: Fiscal agents(typically Blue Cross plans or commercial insurancefirms) under contract to the Health Care FinancingAdministration for administration of specific Medicaretasks. These tasks include determining reasonablecosts for covered items and services, making pay-ments, and guarding against unnecessary use ofcovered services. In this report, intermediaries andcarriers are collectively referred to as fiscal intermedi-aries.

Metabolism: The totality of chemical processes occur-ring in a living organism.

Narcotic: A drug that dulls the senses, relieves pain, andinduces profound sleep.

Neoplastic disease: A condition causing or resulting intumor formation.

Nosocomial infection: An infection originating in ahospital.

Osteomyelitis: Infection of the bone.Outpatient facility: A healthcare facility where medical

services are provided to patients who are not inpatientsof hospitals.

Palliative treatment: Treatment whose goal is patientcomfort rather than cure.

Parenteral drug administration: Entrance of a drug intothe body by means other than through the digestivetract.

Peer Review Organization: Organizations established in1982 (Public Law 97-248) with which the U.S.Department of Health and Human Services contracts toreview the appropriateness of settings of care and thequality of care provided to Medicare beneficiaries.

Per capita payment: A payment rendered to a provider,typically on a monthly basis, to cover costs of all careprovided to that patient during a given time period.

Primary care physician: A physician who providesbasic first-line medical care, such as a practitioner,general pediatrician, obstetrician/gynecologist, andgeneral internist.

Prospective payment: Payment for medical care on thebasis of rates set in advance of the time period in whichthey apply. The unit of payment may vary fromindividual medical services to broader categories, suchas hospital case, episode of illness, or person (cavita-tion).

Prosthetic device: An artificial replacement for a missing(or nonfunctional) body part.


Pulmonary embolism: The sudden obstruction of ablood vessel in the lungs by an abnormal particlecirculating in the blood.

Quality assessment: Measurement and evaluation of thequality of health care provided to individuals or togroups of patients.

Quality assurance: Conduct of activities that safeguardor improve the quality of health care by correctingdeficiencies found through quality assessment.

Retrospective payment: A payment method for healthcare services in which hospitals (or other providers) arepaid for services rendered after the service has takenplace. In this country, the term has traditionallyreferred to hospital payment, since other providershave generally been paid on the basis of chargesinstead of costs.

Secondary infection: A second infection occurring in aperson already suffering from an infection of anothernature. For example, a person being treated by druginfusion for a bone infection could become secondarilyinfected as a result of organisms entering the bodythrough a catheter.

Septicemia: The presence of disease-causing bacteria inthe bloodstream.

Skilled nursing facility: A subacute or long-term carefacility that provides skilled nursing care (i.e., care thatrequires the expertise of a trained nurse).

Subcutaneous drug administration: Entrance of a druginto the body by means of a needle or catheter insertedunder the skin.

Swing-bed: Licensed acute-care beds designated by ahospital to provide either acute or long-term care

services. A hospital qualifying to receive Medicare andMedicaid reimbursement for care provided to swing-bed patients must be located in a rural area (as definedby the U.S. Bureau of the Census), have less than 100acute-care beds, and (when applicable) must havereceived a certificate of need for the provision oflong-term care services from its State health planningand development agency.

Third-party payer: Payment by a private insurer orgovernment program to a medical provider for caregiven to a patient.

Thrombocytopenia: A condition that results in a fewerthan normal number of platelets per unit volume ofblood.

Thromboembolic disease: Obstruction of a blood vesselwith thrombotic material carried by the bloodstreamfrom the site of origin to plug another vessel.

Thrombophlebitis: Inflammation of a vein associatedwith thrombus formation.

Thrombus: An aggregation of blood factors, primarilyplatelets; a clot. If the clot detaches and moveselsewhere in the bloodstream, it is termed an embolus.

Total parenteral nutrition: A feeding system thatincludes all the nutrients needed by the body and thatis introduced into the body intravenously.

Vascular system: The body’s network of arteries, veins,and capillaries.

Vein: A vessel that carries blood from various organs orparts back to the heart.

Vesicant: A substance capable of inducing discharge orblister.

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Documents

Home Drug Infusion Therapy Under Medicare