Issue - Hawaii Medical Service AssociationPointer. 11 58100 1 11 58100 47 1 ... Precertification is required for condit ions and indications that are not listed in the ... Cosmetic

A MESSAGE FROM OUR MEDICAL DIRECTOR

Reporting Requirements

vs. Confidentiality

“privacy” are buzzwords

in today’s health care

environment. Rapid

developments and changes

in technology have altered

health care, as well as the

systems used to record

In this Issue: • A Message from Our Medical Director

• The New Benefi t Year Begins

• NPI Transition Period Extended

• EPSDT Matters

• HIPAA Wants to Help You

• Claims Filing Information

• Drug Formulary Changes

• Provider Handbook Updates

If you have any comments, questions or suggestions for our Bulletin, please call us

at 948-6486 on Oahu, or 1 (800) 440-0640 toll-free from the Neighbor Islands.

and retrieve health information. Computers, telephones,

faxes, and even live video transmissions, are commonly used

to record and transfer information. So it’s not surprising that

medical information are also of utmost concern to HMSA.

Rest assured that we take the protection of member

information very seriously. Although HMSA has both

commercial and government program plans, our staff has

any necessary information that will enable us to process your

claims accurately, conduct utilization and quality assurance

reviews, conduct credentialing and re-credentialing activities,

and investigate fraud and abuse.

As part of our health plan activities, we may use or disclose

protected health information in the course of performing

claims processing and customer service activities. HIPAA

privacy regulations allow HMSA and its participating

providers to share this type of information without having to

obtain individual permission for the purposes of treatment,

payment, and health care operations and without giving the

individual the opportunity to opt out.

HMSA has an established policy that includes administrative,

physical and technical safeguards that ensure the security of

staff receive training and regular re-training in understanding

provided to us is fully protected.

Frank Smith, M.D.

Bulletin Q07-06 October 15, 2007

H M S A ’ S P L A N F O R Q U E S T M E M B E R S

P . O . B o x 3 5 2 0 , H o n o l u l u , H I 9 6 8 1 1 - 3 5 2 0 • O a h u 9 4 8 - 6 3 2 1 • N e i g h b o r I s l a n d s 1 ( 8 0 0 ) 7 7 1 - 0 6 7 7


2

THE NEW BENEFIT YEAR BEGINS

What to Expect

delayed the start date from July 1 to provide extra time for

plans to develop and implement continuity of care plans for

those members who may have changed their health plan due

to the positive enrollment process.

To facilitate access to care through a new QUEST plan,

each plan has shared information regarding previous PCPs,

QUEST has in turn shared this information for transitioning

members with each member’s new health plan. When making

care coordination determinations, HMSA is reviewing this

information to support continuity of care.

Enrollment Grace Period

This year’s positive enrollment process, which required

members to actively select a health plan even if they intended

to stay with their existing plan, resulted in automatic

plan changes for many members who did not submit their

enrollment forms to Med-QUEST by the enrollment deadline.

chose or were assigned to, the state’s Med-QUEST division has

allowed a grace period for QUEST members to change their

health plan. This grace period runs from Aug. 1 to Oct. 31.

For questions or to make a plan selection over the telephone,

members can call the Med-QUEST Customer Service Section at

524-3370 on Oahu, or toll-free at 1 (800) 316-8005. HMSA’s

QUEST Plan is available to members on Oahu, the Big Island,

and Kauai.

Re-issued Membership Cards

All new and continuing HMSA QUEST members were issued

new membership cards to be effective for services beginning

Aug. 1. We strongly encourage providers to review QUEST

membership cards to verify that the member has received a

new card with issue date of Aug. 1 or later.

The ID card will also identify the member’s assigned PCP.

Members who were assigned to HMSA’s QUEST Plan without

selecting a PCP have been assigned to the PCP they had under

their previous plan (as reported by their previous

plan to Med-QUEST) as long as that PCP is part

of HMSA’s QUEST network. Otherwise, we have

assigned these members to a new PCP. Members

who want to change their PCP can contact our

Member Service hotline at 948-6486 or toll-free at

1 (800) 440-0640.

Treatment Plans Honored

authorized under a member’s previous health plan

will be honored by the member’s new plan through

Sept. 14, 2007, or until the member’s medical needs

have been assessed by the member’s new PCP.

During this period, it is expected that the member’s

new PCP will assess their patients’ medical needs

and submit extensions for continuing treatment

if such continued care is needed. As a reminder,

payment is still subject to member eligibility

EPSDT MATTERS

New EPSDT Forms Required in January 2008

Beginning Jan. 1, 2008, all EPSDT services must be

submitted with the new version of the EPSDT form

(DHS 8015) that was introduced by Med-QUEST in

July 2007. Any EPSDT claims submitted with the old

version of the form after January will be returned to

providers to resubmit with the new form.

As explained in our May 2007 Provider Bulletin,

we are only able to accept the original (red ink)

version of the new EPSDT forms to support Optical

Character Recognition (OCR) scanning. Please do

not submit photocopies or any other non-original

versions of the form. EPSDT claims received without

the proper version of the form will experience

processing delays and may be returned to providers

to resubmit with the correct form.

Bulletin Q07-06 October 15, 2007 Bulletin Q07-06 October 15, 2007


3

PCPs should now have a supply of the new red

EPSDT Forms 8015, 8015A and 8016. If you need

additional forms, please contact QUEST Provider

Service at 948-6486 on Oahu or toll-free from the

Neighbor Islands at 1 (800) 440-0640.

Reminder - Other New EPSDT Requirements

We encourage providers to review the new EPSDT

requirements that we issued as Provider Handbook

updates in our May 2007 Provider Bulletin. Please

remember to complete all areas of the EPSDT form.

CLAIMS FILING INFORMATION

Are you submitting UB-04?

HMSA’s Plan for QUEST Members is accepting

the new UB-04 (CMS 1450) claim form. We are

not yet requiring use of the new form; however,

providers who are still using the UB-92 form should

have begun the process of converting to the new

form. HMSA will notify providers in advance before

discontinuing acceptance of the old UB-92 form.

Anesthesia by Surgeon - Mod 47

Effective immediately, HMSA’s QUEST Plan has

adopted these guidelines used by HMSA for its

private commercial plans. HMSA’s QUEST Plan

will allow additional payment of services billed with

QUEST

Provider Handbook.

Claims should be submitted with two service lines-

and the second line lists the anesthesia service with

No-Fault Cases

policyholder with an accompanying payment recap

the no-fault policy. Please provide both documents

with your claim if no-fault coverage is no longer

available. We may not be able to pay for services

Laminaria Insertion

Please remember that insertion of laminaria using

procedure code 59200 requires referral except for

inpatient settings, emergency situations, or when

used in association with intentional terminations of

pregnancies (ITOP).

B Place of Service

C. EMG

D. PROCEDURES, SERVICES, OR SUPPLIES

(Explain Unusual Circumstances) CPT/HCPCS Modifi er

E Diagnosis Pointer.

11 58100 1 11 58100 47 1

EPSDT claims received with forms that are missing required

information will experience processing delays and may be

returned to providers to complete. Some common examples

months since the new EPSDT forms were introduced are

missing service dates and missing provider ID numbers.

Please verify your EPSDT forms for completeness before

submitting. Further guidance is provided in the back of each

EPSDT form and in our QUEST Provider Handbook.

4


Brand Name Generic Name Generic Lofi bra fenofi brate, micronized Generic Lotrel amlodipine/benazepril Generic Omnicef cefdinir Generic Zantac ranitidine, liquid Generic Lamisil terbinafi ne Januvia sitagliptin The following drugs will be deleted effective Oct. 1, 2007: Lamisil terbinafi ne Lofi bra fenofi brate, micronized Lotrel amlodipine/benazepril Omnicef cefdinir Zantac ranitidine, liquid

DRUG FORMULARY CHANGES The following drugs will be added effective Oct. 1, 2007, unless noted otherwise.

WE WANT TO HELP YOU, SO …

Due to federally mandated HIPAA Privacy requirements, we

must verify the identity of each caller before we can release

information. For provider calls, we need to request the

provider’s name, QUEST provider number, and the caller’s

name (if the caller is the provider’s representative). Please keep

this information handy to help us expedite this important

Your call is very important to us so please be aware that,

morning as we assist our callers with issues related to events

that occurred over the weekend. Friday mornings

are also very busy with questions on recently

received payment reports and issues related to events

for the upcoming weekend. Electronic monitoring

allows us to identify the number of calls in queue

and, if necessary, we may need to limit the number

of inquiries per phone call during busy periods so

that more callers can be serviced.

Our phone lines are open to serve you from 7:45

a.m. to 4:30 p.m., Monday through Friday. The

best times to reach us are during the off-peak hours

before 9:30 a.m., from noon to 2 p.m., or from 3:30

to 4:30 p.m.

Botulinum Toxin (BOTOX and Myobloc) - Add new section

Cosmetic and Reconstructive Surgery and Services - Replace

entire section

Emergency Room Services - Add new section

Erythropoietin and Darbepoetin - Add new section

Exenatide (Byetta) - Replace entire section

Fentanyl Transdermal System (Duragesic) - Replace

entire section

Genetic Testing - Replace only the updated page

Intravenous Immune Globulin Therapy (IVIG) - Add

new section

Kyphoplasty - Replace entire section

Occupational Therapy - Replace updated pages

Outpatient Surgical Procedure Related Group (PRG) - Replace

entire section

Panniculectomy/Abdominoplasty - Replace entire section

Physical Therapy - Replace only the updated page

Positron Emission Tomography (PET) - Replace entire section

Sorafenib (Nexavar) - Add new section

Subcutaneous and Intramuscular Injectibles - Replace

entire section

Sunitinib (Sutent) - Add new section

Uterine Artery Embolization to Treat Fibroids - Replace

entire section

Vacuum Assisted Breast Biopsy - Replace entire section


PROVIDER HANDBOOK UPDATES

The following sections of the QUEST Provider

Handbook have been updated to clarify procedures,

correct minor typographical errors, or update codes.

Please add the new sections alphabetically and

replace outdated pages.

Quick Reference

entire section

General Information

Cultural Sensitivity - Replace entire section

Claims Filing Information

Instructions for Completing CMS 1500 Claim

Form - Replace only the updated pages

Benefit Policies

Abatacept (Orencia) - Add new section

Alefacept (Amevive) - Replace entire section

Blepharoplasty - Replace entire section

Bone (Mineral) Density Studies - Replace only the

updated page

5

Services That Require Precertification

QUEST Provider Handbook Quick Reference Rev. 05/07

The following services require precertification before being rendered. Retroactive precertifications after the services have been provided will not be accepted. Written guidelines for most of these services are included in this handbook as referenced below. Providers can obtain the UM criteria and hard copies of the criteria are made available to providers upon request by phone, fax, or mail to QUEST Provider Service.

Amniocentesis and chorionic villus sampling Precertification is required for conditions and indications that are not listed in the BENEFIT POLICIES section of the handbook.

Autologous chondrocyte implantation (ACI) Details for coverage to repair articular cartilage defects of the knee are outlined in the BENEFIT POLICIES section.

Behavioral health Most services do not require precertification for payment. Selected services involving benefit limits and exchanges, outofstate services, outofnetwork providers, transportation and lodging, require pre certification. Guidelines are in the BENEFIT POLICIES section.

Blepharoplasty The procedure must treat a specific medical condition as outlined in the BENEFIT POLICIES section. Pre certification is required as it may be considered cosmetic in certain situations.

Bone density measurement studies Studies required more frequently than once every two years require precertification. Clinical indications and other coverage information are in the BENEFIT POLICIES section.

Carotid Artery Stenting This service is covered with precertification when FDA approved carotid artery stenting systems and embolic protection devices are used for patients meeting the criteria outlined in the BENEFIT POLICIES section.

Clinical Trials Guidelines for coverage of routine care associated with clinical trials are outlined in the BENEFIT POLICIES section.

Continuous Glucose Monitoring of Interstitial Fluid The use of the MiniMed Continuous Glucose Monitoring System (CGMS) requires precertification according to the criteria outlined in the BENEFIT POLICIES section.

Cosmetic surgery HMSA’s Plan for QUEST Members does not cover cosmetic surgery performed solely to correct a person’s appearance. However, cosmetic surgeries that are medically necessary may be considered with appropriate documentation. For a determination, write to HMSA’s PreAuthorization Unit at the address listed in the Quick Reference Guide in this section.

(Continued On Next Page)


Drugs In addition to nonformulary drugs, the following drugs also require precertification. Refer to the BENEFIT POLICIES section for additional information on these drugs as well as on the Drug Formulary and the use of nonformulary drugs.

∗ Abatacept (Orencia) (effective July 1, 2007) ∗ Actimmune (see Interferon, gamma1b (Actimmune)) ∗ Duragesic – when the maximum limit of 20 patches per 30 days is exceeded (see Fentanyl

Transdermal System (Duragesic)) ∗ Enbrel (see Etanercept (Enbrel)) ∗ Erythropoietin and Darbepoetin (for diagnosis of myelodysplastic syndrome or anemia of chronic

disease) ∗ Erbitux ∗ Esomeprazole (see Esomeprazole (Nexium)) ∗ Forteo (see Forteo) ∗ Gleevec (see Imatinib Mesylate (Gleevec)) ∗ Iressa (see Gefitinib (Iressa)) ∗ Lupron (see Lupron) ∗ Provigil (see Modafinil (Provigil)) ∗ Raptiva (see Raptiva) ∗ Rebetron ∗ Remicade (see Remicade) ∗ Sorafenib (Nexavar) ∗ Sunitinib (Sutent) ∗ Synagis (see Synagis) ∗ Tarceva (see Erlotinib (Tarceva)) ∗ Velcade (see Velcade) ∗ Xolair (see Xolair) ∗ Zevalin

Durable medical equipment Most durable medical equipment (DME) does not require precertification unless the cost for purchase or the cumulative rental charge for the duration of the need is $500 or more. Please refer to the BENEFIT POLICIES section for more information about DME items that require precertification.

Genetic testing Precertification is required for predictive genetic testing of asymptomatic patients with symptomatic firstdegree relative(s) when the patient meets specific criteria and is being tested for certain clinical conditions. Details are outlined in the BENEFIT POLICIES section.

Grenz Ray Therapy Precertification is required for GRT that is used for any other malignant lesions not included in the guidelines for benefit coverage in the BENEFIT POLICIES section.

Growth hormone therapy Guidelines for benefit coverage of this service are in the BENEFIT POLICIES section.

Services That Require Precertification (continued)


Hearing aids Binaural hearing aids are covered only for children 20 years and younger with precertification. Monaural hearing aids do not require precertification. See BENEFIT POLICIES section for details.

Hepatitis C Treatment Precertification is required for interferon therapy (including pegylated interferon) when used for the treatment of hepatitis C. Refer to BENEFIT POLICIES for full details.

Home health agency services Precertification is required during the first 60 days if services will be more frequent than three times a week, and for all cases after the first 60 days. Guidelines for coverage of this service are in the BENEFIT POLICIES section.

Hospital admissions For elective inpatient surgery, it is expected the patient will be admitted on the day of the procedure. Requests for priorday admissions will be reviewed to ensure the admission meets the payment determination requirements. Approval can be obtained by calling the HMSA Nurse Coordinator at 9486464 on Oahu or tollfree at 1 (800) 3446122 from the Neighbor Islands.

INTACS – Intrastromal Corneal Ring Segments for Keratoconus Effective August 1, 2006 adult patients age 21 years and over with keratoconus who meet all the criteria for coverage as indicated in the benefit policies section will be eligible for this service with pre certification.

Intensity Modulated Radiation Therapy (IMRT) Indications for coverage are in the BENEFIT POLICIES section of the handbook. Precertification is not required for prostate, and head and neck indications. All other indications require precertification.

IV Therapy The following home IV therapies required precertification prior to the initiation of the therapy. Please refer to HMSA’s Provider handbook for its private plans for details of the precertification guidelines.

∗ Albumin therapy ∗ Inotropic therapy (See Inotropic Infusion Therapy, Home) ∗ Intravenous immune globulin (IVIG therapy (See IVIG)) ∗ Pain management therapy (See Pain Management Therapy, Home Infusion) ∗ Parenteral nutrition therapy (See Total Parenteral Nutrition (TPN))

Kyphoplasty This procedure is covered with precertification. Only those indications listed in the BENEFIT POLICIES section will be covered.

LungVolume Reduction Surgery Lungvolume reduction surgery is covered for patients who meet the criteria listed in the BENEFIT POLICIES section.



Lupron Precertification is required for therapy that will extend past three months for anemia caused by fibroids or six months for management of endometriosis. Precertification is also required for breast cancer as this is not an FDAapproved indication at this time. Precertification is not required for other FDA approved indications.

MRI/MRA/MRV Precertification is required for conditions and indications that are not listed in the BENEFIT POLICIES section.

Noncoronary Brachytherapy Precertification is required.

Nutritional Therapy All parenteral and enteral nutrition therapy requires precertification. Nutritional formula and/or supplements, such as Ensure, also require precertification. A referral to a participating HMSA QUEST provider must be registered with HMSA’s Plan for QUEST Members.

Occupational therapy Therapy in excess of the maximum number indicated in the guidelines under Rehabilitation Benefit for Physical Therapy and Occupational Therapy Services in the BENEFIT POLICIES section must be pre certified before being rendered.

Organ transplants Guidelines for benefit coverage of these services are in the BENEFIT POLICIES section.

Oscillatory Device for Bronchial Drainage (The Vest) This bronchial drainage system is covered for patients meeting the criteria outlined in the BENEFIT POLICIES section of the handbook. An initial twomonth rental trial period will be authorized. Requests for purchase must be submitted with documentation that the patient is compliant with the use of the item.

Outofstate transportation and services All outofstate transportation and services require precertification. Guidelines for benefit coverage of outofstate transportation services are in the BENEFIT POLICIES section.

Panniculectomy Surgical resection of redundant skin and fat in the lower abdominal area for patients who have had significant weight loss is covered with precertification. Patients must meet the criteria outlined in the BENEFIT POLICIES section.

Photochemotherapy for Certain Conditions Precertification is required for the diagnosis codes indicated in the BENEFIT POLICIES section and for all other indications not listed.

Physical therapy Therapy in excess of the maximum number indicated in the guidelines under Rehabilitation Benefit for Physical Therapy and Occupational Therapy Services in the BENEFIT POLICIES section must be pre certified before being rendered.

Services That Require Precertification (continued)


Place of treatment exceptions for surgery A procedure that is normally done in an ASC requires precertification if it will be done in an inpatient setting. A procedure that is normally done in the physician office requires precertification if it will be done in an ASC, inpatient setting, or any other site other than the physician’s office. See BENEFIT POLICIES section for the list of procedures that are normally done in the office or ASC setting.

PolysomnographySleep Studies/Home apnea monitor Studies must be ordered by a pulmonary specialist according to the guidelines of benefit coverage as noted in the BENEFIT POLICIES section.

Positron emission tomography (PET) Indications for PET studies are in the BENEFIT POLICIES section. Scans for indications not listed, as well as all followup scans regardless of indication, require precertification.

Private duty nursing This is not a benefit under QUEST; however, a patient eligible for EPSDT services may receive private duty nursing under the EPSDT program, which covers medical care that is normally not covered under QUEST. Precertification is required. Guidelines for coverage are in the BENEFIT POLICIES section.

Reduction Mammoplasty Effective August 1, 2006, medically appropriate services will be covered with precertification when the patient meets the clinical indications and criteria for coverage.

Referrals to providers not in HMSA’s QUEST network Referrals to providers who are not part of HMSA’s QUEST network must be approved. Refer to “Referrals” in the GENERAL INFORMATION section.

Remicade Remicade is indicated for the treatment of rheumatoid arthritis and Crohn’s disease according to the criteria outlined in the BENEFIT POLICIES section.

Sleep apnea studies and home apnea monitor See PolysomnographySleep Studies.

Speech therapy Speech therapy directed toward evaluation and treatment of disorders that impair speech, voice, language or swallowing is covered subject to the guidelines outlined in the BENEFIT POLICIES section.

Spinal cord stimulator Implantation of spinal cord stimulators is covered as therapy for the relief of chronic intractable pain subject to the conditions outlined in the BENEFIT POLICIES section.

