Minnesota Physician September 2013

Volume XXVll, No. 6

September 2013

End-of-life decisionsTechnology and advancecare planning

By Jeffrey B. Rubins, MD, andTomás Valdivia, MD

Understanding and enacting people’svalues and preferences regardingmedical care for life-limiting disease

are tantamount to achieving the Institutefor Healthcare Improvement’s triple aim ofimproved quality of care, improved experi-ence for patients and families, and reducedunnecessary health care expenditures.

Yet, despite efforts over the pastdecades to realize these goals, only a minor-ity of adults have considered and indicatedtheir wishes for end-of-life care. Less than20 percent of adults have completedadvance directives or have documenteddiscussions about end-of-life care, and only44 percent of people have communicatedtheir end-of-life wishes to family members.

Even when patients’ wishes are known,they are not reliably enacted when patientsare hospitalized. As reported by the Agencyfor Healthcare Research and Quality in2003, only 30 percent of physicians whosepatients had an advance directive wereaware that it existed, and in only 50 percentof cases where an advance directive existedwas it used for end-of-life decisions. Notsurprisingly, nearly 30 percent of allMedicare spending is for treatment duringthe last year of life, representing more than

The Independent Medical Business Newspaper

Reconnecting physicianeducation and clinicalpractice

By Frank Cerra, MD

Health care delivery and the educa-tional systems that produced itsproviders and managers diverged

during the managed care era of the 1980s

and early 1990s, with the caredelivery models moving in a dif-ferent direction from the wayproviders were educated andtrained. Physician education andtraining continued in the Flexnermodel, with its physician-centricprocess of care and moreemphasis on medical science andresearch than on the service and

PRSRTSTDU.S.POSTAGE

PAIDDetriotLakes,MNPermitNo.2655

Shaping our future

Shaping our future to page 10

End-of-life decisions to page 12

The ICD-10 transition is coming October 1, 2014. The ICD-10 transition will change every part of how you provide care, from software upgrades, to patient registration and referrals, to clinical documentation, and billing. Work with your software vendor, clearinghouse, and billing service now to ensure you are ready when the time comes. ICD-10 is closer than it seems.

CMS can help. Visit the CMS website at www.cms.gov/ICD10 for resources to get your practice ready.

2014 COMPLIANCE DEADLINE FOR ICD-10

Official CMS Industry Resources for the ICD-10 Transitionwww.cms.gov/ICD10

NEWICD-10 DEADLINE:

OCT 1, 2014

SEPTEMBER 2013 MINNESOTA PHYSICIAN 3

CAPSULES 4

MEDICUS 7

INTERVIEW 8

ORTHOPEDICSWrist injuries 14By L.T. Donovan, DO

RESEARCHThe Go! study 16By Lara LaCaille, PhD, JenniferSchultz, PhD, and Ryan Goei, PhD

PROFESSIONAL UPDATE:FORENSIC PATHOLOGYCSI Minnesota 18By Lindsey C. Thomas, MD

UROLOGYActive surveillance 24By Thomas J. Stormont, MD

NEUROSURGERYTrigeminal neuralgia 26By Andrew W. Grande, MD,Stephen J. Haines, MD, and IrinaGutsalyuk, MS, PA-C

OTOLARYNGOLOGYTreatment of chronicsinus disease 28By Michael Hopfenspirger, MD

Shaping our future 1Reconnectiong physician educationand clinical practiceBy Frank Cerra, MD

End-of-life decisions 1Technology and advancecare planningBy Jeffrey B. Rubins, MD, andTomás Valdivia, MD

DEPARTMENTS

C O N T E N T S SEPTEMBER 2013 Volume XXVII, No. 6

Minnesota Physician is published once a month by Minnesota Physician Publishing, Inc. Ouraddress is 2812 East 26th Street, Minneapolis, MN 55406; phone (612) 728-8600; fax (612) 728-8601;email [email protected]. We welcome the submission of manuscripts and letters for possible pub-lication. All views and opinions expressed by authors of published articles are solely those of theauthors and do not necessarily represent or express the views of Minnesota PhysicianPublishing, Inc., or this publication. The contents herein are believed accurate but arenot intended to replace legal, tax, business or other professional advice and counsel. Nopart of this publication may be reprinted or reproduced without written permission ofthe publisher. Annual subscriptions (12 issues) are $48.00. Individual issues are $5.00.

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OFFICE ADMINISTRATOR Amanda Marlow [email protected]

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TheIndependentMedicalBusinessNewspaper

www.mppub.com

MarthaMcCusker, MDHennepin CountyMedical Center

FEATURES

ACA update 20By Kathi Wright, JD, Wade Hauser,and Monica Kelley, JD

What’s ahead in healthreform? 22By Donna Zimmerman

SPECIAL FOCUS: HEALTH REFORM

Exp. Date

� Check enclosed � Bill me � Credit card (Visa, Mastercard, American Express, or Discover)

Please mail, call in or fax your registration by 10/17/2013

MINNESOTA HEALTH CARE ROUNDTABLEMINNESOTA HEALTH CARE ROUNDTABLE

Background and focus:For the majority, end-of-lifeis the most medicallymanaged part of life. With itcome complex issues thatinvolve economics, ethics,politics, medical science,and more. Advances in tech-nology are extending lifeexpectancies and requirea redefinition of the term“end-of-life.” It now entails alonger time frame than one’sfinal weeks or hours, andprovokes debate as to whenlife is really over. Mecha-nisms exist to facilitatepersonal direction aroundthis topic, but there is aneed for improved coordina-tion among the entities thatprovide end-of-life support.

Objectives:We will discuss the significant infrastructure thatsupports end-of-life care. We will examine the roles of long-termcare/assisted living, palliative care, gerontology, and hospice. Wewill review the elements that go into creating advanced directives,including societal issues that make having them necessary, and thedifficulties encountered in bringing them to their current state. Wewill present a potential road map to optimal utilization of end-of-lifesupport today and how it may best be improved in the future.

Panelists include:

� Ed Ratner, MD, University of Minnesota Center for Bioethics

� Suzanne M. Scheller, Esq., Scheller Legal Solutions, LLC

� Cheryl Stephens, PhD, MBA, President, CEO,Community Health Information Collaborative

� Tomás Valdivia, MD, MS, CEO, Luminat

� Maggie O'Connor, M.D., Facilitator, Sacred Art of Living & Dying

Sponsors: Community Health Information Collaborative

Luminat • Scheller Legal Solutions

Please send me tickets at $95.00 per ticket. Mail orders to MinnesotaPhysician Publishing, 2812 East 26th Street, Minneapolis, MN 55406.Tickets may also be ordered by phone (612) 728-8600 or fax (612) 728-8601.

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Thursday, October 24, 20131:00 – 4:00 PM • Symphony BallroomDowntown Mpls. Hilton and Towers

Advance careplanning

Addressing end-of-life issues

F O R T I E T H S E S S I O N

4 MINNESOTA PHYSICIAN SEPTEMBER 2013

Critical AccessHospitals FaceReassessmentThe U.S. Department of Healthand Human Services (HHS)recently released a report rec-ommending that two-thirds ofhospitals in the critical accessprogram be reevaluated. Thesefacilities face having their desig-nation removed and their extracost reimbursement eliminated.

Distance requirements togain designation as a criticalaccess hospital—a hospitalmust be at least 35 miles fromanother medical facility—werewaived in 2006 for hospitalsthat offered services that other-wise wouldn’t be available in itsregion. When this exemptionwas removed, hospitals alreadyin the program were allowed tokeep their status.

However, HHS officials saythis increases governmentspending by an estimated$860,000 per hospital annuallyand costs government andMedicare beneficiaries nearly$1 billion more annually than

the law initially allowed.Currently, 79 of the nation’s

1,329 critical access hospitalsare in Minnesota. Ninety per-cent of them fail to meet thedistance requirement.

Several of the Minnesotahospitals that could lose theircritical access designation areaffiliated with large health caresystems, including SanfordHealth, Essentia Health, andMayo Clinic.

Health Care StaffVaccination RatesRise in MinnesotaParticipation in the FluSafeprogram increased this year,according to the MinnesotaDepartment of Health (MDH).This is the third year the pro-gram has been in place.

The intent of FluSafe is toensure all health care staff athospitals and nursing homes inMinnesota get vaccinatedagainst influenza each season.Nationally, the U.S. Departmentof Health and Human Serviceshas set a goal of a 90 percent

vaccination rate of health carepersonnel in its Healthy People2020 objectives. Currently,national rates are estimated at66.7 percent, according to MDHofficials.

MDH’s FluSafe programreport showed that 219 facilitiestook part during the 2012–13flu season. Of the participatingfacilities, 55 reached vaccina-tion levels of at least 90 percent,65 reached 80 percent to 89 per-cent, and 57 reached 70 percentto 79 percent. Of the 145 hospi-tals in Minnesota, 106 tookpart in the program, and 113of about 375 nursing homesparticipated.

“There were 30 facilitiesnew to the program this yearand we’re working hard withour partners to get more facili-ties to take action and partici-pate,” says Kristin Ehresmann,director of Infectious DiseaseEpidemiology Prevention andControl at MDH.

In an effort to help raisevaccination rates, facilities thatare a part of the programreceive access to guidance,tools, and promotional materi-

als through MDH and theCenters for Disease Control andPrevention.

Medtronic BuysCardiocom for$200 MillionAs part of an effort to become ahealth-care service provider,Fridley-based Medtronic haspurchased Chanhassen-basedCardiocom for $200 million.Cardiocom’s technology andservices support remote moni-toring of a range of chronicconditions, including cardiac,respiratory, and high bloodpressure-related diseases. Withthe acquisition, Medtronichopes to use telehealth technol-ogy to coordinate patient carefrom admission to follow-upvisits.

Cindy Resman, director ofcommunications for Medtronic,says, “In the near term,Cardiocom will continue tooperate independently as it doestoday, while we begin to exploreopportunities for integrationwith current Medtronic tech-

C A P S U L E S

Learn more about prediabetes, the NDPP and sites in Minnesota at: www.icanpreventdiabetes.org

• Refer them to a local National Diabetes Prevention Program

• Urge them to lose 7% of their body weight

• Prescribe 150 minutes/week of physical activity

• Ask them to eat more fruits and vegetables and less fat

• Refer them to a cessation program if they smoke

Diabetes CAN be prevented or delayed with simple lifestyle changes!

What can YOU do for PATIENTS WITH PREDIABETES?


nologies and services.”Medtronic hopes to eventu-

ally provide these health careservices on a global scale,according to Mike Genau,Medtronic senior vice presidentand president of its U.S. region.“We will be able to identify,treat, and manage patientsthrough a continuum, regard-less of where they are—hospitalor home,” he says.

MDH Releases2012 Patient ClinicExperience SurveyResults were released on Aug.14 from more than 230,000patients surveyed regardingtheir health care experience at651 primary and specialty clin-ics across Minnesota in 2012.

A 2008 state health reformlaw requires clinics to reporttheir performance on a stan-dard set of quality measures.The nonprofit MinnesotaCommunity Measurement part-nered with the MinnesotaDepartment of Health to collectand report data. The nextreport is expected in 2015.

Patients rated clinics basedon access to care, and interac-tion and communication withphysicians and office staff.Twenty-six clinics scoredabove statistical averages inall categories.

Ninety percent of patientrespondents gave high marksfor physician communicationskills. This measure includedquestions concerning knowl-edge of patients’ medical his-tory, ability to explain things inan understandable manner, lis-tening skills, and whetherphysicians spent enough timewith the patient.

Ninety-two percent repor-ted that clinic office staff wererespectful and helpful. Manyclinics scored lower on accessto care. Patients were askedhow often they were able tosecure appointments whenneeded and how often they sawtheir provider within 15 min-utes of a scheduled appoint-ment. Only 60 percent ofpatients said they experiencedtop-level access to care.

“Having these data bethere, transparent and avail-

able, will help [patient choice]of clinics,” says MinnesotaCommissioner of Health, EdEhlinger, MD. “For providers,this information creates astatewide benchmark that theycan use to learn about theirstrengths and weaknesses, tohelp them improve the qualityof care and the patient experi-ence.”

Eventually, this informa-tion will be integrated into theMNsure online health-insur-ance exchange system, accord-ing to officials.

To see scores, visitwww.mnhealthscores.com.

Allina Study FindsCare GuidesAre EffectiveResults from a Minnesota studypublished in the current issueof Annals of Internal Medicinesuggest that layperson careguides may improve care forpatients with chronic diseasesat a relatively low cost. Thestudy was funded by theRobina Foundation at AllinaHealth and led by Allina physi-cian Richard Adair, MD, withassistance from University ofMinnesota researchers.

The study evaluated 2,135patients from six primary careclinics in Minnesota. Partici-pants were 18 to 79 years ofage and had diagnoses ofhypertension, diabetes, or con-gestive heart failure. Eachpatient was given informationand health care goals for his orher disease, asked to worktoward the goals for one year,and randomly assigned to do sowith, or without, the assistanceof a care guide.

According to researchers,“Care guides were recruited forspecific traits and competen-cies: an outgoing personality,the ability to engage easily withpeople of different ages andbackgrounds, and a second lan-guage, where needed.” Guidesreceived brief training aboutdisease and techniques forbehavior change, then met withpatients on an ongoing basis todiscuss health issues and goalsin layperson language. Care

CAPSULES to page 6

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*Exhibitors feature the latest products, services and medications *Ask the Expert: Questions answered by medical professionals *Exciting speakers on diabetes topics *Healthy Eating cooking and Active Living fitness demo’s *FREE health screenings *FREE Admission *For more information call1-888-DIABETES or visit www.diabetes.org/minneapolisEXPO

American Diabetes Association EXPO Healthcare Professional Breakfast

Saturday, October 12, 2013 at 7:00am Minneapolis Convention Center

Meeting Room 103 DEF

Healthcare Reform: What does this mean for Diabetes Care in MN?

Presentation by Manny Munson-Regala, JD, Assistant to the Commissioner of the Minnesota Department of Health.

The Affordable Care Act will have a significant impact on access to health insurance, insurance consumer reforms, payment reforms, prevention activities and work force changes. Learn how MNsure (the new Minnesota health insurance marketplace), insurance reforms and other provisions of the Affordable Care Act will impact diabetes prevention, diagnosis and management.

Objectives:Describe the impact the Affordable Care Act will have on patients with diabetes and prediabetes. Learn about the impact of MNsure and insurance reforms on access, care delivery and prevention. Learn about diabetes prevention initiatives that could be included in future healthcare reform.

7:00 am - 8:15am Breakfast, Networking, Presentation and Discussion

RSVP on-line at http://diabetesmn.wufoo.com/forms/hcp-breakfast-rsvp/Space is limited. Please RSVP by Friday, October 4, 2013

Event is free of charge and open to all healthcare professionals to attend

C A P S U L E S


guides also followed up withpatients after doctor visits.

Results of the study showedthat, after one year, patientsassigned to a care guide experi-enced a 30.1 percent reductionin unmet health goals, whilethose who were not assigned acare guide experienced a reduc-tion of 12.6 percent.

Coalition SeeksLegislation to PreventOverdose DeathsA state coalition of doctors andpublic health advocates wantsMinnesota legislators to consid-er a bill next session that wouldoffer legal immunity to peoplewho seek emergency servicesfor someone suffering an over-dose and would increase accessto naloxone, a drug that canrevive someone who has over-dosed on an opiate.

Fourteen states and theDistrict of Columbia alreadyhave so-called Good Samaritanlaws in place, and 16 states

have passed laws allowingwider distribution of naloxone,according to the Network forPublic Health Law.

Gavin Bart, MD, director ofthe Division of AddictionMedicine at Hennepin CountyMedical Center, says Minnesotahas seen a dramatic increase inoverdoses in the last sevenyears.

State Appeals CourtAllows Guardians toEnd Life SupportA new ruling by the MinnesotaCourt of Appeals is a gamechanger for an important end-of-life issue. Guardians nowhave the authority to disconnecta ward’s life-support systemswithout approval by the state.The decision will have implica-tions for many of the more than12,000 Minnesotans currentlyunder guardianship.

“Although courts are experi-enced in making reasoned andimpartial decisions, doctors andmedical ethics committees have

the most appropriate knowledgeand expertise to evaluate thepotential for a ward’s long-termrecovery and quality of life andadvising a guardian on end-of-life decision-making,” JudgeNatalie Hudson wrote in herdecision. “Imposing a require-ment for additional courtinvolvement in this processwould be inconsistent with theSupreme Court’s recognition ofa private, medically basedmodel of decision-making.”

Previously, the district courthad ruled that guardians hadthe power to consent to medicaltreatment on behalf of thoseunder their care, but not theauthority to terminate life sup-port. That ruling came in 2012in the case of Jeffers Tschumy, a57-year-old man who sufferedfrom diabetes, effects from astroke, and partial paralysisfrom a spinal infection.

Tschumy had been living ina group home, under the care ofa state appointed guardian,since 2008. When he chokedand suffered severe brain dam-age in 2012, doctors said he had

little hope for recovery. He hadno known family and no healthcare directive. The hospital fileda motion asking a judge toallow Tschumy to be removedfrom life support by clarifyingthat his guardian had the powerto make the decision, or byissuing the order from thecourt. Life-support terminationwas authorized, but theguardian’s request for power asthe decision-maker was denied.

As a result of the ruling,when a guardian requests ter-mination of life support, thestate requires a reasonableeffort be made to obtain agree-ment from the ward and thenearest relative, as well as aphysician’s written statementthat death is imminent or thatinitiating CPR would be med-ically futile or would harm theward. The state may alsorequest a biomedical ethicsreport from the hospital treat-ing the ward. Guardians willappear before a judge, but thefinal decision ultimately will betheir own.

Capsules from page 5

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Maya Babu, MD, MBA, a resident in neuro-surgery at Mayo Clinic, Rochester, has beenelected to the board of trustees of the Ameri-can Medical Association (AMA) for a two-yearterm. Babu graduated from Harvard MedicalSchool and Harvard Business School.Imtiaz Mohamed, MD,has joined the EssentiaHealth–Duluth Clinic’sDigestive Health Center.

He earned his medical degree from MaulanaAzad Medical College in New Delhi and com-pleted a residency in internal medicine and afellowship in gastroenterology at NassauCounty Medical Center/SUNY Stony Brook inEast Meadow, N.Y. Most recently, Mohamed

was practicing in Hayward and Rice Lake,Wis. Thomas Moraghan, MD, has joined theEssentia Health St. Joseph’s-Brainerd Clinicto provide endocrinology services. Moraghanearned his medical degree from the Univer-sity of North Dakota School of Medicine inGrand Forks and served a residency in inter-nal medicine and a fellowship in endocrinol-ogy at the Mayo Graduate School of Medicinein Rochester. Thomas Ortmeier, MD, who is

board-certified in anatomic and clinicalpathology, has joined Essentia Health–St.Joseph’s Medical Center in Brainerd. Heearned his medical degree from the Universityof South Dakota School of Medicine in Vermil-lion and completed his residency in pathologyat the same institution.

Cary H. Mielke, MD, has been appointedchief of staff at Shriners Hospitals for Chil-dren–Twin Cities, where he has served as assis-tant chief of staff since 2006. Mielke earned hismedical degree from the University of Minnesota, completed an or-thopedic surgery residency at Mayo Clinic in Rochester, and com-pleted a fellowship in pediatric orthopedic surgery at the Universityof Utah/ Shriners Hospital for Children–Salt Lake City.

John Silkensen, MD, has been namedmedical director of the kidney transplant pro-gram at Hennepin County Medical Center,Minneapolis. Silkensen graduated from theUniversity of Arkansas College of Medicine,Little Rock, and completed an internal medi-cine residency and nephrology research fel-lowship at the University of Minnesota.

