Minnesota Physician November 2012

Volume XXVll, No. 8

November 2012

A change in culturePrinciples support safer care

By Steven Mulder, MD

About 25 years ago, I was prac-ticing family medicine in ruralMinnesota. I was on call for

the hospital, and having a very busyday—five admissions by noon. Thatevening, as I was pausing to take abreath, I was paged urgently to themedical floor. One of my admissionshad suffered a seizure. The RN onduty told me a glucometer readingwas “less than 40.” She had given thepatient glucagon and the seizure hadresolved after three to four minutes.Save for some brief postictal symp-toms, the patient had no observableresidual effects.

I reviewed the chart and discov-ered to my horror that I had pre-scribed an oral hypoglycemic agent,and the patient was not diabetic. As I sorted things out, it became clearwhat had happened. Two of mymorning admits were elderly gentle-men of similar age and presenting

CULTURE to page 12

The Independent Medical Business Newspaper

As clinicians, we know that practicingmedicine involves a delicate blend ofscience and art. Beyond the

medications and other therapieswe rely on each day, effectivelytreating a particular patientrequires that we draw on a broadset of emotional intangibles, suchas empathy, compassion, and anability to connect on a deeply per-sonal level. We also need to look tothe closest, most important people in apatient’s life and recruit them as a supportsystem.

This is particularly true when it comesto treating depression, bipolar disorder, andother psychiatric conditions, as therapyoften involves a significant dose of “art”that’s tailored to each patient. Whether the

patient is seen in a family practice clinic ora specialist’s office, mental illnesses can

complicate treatment in ways thatchallenge clinicians.

Mood disorders, in addition totaking a severe toll on the patient,strongly ripple through his or herfamily, friends, andcommunity in waysthat other illnesses donot. Also, these disor-

ders are sometimes not wellunderstood by patients orfamilies, perhaps because theyare misrepresented in popularculture—or at least poorlydefined and delineated.

ART to page 10

PRSRT STDU.S. POSTAGE

PAIDDetriot Lakes, MNPermit No. 2655

RURAL HEALTH Page 20

The intersection of art and medicine

Med ed goes to the

theaterBy Mark A. Frye, MD

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

NOVEMBER 2012 MINNESOTA PHYSICIAN 3

CAPSULES 4

MEDICUS 7

INTERVIEW 8

MEDICINE AND THE LAW Sunshine and scrutiny 14By David M. Aafedt, JD, andChristianna L. Finnern, JD

WOUND CARE Venous disease 28By Dana Matthews BSN, MBA,and Dan Morehouse, MD, RVT

HEALTH INSURANCE Medicare in 2013 34By Kelli Jo Greiner

Health care reform and rural health 20By Terry Hill, MPA

A call to duty 22By Kami Norland, MA, ATR,and Julie Benson, MD

Forging connections 24By Maureen Ideker, MBA, BSN,RN; Cindy Loe, RN; MichelleOman, DO; and Nancy Tario, MA

The intersection of art and medicine 1Med ed goes to the theatreBy Mark A. Frye, MD

A change in culture 1Principles support safer careBy Steven Mulder, MD

DEPARTMENTS

SPECIAL FOCUS: RURAL HEALTH

C O N T E N T S NOVEMBER 2012 Volume XXVII, No. 8

FEATURES

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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MINNESOTA HEALTH CARE ROUNDTABLE MINNESOTA HEALTH CARE ROUNDTABLE

Background andfocus: The next stepin health care reforminvolves the patientbecoming moreactively engagedwith staying healthy.New physician reim-bursement modelsreward improvedpopulation health butbring new dynamicsinto the exam room.Incorporating patientattitude and lifestylechoices into healthcare delivery is necessary, but howshould it be done?Creating conceptual

and empirical clarity around this question may be bestaddressed by the term Patient Activation Measure(PAM).

Objectives: We will examine the development ofPAM, what it means and how it works. We will explorepatient engagement methods that have been success-ful and the role of health insurance companies andemployers in this process. We will explore how PAMmay be used across the continuum of care and whosejob it will be to implement and track these measures.We will discuss the challenges that are inherent withinthe concept of PAM and how it may realize its bestpotential.

T H I R T Y - N I N T H S E S S I O N

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4 MINNESOTA PHYSICIAN NOVEMBER 2012

Mayo Study Looks atCancer Drugs’ ValueManufacturers of cancer drugsenjoy a “virtual monopoly” inthe marketplace, which plays arole in the relatively high cost of those drugs, according to anew article in Mayo ClinicProceedings.

The commentary, by oncolo-gist Mustaqeem Siddiqui, MD,and hematologist VincentRajkumar, MD, points out that a recently introduced cancerdrug was judged to extend thelife of a cancer patient by 3.7months. The cost for the drugwas $120,000.

“Sadly, the benefit of thesenew drugs is typically short-lived, and many of these drugsare very expensive,” saysSiddiqui.

The authors acknowledgethat discussion of the value ofsuch drugs can be provocative,but add that the debate is neces-sary at a time when high drugcosts are contributing to risinginsurance premiums and inc -reased costs for government programs such as Medicare.

“The absolute cost to societywill be come increasingly unaf-fordable if every drug with statistically significant but clini-cally unimportant benefit is ap proved,” they write.

The article says that thereare many causes behind the highcost of cancer drugs, includingregulatory costs, drug develop-ment costs, and the tendency towant the newest and best treat-ments for a life-threatening dis-ease such as cancer.

Because of these and otherfactors, the authors write, drugmanufacturers have a kind ofmonopoly when it comes to can-cer drugs. With other medicalconditions, there are a variety of treatments and competitionholds down costs.

Cancer drugs, on the otherhand, often only work for a lim-ited time, and the use of onedrug does not preclude the useof another drug. “Most of thesedrugs provide benefit for a shortduration, typically measured inweeks or months, and then thetumor begins not to respond tothe therapy. In this scenario,physicians really do not choose

the most cost-effective option;they only decide the timing atwhich each option is used,” theauthors write. “Thus, each drugis an effective monopoly becauseeach one will be indicated atsome point during the course ofa patient’s illness.”

The authors call for “value-based pricing” as one means ofaddressing this situation. Such asystem would create metrics forestimating the number of yearsadded to a patient’s life by adrug, adjusted for quality of life.

New Guidelines Met with CautionNew national guidelines for Paptests recommend that womenget tested less often, but a localphysician who recently was rec-ognized for his cancer-screeningefforts reacted with caution tothe new guidelines.

Bradley Linzie, MD, FCAP,is a pathologist at HennepinCounty Medical Center (HCMC)in Minneapolis and recentlyreceived the College of AmericanPathologists (CAP) Foundation2012 Gene and Jean Herbek

Humanitarian Award for helpingto provide free cervical andbreast cancer screenings atNorthPoint Health and WellnessCenter, an affiliate of HCMC.

Linzie says frequency of Paptests depends on each individ-ual’s health history. “This [newrecommendation] is mostly forpeople who have never had anabnormal reading,” Linzie notes.“Age, prior Pap test history, andsexual history [can affect] whenyou need your next Pap test.”

The new guidelines, releasedby the American Congress ofObstetricians and Gynecologists,say that most women should bescreened for cervical cancer viaPap tests every three to fiveyears. For many, this will replacean annual Pap test. Women ages30–65, however, are advised togo five years between Pap testsand to be screened for humanpapilloma virus (HPV) at thesame time as their Pap tests.