Stereotactic radiosurgery, gamma knife procedures Gammaray radiosurgery and linearaccelerator radiosurgery are covered as treatment for small intracranial lesions up to three to four cm. in diameter. Guidelines for benefit coverage are in the BENEFIT POLICIES section.



Supplies Supplies require precertification when the monthly cost is over $500.

Surgery to correct morbid obesity Morbid obesity as defined by HMSA may be treated surgically using noninvestigational procedures. Please refer to “Obesity” in the BENEFIT POLICIES section.

Surgeries, therapies or procedures employing new technology Surgeries, therapies, or procedures that meet payment determination criteria in accordance with HMSA’s guidelines may be considered with appropriate documentation. For a determination, please write HMSA’s PreAuthorization Unit at the address listed in the Quick Reference Guide of this section.

Tarceva Precertification is required for treatment of patients diagnoses with locally advanced or metastatic non small cell lung cancer as outlined in the BENEFIT POLICIES section.

Thoracic Sympathectomy for Hyperhydrosis Surgical treatment of hyperhydrosis must meet the patient criteria outlined in the BENEFIT POLICIES section and be precertified before services are rendered.

Transcutaneous electric nerve stimulator (TENS) TENS is covered for the relief of chronic intractable pain or acute postoperative pain subject to the criteria and guidelines outlined in the BENEFIT POLICIES section.

Transportation, Ground and Air Patients requiring services not available on their home island may be transported offisland to the appropriate provider in the state. Guidelines for coverage are in the BENEFIT POLICIES section.

Uterine Artery Embolization This procedure is covered as an alternative to other surgical techniques for the treatment of fibroids. Pre certification is not required unless the procedure will be done to treat conditions that are not listed in the BENEFIT POLICIES section of the handbook. In those instances, the procedure is considered investigational subject to the precertification requirements.

Vision eyewear Polycarbonate lenses for patients age 21 and over, replacement prostheses and contact lenses for children require precertification. Guidelines for benefit coverage are in the BENEFIT POLICIES section.

C Cultural Sensitivity

QUEST Provider Handbook General Information Rev. 10/07

Cultural background and values shape the world view of each individual. Encouraging HMSA QUEST staff and participating providers to acknowledge that their attitudes, behaviors and beliefs are shaped by their environment leads to more culturally competent professionals. Understanding the impact cultural differences have on successful health care delivery is essential.

3 Key Cultural Competency Messages The HMSA QUEST cultural competency approach is based on the following:

• QUEST members are multicultural with diverse beliefs, values, health practices and socioeconomic needs.

• QUEST members have the right to receive medical services and to be treated with courtesy, consideration and respect.

• HMSA QUEST staff and participating providers should respect this diversity and realize that biases and preconceptions about public assistance recipients, including those with disabilities, can be barriers to successfully delivering health care services.

Member Communication The HMSA Plan for QUEST Members – Member Handbook

Communicating with our members in a culturally aware and appropriate way is a critical part of HMSA’s cultural competency efforts. The member handbook lists important member rights and responsibilities. Member rights are defined so that all members have a clear understanding of their rights under HMSA’s QUEST plan. Specific information is given about member rights and responsibilities in the following areas:

• Information Disclosure

• Accessibility of Services and Providers

• Participation in Treatment Decisions

• Respect and Nondiscrimination

• Confidentiality of Health Information

• Complaints and Appeals

• Plan Information and Benefits

• How to Obtain Language Translation “Free” of Charge

Importantly, the member handbook states the following:

“You have rights under this plan. Exercising your rights will not affect in a negative way how we or network providers treat you. This is true regardless of race, physical or mental disability, ethnicity, gender, sexual orientation, creed, age, religion, national origin, cultural or educational background, economic or health status, English proficiency, reading skills, or the source of the payment for your care.”

In addition to English, the QUEST member handbook is available in Tagalog, Ilocano, Korean and Chinese.



Member Newsletter A newsletter for HMSA QUEST Members is regularly published and distributed to update and keep members informed about their plan. The newsletter explains important health plan benefits, procedures, programs and other important information in a culturally sensitive, clear, concise and easily understandable manner.

Other Member Communication Communications produced by HMSA for QUEST members will include a language block translated in Tagalog, Ilocano, Korean and Chinese stating that the document contains important information and directs the member to call HMSA to request the document in an alternative language or to have it orally translated. There is no charge to QUEST members for translation services.

Participating Provider Directory The HMSA QUEST participating provider directory is distributed to members and provides information about the foreign languages spoken by providers. This allows members to use a physician’s language abilities as a basis for selecting a physician with whom they will be most comfortable.

Care Coordination Through training and this cultural competency plan, HMSA’s integrated care coordination and case management program allow HMSA to meet the diverse needs of QUEST members in a culturally appropriate manner. The program focuses on ensuring timely access and delivery of quality, cost effective health care. Continuity of care is provided through coordination and integration of services. Specifically, HMSA QUEST care coordination and case management focuses on serving members who have exceptional and special health care needs, chronic or high health risk conditions and/or need a spectrum of medical and nonmedical services. Each member requiring this level of care has a care coordinator or case manager committed to designing and implementing an appropriate plan of care to meet his/her needs.

The program includes the message of cultural sensitivity in the Policies and Procedures Manual that is the guiding document for the care coordination program staff:

“HMSA recognizes that Hawaii QUEST members are a multicultural population with diverse beliefs, values, health practices, and socioeconomic needs. As a health plan, cultural sensitivity means respecting such diversity and realizing that biases and preconceptions about recipients, including those with disabilities and those on public assistance, are barriers to accessing quality health care. The care coordination staff will conduct themselves in a nondiscriminatory and inoffensive manner at all times.”

Outreach Programs HMSA QUEST offers outreach programs and services that address cultural and language barriers and effectively deliver appropriate and necessary health services. One example of these types of outreach programs developed by HMSA attempted to increase the mammography screening rates of Filipina women by partnering with the Catholic Church of Hawaii. The goal of the program was to increase breast cancer awareness through the use of culturally appropriate means. The Pastors at St. Philomena’s Parish delivered this message as trusted community leaders. An educational tour of St. Francis Cancer Screening and Education Program was scheduled so women could gain a better understanding of the exam itself by visiting the mammography facilities. The small group format also allowed participants an opportunity to share their experiences. HMSA hopes to be able to use this program as a model with other populations.

C Cultural Sensitivity (continued)


Health Plan and Provider Monitoring To ensure that HMSA provides services to people of all cultures, races, ethnic backgrounds and religions in a manner that respects the worth of the individual members and to ensure that providers comply with all applicable federal and state laws and regulations, HMSA’s grievance resolution processes are culturally and linguistically sensitive and capable of identifying, preventing, and resolving crosscultural conflicts or complaints by members about health care services. HMSA conducts an annual training and selfassessment. This means providing cultural competence training to staff who handle complaints and grievances; providing members information on their right to file a complaint and/or grievance in an easy and understandable language; how to obtain complaint and/or grievance procedures translated into another languages; and providing the contact name and tollfree phone number of the HMSA QUEST grievance coordinator.

HMSA oversees and monitors these culturally or linguistically related complaints and grievances. Such complaints and grievances are trended, analyzed and, when issues are identified, acted on in a timely manner. HMSA, however, does not assume that a lack of complaints from members means that cross cultural conflict or discrimination is not occurring and recognizes members may not recognize that they are being treated inappropriately, or they may have fears or cultural beliefs that inhibit complaining, or may not know that they have the right to complain.

In addition, ethnic data from the Department of Human Services, MedQUEST Division enrollment file, disease burden, utilization, gender and age are reviewed to identify the needs of the population so clinical and preventive programs can be developed to address those needs.

Member Services HMSA is prepared to address the diverse language and cultural needs of QUEST members. Members are informed in their preferred language both verbally and in written notices of their right to receive language assistance services at no charge. The Government Programs, QUEST Operations Unit handles customer service calls from QUEST members. HMSA offers and provides language assistance services, including bilingual staff and interpreter services, at no cost to each member with limited English proficiency at all points of contact, in a timely manner during all hours of operation. HMSA trains its bilingual staff initially upon assignment to operate in a bilingual capacity and annually thereafter or uses contracted, certified interpreters to assure the competence of language assistance provided to limited English proficient members. Unless authorized by the member, HMSA does not use the member’s family and friends to provide interpretation services.

Additionally, HMSA QUEST is able to assist hearing impaired members through the use of a Telephone Display Device.

Provider Communication HMSA recognizes that identifying the health practices and behaviors of QUEST members will enable providers to gain a better understanding of this population and how to most appropriately provide quality health care services. In order to increase provider awareness of the QUEST population’s diversity and encourage providers to address QUEST patients’ needs appropriately, the three key cultural competency messages are included in the HMSA QUEST Participating Provider Handbook.



The Provider Handbook and Provider Bulletins are used as tools to increase provider understanding of QUEST members. HMSA QUEST distributes its Provider Handbook to each new participating provider as they join HMSA’s QUEST plan. Each year, HMSA publishes six scheduled updates to the Provider Handbook in February, April, June, August, October, and December. These updates are included in Provider Bulletins and are distributed to all participating providers. Provider Handbook updates can also be published in other months when necessary.

Articles planned for provider bulletins in 2007 include a “howto” for providers on ways to customize their services for patients from other cultures. Steps include printing or obtaining from community organizations brochures and patient forms in the major languages of their patients, having bilingual staff or making accommodations for friends or family to accompany the patient for translation purposes, and being sensitive to issues of privacy, confidentiality of personal data, restrictions on male/female interaction and other cultural concerns that may impact healthcare.

The following are myths about public assistance recipients and the facts related to those myths. This material is updated annually to include other myths based on culture, ethnicity and their socioeconomic status.

Myth #1 QUEST patients miss appointments and fail to follow doctor’s orders because they don’t care about their health or their doctor.

Fact: Some QUEST patients have valid reasons for appearing noncompliant. Some may be coping with economic hardships forcing them to focus their efforts at meeting only basic life needs. Others may not seek medical care due to dysfunctional relationships, unresolved behavioral health needs and/or a crisis at home. They may feel uneasy discussing these things with their doctor and often may not offer explanations.

Myth #2 Providers have to make all the health care decisions for QUEST patients.

Fact: The patient is the primary decision maker when it comes to his/her own medical care and should be given full facts about a recommended treatment plan. An individual’s economic status and/or disability does not negate a person’s right to make health care decisions for him or herself.

Myth #3 Patients with disabilities who bring companions to medical appointments are incapable of discussing their health or medical needs. Providers should address the companion.

Fact: People with disabilities may have different communication styles and abilities, but can still articulate information about their health and medical status. It’s important to address these individuals directly and recognize that a person with developmental delays may be capable of comprehending or explaining his or her needs.

Myth #4 Patients from other cultures have superstitions and beliefs that are incomprehensible to Americans.

Fact: We must remember that all cultures have beliefs and customs that seem strange to those in other cultures. People in the United States have beliefs that baffle outsiders, such as our fears of black cats crossing our paths, walking under ladders, and the number thirteen. Many cultural beliefs have direct or indirect implications for healthcare.

C Cultural Sensitivity (continued)


The manner in which services are packaged and promoted or the terms used in promotional materials may create problems in crosscultural communication. For example, many Asians believe that the number four is unlucky because when pronounced in Japanese or Chinese it sounds very similar to those cultures’ word for “death”. Thus, items arranged in groups of four, such as pills or syringes can symbolize bad luck for those people who believe in numerology. Just as there are very few hospitals or hotels in America with a thirteenth floor, the same is true for buildings in Asia where they avoid numbering the fourth floor.

Also included in the HMSA QUEST participating provider contract is language attesting to the fact that providers adhere to Title VI of the Civil Rights Act of 1964.

Instructions for Completing CMS 1500 Claim Form (continued)

QUEST Provider Handbook Claims Filing Information Rev. 05/07

The diagnosis code should be entered with the first three digits to the left of the decimal point. It is not necessary to type in the decimal point itself, since it is already printed on the form. You may simply leave a space. The remaining digits (if any), should follow the decimal. If entering a code with more than three beginning digits (e.g., certain E codes), enter the fourth digit directly over (on top of) the period.

Examples: 998.59 790.6 496. V18.0 E8788

Illness: Enter the appropriate ICD9CM diagnosis code(s) to describe the illness.

Always list the primary diagnosis as item 1. If the diagnosis is unknown, list the primary symptom or chief complaint.

Do not list “rule out” diagnoses.

List only those diagnoses that substantially relate to the treatment rendered. Do not list historical diagnoses.

Be sure the diagnosis is appropriate to the gender and age of the patient.

Enter the reference numbers 1, 2, 3 and/or 4 from this block into column 24E to identify the condition being treated by each procedure or service. This must be consistent with the information given in block #19 (patient’s complaint) and block #10 (accident information).

Illness: Enter the appropriate ICD9CM diagnosis code(s) to describe the illness.

Injury: Enter the appropriate ICD9CM diagnosis code(s) (no more than three) to describe the injury. The code must be in the 800999 range of ICD9CM codes.

22 QUEST Resubmission C On adjustment claims, enter the claim number from the Report to Provider which gave the original processing determination for the claim.

23 Prior Authorization Number O Enter the HMSAissued precertification number in this block for services requiring pre certification. The number is not required for processing, and may be retained in the patient’s records as documentation that precertification was obtained.

24 Refer also to separate instructions for 24A through 24J The 24 blocks have been changed from the previous version of the CMS 1500 Claim Form. Each claim line on the form has a shaded upper portion and an unshaded lower portion. Do not attempt to use the upper and lower portions of each claim line independently to create additional service lines. Doing so will cause incomplete or inaccurate processing of your claims. Most text should be entered on the lower, unshaded portion of the service line. (Exceptions are noted below.)



24A Date(s) of Service R Enter the date of service for each procedure or service under “From”. (If both “From” and “To” dates are used, enter the same date in both fields). Each service must be on a separate line. For global surgical services, enter the surgery date. For global maternity services, enter the date of delivery. Do not bill for services not yet rendered (e.g., future dates).

NDC numbers should be entered in the shaded portion of a service line with qualifier N4. See field #24D.

24B Place of Service (POS) R This column has been changed from the previous version of the CMS 1500 claim form.

Enter the appropriate code for each procedure or service provided. Use the twodigit POS codes as specified by CMS (see “Place of Service Codes” in this section).

Be sure the POS code matches the service provided. For example an office visit should be billed with POS 11, while a hospital visit should be billed with POS 21.

Note: For medical pharmacies please use the following POS codes when dispensing injectable drugs and vaccines. Use POS code 11 (office) if the drug or vaccine is administered at the pharmacy or if the patient will be taking the drug or vaccine to the physician’s office for administration. Use place of service code 12 (home) if the patient will be selfadministering the drug at home. For DME items to be used in the patient’s home, use POS code 12 (home).

24C EMG (Emergency Indicator) C This column has been changed from the previous version of the CMS 1500 claim form.

Enter an “X” next to each emergency service. If performed in a hospital emergency room or other emergency facility, the place of service in 24B must coincide.

24Dv Procedures, Services or Supplies R This column has been changed from the previous version of the CMS 1500 claim form. To the right of the solid vertical line, additional space has been added to accommodate up to four modifier codes.

Enter the CPT or HCPCS procedure code for each service. Please use current codes.

Enter only one procedure code per service line.

When applicable, enter one or more twodigit modifiers as found in CPT or HCPCS in the spaces to the right of the procedure code. If more than one modifier is needed to describe the particular service rendered, enter modifier “99” (multiple modifiers) in the first place, followed by up to three additional modifiers. When using the fivedigit service administrative code, place it on the line directly under the procedure code it modifies.

If more than one physician is involved in a surgery, indicate the agreedupon percent of fee distribution.

Instructions for Completing CMS 1500 Claim Form (continued)


Drugs may be listed using National Drug Codes (NDC) after all other services but before any administrative codes as in the following example. Include the quantity immediately following the NDC number. The days supply must be entered in 24G.

24 A. DATE(S) OF SERVICE B. C. D. PROCEDURES, SERVICES, OR SUPPLIES E. F. G. H.

From To PLACE OF (Explain Unusual Circumstances) DIAGNOSIS DAYS OR

EPSDT Family

MM DD YY MM DD YY SERVICE EMG CPT/HCPCS | MODIFIER POINTER $ CHARGES UNIT Plan

07 15 07 07 15 07 11 00005432101 1cc 2 xx|xx 1

When determining metric quantity, refer to the product package label. If “ml” or “cc” is indicated, the metric quantity is the number of ml’s or cc’s whether the product is dry form or liquid, or a singledose disposable syringe such as tubex, bristoject or isoject.

If “ml”, “cc” or “gm” is not indicated on the label, the metric quantity is “1” for each unit. For example, the metric quantity for a product sold in cases of 24 bottles of 100 tablets would be the number of tablets dispensed.

This also applies to products that come with a separate vial or ampule of diluent, when no final volume is stated on the label, to “partial fill” products, and preps in an ointment, cream or powder form.

Products sold in bubble packs, (e.g., Prempro and Premphase) which are packaged two pills per bubble, should be billed by the tablet count, not by the bubble count.

If the product is a “partial fill”, nonunit dose type, such as Dextrose 5% 250 ml in a 500 ml bottle, the metric quantity is the fill volume containing the actual drug, (e.g., 250 ml).

If the product is sold as a unit, the metric quantity is “1” for each unit. For example, the quantity for a box of 100 test tapes is “1” and not the number of tests. This includes multiple drug products packaged and dispensed in “unbreakable” containers, (e.g., Thiosulfil Duo Pack) which are treated as single units with quantity “1” for each unit.

Enter code S9999 to indicate tax (optional). Do not enter multiple tax lines. Enter only one tax line representing the total tax for the claim.

Enter code Z9014 to indicate “Less paid by other carrier.” This code may only be used on hardcopy claims. Do not use the code on EDI claims.

24E Diagnosis Pointer R Enter the supporting indicator reference number (1, 2, 3 or 4) from Block 21 for each procedure or service, up to a maximum of 4 reference numbers.



24F $Charges R Enter a valid charge for each procedure or service (including fivedigit administrative codes). Amounts for tax (code S9999) and “Less Paid by Other Carrier” (code Z9014) should also be entered if applicable. Enter amounts in the standard dollarsandcents format, including the decimal point (e.g., 48.00 ― not 4800). If there is no charge for a service, do not list it on the claim.

24Gv Days or Units R Enter the number of services, units, visits or days applicable to each service. If left blank, the number is assumed to be “1”. List each service separately. For drugs, the quantity is not to exceed 100 doses or a 30 day supply, whichever is greater. Injections billed with Jcodes will be paid only one administration fee for each Jcode billed.

24H EPSDT Family Plan C If billing for an EPSDT examination (e.g., 99384EP) and the required EPSDT form is attached, document the attachment by inserting “Y” in this column.

24I ID Qualifier N/A This column has been changed from the previous version of the CMS 1500 claim form. The column is used to designate whether the NPI is used or a QUEST ID number is used for the ID number shown in 24J.

Not applicable.

24J Rendering Provider Number N/A This column has been changed from the previous version of the CMS 1500 claim form.

Not applicable. HMSA does not require the entry of individual provider numbers by line. Each claim submitted should represent the services provided by a single provider only. The provider’s ID number should be entered in block 33b.

25 Federal Tax I.D. Number N/A The block is for outofstate providers only.

26 Patient’s Account Number O If you include your patient’s account number, up to 10 characters of the number will appear on your Report to Provider.

27 Accept Assignment N/A Not applicable.

A Abatacept (Orencia)

QUEST Provider Handbook Benefit Policies 10/07

I. Description Abatacept (Orencia) is the first drug in a new class of drugs known as costimulation blockers. Abatacept is a genetically engineered fusion protein that blocks the engagement of CD28 on T cells and prevents Tcell activation. Abatacept is used as secondline therapy to treat moderatetosevere active rheumatoid arthritis.