S. Charles Schulz, MD, professor andhead of the Universityof Minnesota Department of Psychiatry, willreceive the Stanley Dean Award for Researchin Schizophrenia in 2014, awarded by theAmerican College of Psychiatrists (ACP) to “agroup or individual that has made a majorcontribution to the treatment of schizo-phrenic disorders.” The award will be pre-sented in February 2014 at the next annualmeeting of the ACP. Before coming to the uni-

versity, Schulz founded the Schizophrenia Program at the MedicalCollege of Virginia and was the medical director of the Schizophre-nia Module at the University of Pittsburgh. He has contributed tothe National Plan on Schizophrenia Research and, with Carol A.Tamminga, MD, of University of Texas Southwestern MedicalSchool, cofounded the International Congress on SchizophreniaResearch.

M E D I C U S

Maya Babu, MD

Imtiaz Mohamed, MD

Thomas Moraghan, MD

John Silkensen, MD

Thomas Ortmeier, MD

S. Charles Schulz, MD


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� Tell us about Hospice of the Twin Cities.Hospice of the Twin Cities is a subsidiary ofMinneapolis Visiting Nurses Association. It is lo-cated in northeast Minneapolis, but serves thegreater metropolitan area. It is a freestanding, non-profit, community-based program that is not affili-ated with any particular health care system, but itdoes have relationshipswith a number of areasources in the Twin Citiesand throughout. Hospice ofthe Twin Cities has beenaround for over 20 years.

� As an associate medicaldirector for Hospice ofthe Twin Cities, what aresome of your duties?

I am there to work with the team to provide thebest possible services for end-of-life care for anindividual patient. I am not necessarily the attend-ing physician, but I’m there as a consultant. I pro-vide support to the primary physician with medica-tion management, if needed, and I work with thehospice panel staff to make sure appropriate careplans are identified. I help in clarifying a patient’slimited prognosis and exact diagnosis for hospice.Patients with a life expectancy of less than sixmonths qualify for hospice. I’m charged byMedicare to assess those patients who live longerthan six months, to ensure they continue to beappropriately served by hospice.

� Given the merits of advance care directives,what are some of the problems with how theyexist today?

One of the problems is that some patients don’thave them. Nobody has really offered to talk to thepatient about them. Sometimes as physicians, wewait for patients to bring it up because it’s reallynot fun to talk to them about what’s going to hap-pen when they’re in the dying process.

A second issue is that sometimes the advancedirective is very vague. The patient may choose notto be dependent on machines if vegetative. Thiscan be a difficult concept to apply in any specificclinical context. A directive generally can provideinformation in terms of how a patient thinks inabsolute “yes” or “no” terms, but it’s not specificenough. Being specific can be difficult because apatient may consider 50 scenarios by which theymight pass, and it might be number 93 that bringsthem to the hospital.

The third problem is that it’s hard to find themwhen you need them. There’s a problem with actu-ally passing the document from one place to ano-ther. One approach has been to try to scan theminto various electronic health records, but there’sno guarantee the patient will end up at the place

those records are stored. Ideally, clinical informa-tion is portable and should be able to be accessedby caregivers from different systems as patientsmove about in the health care world.

� How do you define the term “end of life?”End-of-life is such a blurry term. We doctors are

notoriously bad at determininghow much time people have left.I’m also a geriatrician, and lookat functional decline. When peo-ple start to lose abilities likebeing able to walk about andtake themselves to the bath-room, etc., that’s a sign that thetrajectory of life is in decline.Functional status and an expec-tation of less than six months

to live play a large role in determining whether ornot a patient is in a time frame where hospice iswarranted.

� What advice would you give physicians for talk-ing to patients about end-of-life care issues?

One is that it’s important to do it because it’s the bestway we can identify what’s important to a patient andhonor their preferences. The earlier we learn that, thebetter we can incorporate it into the plan of care.Patients’ goals do change, so having the conversationonce isn’t the end. I try to make it a practice to get iton the table in that first or second visit. Discussing itwhen it’s not a crisis moment is helpful, but certainlydiscuss it at a point of change for the patient—a newdiagnosis or a serious illness is an opportunity. It’simportant to communicate the need for an advancecare directive.

� Tell us about hospice service.Hospice is a service that is designed to provide careto a patient at the end of life, when that patient hasless than six months to live. That care can be pro-vided wherever people happen to live—in a privatehome, nursing home, assisted-living setting or resi-dential hospice house. There are also care homesnot affiliated with hospice programs that provide24-hour care. This is called the “hospice benefit,”and the extra charge is usually not covered byinsurance. These homes have a very therapeuticenvironment, but are often very expensive.Essentially, if a patient is an appropriate candidatefor hospice services, it doesn’t matter where theylive, hospice will go to them.

� What are the biggest misconceptions that physi-cians have about hospice care?

When patients come to hospice, more often thannot they have a relationship with a private physi-cian. The hope is that the physician will continueto be involved because of that relationship.

Martha McCusker, MDHennepin CountyMedical Center

Martha McCusker, MD, isboard-certified in internal

medicine, geriatrics,and hospice and palliative

medicine. Her work atHennepin County MedicalCenter involves caring forolder adults across the

spectrum of care, includingthose living independently,

in assisted livingenvironments, in short-term rehabilitation, andin long-term care. She isalso medical director for

Hospice of the Twin Citiesin Minneapolis.

Preparing for the end of life


I N T E R V I E W

Patients’ goals do

change, so having

the conversation

once isn’t the end.

Sometimes physicians don’t realize they cancontinue to work with their patient to theextent they choose. Hospice allows the pri-mary care physician to stay involved with asmuch hands-on care as they like, while themedical director is there within some regu-latory construct. The second misconceptionis that it’s sometimes challenging to accu-rately predict a six-month life expectancy. Ifa physician isn’t sure, he or she might notconsider hospice. It’s perfectly fine for aphysician to discuss an unclear diagnosiswith hospice directors.

� How do the issues of providing hospice inoutstate areas differ from providing thoseservices in the metro area?

In a rural community, hospice nurses aregoing to see a lot more windshield time,even though they also spend a lot of time onthe road in the metropolitan area. Doctorsneed to have face-to-face visits with hospicepatients who have been on the program fora certain period of time. If it can be face-to-face via a screen, what’s so different aboutthat than Skyping to your grandkids? UsingiPads could work as well. Utilizing informa-tion technology has really become key inmaximizing efficiency. From year to year, Isee more people, even older people, embrac-ing technology.

� How do you see the role of hospice grow-ing as time goes by?

A tool called POLST, or Physician Orders forLife Sustaining Treatment, is developing.Ideally, this document should be completedin discussion with the patient, family, anurse, and/or a social worker to discuss thepatient’s preferences in terms of being keptalive by machines. Then the physician isable to translate that into a specific set oforders for certain circumstances, residing asa physician order that can be recognizedacross different health care settings. It’s not100 percent guaranteed, but it’s a very bigstep forward in terms of having that infor-mation created ahead of time for the patientand then having it available at the timewhen you need it.

Ideally, a paper copy is given to thepatient, who would be responsible for carry-ing it from one place to the next. That’s nota realistic expectation, so work is being doneto have access to the record in real time,when needed.

� What are the biggest challenges that hos-pice care faces? Are payment issues oneof them?

I think the Medicare payment issue is one ofthem. Generally, it is paid on a per diembasis regardless of the levels of work duringthe process. There is discussion aboutchanging the model of care, so that rather

than having a set payment for every day, itwould be larger for the first week, lesser inthe middle, and larger for the last week.

Another challenge in expanding the hos-pice program has been identifying theappropriate stage to bring the services in topatients. Hospice was originally modeledaround care for cancer patients, which wasa fairly predictable clinical course at thetime. There was a period of time when youknew they would lose functional status,become more ill, and eventually die. That’snot true anymore because of the explosionin different cancer treatments. That particu-lar model of care, which is normally thoughtto be about six months, doesn’t really evenfit cancers anymore. Hospice is started tooearly or too late in many cases.

� What needs to change in terms of socie-tal perceptions of the end of life?

Death is part of life. We are in a life-affirm-ing society where people really don’t want toadmit that all good things come to an end.We need to get past the mindset that doctorscan fix everything and that we will all liveforever. Taking away some of the clinical,sterile approach to death and addressingother spiritual, emotional, and psychologicalaspects are important. There’s something wecall the four gifts, which is a patient saying,“I forgive you, please forgive me, I love you,and goodbye.” Simple, but very powerful.


2013 CME ActivitiesCare Across the Continuum: A Trauma & Critical Care ConferenceSeptember 27, 2013

NPHTI/Pediatric Clinical HypnosisOctober 3-5, 2013

Twin Cities Sports Medicine October 4-5, 2013

Maintenance of Certification in Anesthesiology (MOCA) Training October 5, 2013

Psychiatry Review: New Directions in Diagnosis & TreatmentOctober 7-8, 2013

Got Your Shots? 2013 Immunization ConferenceOctober 10-11, 2013

Transplant Immunosuppression 2013October 16-19, 2013

Practical DermatologyOctober 25-26, 2013

ONLINE COURSES (CME credit available)www.cme.umn.edu/online

Global Health - 7 Modules to include Travel Medicine, Refugee & Immigrant Health

Nitrous Oxide for Pediatric Procedural SedationFetal Alcohol Spectrum Disorders (FASD) - Early Identification & Intervention

For a full activity listing, go to www.cmecourses.umn.edu

(All courses in the Twin Cities unless noted)

Office of Continuing Medical Education612-626-7600 or 1-800-776-8636 email: [email protected]

Promoting a lifetime of outstanding professional practice

Pediatric Trauma SummitNovember 1-2, 2013

Donald Gleason Conference on Prostate & Urologic CancersNovember 8, 2013

Internal Medicine Review & UpdateNovember 13-15, 2013

Emerging Infections in Clinical Practice & Public Health: New DevelopmentsNovember 22, 2013

2014 CME ActivitiesCardiac ArrhythmiasApril 4, 2014

Integrated Behavioral Healthcare ConferenceApril 25, 2014

Annual Surgery Course: Vascular SurgeryMay 1-2, 2014

Global Health Training (weekly modules)May 5-30, 2014

Midwest Cardiovascular ForumMay 17-18, 2014

Bariatric Education Days: Decade of Bariatric EducationMay 21-22, 2014

University of Minnesota Continuing Professional Development


care components of medicine, inthe context of the existing fee-for-service payment system.Managed care, in contrast,began reshaping the process ofcare and people’s access to it.Doctors increasingly foundthemselves needing additionalskill and to be “trained-in” to theenvironment in which they werepracticing.

In the mid-1990s, changes inthe health care marketplace,medical payment systems, andpublic policy began to affectboth the medical education andthe care delivery sectors.Changes in the marketplaceincluded:

• Decreasing access to care• Increasing cost of care• Emphasis on encountersof care and a fee-for-serv-ice reimbursement system

• Non-involvement of con-sumers of health services

• Changing demographics asthe population aged, hadmore chronic disease andincreasing demand for

acute medical services,and lived longer

• The need for a greateremphasis on public healthin the process of care, e.g.,prevention, wellness, end-of-life care, and chronicdisease management

Over time, the effects ofthese changes led to these majorshifts in care delivery,which have continuedto the present:

• Health systemintegration andemployment ofproviders

• A move awayfrom fee-for-serv-ice to more popu-lation-orientedsystems, such asglobal fees

• Increased empha-sis on perform-ance, and per-formance measurement, ofproviders and systems

• Identification of majornew skills for which tradi-tionally trained providerswere not prepared

• Accountability for achiev-ing improved healthoutcomes for populations,and quality and costof care

• Increasing focus onpeople, families, andcommunities

Concomitant challenges,many of them resulting from the

marketplace developments, werealso occurring in academia. Asthe cost of educating and train-ing doctors rose dramatically,medical students started takingon large amounts of debt—aphenomenon that skewed thechoice of careers toward spe-cialties with higher reimburse-ments and fewer hours ofwork. A shortage of primarycare physicians, combined withincreased consumer demandfor services, contributed toreduced access to care. Medicaleducators began hearing thatthe providers they were pro-ducing did not match up withthe skills that were needed inclinical practice, resulting in aneed for months (or years) ofcostly retrainingin the workplace. There was noagreement on the ever-chang-ing care delivery model and noworkforce plan with whicheducational institutions couldrespond in their enrollmentand teaching models. In addi-tion, many health systemsimplemented their own educa-tional and outcomes researchprograms, which were general-ly poorly connected with thehealth professional schools.

In terms of public policy,the 2008 Minnesota Health Actand the federal Affordable CareAct, passed in 2010, have accel-

erated the pace of change in thecare delivery system. Health carehomes, accountable care sys-tems, and accountable care com-munities have been implemen-ted, along with new incentivesfor aligning prevention, inpa-tient, and non-hospital care andpayment systems. Provider andsystem performance based on

achieving improved efficiency,productivity, and outcomes israpidly becoming aligned withpayment systems.

These disruptive energies inboth the care delivery and theeducational systems are signifi-cantly affecting the educationand clinical readiness of physi-cians. Overall, we need to alignthe educational system produc-ing the providers with the sys-tem within which care is deliv-ered. The discussion belowaddresses three key areas wheremedical education is adapting toprepare medical students for theredesign of health care delivery:

• The educational frame-work and environment

• Education content• Interprofessional educa-tion and practice

Educational framework andenvironment

Medical education is movingfrom a focus on medical stu-dents and educators to one thatviews all participants—includingstudents, residents, faculty, prac-titioners, other providers,administrators—as learners withcontributions to make. Thisreflects the shift in emphasistoward patient-centered and evi-dence-based care, including pre-vention, population health, anddirect consumer engagement.

Medical education isdefining new skills,competencies, andcapabilities to beaddressed in thecurriculum.

Shaping our future from cover

In addition, medical educa-tion is increasingly viewed as aprocess of lifelong learning, in acontinuum from learning insti-tution to advanced training tocontinuous learningthroughout practice.And that learning isno longer mainlyclassroom-based.The new tools ofsimulation, onlinelearning, socialmedia, and smart-phones are changingthe approach tolearning for bothproviders and con-sumers. The physi-cian-centric Flexner model, inwhich the patient/client presentswith a disease that requiresdiagnosis and management, istransforming to a model ofshared responsibility andaccountability for the achieve-ment of health goals, usinginterprofessional approachesand providers, ina variety of settings.

Educational content

In order to produce a bettermatch between the graduatingprovider and the practice envi-ronment, medical education isdefining new skills, competen-cies, and capabilities to beaddressed in the curriculum.This shift recognizes that educa-tion and practice need to recon-nect, particularly in communitysettings, where the largest shareof the training of physicians andsurgeons occurs. In addition,there is growing awareness thatthe provider systems and theeducation community need toform partnerships that definethe needs and then evaluate per-formance in the practicing com-munity in a way that continuallyinforms the lifelong learningprocess.

Retraining efforts by thehealth systems have identifiedareas where graduating learnersappear to be deficient, and med-ical schools are making progressin incorporating concepts of evi-dence-based care and patient-centered care into the curricu-lum and its learning experi-ences. Team competencies forinterprofessional care delivery,

particularly in the area ofpatient safety, have been devel-oped and are being incorporatedinto learning experiences at vari-ous stages of provider develop-

ment, as well as into accredita-tion standards.

New content is being imple-mented to support the essentialnew skills in the learning andworking environments. Forexample, in recognition thatimproving health outcomesrequires that public healthbecome part of health care, newcontent and learning experiencesare providing medical studentswith a working knowledge ofprevention, wellness, publichealth practice and populationhealth, and social determinantsof health.

Another area of increasingimportance is informatics, a dis-cipline that includes the skills ofinformation acquisition, man-agement, analysis, and applica-tion in real-time settings so theright information is in the rightplace at the right time to makethe right decision. These basicskills can be applied in databasemanagement to support servicelines, performance and out-comes assessment, and coordi-nation of complex health needs.

Functioning as a provideremployee in an integrated healthsystem requires additional skillsin leadership, including anawareness of where one fits inthe organizational structure, anunderstanding of systems ofcare, and an appreciation ofhow to deploy the workforce ina way that creates a satisfyingwork environment. New contentaddressing these skills will likelydraw from disciplines such asbehavioral economics and thesocial sciences.

In the redesigned health-care delivery system, providerswill be working in new relation-ships with new types of pro-viders, often in interprofession-

al teams designed to meet thedifferent needs of individuals,families, and communities,located in diverse settings.Some teams will continue tobe physician-dominant, particu-larly in areas of medical diagno-sis, complex medical manage-ment, and skilled proceduralintervention. In other areas,such as primary care, manage-ment of chronic disease, end-of-life care, prevention, and well-ness, nurse clinician-centric

models are evolving. Socialservices are increasingly takingthe lead in helping communitiesand families achieve healthgoals. Clinical pharmacy is

implementingmodels of med-ication manage-ment where apharmacist mayserve as aprovider or aspart of a careteam, dependingon the setting. Weneed to educatephysicians towork effectivelywith these new

professionals and as productiveteam members.

Interprofessional educationand practice

Redesign of medical educationneeds to happen in conjunctionwith the redesign of the caremodel, with both orientedtoward improving health out-comes. Building new content,skills, and competencies into the


Redesign of medicaleducation needs to happen in

conjunction with theredesign of the care model.

Shaping our future to page 38

Do you have patients with trouble usingtheir telephone due to hearing loss, speechor physical disability?

If so…the TED Programprovides assistive telephoneequipment at NO COSTto those who qualify.

Please contact us,or have your patientscall directly, for moreinformation.

1-800-657-3663www.tedprogram.org

The Telephone Equipment Distribution Program is funded through theDepartment of Commerce Telecommunications Access Minnesota (TAM)and administered by the Minnesota Department of Human Services

Duluth • Mankato • MetroMoorhead • St. CloudTe

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$1.65 billion in expenses that,when asked, most patients saythey do not want.

In response to these con-cerns, several states havelaunched initiatives or fundedorganizations that focus onimproving communicationbetween doctors and patientsabout prognosis and treatments.In addition, many medicalschools and continuing medicaleducation programs have devel-oped training modules to helpproviders communicate badnews, manage transitions to pal-liative care, and handle requestsfor therapies that are likely to befutile.

While important, suchefforts alone will likely not besufficient to ensure that patientsreceive the care they want.Although facilitated conversa-tions are more personalized,they also are resource intensive,are difficult to extend to largepopulations, and introduce agreat deal of variability into thefinal product.

In addition, most of the

available paper-based healthcare documents direct patientsto accept or refuse interventions(for example, intubation, dialy-sis, tube feedings) rather than todetermine patients’ preferencesregarding the minimal quality oflife that they would find accept-able after proposed treatments.Typically, the choices aboutthese interventions are presentedin such documents in the con-text of extreme clinical scenarios(such as brain death, permanentcoma, or impending deathdespite treatment), which arenot typical of the clinical situa-tions where decisions must bemade in the hospital. Moreover,the individuals designated ashealth care agents seldom par-ticipate in these discussions.Finally, these directives are notusually accessible to providers atimportant junctures in healthcare, such as in the emergencydepartment or mobile ICU.

Using technology to improvethe advance directive process

Technology increasingly is beingused to improve the advanced-

care planning process. On theprovider side, web-based pro-grams are improving providers’awareness of and skill at dis-cussing difficult decisions. Web-based video decision-supporttools can help providers facili-tate conversations with patients.The Advance Care PlanningDecisions website (see sidebaron p. 13), produced by a non-profit foundation, makes avail-able a series of culturally appro-priate and easy to use informa-tional videos for providers tohelp patients understand the tra-jectory of certain diseases,including advanced dementia,cancer, and heart disease.