Linzie says that false posi-tive Pap tests can result in intru-sive follow-up procedures forwomen, so he understands thereasons for the new guidelines.“We’re not going to know until

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we try it,” he says. “I think theintentions are good.” His con-cern, he adds, is whetherpatients will be able to keeptrack of the three- or five-yeargap between tests and knowwhen it is time to be retested.

“The things that should helpare universal coverage and elec-tronic medical records (EMRs)that help remind everyone whenthey need their next tests,” hesays. But underserved popula-tions and immigrant popula-tions, like the patients he hasworked with at NorthPoint,sometimes don’t have EMRs andare not as aware of the need forscreenings, Linzie says.

Substance Abuse IsFocus of StatewideStrategy by DHSThe Minnesota Department ofHuman Services (DHS) haslaunched a statewide strategy toaddress substance abuse andaddiction. Included in the strat-egy is a focus on prescription ofopiates and the abuse of suchdrugs—which officials describeas a pressing concern.

The new approach empha-sizes coordination betweenagencies and a multifacetedapproach to preventing andreducing substance abuse. Thestate departments of correc-tions, education, health, andpublic safety are all involved, aswell as the state judicial board,the Minnesota National Guard,and the Minnesota Board ofPharmacy.

“Substance abuse is a seri-ous and costly issue that affectsus all,” says DHS CommissionerLucinda Jesson. “The long-termand immediate steps recom-mended in this comprehensivestrategy will help save lives anddollars by making our preven-tion and treatment efforts moreefficient and effective.”

The coalition will seek tobalance public safety, preven-tion, intervention, and treatmentand recovery services in an ef -fort to reduce substance abuse.Officials are recommendingintegration of screening servicesin all health care settings andexpanded use of recovery cen-ters throughout the state.

Grant Will Help U of M Lead Effort inMedical EducationThe University of MinnesotaAcademic Health Center hasbeen chosen to lead a $4 mil-lion effort to improve coordina-tion of medical education andpractice, particularly in med-ically underserved areas.

The grant was announcedby the Health Resources andServices Administration(HRSA) on Sept. 14. Officialswith HRSA say the U of M willcreate a Coordinating Centerfor Interprofessional Educationand Collaborative Practice,which will partner with othertraining and health deliverysites around the country.

“Health care delivered bywell-functioning coordinatedteams leads to better patientand family outcomes, more effi-cient health care services, andhigher levels of satisfactionamong health care providers,”says HRSA Administrator MaryWakefield, PhD, RN. “We allshare the vision of a U.S. healthcare system that engagespatients, families, and commu-nities in collaborative, team-based care. This coordinatingcenter will help us move for-ward to achieve that goal.”

Officials say the center willaid in the development ofhealth reform innovations suchas accountable care organiza-tions, patient-centered medicalhomes, and transitional caremodels.

Meningitis ConcernsRising Due toContaminationPublic health officials haveexpanded their monitoring of health care facilities as ameningitis outbreak linked to injectable drugs continues to claim victims.

The Minnesota Depart-ment of Health (MDH) said on Oct. 16 that 129 clinics in thestate have received injectabledrugs from New EnglandCompounding Center (NECC).Since Oct. 4, state and federalagencies have been investigat-

CAPSULES to page 6

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ing NECC and the outbreak offungal infections linked to con-taminated products from thatcompany.

Nearly 250 cases of menin-gitis have been documented bythe Centers for Disease Controland Prevention (CDC) nation-wide. That agency, along withthe Food and Drug Administra-tion (FDA), is working withstate governments to track theoutbreak and advise patientsand physicians on treatment.There have been 19 deathslinked to the outbreak, thoughnone had been reported inMinnesota as of Nov. 5. Sevencases of meningitis have beenreported in this state. Publichealth officials stress that thistype of meningitis is not conta-gious.

Originally, the concern waslimited to patients who had hadsteroid injections due to ortho-pedic conditions, and inMinnesota, only two facilitieswere known to use the NECCdrug for those kinds of treat-ments. However, the CDC and

FDA have announced a possiblecase of meningitis associatedwith a second steroid producedby NECC and that a NECC drug used in open heart surgeryhas been associated with apatient who developed a fungalinfection.

MDH officials say that theyattempted to contact nearly1,000 patients about the origi-nal concern over the orthopedicsteroid linked to the meningitisoutbreak. State officials wereable to contact nearly all ofthose patients by mid-October.

In a statement, MDH notedthe FDA is now asking healthcare providers to follow up onother drugs manufactured byNECC, and to check patientswho received NECC productsfor symptoms of meningitis.

C. Difficile Linked To Antibiotic UseA serious gastrointestinal condition is linked to antibioticuse, concludes a study byresearchers at Mayo Clinic inRochester.

In a study led by SahilKhanna, MBBS, a Mayo Clinicgastroenterologist, researchersfound that infections caused bythe bacterium Clostridium diffi-cile, also known as C. difficile,are becoming more commonand more severe in hospitalizedchildren and the elderly. Thestudy says this is due in largepart to greater use of antibi-otics.

C. difficile is the most com-mon cause of diarrhea in hospi-tals and can lead to life-threat-ening inflammation of thecolon. The condition is linkedto 14,000 U.S. deaths annually.

The study analyzed fiveyears of data from the NationalHospital Discharge Survey andfound that of an estimated 13.7 million hospitalized chil-dren, the 46,176 with C. difficileinfections had significantlylonger hospital stays, moreinstances of colon surgery,increased admission to long- orshort-term care facilities, and ahigher risk of death.

“Despite increased aware-ness of C. difficile in children

and advancements in manage-ment and prevention, thisremains a major problem inhospitalized children,” saysKhanna. The study also foundthat elderly patients also have a greater risk of complicationsfrom C. difficile and of dyingfrom the infection.

Researchers say increaseduse of antibiotics is a primaryreason for the increasing infec-tion rates. When a person takesantibiotics, good bacteria thatprotect against infection aredestroyed. When these bacteriaare destroyed, patients are vul-nerable to C. difficile picked upfrom contaminated surfaces orspread from a health careprovider’s hands.

Capsules from page 5

In personInboxWhen changes in the local health care landscape promised a major infl ux of new UCare members coming through metro-area clinics and hospitals, we made sure those providers were prepared. In a span of just two weeks, May Ly was among the UCare staff that personally visited 449 unique health care locations to offer a heads-up and explain the impacts. Because being responsive to our partners’ needs isn’t just talk—it’s what we mean by health care that starts with you.

| provider assistance: 1-888-531-1493 | ucare.org/providers | ©2012, UCare.

Cardiologist John Lesser, MD, has been namedpresident of the Society of CardiovascularComputer Tomography. Lesser serves as direc-tor of cardiovascular CT and MRI at the Minneapolis Heart Institute at Abbott North-western Hospital. He is also an adjunct associ-ate professor of medicine at the University ofMinnesota.

The American Society of Hematology hashonored University of Minnesota Medical

School blood and marrow transplant specialistBruce Blazar, MD, with the 2012 Ernest BeutlerLecture and Prize for his significant advances inthe field of bone marrow transplantation (BMT)and adoptive immunotherapy. Blazar is a Regents professor of pediatrics, chief of the Pediatric Blood and Marrow TransplantationProgram, and Andersen Chair in TransplantationImmunology at the U of M. He is internationallyrecognized as a foremost physician-scientist inthe field of BMT and also serves as founding director of the univer-sity’s Clinical and Translational Science Institute and the Center forTranslational Medicine. Blazar also was recently elected to member-ship in the Institute of Medicine. This is one of the highest honors inthe medical field, given to individuals who have demonstrated out-

standing professional accomplishments andcommitment to service.