II. Criteria/Guidelines A. Abatacept (Orencia) may be used as monotherapy or in combination with DMARDs (e.g.,

methotrexate). Abatacept may be eligible for coverage when all of the following criteria are met:

1. Abatacept is being recommended by a rheumatologist, AND

2. Abatacept is being used for the treatment of moderately to severely active rheumatoid arthritis based on the criteria in Appendix 1 for patients ≥ 18 years, AND

3. There is documentation that supports prior treatment(s) with one or more disease modifying antirheumatic drugs (DMARDs), such as methotrexate or tumor necrosis factor (TNF) antagonists, with an inadequate response after a trial of at least three months, or contraindication or intolerance to DMARD therapy. Include prior treatment documentation with the Drug Review Request when precertifying abatacept treatment.

B. For extension requests for abatacept, documentation (e.g., chart notes) must indicate disease stability or improvement.

III. Limitations/Exclusions A. The combined use of abatacept and a TNF antagonist such as adalimumab, infliximab, and

etanercept or with an interleukin1 (IL1) inhibitor, such as anakinra, is not recommended by the FDA.

IV. Administrative Guidelines A. Precertification of abatacept is required. To precertify, complete HMSA’s Drug Review

Request and mail or fax the form along with the required documentation as indicated.

B. Initial precertification

1. A maximum of six months may be authorized when criteria are met.

C. Continued precertification

1. For continued authorization after the initial sixmonth period, documentation (including chart notes) indicating disease stability or improvement must be provided. The maximum period that may be reauthorized is 12 months. Subsequent requests for continued authorization, if warranted, will also be approved for a maximum of 12 months. Please include this documentation with the Drug Review Request.

ICD9CM Code Description 714.0 – 714.2 Rheumatoid arthritis (code range)



HCPCS Code Description J0129 Injection, abatacept, 10 mg (Orencia)

V. Scientific Background There are no clinical studies that have compared abatacept to other treatments for rheumatoid arthritis (RA) including TNF antagonists. The randomized controlled trials have compared abatacept to placebo. In phase II and phase III trials, researchers concluded that patients taking abatacept had significantly greater improvement in ACR20, 50, and 70 when compared to placebo. Patients included in the trials had failed methotrexate (MTX). In one trial, researchers studied patients who had failed response to antiTNF therapy.

Two randomized controlled trials investigated the use of abatacept for six months (Kremer et al, 2003; Genovese et al (2005). Kremer et al (2003) studied patients who failed methotrexate and Genovese et al (2005) studied those who had failed antiTNF therapy. Both trials found that abatacept was significantly more effective in treating RA than placebo.

At six months, abatacept treated patients had the following ACR measures compared to the placebo group:

ACR Measure Patients treated with abatacept (%) Patients with placebo (%) ACR 20 50 to 60 19.5 to 35 ACR 50 20.3 to 36.5 3.8 to 11.8 ACR 70 10.2 to 16.5 1.5 to 1.7

In the only randomized controlled trial that studied patients for a year, Kremer, et al. (2005) had similar results.

At followup, abatacept treated patients had the following ACR measures compared to the placebo group:

ACR Measure Patients treated with abatacept (%) Patients with placebo (%) ACR 20 62.6 36.1 ACR 50 41.7 20.2 ACR 70 20.9 7.6

Kremer et al (2005) found that abatacept treated patients had a higher rate of remission compared to placebo (34.8 percent versus 10.1 percent, p<0.001). Genovese, et al. (2005) found that 47.3 percent of abatacept treated patients had improvement in physical function compared to 22.3 percent of placebo patients (p<0.001).

In clinical trials, abatacept was well tolerated, with an overall safety profile comparable to that of placebotreated patients. The most commonly reported side effects were headache, dizziness, upper respiratory tract infection, nasopharyngitis, and nausea. There were, however, observations of serious adverse reactions when abatacept was used concurrently with TNF inhibitors. The most serious were severe infections and malignancy.

VI. Important Reminder The purpose of this Medical Policy is to provide a guide to coverage. This Medical Policy is not intended to dictate to providers how to practice medicine. Nothing in this Medical Policy is

A Abatacept (Orencia) (continued)


intended to discourage or prohibit providing other medical advice or treatment deemed appropriate by the treating physician.

Benefit determinations are subject to applicable member contract language. To the extent there are any conflicts between these guidelines and the contract language, the contract language will control.

This Medical Policy has been developed through consideration of the medical necessity criteria under Hawaii’s Patients’ Bill of Rights and Responsibilities Act (Hawaii Revised Statutes §432E 1.4), generally accepted standards of medical practice and review of medical literature and government approval status. HMSA has determined that services not covered under this Medical Policy will not be medically necessary under Hawaii law in most cases. If a treating physician disagrees with HMSA’s determination as to medical necessity in a given case, the physician may request that HMSA consider the application of this Medical Policy to the case at issue.

VII. References 1. Orencia (abatacept) prescribing information. BristolMyers Squibb Company; Princeton, NJ.

December 2005.

2. Kremer JM, et al. Treatment of rheumatoid arthritis by selective inhibition of Tcell activation with fusion protein CTLA4Ig. N Engl J Med 2003;349:190715.

3. Kremer JM, et al. Treatment of rheumatoid arthritis with the selective costimulation modulator abatacept: twelvemonth results of a phase IIb, doubleblind, randomized, placebocontrolled trial. Arthritis Rheum 2005;52:226371.

4. Genovese MC, et al. Abatacept for rheumatoid arthritis refractory to tumor necrosis factor alpha inhibition. N Engl J Med 2005;353:11423.

5. CHA Health. Coverage Guidelines. Orencia (abatacept). Last review date: March 9, 2006.

6. The Regence Group. Orencia, abatacept. Policy No: dru129. Revised May 19, 2006.

7. Felson DT, et al. American College of rheumatology preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum 1995;38:727735.

VIII.Appendix Appendix 1 American College of Rheumatology (ACR) Classification Criteria for the

Diagnosis of Rheumatoid Arthritis Diagnosis of RA requires the presence of four of the seven criteria below:

1 Morning stiffness in and around joints lasting more than one hour 2 Arthritis in at least one area in a wrist, metacarpophalangeal (MCP), or proximal

interphalangeal (PIP) joint (hands or fingers) for > six weeks 3 Simultaneous swelling or fluid accumulation in 3 or more joints for > six weeks 4 Symmetric (bilateral joint) involvement for > six weeks 5 Presence of rheumatoid nodules 6 Positive serum rheumatoid factor 7 Radiographic changes typical of RA (erosion or unequivocal bony decalcification

in or adjacent to the involved joint) on hand and wrist present

A Alefacept (Amevive)

QUEST Provider Handbook Benefit Policies Rev. 10/07

This policy has been archived and is no longer reviewed. Precertification is no longer required.

B Blepharoplasty


I. Description Blepharoplasty is a surgical procedure performed on the upper or lower eyelids to excise skin, muscle, and fat. It can be cosmetic or functional. Reconstructive or functional blepharoplasty is most commonly performed to correct a diminished visual fields caused by the weight of excess tissue of the upper eyelid, called ptosis. Reconstructive blepharoplasty is also performed to treat eyelid lesions or alterations resulting from inflammatory processes such as Graves’ disease, blepharochalasis and floppy eyelid syndrome. Trauma to the eyelids and/or orbit may also be indications for blepharoplasty.

II. Criteria/Guidelines A. Blepharoplasty and repair of blepharoptosis may be covered when performed as

reconstructive/functional surgery for any of the following indications:

1. Correction of visual impairment of near or far vision due to dermatochalasis, blepharochalasis or blepharoptosis;

2. Correction of symptomatic redundant skin weighing down on upper lashes;

3. Correction of chronic symptomatic dermatitis of pretarsal skin caused by redundant upper lid skin;

4. Prosthesis difficulties in an anophthalmia socket;

5. Correction of lid retraction when the patient is unable to close the eyelids fully leading to dryness of the eye or corneal exposure;

6. Correction of lower eyelid blepharoptosis in the presence of massive lower eyelid edema secondary to systemic corticosteroid therapy, myxedema, Graves’ disease, nephrotic syndrome, or a number of other metabolic or inflammatory disorders. The excessive eyelid bulk, even after satisfactory treatment of the underlying systemic, disease may preclude proper positioning of eyeglasses.

7. Correction of lower eyelid blepharoptosis may also be required in cases of epiblepharon or entropion in which an extra roll of pretarsal skin and orbicularis muscle deflects the eyelashes against the cornea causing corneal irritation or erosion.

B. Visual fields demonstrate a minimum 12 degree or 30 percent loss of upper field of vision with upper lid skin and/or upper lid margin in repose and elevated (by taping the lid) to demonstrate potential correction by the proposed procedure or procedure(s). Visual fields are not required when blepharoplasty is for any of the following conditions:

1. Toxic diffuse goiter

2. Entropian and trichiasis of eyelid

3. Congenital deformities of eyelids

4. Artificial eye (Continued On Next Page)


III. Limitations/Exclusions A. Use of this procedure for any diagnosis other than those listed above will be considered not

medically appropriate and coverage/payment will be denied.

B. Payment will not be made for ptosis repairs performed for cosmetic reasons.

IV. Administrative Guidelines A. Precertification is required. To precertify, please complete HMSA’s Precertification

Request and mail or fax the form as indicated along with the required documentation.

B. All of the following documentation must be submitted with the precertification request:

1. Results of the visual field tests;

2. Patient complaints of interference with vision or visual field, difficulty reading due to upper eyelid drooping, looking through the eyelashes or seeing the upper eyelid skin or chronic blepharitis.

3. Photographs demonstrating one or more of the following conditions:

a. The upper eyelid margin approaches to within 2.5 mm (1/4 of the diameter of the visible iris) of the corneal light reflex.

b. The upper eyelid skin rests on the eyelashes.

c. The upper eyelid shows the presence of dermatitis.

d. The upper eyelid position contributes to difficulty tolerating a prosthesis in an anophthalmia socket.

ICD9CM Codes Description 242.00 – 242.01 Toxic diffuse goiter, with or without mention of thyrotoxic crisis or storm 374.00 – 374.05 Entropion and trichiasis of eyelid (code range) 374.10 – 374.14 Ectropion (code range) 374.20 – 374.23 Lagophthalmos (code range) 374.30 – 374.34 Ptosis of eyelid (code range) 374.87 Dermatochalasis 743.61 Congenital ptosis 743.62 Congenital deformities of eyelids V43.0 Organ or tissue replaced by other means, eye globe

B Blepharoplasty (continued)

CPT only © 2007, American Medical Association. All rights reserved. QUEST Provider Handbook Benefit Policies Rev. 10/07

CPT Codes Description 15820 Blepharoplasty, lower eyelid; 15821 with extensive herniated fat pad 15822 Blepharoplasty, upper eyelid; 15823 with excessive skin weighing down lid 67901 Repair of blepharoptosis; frontalis muscle technique with suture or other

material (e.g., banked fascia) 67902 frontalis muscle technique with autologous facial sling (includes obtaining

fascia) 67903 (tarso) levator resection or advancement, internal approach 67904 (tarso) levator resection or advancement, external approach 67906 superior rectus technique with fascial sling (includes obtaining fascia) 67908 conjunctivotarsoMuller’s musclelevator resection (e.g., FasanellaServat

type) 67911 Correction of lid retraction

V. Important Reminder The purpose of this Medical Policy is to provide a guide to coverage. This medical Policy is not intended to dictate to providers how to practice medicine. Nothing in this Medical Policy is intended to discourage or prohibit providing other medical advice or treatment deemed appropriate by the treating physician.



VI. References 1. American Academy of Ophthalmology. Ophthalmic technology assessment: Functional

indications for upper and lower eyelid blepharoplasty. Ophthalmology. April 1995. Vol.102, 693695.

2. Blue Cross and Blue Shield Association. Medical Policy Reference Manual. Reconstructive/Cosmetic Services. October 2003:10.01.09. No reviews scheduled since 2003.

3. Noridian Administrative Services, LLC, Medicare Part B. Blepharoplasty, blepharoptosis and brow lift. L16754. 1/1/2006. http://www.cms.hhs.gov/mcd/viewlcd.asp? lcd_id=16754&lcd_version=5&show=all

B Bone (Mineral) Density Studies (continued)


3. Bone mass measurement procedures that are not reasonable or necessary for the diagnosis, treatment or monitoring of a qualified individual as defined in this policy.

4. Radiography procedures performed by individuals other than “Certified Radiographers” or physicians.

CPT Codes Description 76977 Ultrasound bone density measurement and interpretation, peripheral site(s), any

method 77078 Computed tomography bone mineral density study, one or more sites; axial

skeleton (e.g., hips, pelvis, spine) 77079 appendicular skeleton (peripheral) (e.g., radius, wrist, heel) 77080 Dual energy Xray absorptiometry (DXA), bone density study, one or more sites;

axial skeleton (e.g., hips, pelvis, spine) 77081 appendicular skeleton (peripheral) (e.g., radius, wrist, heel) 77083 Radiographic absorptiometry (e.g., photdensitometry, radiogrammetry), one or

more sites 78350 Bone density (bone mineral content) study, one or more sites; single photon

absorptiometry

HCPCS Code Description G0130 Single energy Xray absorptiometry (SEXA) bone density study, one or more

sites; appendicular skeleton (peripheral) (e.g., radius, wrist, heel)

ICD9CM Codes Description 252.00 – 252.08 Disorders of parathyroid gland 255.0 Cushing’s syndrome 256.2 Postablative ovarian failure 256.31 Premature menopause 256.39 Other ovarian failure 256.9 Unspecified ovarian dysfunction 257.1 Postablative testicular hypofunction 257.2 Other testicular hypofunction 259.3 Ectopic hormone secretion, not elsewhere classified (includes ectopic

hyperparathyroidism) 585.3 Chronic kidney disease, Stage III (moderate) 585.4 Stage IV (severe) 585.5 Stage V 627.2 Symptomatic menopausal or female climacteric states 627.4 Symptomatic states associated with artificial menopause (includes postartificial

menopause syndromes) 627.8 Other specified menopausal and postmenopausal disorders 627.9 Unspecified menopausal and postmenopausal disorders 714.0 Rheumatoid arthritis 733.00 – 733.09 Osteoporosis 733.13 Pathologic fracture of vertebrae (includes collapse of vertebra NOS)



ICD9CM Codes Description 733.90 Disorder of bone and cartilage, unspecified 737.10 – 737.19 Kyphosis (acquired) 737.20 – 737.29 Lordosis (acquired) 737.30 Scoliosis (kyphoscoliosis), idiopathic 758.6 Gonadal dysgenesis (includes Turner’s syndrome) 805.00 – 805.08 Fracture, vertebral column, without mention of spinal cord injury, cervical, closed 805.10 – 805.18 cervical, open 805.2 dorsal (thoracic), closed 805.3 dorsal (thoracic), open 805.4 lumbar, closed 805.5 lumbar, open 805.6 sacrum and coccyx, closed 805.7 sacrum and coccyx, open 805.8 unspecified, closed 805.9 unspecified, open 806.00 – 806.9 Fracture, vertebral column, with spinal cord injury, cervical, closed 806.10 – 806.19 cervical, open 806.20 – 806.29 dorsal (thoracic), closed 806.30 – 806.39 dorsal (thoracic), open 806.4 lumbar, closed 806.5 lumbar, open 806.60 – 806.69 sacrum and coccyx, closed 806.70 – 806.79 sacrum and coccyx, open 806.8 unspecified, closed 806.9 unspecified, open 807.01 – 807.09 Fracture rib(s), closed 807.10 – 807.19 rib(s), open 808.0 Fracture, pelvis, acetabulum, closed 808.1 acetabulum, open 808.2 pubis, closed 808.3 pubis, open 808.41 – 808.49 other specified part, closed 808.51 – 808.59 other specified part, open 808.8 unspecified, closed 808.9 unspecified, open 812.00 – 812.09 Fracture, humerus, upper end, closed 812.10 – 812.19 upper end, open 812.20 – 812.21 shaft or unspecified part, closed 812.30 – 812.31 shaft or unspecified part, open 812.40 – 812.49 lower end, closed 812.50 – 812.59 lower end, open 813.40 – 813.45 Fracture, radius, ulna, lower end, closed 813.50 – 813.54 Fracture, radius, ulna, lower end, open 820.00 – 820.09 Fracture, femur neck, transcervical, closed 820.10 – 820.19 transcervical, open

B Botulinum Toxins (BOTOX and Myobloc)


These guidelines are effective December 1, 2007

I. Description Botulinum is a family of toxins produced by the anaerobic organism Clostridia botulinum. There are seven distinct serotypes designated as type A, B, C1, D, E, F, and G. In this country, two preparations of botulinum are available, produced by two different strains of bacteria: type A (Botox) and type B (Myobloc). When administered intramuscularly, all botulinum toxins reduce muscle tone by interfering with the release of acetylcholine from nerve endings.

The U.S. Food and Drug Administration (FDA)approved label for Botox states that it is indicated for the treatment of cervical dystonia in adults to decrease the severity of abnormal head position and neck pain associated with cervical dystonia, the treatment of severe hyperhidrosis that is inadequately managed with topical agents, the treatment of strabismus and blepharospasm associated with dystonia, including benign essential blepharospasm or VII nerve disorders in patients 12 years of age and above.

The FDAapproved label for Myobloc states that it is indicated for the treatment of cervical dystonia to reduce the severity of abnormal head position and neck pain associated with cervical dystonia.

II. Criteria/Guidelines A. The use of botulinum toxin may be considered medically necessary for the FDAlabeled

indications of strabismus, blepharospasm, facial nerve (VII) disorders, or cervical dystonia.

B. The use of botulinum toxin may be considered medically necessary for offlabel indications including the treatment of dystonia resulting in functional impairment (interference with joint function, mobility) and/or pain in patients with any of the following hereditary, degenerative, or demyelinating diseases of the central nervous system:

1. Idiopathic torsion dystonia

2. Symptomatic torsion dystonia

3. Orofacial dyskinesia

4. Organic writer’s cramp

5. Hereditary spastic paraplegia

6. Neuromyelitis optica

7. Schilder’s disease

8. Spastic hemiplegia

9. Spasticity related to stroke

10. Infantile cerebral palsy (Continued On Next Page)

CPT only © 2007, American Medical Association. All rights reserved. QUEST Provider Handbook Benefit Policies 10/07

11. Spasmodic torticollis

C. The use of botulinum toxin may be considered medically necessary for laryngeal spasm and torticollis (whether congenital, due to child birth injury, or traumatic).

D. The use of botulinum toxin may be considered medically necessary for achalasia in patients who have not responded to dilation therapy or who are considered poor surgical candidates.

E. The use of botulinum toxin may be considered medically necessary in the treatment of chronic anal fissure.

F. The use of botulinum toxin may be considered medically necessary for severe primary hyperhidrosis in the small subset of patients:

1. who are inadequately managed with topical agents and

2. with sweating that is intolerable and that interferes with the patient’s daily activities with a Hyperhidrosis Disease Severity Scale score of a 3 or 4. a. Score 3: “sweating is barely tolerable and frequently interferes with my daily

activities.”

b. Score 4: “sweating is intolerable and always interferes with my daily activities.”

G. The use of botulinum toxin may be considered medically necessary for secondary gustatory hyperhidrosis.

H. The use of botulinum toxin may be considered medically necessary as a treatment of incontinence due to detrusor overreactivity caused by spinal cord injury that is inadequately controlled with anticholinergic therapy.

I. The use of botulinum toxin may be considered medically necessary as a treatment of sialorrhea.

III. Limitations/Exclusions A. The use of botulinum toxin is considered investigational for other indications, including but

not limited to headaches including migraine, chronic low back pain, myofascial pain syndrome, or tremors such as benign essential tremor, chronic motor tic disorder (ICD9CM code 307.22), and tics associated with Tourette's syndrome (ICD9CM code 307.23), lateral epicondylitis, benign prostatic hyperplasia, detrusor overreactivity not due to spinal cord injury, and detrusor sphincteric dyssynergia.

B. The use of botulinum toxin is considered not medically necessary as a treatment of wrinkles or other cosmetic indications.

IV. Administrative Guidelines A. Injection of the vocal cords is done in association with laryngoscopic guidance. As indicated

by CPT codes 31513, 31570, or 31571, laryngoscopy is considered an integral part of the

B Botulinum Toxins (BOTOX and Myobloc) (continued)


procedure and separate billing for laryngoscopy and injection is not warranted.