For patients, the PREPAREwebsite was launched this yearby clinical investigators at theSan Francisco VA MedicalCenter, UCSF, and the VeteransHealth Research Institute. Asreported in the November 2012issue of the Journal of Pain andSymptom Management, theresearchers studied English- andSpanish-speaking patients andsurrogate decision-makers whoreported having to make seriousmedical decisions for themselvesor for loved ones. Qualitativeanalysis confirmed that advancedirectives were not sufficient toprepare patients and surrogatesfor medical decision-making.Many participants recognizedthat focusing solely on treat-ments, such as mechanical ven-tilation, was not sufficient tohelp with the “many decisions”which they were facing. As aresult, the PREPARE tool wasconstructed using straightfor-ward language, videos, concreteexamples, and simple step-by-step instructions to be a patient-friendly online resource to helppatients identify what is mostimportant in their lives, to com-municate that information tofamily/friends and doctors, andto make informed medical deci-sions when necessary. The web-site’s audio-visual interface istailored to typically underservedpopulations and is written at afifth-grade reading level. Itincludes voice-overs of all text,closed-captioning for the hear-ing impaired, and large font forthe visually impaired. Whencompleted, the program pro-

duces an Action Plan thatpatients can use to facilitate dis-cussions with their family andproviders.

As another example, TheConversation Project website wascofounded by journalist Ellen

Goodman as a national cam-paign to help people talk abouttheir wishes for end-of-life careand, by normalizing these kindsof discussions, to transform ourdeath-adverse culture. In similarfashion, Caring Connections, aproject of the National Hospiceand Palliative Care Organi-zation, is an informational web-site with resources to encouragepeople to plan for their medicalcare before they get sick.

Making Your Wishes Known:Planning Your Medical Future isan online, interactive, computer-based decision tool developed byresearchers at Penn State. Thewebsite uses multimedia formatsto provide tailored informationand help individuals clarify theirvalues through reflective exerci-ses. A unique multi-attribute uti-lity algorithm translates individ-ual values and preferences into adetailed advance directive com-prising both general and specificwishes. The program has beenshown to be feasible and effec-tive in published studies.

To address the problem ofhaving advance directives acces-sible when needed, several stateshave recently establishedstatewide electronic registries forform-based advance directives.In addition, several stand-aloneregistries for advance directivesare available, including theAmerica Living Will Registry,Choices Bank, DocuBank,MyHealthDirective.com, andU.S. Living Will.

Advancing technology’spromise

The examples above illustratethe promise of technology forimproving the process of creat-

Less than 20 percentof adults have

completed advancedirectives.

End-of-life decisions from cover


Victoza® is a registered trademark of Novo Nordisk A/S.© 2013 Novo Nordisk All rights reserved. 0513-00015590-1 June 2013

Indications and UsageVictoza® (liraglutide [rDNA origin] injection) is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.Because of the uncertain relevance of the rodent thyroid C-cell tumor findings to humans, prescribe Victoza® only to patients for whom the potential benefits are considered to outweigh the potential risk. Victoza®

is not recommended as fi rst-line therapy for patients who have inadequate glycemic control on diet and exercise.Based on spontaneous postmarketing reports, acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victoza®. Victoza® has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for pancreatitis while using Victoza®. Other antidiabetic therapies should be considered in patients with a history of pancreatitis.Victoza® is not a substitute for insulin. Victoza® should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis, as it would not be effective in these settings.Victoza® has not been studied in combination with prandial insulin.

Important Safety InformationLiraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice. It is unknown whether Victoza® causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as human relevance could not be ruled out by clinical or nonclinical studies. Victoza® is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Based on the fi ndings in rodents, monitoring with serum calcitonin or thyroid ultrasound was performed during clinical trials, but this may have increased the number of unnecessary thyroid surgeries. It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate

human risk of thyroid C-cell tumors. Patients should be counseled regarding the risk and symptoms of thyroid tumors.Do not use in patients with a prior serious hypersensitivity reaction to Victoza® (liraglutide [rDNA origin] injection) or to any of the product components.Postmarketing reports, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis. Discontinue promptly if pancreatitis is suspected. Do not restart if pancreatitis is confi rmed. Consider other antidiabetic therapies in patients with a history of pancreatitis.When Victoza® is used with an insulin secretagogue (e.g. a sulfonylurea) or insulin serious hypoglycemia can occur. Consider lowering the dose of the insulin secretagogue or insulin to reduce the risk of hypoglycemia.Renal impairment has been reported postmarketing, usually in association with nausea, vomiting, diarrhea, or dehydration which may sometimes require hemodialysis. Use caution when initiating or escalating doses of Victoza® in patients with renal impairment.Serious hypersensitivity reactions (e.g. anaphylaxis and angioedema) have been reported during postmarketing use of Victoza®. If symptoms of hypersensitivity reactions occur, patients must stop taking Victoza® and seek medical advice promptly.There have been no studies establishing conclusive evidence of macrovascular risk reduction with Victoza® or any other antidiabetic drug.The most common adverse reactions, reported in ≥5% of patients treated with Victoza® and more commonly than in patients treated with placebo, are headache, nausea, diarrhea, dyspepsia, constipation and anti-liraglutide antibody formation. Immunogenicity-related events, including urticaria, were more common among Victoza®-treated patients (0.8%) than among comparator-treated patients (0.4%) in clinical trials.Victoza® has not been studied in type 2 diabetes patients below 18 years of age and is not recommended for use in pediatric patients.There is limited data in patients with renal or hepatic impairment.

Please see brief summary of Prescribing Information on adjacent page.

*Victoza® 1.2 mg and 1.8 mg when used alone or in combination with OADs.†Victoza® is not indicated for the management of obesity, and weight change was a secondary end point in clinical trials.

PROVEN.For adult patients with type 2 diabetes, Victoza® offers these benefi ts and more.

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Victoza® (liraglutide [rDNA origin] injection) Rx Only BRIEF SUMMARY. Please consult package insert for full prescribing information.

WARNING: RISK OF THYROID C-CELL TUMORS: Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice. It is unknown whether Victoza® causes thyroid C-cell tumors, including medullary thyroid carci-noma (MTC), in humans, as human relevance could not be ruled out by clinical or nonclinical studies. Victoza® is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Based on the findings in rodents, monitoring with serum calcitonin or thyroid ultrasound was performed during clinical trials, but this may have increased the number of unnecessary thyroid surgeries. It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate human risk of thyroid C-cell tumors. Patients should be counseled regarding the risk and symptoms of thyroid tumors [see Contraindications and Warnings and Precautions].

INDICATIONS AND USAGE: Victoza® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Important Limitations of Use: Because of the uncertain relevance of the rodent thyroid C-cell tumor findings to humans, prescribe Victoza® only to patients for whom the potential benefits are considered to outweigh the potential risk. Victoza® is not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exercise. Based on spon-taneous postmarketing reports, acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victoza®. Victoza® has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for pancreatitis while using Victoza®. Other antidiabetic therapies should be considered in patients with a history of pancreatitis. Victoza® is not a substitute for insulin. Victoza® should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis, as it would not be effective in these settings. The concurrent use of Victoza® and prandial insulin has not been studied.CONTRAINDICATIONS: Do not use in patients with a personal or family history of medullary thyroid car-cinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Do not use in patients with a prior serious hypersensitivity reaction to Victoza® or to any of the product components.WARNINGS AND PRECAUTIONS: Risk of Thyroid C-cell Tumors: Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors (adenomas and/or carcinomas) at clinically rele-vant exposures in both genders of rats and mice. Malignant thyroid C-cell carcinomas were detected in rats and mice. A statistically significant increase in cancer was observed in rats receiving liraglutide at 8-times clinical exposure compared to controls. It is unknown whether Victoza® will cause thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as the human relevance of liraglutide-induced rodent thyroid C-cell tumors could not be determined by clinical or nonclinical studies. In the clinical trials, there have been 6 reported cases of thyroid C-cell hyperplasia among Victoza®-treated patients and 2 cases in comparator-treated patients (1.3 vs. 1.0 cases per 1000 patient-years). One comparator-treated patient with MTC had pre-treatment serum calcitonin concentrations >1000 ng/L suggesting pre-existing disease. All of these cases were diagnosed after thyroidectomy, which was prompted by abnormal results on routine, protocol-specified measurements of serum calcitonin. Five of the six Victoza®-treated patients had elevated calcitonin concentrations at baseline and throughout the trial. One Victoza® and one non-Victoza®-treated patient developed elevated calcitonin concentrations while on treatment. Calcitonin, a biological marker of MTC, was measured throughout the clinical development program. The serum calcitonin assay used in the Victoza® clinical trials had a lower limit of quantification (LLOQ) of 0.7 ng/L and the upper limit of the refer-ence range was 5.0 ng/L for women and 8.4 ng/L for men. At Weeks 26 and 52 in the clinical trials, adjusted mean serum calcitonin concentrations were higher in Victoza®-treated patients compared to placebo-treated patients but not compared to patients receiving active comparator. At these timepoints, the adjusted mean serum calcitonin values (~1.0 ng/L) were just above the LLOQ with between-group differences in adjusted mean serum calcitonin values of approximately 0.1 ng/L or less. Among patients with pre-treatment serum calcitonin below the upper limit of the reference range, shifts to above the upper limit of the reference range which persisted in subsequent measurements occurred most frequently among patients treated with Victoza® 1.8 mg/day. In trials with on-treatment serum calcitonin measurements out to 5-6 months, 1.9% of patients treated with Victoza® 1.8 mg/day developed new and persistent calcitonin elevations above the upper limit of the reference range compared to 0.8-1.1% of patients treated with control medication or the 0.6 and 1.2 mg doses of Victoza®. In trials with on-treatment serum calcitonin measurements out to 12 months, 1.3% of patients treated with Victoza® 1.8 mg/day had new and persistent elevations of calcitonin from below or within the reference range to above the upper limit of the reference range, compared to 0.6%, 0% and 1.0% of patients treated with Victoza® 1.2 mg, placebo and active control, respectively. Otherwise, Victoza® did not produce consistent dose-dependent or time-dependent increases in serum calcitonin. Patients with MTC usually have calcitonin values >50 ng/L. In Victoza® clinical trials, among patients with pre-treatment serum calcitonin <50 ng/L, one Victoza®-treated patient and no comparator-treated patients developed serum calcitonin >50 ng/L. The Victoza®-treated patient who developed serum calcitonin >50 ng/L had an elevated pre-treatment serum calcitonin of 10.7 ng/L that increased to 30.7 ng/L at Week 12 and 53.5 ng/L at the end of the 6-month trial. Follow-up serum calcitonin was 22.3 ng/L more than 2.5 years after the last dose of Victoza®. The largest increase in serum calcitonin in a comparator-treated patient was seen with glimepiride in a patient whose serum calcitonin increased from 19.3 ng/L at baseline to 44.8 ng/L at Week 65 and 38.1 ng/L at Week 104. Among patients who began with serum calcitonin <20 ng/L, calci-tonin elevations to >20 ng/L occurred in 0.7% of Victoza®-treated patients, 0.3% of placebo-treated patients, and 0.5% of active-comparator-treated patients, with an incidence of 1.1% among patients treated with 1.8 mg/day of Victoza®. The clinical significance of these findings is unknown. Counsel patients regarding the risk for MTC and the symptoms of thyroid tumors (e.g. a mass in the neck, dysphagia, dyspnea or persistent hoarseness). It is unknown whether monitoring with serum calcitonin or thyroid ultra-sound will mitigate the potential risk of MTC, and such monitoring may increase the risk of unnecessary procedures, due to low test specificity for serum calcitonin and a high background incidence of thyroid disease. Patients with thyroid nodules noted on physical examination or neck imaging obtained for other reasons should be referred to an endocrinologist for further evaluation. Although routine monitoring of serum calcitonin is of uncertain value in patients treated with Victoza®, if serum calcitonin is measured and found to be elevated, the patient should be referred to an endocrinologist for further evaluation. Pancreati-tis: Based on spontaneous postmarketing reports, acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, has been observed in patients treated with Victoza®. After initiation of Victoza®, observe patients carefully for signs and symp-toms of pancreatitis (including persistent severe abdominal pain, sometimes radiating to the back and which may or may not be accompanied by vomiting). If pancreatitis is sus-pected, Victoza® should promptly be discontinued and appropriate management should be initiated. If pancreatitis is confirmed, Victoza® should not be restarted. Consider antidia-betic therapies other than Victoza® in patients with a history of pancreatitis. In clinical trials of Victoza®, there have been 13 cases of pancreatitis among Victoza®-treated patients and 1 case in a compara-tor (glimepiride) treated patient (2.7 vs. 0.5 cases per 1000 patient-years). Nine of the 13 cases with Victoza® were reported as acute pancreatitis and four were reported as chronic pancreatitis. In one case in a Victoza®-treated patient, pancreatitis, with necrosis, was observed and led to death; however clinical causal-

ity could not be established. Some patients had other risk factors for pancreatitis, such as a history of cholelithiasis or alcohol abuse. Use with Medications Known to Cause Hypoglycemia: Patients receiving Victoza® in combination with an insulin secretagogue (e.g., sulfonylurea) or insulin may have an increased risk of hypoglycemia. The risk of hypoglycemia may be lowered by a reduction in the dose of sulfonylurea (or other concomitantly administered insulin secretagogues) or insulin Renal Impairment: Victoza® has not been found to be directly nephrotoxic in animal studies or clinical trials. There have been postmarketing reports of acute renal failure and worsening of chronic renal failure, which may sometimes require hemodialysis in Victoza®-treated patients. Some of these events were reported in patients without known underlying renal disease. A majority of the reported events occurred in patients who had experienced nausea, vomiting, diarrhea, or dehydration. Some of the reported events occurred in patients receiving one or more medications known to affect renal function or hydration status. Altered renal function has been reversed in many of the reported cases with supportive treatment and discontinuation of potentially caus-ative agents, including Victoza®. Use caution when initiating or escalating doses of Victoza® in patients with renal impairment. Hypersensitivity Reactions: There have been postmarketing reports of serious hyper-sensitivity reactions (e.g., anaphylactic reactions and angioedema) in patients treated with Victoza®. If a hypersensitivity reaction occurs, the patient should discontinue Victoza® and other suspect medications and promptly seek medical advice. Angioedema has also been reported with other GLP-1 receptor agonists. Use caution in a patient with a history of angioedema with another GLP-1 receptor agonist because it is unknown whether such patients will be predisposed to angioedema with Victoza®. Macrovascular Outcomes: There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Victoza® or any other antidiabetic drug.ADVERSE REACTIONS: Clinical Trials Experience: Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly com-pared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of Victoza® has been evaluated in 8 clinical trials: A double-blind 52-week monotherapy trial com-pared Victoza® 1.2 mg daily, Victoza® 1.8 mg daily, and glimepiride 8 mg daily; A double-blind 26 week add-on to metformin trial compared Victoza® 0.6 mg once-daily, Victoza® 1.2 mg once-daily, Victoza® 1.8 mg once-daily, placebo, and glimepiride 4 mg once-daily; A double-blind 26 week add-on to glimepiride trial compared Victoza® 0.6 mg daily, Victoza® 1.2 mg once-daily, Victoza® 1.8 mg once-daily, placebo, and rosiglitazone 4 mg once-daily; A 26 week add-on to metformin + glimepiride trial, compared double-blind Victoza® 1.8 mg once-daily, double-blind placebo, and open-label insulin glargine once-daily; A double-blind 26-week add-on to metformin + rosiglitazone trial compared Victoza® 1.2 mg once-daily, Victoza®

1.8 mg once-daily and placebo; An open-label 26-week add-on to metformin and/or sulfonylurea trial compared Victoza® 1.8 mg once-daily and exenatide 10 mcg twice-daily; An open-label 26-week add-on to metformin trial compared Victoza® 1.2 mg once-daily, Victoza® 1.8 mg once-daily, and sitagliptin 100 mg once-daily; An open-label 26-week trial compared insulin detemir as add-on to Victoza® 1.8 mg + met-formin to continued treatment with Victoza® + metformin alone. Withdrawals: The incidence of withdrawal due to adverse events was 7.8% for Victoza®-treated patients and 3.4% for comparator-treated patients in the five double-blind controlled trials of 26 weeks duration or longer. This difference was driven by withdrawals due to gastrointestinal adverse reactions, which occurred in 5.0% of Victoza®-treated patients and 0.5% of comparator-treated patients. In these five trials, the most common adverse reactions leading to withdrawal for Victoza®-treated patients were nausea (2.8% versus 0% for comparator) and vomiting (1.5% versus 0.1% for comparator). Withdrawal due to gastrointestinal adverse events mainly occurred during the first 2-3 months of the trials. Common adverse reactions: Tables 1, 2, 3 and 4 summarize common adverse reactions (hypoglycemia is discussed separately) reported in seven of the eight controlled trials of 26 weeks duration or longer. Most of these adverse reactions were gastrointestinal in nature. In the five double-blind clinical trials of 26 weeks duration or longer, gastrointestinal adverse reactions were reported in 41% of Victoza®-treated patients and were dose-related. Gastrointestinal adverse reactions occurred in 17% of comparator-treated patients. Common adverse reactions that occurred at a higher incidence among Victoza®-treated patients included nausea, vomiting, diarrhea, dyspepsia and constipation. In the five double-blind and three open-label clinical trials of 26 weeks duration or longer, the percentage of patients who reported nausea declined over time. In the five double-blind trials approximately 13% of Victoza®-treated patients and 2% of comparator-treated patients reported nausea during the first 2 weeks of treatment. In the 26-week open-label trial comparing Victoza® to exenatide, both in combination with metformin and/or sulfonylurea, gastrointestinal adverse reactions were reported at a similar incidence in the Victoza® and exenatide treatment groups (Table 3). In the 26-week open-label trial comparing Victoza® 1.2 mg, Victoza® 1.8 mg and sitagliptin 100 mg, all in combination with metformin, gastrointestinal adverse reactions were reported at a higher incidence with Victoza® than sitagliptin (Table 4). In the remaining 26-week trial, all patients received Victoza® 1.8 mg + metformin during a 12-week run-in period. During the run-in period, 167 patients (17% of enrolled total) withdrew from the trial: 76 (46% of withdrawals) of these patients doing so because of gastrointestinal adverse reactions and 15 (9% of withdrawals) doing so due to other adverse events. Only those patients who completed the run-in period with inadequate glycemic control were randomized to 26 weeks of add-on therapy with insulin detemir or continued, unchanged treatment with Victoza® 1.8 mg + metformin. During this randomized 26-week period, diarrhea was the only adverse reaction reported in ≥5% of patients treated with Victoza® 1.8 mg + metformin + insulin detemir (11.7%) and greater than in patients treated with Victoza® 1.8 mg and metformin alone (6.9%).Table 1: Adverse reactions reported in ≥5% of Victoza®-treated patients in a 52-week monotherapy trial

All Victoza® N = 497 Glimepiride N = 248Adverse Reaction (%) (%)Nausea 28.4 8.5Diarrhea 17.1 8.9Vomiting 10.9 3.6Constipation 9.9 4.8Headache 9.1 9.3

Table 2: Adverse reactions reported in ≥5% of Victoza®-treated patients and occurring more frequently with Victoza® compared to placebo: 26-week combination therapy trials

Add-on to Metformin TrialAll Victoza® + Metformin

N = 724Placebo + Metformin

N = 121Glimepiride + Metformin

N = 242Adverse Reaction (%) (%) (%)Nausea 15.2 4.1 3.3Diarrhea 10.9 4.1 3.7Headache 9.0 6.6 9.5Vomiting 6.5 0.8 0.4