Saravana Balaraman, MD, has joinedRiverView Health and will practice on the maincampus in Crookston, where he will specializein family medicine. Balaraman previously waschief resident of family medicine at Stamford(Conn.) Hospital. Prior to that, he completed ayear of specialty training in general surgery atProvidence Hospital in Southfield, Mich. Healso worked as a research scholar in otology.

Balaraman received his medical degree at JJM Medical College inDavangere, India. He did his postgraduate training in ear, nose, andthroat at Command Hospital (Indian Airforce), in Bangalore, India.

Essentia Health has added several physicians to its clinics inMinnesota. Theresa Weerts, MD, has joined the Family MedicineDepartment at Essentia Health St. Mary’s–Superior Clinic. Weertsattended medical school at Stritch School of Medicine at LoyolaUniversity in Maywood, Ill. She completed a family medicine resi-dency at Adventist Hinsdale Hospital in Hinsdale, Ill., and is board-certified in family medicine. Kristin Lusian, DO, has joined theFamily Medicine Department at Essentia Health–Ashland Clinic. Lusian received her doctorate in osteopathic medicine from DesMoines University. Brian Junnila, MD, has joined the EmergencyMedicine Department at Essentia Health–St. Mary’s Medical Center.He completed an emergency medicine residency at Detroit MedicalCenter and received his medical degree from Ross University Schoolof Medicine in Roseau, West Indies. Antonio Laudito, a cardiotho-racic surgeon, has joined the Essentia Health–St. Mary’s Heart andVascular Center. Laudito graduated from University of Turin (Italy)Medical School and completed his general surgery residency atMount Sinai Hospital in New York. Following his cardiothoracicsurgical residency at University of Miami–Jackson Memorial Hospi-tal in Florida, he completed a pediatric cardiac surgical residency at University of California, San Francisco. Ifeyinwa Igwe, MBBS,has joined the pain management team at Essentia Health–DuluthClinic. Igwe completed a residency at St. Luke’s–Roosevelt HospitalCenter in New York and a fellowship in pain and palliative care atMetropolitan Hospital in New York, as well as an internship and residency at North General Hospital in New York. Igwe received her bachelor of medicine, bachelor of surgery degree at the Univer-sity of Nigeria in Enugu.

M E D I C U S

John Lesser, MD

Bruce Blazar, MD

Saravana Balaraman, MD


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■ How did Hearts Beat Back—The Heart of NewUlm Project get started?

Dick Pettingill, who was CEO of Allina at that time,challenged the organization about what they weredoing to help communities. Two giant projectswere born out of Pettingill’s challenge; one of themwas the Backyard Initiative in the area aroundAllina headquarters in Minneapolis, and the otherone was The Heart of New Ulm Project.

Kevin Graham, MD, head of the MinneapolisHeart Institute at the time, was a cardiologist whostarted coming down here to New Ulm more than20 years ago. New Ulm had become really, reallygood at treating acute MIs. The issue became,“What can we do to push thetreatment upstream a little bit, toactually try to prevent early heartattacks and to prevent early-onset disease?”

New Ulm got in the mixbecause of Dr. Graham’s famil-iarity with the community here,but also because it’s a town of13,000 to 14,000, and over 90percent of the people here had amedical chart. When the project started in 2009,we were already three or four years into an elec-tronic medical record, which tied into AbbottNorthwestern Hospital and to the whole Allina sys-tem, so that we had an excellent ability to catchdata on people. With a relatively small town thathad a high percentage of people involved in ourmedical center here and who all had data on a cen-tralized medical record, it seemed like a great placeto step in and try to do a project like this.

■ What can you tell us about your role in the project?

The idea definitely came from Minneapolis andfrom Allina, but from the get-go there was atremendous amount of community involvementhere. Before I even got involved, there was a lot ofplanning with about 30-some people on the com-munity steering committee.

Then I was asked to join the project. What Iam charged to do is take what goes on at theresearch office, which is located at the HeartInstitute in Abbott Hospital in Minneapolis, andhelp coordinate that with the primary care andother provider staff here in New Ulm. We also havea staff of four to five people on the ground herewho are interacting with businesses, the schools,restaurant folks, and the community at large.

My job is to be the go-between and try to keepinformation flowing, find out how the providersand patients in the community here are reacting tothings and feed that information back to the peoplewho are designing the program. And then the otherway around, to take the information that designers[in Minneapolis] are giving me and try to get it outto the providers here, so that people know what’s

going on and can feel part of it. Even though the program did come from Allina, it’s been very important to us that it does not feel like theprogram is being imposed from somebody in thebig city.

■ The project is in its fifth year now. What are you finding?

This program started with a free public screeningin 2009. Over the course of about six to eightmonths we had a free screening program for every-body in the community over 18, and we have over5,000 people out of our adult population of 10,000who came through the screening.

We found that like much ofMinnesota and much of America,people were too overweight, tooinactive, and smoked too much.We used that as the initial datapool to look at what we set out to do here. The idea was torescreen every two years, so wedid another screening in 2011.

We found that we have beenable to make an impact on how

many people are smoking, how many people aretaking an aspirin a day, how many people at leastare involved in doing some kind of thing—whetherit is increasing their activity, or increasing thenumber of fruits and vegetables in their daily diet,or things like that.

One of the things that surprised me has beenawareness of the project. We had a phone survey acouple of years ago, and 94 percent of people inour area knew about the program.

I see this as trying to create a critical mass, achange in norms of behavior, be that smoking, gen-eral physical activity, choices in eating—both whatyou eat and how much you eat—to try to pushback the big glacier of what seems like the inevit-ability of rolling toward increased obesity andhigher cardiovascular risk.

■ The name of the community is on the project.Do people buy into it because of that?

Yes, they do. This is not a totally insular commun -ity, but it’s a small community and it has thisstrong German heritage—there is still a sense ofpride in being part of this community.

I think this is an ideal place to try this pro-gram. Racially, New Ulm is not a diverse commun -ity, but on the socioeconomic spectrum, it really isquite diverse. We have only one hospital and med-ical facility and most of the people have come hereat some point.

I think in a bigger community, where there arelots of hospitals and lots of different clinic entitiesand lots of different employers, you’re probablygoing to be working at finding groups that natu -rally coalesce, whether that’s a neighborhood com-munity or some other group that somehow identi-

Charles Stephens, MD The Heart of New Ulm Project

Hearts Beat Back—The Heart of New Ulm

Project is a campaign toreduce the number ofheart attacks in the New Ulm area over aperiod of 10 years.

The project is sponsoredby Allina Health, whichowns the community’shospital, the New Ulm

Medical Center. The Minneapolis Heart

Institute is another partner in the project.

As the project’s medical director,

Charles Stephens, MD,helps with the design

of clinical interventionsand serves as a liaisonbetween the project

planners and front-linepractitioners at NewUlm Medical Center.Stephens, a family

practice physician, is a graduate of the

University of California,San Francisco School of

Medicine.

Embracing better health


I N T E R V I E W

I see this as trying to create a critical mass,

a change in normsof behavior.

fies itself, where there is already some com-munity closeness.

One other surprising thing that I saw inour community was from the person whoworks specifically with stores and restau-rants. With convenience stores, when peoplecome and grab their coffee on the way towork, just making a little change at thecheckout helps, having healthy options rightthere, so that they have apples and bananasthat are priced the same or cheaper than thecandy bars and power bars.