B. Botulinum toxin as a treatment of achalasia requires a separate endoscopy procedure, which is billed separately. CPT established two codes (43201 and 43236) for upper GI endoscopy procedures with submucosal injection, any substance. These codes could apply to the use of botulinum toxin for the treatment of achalasia.

CPT Codes Description 31513 Laryngoscopy, indirect; with vocal cord injection 31570 Laryngoscopy, direct, with injection into vocal cord(s), therapeutic 31571 with operating microscope or telescope 43201 Esophagoscopy, rigid or flexible; diagnostic, with or without collection of

specimen(s) by brushing or washing, with directed submucosal injection(s) any substance

43236 Upper gastrointestinal endoscopy including esophagus, stomach, and either the duodenum and/or jejunum as appropriate; diagnostic, with or without collection of specimen(s) by brushing or washing, with directed submucosal injection(s), any substance

64612 Chemodenervation of muscle(s); muscle(s) innervated by facial nerve (e.g., for blepharospasm or hemifacial spasm)

64613 neck muscle(s), (e.g. for spasmodic torticollis, spasmodic dysphonia) 64614 extremity(s) and/or trunk muscle(s) (e.g. for dystonia, cerebral palsy,

multiple sclerosis) 64640 Destruction by neurolytic agent; other peripheral nerve or branch 67345 Chemodenervation of extraocular muscle 92265 Needle oculoelectromyography, one or more extraocular muscles, one or both

eyes, with medical diagnostic evaluation 95873 Electrical stimulation for guidance in conjunction with chemodenervation (list

separately in addition to code for primary procedure) 95874 Needle electromyography for guidance in conjunction with chemodenervation

(list separately in addition to code for primary procedure)

ICD9 CM Code Description 99.29 Injection (or infusion) of other therapeutic or prophylactic agent

HCPCS Codes Description J0585 Botulinum toxin type A, per unit (this code is for BOTOX) J0587 Botulinum toxin type B, per 100 units (this code is for Myobloc)

ICD9 CM Codes Description 333.6 Genetic torsion dystonia 333.7 Symptomatic torsion dystonia 333.79 Other acquired torsion dystonia 333.81 Blepharospasm 333.82 Orofacial dyskinesia



ICD9 CM Codes Description 333.83 Spasmodic torticolis

excludes: tortocolis NOS (723.5) hysterical (300.11) psychogenic (306.0)

333.84 Organic writer’s cramp 333.89 Fragments of torsion dystonia, other 334.1 Hereditary spastic paraplegia 340 Multiple sclerosis 341.0 – 341.9 Other demyelinating diseases of central nervous system 342.11 – 342.12 Spastic hemiplegia 343.0 – 343.9 Infantile cerebral palsy 350.8 Other specified trigeminal nerve disorders 351.8 Other facial nerve disorders (includes facial myokymia, Melkersson’s

syndrome) 378.00 – 378.90 Strabismus and other disorders of binocular eye movements 478.75 Laryngeal spasm (includes laryngismus (stridulus)) 527.7 Disturbance of salivary secretion 530.0 Achalasia and cardiospasm 565.0 Anal fissure 705.21 Disorders of sweat glands Primary focal hyperhidrosis 723.5 Torticolis, unspecified (includes contracture of neck)

excludes: congenital (754.1) due to birth injury (767.8) hysterical (300.11) ocular torticolis (781.93) psychogenic (306.0) spasmodic (333.83) traumatic, current (847.0)

728.85 Spasm of muscle 780.8 Generalized hyperhidrosis 781.0 Abnormal involuntary movements 784.49 Voice disturbance, other (dysphonia)

V. Scientific Background Myofascial Pain Syndrome Painful muscles with increased tone and stiffness containing trigger points characterize myofascial pain syndrome. Patients are often treated with injections of the trigger points with saline, dilute anesthetics, or dry needling. These trigger point injections, while considered established therapy, have been controversial since it is unclear whether any treatment effect is due to the injection, dry needling of the trigger point, or a placebo effect. Among three studies on cervicothoracic myofascial pain syndrome, Wheeler and colleagues (5) conducted a randomized trial of 33 patients who were randomized into three groups; one group receiving 50 units of botulinum toxin, one group receiving 100 units of botulinum toxin, and one group receiving normal saline. All three groups showed similarly significant treatment effects, based on the Neck Pain and Disability Visual Analogue Scale. These same authors (6) later found no differences among 50 patients randomized



to highdose botulinum toxin or placebo. A crossover study of only six patients (7) found significantly better results for botulinum toxin over placebo at two and four weeks for four of five pain outcomes. Together, these three studies are insufficient to permit conclusions about the effects of botulinum toxin on cervicothoracic myofascial pain syndrome.

Three studies addressed another form of myofascial pain, piriformis syndrome, characterized by buttock tenderness and sciatica. One study of nine patients (8) compared botulinum toxin with placebo, finding that postinjection pain scores were significantly improved in the treatment group for only one of four pain domains, while none improved in the placebo group. Another study of 36 patients (9) had a high loss to followup (23 percent) and found that the botulinum toxin group had a significantly higher proportion with 50 percent or greater reduction in pain on each of the last two followup visits, compared with placebo. These small and flawed studies do not establish that the effects of botulinum toxin exceed those of placebo. A third study (10) comparing botulinum toxin with methylprednisolone found better results for the former, but placebo effects were not considered. The evidence for piriformis myofascial pain syndrome does not support conclusions about the effects of botulinum toxin.

Tremor Tremor may be defined as alternate or synchronous contractions of antagonistic muscles. Some patients may be disabled by severe or taskspecific tremors. Tremors are also a frequent component of dystonias, and successful treatment of dystonias resulted in an improvement in tremors. Botulinum toxin has been investigated in patients with tremors unrelated to dystonias. One randomized study has been reported of ten patients with essential head tremor. (16) Patients were randomized to receive either botulinum injections into the sternocleidomastoid and splenius capitus muscle. Five patients improved in the treatment group compared to three in the control group. The lack of statistical significance may be related to the small size of the study. Two randomized, placebocontrolled studies addressed essential hand tremors, enrolling 133 and 25 patients, respectively (17, 18). In both studies, inconsistent significant advantages for botulinum toxin were found on tremor symptom scales, but none were shown on functional outcomes. Thus, the clinical significance of these findings is unclear.

Migraine This indication, as well as tension headaches, was addressed in TEC Assessments completed in 2002 and 2004. The interest in using botulinum as a treatment of migraine stemmed from the observation that patients receiving pericranial injections of botulinum toxin for other reasons reported a decrease in the incidence in migraine. While it may exert its effect by relieving the associated muscle tension associated with migraine, others have proposed an independent action. Silberstein and colleagues reported on a doubleblind, randomized, placebocontrolled trial of pericranial injections of botulinum toxin as a prophylactic treatment of migraine. A total of 123 patients were randomized to receive either placebo injections or 25 U or 75 U of botulinum toxin injected in various sites pericranially. (19) The patients were followed up for three months after the injections, during which time they kept a headache diary. A significantly greater proportion of patients receiving 25 U of botulinum (but not 75 U) reported a decrease of two or more migraines. While this study suggests that botulinum toxin may be an effective prophylactic therapy for migraines, there is no underlying scientific explanation for the treatment effect, and the lack of a dose response effect also undermines the findings. A recent study by Evers et al. (20) randomized 60 patients to either zero units, 16 units or 100 units of botulinum toxin to the frontal and neck muscles. There were no significant differences between groups on six headache outcomes and a



depression scale. The 16unit group had significantly better results than the zerounit group on accompanying symptoms (photophobia, phonophobia, nausea, and vomiting), but this was shown only on posthoc analysis. These two studies together provide only very weak evidence for the benefits of botulinum toxin for migraine. In addition, no data compare botulinum to other prophylactic therapies, such as calcium channel blockers, beta blockers, nonsteroidal anti inflammatory drugs, or selective serotonin reuptake inhibitors.

Update on Migraine Headache A review article published by Evers (21) in 2006 cites seven randomized, doubleblind, placebo controlled trials, including the studies by Silberstein and colleagues, and Evers and colleagues described previously. Some of these studies were quite large, enrolling more than 200 patients, but have not yet been published in peerreviewed journals. Five of these studies show no significant reduction in migraine. The Evers review did not include a recent study by Elkind and colleagues (22) which randomized 418 patients to sequential treatments of botulinum toxin or placebo. No consistent significant differences were observed for any outcome. Thus, in contrast to singlearm studies and retrospective studies, the preponderance of randomized clinical trial evidence shows no significant effect of botulinum toxin in reducing frequency of migraine.

Tension Headache The 2002 TEC Assessment reviewed four trials providing data for 125 patients (2326). Only one of these studies gave data suggesting better outcome for botulinum toxin over placebo. Four additional studies were found by the 2004 TEC Assessment, with data for 223 patients (2730). Taking previously available and recent studies together, among five of eight studies that identified a primary outcome, none found statistically significant benefits for botulinum toxin over placebo for that outcome. In two studies, the primary outcome was area under the headache curve (AUC), computed as the sum of the product of headache duration and severity across days. The primary outcome was headache severity in two studies and headache frequency in one study.

Two of the eight studies had fair quality ratings, while the other six were rated as poor. Neither of the two betterrated studies found significant differences between placebo and botulinum toxin groups. The largest study (n=107) found no differences between groups on six outcomes. The second study rated as fair in quality found no significant differences on five outcomes. Three of the six studies rated as poor in quality found inconsistent significant results. In one of these studies, there did not appear to be a statistically significant result on the primary outcome or four other outcomes, while three global rating scales significantly favored the botulinum toxin group. Groups differed greatly on the baseline mean frequency of headaches and the authors did not mention adjustment for confounding in the data analysis. Two other poorquality studies finding selected significant differences between groups did not evaluate comparability of groups on any baseline characteristics or specify that analyses used adjustment techniques, so it is unclear whether findings were influenced by confounding. The failure of two betterquality studies to find betweengroup differences calls into question the weakly positive findings of three poor quality studies. Overall, the evidence is not sufficient to support conclusions about the effects of botulinum toxin on tension headaches.

Update on Tension Headache The previously mentioned 2006 review by Evers (21) found 10 randomized, doublebind placebo controlled studies. Only one study found a statistically significant reduction in the primary endpoint for headache frequency. The most recent study by Silberstein and colleagues (31) enrolled the largest number of subjects: 300 patients. There was no statistically significant



difference between placebo and four botulinum dose groups for the primary end point of headache free days per month. At this point in time, a large and consistent body of randomized trial evidence shows little evidence showing efficacy of botulinum toxin for tension headache.

Cluster Headache No controlled trials have been reported on this type of headache.

Cervicogenic Headache Freund and colleagues reported on a placebocontrolled trial that randomized 26 patients with chronic headache related to whiplash injury to receive either botulinum toxin or placebo injections. (29) Although the treatment group reported a significant improvement in pain while the placebo group reported no improvement, the study design was flawed in that the placebo group reported less pain at baseline.

Chronic Low Back Pain The literature search revealed a single study using botulinum toxin A in patients with low back pain. Foster et al. (30) report a randomized, doubleblind study of botulinum toxin A in 31 consecutive patients with chronic low back pain. Study selection criteria included low back pain of at least six months' duration with more predominant pain on one side. Patients were excluded if there was a systemic inflammatory disorder, acute pathology on MRI, or involvement in worker’s compensation or litigation among other criteria.

The outcome measures used in this study were a visual analogue scale (VAS) for pain, measured at baseline, three weeks and eight weeks, and a 50 percent reduction was considered a response. The Oswestry Low Back Pain Questionnaire (OLBPQ) was used to measure functional ability at baseline and at eight weeks. This measure has ten different subscales (pain, personal care, lifting, walking, sitting, standing, sleeping, sex, social life, and traveling) each rated zero to five. Responders were required to show a twopoint reduction on the pain subscore and at least one of other subscales. Three patients withdrew or were lost to followup over the course of the eight week study, and these subjects were included in the intenttotreat analysis as nonresponders. Patients were injected with 40 units of Botox (Allergan, Inc.) at five lumbosacral locations for a total of 200 U (treated group) or saline placebo (placebo group). Injections were made on one side of the back only, depending on predominance of pain.

At baseline, pain scores on the VAS in the treated group ranged from six to 10, with an average of 7.5; in the placebo group, scores ranged from five to 10, with an average of seven. At three weeks, 73.3 percent of treated patients and 25 percent of placebo showed a response on VAS scores (p=0.012). This difference in VAS scores remained significant at eight weeks with 60 percent of treated patients and 12.5 percent of placebo patients still responding (p=0.009). The OLBPQ assessment at eight weeks showed that 66.7 percent of treated patients and 18.8 percent of placebo patients were responders (p=0.011).

These results show clinically significant and statistically significant improvements in treated patients as compared with placebo on all three outcome assessments.

However, this is only one suggestive study that included 31 subjects, and replication of these findings would be desirable. The population with chronic low back pain is a heterogeneous population, and results in this small group of selected subjects cannot be used to generalize results



for the whole population with chronic low back pain. Furthermore, studies should examine the longterm effectiveness of using repeated courses of botulinum toxin to determine the durability of repeated treatments.

Lateral Epicondylitis Wong and colleagues reported on the results of a doubleblind, placebocontrolled trial that randomized 60 patients with lateral epicondylitis of at least three months’ duration to receive either a single intramuscular injection of botulinum toxin or placebo, targeted at the tender spot in the elbow (39). Patients who had previously received steroid injections were excluded. The primary outcome was mean VAS scores at baseline and at four weeks. In the botulinum group, the mean VAS score improved from 65.5 mm to 25.3 mm at four weeks, compared to a change of 66.2 mm to 50.5 mm in the placebo group, a statistically significant difference. Mild paresis was reported in four patients in the botulinum group, a side effect that may have resulted in unblinding of these participants. In a similarly designed study of 40 patients, Hayton and colleagues reported no treatment effect at three months (40). However, the injection site was targeted at five cm distal to the most tender spot, and a different formulation of botulinum toxin was used. Given the discrepant results of these two small studies, larger studies with longer followup are necessary to confirm a treatment effect.

Urologic Applications Botulinum has been studied as a treatment of nonneurogenic detrusor overreactivity (i.e., urge incontinence) (42); however, no controlled studies were identified in a literature search.

De Seze and colleagues performed a study of 13 patients with chronic urinary retention due to detrusor sphincter dyssynergia who were randomized to receive perineal botulinum toxin or lidocaine injections into the external urethral sphincter (43). The primary outcome was postvoid residual volume measured at days one, three, and 30 after injection. In the botulinum group, there was a significant decrease in the postvoid residual volume compared to no change in the control group receiving a lidocaine injection. Improvements were also seen in the satisfaction scores and other urodynamic outcomes. While these results are promising, the sample size of 13 is too small to draw firm conclusions.

Maria and colleagues reported on 30 patients with benign prostatic hyperplasia (BPH) who were randomized to receive either intraprostatic botulinum or saline injection (44). The rationale for botulinum treatment is based on the theory that symptoms of BPH are in part due to a static component related to prostate size and a dynamic component related to the contraction of smooth muscle within the gland. Botulinum therapy addresses this latter component. Inclusion criteria for this trial included moderate to severe symptoms of BPH based on the American Urological Association (AUA) score and a mean peak urinary flow rate of no more than 15 mL/s with a voided volume of 150 mL or less. The primary endpoints were changes in the AUA score and peak urinary flow rates, measured at one and two months posttreatment. Among those receiving botulinum toxin, the AUA symptom score decreased by 65 percent, compared to no significant change in the control group. The mean peak urinary flow rate was significantly increased in the treatment group. Given the prevalence of BPH, larger trials comparing the role of BPH with other medical and surgical therapies are warranted.

VI. Important Reminder The purpose of this Medical Policy is to provide a guide to coverage. This Medical Policy is not intended to dictate to providers how to practice medicine. Nothing in this Medical Policy is



intended to discourage or prohibit providing other medical advice or treatment deemed appropriate by the treating physician.



VII. References 1. BCBSA 1996 TEC Assessment; Tab 6.

2. BCBSA 2004 TEC Assessment, Tab 10.

3. BCBSA 2002 TEC Assessment, Tab 16.

4. Vaezi MF, Richter JM, Wilcox CM et al. Botulinum toxin versus pneumatic dilatation in the treatment of achalasia: a randomized trial. Gut 1999; 44(2):2319.

5. Wheeler AH, Goolkasian P, Gretz SS. A randomized, doubleblind, prospective pilot study of botulinum toxin injection for refractory, unilateral, cervicothoracic, paraspinal myofascial pain syndrome. Spine 1998; 23(15):16627.

6. Wheeler AH, Goolkasian P, Gretz SS. Botulinum toxin A for the treatment of chronic neck pain. Pain 2001; 94(3):25560.

7. Cheshire WP, Abashian SW, Mann JD. Botulinum toxin in the treatment of myofascial pain syndrome. Pain 1994; 59(1):659.

8. Childers MK, Wilson DJ, Gnatz SM et al. Botulinum toxin type A use in piriformis muscle syndrome: a pilot study. Am J Phys Med Rehabil 2002; 81(10):7519.

9. Fishman LM, Anderson C, Rosner B. BOTOX and physical therapy in the treatment of piriformis syndrome. Am J Phys Med Rehabil 2002; 81(12):93642.

10. Porta M. A comparative trial of botulinum toxin type A and methylprednisolone for the treatment of myofascial pain syndrome and pain from chronic muscle spasm. Pain 2000; 85(1 2):1015.

11. Kirazli Y, On AY, Kismali B et al. Comparison of phenol block and botulinus toxin type A in the treatment of spastic foot after stroke: a randomized, doubleblind trial. Am J Phys Med Rehabil 1998; 77(6):5105.



12. Smith SJ, Ellis E, White S et al. A doubleblind placebocontrolled study of botulinum toxin in upper limb spasticity after stroke or head injury. Clin Rehabil 2000; 14(1):513.

13. Maria G, Cassetta E, Gui D et al. A comparison of botulinum toxin and saline for the treatment of chronic anal fissure. N Engl J Med 1998; 338(4):21720.

14. Jost WH. One hundred cases of anal fissure treated with botulinum toxin: early and longterm results. Dis Colon Rectum 1997; 40(9):102932.

15. Brisinda G, Maria G, Bentivoglio AR et al. A comparison of injections of botulinum toxin and topical nitroglycerin ointment for the treatment of chronic anal fissure. N Engl J Med 1999; 341(2):659.

16. Pahwa R, Busenbark K, SwansonHyland EF et al. Botulinum toxin treatment of essential head tremor. Neurology 1995; 45(4):8224.

17. Brin MF, Lyons KE, Doucette J et al. A randomized, double masked, controlled trial of botulinum toxin type A in essential hand tremor. Neurology 2001; 56(11):15238.

18. Jankovic J, Schwartz K, Clemence W et al. A randomized, doubleblind, placebocontrolled study to evaluate botulinum toxin type A in essential hand tremor. Mov Disord 1996; 11(3):2506.

19. Silberstein S, Mathew N, Saper J et al. Botulinum toxin type A as a migraine preventive treatment. Headache 2000; 40(6):44550.

20. Evers S, VollmerHaase J, Schwaag S et al. Botulinum toxin A in the prophylactic treatment of migraine – a randomized, doubleblind, placebocontrolled study. Cephalalgia 2004; 24(10):83843.

21. Evers S. Status on the use of botulinum toxin for headache disorders. Curr Opin Neurol 2006; 19(3):3105.

22. Elkind AH, O’Carroll P, Blumenfeld A et al. A series of three sequential, randomized controlled studies of repeated treatments with botulinum toxin type A for migraine prophylaxis. J Pain 2006; 7(10):68896.

23. Rollnik JD, Karst M, Fink M et al. Botulinum toxin type A and EMG: a key to the understanding of chronic tensiontype headaches? Headache 2001; 41(10):9859.

24. Rollnik JD, Tanneberger O, Schubert M et al. Treatment of tensiontype headache with botulinum toxin type A: a doubleblind placebocontrolled study. Headache 2000; 40(4):300 5.

25. Schmitt WJ, Slowey E, Fravi N et al. Effect of botulinum toxin A injections in the treatment of chronic tensiontype headache: a doubleblind, placebocontrolled rial. Headache 2001; 41(7):65864.