Add-on to Glimepiride TrialAll Victoza® +

Glimepiride N = 695Placebo + Glimepiride

N = 114Rosiglitazone +

Glimepiride N = 231Adverse Reaction (%) (%) (%)Nausea 7.5 1.8 2.6Diarrhea 7.2 1.8 2.2


Constipation 5.3 0.9 1.7Dyspepsia 5.2 0.9 2.6

Add-on to Metformin + GlimepirideVictoza® 1.8 + Metformin

+ Glimepiride N = 230Placebo + Metformin + Glimepiride N = 114

Glargine + Metformin + Glimepiride N = 232

Adverse Reaction (%) (%) (%)Nausea 13.9 3.5 1.3Diarrhea 10.0 5.3 1.3Headache 9.6 7.9 5.6Dyspepsia 6.5 0.9 1.7Vomiting 6.5 3.5 0.4

Add-on to Metformin + RosiglitazoneAll Victoza® + Metformin +

Rosiglitazone N = 355Placebo + Metformin + Rosiglitazone

N = 175Adverse Reaction (%) (%)Nausea 34.6 8.6Diarrhea 14.1 6.3Vomiting 12.4 2.9Headache 8.2 4.6Constipation 5.1 1.1

Table 3: Adverse Reactions reported in ≥5% of Victoza®-treated patients in a 26-Week Open-Label Trial versus Exenatide

Victoza® 1.8 mg once daily + metformin and/or sulfonylurea

N = 235

Exenatide 10 mcg twice daily + metformin and/or sulfonylurea

N = 232Adverse Reaction (%) (%)Nausea 25.5 28.0Diarrhea 12.3 12.1Headache 8.9 10.3Dyspepsia 8.9 4.7Vomiting 6.0 9.9Constipation 5.1 2.6

Table 4: Adverse Reactions in ≥5% of Victoza®-treated patients in a 26-Week Open-Label Trial versus Sitagliptin

All Victoza® + metformin N = 439

Sitagliptin 100 mg/day + metformin N = 219

Adverse Reaction (%) (%)Nausea 23.9 4.6Headache 10.3 10.0Diarrhea 9.3 4.6Vomiting 8.7 4.1

Immunogenicity: Consistent with the potentially immunogenic properties of protein and peptide pharma-ceuticals, patients treated with Victoza® may develop anti-liraglutide antibodies. Approximately 50-70% of Victoza®-treated patients in the five double-blind clinical trials of 26 weeks duration or longer were tested for the presence of anti-liraglutide antibodies at the end of treatment. Low titers (concentrations not requiring dilution of serum) of anti-liraglutide antibodies were detected in 8.6% of these Victoza®-treated patients. Sampling was not performed uniformly across all patients in the clinical trials, and this may have resulted in an underestimate of the actual percentage of patients who developed antibodies. Cross-reacting anti-liraglutide antibodies to native glucagon-like peptide-1 (GLP-1) occurred in 6.9% of the Victoza®-treated patients in the double-blind 52-week monotherapy trial and in 4.8% of the Victoza®-treated patients in the double-blind 26-week add-on combination therapy trials. These cross-reacting antibodies were not tested for neutralizing effect against native GLP-1, and thus the potential for clinically significant neutralization of native GLP-1 was not assessed. Antibodies that had a neutralizing effect on liraglutide in an in vitro assay occurred in 2.3% of the Victoza®-treated patients in the double-blind 52-week monotherapy trial and in 1.0% of the Victoza®-treated patients in the double-blind 26-week add-on combination therapy trials. Among Victoza®-treated patients who developed anti-liraglutide antibodies, the most common category of adverse events was that of infections, which occurred among 40% of these patients compared to 36%, 34% and 35% of antibody-negative Victoza®-treated, placebo-treated and active-control-treated patients, respectively. The specific infections which occurred with greater frequency among Victoza®-treated anti-body-positive patients were primarily nonserious upper respiratory tract infections, which occurred among 11% of Victoza®-treated antibody-positive patients; and among 7%, 7% and 5% of antibody-negative Victoza®-treated, placebo-treated and active-control-treated patients, respectively. Among Victoza®-treated antibody-negative patients, the most common category of adverse events was that of gastrointestinal events, which occurred in 43%, 18% and 19% of antibody-negative Victoza®-treated, placebo-treated and active-control-treated patients, respectively. Antibody formation was not associated with reduced efficacy of Victoza® when comparing mean HbA1c of all antibody-positive and all antibody-negative patients. However, the 3 patients with the highest titers of anti-liraglutide antibodies had no reduction in HbA1c with Victoza®

treatment. In the five double-blind clinical trials of Victoza®, events from a composite of adverse events potentially related to immunogenicity (e.g. urticaria, angioedema) occurred among 0.8% of Victoza®-treated patients and among 0.4% of comparator-treated patients. Urticaria accounted for approximately one-half of the events in this composite for Victoza®-treated patients. Patients who developed anti-liraglutide antibodies were not more likely to develop events from the immunogenicity events composite than were patients who did not develop anti-liraglutide antibodies. Injection site reactions: Injection site reactions (e.g., injection site rash, erythema) were reported in approximately 2% of Victoza®-treated patients in the five double-blind clinical trials of at least 26 weeks duration. Less than 0.2% of Victoza®-treated patients discontinued due to injection site reactions. Papillary thyroid carcinoma: In clinical trials of Victoza®, there were 7 reported cases of papillary thyroid carcinoma in patients treated with Victoza® and 1 case in a comparator-treated patient (1.5 vs. 0.5 cases per 1000 patient-years). Most of these papillary thyroid carcinomas were <1 cm in greatest diameter and were diagnosed in surgical pathology specimens after thyroidectomy prompted by findings on protocol-specified screening with serum calcitonin or thyroid ultrasound. Hypoglycemia: In the eight clinical trials of at least 26 weeks duration, hypoglycemia requiring the assistance of another person for treatment occurred in 11 Victoza®-treated patients (2.3 cases per 1000 patient-years) and in two exenatide-treated patients. Of these 11 Victoza®-treated patients, six patients were concomitantly using metformin and a sulfonylurea, one was concomitantly using a sulfonylurea, two were concomitantly using metformin (blood glucose values were 65 and 94 mg/dL) and two were using Victoza® as monotherapy (one of these patients was undergoing an intravenous glucose tolerance test and the other was receiving insulin as treat-ment during a hospital stay). For these two patients on Victoza® monotherapy, the insulin treatment was the likely explanation for the hypoglycemia. In the 26-week open-label trial comparing Victoza® to sitagliptin,

the incidence of hypoglycemic events defined as symptoms accompanied by a fingerstick glucose <56 mg/dL was comparable among the treatment groups (approximately 5%).Table 5: Incidence (%) and Rate (episodes/patient year) of Hypoglycemia in the 52-Week Monotherapy Trial and in the 26-Week Combination Therapy Trials

Victoza® Treatment Active Comparator Placebo ComparatorMonotherapy Victoza® (N = 497) Glimepiride (N = 248) NonePatient not able to self−treat

0 0 —

Patient able to self−treat 9.7 (0.24) 25.0 (1.66) —Not classified 1.2 (0.03) 2.4 (0.04) —Add-on to Metformin Victoza® + Metformin

(N = 724)Glimepiride +

Metformin (N = 242)

Placebo + Metformin (N = 121)

Patient not able to self−treat

0.1 (0.001) 0 0

Patient able to self−treat 3.6 (0.05) 22.3 (0.87) 2.5 (0.06)Add-on to Victoza® +Metformin

Insulin detemir + Victoza® + Metformin

(N = 163)

Continued Victoza®

+ Metformin alone (N = 158*)

None


0 0 —

Patient able to self−treat 9.2 (0.29) 1.3 (0.03) —Add-on to Glimepiride

Victoza® + Glimepiride (N = 695)

Rosiglitazone + Glimepiride (N = 231)

Placebo + Glimepiride (N = 114)


0.1 (0.003) 0 0

Patient able to self−treat 7.5 (0.38) 4.3 (0.12) 2.6 (0.17)Not classified 0.9 (0.05) 0.9 (0.02) 0Add-on to Metformin + Rosiglitazone

Victoza® + Metformin + Rosiglitazone

(N = 355)

None

Placebo + Metformin + Rosiglitazone

(N = 175)Patient not able to self−treat

0 — 0

Patient able to self−treat 7.9 (0.49) — 4.6 (0.15)Not classified 0.6 (0.01) — 1.1 (0.03)Add-on to Metformin + Glimepiride

Victoza® + Metformin + Glimepiride

(N = 230)

Insulin glargine + Metformin +

Glimepiride (N = 232)

Placebo + Metformin + Glimepiride

(N = 114)Patient not able to self−treat

2.2 (0.06) 0 0

Patient able to self−treat 27.4 (1.16) 28.9 (1.29) 16.7 (0.95)Not classified 0 1.7 (0.04) 0

*One patient is an outlier and was excluded due to 25 hypoglycemic episodes that the patient was able to self-treat. This patient had a history of frequent hypoglycemia prior to the study.In a pooled analysis of clinical trials, the incidence rate (per 1,000 patient-years) for malignant neoplasms (based on investigator-reported events, medical history, pathology reports, and surgical reports from both blinded and open-label study periods) was 10.9 for Victoza®, 6.3 for placebo, and 7.2 for active comparator. After excluding papillary thyroid carcinoma events [see Adverse Reactions], no particular cancer cell type predominated. Seven malignant neoplasm events were reported beyond 1 year of exposure to study medica-tion, six events among Victoza®-treated patients (4 colon, 1 prostate and 1 nasopharyngeal), no events with placebo and one event with active comparator (colon). Causality has not been established. Laboratory Tests: In the five clinical trials of at least 26 weeks duration, mildly elevated serum bilirubin concentrations (elevations to no more than twice the upper limit of the reference range) occurred in 4.0% of Victoza®-treated patients, 2.1% of placebo-treated patients and 3.5% of active-comparator-treated patients. This finding was not accompanied by abnormalities in other liver tests. The significance of this isolated finding is unknown. Vital signs: Victoza® did not have adverse effects on blood pressure. Mean increases from baseline in heart rate of 2 to 3 beats per minute have been observed with Victoza® compared to placebo. The long-term clinical effects of the increase in pulse rate have not been established. Post-Marketing Experience: The following additional adverse reactions have been reported during post-approval use of Victoza®. Because these events are reported voluntarily from a population of uncertain size, it is gener-ally not possible to reliably estimate their frequency or establish a causal relationship to drug exposure: Dehydration resulting from nausea, vomiting and diarrhea; Increased serum creatinine, acute renal failure or worsening of chronic renal failure, sometimes requiring hemodialysis; Angioedema and anaphylactic reactions; Allergic reactions: rash and pruritus; Acute pancreatitis, hemorrhagic and necrotizing pancreatitis sometimes resulting in death.OVERDOSAGE: Overdoses have been reported in clinical trials and post-marketing use of Victoza®. Effects have included severe nausea and severe vomiting. In the event of overdosage, appropriate supportive treat-ment should be initiated according to the patient’s clinical signs and symptoms.More detailed information is available upon request. For information about Victoza® contact: Novo Nordisk Inc., 800 Scudders Mill Road, Plainsboro, NJ 08536, 1−877-484-2869Date of Issue: April 16, 2013 Version: 6Manufactured by: Novo Nordisk A/S, DK-2880 Bagsvaerd, DenmarkVictoza® is covered by US Patent Nos. 6,268,343, 6,458,924, 7,235,627, 8,114,833 and other patents pending. Victoza® Pen is covered by US Patent Nos. 6,004,297, RE 43,834, RE 41,956 and other patents pending.© 2010-2013 Novo Nordisk 0513-00015681-1 5/2013


R E S E A R C H

According to the Centersfor Disease Control andPrevention, more than

one-third of Americans are nowconsidered obese. Efforts to pre-vent obesity involve changingthe individual behaviors thatcontribute to obesity, mainlyhealthful eating and physicalactivity as well as the social andphysical context in which thosebehaviors take place. Due totheir existing networks andavailable resources, worksitesare a logical place to help indi-viduals make healthy choicesthrough health promotionefforts.

To address high rates of obe-sity among the working-age pop-ulation, employers are engagingin worksite interventions. In thepast 10 years, the number ofemployers offering wellness ben-efits has increased significantly.According to a 2010 survey bythe Kaiser Family Foundationand the Health Research andEducational Trust, 92 percent ofemployers with 200 or moreemployees reported offeringwellness programs. Within theseprograms, the most frequently

targeted behaviors are physicalactivity (addressed by 63 percentof employers with programs),smoking (60 percent), andweight loss (53 percent).

Employer-based wellnessprograms will likely increase asa result of the Affordable CareAct (ACA). Under the ACA’s pro-visions, employers may awardemployees up to 20 percent oftheir cost of health plan cover-age for participating in wellnessprograms that require meetinghealth-related standards. Theaward increases to 30 percentin 2014.

The purpose of our project(named the “Go!” program) wasto partner with a communityhospital to plan, implement, andevaluate a multi-component obe-sity prevention program in its

workplace. Approximately60 percent of employees at thishospital were obese or over-weight; this rate is not surpris-ing, given the high degree ofstress and time constraintshealth care professionals face.

The prevention programtargeted individual and interper-sonal determinants of eatingbehavior and physical activity, aswell as the social and physicalcontext in which these behaviorstake place. It was hypothesizedthat simultaneously offeringindividual tools, providing infor-mation and persuasive messag-ing, and changing the socialenvironment would lead tohealthier eating, increased phys-ical activity, and reduced riskfor obesity.

The interventions includedfive integrated components:

• Nutrition labeling in theworksite cafeteria

• Physical changes to cafete-ria environment

• Distributing pedometers toemployees

• Persuasive messagingthroughout employee com-mon areas

• Using peer helpers toaddress social normsaround eating and physicalactivity behaviors

Methods

Interventions. Nutrition labelingin the worksite cafeteria consis-ted of creating traffic light labels(green = go, eat frequently; yel-low = caution, eat in moderateportions; red = stop, eat in smallportions) on all foods and bever-ages based on caloric density(calories per gram of food) (seeFig. 1). Total calories and num-ber of steps required to burnthose calories were included onthe color-coded label. The labelswere placed prominently at thepoint of selection.

Environmental changes in

the cafeteria included rearrang-ing the physical layout of thecafeteria (e.g., bakery casemoved from central location andreplaced with a healthy “grab-and-go” case), changing thespoon size for self-serve items,and offering half-portions forhalf-price.

To complement the foodlabeling intervention (i.e., thestep counts on the labels), wedistributed pedometers toemployees who participated inthe study (i.e., those who com-pleted the baseline survey andmeasurement). Research sug-gests that worksite walking pro-grams using pedometers haveproduced increases in moderateintensity physical activity levels,improved attitudes toward phys-ical activity, and increased moti-vation. A stairwell interventionand campus walking routes weredeveloped to encourage employ-ees to increase their physicalactivity.

Health communication mes-sages in the cafeteria and work-site areas were used to changeemployee perceptions of the riskposed by obesity, their attitudestoward eating healthfully andexercising, and their self-efficacyto engage in those recommen-ded behaviors. Posters, tabletoppers, and pamphlets featuredpersuasive messages abouthealthful eating and physicalactivity. A website was developedthat provided relevant informa-tion to improve healthful behav-iors (e.g., ideas on how to eatmore nutritious meals, caloriecounts, recipes, walking routes,gym locations, BMI calculators,and walking journals).

Another innovative featureof the Go! intervention wasusing social networks to influ-ence behaviors around healthyeating and physical activity. Weidentified employees who wereconsidered by their peers to berespected, socially connected,and influential. These peerhelpers were members of thesocial network to whom othermembers naturally turned to foradvice and support. They weretrained on how to engage col-leagues about healthful eatingand physical activity, as well ashow to change the work environ-

The Go! studyA multi-component approach to

improving worksite health

By Lara LaCaille, PhD, Jennifer Schultz, PhD,and Ryan Goei, PhD


ment to promote healthfulbehaviors (e.g., promotinghealthy snacks in break rooms).

Study design and participa-tion. A quasi-experimentaldesign was used to examine theeffectiveness of the Go! interven-tion over a 12-month period.The intervention group consistedof on-campus hospital employ-ees, whereas the comparisongroup consisted of the employ-ees who worked at off-campussatellite clinics.

A survey was distributed atbaseline and at six months and12 months post-baseline. Vari-ables of interest included thekey constructs of knowledge,attitude, social norms, self-efficacy, and perceptions of risk,as well as self-reported healthbehaviors. In addition, demo-graphics, readiness to change,and perceived barriers to chang-ing health behaviors werecollected. Employees whoagreed to participate completedanthropometric measurement(BMI, waist circumference) atbaseline, six months, and 12months. In addition, we collect-

ed data on food purchasingfrom the worksite cafeteria. Thecomparison group also complet-ed the surveys and the anthro-pometric measurements.

A total of 407 hospitalemployees in the interventiongroup and 92 clinic employeesin the comparison group wereassessed during the course ofthe study (22 percent and 59 per-cent response rate, respectively).Of these, 278 hospital employeesand 74 clinic employees com-pleted the 12-month assessment.Fifty-one peer helpers were alsoengaged in the intervention.

Results

Of employees completing the base-line and final assessments (hospi-tal n = 278; clinic n = 74), themajority were white (91.2 per-cent), female (85.3 percent), andmarried (66.5 percent). Mean agewas 43.3 + 11.5 years with a BMIof 28.1 + 6.2 (64.7 percent over-weight/obese). The most frequentoccupations represented in thesample were nursing (33.3 per-cent), service (21.0 percent), andclerical (16.3 percent).

Most hospital employees(86.8 percent) reported that theinterventions in the Go! programshould be continued by the hos-pital, with slightly fewer (73.4percent) indicating it had had an

impact on changing their behav-iors. Overall, approximately 85percent of hospital employeesreported that the traffic lightlabels were useful, with 25.2 per-

Figure 1. Traffic lights poster at a drink vendingmachine in the Surgery Department

The Go! study to page 32

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P R O F E S S I O N A L U P D A T E : F O R E N S I C P A T H O L O G Y

“CSI,” “CrossingJordan,” “Autopsy,”“Body of Proof,”

“Cold Case Files,” “Rizzoli &Isles,” “NCIS,” “Dr. G: MedicalExaminer”—it seems that everyother show on television thesedays features a forensic patholo-gist, and it’s usually a young andglamorous woman. But what isthe reality of the life of a foren-sic pathologist?

• Opening the trunk of a carin an abandoned parkinglot to find the body of ayoung woman who hasbeen shot in the back.

• Watching a young fatherlovingly place his deadbaby in the medicolegaldeath investigator’s car fortransport to the medicalexaminer’s office, after hefell asleep and probablyrolled over on her duringthe night.

• Explaining to a motherthat her teenage son hadfinally taken his life afternumerous previousattempts, despite her hero-ic efforts to save him.

• Learning again and again

that the human capacity for cru-elty is almost overwhelming, butnever greater than the humancapacity for kindness.

As forensic pathologists, wesee people at the worst time oftheir lives, when a loved one hasdied suddenly and unexpectedly,and are privileged to help themand be helped by them.

Emergence of a subspecialty

Forensic pathology is a relativelynew field of medicine. It was notuntil 1959 that the AmericanBoard of Pathology recognizedforensics as a subspecialty ofpathology and began a certifica-tion process. Since that time,slightly fewer than 1,500 peoplehave become board-certified,making it one of the smallestspecialties in medicine. Eachyear only 35–40 physicians get

trained in forensic pathology,compared to about 15,000 whogo into internal medicine. Herein Minnesota there are 19 board-certified forensic pathologists,most of whom work in medicalexaminer offices.