We’re doing these things so that asyou’re there pulling your money out of yourwallet, you have a chance to grab an applethat costs 50 cents instead of $1.50, thesame price [as a candy bar] or less; givingyou a choice. The convenience stores havebeen really receptive to that and their salesof those things have significantly improved.I think things like that are easily exportableto a commun ity anywhere.

■ From the medical provider point of view, how do you encourage theirinvolvement?

Our program has been offering grandrounds, educational sessions every three tosix months, talking sometimes about thebread-and-butter stuff having to do with diabetes treatments, guidelines for lipidsand blood pressure, sometimes stretching ita bit further, looking at far-flung ideas in

epidemiology, and things like that. This isjust to keep people up on the subject. On theground, our group has incentive goals, somefinancial and some performance goals.

It’s the same critical mass phenomenonhere. We have had a lot more people whoare more comfortable pushing patients to dothings like take another antihypertensivemedication or to increase their dose of astatin to get the cholesterol level down, totake their aspirin when they’re in one of thedemographic groups.

There has definitely been a shift in howpeople see it, and I think people have beensurprised and gratified after taking a bitmore of an aggressive stance on the preven-tive treatment side.

■ What has been the most rewardingaspect of working on this project?

The most heartening for me has been theproject’s effect on people. You look atpatients who you’re afraid are walking timebombs, who you’re never going to do any-thing to help, and then they show up out ofthe blue and say, “Did you notice that I lost10, 20, 50, 80 pounds?” You just look atthem and say, “Wow.”

I have a great story. This fellow, whowas maybe in his late 40s, went to one ofthe screenings and was shocked to find hisblood pressure and cholesterol were way outof whack and he was overweight. I saw him

after that as a patient, and we started himon medication for blood pressure and forcholesterol and things. Then he had one follow-up and we saw that the medicationswere working, and then I didn’t see him fora long time.

I got a note from him saying, “I’mdoing well with my weight loss. I’m goingto quit taking the medicines and then Iwant to get retested and see how I’mdoing.” In one year, he had lost 98 pounds,he had gone off his cholesterol-loweringmedicine and one of his blood pressurepills, his cholesterol numbers were perfect,and his blood pressure was well controlledon one low dose of an inexpensive dailyblood pressure medication.

I said, “How’d you do it?” And he said,“You know, I just realized I needed tochange, so I eat less when I eat, and I don’teat between meals, and I just make sure I dosomething every day.”

You hear so many stories of, “Doc, it’sjust impossible.” And that’s probably true forsome people, but then you find a story likethat where somebody loses 100 pounds andhe loses the need for two medications andsays I feel better, and I don’t feel like I’vehad to make any huge sacrifices. To me,that’s what it’s all about, just having peoplebe able to go about their lives and feel a lit-tle bit better and not need to have so muchinteraction with medications.


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While sometimes makingthe healing process challenging,these characteristics of mooddisorders also create newopportunities as we think abouthow we educate medical andmental health professionals,patients, and the public.

Is there a better way?In 2011, our Departmentof Psychiatry and Psychol-ogy began planning a dis-tinctive continuing med-ical education experiencein collaboration with the Mayo School ofContinuous ProfessionalDevelopment and MayoClinic Center for Human-ities in Medicine. The lat-ter is a unique group that bringsmusic, dance, art, and theater toMayo and offers various human-ities-related selectives for MayoMedical School students.

As every physician knows,CME courses traditionallyinclude a lot of talks and pre-sentations in large, impersonallecture hall atmospheres. To

be sure, such courses certainlyhave their place, especiallywhen teaching the “science” of medicine. But what aboutwhen focusing on the “art” ofmedicine?

Our department began towonder: Is there a better wayto deliver some aspects of psy-chiatry and psychology CME?

By thinking outside the lecturehall, might we connect withmental health providers on amore human—and more effec-tive—level?

We arrived at the idea ofbringing psychiatry and psy-chology, particularly mood dis-orders, into the theater. Theaterseemed to fit well with mood

disorders because the stage hasalways been a place to explorelife stories—stories of hope andsadness, success and failure,love and hate, triumph andstruggle. When stories arebrought to life in the theater, we often get swept up in themoment, emerging emotionallycharged and with a fresh per-

spective on the topic at hand.

Mayo Clinic and the theaterWithin Mayo Clinic’s long his -tory of weaving the arts andhumanities into medicine aremany instances of theaterbeing used as a medium.During the 1980s, Mayo had anongoing series that broughtwell-known actors to Rochesterfor an evening performance,such as Jason Robards Jr. pre-senting staged readings from“The Iceman Cometh” andElaine Stritch presenting pas-sages from “Love Letters.”

One relationship that par-ticularly stands out is MayoClinic’s link to the GuthrieTheater in Minneapolis. Thisconnection goes back morethan a decade to 2001, whenveteran Guthrie actorNathaniel Fuller came to Mayofor a staged reading of “MollySweeney,” a play about a blindwoman, her husband, and hereye surgeon that touches onthe complexities inherent inthe doctor-patient relationship.

In 2006, Mayo Clinic andthe Guthrie presented a read-ing of the critically acclaimedplay “Miss Evers’ Boys,” whichrecounts the infamousTuskegee syphilis experiment.After the reading, a panel dis-cussion explored the seriousbioethical issues the studyraised. A similar reading-and-discussion format was used in2008 when British actorCharles Keating visited Mayo

to present the aging-focusedplay “I and I: The Sense ofSelf.”

The Guthrie has alsoworked with Mayo MedicalSchool and the Center forHumanities in Medicine on theweeklong selective course“Telling the Patient’s Story,”which has been held twice now

for Mayo medicalstudents and oncefor residents. In thecourse, Guthrie pro-fessionals teach act-ing and storytellingskills to participants,aiming to help themmaster the art ofeffective and empa-thetic patient inter-action. Students

sharpen their ability to listenmore effectively to patients andhome in on key points, thenreflect on that information anduse it to guide the next steps inthe patient’s diagnosis or treat-ment plan. Most importantly,they become better at sharingthat plan with the patient in away that makes sense andmotivates him or her to stick to it. This has been a very successful collaboration, withstudents saying they’ve found it very easy to put their newskills into practice with actualpatients.

But for our mood disorderscourse, we knew we had to domore than bring the theater toMayo Clinic. Mayo Clinic had to go to the theater.

Mood disorders take the stageDepression and bipolar disor-der met theater in May whenour department presented“Windows into Mood: Storiesof Depression and Mania” atthe Guthrie. In putting the day-long CME course together, weaimed to combine the scienceand art of mood disorders for abroad audience.

For medical and mentalhealth professionals interestedin learning more about the ill-nesses, there were conventionalscientific talks on mania, mind-fulness and depression, familysupport strategies, mood disor-ders in children and teens, andthe need for earlier interven-tion and prevention.

Art from cover


When stories are brought to life in the theater, we often get swept

up in the moment, emerging emotionally charged and with a fresh

perspective on the topic at hand.

The “art” came by way ofpatient stories and performan -ces that were interspersedthroughout the course. Formost of the clinicians, this wasa first in all their years ofattending CME courses. Thesestories and performances alsogave the patients in attendancea fresh outlook on their ongo-ing recovery, whileinspiring families andfriends to see theirloved one’s mood dis-order in a new light.