26. Smuts JA, Baker MK, Smuts HM et al. Prophylactic treatment of chronic tensiontype headache using botulinum toxin type A. Eur J Neurol 1999; 6 (suppl 4):S99102.

27. Ondo WG, Vuong KD, Derman HS. Botulinum toxin A for chronic daily headache: a randomized, placebocontrolled, parallel design study. Cephalalgia 2004; 24(1):605.

28. Padberg M, de Bruijn, de Haan RJ et al. Treatment of chronic tensiontype headache with botulinum toxin: a doubleblind, placebocontrolled clinical trial. Cephalalgia 2004; 24(8):67580.

29. Relja M, Telarovic S. Botulinum toxin in tensiontype headache. J Neurol 2004; 251(suppl 1):I124.

30. SchulteMattler WJ, Krack P Treatment of chronic tensiontype headache with botulinum toxin A: a randomized, doubleblind, placebocontrolled multicenter study. Pain 2004;109(12):110 4.

31. Silberstein SD, Gobel H, Jensen R et al. Botulinum toxin type A in the prophylactic treatment of chronic tensiontype headache: a multicentre, doubleblind, randomized, placebocontrolled, parallelgroup study. Cephalalgia 2006; 26(7):790800.

32. Freund BJ, Schwartz M. Treatment of chronic cervicalassociated headache with botulinum toxin A: a pilot study. Headache 2000; 40(3);2316.

33. Matthew NT, Frishberg BM, Gawel M et al. Botulinum toxin type A (BOTOX) for the prophylactic treatment of chronic daily headache: a randomized, doubleblind, placebo controlled trial. Headache 2005; 45(4):293307.

34. Silberstein SD, Stark SR, Lucas SM et al. Botulinum toxin type A for the prophylactic treatment of chronic daily headache: a randomized, doublebind, placebocontrolled trial. Mayo Clin Proc 2005; 80(9):112637.

35. Foster L, Clapp L, Erickson M et al. Botulinum toxin A and chronic low back pain: a randomized, doubleblind study. Neurology 2001; 56(10):12903.

36. Ondo WG, Hunter C, Moore W. A doubleblind placebocontrolled trial of botulinum toxin B for sialorrhea in Parkinson’s disease. Neurology 2004; 62(1):3740.

37. Mancini F, Zangaglia R, Cristina S et al. Doubleblind, placebocontrolled study to evaluate the efficacy and safety of botulinum toxin type A in the treatment of drooling in Parkinsonism. Mov Disord 2003; 18(6):6858.

38. Lipp A, Trottenberg T, Schink T et al. A randomized trial of botulinum toxin A for treatment of drooling. Neurology 2003; 61(9):127981.

39. Wong SM, Hui ACF, Poon DWF et al. Treatment of lateral epicondylitis with botulinum toxin: a randomized, doubleblind, placebocontrolled trial. Ann Intern Med 2005; 143(11):7937.



40. Hayton MJ, Santini AJ, Hughes PJ et al. Botulinum toxin injection in the treatment of tennis elbow. A doubleblind, randomized, controlled, pilot study. J Bone Joint Surg Am 2005; 87(3):5037.

41. Schurch B, de Seze M, Denys P et al. Botulinum toxin type A is a safe and effective treatment of neurogenic urinary incontinence: results of a single treatment, randomized, placebo controlled 6month study. J Urol 2005; 174(1):196200.

42. Werner M, Schmid DM, Schussler B. Efficacy of botulinumA in the treatment of detrusor overactivity incontinence: a prospective nonrandomized study. Am J Obstet Gynecol 2005; 192(5):173540.

43. de Seze M, Petit H, Gallien P et al. Botulinum a toxin and detrusor sphincter dyssynergia: a doubleblind lidocainecontrolled study in 13 patients with spinal cord disease. Eur Urol 2002; 42(1):5662.

44. Maria G, Brisinda G, Civello IM et al. Relief by botulinum toxin of voiding dysfunction due to benign prostatic hyperplasia: results of a randomized, placebocontrolled study. Urology 2003; 62(2):25965.

45. www.botox.com/download/HDSS_Scale.pdf Hyperhidrosis Disease Severity Scale. Accessed February 27, 2007.

C Cosmetic and Reconstructive Surgery and Services


I. Description Cosmetic services are services that are primarily intended to improve a person’s natural appearance, but which do not restore or materially improve a physical function, or which are prescribed for psychological or psychiatric reasons.

Reconstructive surgery is performed on abnormal structures of the body, caused by congenital defects, developmental abnormalities, trauma, infection, tumors or disease. It is generally performed to improve function, but may also be done to approximate a normal appearance.

II. Criteria/Guidelines A. HMSA plans only cover services and supplies that restore or materially improve a physical

function.

B. Reconstructive surgery is covered only when required to restore, reconstruct or correct one or more of the following:

1. Any bodily function that was lost, impaired, or damaged as a result of an illness or injury, OR

2. Developmental abnormalities which are present from birth and which severely impair or impede normal, essential bodily functions, OR

3. The breast on which a mastectomy for cancer or the prevention of cancer was performed, and surgery for the reconstruction of the other breast to produce a symmetrical appearance (including prostheses).

a. Treatment for complications of mastectomy and reconstruction, including lymphedema is also covered.

III. Limitations/Exclusions A. A cosmetic service is considered a benefit exclusion and, therefore, is ineligible for coverage.

Cosmetic services are those services and supplies that are primarily intended to improve a member’s natural appearance. Furthermore, treatment of complications of a noncovered procedure is not covered.

IV. Administrative Guidelines A. If a provider is planning a procedure or service that potentially may be considered to be

cosmetic in nature, precertification should be obtained to determine if the service will be covered. To precertify, please complete HMSA’s Precertification Request and mail or fax the form as indicated. For more information, these could be accessed: Benefit Information, Cosmetic Procedures and Services That Require Precertification.

V. Important Reminder The purpose of this Medical Policy is to provide a guide to coverage. This Medical Policy is not intended to dictate to providers how to practice medicine. Nothing in this Medical Policy is intended to discourage or prohibit providing other medical advice or treatment deemed appropriate by the treating physician.





VI. References 1. American Medical Association H475.992 Definitions of “Cosmetic” and “Reconstructive”

Surgery. Accessed December 19, 2006 at: http://www.amaassn.org/.

2. HMSA Guide to Benefits. January 2007. PPO.

3. HMSA Guide to Benefits. January 2007. Federal Plan 87.

E Emergency Room Services


Services provided on the same day as a covered emergency room service that are covered and separately billable include but are not limited to:

• Emergency room facility fee

• Diagnostic testing (laboratory testing, radiology, other imaging procedures)

• Therapeutic services and treatments such as inhalation treatment, intravenous infusion, injections of antibiotics, etc.

• Medical supplies such as casting material, splints, intravenous administration sets.

• Certain durable medical equipment for use by the specific patient such as crutches.

Exclusions and Limitations • Emergency room services that result in an inpatient admission to the acute care hospital are

considered part of the inpatient hospital stay.

• Physician services

• Ambulance services

• Standard emergency room supplies and equipment such as blood pressure monitoring devices, sheets, underpads, suction machines, sutures, scissors, oximeters, bed pans, thermometers, tongue blades, etc.

• Supplies that are an integral part of the procedures. Examples are clean catch kits when urinalysis and/or cultures are done, electrodes when ECGs are done, blood specimen containers when blood chemistries are drawn. Usage of updraft, nebulizer and oxygen are not billable as supplies.

E Erythropoietin and Darbepoetin



I. Description Endogenous erythropoietin (EPO) is a glycoprotein hematopoietic growth factor synthesized at the cellular level by cells near the renal tubules in response to changes in the blood oxygen concentration. When a patient is anemic, the ability of the blood to carry oxygen is decreased. An oxygensensing protein in the kidney detects the decrease in blood oxygen concentration and induces the production of erythropoietin (EPO), which then acts upon the erythroid cell line in the bone marrow to stimulate hematopoiesis.

Darbepoetin is a longacting form of erythropoietin, a protein that stimulates the production of red blood cells and is used for the treatment of anemia.

II. Criteria/Guidelines A. Recombinant erythropoietin (EPO) and darbepoetin alfa (Aranesp) are considered medically

necessary for:

1. Treatment of symptomatic anemia associated with chronic renal failure (with or without the use of dialysis) until the hematocrit reaches a target of 30 to 36 percent.

2. Treatment of symptomatic anemia (pretreatment hematocrit < 36 percent) in AZT treated HIV infected patients, when the dose of AZT is equal to or less than 4,200 mg per week and the patient’s pretreatment endogenous erythropoietin level is < 500 mUnits/mL. The maximum dosage of erythropoietin should be a total of 60,000 units per week (in single or divided doses).

3. Treatment of symptomatic anemia in cancer patients with nonmyeloid malignancies whose anemia is due to the effect of concomitantly administered chemotherapy expected to last over a minimum of two months (treatment of patients with grossly elevated serum erythropoietin levels (e.g., >200 mU/ml) is not recommended).

4. Treatment of anemic patients (pretreatment hemoglobin is 11 to 13 g/dL) scheduled to undergo elective, noncardiac, nonvascular surgery to reduce the need for allogeneic blood transfusions. Indicated for patients at high risk for perioperative transfusions with significant, anticipated blood loss, for example, for patients expected to lose > two units of blood. Erythropoietin dosage is appropriate up to a total of 60,000 units per week (in single or divided doses).

5. Treatment of patients withmyelodysplastic syndromes with pretreatment hematocrit ≤ 27 percent or hemoglobin ≤ nine g/dL or transfusion dependency. Precertification is required for this indication. If approved, an initial certification will be given for three months. Subsequent approval for up to one year may be given based on positive clinical outcome at the end of the initial authorization period.

6. Treatment of patients following allogeneic bone marrow transplantation.



7. Treatment of patients with anemia associated with the management of hepatitis C with a combination of ribavirin and interferon alfa or ribavirin and peginterferon alfa at a dose of erythropoietin of up to 60,000 units per week (in single or divided doses). One of the following criteria must be met:

a. The patient’s hemoglobin (Hgb) is < 11.0 g/dL; or

b. The patient has a comorbid condition (e.g., cirrhosis, CHF, COPD) requiring treatment of mild to moderate anemia.

8. Treatment of anemia (pretreatment hematocrit < 32 percent) in low birth weight infants at doses of erythropoietin to 1,000 units per week.

9. Treatment of limited acute severe anemia (pretreatment hematocrit ≤ 24 percent) when a blood transfusion would otherwise be needed, such as with blood loss after trauma, at erythropoietin doses up to a total of 60,000 units per week (in single or divided doses).

10. Treatment of anemia of chronic disease characterized by a pretreatment hematocrit of ≤ 27 percent or hemoglobin ≤ 9 g/dL or transfusion dependency at doses of erythropoietin up to a total of 60,000 units per week (in single or divided doses). Precertification is required for this indication. If approved, an initial certification will be given for three months. Subsequent approval for up to one year may be given based on positive clinical outcome at the end of initial authorization period.

a. The patient’s own erythropoietin levels are ≤ 500 mU/ml; and

b. Patient’s transferrin saturation is at least 20 percent and ferritin at least 100 ng/mL.

11. Treatment of patients who donate blood frequently to increase the capacity for donation (for future autologous transfusion) prior to elective surgery. This medication has been found effective in females, patients with low packedcell volumes due to anemia or small body size, and patients requiring donation of ≥ four units of blood.

12. Treatment of patients with chronic anemia associated with neoplastic diseases.

III. Limitations/Exclusions A. Patients with anemia of chronic diseases OR myelodysplastic syndromes should be

initially limited to a 3month trial period with EPO.

B. If no response to EPO is observed, ongoing therapy would not be indicated. The target hematocrit range is generally 30 percent to 36 percent or documentation of a decrease in transfusion requirements.

IV. Administrative Guidelines A. Precertification is only required for the diagnosis of myelodysplastic syndrome OR anemia of

chronic disease (see Criteria II.A.5. and II.A.10.).

E Erythropoietin and Darbepoetin (continued)


B. HMSA reserves the right to perform retrospective review using the above criteria to validate if services rendered for other diagnoses were medically necessary.

CPT Codes Description 90765 Intravenous infusion, for therapy, prophylaxis, or diagnosis (specify substance

or drug); initial, up to 1 hour (new code effective 1/1/06) 90772 Therapeutic, prophylactic, or diagnostic injection (specify substance or drug);

subcutaneous or intramuscular (new code effective 1/1/06)

HCPCS Codes Description J0881 Injection, darbepoetin alfa, 1 microgram (nonESRD use) J0882 Injection, darbepoetin alfa, 1 microgram (for ESRD on dialysis) J0885 Injection, epoetin alfa, (for nonESRD use), 1000 units J0886 Injection, epoetin alfa, 1000 units (for ESRD on dialysis) Q4081 Injection, epoetin alfa, 100 units (for ESRD on dialysis)

ICD9 Procedure Description 99.29 Injection or infusion of other therapeutic or prophylactic substance

ICD9 Diagnosis Description 042 HIV disease 070.54 Chronic hepatitis C without mention of hepatic coma 140.0 – 149.9 Malignant neoplasm of lip, oral cavity and pharynx 150.0 – 159.9 Malignant neoplasm of digestive organs and peritoneum 160.0 – 165.9 Malignant neoplasm of respiratory and intrathoracic organs 170.0 – 176.9 Malignant neoplasm of bone, connective tissue, skin and breast 179 – 189.9 Malignant neoplasm of genitourinary organs 190.0 – 199.1 Malignant neoplasm of other and unspecified sites 200.0 – 200.8 Lymphosarcoma and reticulosarcoma 201.00 – 201.98 Hodgkin’s disease 202.00 – 202.98 Other malignant neoplasms of lymphoid and histiocytic tissue 230.0 – 234.9 Carcinoma in situ 235.0 – 235.9 Neoplasm of uncertain behavior of digestive and respiratory systems 236.0 – 236.9 Neoplasm of uncertain behavior of genitourinary organs 237.0 – 237.9 Neoplasm of uncertain behavior of endocrine glands and nervous system 238.0 Neoplasm of uncertain behavior of other and unspecified sites and tissues;

bone and articular cartilage 238.1 Neoplasm of uncertain behavior of other and unspecified sites and tissues;

connective and other soft tissue 238.2 Neoplasm of uncertain behavior of other and unspecified sites and tissues;

skin 238.3 Neoplasm of uncertain behavior of other and unspecified sites and tissues;

breast 285.21 Anemia in chronic kidney disease 285.22 Anemia in neoplastic disease 585.3 – 585.9 Chronic kidney disease (CKD), stage III to V, ESRD, and unspecified



ICD9 Diagnosis Description 586 Renal failure, unspecified 587 Renal sclerosis, unspecified 776.6 Anemia of prematurity V42.0 Kidney transplant V58.11 Encounter for antineoplastic chemotherapy

V. Scientific Background Anemia associated with chronic renal failure For the treatment of symptomatic anemia associated with chronic renal failure, the FDA prescribing information indicates that once the hematocrit reaches the suggested target range of 30 to 36 percent, that level can be sustained by erythropoietin therapy in the absence of iron deficiency and concurrent illnesses. A nondialysis patient should start with a hemoglobin of < 10 g/dL. The National Kidney Foundation’s Kidney Disease Outcomes Quality Initiative (K/DOQI) guidelines for 2000 states that the target range for hemoglobin (hematocrit) should be 11 g/dL (33 percent) to Hgb 12 g/dL (36 percent).

Anemia related to therapy with AZT in HIVinfected patients HIV disease and its treatment, particularly with zidovudine (AZT), can cause anemia. Erythropoietin use in this patient population has been shown to increase hematocrit, decrease transfusion requirement and increase energy. Erythropoietin administration was associated with a decreased risk of dying among these patients with anemia. According to FDA prescribing information, patients with endogenous serum erythropoietin levels > 500 mUnits/ml do not appear to respond to erythropoietin therapy.

Anemia in cancer patients with nonmyeloid malignancies due to concomitant chemotherapy Administration of erythropoietin has been shown to increase hemoglobin levels and reduce the numbers of transfusions in patients with nonmyeloid malignancies who receive concomitant chemotherapy.

Anemia and autologous blood donations before surgery Patients with a baseline hematocrit of ≤ 39 percent receiving erythropoietin before surgery were able to increase the number of units of blood they were able to predeposit, thereby decreasing the need for transfusion after surgery.

A placebocontrolled trial before major orthopedic surgery found that patients with a baseline hemoglobin of 10 to 13 gm/dl who were treated with erythropoietin required fewer transfusions.

Anemia of chronic disease (ACD) ACD is a condition of impaired iron utilization where hemoglobin is low (> 9 mg/dL, target 12 mg/dL) but tissue iron (such as in storage) is normal or high. ACD is seen in a wide range of chronic malignant, autoimmune (juvenile rheumatoid arthritis, rheumatic fever, etc.), leukemic, inflammatory (Crohn’s disease, and ulcerative colitis, etc.), and infectious disease (chronic bacterial endocarditis, osteomyelitis, etc.) conditions.

Treatment of ACD in rheumatoid arthritis with epoetin alfa 240 IU/kg three times weekly after six weeks was shown to restore normal hemoglobin levels.

E Erythropoietin and Darbepoetin (continued)


Anemia in low birth weight infants Epoetin alfa in lowbirth weight infants less than 1500 grams was shown to increase hematocrit levels and reduce the need for transfusions compared to placebo.

VI. Important Reminder The purpose of this Medical Policy is to provide a guide to coverage. This Medical Policy is not intended to dictate to providers how to practice medicine. Nothing in this Medical Policy is intended to discourage or prohibit providing other medical advice or treatment deemed appropriate by the treating physician.



VII. References 1. Blue Cross Blue Shield Association. Medical Policy Reference Manual. Erythropoietin

(Epoetin Alfa). 5.01.04. Revised December 14, 2005.

2. Darbepoetin (Aranesp): Prescribing Information. Amgen Corporation. December 2004. http://www.fda.gov/cder/foi/label/2004/103951_5069lbl.pdf

3. Epoetin alfa (Epogen): Prescribing Information. Amgen Corporation. November 2004. http://www.fda.gov/cder/foi/label/2004/103234_5076lbl.pdf

4. National Kidney Foundation Kidney Disease Outcomes Quality Initiative. 2000 Guidelines for anemia of chronic kidney disease.

5. Regence Medication Policy Manual. Aranesp, darbepoetin. Policy No: dru076. Revised July 22, 2005.

6. Regence Medication Policy Manual. Epogen, Procrit, epoetin alfa. Policy No: dru012. Revised July 22, 2005.

7. US PDI. Epoetin Alfa (Systemic). 2004 Thomson Micromedex.

8. US PDI. Darbepoetin Alfa (Systemic). 2006 Thomson Micromedex.

E Exenatide (Byetta)


This policy has been archived and is no longer reviewed. Precertification is no longer required for this service.

F Fentanyl Transdermal System (Duragesic)


I. Description Form: Dermal patch Quantity Limit: Not more than 20 patches every 30 days

Fentanyl transdermal system (Duragesic) contains a high concentration of the potent Schedule II opioid agonist. Schedule II opioid substances which include fentanyl, hydromorphone, methadone, morphine, oxycodone, and oxymorphone have the highest potential for abuse and associated risk of fatal overdose due to respiratory depression. Fentanyl can be abused and is subject to criminal diversion. The high content of fentanyl in patch form makes it a particular target.

Fentanyl is indicated in the management of persistent, moderate to severe, chronic pain that:

1. Requires continuous, around the clock, opioid administration for an extended period of time, and

2. Cannot be managed by other means such as nonsteroidal analgesics, opioid combination products, or immediate release opioids.

II. Criteria/Guidelines A. Fentanyl is considered medically appropriate for the treatment of moderate to severe pain when

at least one of the following are met:

1. The patient has a diagnosis of a clinically significant cancer, or

2. The patient is enrolled in a hospice program, or

3. The patient meets hospice criteria (see Hospice Care), or

4. The patient has a diagnosis of chronic pain (i.e., pain that significantly interferes with activities of daily living for greater than threemonths in duration).

a. For nonmalignant chronic pain, the prescriber must initiate an Opioid Treatment Agreement with the patient that documents the goals of the therapy, compliance and safety issues.