The history of death investi-gation is no doubt as old ashuman civilization, but the sys-tem we use in the United Statesbegan in England in 1194, whenthe Articles of Eyre establishedthe office of coroner (from theLatin custos placitorum coronaefor Keepers of the Pleas of theCrown). Initially more of afinancial office, over time thecoroner’s role evolved into thatof death investigation. Englishsettlers brought the office ofCoroner with them to the newworld. In the 1800s, in bothEngland and parts of the UnitedStates, there was recognition ofthe need for a more medicalapproach to death investigation;this led to the birth of medicalexaminers.

Historically, a coroner hasbeen an elected official who mayor may not have any particulartraining in medicolegal deathinvestigation, whereas a medicalexaminer is generally under-stood to be a forensic patholo-gist who is appointed by thecounty board or other governingbody. In Minnesota we haveboth coroners, who are physi-cians, and medical examiners,who are board-certified forensicpathologist physicians.

The nuts and bolts of forensicpathology

While it is different from what ispresented on television, thework of a forensic pathologist isvery rewarding. We get to helpfamilies find answers to explainwhy their loved one died sud-denly and unexpectedly. We getto help the public health systemto identify infectious diseasesand other preventable causes of

death. We get to help the justicesystem to appropriately deter-mine which deaths occurred atthe hands of another person andto testify and explain to jurieshow those deaths happened. Weget to help the public safety sys-tem by providing data that canbe used to improve the safety ofvehicles and roads. And we getto help the public by facilitatingorgan and tissue donation,determining which deaths havea genetic cause, recognizingunsafe consumer products andreporting them, detecting trendsin deaths due to drug abuse, andin myriad other ways.

Some of the challenges ofworking as a forensic pathologistare attributable to the very publicnature of our work. In high-pro-file cases, there is a great deal ofpressure to provide answersimmediately. In reality, laboratoryand other tests take longer than isoften portrayed in the media, andthis can cause frustration for allinvolved. In addition, data prac-tices laws limit what informationmedical examiners can disclose,and this also can add to the diffi-culty of providing appropriateinformation to the public.Another stressor for forensicpathologists is the element of tes-tifying in court. It often seemsthat the goal of the “other side” isto make a witness appear foolish,and such courtroom confronta-tions can take their toll. Finally,forensic pathologists’ almost dailyexposure to violence and tragedyrequires special coping skills.

A common misconception isthat the medical examiner ispart of the law enforcementprosecution team. While medicalexaminers work collaborativelywith those agencies, it is impor-tant that medical examinersremain independent to ensurethat the public has trust in thedeterminations made. TheInnocence Project has foundthat improper forensic sciencehas been the cause of manywrongful convictions and it isimportant that forensic patholo-gists work to prevent such mis-carriages of justice. There havebeen cases in which a forensicpathologist erroneously classi-fied a death as a homicide, lead-ing to the prosecution of an

CSI MinnesotaA subspecialty that requires sharp knives,

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innocent person. In other situa-tions a forensic pathologist hasmade statements that are notscientifically supportable, con-cerning the nature of theinjuries sustained by a decedent.It is crucial for forensic patholo-gists to remember that their roleis not to create a story to assistany particular “side,” but rathersimply to document the findingsand determine whether or not

they are consistent with the his-tory that is given.

Forensic pathologists alsohave a role in human rightsinvestigations. In the late 1980s,the group now known as TheAdvocates for Human Rightsbegan working with experts,including two forensic patholo-gists in Minneapolis, to produce“The Manual on the EffectivePrevention and Investigation of

Extra-Legal, Arbitrary andSummary Executions.” Themanual was published by theUnited Nations in 1991 and tothis day remains a valuable doc-ument internationally for inves-tigating suspicious deaths.

Advances in the field

Much about forensic pathologyhas not changed since 1959—westill need sharp minds and sharp

knives. Butthere havebeen someimportantdevelop-ments inmedicolegaldeath inves-tigation,

such as the use of DNA. DNAwas first used forensically inEngland in 1987, when a suspectwith the improbable name ofMr. Pitchfork was arrested forthe murder of two girls after hisDNA was matched to samplescollected from the victims.

In 1991, a 23-year-oldwoman was murdered in herapartment in Minneapolis. Theforensic pathologist who per-

formed her autopsy collectedspecimens for potential DNAtesting, although at that point ithad never been used in a homi-cide case in Minnesota. TheDNA found on her body wasmatched by a “cold hit” to DNAthat had been taken from a con-victed sex offender before he leftprison earlier in 1991. (A “coldhit” is when a DNA profileobtained from a victim or sceneis matched to a DNA profile in aDNA database, rather than oneobtained directly from a sus-pect.) Previously, he had notbeen connected in any way toher death. If the forensic pathol-ogist had not collected thatspecimen, he probably wouldnever have been charged withher murder. Who knows howmany other young women hemight have killed had he notbeen stopped? This was the firsttime in the U.S. that DNA hadbeen used in this way—allbeginning with the astute foren-sic pathologist!

Another advance in forensicpathology is the use of post-mortem medical imaging, suchas 3-D computed tomography

(CT) scans or magnetic reso-nance imaging (MRI). This issometimes referred to as “virtualautopsy.” While these high-techimages provide many advan-tages as an adjunct to autopsies,they will never replace a com-plete hands-on autopsy. And,unfortunately, due to the highcosts of the instruments, veryfew medical examiner offices inthe U.S. have ready access tosuch imaging techniques. This isan area of interest and researchfor the future.

While not all forensic patho-logists wear high heels and low-cut blouses, almost all of ushave a real passion for our work,just like our TV counterparts.We believe that what we aredoing matters, which at the endof the day is what everyonewants—to feel our precious timeis being spent on something ofvalue and that we are making adifference in the world.

Lindsey C. Thomas, MD, is a board-certified forensic pathologist and an assis-tant medical examiner in the HennepinCounty Medical Examiner’s Office, servingHennepin, Dakota, and Scott counties.

Some of the challenges of workingas a forensic pathologist are

attributable to the very publicnature of our work.

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S P E C I A L F O C U S : H E A L T H R E F O R M

Some of the highest profileelements of the AffordableCare Act (ACA) are sched-

uled to take effect between thisfall and 2015. These include newnotice and health insurance cov-erage-offering requirements foremployers; the requirement thatnearly everyone obtain healthinsurance; and the end to preex-isting condition limitations foreveryone. In addition, states willbegin to operate health insur-ance exchanges (the federal gov-ernment will run exchanges innon-participating states) andwill receive funding to expandMedicaid.Minnesota’s physicians are

likely aware of these changes.However, they may be less confi-dent about their knowledge ofhow the ACA will affect their rolesas employers and employees. Thisarticle focuses on a few ACA com-ponents that employers mustaddress in 2014. Each of thesearises from the basic requirementthat employers with 50 or morefull-time workers must either pro-vide insurance coverage to full-time employees or pay a penaltyfor not offering coverage.

Prepare for play-or-play

One of the ACA’s central require-ments—sometimes called “play-or-pay”—requires that employerswith 50 or more full-time (30hours per week) employees, orfull-time equivalents, must pay apenalty if they do not offergroup health coverage to full-time employees and theirdependents. The statute consid-ers children, but not spouses, tobe dependents.Play-or-pay was supposed to

start in 2014; however, on July 2 ofthis year, the federal governmentannounced a one-year delay. Thedelay gives the government moretime to implement reportingrequirements and gives employersmore time to determine whichemployees must be offered bene-fits and how best to satisfy report-

ing requirements.In 2015, employers who fail

to offer qualifying coverage mustpay a penalty if an employeereceives subsidized coveragefrom the exchange (now calledthe “Health InsuranceMarketplace”). Individualswhose incomes are between

100 and 400 percent of the fed--eral poverty guidelines are eligi-ble for subsidies. In participat-ing states like Minnesota, indi-viduals with income below138 percent of the poverty guide-line are eligible for Medicaidrather than a subsidy. Accord-ingly, very low-income and rela-tively high-income individualsare not subsidy-eligible, andemployers will not pay a penaltyif these employees obtain cover-age subsidies from theMarketplace.The penalty amount de-

pends on whether the employerfails to offer coverage orwhether it offers coverage that isnot ACA compliant. Employersfailing to offer coverage will paya penalty based on the employ-er’s total number of employees(even if only one employeeobtains a subsidy). Employersoffering non-compliant coveragewill pay a penalty based on thenumber of employees actuallyreceiving subsidies. In additionto the size of the penalty, whendetermining whether to providecoverage, employers shouldremember that they cannot takea tax deduction for the penalty,but they can continue to take atax deduction for the cost of

providing coverage.Employers should continue

to develop systems to determinewhich employees must beoffered coverage. Part-time,variable-hour, and seasonalemployees will pose challengesin making this determination.An IRS-approved “look-back”method allows employers timeto determine whether employeeswork full time before beingrequired to offer coverage.Hours worked in 2013–2014must be tracked to determinewho is eligible in 2015. Thismay require employers to beginto measure employees’ hoursimmediately. Employers should

also monitor guidance from thefederal departments of Laborand Treasury.

Notify employees of theHealth Insurance Marketplace

The “exchange notice” require-ment requires action now. InOctober 2013, the state or fed-eral government will open aHealth Insurance Marketplacein each state. In Minnesota, thestate will operate its MNsurehealth insurance exchange. Atleast three months prior tooperation—meaning by Oct. 1,2013—employers must notifyemployees of their option toobtain coverage through theMarketplace.Many small employers that

need not offer insurance cover-age still must distribute thenotice, as all employers that aresubject to the Fair LaborStandards Act (which generallyincludes all employers withannual revenues over $500,000)must send the notice. Moreover,the ACA generally requiresemployers to provide coveragefor full-time employees only.Nevertheless, employers mustnotify all current employees oftheir option to obtain coveragethrough the Marketplace. After

ACA updateProviders are subject to employer

requirements, too

By Kathi Wright, JD, Wade Hauser, and Monica Kelley, JD

Provider organizations need to beassessing ACA compliance from manydifferent perspectives, based on thevarious roles the organization plays.


providing the initial notice thisOctober, employers need to pro-vide the notice to all newemployees within two weeks oftheir start date.In addition to explaining the

existence of the Marketplaceand the services it provides, thenotice must tell employeeswhether the employer offerscoverage, and must indicatewhether the employer’s coveragemeets the ACA’s minimum valueand affordability requirements.The notice must further informemployees that if their employ-er’s plan does not meet the ACA’srequirements, the employeesmay be eligible for subsidizedcoverage through the Market-place, but if they receive cover-age through the Marketplace,they may lose any contributiontheir employer would havemade to their cost of obtaininghealth insurance. Finally, thenotice must inform employeesthat they can exclude the valueof employer contributions totheir health insurance premi-ums from their taxable income.The Department of Labor

(DOL) has created model noticesto help employers comply withthese requirements and toensure that the notice helpsemployees assess their options.• The model notice foremployers offering cover-age may be viewed atwww.dol.gov/ebsa/pdf/FLSAwithplans.pdf.• The model notice foremployers that do notoffer coverage may beviewed atwww.dol.gov/ebsa/pdf/FLSAwithoutplans.pdf.In sum, employers must

take several steps to comply withthe notice requirement:• First, employers mustdetermine which employ-ees are eligible for cover-age.• Second, employers shouldconsult their insuranceproviders or third-partyadministrators to deter-mine whether their cover-age meets the ACA’s mini-mum-value requirements.• Third, employers shoulddetermine the cost of apremium for employee-

only coverage (meaning itdoes not include depend-ents); this will allowemployers to assesswhether their coveragemeets the ACA’s affordabil-

ity requirements.• Fourth, employers shouldcompose the notice (or usethe DOL model) and sendit to employees.

Keep careful records for thecoming reporting requirement

The ACA requires employers toprovide full-time employees, andthe IRS, with certain informa-tion regarding insurance cover-age provided during the previousyear. Given the one-year delay,employers do not need to pro-vide this information until Jan.31, 2016. This delay will allowthe Treasury Department toissue detailed guidance aboutthe look-back requirement.While more guidance will be

welcome, it is clear that employ-ers must maintain carefulrecords of the group health cov-erage they provide in 2015 andin future years. Employers willhave to provide information tothe IRS regarding whether theyoffered their full-time employeescoverage that complies with theACA’s minimum value andaffordability requirements. TheIRS report must specify thelength of the waiting periodbefore employees can obtaincoverage, the monthly premiumfor the lowest-cost option ineach of the plan’s enrollmentcategories, and the proportionthat the employer pays of thetotal benefits the plan provides.In addition, the report mustdetail how many full-timeemployees the employer hadduring each month of the previ-ous year and each full-timeemployee’s name, address, andtax identification number.Finally, the report must specify

the months in which eachemployee received coverage thatcomplies with the ACA.Employers must provide

employees with similar informa-tion. The report to employees

must detail the employer’s con-tact information and the infor-mation that the employer pro-vided to the IRS about theemployer’s coverage. Treasuryguidance is expected before theend of 2013, but even before itcomes, employers can make surethey have systems in place totrack the information needed toproduce the reports.

Consider how the Marketplacemay reduce COBRA’s bite

The ACA did not make anydirect changes to COBRA con-tinuation health coverage, but

the statutes may interact in sur-prising ways. In general, COBRAprovides that a person enrolledin a group health plan on theday of a qualifying event (suchas a termination of employmentor a disqualifying reduction inhours) can purchase continuingcoverage from the plan for a cer-tain period, typically 18 months.The cost of continuation cover-age will very likely be higherthan when he or she wasenrolled in the plan becausemost employers do not con-tribute to the cost of COBRAcoverage. Thus, the people mostlikely to take COBRA are alsothose who are most likely tohave expensive health careneeds; this is the problem of“adverse selection.”After 2014, qualifying indi-

viduals may be less likely toelect COBRA. This is becausethe DOL recently clarified thateligibility for COBRA does nothinder potential enrollees’ abilityto obtain coverage from theMarketplace. If the potentialenrollee is eligible for a subsidy,

By Oct. 1, 2013, employers mustnotify employees of their option to

obtain coverage through theHealth Insurance Marketplace.

ACA update to page 36

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S P E C I A L F O C U S : H E A L T H R E F O R M

Health care reform isalready happening,more is on its way—

and not all of it is mandatedby law. In fact, we have beenreforming health care in thiscommunity for decades andlead the country in areas ofpublic health achievements,accountable care, publicreporting, and high rates ofprivate and public insurancecoverage. Still, health carecosts too much. On the currenttrajectory, by 2021 the averagefamily in the U.S. could spend$41,868 on health care.

What, then, does theAffordable Care Act (ACA)mean for the future of healthcare in Minnesota?

Some of the most sweep-ing changes in the AffordableCare Act are set to take effectJan. 1, 2014. Most changesdeal with insurance reform:increasing the number of peo-ple with coverage by expand-ing state publicprograms (Medicaid andMinnesotaCare) and offeringsubsidies for individuals whopurchase coverage for them-

selves and their families.Minnesota will begin oper-

ating its own health insuranceexchange marketplace,MNsure, on Oct. 1, 2013.There, those who qualify asan individual or as a smallemployer group can enroll instate public programs andaccess subsidies. In addition,Minnesota will expand itsMedical Assistance program(Medicaid) to cover individualsand families up to 133 percentof the federal poverty level($15,000 for individuals,$31,000 for a family of four).

The newly insured

An estimated additional250,000 people will enter theinsurance market as a result ofthe requirement that allAmericans carry a standard

level of medical insurance(“the individual mandate”).Coupled with this mandate isthe provision known as “guar-anteed issue,” under whichanyone who applies for healthinsurance will be eligible forcoverage, regardless of healthcondition. The vast majority ofthese new entrants intoMinnesota’s insurance marketwill likely qualify for a tax sub-sidy or be eligible under theMedicaid expansion. This isgood news for low-income citi-zens previously unable to qual-ify or afford care, as well asfor the safety net pro-vidersthat underwrite uncompensat-ed care.

With 91 percent ofMinnesotans already coveredby health insurance, the statehas an important opportunityto engage people who qualifyfor government programs butare not enrolled. They accountfor 60 percent of Minnesota’suninsured population. Reach-ing these individuals andenrolling them will be key toour state’s success in attainingnearly universal coverage.

The currently insured

How will the law affect con-sumers who get their healthcoverage through theiremployer or who buy it ontheir own?

Seniors on Medicare andthose who obtain insurancethrough a large employergroup will notice few changesin 2014. There are some addi-tional benefits for Medicare,such as a preventive care visitand additional prescriptiondrug coverage in Part D. How-ever, many of those provisionsare included in seniorMedicare health plans already.

People in mid-sizedemployer groups and in fully

insured employer groups willsee some new benefits addedas a result of the new federallyrequired benefit set (referredto as essential health benefits).The benefits consist of a pack-age of services such as hospi-talization and clinic care,maternity and newborn care,and prevention and wellnessservices.

Individuals, families, andsmall businesses purchasingtheir own coverage will likelyexperience the most change.Today, the most popular prod-ucts sold in Minnesota forindividuals, families, and smallgroups are those that havehigher deductibles, benefitflexibility, and lower monthlypremiums. The ACA’s newbenefits requirements and newtaxes and assessments willhave the most impact on thoseplan designs and their underly-ing premium structure. Sub-sidies will offset some of thecost of the additional benefits,and individual circumstanceswill vary.

The good news is that indi-viduals will have many choices

What’s ahead inhealth reform?

Implications of ongoing changesin health care

By Donna Zimmerman

The future challenge of the ACA will be tomove the largest payers, Medicare andMedicaid, into the type of value-basedmodel we’ve pioneered in Minnesota.


of plans, both inside and out-side of the health insuranceexchange. Those not accessingsubsidies will have the optionto purchase just as they dotoday from their carrier,online, or through a broker.

The law also creates anobligation for employers withmore than 50 full-time-equiva-lent employees to provideaffordable insurance, or facea penalty if their employeesaccess subsidized insurance inthe exchanges. Implementationof this provision has beendelayed until January 2015.

Next up: payment reforms

While the ACA is currentlyfocused on covering more peo-ple, reforms to date have notfundamentally addressed theunderlying costs of healthcare. The ACA has createdsome new mechanisms, suchas accountable care organiza-tions, to introduce value-basedpayment (i.e., for qualityrather than quantity of care)for physicians and hospitals inMedicare. These measures aredesigned to drive more quality,value, and accountability inthe traditional Medicare pro-gram, implementing modelsthat have emerged in healthplans, hospitals, and clinics.

In Minnesota, through thework of organizations suchas the Institute for ClinicalSystems Improvement andMinnesota CommunityMeasurement, and through theinnovations of health plans,

clinics, and hospitals, we werelaying the groundwork forACA implementation longbefore the law was conceived.Expanding these models willdo more than the ACA alone tobring down costs and improvethe patient’s experience and

the quality of their care.One of these innovations,

developed by HealthPartners,is a unique total cost of caremeasurement tool thatincludes total resources usedin the course of providing carein addition to the costs ofmedical services. As we moveinto ACA implementation, thisdistinctive analysis is likely tobe broadly adopted, as it morefully reflects the consumptionof dollars, manpower, andresources and, thus, betterillustrates where costs can becontained. HealthPartners andother organizations providethis information to health careproviders to demonstrate areasof opportunity for improve-ment. This metric earned thefirst-ever endorsement by theNational Quality Forum for acost measurement approach.The tool is available free ofcharge to organizationsaround the country and is cur-rently being used in 23 statesby 65 different organizations.

Most health care pro-viders in Minnesota are wellequipped to perform undernew accountable models ofcare, with the evolution of the“health care home,” a reformchampioned by the MinnesotaLegislature in 2008, andpatient-centered care. Theseearlier reforms lay the founda-tion for the more comprehen-sive work underway today. Forexample, at HealthPartners,75 percent of our medicalreimbursements to health care

professionals now occur on anon-fee-for-service basis.