Bringing bipolar disorder to lifeKay Redfield Jamison,PhD, the Dalio FamilyProfessor in MoodDisorders and co-direc-tor of the Mood DisordersCenter at Johns HopkinsHospital in Baltimore, gave thekeynote talk on creativity andmood disorders. As she detailedthe complex interplay betweencreativity and madness, shehighlighted several famous writ-ers, poets, and artists whoexhibited signs of mood disor-ders, including Edgar Allan Poe,Ernest Hemingway, VirginiaWoolf, and Vincent van Gogh.Jamison brought a unique per-spective to the course, as sheboth studies these illnesses as aclinician-researcher and haspersonally battled bipolar disor-der since her late 20s. She haschronicled her experience withthe illness in “An Unquiet Mind:A Memoir of Moods andMadness,” one of her severalbooks.

We also welcomed actressand writer Mary Pat Gleason, aMinnesota native who chan-neled her struggle with bipolardisorder into “StoppingTraffic,” a one-woman play sheperformed during the course.The play’s title comes from alife event, in which her bipolardisorder once led her to believeshe could step into Los Angelestraffic—and stop it.

Attendees also heard fromMark Meier, executive directorof the Face It Foundation, aMinneapolis-based organiza-tion that helps men recognizeand address their depression.The foundation grew out ofMeier’s own long and some-

times chilling fight withdepression, an illness thatpushed him to the brink of sui-cide. As he sat with a loadedgun in his mouth one night, itwas his baby daughter’s loudcries that pulled him back fromthe edge, opening the door forhim to start his path to recov-ery. Today, in addition to lead-

ing Face It, Meier is a licensedclinical social worker, anadjunct faculty member andresearcher at the University of Minnesota, and a frequentspeaker on depression.

Looking aheadParticipant feedback told usthat “Windows into Mood” wasa well-received and effectivecourse. What seemed to workparticularly well was the waythat the latest science, includingnew imaging and clinical trialdata, was linked to intimatelypersonal perspectives and testi-monials. One medical profes-sional called it “the best CMEcourse I have ever been to.”

Another attendee, a womanwho had been successfullytreated for bipolar disorder,really connected with Mary PatGleason’s play. In the question-and-answer session after theperformance, this attendeestood up and relayed her per-sonal experience with bipolardisorder to the entire audience.This was after not feeling com-fortable enough to share herstory with a few fellow atten-dees during lunch.

So where do we go fromhere? Recognizing the successof “Windows into Mood,” ourdepartment will again collabo-rate with the Guthrie when thetheater brings Eugene O’Neill’s“Long Day’s Journey intoNight” to the stage in January2013. This Pulitzer Prize- winning play chronicles a

family’s struggle with addic-tions, another key focus area inour Department of Psychiatryand Psychology.

My colleague TimothyLineberry, MD, is directing the Mayo Clinic CME event“Windows into Hope: Stories ofAddiction and Recovery” on Saturday, Jan. 26, 2013.

National experts will providefast-paced education before thematinee performance, and afterthe show they’ll discuss theimpact and treatment of addic-tions through the lens of theplay. Also joining us will beactress Melissa Gilbert, whohas successfully overcomeaddiction.

As with “Windows intoMood,” course participants canexpect a blend of science andart aimed at a wide audience,from updates on the neurobiol-ogy and treatment of addictionto patient stories and experi-ences. Addictions, like mooddisorders, often carry a certainsocial stigma, so we see an

addictions-focusedCME event tied to“Long Day’s Journeyinto Night” as an excel-lent opportunity to con-tinue exploring the ben-efits and possibilities oftheater-based continu-ing medical educationin psychiatry and psy-chology.

Mark A. Frye, MD, is chair of theDepartment of Psychiatry andPsychology at Mayo Clinic in Rochester.He is also director of the Mayo ClinicDepression Center, a member of theNational Network of Depression Centers.

The author wishes to acknowledge theassistance of Matthew Sluzinski in thepreparation of this article.


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What seemed to work particularly wellwas the way that the latest science,

including new imaging and clinical trialdata, was linked to intimately personal

perspectives and testimonials.

complaint. One was diabetic, theother was not; I had ordered thehypoglycemic agent for thewrong patient.

As I changed the order tothe correct patient, the nursepolitely averted her gaze. Ishared with the patient that hehad had a “little spell,” but thathe would be fine. I did not com-municate with his family. I rue-fully shared my experience witha trusted colleague, whose re -sponse was, “Been there, donethat!” I did not consider sharingmy experience more widely; theculture of the time led me tobelieve that could have resultedin an uncomfortable and poten-tially punitive response for meand the nursing staff.

Fast-forward 22 years. I’mserving as the director of med-ical affairs at another ruralMinnesota hospital. A patient isdealing with a frustrating,chronic problem that is defyingresolution. By chance, we dis-cover that the normal range wehad calculated for a lab test wasoff by a factor of 10. The patientultimately does well, but her

course is affected due to thiserror.

The staff member who hadperformed the calculation wasmortified. Investigation revealedthe action to be simple humanerror within a system that wasnot designed to deal with theinevitability of such errors. Afterreviewing the event, we changedour process so that all such cal-culations must be independentlyperformed by two people, con-firming matching results. Wemet with the patient and spouseand explained what had hap-pened and what we had done tominimize the risk of it happen-ing again.

The two very differentresponses to these error eventsdemonstrate a profound culturechange—one that stresses learn-ing and accountability over pun-ishment and blame.

A perspective of shared responsibility

Historically, health care hasbeen a punitive culture. Twenty-five years ago, sharing my expe-rience so that others could learnand improve didn’t occur to me.

The way we addressed such inci-dents was to minimize or dis-count them as aberrations, or todiscipline those involved, as acautionary tale to others. Overtime, however, we realized thatthat approach was resulting inthe loss of invaluable learningopportunities. We then migratedto a “blame-free” culture, inwhich all errors were assumedto be system-based and individ-ual accountability assumed lessimportance. But in fact, peopledo make choices about theirbehavior, and a level of account-ability is necessary.

Enter Just Culture, a riskmodel for dealing with errorwithin organizations. AtHutchinson Area Health Care,we began learning about thismodel of care eight years agowhen we joined two otherMinnesota health care organiza-tions in a collaborative withDavid Marx, JD, a systems engi-neer who was working to trans-late Just Culture from the aero-space and transportation indus-tries to health care.

Many people think thisapproach to safe care is simply

“doing the right thing.” It is thatand much more. Rather thanbeing simply a reset of where weare on the “punitive” to “blame-less” continuum, this modellooks at issues of risk and errorfrom the perspective of sharedaccountability for patient safetyand risk reduction. The organi-zation is responsible for creatinga safe system; the individual isresponsible for the quality of thechoices he or she makes.

System improvement isaddressed through the organiza-tional quality improvementprocess, such as our organiza-tion’s PDSA (Plan-Do-Study-Act)model.

Individual choices are dealtwith in a prescribed, rigorousprocess. The Just Culture “algo-rithm” identifies three categoriesof behaviors that breach theorganization’s policies: HumanError, At Risk, and Reckless.Response to Human Errorbehavior, unless it occurs repeat-edly, is to console the employeeand address system issues. AtRisk behavior, which in someinstances may be justified, gen-erally requires additional coach-


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ing and, sometimes, remedialaction. Reckless behaviorrequires discipline or termina-tion. For example:• Pulling a lab report from a

printer and placing it on thewrong chart would be anexample of a Human Error.

• Drawing up a parenteral pedi-atric medication and not dou-ble-checking it with anotherRN before administration, perorganizational policy, would beAt Risk behavior (potentiallyjustified in rare instances).