III. Limitations/Exclusions A. Prescriptions for fentanyl on a “PRN” or “as needed” basis will not be covered. Breakthrough

pain should be managed using immediate release preparations.

B. The quantity of medication approved for dispensing will be limited to 20 patches per 30 days. Quantities in excess of this amount will require precertification.

IV. Administrative Guidelines A. Quantities in excess of 20 patches per 30 days require precertification. Please complete

HMSA’s Drug Review Request and mail or fax the form as indicated.

1. Precertification requests must include a complete care plan with all of the following:



a. Reason why more than 20 patches is being requested.

b. A treatment plan with long and shortterm goals.

c. Member’s history, physical, and diagnosis.

d. Six months of clinical notes from the ordering physician.

e. A copy of the patient’s signed Opioid Treatment Agreement.

B. This policy applies to both brand and generic form.




VI. References 1. Aetna. Duragesic. Pharmacy Coverage Policy Bulletins. May 6. 2003.

2. AHQR. Management of Cancer Pain. Summary, Evidence Report/Technology Assessment: Number 35. AHQR Publication No. 01E033, Jan. 2001. Agency for Healthcare Research and Quality, Rockville, MD. http://www.ahrq.gov/clinic/epcsums/canpainsum.htm.

3. Janssen Pharmaceutica. Duragesic prescribing information. Titusville, NJ. February 2001.

4. Janssen Pharmaceutica. Duragesic prescribing information. Titusville, NJ. February 2005. Important Drug Warning.

5. Payne R, Mathias SD, et al. Quality of life and cancer pain: satisfaction and side effects with transdermal fentanyl versus oral morphine. J Clin Oncol. April 1998;16(4): 1588193.

6. The Medical Letter. Drugs for Pain. Volume 42, Issue 1085. Aug. 21, 2000.

7. Woodroffe MA, Hays H. Fentanyl transdermal system: Pain management at home. Can Fam Physician. Feb. 1997;43:268272.

G Genetic Testing (continued)


CPT Codes Description 83903* mutation scanning, by physical properties (e.g., single strand conformational

polymorphisms (SSCP), heteroduplex, denaturing gradient gel electrophoresis (DGGE), RNA’ase A), single segment, each

83904* mutation identification by sequencing, single segment, each segment 83905* mutation identification by allele specific transcription, single segment, each

segment 83906* mutation identification by allele specific translation, single segment, each

segment 83912* interpretation and report 88230* Tissue culture for nonneoplastic disorders; lymphocyte 88233 skin or other solid tissue biopsy 88237* Tissue culture for neoplastic disorders; bone marrow, blood cells 88239 solid tumor (approved for breast only) 88240* Cryopreservation, freezing and storage of cells, each cell line 88241* Thawing and expansion of frozen cells, each aliquot 88245* Chromosome analysis for breakage syndromes; baseline Sister Chromatid

Exchange (SCE), 2025 cells 88248* baseline breakage, score 50100 cells, count 20 cells, 2 karyotypes (e.g., for

ataxia telangiectasia, Fanconi anemia, fragile X) 88249* score 100 cells, clastogen stress (e.g., diepoxybutane, mitomycin C, ionizing

radiation, UV radiation) 88261* Chromosome analysis; count 5 cells, 1 karyotype, with banding 88262* count 1520 cells, 2 karyotypes, with banding 88263* count 45 cells for mosaicism, 2 karyotypes, with banding 88264* analyze 2025 cells 88271* Molecular cytogenetics, DNA probe, each (e.g., FISH) 88272* chromosomal in situ hybridization, analyze 35 cells (e.g., for derivatives and

markers) 88273* chromosomal in situ hybridization, analyze 1030 cells (e.g., for

microdeletions) 88274* interphase in situ hybridization, analyze 2599 cells 88275* interphase in situ hybridization, analyze 100300 cells 88280* Chromosome analysis; additional karyotypes, each study 88283* additional specialized banding technique (e.g., NOR, Cbanding) 88285* additional cells counted, each study 88289* additional high resolution study 88291* Cytogenetics and molecular cytogenetics, interpretation and report

HCPCS Codes Description S3818 Complete gene sequence analysis; BRCA 1 gene S3819 Complete gene sequence analysis; BRCA 2 gene S3820 Complete BRCA 1 and BRCA 2 gene sequence analysis for susceptibility to

breast and ovarian cancer



HCPCS Codes Description S3822 Single mutation analysis (in individual with a known BRCA 1 or BRCA 2

mutation in family) for susceptibility to breast and ovarian cancer S3823 Three mutation BRCA 1 and BRCA 2 analysis for susceptibility to breast and

ovarian cancer in Ashkenazi individuals S3828 Complete gene sequence analysis; MLH1 gene S3829 MSH2 gene S3830 Complete MLH1 and MLH2 gene sequence analysis for hereditary non

polyposis colorectal cancer (HNPCC) genetic testing S3831 Single mutation analysis (in individuals with a known MLH1 and MLH2

mutation in the family) for hereditary nonpolyposis colorectal (HNPCC) genetic testing

S3833 Complete APC gene sequence analysis for susceptibility to familial adenomatous polyposis (FAP) and attenuated (FAP)

S3834 Single mutation analysis (in individual with a known APC mutation in the family) for susceptibility to familial adenomatous polyposis (FAP) and attenuated FAP

S3840 DNA analysis for germline mutations of the RET protooncogene for susceptibility to multiple endocrine neoplasia type 2

S3841 Genetic testing for retinoblastoma S3842 Genetic testing for Von HippelLindau disease S3843 DNA analysis of the F5 gene for susceptibility to factor V Leiden thrombophilia S3844 DNA analysis of the connexin 26 gene (GJB2) for susceptibility to congenital,

profound deafness S3845 Genetic testing; alphathalassemia S3846 hemoglobin E betathalassemia S3847 TaySachs disease S3848 Gaucher disease S3849 NiemannPick disease S3850 sickle cell anemia S3851 Canavan disease S3852 DNA analysis for APOE epsilon 4 allele for susceptibility to Alzheimer’s

disease



This Medical Policy has been developed through consideration of the medical necessity criteria under Hawaii's Patients' Bill of Rights and Responsibilities Act (Hawaii Revised Statutes § 432E 1.4), generally accepted standards of medical practice, and review of medical literature and government approval status. HMSA has determined that services not covered under this Medical Policy will not be medically necessary under Hawaii law in most cases. If a treating physician

I Intravenous Immune Globulin Therapy (IVIG)



I. Description Intravenous immune globulin (IVIG) is a sterile, highly purified preparation of unmodified immunoglobulins, which are isolated from large pools of human plasma. IVIG is an infusion used to treat patients with inherited or acquired immune deficiencies. It provides passive immunity against infection by increasing a person’s antibody titer and antigenantibody reaction potential. IVIG supplies a broad spectrum of IgG antibodies against bacterial, viral, parasitic, and mycoplasmal antigens.

II. Criteria/Guidelines A. IVIG therapy is considered medically necessary for the following FDA approved indications:

1. Treatment of primary immunodeficiencies, including:

a. Congenital agammaglobulinemia (Xlinked agammagloblinemia)

b. Hypogammaglobulinemia

c. Common variable immunodeficiency

d. Xlinked immunodeficiency with hyperimmunoglobulin M

e. Severe combined immunodeficiency

f. WiskottAldrich syndrome

2. Idiopathic thrombocytopenic purpura (ITP).

3. Prevention of graftversushost disease in nonautologous bone marrow transplant patients age 20 or older in the first 100 days after transplantation.

4. Kawasaki syndrome when used in conjunction with aspirin.

5. Prevention of infection in:

a. HIVinfected pediatric patients.

b. Bone marrow transplant patients age 20 or older in the first 100 days after transplantation.

c. Patients with primary defective antibody synthesis.

d. Patients with hypogammaglobulinemia and/or recurrent bacterial infections associated with Bcell chronic lymphocytic leukemia (CLL).



B. IVIG therapy may be considered medically necessary for the following offlabel indications:

1. Refractory dermatomyositis when used as second line treatment for patients who are unresponsive to corticosteroid therapy.

2. Fetal alloimmune thrombocytopenia

3. Myasthenic crisis (i.e., an acute episode of respiratory muscle weakness) in patients with contraindications to plasma exchange; and myasthenia gravis patients with chronic debilitating disease despite treatment with cholinesterase inhibitors, or complications from or failure of steroids and/or azathioprine.

4. For the following autoimmune mucocutaneous blistering diseases, IVIG should be given along with conventional treatments and discontinued once the conventional therapy has taken effect:

a. Pemphigus vulgaris

b. Pemphigus foliaceus

c. Bullous pemphigoid

d. Mucous membrane pemphigoid (cicatrical pemphigoid, benign mucous membrane pemphigoid), with or without mention of ocular involvement.

e. Epidermolysis bullosa acquisita

C. IVIG therapy for the following offlabel indications may be considered medically necessary with precertification:

1. Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) for patients who met all of the following criteria:

a. Significant functional disability.

b. Slowing of nerve conduction velocity on EMG/NCS.

c. Elevated spinal fluid protein on lumbar puncture or a nerve biopsy confirming the diagnosis.

2. GuillainBarre syndrome. IVIG therapy can be used as an laternative to plasma exchange for patients who meet one of the criteria below:

a. Deteriorating pulmonary function tests.

b. Rapid deterioration with symptoms for less than two weeks.

c. Rapidly deteriorating ability to ambulate.

I Intravenous Immune Globulin Therapy (IVIG) (continued)


d. Frank inability to ambulate independently for ten meters.

3. Multifocal motor neuropathy in patients with antiGM1 antibodies and conduction block when conventional therapy was ineffective or not tolerated.

4. Relapsingremitting multiple sclerosis when conventional therapy was ineffective or not tolerated.

D. IVIG services should be provided in an outpatient facility. Patients must meet the definition of homebound as found in the Glossary to receive therapy at home.

III. Limitations/Exclusions A. The clinical evidence does not support the use of IVIG therapy for the following indications

including, but not limited to:

B. Precertification is required and may be given for up to one year relapsingremitting multiple sclerosis. Requests must include the conventional therapies that were tried and found to be ineffective, not tolerated or contraindicated.

C. Precertification is required for services performed in a home setting. Requests must include documentation supporting the patient’s homebound status.

D. To precertify please complete HMSA’s Drug Review Request and mail or fax the form as indicated, along with the necessary documentation.

E. If the patient requires therapy beyond the authorized duration, an extension request must be submitted with the physician’s updated orders and clinical information substantiating that IVIG is effective and the need for the extension.

F. A precertification request is usually submitted by the IV therapy provider. Physicians, however, shuld provide IV therapy providers with updated orders, clinical information and any other pertinent documentation that would be used to meet precertification requirements.

G. Services that do not require precertification are subject to retrospective review. If applicable, payment for services that did not meet criteria will be recouped.

H. Applicable codes:

HCPCS Codes Description J1562 Injection, immune globulin, subcutaneous, 100 mg J1566 Injection, immune globulin, intravenous, lyophilized (e.g., powder), 500 mg J1567 Injection, immune globulin, intravenous, nonlyophilized (e.g., liquid), 500

mg Q4087 Injection, immune globulin, (octagam), intravenous, nonlyophilized, (e.g.,

liquid), 500 mg Q4088 Injection, immune globulin, (gammagard), intravenous, nonlyophilized, (e.g.,

liquid), 500 mg



HCPCS Codes Description Q4089 Injection, immune globulin, (flebogamma), intravenous, nonlyophilized, (e.g.,

liquid), 500 mg Q4092 Injection, immune globulin, (Gamunex), intravenous, nonlyophilized, (e.g.,

liquid), 500 mg

ICD9CM Codes Description 041.00 – 041.9 Bacterial infection, code range 042 Human immunodeficiency virus (HIV) disease 204.10 – 204.11 Chronic lymphoid leukemia 279.00 Hypogammaglobulinemia, unspecified 279.04 – 279.05 Immunodeficiency (Xlinked) 279.06 Common variable immunodeficiency 279.12 WiskottAldrich syndrome 279.2 Combined immunity deficiency 279.3 Unspecified immunity deficiency 287.30 Primary thrombocytopenia, unspecified 287.5 Thrombocytopenia, unspecified 340 Multiple sclerosis 354.0 – 355.9 Mononeuritis, code range 356.4 – 356.9 Idiopathic peripheral neuropathy, code range 357.0 Acute infective polyneuritis (includes GuillainBarre syndrome) 357.81 Chronic inflammatory demyelinating polyneuritis 358.80 – 358.81 Myasthenia gravis 426.0 – 426.9 Conduction disorders, code range 446.1 Acute febrile mucocutaneous lymph node syndrome [MCLS] (Kawasaki

disease) 694.4 Pemphigus (includes pemphigus vulgaris or pemphigus foliaceus) 694.5 Pemphigoid (includes bullous pemphigoid) 694.60 Benign muccous membrane pemphigoid (a.k.a., cicatrical pemphigoid)

without mention of ocular involvement 694.61 with ocular involvement 694.8 Other specified bullous dermatoses 710.3 Dermatomyositis 776.1 Transient neonatal thrombocytopenia V42.81 Bone marrow replaced by transplant



I Intravenous Immune Globulin Therapy (IVIG) (continued)



VI. References 1. BCBSA Medical Policy Reference Manual: Intravenous Immune Globulin Therapy. 8.01.05,

April 2006.

2. Centers for Medicare and Medicaid Services. National Coverage Determination for Intravenous Immune Globulin for the Treatment of Autoimmune Mucocutaneous Blistering Diseases. NCD #250.3. Effective October 1, 2002.

3. Chen C, Danekas LH, Ratko TA et al. A multicenter drug use surveillance of intravenous immunoglobulin utilization in U.S. academic health centers. Ann Pharmacother. 2000 March;34(3):2959.

4. Dalakas MC. Mechanism of Action of Intravenous Immunoglobulin and Therapeutic Considerations in the Treatment of Autoimmune Neurologic Disease. Neurology; 1998 December 51 (6 Supplement 5):S28.

5. Lativ N, Gorson K et al. Diagnosis and treatment of chronic immunemediated neuropathies, Review article J Clin Neuromusc Dis; 2006; 7: 141157.

6. Ratko TA, Brunett DA, Foulke GE et al. Recommendations for Offlabel Use of Intravenously Administered Immunoglobulin Preparations. University Hospital Consortium Expert Panel for OffLabel Use of Polyvalent Intravenously Administered Immunoglobulin Preparations. JAMA; 1995 June 21;273(23):186570.

7. The Regence Group. Medication Policy Manual. IVIG Intravenous Immunoglobulins: Revised/Effective date May 29, 2007.

8. Thompson Microdex Drug Information for the Health Care Professional. Immune Globulin Intravenous, updated monograph 09/22/2005.

9. Transfusion Committee Massachusetts General Hospital Consensus indications for IVIG, Oct. 2001.

K Kyphoplasty



I. Description Kyphoplasty is an orthopedic or neurosurgical procedure used to treat individuals with one or more vertebral body compression fractures. Under fluoroscopic guidance, a small cannula is introduced and balloon catheters are inserted and inflated to create a space within the vertebrae. The balloon catheters are removed and the space is filled with a bone cement mixture, usually polymethylmethacrylate (PMMA). The goal is to restore height to the bone, thus reducing deformity of the spine and to immediately stabilize the fracture. The procedure is usually performed on both sides of the vertebral body through the pedicles. The patient requires a oneday hospital stay and the procedure is usually performed under general anesthesia.

II. Criteria/Guidelines A. Percutaneous kyphoplasty is considered medically appropriate when one of the following

criteria are met:

1. The patient has acute vertebral compression fractures secondary to osteoporosis, has experienced pain for at least four weeks, and has failed an adequate trial of conservative therapy that includes, but is not limited to:

a. Initial bed rest with progressive activity

b. Back bracing

c. Analgesics

2. The severity of pain causes significant immobility and impairment of activities of daily living and/or requires maximal pain management.

B. All candidates for kyphoplasty must be treated medically for osteoporosis to prevent additional fractures.

III. Limitations/Exclusions A. Kyphoplasty may not be performed on more than three vertebral bodies in a single operative

session.

B. Based on our assessment of peerreviewed literature, HMSA believes that percutaneous kyphoplasty has not been proven to be medically effective for indications other than those listed in this policy. HMSA considers kyphoplasty investigational for all other indications.

C. Kyphoplasty is contraindicated for compression fractures that are more than one year old.

D. Kyphoplasty is not to be performed as prophylaxis for either osteoporosis of the spine or chronic back pain if associated with old, healed compression fracture(s).

E. Because of safety concerns, kyphoplasty is contraindicated for patients with the following conditions:



1. Uncorrected coagulation disorders;

2. Underlying infection (e.g., osteomyelitis of the involved vertebra);

3. Severe cardiopulmonary disease;

4. Extensive vertebral destruction (such as vertebra reduced to less than onethird of its original height);

5. Neurological symptoms related to spinal compression;

6. Allergy to any component required for the procedure.

F. Other considerations

1. Consideration must be given to the extent of the disease, the spinal level involved and previous treatments attempted before considering kyphoplasty as an option.

2. In situations when a patient’s condition makes the procedure unsafe, or if there will be limited or no significant improvement in activities of daily living, kyphoplasty will not be eligible for payment.

IV. Administrative Guidelines A. Precertification is required. To precertify, please complete HMSA’s Precertification

Request and mail or fax the form as indicated.

B. Prior to performing percutaneous kyphoplasty, the medical record must show:

1. There is a high degree of certainty through targeted, documented physical exam and ancillary studies such as xray, bone scan, MRI, that the pain is caused by a nonhealing fracture.

a. Documentation must include results of xrays and/or MRI studies.

b. Documentation must include results of a bone scan, if indicated, or if the age of the fracture(s) is indeterminate.

2. An ancillary study confirms that the pain is not caused by the presence of a spinal or disc fragment.

3. The vertebral body height is not less than onethird of its original height.

C. The physician performing kyphoplasty must be credentialed and privileged by the hospital to perform open back surgery and be certified to perform kyphoplasty.

D. CPT code 20225 for a bone biopsy is considered incidental to the kyphoplasty procedure and is not payable separately.

K Kyphoplasty (continued)


Inpatient Procedure Code Description (for hospital use) 81.66 Kyphoplasty

ICD9CM Codes Description 733.13 Pathologic fracture of vertebrae

and one of the following: 733.00 Osteoporosis, unspecified 733.01 Senile osteoporosis 733.02 Idiopathic osteoporosis 733.03 Disuse osteoporosis 733.09 Other osteoporosis

CPT Codes Description 22523 Percutaneous vertebral augmentation, including cavity creation

(fracture reduction and bone biopsy included when performed) using mechanical device, one vertebral body, unilateral or bilateral cannulation (e.g., kyphoplasty); thoracic

22524 lumbar 22525 each additional thoracic or lumbar vertebral body (list separately

in addition to code for primary procedure)




VI. References 1. Blue Cross Blue Shield of North Carolina. Corporate Medical Policy. Vertebroplasty and

Kyphoplasty Percutaneous. Revised June 2005.

2. BCBS Tennessee Medical Policy. Kyphoplasty policy. Effective November 1, 2004. No further update.

3. Excellus Medical Policy. Percutaneous Vertebroplasty/Kyphoplasty. (6.01.17). Revised: 5/18/2006.



4. FDA Public Health Web Notification. Complications related to the use of bone cement in treating compression fractures of the spine. Updated May 7, 2004. http://www.fda.gov/cdrh/safety/bonecement.html

5. Garfin SR. A retrospective review of early outcomes of balloon kyphoplasty, North American Spine Society Proceedings, Seattle, Wash., October 31November 3, 2001. Abstract 24B.

6. Garfin SR, Yuan HA, Reiley MA. New technologies in spine: kyphoplasty and vertebroplasty for the treatment of painful osteoporotic compression fractures. Spine 2001; 26(14):15111515.

7. Health Technology Assessment Information Services. Windows on medical technology (2006, March). Percutaneous kyphoplasty for the treatment of vertebral fractures. ECRI HTAIS. Updated March 2006. Issue No. 132.