The future challenge of theACA will be to move thelargest payers, Medicare andMedicaid, into the type ofvalue-based model we’ve pio-neered in Minnesota—a power-

ful catalyst to move furtheraway from fee-for-service pay-ments. We have already seenthe significant benefits forpatients in decreasing prevent-able hospital admissions/read-missions, and gains in chronicdisease management, such asoptimal diabetes care.

A continued evolution

Creating healthy communitiesmay be the most importantlong-term strategy in address-ing our health care costs intothe future. Real reform meansforging stronger partnershipswith our patients and with thecommunities we serve toimprove health and make caremore accessible with the goalof avoiding, rather than simplymanaging, costly chronic dis-ease.

Prevention and wellnessare the best-cost medicine ofall. They are also least avail-able to the underserved popu-lations that most need us to dowhat the ACA does not:improve the affordability ofthe system by rethinking howwe deliver care. Since only 20

percent of our health out-comes are related to clinicalcare—with health behaviors,the socioeconomic environ-ment, and the physical envi-ronment, accounting for therest—we will need to work inpartnership with community-based organizations, govern-ment, and our patients andhealth plan members to havean impact on these variables.

We know for certain thatthe proven methods of provid-ing better care, improving thepatient experience, and reduc-ing costs will continue to beimportant in the new ACAworld. We also know that wecannot continue on the paththat leads to annual costs of$41,868 per family for healthcare and coverage. We can allagree that this is what compelsus to further action in healthreform.

Donna Zimmerman is senior vice presi-dent for government and communityrelations at HealthPartners.

At HealthPartners, 75 percent of ourmedical reimbursements to health care

professionals now occur on anon-fee-for-service basis.

Connecting your business to your market

Connecting your business to your market

By Robert Sweet, MD“I have prostate cancer

… and I want a robotic

prostatectomy ” This is

a common presenting“chief complaint” heard

nowadays in urologists’

offices across the state

and across the country

If you perform robotic prostatectomy, it

can be a plus in marketing your practice

If you don’t, you either try to convince your

patient that robotic prostatectomy isn’t all

it’s cracked up to be, or you refer him to

someone who does itTo date, removing the prostate with the

aid of a robot is the most common current

application of robotic surgery Approx-

imately 90,000 radical prostatectomies

are done annually in the United

and, according to Int i

of Sunnyvalma

figure, given the rela-tively recent adoption

of the robot for use in

clinical applicationsThe rapid growth in

this field promisesto permanently alter

the way surgical proce-

dures—especially mini-

mally invasive surgeries—are performed

and taughtThe current state-of-the-art

The da Vinci robot and its

progeny, the da Vinci S HD

surgical system, were r l

in 1999 and 200Esse

Volume XXI, No.7October 2007


B edside manner may be

viewed as a “soft” skill these

days, and advances in medi-

cine continue to heighten the

emphasis on clinical and technical

expertise But as medicine shifts its

focus to become more patient cen-

tered, patient experience is fast gain-

ing ground as a key measure of qual-

ity In 2004, for example, the U S

Medical Licensing Examination

added a national skills test on per-

sonal interaction and communica-

tion that medical students must pass

to be eligible for licensure And this

year, the National Committee for

Quality Assurance (NCQA) added

“shared decision-making” as one of

seven measures to assess patient

experienceShared decision-making involves

systematic interaction with patients

to arrive at an informed decision,

based on their values and prefer-

DECISION-MAKING to page 12

Talk it outShared decision-making improves

the patient experienceBy Marcus Thygeson, MD,

and Karen Kraemer, RN, CMC

Lending ahandRobotic surgerymakes inroads into the

OR and beyond

Special Focus: R

Volume XXI, No.8November 2007


Bringing a new medical deviceto market was a lot easierin the good old dessenti

Bringing a newmedical deviceto marketThe challengesof picking a winnerBy Curt Miller

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U R O L O G Y

The debate over newlydiagnosed prostate can-cer continues to rage

with the central theme beingthe risk of overtreatment as aresult of PSA screening. In themidst of the ongoing controver-sy whether and when to screenfor prostate cancer, primarycare physicians and theirpatients are caught in the mid-dle, trying to sort through themixed signals on PSA screeningand the various provider-driventreatment recommendationsonce cancer is diagnosed. Oftenthe major question many newlydiagnosed men face today isnot so much “What is the besttreatment?” as “Is treatmenteven necessary?”This article provides one

urologist’s view of two maintopics: 1) the clinical signifi-cance of prostate cancer andcurrent screening recommenda-tions; and 2) an overview oftreatment options with thefocus on the hottest new treat-ment available: active surveil-lance (AS).

Current prostate cancerstatistics and guidelines

Prostate cancer is the secondmost common cause of cancer-related death in the U.S.—about 30,000 men die yearly,usually from painful bonymetastasis. More than 220,000men in the U.S. are diagnosedwith prostate cancer each year,in part due to PSA screening.Prostate cancer is diagnosed byfinding either elevated levels ofPSA or a nodule on digital rec-tal exam (DRE), either of whichcan lead to transrectal ultra-sound-guided biopsy(TRUSBx).Since the advent of PSA

screening in the late 1980s, thelifetime risk of being diagnosedwith prostate cancer has dou-bled to one in six. With this

increased screening has come ashift to younger age (average67), lower stage, and aggres-siveness at diagnosis, and to anincreased rate of survival. Thegreatest survival benefit withscreening and curative treat-ment is seen in younger men(under 70) with “higher risk”cancers. The majority ofprostate cancers diagnosedtoday are defined as “lowrisk”—small volume, low gradeon pathologic examination,and, thus, believed to have lowlethal potential.In the pre-PSA era, a small-

er proportion of men werebeing treated with curativeintent, as many otherwise diedof other causes or were palliat-ed because their cancer wasfound at an advanced stage.The curative treatments offeredwere external beam radiationtherapy (RT) or open radicalprostatectomy (open RP). WithPSA screening, the increase indiagnoses of early prostate can-cer has led to a dramaticincrease in the number of mentreated and an expansion intheir treatment options. Inaddition to external beam RTand open RP, options todayinclude brachytherapy, image-guided RT, intensity-modulatedRT, Cyberknife robotic radio-surgery, robotic RP, cryoabla-tion, and proton therapy. Thesenewer treatments may havelower complications; however,they are often promoted despitethe lack of evidence of long-term oncologic success.The increased volume of

men treated for prostate cancerhas helped propel prostate can-cer screening into the nationaldebate over quality of life andincreasing health care costs.In 2012, the United StatesPreventive Services Task Force(USPSTF) recommended againstPSA screening in asymptomatic

men regardless of age, suggest-ing that the harms of screeningoutweigh their benefits.Recently the American

Urological Association (AUA)also issued new screening rec-ommendations largely basedupon the premise that “thedecision to undergo PSAscreening involves weighing thebenefits of preventing prostatecancer mortality in 1 of every1,000 men screened over adecade against the knownpotential harms associated withscreening and treatment.” TheAUA recommends that asymp-tomatic men 55–69 years of ageshould be offered screening atleast every two years. [TheAUA’s prior recommendationwas annual testing for menover 40 years of age, with noclear upper age cutoff.] It isimportant to note that the agecutoffs and interval of screen-ing should be individualizedand adjusted for those whohave life expectancy greaterthan 10 years, are symptomatic(e.g., voiding problems), or areat high risk (e.g., family history,African American).This seismic shift in screen-

ing recommendations reflectsthe risk of overtreatment and,thus, the need for a more selec-tive approach, with active sur-veillance an increasingly validstrategy in the treatment con-tinuum.

What is active surveillance?

AS is close monitoring withcurative intervention if thereare signs (triggers) of tumorprogression. This differs from“watchful waiting” (no inter-vention until signs of progres-sion and then initiating pallia-tive treatment). There are manyAS protocols (Table 1 lists afew), with varying inclusionand monitoring criteria. All ofthem rely on DRE, PSA, andTRUSBx results as markers forprostate cancer monitoring.The upside of AS for the

patient is obvious: maintainingthe option of curative treat-ment, no decrease in lifespan,and preserving quality of lifewithout the long term sideeffects of treatment, such aserectile dysfunction and incon-

Active surveillance“Back to the future”

with prostate cancer treatment

Thomas J. Stormont, MD


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tinence. The main downside isthe concern that the tumor willprogress and that the windowof curability will pass.It is estimated that up to 50

percent of men with newlydiagnosed prostate cancer maybe candidates for AS, yet only10 percent in the U.S. areenrolled (compared to 30 per-cent in Europe). Reasons citedfor not implementing AS forqualified men include legalissues (litigation for undertreat-ment by the provider); uncer-tainties of predicting diseaseprogression; economic factors(doctors/hospitals are paid tointervene); lack of patient edu-cation; dearth of long-termdata; and absence of uniformAS guidelines. In addition, theemotional and physical costs tothe family and patient cannotbe minimized: Repeated testingcan cause significant anxiety,and occasionally biopsies canlead to infection.

Evidence for AS

There is growing evidence forthe validity of active surveil-lance. Perhaps the most com-pelling recent study to supportAS was the PIVOT (RadicalProstatectomy versus Observa-tion in Localized ProstateCancer) trial reported in 2012.This study involved 731 menrandomized to observation ver-sus RP, followed for 10 years.The study found no difference inmortality for those men in thelow risk category.Although the PIVOT study

and studies from all other insti-tutions suffer from a dearth oflong-term (decades-long) dataand are based on varying proto-cols, in general there is excel-lent survival for AS patientswhen this option is properlychosen, and when patients arefollowed closely and treatedwith curative intent if there isdisease progression.

Monitoring and triggers forcurative treatment

There are multiple protocols forAS, each with varying criteriafor monitoring (Table 2). It isthe general consensus that high-er-grade cancers (Gleason score>6) or those with palpable nod-

ules (T2) or higher PSA level(>10) often have poorer long-term outcomes and survival.Thus, suitable candidates for ASin general are those men consid-ered low risk (i.e., Gleason score<6, Stage T1C with a PSA level<10). Age is a variable criterion;most protocols including anyage as suitable, but some limitAS to men over 60.There are no proven treat-

ments to inhibit progression formen on these protocols, butthey often want to be proactiveand thus are easy prey for sup-plements promoting unprovenbenefits. It is known that alifestyle good for a man’s car-diovascular system is also bene-ficial to the prostate. And sincea man is much more likely todie from cardiovascular com-plications than his low-riskprostate cancer, men on ASshould be encouraged to lead amore heart-healthy lifestyle.Prescribing drugs in the

5-ARI class (dutasteride orfinasteride) to treat AS hasbeen proposed. REDEEM(Reduction by Dutasteride ofClinical Progression Events inExpectant Management ofProstate Cancer), a three-yearstudy of 302 patients, showed a40 percent reduction in pro-gression of low-risk prostatecancer for men on AS.There are some variations

in monitoring. Most protocolscombine frequent DRE andPSA with an occasionalTRUSBx. Triggering activetreatment because of apparenttumor progression needs to bebetter specified within guide-lines. The main trigger is usual-

ly a change in TRUSBx results;recognizing that there may besampling variations, anincrease in either volume orGleason score usually leads tointervention. The use of PSAkinetics or density has proventhe least predictive of tumorprogression. Studies haveshown that about 30 percent ofmen drop out of the AS moni-toring and undergo treatmentwithin five years, usuallybecause of a significant changein biopsy results, PSA, orpatient preference.

The future of AS

How AS develops as a treat-ment option may depend uponboth education and technology.The expanding role of a shareddecision-making process thatincludes AS as a viable optionwhen counseling newly diag-nosed men will be helpful. Inaddition, the accruing ASpatient survival data at themultiple international studysites will further validate itsrole.With regard to technology,

genetic biomarkers and imag-ing appear to hold the mostpromise in classifying tumoraggressiveness and predictingdisease progression. TheOncotypeDx Prostate cancertest (Genomic Health) and theProlaris test (Myriad Genetics)analyze gene activity levels togenerate scores that help pre-dict both the aggressivenessand lethality of prostate cancerobtained from the TRUSBx.Imaging is another area of

interest, with multiparametricMRI showing promise in helping

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Pearls

1. Prostate cancer screening should be individualized. New recom-mendations are to offer PSA screening at least biannually to men55–69 years of age. Timing of PSA screening should be adjustedin high-risk men, men who have voiding problems and/or if thereis a >10-year life expectancy.

2. Active surveillance (AS) means to closely watch newly diagnosedprostate cancer with the intent to cure if it progresses.

3. AS appears to be a valid and safe option for some men, but morecontrolled and better-defined studies are needed.

4. Repeat biopsy results are the most important monitoring variable;PSA level is less accurate.

5. AS will most likely be augmented in the near future by integratinggenetic testing and improved imaging (MRI).

Active surveillance to page 34

N E U R O S U R G E R Y

For the 51-year-old patientwho came to see me—I’llcall her Anna—the sharp,

electrical-like pain that hadbegun shooting across her cheekwas like nothing she’d ever expe-rienced. It appeared to be aris-ing from one of her molars andmade her gasp with horror whenshe talked, ate, or tried to brushher teeth. Even the lightestbreeze against her face couldcause a terrible jolt of sensation.She had been to see a dentist,and though no decay was appar-ent on her X-rays, it seemed thebest option to get rid of the painwas to have the tooth extracted.But the worst part was that evenafter the tooth had been pulled,Anna’s pain persisted.

The problem, it turned out,wasn’t her tooth at all, but a dis-ease of the facial nerve known astrigeminal neuralgia (TN). Alsoknown in centuries-old medicalliterature as tic douloureux andFothergill’s disease, TN has beendescribed as one of the mostpainful in human experience. Its“lightning-like” sensations makebasic facial movements excruci-

ating and cause incapacitatingdistress. Some patients even saythe pain is so severe they haveconsidered suicide. Unfortu-nately, the condition is morecommon than most people real-ize. Annually in the U.S., theAmerican Association ofNeurological Surgeons reports

more than 150,000 new TN diag-noses are made each year. Mostpatients are older than 50, butsome are young adults in their20s. According to the NationalInstitute of NeurologicalDisorders and Stroke, women

tend to be affected more oftenthan men. Specific risk factorsfor TN remain a mystery, thoughheredity can play a role, ascan hypertension and multiplesclerosis.

In fact, little is known aboutwhat initiates TN, or why theabnormal pain signal continues

to repeat itself. What’s crucialfor patients is to have the painidentified quickly as TN and tobegin appropriate treatment. Inthe neurosurgery department atthe University of Minnesota, weare currently seeing as many asfour new patients a week andmore than 200 cases annually.Like my patient Anna, however,nearly 30 percent of the patientshave had teeth extracted beforeTN is considered as a possiblesource of the problem.

The pain of TN is distinctfrom a toothache, presenting asa sharp, lancinating pain withan electrical shock-like quality. Itoften occurs in short jabs orrepetitive firing, “an ice pick inthe face,” and not a continuousache. TN pain is isolated to oneside of the face (although bilat-eral disease is encountered in2 percent of patients and in20 percent of those with coexist-ing multiple sclerosis). Impor-tantly, most TN patients havetriggers for their pain: a breeze,the patter of shower water, talk-ing on the phone, putting onglasses, kissing, or eating certainfoods, including chocolate.Because the pain is so severe,they learn to avoid these trig-gers, living a life of fear andavoidance.

Fortunately, several effectivetreatments are available to re-lieve the pain for long stretchesof time. The first step is an MRI

scan to rule out any other possi-ble causes of compression ordamage to the trigeminal nerve,such as the presence of a tumor.Many patients’ TN can be helpedwith an antiepileptic medica-tion, like Tegretol (carba-mazepine), on its own or incombination with other anticon-vulsants. (Typically, analgesicsand opioids are not helpful inaddressing the flashes of recur-ring pain caused by TN.) Whenseizure medications fail torelieve the pain or gradually loseeffectiveness over time, severalsurgical techniques are availableto address the abnormal signaloccurring in the nerve.

The gold-standard treat-ment remains microvasculardecompression (MVD), a surgerythat alleviates TN pain bybuffering the trigeminal nervefrom pressure and pulsationscaused by a nearby blood vessel.Developed in 1966 by neurosur-geon Peter Jannetta, MD, thetechnique was originally greetedwith skepticism, but overdecades it has consistently beenshown to be an effective treat-ment for TN. Jannetta trained ageneration of neurosurgeons(including Stephen Haines, MD,head of the University ofMinnesota Department ofNeurosurgery) to perform MVD,which is also known as theJannetta procedure.

The procedure begins with asmall incision behind the ear.The surgeon drills a small holein the skull, and then isolatesthe blood vessel that is imping-ing on the trigeminal nerve.Once the artery has been movedaway from the nerve, a piece ofTeflon felt—one-quarter of a mil-limeter thick—is placed betweenthe nerve and the artery to pre-vent the aggravation of thenerve. Typically patients stay inthe ICU overnight, and thenrecuperate in the hospital for aday or two. Success rates for theprocedure are as high as 95 per-cent. In the past, neurosurgeonssteered away from MVD whentreating patients older than 65,but a recent study in the Journalof Neurosurgery showed that, inexperienced hands, even patientsover 75 years of age fare welland that complication rates areno higher than for any other

Trigeminal neuralgiaTreating “the world’s worst pain”

By Andrew W. Grande, MD, Stephen J. Haines, MD,and Irina Gutsalyuk, MS, PA-C


Trigeminal neuralgia has beendescribed as one of the

most painful diseases in human experience.

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general surgical procedure.For patients who may have

trouble tolerating surgery, or forthose who undergo MVD andhave a recurrence (10 percent at15 years), percutaneous radiofre-quency rhizotomy can be apreferable solution. In the per-cutaneous approach, the neuro-surgeon inserts a cannulathrough a hole, the foramenovale at the base of the skull. Anelectrode threaded through thecannula can be directed to oneof the three branches of thetrigeminal nerve: the ophthalmic(known as V1), the maxillary(V2), or the mandibular (V3)division. The patient is thenroused from anesthesia.Following momentary stimula-tions of an electrode, the patientcan affirm whether the painlocation mimics the day-to-dayTN syndrome. Then the patientis put under anesthesia again, asradiofrequency stimulation fromthe electrode heats and injuresthe aggravated branch of thenerve. The injury dulls sensationin the nerve and reduces pain.The procedure is done inapproximately 30 minutes and

the patient can go home thesame day. This approach canoffer pain relief in up to 95 per-cent of patients, with recurrencerates slightly higher than MVD(one study reported approxi-mately 20 percent at 15 years).

Other percutaneous proce-dures, done with patients undergeneral anesthesia, use a smallinjection of glycerol near thetrigeminal nerve ganglion, or aninflatable balloon that can crushthe trigeminal nerve. Anotherapproach is to use Gamma radi-ation near the brain stem wherethe nerve originates. Typically,Gamma radiation requires twoto three months to take fulleffect. Studies have shown that50 percent of people are ableto stop their medication andremain free of pain. Another25 percent may be able to con-trol their pain by continuing totake a medication like Tegretol.The recurrence rate is approxi-mately 50 percent at two years.

Undoubtedly, treatments willcontinue to improve as we learnmore about what initiates TNpain. The University of Minne-sota is currently developing anew Facial Pain Center toresearch and treat TN and syn-dromes like it. With the use ofultra-high resolution magneticresonance imaging available atthe university, we soon may beable to identify problems inthe main tract of the trigeminalnerve—as one might peer intoindividual fibers of an opticcable—before the nerve bran-ches. It is hoped that betterimaging will lead to new diag-nostic tools, so that we canquickly and easily locate thesource of a patient’s TN. In addi-tion, we’re hopeful that newimaging techniques ultimatelywill help tease out the patho-physiology of this age-old syn-drome, so that we may under-stand more about patients whoare at risk and about those who

will be helped by treatment.While TN is typically treated

by either neurologists or neuro-surgeons, patients frequently areseen first by their primary carephysician or dentist. Because ofthe severity of the pain, a quickdiagnosis is essential. My patientAnna ultimately was able toundergo MVD, and the terribleshock-like sensations she wasexperiencing resolved. With aspeedy diagnosis and the appro-priate TN treatment, patientssuffering the world’s worst paincan find that their lives improveimmensely.