• Performing an act intended toinjure a patient is Recklessbehavior.

Adopting the model

Our organizational leadershipgroup was fairly quick to graspthese principles; looking at inci-dents and errors through thatlens has become nearly secondnature for this group. Movingthose principles into our med-ical staff and peer review pro -cesses has been more challeng-ing and remains a work inprogress.

One challenge is that physi-cian peer review has long suf-

fered from outcome bias; theseverity of an error and the cul-pability of a physician tradition-ally have been determined bythe ultimate impact on a patient.For example, if a surgeon refus-es to participate in a “time out”protocol and an error occurs butthere is no adverse outcome (aswill be the case at least 99.9 per-cent of the time), the naturaltendency for the medical staff isto deal with it quite differentlythan if the outcome is a wrong-site surgery. Under the JustCulture model, both scenarioswould constitute at-risk behaviorand would be dealt with bycoaching the physician andpotentially disciplining him orher if there was continued non-compliance. This approach runscounter to the medical commu-nity’s historical cultural andintuitive response.

If these concepts are chal-lenging in our medical staff con-text, they are even more so inexternal environments such asthe media and the law, whereoutcome bias is also alive andwell. Malpractice allegations,especially as they are played out

in the media and the courtroom,starkly reveal that the principlesof Just Culture are not universal-ly accepted. It can be difficult tohold to these principles withinour organizations in the face ofsuch outside pressures. We cando our best to try to educatethese constituencies, but oftenwe must just accept that therules in these arenas are differ-ent and are unlikely to changeany time soon.

Impact on care

Learning these principles andembedding them in our organi-zation and medical staff hasrequired commitment andresources, but it has been worththe effort. Now, staff and physi-cians more often see their workthrough the lens of risk aware-ness and reduction, rather thanone of self-preservation and fear.

As the concepts of JustCulture have become more wide-ly accepted in medicine, thisorganizational model is havingan impact. Recently, a colleaguerelated an experience with apatient he had referred to a terti-ary center. As the patient was

being prepared for discharge,the attending physician at thereferral hospital called to updatethe referring physician on thepatient’s hospital course and fol-low-up plans. He also relatedthat the patient’s stay had beenprolonged due to a medicalerror. As the attending wasentering admission orders intothe electronic health record, hehad added an extra digit to aninsulin order, resulting in hypo-glycemia, a seizure, and transferto the ICU. This error had beendisclosed to the patient and fam-ily, as well as to my colleague,and a root cause analysis wasinitiated to learn how to preventor mitigate the impact of aninevitable human error like this.

What a poignant bookend tomy experience from 25 yearsago! On the one hand, humanshaven’t changed—we still makeerrors. On the other hand, we’vecome such a long way in learn-ing from those errors and reduc-ing their frequency and impact.It is our responsibility to do noless.

Steven Mulder, MD, is president andCEO of Hutchinson Area Health Care.


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M E D I C I N E A N D T H E L A W

The “Sunshine Act” cer -tainly sounds pleasant,but don’t be fooled by the

name. It is a powerful tool forprosecutors. The PhysicianPayments Sunshine Act wassigned into law by PresidentObama in March 2010 as part of the Patient Protection andAffordable Care Act (ACA), andwill take effect Jan. 1, 2013. The act requires drug and devicecompanies to report almost anypayment or transfer of value tophysicians of over $10. Thesereports will be made publiclyavailable on a government website, and recipients of suchpayments will be identified byname. There are large fines foreach unreported payment, sodrug and device companies have incentive to be thorough in their reporting. The SunshineAct also makes it much easierfor prosecutors to identify trans-actions that violate these federalstatutes, including the federalAnti-Kickback Statute (AKS),the False Claims Act, and Stark Laws.

The Sunshine Act is a game changer

With unprecedented breadth andtransparency, the Sunshine Actrequires pharmaceutical, device,biological, and other medical

supply companies whose prod-ucts are paid for by governmenthealth care programs (“coveredmanufacturers”) to report pay-

ments or transfers of value tophysicians or teaching hospitalsfor consulting, nonconsultingservices, honoraria, gifts, enter-tainment, travel, food, research,charitable contributions, royal-

ties or licenses, ownership orinvestment interests, faculty orspeaker compensation, grants,and anything else required byHealth and Human Services(HHS). There are several excep-tions to the reporting require-ments, including paymentsunder $10 (or $100 aggregatedannually), product samples, edu-cational materials for patients,certain medical device loans,warranties, discounts or cashrebates, transfers of value tophysician patients, charity careitems, dividends from a publiclytraded security fund, employeehealth care coverage, nonmed-ical professional services, andlegal services. HHS will makethis reported data publicly avail-able on a government website.

The first report is dueMarch 31, 2013. The reports will identify the covered recipi-ent by name, and both coveredmanufacturers and coveredrecipients have 45 days to cor-rect any information provided toHHS before it is made public.Covered manufacturers facelarge fines for each unreportedpayment—up to $100,000 foreach instance, meaning thatdrug and device manufacturersare unlikely to be noncompliant.Nevertheless, physicians shouldguard themselves against inac-

curate reports; but, more impor-tantly, they should identify andeliminate risky transactions withdrug and device manufacturers.Though physicians are not sub-ject to fines under the SunshineAct, they are subject to civil andeven criminal penalties underthe AKS, the False Claims Act,and the Stark Law. Increasedtransparency under the Sun-shine Act may allow prosecutorsto identify transactions that vio-late these federal statutes.

Now that federal prosecu-tors will have easy access to thedetails of almost every paymentmade to physicians from cov-ered manufacturers, physicianswho intentionally or inadver -tently walk the line in their rela-tionships with these companiesmay end up on the wrong side of the law. Beyond being armedwith knowledge and honestlyidentifying risky arrangements,physicians must also take practi-cal steps now to prepare formore “sunlight” and to navigatethe still-evolving rules of thegame.

Existing federal law interactionwith the Sunshine Act

The state and federal reportingrequirements are sure to garnerheightened scrutiny, not only bythe press and public, but alsoregulators and prosecutors. TheAKS prohibits any remunerationto physicians for speaking, travel, consulting, or other serv-ices if the payment is intendedto induce the physician to pre-scribe a medication or devicethat is paid for by Medicare orMedicaid. If a physician know-ingly or willfully solicits orreceives payments, it is a felonyunder the AKS and carries civilpenalties. Under the ACA, AKSviolations can result in FalseClaims Act violations, whichcarry criminal and civil penaltiesof $5,000–$10,000 per violation.

Physicians should take stepsto insulate themselves from liability by understanding andstrictly adhering to theserequirements, including the AKS“safe harbors” described by theOffice of Inspector General(OIG), which protect certainpayments and business arrange-ments from criminal and civil

Sunshine and scrutiny

Managing compliance with the ACA’s Sunshine provisions from

a provider perspective

By David M. Aafedt, JD, and Christianna L. Finnern, JD


SUNSHINE to page 18

The act requires drug and device companiesto report almost any payments or transfer

of value to physicians of over $10.