8. Kyphon Inc. Product Information. http://www.kyphon.com

9. Lane JM, Giradi F, Khan SN et al. Preliminary outcomes of the first 311 consecutive kyphoplasties for the fixation of painful osteoporotic vertebral compression fractures. International Society for the Study of the Lumbar Spine, 28 th Annual Meeting, Edinburgh, Scotland, June 1923, 2001. Abstract 109.

10. Lane JM, Girardi FP, Khan SN et al. Preliminary outcomes of the first consecutive kyphoplasties for the fixation of painful osteoporotic vertebral compression fractures. J Bone Miner Res 2000; 15 (suppl 1):S198 (abstract).

11. Ledlie JT, et al. Balloon kyphoplasty: oneyear outcomes in vertebral body height restoration, chronic pain, and activity levels. J Neurosurg: (Spine 1) 2003 Jan; 98:3642.

12. Lieberman IH, Dudeney S, Reinhardt MK, et al. Initial outcome and efficacy of kyphoplasty in the treatment of painful osteoporotic vertebral compression fractures. Spine 2001;26(14):16311637.

13. Medical Policy Reference Manual. Percutaneous kyphoplasty (6.01.38). Washington. DC: BlueCross BlueShield Association. October 2006.

14. Noridian Administrative Services, LLC. Medicare Part B. LCD for Vertebroplasty, Kyphoplasty; Percutaneous (L15101). http://www.cms.hhs.gov/mcd/viewlcd.asp?lcd_id=15101&lcd_version=5&show=all

15. Theodorou DJ, et al. Percutaneous balloon kyphoplasty for the correction of spinal deformity in painful vertebral body compression fractures. Clin Imag 2002 JanFeb:26(1):15.

O Occupational Therapy


I. Description Occupational therapy is a form of rehabilitation therapy involving the treatment of neuromusculoskeletal function through the use of specific tasks or goaldirected activities designed to improve the functional performance of an individual.

Occupational therapy involves cognitive, perceptual, safety, and judgment evaluations and training. These services emphasize useful and purposeful activities to improve neuromusculoskeletal functions and to provide training in activities of daily living.

Activities of daily living include: feeding, dressing, bathing, and other selfcare activities. Other occupational therapy services include the design, fabrication, and use of orthoses, and guidance in the selection and use of adapted equipment.

II. Criteria/Guidelines A. Occupational therapy is covered only for the diagnoses and procedure codes listed below.

B. Services must meet all the following criteria:

1. The therapy is ordered by a physician under an individual treatment plan.

2. The therapy is provided by a licensed occupational therapist.

3. The therapy is necessary to sufficiently restore neurological and/or musculoskeletal function that was lost or impaired due to an illness or injury. Neurological and/or musculoskeletal function is sufficiently restored when one of the following first occurs:

a. Neurological and/or musculoskeletal function is the level of the average healthy person of the same age, or

b. When improvement beyond what is expected with activities of daily living, prescribed home exercise, and passage of time, is unlikely.

4. The purpose of the therapy is to achieve a specific diagnosisrelated goal for a patient who has a reasonable expectation of achieving significant improvement in a reasonable and predictable period of time.

a. Significant is defined as a measurable increase in the patient’s present level of physical and functional abilities that can be attained with shortterm therapy.

5. The therapy must include a home exercise/education program to be initiated at the first occupational therapy visit. The occupational therapist must document the patient’s participation in and compliance with the home exercise/education program.

C. Modalities defined by CPT as requiring constant attendance or direct oneonone patient contact must be provided by the licensed occupational therapist using constant, direct, oneon one patient contact.



III. Limitations/Exclusions A. Occupational therapy benefits are not available for maintenance programs which are defined as

activities that preserve the patient’s present level of function and prevent regression of that function. Maintenance begins when the therapeutic goals of a treatment plan have been achieved or when no additional functional progress is apparent.

B. Occupational therapy benefits are not available for:

1. Sports enhancement or returning the member to active sports participation;

2. Ongoing treatment solely to improve endurance and distance;

3. General exercise programs to promote overall fitness;

4. Programs to provide diversion or general motivation;

5. Long term therapy;

6. Group exercise therapy programs: defined as the simultaneous treatment of two or more patients who may or may not be doing the same activities.

7. Maintenance programs: defined as activities that preserve the patient’s present level of function and prevent regression of that function. Maintenance begins when the therapeutic goals of a treatment plan have been achieved, or when no additional functional progress is apparent.

C. The therapy and diagnoses listed below is a guide to the number of visits deemed medically necessary.

IV. Administrative Guidelines A. Providers of physical and occupational therapy must inquire and document if the patient

receiving services for the same injury from another PT/OT provider. The total number of visits for the same injury, regardless of the number of PT/OT providers seen, must not exceed the maximum number of visits listed below.

B. Precertification is required if a patient is receiving physical therapy and/or occupational therapy for the same injury and the number of combined visits exceeds the maximum number of visits listed below.

C. Payment for service is based on date of onset of illness or injury. Reinjuries within 30 days are considered the same injury.

D. Occupational therapy benefits are not available to treat conditions which are otherwise excluded from coverage under the Member’s plan.

E. The frequency of visits should be appropriate according to the patient’s physical condition and stage of healing.

O Outpatient Surgical (PRG) List (continued)


Effective July 1, 2007, the QUEST plan adopted the guidelines used by HMSA for its private plans. Please refer to the list of codes in the HMSA Provider ELibrary for its private business plans.

P Panniculectomy/Abdominoplasty



I. Description Panniculectomy is the surgical resection of the overhanging “apron” of redundant skin and fat in the lower abdominal area. A panniculus is often seen in men or women who have had significant weight loss or in morbidly obese persons. The panniculus can cause difficulty in fitting into clothing, interference with personal hygiene, impair ambulation and can be associated with lower back pain or pain in the panniculus itself. The redundant skin folds are predisposed to areas of intertrigo, which can give rise to infections of the skin (e.g., dermatitis, folliculitis, subcutaneous abscesses) or panniculitis.

Abdominoplasty is a surgical procedure, which tightens a lax anterior abdominal wall caused by diastasis recti and removed excess fat and abdominal skin. This procedure, also referred to as a “tummy tuck,” reduces the appearance of a protruding abdomen, giving a flatter, firmer, tighter stomach and thin waist and provides an overall improvement in the person’s shape and figure. Liposuction also may be performed in conjunction with a “tummy tuck” to further sculpt the abdomen or remove fat from other areas such as the hip.

II. Criteria/Guidelines A. A panniculectomy will be covered in a patient with stable weight, when any of the following

criteria are met:

1. There are recurrent, documented rashes that do not respond to conventional treatment.

2. There are documented recurrent or nonhealing ulcers that do not respond to conventional treatment.

3. There is a functional impairment, such as significant difficulty with walking.

B. Surgical procedures for the removal of redundant skin in other areas of the body (e.g., upper arm brachiocoplasty, thighplasty and hipplasty) must meet the same criteria as panniculectomy in order to be considered medically necessary.

III. Limitations/Exclusions A. An abdominoplasty or “tummy tuck” (CPT 15847 used in conjunction with CPT 15830) is

considered cosmetic, therefore ineligible for coverage.

IV. Administrative Guidelines A. Precertification is required for panniculectomy. To precertify, please complete the Pre

certification Request and mail or fax the form as indicated.

B. Front and lateral view photographs or digital images demonstrating the size of the panniculus and/or other affected body parts and the nature or extent of skin irritation, cellulitis or skin necrosis are required.

CPT Codes Description 00802 Anesthesia for procedures on lower anterior abdominal wall; panniculectomy



CPT Codes Description 15830 Excision, excessive skin and subcutaneous tissue (includes lipectomy);

abdomen, infraumbilical panniculectomy 15832 thigh 15833 leg 15834 hip 15835 buttock 15836 arm 15837 forearm or hand 15838 submental fat pad 15839 other area 19316 Mastopexy

ICD9CM Codes Description 278.1 Localized adiposity 682.2 Other cellulitis and abscesstrunk 695.89 Other specified erythematous conditions 701.8 Other specified and hypertrophic and atrophic conditions of the skin 707.9 Chronic ulcer of unspecified site 724.1 Pain in thoracic spine 724.2 Disorders of backlumbago 729.30 Panniculitis, unspecified site 729.39 Panniculities, other site




VI. References 1. American Society of Plastic Surgeons. ASPS recommended insurance coverage criteria for

thirdparty payers. Surgical treatment of skin redundancy following massive weight loss: September 2005.

2. Blue Cross and Blue Shield of Massachusetts. Plastic Surgery. Medical Policy Manual. Posted 11/9/06: 68.

P Physical Therapy


I. Description Physical therapy is the treatment of disease or injury using therapeutic exercise and other interventions that focus on range of motion, improving posture, locomotion, strength, endurance, balance, coordination, joint mobility, flexibility, and on alleviating pain. Physical therapy also integrates all of the above so a patient may regain functional activities of daily living.

Treatment may include active and passive modalities using a variety of means and techniques based upon biomechanical and neurophysiological principles.

II. Criteria/Guidelines A. Physical therapy is covered only for the diagnoses and procedure codes listed below.

B. Services must meet all the following criteria:

1. The therapy is ordered by a physician under an individual treatment plan.

2. The therapy is provided by a licensed physical therapist.

3. The therapy is necessary to sufficiently restore neurological and/or musculoskeletal function that was lost or impaired due to an illness or injury. Neurological and/or musculoskeletal function is sufficiently restored when one of the following first occurs:

a. Neurological and/or musculoskeletal function is the level of the average healthy person of the same age, or

b. When improvement beyond what is expected with activities of daily living, prescribed home exercise, and passage of time, is unlikely.

4. The purpose of the therapy is to achieve a specific diagnosisrelated goal for a patient who has a reasonable expectation of achieving significant improvement in a reasonable and predictable period of time.

a. Significant is defined as a measurable increase in the patient’s present level of physical and functional abilities that can be attained with shortterm therapy.

5. The therapy must include a home exercise/education program to be initiated at the first physical therapy visit. The physical therapist must document the patient’s participation in and compliance with the home exercise/education program.

C. Modalities defined by CPT as requiring constant attendance or direct oneonone patient contact must be provided by the licensed physical therapist using constant, direct, oneonone patient contact.

III. Limitations/Exclusions A. Physical therapy benefits are not available for the following:

1. Sports enhancement or returning the member to active sports participation;



2. Ongoing treatment solely to improve endurance and distance;

3. General exercise programs to promote overall fitness;

4. Programs to provide diversion or general motivation;

5. Long term therapy;

6. Group exercise/therapy programs: defined as the simultaneous treatment of two or more patients who may or may not be doing the same activities.

7. Maintenance programs: defined as activities that preserve the patient’s present level of function and prevent regression of that function. Maintenance begins when the therapeutic goals of a treatment plan have been achieved, or when no additional functional progress is apparent.

B. The maximum number of physical therapy visits for each diagnosis is listed below. Requests for additional visits will be reviewed for medical necessity.

IV. Administrative Guidelines A. Providers of physical and occupational therapy must inquire and document if the patient is

receiving services for the same injury from another PT/OT provider. The total number of visits for the same injury, regardless of the number of PT/OT providers seen, must not exceed the maximum number of visits listed below.

B. Precertification is required if a patient is receiving physical therapy and/or occupational therapy for the same injury and the number of combined visits exceeds the maximum number of visits listed below.

C. Payment for service is based on date of onset of illness or injury. Reinjuries within 30 days are considered the same injury.

D. Physical therapy benefits are not available to treat conditions which are otherwise excluded from coverage under the Member’s plan.

E. The frequency of visits should be appropriate according to the patient’s physical condition and stage of healing.

Covered Codes

CPT Codes Description 97001 Physical therapy evaluation 97002 Physical therapy reevaluation 97003 Occupational therapy evaluation 97004 Occupation therapy reevaluation

P Positron Emission Tomography (PET)



I. Description PET scans currently requiring precertification will be managed by National Imaging Associates, Inc. (NIA). HMSA has made this change to ensure appropriate utilization of advanced diagnostic imaging services, and to provide support services to physicians who may have questions about the appropriateness of PET can versus other imaging options.

II. Precertification Precertification is required for PET services that do not meet the criteria listed in the HMSA Diagnostic Imaging Guidelines and for repeat studies performed within 12 months of a previous study.

A. Ordering Physician

1. The ordering physician is responsible for obtaining precertification.

a. To obtain precertification, physicians should call NIA toll free at 1 (866) 3069729, from 6 a.m. to 6 p.m. weekdays, Hawaii time. The NIA center is closed on Saturdays, Sundays and federal holidays.

b. If a planned study is scheduled after hours, on weekends or holidays, call NIA in advance to obtain precertification.

c. If a study is performed on an urgent basis, contact NIA on the following business day to obtain a retrospective certification.

2. About 60 percent of precertification requests can be approved during the initial phone call. If additional clinical review by NIA clinical staff is required, the ordering physician can check the status of a pending precertification request through NIA’s Authorization Verification System at www.RADMD.com.

B. Facilities

1. The facility performing the service should verify whether precertification has been obtained by the ordering physician.

a. To verify precertification has been given, facility staff can check NIA’s Authorization Verification System at www.RADMD.com.

b. The facility may also verify precertification by asking the ordering physician for the precertification number issued by NIA.

III. Administrative Guidelines A. PET scans will be allowed for the following indications without precertification. The use of

PET scan for all other indications must be precertified.



ICD9 CM Codes Description 140.0 – 140.9 Malignant neoplasm of the lip 141.0 – 141.9 tongue 142.0 – 142.9 major salivary glands 143.0 – 143.9 gum 144.0 – 144.9 floor of mouth 145.0 – 145.9 other and unspecified parts of mouth 146.0 – 146.9 oropharynx 147.0 – 147.9 nasopharynx 148.0 – 148.9 hypopharnyx 149.0 – 149.9 other and illdefined sites within the lip, oral cavity and pharynx 150.0 – 150.9 esophagus 153.0 – 153.9 colon 154.0 – 154.8 rectum, rectosigmoid junction and anus 158.0 – 158.9 retroperitoneum and peritoneum 160.0 – 160.9 nasal cavities, middle ear and accessory sinuses 161.0 – 161.9 larynx 162.2 – 162.9 bronchus, lung 170.0 – 170.9 bone and articular cartilage 171.0 Malignant neoplasm of connective and other soft tissue of head, face, and neck 171.2 upper limb, including shoulder 171.3 lower limb, including hip 171.5 abdomen 171.6 pelvis 171.7 trunk, unspecified 172.0 – 172.9 Malignant melanoma; skin 173.0 – 173.9 Malignant neoplasm; skin 1900 – 190.9 eye 191.0 – 191.9 brain 193 thyroid gland 195.0 head, face and neck 200.00 – 200.88 Lymphosarcoma and reticulosarcoma 201.00 – 201.98 Hodgkin’s disease 202.00 – 202.08 Other malignant neoplasms – nodular lymphoma 202.10 – 202.18 mycosis fungoides 202.20 – 202.28 Sezary’s disease 202.80 – 202.88 other lymphomas 205.30 – 205.31 Myeloid sarcoma 235.7 Neoplasms of uncertain behavior, trachea, bronchus, and lung (solitary

pulmonary nodule) 345.10 – 345.11 Generalized convulsive epilepsy code range 345.3 Grand mal status 345.40 – 345.41 Partial epilepsy, with impairment of consciousness 345.50 – 345.51 Partial epilepsy, without mention of impairment of consciousness 414.8 Chronic ischemic heart disease, other specified forms 414.9 unspecified

P Positron Emission Tomography (PET) (continued)


B. Precertification denied or not sought

1. If precertification is denied because services are determined not to be medically indicated, payment will not be made. The facility and/or radiologist may not bill the member for the denied services, except in cases where the member has been informed of the precertification denial, has agreed to be financially responsible for the charges and has signed an Agreement of Financial Responsibility prior to the services being rendered.

2. If precertification was not sought or given prior to services being performed, the claim will be subject to medical review. HMSA will seek additional information from the ordering physician and will review the claim based on the information provided. If the information provided does not meet criteria for coverage, benefits will be denied for the services. Neither the radiologist nor the facility may bill the member.

C. Payment

A precertification number from NIA does not guarantee HMSA payment. Payment is subject to plan benefits, member and provider eligibility at the time of service.

IV. Important Reminder The purpose of this Medical Policy is to provide a guide to coverage. This Medical Policy is not intended to dictate to providers how to practice medicine. Nothing in this Medical Policy is intended to discourage or prohibit providing other medical advice or treatment deemed appropriate by the treating physician.



S Sorafenib (Nexavar)


I. Description Sorafenib (Nexavar) is an oral medication used to treat advanced renal cell carcinoma. It is a small molecule that acts by inhibiting multiple receptor tyrosine kinases, some of which are implicated in tumor growth, pathologic angiogenesis, and metastatic progression of cancer.

Renal cell carcinoma (RCC) makes up more than 80% of all kidney cancers. It is frequently resistant to conventional chemotherapy and patients with advanced RCC often have poor outcomes.

Progression free survival was an intermediate endpoint and was statistically superior for patients taking sorafenib versus placebo in 769 patients. Overall survival was the clinically relevant endpoint but was not reported as the trial was unblinded before the endpoint could be calculated. There are no head to head trials that compare sorafenib to any other treatment for advanced RCC.

II. Criteria/Guidelines A. Patients diagnosed with advanced renal cell carcinoma may be eligible for coverage with

sorafenib (Nexavar) if the following criteria are met:

1. The use of sorafenib must be recommended by an oncologist or hematologist; and

2. The patient must have a diagnosis of advanced renal cell carcinoma (ARCC).

B. Requests for continuing therapy with sorafenib may be approved if the patient shows no progression of disease.

III. Limitations/Exclusions These criteria will continue to apply when sorafenib becomes available in generic form.

IV. Administrative Guidelines A. Precertification is required for the initial three months of therapy. Patients may be eligible for

coverage when all of the following documentation, that confirms the diagnosis of advanced renal cell carcinoma, is submitted.

1. Clinical notes that include the history of previous treatments;

2. Current oncology notes;

3. Pathology reports;

4. Imaging studies.

5. To precertify, please complete HMSA’s Drug Review Request and mail or fax the form as indicated.

B. Precertification is required for renewals of sorafenib and will be eligible for an additional three months when all of the following documentation is submitted:

1. Current oncology notes documenting the patient’s response to treatment and showing no progression of disease; and.



2. Current imaging studies that can be compared with previous imaging studies and shows no progression of disease.

V. Scientific Background The safety and efficacy of sorafenib were studied in two randomized controlled trials. The first study of 769 patients with ARCC investigated overall progression and progression free survival (PFS) in a multicenter, randomized, doubleblind, placebocontrolled phase III trial. Patients had received one prior systemic therapy. Progressionfree survival is defined as the time from randomization to progression or death from any cause, whichever occurred earlier. Tumor response rate was a secondary endpoint. Subjects received 400 mg of the drug or placebo twice daily, until evidence of PFS was observed. Patients receiving 400 mg sorafenib demonstrated 167 days of PFS compared to 84 days for patients receiving placebo.

A subset analyses included patients who had not previously received interferon treatment. This resulted in PFS of 172 days versus 85 days for patients on placebo.

Another subset analysis radiologically monitored tumor response but was not statistically significant; seven patients (2%) who received sorafenib had a confirmed partial response but placebo patients did not.

The second clinical study was a Phase 2 randomized discontinuation trial in patients with metastatic malignancies including ARCC. The study investigated progression free survival at 24 weeks. All patients received sorafenib for the first 12 weeks. Patients with less than a 25 percent change in tumor measurements from baseline were randomized to sorafenib or to placebo for an additional 12 weeks. If progression was observed, placebo patients were able to cross over to sorafenib. Patients with tumor shrinkage, continued on sorafenib and patients with tumor growth of more than 25 percent discontinued treatment.

Two hundred two patients with ARCC were enrolled in this study. After the initial 12 weeks of therapy with sorafenib, 79 patients with ARCC continued on open label sorafenib, 65 were randomized to sorafenib or placebo. At 24 weeks, the 65 patients randomized to sorafenib had significantly longer progression free survival than the placebo group, 163 days versus 41 days, respectively.