The three authors comprise the trigeminalteam within the Department ofNeurosurgery at the University ofMinnesota, Minneapolis. Andrew W.Grande, MD, is an assistant professor inthe Department of Neurosurgery and co-directs the Earl Grande Stroke and StemCell Laboratory in the Stem Cell Instituteat the U of M. Stephen J. Haines, MD,heads the Department of Neurosurgery,where he is a professor and holds theLyle A. French Chair. Irina Gutsalyuk,MS, PA-C, is a physician assistant in theFacial Pain Center, and specializes inaddressing the particular needs of patientswith trigeminal neuralgia.


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The gold-standard treatment remainsmicrovascular decompression.

O T O L A R Y N G O L O G Y

Sinusitis encompasses abroad range of diseaseprocesses. General cate-

gories include acute sinusitis,recurrent acute sinusitis, andchronic sinusitis (with or with-out polyps). Each disease cate-gory has a unique set of poten-tial causes and treatments.While acute sinusitis is typicallya self-limiting process, the othersubtypes can be quite disablingfor sufferers. Recurrent acutesinusitis and chronic sinusitisaffect approximately 15 percentof Americans. Those burdenedwith chronic sinus disease canexpect an impact on their quali-ty of life worse than that seenwith sufferers of back pain, con-gestive heart failure, and COPD(Gliklich R. and Metson, R.,Otolaryngol Head Neck Surg,113(1), 1995).

Nonsurgical treatments

First-line treatments for bothrecurrent acute and chronicsinusitis involve a step-wisesequence of nonsurgical thera-pies. Initial recommended treat-ments may simply comprise

OTC medications, includingdecongestants, antihistamines,and saline lavage. For poorlyresponsive disease, the treat-ments may escalate to prescrip-tion medications. These mayinclude topical steroid and anti-histamines, antibiotics (oral orlavage), leukotriene modifiers,and oral steroids. In some cases,patients may be referred to aller-gy /immunology specialists forevaluation of atopic disease ordeficiency in the immuneresponse.

While this treatment para-digm holds for the majority ofpatients, it bears mention thatthe efficacy of most of the inter-ventions for chronic sinusitiscannot be supported by high-

quality studies. Furthermore, theunderlying mechanisms respon-sible for chronic sinusitis are notwell understood, and broadlyeffective nonsurgical therapieshave not advanced beyond thosementioned above.

Surgical treatments

For patients not achieving a sat-isfactory degree of disease reso-lution, surgical options typicallybecome the next consideration.Surgery itself includes a widevariety of procedures. The extentand specific type of surgery arechosen appropriate to the sever-ity of disease and to the degreelikely to provide symptom relief.

During the infancy of endo-scopic sinus surgery in the1950s, procedures tended to berather extensive with a goal ofremoving large amounts of dis-eased tissue. Endoscopic sinussurgery has evolved significant-ly and is now the standard sur-gical approach. The contempo-rary approach aims for maxi-mal tissue/anatomy preserva-tion while focusing on opening“bottleneck” areas in hopes ofencour-aging thereturn ofnormalphysiolo-gy. Thisproce-dure hasbeen fur-ther enhanced with the intro-duction of highly accurate andsophisticated image-guidancesystems. These intraoperativetools allow surgeons to operatein complicated scenarios withgreater confidence whileachieving more thorough dis-ease eradication and fewercomplications.

The most recent develop-ment in sinus surgery, balloon

sinus dilation, is rapidly becom-ing a favored tool in the sinussurgeon’s toolbox. While dilationof sinus ostia is not exactly anovel concept, its more recentdevelopment in the era of mini-mally invasive and endoscopicsinus surgery has brought it tothe forefront. The conceptunderlying this procedure movesaway from tissue removal andtoward tissue reshaping.

In traditional endoscopicsinus surgery, an obstructedsinus may be treated withremoval of the involved tissue.Even when focusing on maximaltissue preservation, thisapproach still involves a level oftissue damage, scar formation,and recovery time. Balloon dila-tion procedures may approachthis same problem with dilationof the sinus ostium alone, leav-ing all structures intact. Resultshave shown the two approachesto be equivalent in terms oflong-term patency.

Balloon dilation technologyhas itself undergone a series ofinnovations since its introduc-tion in the mid-2000s (tools forthe procedure were approved bythe FDA in 2005). Initial tech-nique protocols involved theroutine use of intraoperativefluoroscopy to verify placementof the balloon guide wire withinthe desired sinus. While this isstill an option, most surgeonsnow use a lighted guide wire toconfirm proper placement byobserving trans-illuminationthrough neighboring tissues.

This may resultin reducingboth operativetime and costwhile eliminat-ing unneces-sary exposureto radiation.

Perhaps the most significantadvance in sinus surgery sincethe introduction of balloon dila-tion is the ability to performthese balloon procedures in thesurgeon’s office rather than anoperating room. Indeed, a signif-icant portion of patients whowould otherwise be treatedunder general anesthesia nowmay never need to set foot in asame-day surgery center fortheir sinus procedures. The new

Treatment of chronicsinus disease

Support grows for in-officeballoon sinus dilation technology

By Michael Hopfenspirger, MD


Balloon sinus dilation israpidly becoming a

favored tool in the sinussurgeon’s toolbox.

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experience will look more likethe case described below.

A case history

Jane Doe has a several-year his-tory of recurrent sinus infec-tions, suffering about four to sixinfections per year. While eachinfection is generally treatedwith a blend of OTC remediesand antibiotics and resolves, theproblem inevitably returns andleaves her missing out on workand enjoyment. Ultimately, sheis referred to an otolaryngolo-gist. Examination reveals nar-rowing and inflammation withinthe osteomeatal complex area,where several sinuses drain. Heranatomy appears favorable, andshe is eager to have somethingdone to stop this cycle.

Wanting something mini-mally invasive that doesn’trequire general anesthesia andinvolves minimal recovery time,Jane opts for office-based maxil-lary sinus balloon dilation.While Jane reclines comfortablyin a procedure chair and listensto some relaxing music, her sur-geon places cottonoids saturatedin topical anesthetics and decon-gestants in both nasal passages.After a few minutes, the cotton-oids and key areas around theobstruction are injected withlocal anesthesia (the experiencehas been compared to being anes-thetized for a dental procedure).

The surgeon then places aslender, curved device throughthe narrowed opening and con-firms proper placement usingthe lighted tip. Next, the balloonis inflated, widening the open-ing. Jane has been prepared toexpect a mild crunching soundas this occurs, and otherwiseremains comfortable. Satisfiedwith the result, the surgeonmoves to the other sinus. Withinan hour or two of arriving, Janegets up and walks out the door.

Treatment considerations

The above scenario could bemodified in many differentways. All of the paranasalsinuses, with the exception ofthe ethmoids, can be treated inthis setting using the ballooncatheter. The most commonlytreated sinuses are the maxillaryand frontals, with one to four

sinuses being treated in thetypical visit.

The ethmoid sinuses presentsomething of a conundrumwithin this emerging sinus pro-cedure landscape. Many tradi-tional endoscopic sinus proce-dures involve at least an anteriorethmoidectomy, treating an areaof ethmoid cells in the osteo-meatal complex area. Might eth-moid disease resolve once theneighboring sinus ostia areimproved, obviating the need toaddress this area in some cases?Data on this question likely willbe emerging over the next fewyears.

Generally, candidates for theballoon sinus dilation procedurewould include sufferers of recur-rent acute sinusitis (as in theexample above) and some formsof chronic sinusitis. While non-surgical options should still beexplored first in these patients,the in-office nature of a balloonprocedure may lend itself totreating those patients who tra-ditionally would not (yet) becandidates for sinus surgery.While this may include patientswith risk factors incompatiblewith general anesthesia, it mayalso broaden the candidate poolto those who wouldn’t otherwisebe considered to have diseaseserious enough for traditionalsinus surgery. These indicationsare evolving.

Candidates for balloon dila-tion procedures also should becomfortable with the idea ofbeing awake during their sinusprocedures. A patient’s trepida-tion can be tempered with pre-procedure anxiolytics, if desired.Finally, candidates should havefavorable anatomy. Significantseptal deviations, prior surgeryresulting in significant scarring,or landmark confusion may be

difficult hurdles to overcome inthis setting.

In addition to the variousfactors that might steer a patienttoward this procedure versus itsmore traditional operating roomcounterpart (or no procedure atall), the issue of cost will likelybecome more and more perti-nent. With high-deductiblehealth plans becoming morecommon, patients are beingasked to shoulder more of theirown health care costs. Price-con-scious consumers may comparethe typical fees associated withan operating room procedureand these office-based options.In many cases, they will discoverthat their out-of-pocket expenses

will be significantly lower withthe in-office balloon sinus proce-dures. This may have the addedeffect of bringing into the discus-sion patients who would other-wise be unable to afford sinussurgery. Insurance companies arerecognizing this cost savings andincreasingly are including in-office balloon sinus proceduresamong their covered services.

As the published data accu-mulate in support of balloonsinus dilation, more and moreotolaryngologists are embracingthis technology and incorporat-ing it into their practices.Exactly where and how theseprocedures should fit into thetreatment algorithms will con-tinue to be debated (and rightlyso). Regardless, these proce-dures do add to the highly tech-nical and less invasive sinus sur-gery toolbox.

Michael Hopfenspirger, MD, is anotolaryngologist at Ridgeview SpecialtyClinics. His special interests include medicaland surgical diseases of the head andneck, including chronic ear and sinusdiseases, and neck cancer and trauma.


Pearls

• Recurrent acute sinusitis patients in addition to chronic sinusitispatients may be candidates for surgical treatment.

• Many candidates for sinus surgery are candidates for balloon sinusdilation procedures.

• Only local and topical anesthesia is needed for office-based balloonsinus dilation surgery.

• Long-term patency for balloon sinus dilation is on par with traditionalmethods, and the revision rate is lower for the balloon procedure.

• The balloon sinus dilation procedure may allow patients to return towork within days.

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ing advance directives. However,the potential of technology toensure that people’s values andpreferences regarding medicalcare for life-limiting disease areenacted has not yet been real-ized. The ideal solution would:

• Identify the populationat risk (via predictivemodeling)

• Be deployed on a provider-centric basis

• Serve the needs of adiverse population ratherthan “one-size-fits-all”

• Be scalable and efficient• Produce results that areinterpretable and meaning-ful to providers duringhospitalizations; availablein the clinical workflowengines; and includerobust reporting to demon-strate effectiveness

A number of recent start-upcompanies have tackled variousaspects of this type of solution.TrueNorth Healthcare is pilotinga beta version of its product thatis intended as an online servicefor patients to record their legalhealth-care agent and then sharethis information with loved ones

and health care providers.MyDirectives is a free, web-

based system that allows con-sumers to create, update, store,and retrieve secure health caredirectives. The product includesthe elements of a living will, ahealth-care power of attorney, ado-not-attempt-resuscitationform, and organ donation andautopsy preferences, and isstored in a secure database. Thedocuments are available topatients and their providers atall times, using the government’snew Blue Button system, whichprovides patients with a quickand secure way to access theirelectronic health. The productalso has a unique feature ofsending a copy of the documentto the designated health careagents by email and asking themto sign electronically, so as toacknowledge their awareness ofthe advance directives.

The most recent and com-prehensive product is Lumināt,designed by a Minnesota-basedcompany. Intended for use withhealth systems, the productcomprises four key components.The first is a predictive model

powered bydata fromthe healthcare organi-zation’s elec-tronic med-ical recordto engagethe popula-tions mostin need ofan advancecare plan or, regardless of need,most open to completing one.

The second design compo-nent is Lumināt’s cloud-basedtechnology, which helps healthsystems’ patients create advancecare plans that will be inter-pretable by and meaningful toproviders during hospitaliza-tions. The process combines gen-eral education with patientvideos and is designed forextreme ease of use. The advancecare plan can be self-guided or,ideally, created with the help of afacilitator in or outside the clini-cal setting. In either approach,the planning can be done withfamily members in the samelocation or in geographicallydiverse settings. The process isdesigned to encourage the shar-ing of results with designatedhealth care agents and providers,and establishes a plan for updat-ing the plan and re-sharing on aroutine basis.

Third, Lumināt will inte-grate the results of the advancecare planning process into thehealth system’s workflow man-agement tools (usually the elec-tronic medical record). Pro-viders will be able to access,review, and revise with patientstheir advance directives usingthe EMR as part of their outpa-tient visit activities. More impor-tantly, this accessibility willensure that the most recent ver-sion of the patient’s advancedirectives is readily availablewhen they present to the emer-gency department, or if neededduring their hospital course.

Fourth, by synchronizingwith data from the health sys-tem, Lumināt can report on theeffectiveness of processes fordeveloping valid advance careplans, enactment of those plansto deliver care consistent withparticipants’ wishes, and thefinancial impact of providing

desired care. Lumināt is highlyscalable, research-based, andphysician-developed to ensurethat patient preferences areenacted at critical junctures inmedical care.

A health care priority

The efforts of health-care deliv-ery organizations to achieve carethat is consistent with the tripleaims of improving quality ofcare, improving experience forpatients and families, and reduc-ing expenditures for medicalcare that is not desired, especi-ally for people at or nearing endof life, must be facilitated. As ourpopulation ages, these issues willbe priorities for our health caresystems and for each one of us.

While technology is wellestablished in most parts of caredelivery systems, it has not yetachieved its potential to applypeople’s values and choices fortheir medical care at critical carejunctures. Now, technologicalsolutions are building on thatpromise in the realm of end-of-life care. Using these emergingapplications, health-care deliveryorganizations will be able toidentify appropriate patients,engage them in documentingtheir wishes with research-basedmethodology, integrate theirpreferences directly into themedical care workflow, and ana-lyze their success to provide thecare that patients want at alower cost.

Jeffrey B. Rubins, MD, practices withHennepin Faculty Associates at HennepinCounty Medical Center, and is a professorat the University of Minnesota MedicalSchool. He is ABIM board-certified in inter-nal medicine, pulmonary medicine, andhospice and palliative care. TomásValdivia, MD, an internist and medicalinformaticist with 20-plus years’ executiveexperience in health care, is co-founderand CEO of Minnesota-based Lumināt andValquist, LLC.

Advance Care Planning Decisions: www.acpdecisions.org/Prepare: www.prepareforyourcare.org/

The Conversation Project: theconversationproject.org/Caring Connections: www.caringinfo.org/

Making Your Wishes Known: Planning Your Medical Future:www.makingyourwishesknown.com/

TrueNorth Healthcare: truenorthhealthcare.squarespace.com/MyDirectives: www.mydirectives.com/en/

Resources

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Warroad, MNRoseau, MN

Crookston, MN

Contact:Kerri Hjelmstad, Physician Recruiter

Altru Health SystemPO Box 6003

Grand Forks, ND 58201-6003

1-800-437-5373 Fax: [email protected]


Opportunities for full-time and part-time staffare available in the following positions:

US Citizenship required or candidates must have proper authorizationto work in the US.Physician applicants should be BC/BE.Applicant(s)

selected for a position may be eligible for an award up to themaximum limitation under the provision of the Education Debt

Reduction Program.Possible recruitment bonus. EEO Employer.

Nola Mattson, [email protected] Resources

4801 Veterans Drive, St. Cloud, MN 56303

(320) 255-6301

St. Cloud VAHealth Care SystemBrainerd | Montevideo | Alexandria

For more information:Visit www.USAJobs.gov or contact

• Associate Director,Primary & SpecialtyMedicine (IM)

• Dermatologist

• Geriatrician/Hospice/Palliative Care

• Internal Medicine/Family Practice

• Medical Director-Extended Care & Rehab(Geriatrics)

• Pain Specialist

• Psychiatrist

• Urgent Care Physician(IM/FP/ER)

Applicants must be BE/BC.

Competitive salary and benefits with recruitment/relocation incentive and performance pay possible.

Please contact or fax CV to:

Joel Sagedahl, M.D.5700 Bottineau Blvd., Crystal, MN 55429

763-504-6600 Fax 763-504-6622

www.NWFPC.com

Join the top ranked clinic

in the Twin CitiesA leading national consumermagazine recently recognizedour clinic for providing the bestcare in the Twin Cities based on quality and cost. We are currently seeking new physicianassociates in the areas of:

• Family Practice

• Urgent Care

We are independent physician-owned and operated primaryclinic with three locations in theNW Minneapolis suburbs. Work-ing here you will be part of anaward winning team with partner-ship opportunities in just 2 years. We offer competitive salary andbenefits. Please call to learn howyou can contribute to our innova-tive new approaches to improvinghealth care delivery.

Fairview Health ServicesOpportunities to fit your life

Fairview Health Services seeks physicians to improve the health of the communities we serve. We have a variety of opportunities that allow you to focus on innovative and quality care. Be part of our nationally recognized, patient-centered, evidence-based care team.

We currently have opportunities in the following areas:

• Dermatology• Emergency Medicine• Family Medicine• General Surgery• Geriatric Medicine• Hospitalist

• Internal Medicine• Med/Peds• Ob/Gyn• Pediatrics• Psychiatry• Urgent Care

Visit fairview.org/physicians to explore our current opportunities, then apply online, call 800-842-6469 or e-mail [email protected] Sorry, no J1 opportunities.

fairview.org/physicians TTY 612-672-7300EEO/AA Employer


cent (“regularly”) and 47.5 per-cent (“occasionally”) using thelabels in making decisions aboutfood.

Self-reported stairwell useincreased during the interven-tion from a rather high baselinelevel of 76 percent to 80 percent,84 percent, and 77 percent at thethree subsequent interventionphases (significant effect atp=.002). Statistical analysesrevealed that gender and BMIwere related to stair use.Females reported less stairwelluse than males, and BMI wasinversely associated with fre-quency of using the stairs. Inaddition, the hospital employeesreported a significant increase inwalking from baseline and incomparison with the clinicgroup. However, other self-reported physical activity anddietary intake, waist circumfer-ence, weight, and BMI measure-ments did not significantly differbetween the groups or over time.Notably, hospital employeesgained significantly less weight(mean=0.26 lb, p=.005) than is

typically found in the U.S. adultpopulation (mean=1.8 lb),whereas the clinic employeesweight gain (mean=1.56 lb,p=.81) was not significantlydifferent than is typical.

Qualitative interviews withpeer helpers showed that theytook on many helping roles,viewed themselves as becomingeffective role models, and con-tributed to creating health-pro-moting social and environmentalchanges at work.

Discussion

The primary goal of this inter-vention was to encourage em-ployees to make modest changesin their health behaviors thatwould help prevent weight gain.Therefore, employees were notrecruited for participation in tar-geted weight loss, as is often typ-ical in randomized clinicalweight-loss trials. Employees inthe intervention group were ableto prevent the typical annualweight gain of 1.8 pounds.

The data also suggest thatimplementing low-impact physi-cal activity (e.g., walking, stair

use) may be more easily incorpo-rated into the worksite settingthan more challenging behaviorsof altering dietary habits andincreasing more vigorous formsof physical activity. Employeesexpressed positive attitudestoward nutrition labeling, envi-ronmental changes, and the Go!program, and were receptive tocontinuation of these efforts intheir worksite.