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 treat-ment-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 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 gly-cemic 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. In clinical trials of Victoza®, there were more cases of pancreatitis with Victoza® than with comparators. Victoza® has not been studied sufficiently in patients with a history of pancreatitis to determine whether these patients are at increased risk for pancreatitis while using Victoza®. Use with caution 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 insulin has not been studied.CONTRAINDICATIONS: Victoza® is contraindicated in patients with a personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).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 relevant 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 receiv-ing 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 [see Boxed Warning, Contraindications]. In the clinical trials, there have been 4 reported cases of thyroid C-cell hyperplasia among Victoza®-treated patients and 1 case in a compara-tor-treated patient (1.3 vs. 0.6 cases per 1000 patient-years). One additional case of thyroid C-cell hyperplasia in a Victoza®-treated patient and 1 case of MTC in a comparator-treated patient have sub-sequently been reported. This 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. Four of the five liraglutide-treated patients had elevated calcitonin concentrations at baseline and throughout the trial. One liraglutide and one non-liraglutide-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 reference 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 fre-quently 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 consis-tent 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 calci-tonin <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, calcitonin 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 ultrasound 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 evalua-tion. 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. Pancreatitis: In clinical trials of Victoza®, there were 7 cases of pancreatitis among Victoza®-treated patients and 1 case among comparator-treated patients (2.2 vs. 0.6 cases per 1000 patient-years). Five cases with Victoza® were reported as acute pancreatitis and two cases with Victoza® were reported as chronic pancreatitis. In one case in a Victoza®-treated patient,

pancreatitis, with necrosis, was observed and led to death; however clinical causality could not be established. One additional case of pancreatitis has subsequently been reported in a Victoza®-treated patient. Some patients had other risk factors for pancreatitis, such as a history of cholelithiasis or alcohol abuse. There are no conclusive data establishing a risk of pancreatitis with Victoza® treatment. After initiation of Victoza®, and after dose increases, observe patients carefully for signs and symptoms 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 suspected, Victoza® and other poten-tially suspect medications should be discontinued promptly, confirmatory tests should be performed and appropriate management should be initiated. If pancreatitis is confirmed, Victoza® should not be restarted. Use with caution in patients with a history of pancreatitis. Use with Medications Known to Cause Hypoglycemia: Patients receiving Victoza® in combination with an insulin secretagogue (e.g., sulfonylurea) may have an increased risk of hypoglycemia. In the clinical trials of at least 26 weeks duration, hypoglycemia requiring the assistance of another person for treatment occurred in 7 Victoza®-treated patients and in two comparator-treated patients. Six of these 7 patients treated with Victoza® were also taking a sulfonylurea. The risk of hypoglycemia may be lowered by a reduction in the dose of sulfonylurea or other insulin secretagogues [see Adverse Reactions]. 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 [see Adverse Reactions]. 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 [see Adverse Reactions]. Some of the reported events occurred in patients receiving one or more medica-tions 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 causative agents, including Victoza®. Use caution when initiating or escalating doses of Victoza® in patients with renal impairment. Macrovascular Outcomes: There have been no clinical studies establishing con-clusive 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 compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of Victoza® was evaluated in a 52-week monotherapy trial and in five 26-week, add-on combination therapy trials. In the monotherapy trial, patients were treated with Victoza® 1.2 mg daily, Victoza® 1.8 mg daily, or glimepiride 8 mg daily. In the add-on to metformin trial, patients were treated with Victoza® 0.6 mg, Victoza® 1.2 mg, Victoza® 1.8 mg, placebo, or glimepiride 4 mg. In the add-on to glimepiride trial, patients were treated with Victoza® 0.6 mg, Victoza® 1.2 mg, Victoza® 1.8 mg, placebo, or rosiglitazone 4 mg. In the add-on to metformin + glimepiride trial, patients were treated with Victoza® 1.8 mg, placebo, or insulin glargine. In the add-on to metformin + rosiglitazone trial, patients were treated with Victoza® 1.2 mg, Victoza® 1.8 mg or placebo. 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 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. 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. Tables 1, 2 and 3 summarize the adverse events reported in ≥5% of Victoza®-treated patients in the six controlled trials of 26 weeks duration or longer.Table 1: Adverse events reported in ≥5% of Victoza®-treated patients or ≥5% of glimepiride-treated patients: 52-week monotherapy trial

All Victoza® N = 497 Glimepiride N = 248Adverse Event Term (%) (%)Nausea 28.4 8.5Diarrhea 17.1 8.9Vomiting 10.9 3.6Constipation 9.9 4.8Upper Respiratory Tract Infection 9.5 5.6Headache 9.1 9.3Influenza 7.4 3.6Urinary Tract Infection 6.0 4.0Dizziness 5.8 5.2Sinusitis 5.6 6.0Nasopharyngitis 5.2 5.2Back Pain 5.0 4.4Hypertension 3.0 6.0

Table 2: Adverse events 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 Trial

All Victoza® +Metformin N = 724

Placebo + Metformin N = 121

Glimepiride + Metformin N = 242

Adverse Event Term (%) (%) (%)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 Trial

All Victoza® +Glimepiride N = 695

Placebo + Glimepiride N = 114

Rosiglitazone + Glimepiride N = 231

Adverse Event Term (%) (%) (%)Nausea 7.5 1.8 2.6Diarrhea 7.2 1.8 2.2


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 treat-ment-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 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 gly-cemic 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. In clinical trials of Victoza®, there were more cases of pancreatitis with Victoza® than with comparators. Victoza® has not been studied sufficiently in patients with a history of pancreatitis to determine whether these patients are at increased risk for pancreatitis while using Victoza®. Use with caution 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 insulin has not been studied.CONTRAINDICATIONS: Victoza® is contraindicated in patients with a personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).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 relevant 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 receiv-ing 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 [see Boxed Warning, Contraindications]. In the clinical trials, there have been 4 reported cases of thyroid C-cell hyperplasia among Victoza®-treated patients and 1 case in a compara-tor-treated patient (1.3 vs. 0.6 cases per 1000 patient-years). One additional case of thyroid C-cell hyperplasia in a Victoza®-treated patient and 1 case of MTC in a comparator-treated patient have sub-sequently been reported. This 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. Four of the five liraglutide-treated patients had elevated calcitonin concentrations at baseline and throughout the trial. One liraglutide and one non-liraglutide-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 reference 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 fre-quently 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 consis-tent 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 calci-tonin <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, calcitonin 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 ultrasound 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 evalua-tion. 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. Pancreatitis: In clinical trials of Victoza®, there were 7 cases of pancreatitis among Victoza®-treated patients and 1 case among comparator-treated patients (2.2 vs. 0.6 cases per 1000 patient-years). Five cases with Victoza® were reported as acute pancreatitis and two cases with Victoza® were reported as chronic pancreatitis. In one case in a Victoza®-treated patient,