This Medical Policy has been developed through consideration of the medical necessity criteria under Hawaii’s Patients’ Bill of Rights and Responsibilities Act (Hawaii Revised Statutes §432E 1.4), generally accepted standards of medical practice and review of medical literature and government approval status. HMSA has determined that services not covered under this Medical Policy will not be medically necessary under Hawaii law in most cases. If a treating physician

S Sorafenib (Nexavar) (continued)


disagrees with HMSA’s determination as to medical necessity in a given case, the physician may request that HMSA consider the application of this Medical Policy to the case at issue.

VII. References 1. FDA: Center for drug evaluation and research. Label Information for sorafenib. Accessed June

12, 2006. http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm? fuseaction=Search.DrugDetails

2. Motzer RJ, Bacik J, Schwartz L H, Reuter V, Russo P, Marion S, Mazumdar M. Prognostic Factors for Survival in Previously Treated Patients With Metastatic Renal Cell Carcinoma. J Clin Oncol. 2004;22(3):454463.

3. Sorafenib prescribing information. Bayer Pharmaceuticals Corp.; West Haven, CT. December 2005.

4. Ratain MJ, Eisen T, Stadler WM, Flaherty KT, Gore M, Desai A, Patnaik A, Xiong HQ, Schwartz B, O’Dwyer P. Final findings from a phase II, placebocontrolled, randomized discontinuation trial (RDT) of sorafenib (BAY 43–9006) in patients with advanced renal cell carcinoma (RCC). J Clin Oncol. 2005 ASCO Annual Meeting Proceedings. 2005;23 (16S) June 1 Supplement. 4544.

5. Ratain MJ, Eisen T, Stadler WM, Flaherty KT, Gore M, Desai A, Patnaik A, Xiong HQ, Schwartz B, O’Dwyer P. Phase II, placebocontrolled, randomized discontinuation trial of sorafenib in patients with metastatic renal cell carcinoma. J Clin Oncol. 2006;24(16) 2505 2512.

S Subcutaneous and Intramuscular Injectables


I. Description Home subcutaneous and intramuscular injectable therapy is initiated by a physician who oversees the care of the patient at home and is designed to achieve patient specific therapeutic outcomes. These injectable drugs may be administered at home by the patient, caregiver or nurse.

II. Drug Selection A. The drug(s) selected must be FDAapproved for indication dosage, frequency and duration.

B. If the drug is prescribed for indications not approved by the FDA, this “offlabel” indication must follow HMSA policy.

III. Criteria/Guidelines A. If HMSA has an existing policy on the specific drug, the criteria and precertification

requirements should be followed.

B. If there is no HMSA policy covering the specific drug, HMSA’s policy onOffLabel Drug Use should be consulted for criteria and precertification requirements.

IV. Documentation A. The following documentation should appear in the patient’s case file. In addition, this

information should be included with extension requests:

1. Physician’s orders/prescriptions including:

a. the drug regimen

b. name of drug, dosage, and frequency

c. route of administration and

d. duration (start and end dates)

2. Clinical information regarding the patient’s diagnosis

3. Clinical information documenting the patient’s progress and response to therapy

4. Patient or caregiver’s informed consent for home injectable therapy

V. Claims Filing Information Please use the code listed in the specific HMSA policy that pertains to the drug or the NDC number for that drug and dosage.

Subcutaneous and Intramuscular Injectables Description Code Identify drugs dispensed using NDC number NDC number



Example The patient has multiple sclerosis. The attending physician has prescribed 0.25 mg of Betaseron, injected subcutaneously, every other day.

The provider has dispensed a 30day supply of Betaseron to the patient for selfadministration at home. Betaseron comes in individual vials for reconstitution (one vial equals one unit). The vials contain 0.3 mg of Betaseron, but once reconstituted, any unused portion must be discarded. To obtain the required 0.25 mg the patient must use a new vial for each injection. Therefore, the provider dispensed 15 vials.

NDC: 50419052315 x 15 units

S Sunitinib (Sutent)


I. Description Sunitinib (Sutent) is an oral medication used to treat gastrointestinal stromal tumor (GIST) and advanced renal cell carcinoma (ARCC). Sunitinib is a multikinase inhibitor that targets several receptor tyrosine kinases to deprive the tumor cells of the blood supply and nutrients needed to grow.

Patients with GIST, are candidates for sunitinib after failing treatment with imatinib (Gleevec). Patients showed significant improvement in delaying time to tumor progression when compared to patients taking placebo. Progression free survival also increased when compared to placebo. There are about 5,000 cases of gastrointestinal stromal tumor yearly. Advanced kidney cancer affects about 32,000 people per year.

FDA approval for sunitinib for advanced kidney cancer was based on partial response rates and duration of responses.

II. Criteria/Guidelines A. Requests for sunitinib (Sutent) for gastrointestinal stromal tumor or advanced renal cell

carcinoma must meet the following criteria.

1. The use of sunitinib must be recommended by an oncologist or hematologist, and

2. The patient has a diagnosis of gastrointestinal stromal tumor that is refractory (no longer responding) to, or has an intolerance to imatinib (Gleevec); or

3. The patient has a diagnosis of advanced renal cell carcinoma.

B. Requests for continuing therapy with sunitinib may be approved if the patient shows no progression of disease.

III. Limitations/Exclusions These criteria will continue to apply when sunitinib becomes available in a generic form.

IV. Administrative Guidelines A. Precertification is required for the initial three months of therapy. Patients may be eligible for

coverage when all of the following documentation that confirms the diagnosis of gastrointestinal stromal tumor or advanced renal cell carcinoma or GIST, is submitted.

1. Clinical notes that include the history of previous treatments;

2. Current oncology notes;

3. Pathology reports;

4. Imaging studies.

B. To precertify, please complete HMSA’s Drug Review Request and mail or fax the form as indicated.



C. Precertification is required for renewals of sunitinab and will be eligible for an additional three months when all of the following documentation is submitted:

1. Current oncology notes documenting the patient’s response to treatment and showing no progression of disease.

2. Current imaging studies that can be compared with previous imaging studies and shows no progression of disease.




VI. References 1. FDA; Center for drug evaluation and research. Label information for sunitinib. Accessed June

12, 2006. http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm? fuseaction=Search.Label_ApprovalHistory

2. Motzer RJ, Dror Michaelson M, Redman BG. et al. Activity of SU11248, a multitargeted inhibitor of vascular endothelial growth factor receptor and plateletderived growth factor receptor, in patients with metastatic renal cell carcinoma. J Clin Oncol. 2006; 24(1):1624.

3. Motzer RJ, Rini BI, Bukowski RM, et al. Sunitinib in Patients With Metastatic Renal Cell Carcinoma. JAMA. 2006;295:25162524.

4. Sutent prescribing information, Pfizer Labs, New York, NY. January 2006.

U Uterine Artery Embolization to Treat Fibroids


I. Description Uterine artery embolization is the therapeutic introduction of small synthetic substances (polyvinyl alcohol (PVA), or gelatin sponge particles) into the uterine arteries to occlude them. The procedure has been used to control acute pelvic hemorrhage, cervical ectopic pregnancy, or benign growths that develop in the uterine wall. For the treatment of fibroids (leiomyomas), a catheter is inserted through the femoral artery to the uterus using Xray imaging (fluoroscopic) guidance. An arteriogram is performed to map the blood supply to the uterus and fibroids, and the embolization substances are slowly injected into the vessels, blocking the blood supply to the fibroids. As a result of the restricted blood flow, the tumors begin to shrink.

There are two primary surgical interventions for the treatment of symptomatic fibroids: myomectomy and hysterectomy. Hysterectomy is the definitive surgical treatment when future fertility is not desired. Uterine artery embolization is a minimally invasive procedure, which may be used as an alternative to other surgical techniques. Complications include angiography complications, contrast reaction, severe pain requiring hospitalization, menorrhagia, leukocytosis, infection, ischemia of bladder, claudication, possible infertility, induction of menopause, regrowth of fibroids, or complete necrosis requiring hysterectomy.

II. Criteria/Guidelines A. Uterine artery embolization for the treatment of fibroids is eligible for benefit coverage as an

alternative to surgery when recommended by the patient’s gynecologist.

B. The following criteria must be met and documented:

1. The fibroid(s) is confirmed by ultrasound or MRI within the last three (3) months. MRIs are eligible for coverage only if an ultrasound is performed first and found to be inconclusive.

2. The fibroid(s) is unresponsive to alternative conservative medical management.

3. One or more of the following symptoms must be present and attributed to the fibroid(s):

a. Menorrhagia (abnormally heavy or prolonged menstrual bleeding, with or without anemia).

b. Chronic pelvic, back or leg pain or discomfort.

c. Obstruction or compression on the bladder, ureters or kidneys.

d. Constipation

4. There is no suspicion or history of pedunculated endrometrial fibroid(s) or polyp(s).

5. There is no suspicion of malignancy of cervix or leiomyosarcoma (e.g., rapid growth).

C. When applicable, documentation must include the following indications:

1. History of failed myomectomy. (Continued On Next Page)


2. Recurrent growth after myomectomy.

3. Symptoms refractory to conservative medical treatment.

D. The following evaluations when applicable, must be performed prior to the procedure:

1. A current negative pregnancy test result for childbearing age patients suspected of being pregnant.

2. A current negative test for venereal disease (e.g., gonorrhea and chlamydia), for patients with a history of pelvic inflammatory disease or for patients at risk of or suspected of having venereal disease.

3. A current negative endometrial biopsy report for patients with a history of abnormal uterine bleeding or when endometrial cancer is suspected.

4. Pelvic ultrasound. MRI is only performed if medically necessary (e.g., adenomyosis, narrow pedicle of pedunculated myoma, intracavitary mass).

E. Patient understands and is informed of the risks associated with future fertility/pregnancy.

III. Limitations/Exclusions A. Uterine artery embolization for other nonemergent indications may be considered

investigational subject to review by the Medical Director. Precertification requests must be supported by documentation from peerreviewed literature to support the safety, efficacy and longterm results.

B. Uterine artery embolization for fibroids is not appropriate for patients with the following conditions:

1. The existence of a medical condition where the use of intravenous (IV) iodinated contrast agent is contraindicated (e.g., history of contrast media allergy, high risk of contrastinduced renal failure in diabetes with renal insufficiency).

2. Bleeding disorders or the patient is currently being treated with anticoagulant therapy.

3. A medical condition that makes the patient hemodynamically unstable (e.g., congestive heart failure or renal insufficiency).

4. Narrow pedunculate of a myoma or intracavitary mass.

5. Adenomyosis.

6. Pelvic inflammatory disease.

7. Suspicion of malignancy of uterus or cervix.

8. Asymptomatic patients with confirmed diagnoses of uterine fibroids.

U Uterine Artery Embolization to Treat Fibroids (continued)


9. Infertility secondary to uterine fibroids.

10. Patient is on exogenous estrogen.

C. Repeat transcatheter embolization of uterine arteries to treat persistent symptoms of uterine fibroids after an initial uterine artery embolization is considered investigational as there is no literature to support its success.

D. Uterine artery embolization for the treatment of infertility secondary to fibroids is not a covered benefit.

E. MRI for follow up to uterine artery embolization is not medically necessary. MRA for pre or post uterine artery embolization is also considered not medically necessary.

IV. Administrative Guidelines A. Precertification is not required for this service unless as noted in III.A Uterine artery

embolization for all other nonemergent indications may be considered investigational subject to review by the Medical Director. Precertification requests must be supported by documentation from peerreviewed literature to support the safety, efficacy and longterm results.

ICD9CM Code Description 218.0 – 218.9 Uterine leiomyoma

CPT Code Description 37210 Uterine fibroid embolization (UFE, embolization of the uterine arteries to

treat uterine fibroids, leiomyomata), percutaneous approach inclusive of vascular access, vessel selection, embolization, and all radiological supervision and interpretation, intraprocedural roadmapping, and imaging guidance necessary to complete the procedure

HCPCS Code Description S2250 Uterine artery embolization for uterine fibroids



V. References 1. AHRQ Evidence Report/Technology Assessment: Number 34 (2001, Jan) Management of

uterine fibroids.

2. Blue Cross Blue Shield Association. Transcatheter uterine artery embolization to treat uterine fibroids. Medical Policy Reference Manual. Policy #4.01.11. July 2003.

3. ECRI Windows on Medical Technology (2001, Feb) Uterine artery embolization for the treatment of fibroids.

4. RougierChapman D, Key SM, Ryan M (2001) Uterine artery embolization for the treatment of symptomatic fibroid disease. Applied Radiology, 30 (9) 11 – 17.

5. Simon JR, Silverstein MI (2001) Uterine artery embolization for fibroids: Procedure, results, and complications. Supplement to Applied Radiology, 30 (7) 1728.

6. Spies JB, Asher SA, Roth AR, et al. (2001) Uterine artery embolization for leiomyomata. Obstetrics and Gynecology, 98:2934.

7. The American College of Obstetricians and Gynecologists (ACOG) (2002, June) Uterine artery embolization: Evidence increasing on its success in treating fibroids.

V Vacuum Assisted Breast Biopsy


I. Description Vacuum assisted core biopsy is a technique in which a cannula equipped with a suction device is inserted into the breast through a small skin incision. Multiple cores can be taken using one incision. The Mammotome and ABBI are different types of vacuum assisted breast biopsy (VABB) systems. A metallic clip may be placed at the site of the biopsy to facilitate its identification if further surgical excision or radiologic followup is necessary. Initially used for biopsying clusters of microcalcifications, the use of VABB has expanded to include biopsy of a wider range of palpable and nonpalpable breast lesions.

A variety of imaging techniques may accompany the biopsy. Stereotactic guidance is particulary useful for guiding the biopsy of microcalcifications. Ultrasound guidance may be preferable for masses that have been previously detected by ultrasound. Advantages of ultrasound guidance include the absence of radiation. Computed tomography (CT) and magnetic resonance imaging (MRI) are also used for guidance.

When the results of fine needle aspiration or conventional needle core biopsy are suspicious or positive for malignancy, an open excisional biopsy or lumpectomy is typically performed to confirm the findings and ensure that the entire lesion has been removed.

II. Criteria/Guidelines A. Vacuum assisted breast biopsy is the preferred method of sampling suspicious micro

calcifications and is medically necessary for this indication.

B. Patients with other types of nonpalpable breast lesions may be eligible for coverage of vacuum assisted breast biopsy as an alternative to standard core biopsy or fine needle aspiration. Documentation for the medical necessity of VABB (compared to standard core biopsy or fine needle aspiration) must be included in the medical record and available if requested.

III. Limitations/Exclusions A. Vacuum assisted breast biopsy is not eligible for coverage for patients with palpable breast

lesions.

B. Vacuum assisted breast biopsy is not eligible for coverage for patients as an alternative to open excisional biopsy or lumpectomy.

C. Combinations of fine needle biopsy or conventional core biopsy and vacuum assisted breast biopsy will not be eligible for coverage.

IV. Administrative Guidelines

CPT Codes Description 19103 Biopsy of breast, percutaneous, automated, vacuum assisted or rotating biopsy

device, using imaging guidance 19295 Image guided placement, metallic localization clip, percutaneous, during

breast biopsy (list separately in addition to code for primary procedure) 76098 Radiological exam, surgical specimen



CPT Codes Description 76942 Ultrasonic guidance for needle placement (e.g., biopsy, aspiration, injection,

localization device), imaging supervision and interpretation 77031 Stereotactic localization guidance for breast biopsy or needle placement (e.g.,

for wire localization or for injection), each lesion, radiological supervision and interpretation

77032 Mammographic guidance for needle placement, breast (e.g., for wire localization or for injection), each lesion, radiological supervision and interpretation

99070 Supplies and materials (except spectacles), provided by physician over and above those usually included with the office visit or other services rendered (list drugs, drays, supplies, or materials provided)

ICD9CM Codes Description 174.0 – 174.9 Malignant neoplasm, female breast 175.0 – 175.9 Malignant neoplasm, male breast 217 Benign neoplasm, breast 233.0 Carcinoma in situ, breast 238.3 Neoplasm of uncertain behavior, breast 239.3 Neoplasms of unspecified nature, breast 611.72 Lump or mass in breast 793.81 Nonspecific abnormal findings on radiological and other examination, breast,

mammographic microcalcification

Procedure Codes Description 85.11 Closed (percutaneous) (needle) biopsy of breast 87.37 Soft tissue xray of thorax, other mammography

V. Scientific Background Vacuum assisted breast biopsy (VABB) has found acceptance by physicians. The Mammotome device has particularly found favor because of its efficacy in sampling microcalcifications. VABB samples are larger and this is thought to reduce false negative results.

Studies comparing fine needle aspiration, conventional core biopsy, and vacuum assisted core biopsy have not been done. Meyer et al., (1997) investigated vacuum assisted and traditional core biopsy and results suggested that vacuum assisted breast biopsy is more effective in sampling microcalcifications. Nesbit and colleagues (2000) also found VABB was associated with improved sampling of microcalcifications.

Diagnostic accuracy was examined by Jackman and associates (1997). They concluded that the increased amount of tissue obtained and examined using VABB, increased diagnostic accuracy when compared to conventional core biopsy. Underestimates of carcinoma were significant with both of these non surgical biopsy procedures, therefore, surgical biopsy must still be performed when non surgical biopsies had suspicious findings.

Simon et al., (2000) looked at the safety of VABB based on bleeding time and found bleeding time was less than 10 minutes. Burbank (1997) found about a one percent complication rate when 340 vacuum assisted breast biopsies were investigated. Liberman and colleagues (1997), and Lamm

V Vacuum Assisted Breast Biopsy (continued)


and Jackman (2000) looked at the future use of mammograms in patients having had VABB. There was minimal scarring as a result of VABB and they concluded that mammographic findings were not compromised.




VII. References 1. Adrales G, Turk P, Wallace T et al. Is surgical excision necessary for atypical ductal

hyperplasia of the breast diagnosed by Mammotome? Am J Surg 2000; 180(4):3135.

2. BlueCross Blue Shield Association Medical Policy Reference Manual Policy 6.01.09 Vacuum assisted breast biopsy. (1:2003).

3. Burbank F. Stereotactic breast biopsy: comparison of 14 and 11gauge Mammotome probe performance and complication rates. Am Surg 1997; 63(11):98895.

4. Darling ML, Smith DN, Lester SC et al. Atypical ductal hyperplasia and ductal carcinoma in situ as revealed by largecore needle breast biopsy: results of surgical excision. AJR Am J Roentgenol 2000; 175(5):13416.

5. Jackman RJ, Burbank F, Parker SH et al. Atypical ductal hyperplasia diagnosed at stereotactic breast biopsy: improved reliability with 14gauge, directional, vacuumassisted biopsy. Radiology 1997; 204(2):4858.

6. Kettritz U, Rotter K, Schreer I, Murauer M, SchulzWendtland R, Peter D. Heywang Krobrunner SH. Stereotactic vacuum assisted breast biopsy in 2874 patients: A multicenter study. Cancer 2004 Jan 15; (2)24551.

7. Lamm RL, Jackman RJ. Mammographic abnormalities caused by percutaneous stereotactic biopsy of histologically benign lesions evident on followup mammograms. AJR Am J Roentgenol 2000; 174(3):7536.



8. Lehman DC, Deperi ER, Peacock S, McDonough MD, Demartini WB, Shook J. Clinical experience with MRIguided vacuum assisted breast biopsy. Am J Roentgenol 2005 June; 184(6):17877.

9. Liberman L, Hann LE, Dershaw DD et al. Mammographic findings after stereotactic 14gauge vacuum biopsy. Radiology 1997; 203(2):3437.

10. Meyer JE, Smith DN, DiPiro PJ et al. Stereotactic breast biopsy of clustered microcalcifications with a directional, vacuumassisted device. Radiology 1997; 204(2):5756.

11. Nisbet AP, BorthwickClark A, Scott N. 11gauge vacuumassisted directional biopsy of breast calcifications, using upright stereotactic guidance. Eur J Radiol 2000; 36(3):1446.

12. Simon JR, Kalbhen CL, Cooper RA et al. Accuracy and complication rates of USguided vacuumassisted core breast biopsy: initial results. Radiology 2000; 215(3):6947.

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