Physicians can take a moreactive role in their workplaceby promoting healthful eatingand physical activity. Somesuggestions:

• By improving their owndietary and physical activ-ity habits, physicians canserve as role models andinformal peer helpers.

• Physicians can take theinitiative to work withtheir food service directorand nutritionists toencourage healthy portionsizes, nutritious food, andcaloric labeling at theirworksite. Physicians canhelp promote balancedmenus at their workplace,

aiming to increase low-energy-density (green)foods, decrease theamount of high-energy-density (red) foods, andeliminate sugar-sweetenedbeverages.

• Working with hospitalleadership, physicians canhelp create a healthierworksite.

Support for these kinds ofworksite initiatives is growing,and so are the available onlineresources. A starting point forphysicians wanting to getinvolved is the Healthier Hos-pitals Initiative (www.healthier-hospitals.org).

Lara LaCaille, PhD, and JenniferSchultz, PhD, were co-principal investi-gators for the Go! program. LaCaille is anassistant professor in the Department ofPsychology and Schultz is an associateprofessor in the Department of Economicsat the University of Minnesota–Duluth.Ryan Goei, PhD, Department ofCommunication, is an associate professorat the University of Minnesota–Duluth.

The Go! Study from page 17

Emergency Medicine

Hibbing Little Falls Park Rapids Alexandria Austin

For more information contact Tina Dalton or Mike Coulter at 800-458-5003, email:[email protected] or visit our website at

www.epamidwest.com

Your Emergency Practice Partner

Emergency Practice Associates has immediate full-time, part-time and locums opportunities at our sites in:

Applicants can apply online atwww.USAJOBS.gov

Sioux Falls VA Health Care SystemWorking with and for America’s Veterans is a privilegeand we pride ourselves on the quality of care weprovide. In return for your commitment to qualityhealth care for our nation’s Veterans, theVA offers anincomparable benefits package.

TheVAHCS is currently recruiting for the followinghealthcare positions in the following location.

Sioux Falls VA HCS, SD

Sioux Falls VA HCS(605) 333-6858

www.siouxfalls.va.gov

Primary Care(Family Practice orInternal Medicine)

Psychiatrist

Hospitalist

Endocrinology

Emergency Medicine

Pulmonologist


Live in the relaxed lake country of Mille Lacs andpractice medicine where you will make a difference.

We’re looking for a Family Physician to join us atMille Lacs Health System in Onamia, Minnesota.

Loan forgiveness options – J-1Visas considered.

Contact: Fern Gershone: [email protected] Dr. Tom Bracken: [email protected]

7 FAMILY PHYSICIANS • 9 PAs • CRITICAL ACCESS HOSPITAL ER STAFFED 24/7 • ATTACHED GERIATRIC UNIT & LTC FACILITY • 4 CLINICS

Caring for body, mind and spirit. Onamia, MN • mlhealth.org • 877 -535-3154

AIRFORCE.COM/HEALTHCARE

© Paid for by the U.S. Air Force. All rights reserved.

guide biopsies, and, possiblymonitor tumor progressionbetter than the current stan-dard of ultrasound. Both thegenetic assays and MRI havelimited clinical use currentlybecause of expense andbecause they are not includ-ed in current AS protocols.

A valid role for AS

There is a shift underway inprostate cancer screening—and, thus, the treatment ofprostate cancer patients—toward the pre-PSA era:Less screening will lead tofewer men being treatedwith curative intent.The USPSTF recom-

mendation against allprostate cancer screeninghas been described as a“meat cleaver” approach toreducing some of the mor-bidity and costs associatedwith prostate cancer. TheAUA recognizes thereremains a valid role for amore focused and personal-ized PSA screening through

improved risk stratification.Urologists are uniquely

positioned to be the ulti-mate educators and advo-cates for our patients. Withmore focused use ofresources, the treatingphysicians and our patientstogether can ultimatelydetermine the best treat-ment possible. Thisincludes recognizing thatactive surveillance—whileimperfect and evolving—isa valid initial treatmentoption for many men withnewly diagnosed prostatecancer.

Thomas J. Stormont, MD,is a urologist with StillwaterMedical Group.


Active surveillance from page 25TABLE 1. Inclusion criteria for some AS protocols.

AS Protocol University ofToronto

JohnsHopkins

University of CaliforniaSan Francisco

Clinical stage* T1C T1C T1 or T2

PSA <10 N/A <10

Gleason score** <3+3 = 6 <3+3 = 6 <3+3 = 6

PSA density*** – <.15

# Positive biopsy cores <2 <33%

*Clinical stage: T1C denotes nonpalpable prostate cancer detected on PSA; T2denotes prostate cancer with a palpable nodule.

**Gleason score: The histologic appearance seen on biopsy. Prostate cancer isgraded 1–5, with 5 being the most aggressive. The score isthe sum of two most common grades found on biopsy.

***PSA density: PSA/prostate volume on TRUSBx.

TABLE 2. Monitoring interval for some AS protocols.

AS Protocol University ofToronto

JohnsHopkins

University of CaliforniaSan Francisco

PSA3 months for2 years, then

every 6 months6 months 3 months

DRE 6 months 6 months 3 months

Repeat Biopsy6–12 months for

first year, thenevery 3–4 yrs

yearlyTRUS only for 6–12

months, then TRUSBx for1–2 years

Shar GrigsbyHealth Center - East

20 Burdick Expressway Minot ND 58702

Ph: (800) 598-1205, Ext 7860 Pager #0318

Email: [email protected]

For immediate confidential consideration, or to learn more, please contact

www.trinityhealth.org

Physicians are offered a generous guaranteed base salary. Benefits also include a health and dental plan, life and disability insurance, 401(k), 401(a), paid vacation, continuing medical education allowance and relocation assistance.

Ambulatory Internal MedicineGeneral Surgery

PsychiatryUrology

Trinity HealthOne of the region’s premier healthcare providers.

Based in Minot, the trade center for Northern and Western North Dakota, Trinity Health offers the opportunity to work within a dramatically growing community that offers more than just a high quality of life.

Comprised of a network of nearly 200 physicians in hospitals, clinics and nursing homes,Trinity Health hosts a Level II Trauma Center, Critical Care Helicopter Ambulance, Rehab Center, Open Heart and Lung Program, Joint Replacement Center and Cancer Care Center.

Currently Seeking BC/BE

Contact us for a complete list of openings.


Family Medicine

St. Cloud/Sartell, MN

We are actively recruiting exceptional full-time BE/BC Family Medicine physicians to join our primary care team at the HealthPartners Central Minnesota Clinics - Sartell. This is an out-patient clinical position. Previous electronic medical record experience is helpful, but not required. We use the Epic medical record system in all of our clinics and admitting hospitals.

Our current primary care team includes family medicine, adult medicine, OB/GYN and pediatrics. Several of our specialty services are also available onsite. Our Sartell clinic is located just one hour north of the Twin Cities and offers a dynamic lifestyle in a growing community with traditional appeal.

HealthPartners Medical Group continues to receive nationally recognized clinical performance and quality awards. We offer a competitive compensation and benefi t package, paid malpractice and a commitment to providing exceptional patient-centered care.

Apply online at healthpartners.jobs orcontact [email protected] Diane at 952-883-5453; toll-free:800-472-4695 x3. EOE

healthpartners.com

www.olmstedmedicalcenter.org

Olmsted Medical Center,a 150-clinician multi-specialty

clinic with 10 outlyingbranch clinics and a 61 bed

hospital, continues to experiencesignificant growth.

Olmsted Medical Centerprovides an excellent

opportunity to practice qualitymedicine in a family oriented

atmosphere.

The Rochester communityprovides numerous cultural,educational, and recreational

opportunities.

Olmsted Medical Centeroffers a competitive salary

and comprehensivebenefit package.

EOE

Opportunities availablein the following specialties:

DermatologySoutheast Clinic

Family MedicinePine Island Clinic

HospitalistRochester Hospital

Advanced Wound CareRochester Hospital

Internal MedicineSoutheast Clinic

Send CV to:

OlmstedMedical CenterAdministration/Clinician Recruitment

102 Elton Hills Drive NWRochester, MN 55901

email: [email protected]

Phone: 507.529.6748Fax: 507.529.6622

Avera Marshall RegionalMedical Center300 S. Bruce St.Marshall, MN 56258

www.averamarshall.org

Physician Practice OpportunitiesAvera Marshall Regional Medical Center is part of the Avera systemof care. Avera encompasses 300 locations in 97 communities in afive-state region. The Avera brand represents system strength andlocal presence, compassionate care and a Christian mission, clini-cal excellence, technological sophistication, an array of specialtycare and industry leadership.

General Surgery

Radiology/Oncology

Internal Medicine

Psychiatry

Pediatrics

Obstetrics/Gynecology

Family Practice

Ophthalmology

Optometry

For details on these practice opportunities go tohttp://www.avera.org/marshall/physicians/

For more information, contact Dave Dertien,Physician Recruiter, at [email protected]

Currently we are seeking to add the following specialists:

Orthopaedic Surgery

OpportunityLive in Beautiful

Minnesota Resort Community

An immediate opportunity is avail-able for a BC/BE orthopedic surgeon in Bemidji, MN. Join threeboard certified orthopedic surgeonsin this beautiful lakes community.Enjoy practicing in a new Orthopedic& Sport Medicine Center, openingspring 2013 and serving a region of100,000.

Live and work in a community thatoffers exceptional schools, a stateuniversity with NCAA Division Ihockey and community symphonyand orchestra. With over 500 milesof trails and 400 surrounding lakes,this active community was ranked a “Top Town” by Outdoor LifeMagazine. Enjoy a fulfilling lifestyleand rewarding career. To learn more about this excellent practiceopportunity contact:

Celia Beck, Physician RecruiterPhone: (218) 333-5056Fax: (218) 333-5360Email: [email protected]

AA/EOE - Not subject to H1B Caps

coverage from the Marketplaceis likely to be cheaper thanCOBRA.This change in health cover-

age has benefits for bothemployers and employees.Adverse selection of COBRAraises the cost of the employer’splan. Employers can avoid someof these costs if more COBRA-eligible former enrollees obtaincoverage from the Marketplace.After a qualifying event,

employers must notify potentialenrollees of their eligibility forCOBRA. The DOL recentlyrevised a model notice thatemployers can use to satisfythis requirement. The revisednotice informs readers abouttheir potential eligibility forsubsidized coverage from theMarketplace. The model noticecan be viewed online atwww.dol.gov/ebsa/modelelec-tionnotice.doc.The ACA may have other

implications for COBRA cover-age. For example, the ACAenacted new nondiscrimination

rules that prohibit employersfrom providing certain healthbenefits solely to highly compen-sated individuals. DOL, the IRS,and the Department of Healthand Human Services delayedimplementation of the nondis-crimination rules. When therules go into effect, however,employers may no longer beable to offer highly compensatedemployees severance packagesthat include favorable COBRAcoverage. Employers shouldkeep this in mind as they offerseverance packages.The Department of Labor’s

health reform website providesinformation on many ACAcompliance issues, includingCOBRA, at www.dol.gov/ebsa/healthreform/.

Special issues for providers asemployers

Most employer ACA respon-sibilities are not unique to par-ticular types of employers.However, providers should beaware of a few issues that maybe more likely to arise in theirrole as employers.

For example, the 50-employee threshold for beingsubject to ACA play-or-payrequirements may affect manyprovider organizations, fromsolo practitioners to very largeentities employing hundreds orthousands of people. Evenprovider organizations that arepart of a larger entity will needto be aware of ACA complianceinitiatives, because some penal-ties are assessed at the employerlevel, which may—or may not—be the provider organization ifit is part of a larger controlledgroup entity.Another consideration is

that provider organizations aregearing up for many changesunder the ACA that affect thedelivery of medical services.With all the changes that willoccur on that front, it may beeasy for them to overlookemployer requirements. Providerorganizations need to be assess-ing ACA compliance from manydifferent perspectives, based onthe various roles the organiza-tion plays.

Keep alert for guidance

Government agencies con-tinue to issue regulations toimplement the ACA. Keep alertfor new guidance and ask forhelp. The DOL website www.dol.gov/ebsa/healthreform/ is agood source for updates andadditional information.Employers can register to

receive email updates when newinformation is added to the site.Another good source for generalACA information is www.health-care.gov/. Finally, knowledgeableemployee benefits attorneys canhelp employers comply with theACA in the way that is best forbusiness, employees, andpatients.

Kathi Wright, JD, is a principal andMonica Kelley, JD, is a senior associate inthe Employee Benefits and ExecutiveCompensation group in the law firm ofGray Plant Mooty, Minneapolis. WadeHauser is a summer associate at GrayPlant Mooty; he is a JD candidate at theUniversity of Iowa College of Law.


ACA update from page 21

Here to care

At Allina Health, we’re here to care, guide, inspire and comfort the millions of patients we see each year at our90+ clinics, 11 hospitals and through a wide variety of specialty care services throughout Minnesota and western Wisconsin. We care for our employees by providing rewarding work, flexible schedules and competitive benefitsin an environment where passionate people thrive and excel.

Make a difference. Join our award-winning team.Madalyn Dosch,Physician Recruitment ServicesToll-free: 1-800-248-4921 Fax: [email protected]

allinahealth.org/careersEOE/AA10127 0213 ©2013 ALLINA HEALTH SYSTEM ® A TRADEMARK OF ALLINA HEALTH SYSTEM

Emergency Room Physicians

Looking for leisure work hours?

• Immediate openings

• Casual weekend or eveningshift coverage

• Choose from 12 or 24 hourshifts

• Competitive rates• Paid malpractice

Attention Physicians

763-682-5906 • 1-800-876-7171

F-763-684-0243

[email protected]

• Set your own hours

• No contract

• No obligations

Great Emergency Department in Southern Minnesota


Spine Surgeons, join our team and set thestandards for patient care.Orthopaedic Associates of Duluth is seeking a highly motivatedpassionate and experienced SPINE SURGEON to provideoutstanding orthopaedic care to its patients. The successful candidatewill be part of our expanding and growing, well-respected team thatserves patients from Duluth to northern Minnesota.

Orthopaedic Associates of Duluth is a group of nine orthopaedicsurgeons that provide comprehensive orthopaedic services rangingfrom specialty specific exams and diagnosis to state-of-the-art in-office MRI and imaging and surgery at their physician-owned surgerycenter.

Email CV to [email protected] call 800-461-8843 (Sue) or 218-625-2731 (June)

Urgent Care

We have part-time and on-call

positions available at a variety of Twin

Cities’ metro area HealthPartners

Clinics. We are seeking BC/BE full-

range family medicine and internal

medicine pediatric (Med-Peds)

physicians. We offer a competitive

salary and paid malpractice.

For consideration, apply online at

healthpartners.jobs and follow the

Search Physician Careers link to view

our Urgent Care opportunities. For

more information, please contact

[email protected]

or call Diane at: 952-883-5453;

toll-free: 1-800-472-4695 x3. EOE

healthpartners .com

The perfect matchof career and lifestyle.

Affiliated Community Medical Centers is a physician owned multi-specialty group with 11 affiliate sites located in western andsouthwestern Minnesota. ACMC is the perfect match for healthcare providerswho are looking for an exceptional practice opportunity and a high quality of life.Current opportunities available for BE/BC physicians in the following specialties:

For additional information, please contact:

Kari Bredberg, Physician [email protected], (320) 231-6366

Julayne Mayer, Physician [email protected], (320) 231-5052

www.acmc.com

• ENT• Family Medicine• Geriatrician/Outpatient

Internal Medicine• Hospitalist• Infectious Disease

• Internal Medicine• Med/Peds Hospitalist• OB/GYN• Oncology• Orthopedic Surgery• Psychiatry

• Psychology• Pediatrics• Pulmonary/

Critical Care• Radiation Oncology• Rheumatology

Orthopaedic Surgery

OpportunityLive in Beautiful

Minnesota Resort Community

An immediate opportunity is avail-able for a BC/BE orthopedic surgeon in Bemidji, MN. Join threeboard certified orthopedic surgeonsin this beautiful lakes community.Enjoy practicing in a new Orthopedic& Sport Medicine Center, openingspring 2013 and serving a region of100,000.

Live and work in a community thatoffers exceptional schools, a stateuniversity with NCAA Division Ihockey and community symphonyand orchestra. With over 500 milesof trails and 400 surrounding lakes,this active community was ranked a “Top Town” by Outdoor LifeMagazine. Enjoy a fulfilling lifestyleand rewarding career. To learn more about this excellent practiceopportunity contact:

Celia Beck, Physician RecruiterPhone: (218) 333-5056Fax: (218) 333-5360Email: [email protected]

AA/EOE - Not subject to H1B Caps


educational model will require anew kind of partnership—onethat links the education commu-nity, the practicing community,the delivery systems, and publichealth.

The shift in education andcare delivery will make use ofconsumer-focused models forachieving health; workforceplanning; an integrated continu-um of care; and communities ofself-care, occurring in a fullclosed-loop system for continu-ous improvement. Along theway, stakeholders will needto share information and re-sources, foster public-privatepartnerships, develop newfinancial support models, anduse innovative communicationtechnologies.

A major national effort toachieve these new relationshipsis being coordinated by theNational Center for Interprofessional Practice and Education(NCIPE). To relink educationwith care delivery, the center isusing the core approaches ofleadership, collaborative prac-

tice and system transformation,education and training, researchevaluation and scholarship, anddevelopment of new and innova-tive models. In moving ahead,the center must also develop thedata that demonstrates the valueof this approach in a convincingand practical way. Models arebeing developed and pilotedwith partners across the nation,and then made available for use.

At the core of the group’smission is the development of aninterprofessional nexus connect-ing education and clinical prac-tice approaches in order toimprove health outcomes. Thegoals of this realignment andintegration of education and theprocess of care include reducingcost and adding value to thealignment, improving the qualityof the user and learner experi-ence, and sharing responsibilityand accountability for achievinghealth outcomes. Examples ofevolving nexus projects are:

• Achieving specificimprovements in patientsafety

• Preventing prediabetes

from becoming clinicaldiabetes

• Reducing the cost ofretraining

• Creating a community-based primary care med-ical-home network withina health system

• Implementing a surgicalteam model of operatingroom performance

The Minnesota Nexus hasbeen formed of public, private,and educational health leader-ship to bring together educationand clinical practice inMinnesota’s health environment.Among the group’s priorities aredeveloping a health workforceplan and the continuum oflearning for medical profession-als; establishing a partnershipamong the health systems andthe health education institu-tions; and creating new sustain-able models for the financialsupport and continued develop-ment of health initiatives. Formore about the MinnesotaNexus, go to www.nexusipe.org.

Redesigning and realigningmedical education and clinical

practice to achieve improvedhealth status; health quality;value-added financing; andengagement of people, families,and communities are essentialfor all our futures and those ofour children. We must shape ourfuture now.

Frank Cerra, MD, is a professor in theSurgery Department in the University ofMinnesota Medical School and an adjunctprofessor in the U of M School of PublicHealth. Cerra is emeritus senior vice presi-dent for health sciences and holds theMcKnight Presidential Leadership Chair atthe University of Minnesota. He is senioradvisor to the director of the NationalCenter for Interprofessional Practice andEducation and also serves as its deputydirector.

Shaping our future from page 11

(952) 925-9455 www.mapeterson.com

View your homein a new way.

At MMIC, we believe patients get the best care when doctors, staff and administrators are humming the same tune. So we put our energy into creating risk solutions that help everyone feel confi dent and supported. Solutions such as medical liability insurance, physician well-being, health IT support and patient safety consulting. It’s our own quiet way of revolutionizing health care.

To join the Peace of Mind Movement, give us a call at 1.800.328.5532 or visit MMICgroup.com.

The more weget together, thehappier and healthier we’ll be.

Documents

Minnesota Physician September 2013