pancreatitis, with necrosis, was observed and led to death; however clinical causality could not be established. One additional case of pancreatitis has subsequently been reported in a Victoza®-treated patient. Some patients had other risk factors for pancreatitis, such as a history of cholelithiasis or alcohol abuse. There are no conclusive data establishing a risk of pancreatitis with Victoza® treatment. After initiation of Victoza®, and after dose increases, observe patients carefully for signs and symptoms 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 suspected, Victoza® and other poten-tially suspect medications should be discontinued promptly, confirmatory tests should be performed and appropriate management should be initiated. If pancreatitis is confirmed, Victoza® should not be restarted. Use with caution in patients with a history of pancreatitis. Use with Medications Known to Cause Hypoglycemia: Patients receiving Victoza® in combination with an insulin secretagogue (e.g., sulfonylurea) may have an increased risk of hypoglycemia. In the clinical trials of at least 26 weeks duration, hypoglycemia requiring the assistance of another person for treatment occurred in 7 Victoza®-treated patients and in two comparator-treated patients. Six of these 7 patients treated with Victoza® were also taking a sulfonylurea. The risk of hypoglycemia may be lowered by a reduction in the dose of sulfonylurea or other insulin secretagogues [see Adverse Reactions]. 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 [see Adverse Reactions]. 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 [see Adverse Reactions]. Some of the reported events occurred in patients receiving one or more medica-tions 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 causative agents, including Victoza®. Use caution when initiating or escalating doses of Victoza® in patients with renal impairment. Macrovascular Outcomes: There have been no clinical studies establishing con-clusive 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 compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of Victoza® was evaluated in a 52-week monotherapy trial and in five 26-week, add-on combination therapy trials. In the monotherapy trial, patients were treated with Victoza® 1.2 mg daily, Victoza® 1.8 mg daily, or glimepiride 8 mg daily. In the add-on to metformin trial, patients were treated with Victoza® 0.6 mg, Victoza® 1.2 mg, Victoza® 1.8 mg, placebo, or glimepiride 4 mg. In the add-on to glimepiride trial, patients were treated with Victoza® 0.6 mg, Victoza® 1.2 mg, Victoza® 1.8 mg, placebo, or rosiglitazone 4 mg. In the add-on to metformin + glimepiride trial, patients were treated with Victoza® 1.8 mg, placebo, or insulin glargine. In the add-on to metformin + rosiglitazone trial, patients were treated with Victoza® 1.2 mg, Victoza® 1.8 mg or placebo. 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 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. 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. Tables 1, 2 and 3 summarize the adverse events reported in ≥5% of Victoza®-treated patients in the six controlled trials of 26 weeks duration or longer.Table 1: Adverse events reported in ≥5% of Victoza®-treated patients or ≥5% of glimepiride-treated patients: 52-week monotherapy trial

All Victoza® N = 497 Glimepiride N = 248Adverse Event Term (%) (%)Nausea 28.4 8.5Diarrhea 17.1 8.9Vomiting 10.9 3.6Constipation 9.9 4.8Upper Respiratory Tract Infection 9.5 5.6Headache 9.1 9.3Influenza 7.4 3.6Urinary Tract Infection 6.0 4.0Dizziness 5.8 5.2Sinusitis 5.6 6.0Nasopharyngitis 5.2 5.2Back Pain 5.0 4.4Hypertension 3.0 6.0

Table 2: Adverse events 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 Trial

All Victoza® +Metformin N = 724

Placebo + Metformin N = 121

Glimepiride + Metformin N = 242

Adverse Event Term (%) (%) (%)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 Trial

All Victoza® +Glimepiride N = 695

Placebo + Glimepiride N = 114

Rosiglitazone + Glimepiride N = 231

Adverse Event Term (%) (%) (%)Nausea 7.5 1.8 2.6Diarrhea 7.2 1.8 2.2

prosecution. This applies equallyto the Stark Law, which pro-hibits referrals by physicians toentities in which they or theirimmediate family members havea financial interest. [TheSunshine Act could implicateStark because it requires publicdisclosure of physician invest-ment or ownership interests indrug or device companies.]These federal laws mean that theincreased transparency requiredby the Sunshine Act carries bigimplications for physicians.

Minnesota’s PhysicianGift-Ban Act and federal law

Practitioners in Minnesotaalready have experience withsunshine laws. In 1993,Minnesota became the first stateto enact laws regulating gifts toproviders from pharmaceuticalmanufacturers or wholesaledrug distributors. The lawdefines “practitioner” to includedoctors of medicine, doctors ofosteopathy duly licensed to prac-tice medicine, as well as doctorsof dentistry, optometry, podiatry,

and veterinary medicine (Minn.Stat. §151.01, subd. 23, 2011).The Physician Gift-Ban Act bansgifts from manufacturers orwholesale drug distributors, or

their agents, to “practitioners,”excluding such things as drugsamples, items with a combinedretail value of less than $50 (percalendar year), payments tomedical conference sponsors,and reasonable honoraria.

Under the law, companiesmust file a publicly availableannual report to the Board ofPharmacy (Board), detailingpayments to identified recipientstotaling over $100 per year tosponsors of educational pro-grams, for honoraria, or for pro-fessional or consulting services.Requests for access to the datahave been few, and Minnesota’sreporting requirements are farless stringent than the SunshineAct, meaning that Minnesotaphysicians who receive pay-ments from device manufactur-ers will face a new level of scru-tiny when the federal SunshineAct reports are published (seeJoseph S. Ross et al., Pharma-ceutical company payments tophysicians: early experienceswith disclosure laws in Vermontand Minnesota, JAMA 2007;297(11):1216, 1218).

Prepare to face the light

Physicians must prepare for theSunshine Act’s implementationby understanding the specificsof their interactions with cov-

ered manufacturers and identify-ing all areas of potential risk,including consulting agree-ments, purchasing deals,research funding, speaker hono-raria, and the like. High-volumeproviders or physicians on for-mulary committees should beespecially vigilant because theyare enticing targets for prosecu-tors looking to make headlines.In addition, physicians shouldtake practical steps now to pre-pare for the new disclosurerules.

Practices should prepare aSunshine Act compliance policy,including, for example, a harddollar limit on payments fromcovered manufacturers, recog-nizing that patients, competi-tors, and prosecutors now haveaccess to the records of thesepayments. If the physician isconfident that all arrangementswith a covered manufacturer arelegitimate and represent fairmarket value, existing arrange-ments may be safe. Substantialconsulting agreements and pur-chasing contracts for drugs andequipment must be evaluated forfairness. A legal opinion may beadvisable for large contracts. Acopy of the compliance programshould be attached to consultingagreements, and, most impor-tantly, a physician should objec-


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Highlights from an interview with Minnesota’s “Physician Gift-Ban” regulator

We recently had the opportunity to interview theperson responsible for administering and enforcingMinnesota’s “Physician Gift-Ban,” Cody Wiberg,PharmD, the executive director of the MinnesotaBoard of Pharmacy (Board). Here are key take-aways from the interview:• Minnesota has never taken action against anyone

for improper or inadequate reporting, or for failure to report. To Dr. Wiberg’s knowledge, there have not been any major reporting issueswarranting discipline.

• The Legislature has not provided the Board withresources to audit the reports and compare themwith the actual payments made by regulated companies, so it is possible that some reports areinaccurate.

• Notwithstanding the absence of funding, theBoard does not believe any large companies are noncompliant.

• If the Board did find that a smaller company didnot report, the Board would likely not disciplinethe company but simply send a letter asking thecompany to comply.

• The Board has never disciplined a company forviolating the partial gift ban.

• Dr. Wiberg noted that, candidly, it would be difficult to uncover violations of the law unless a

competitor of the company alerted the Board or ifthere was a whistleblower at the provider’s office,clinic, or hospital.

• Dr. Wiberg believes the partial gift ban and thepublicity surrounding it has changed the behaviorof companies within the state. He believes thatcompanies are no longer providing dinners tophysicians at educational/promotional events andare no longer providing lunches.

• After an article appeared in the Journal of theAmerican Medical Association, the Boardreceived numerous requests for the paymentreports from doctors, clinics, and hospitals all theway back to the date the law took effect. Dr.Wiberg said that physicians were concerned tosee what was publicly reported about their rela-tionships with companies.

• Dr. Wiberg is often asked whether the partial gift ban and reporting requirements led to anincreased use of generic drugs. He said that while the state Medicare agency has seenincreased prescriptions for generic drugs (he said generic drugs make up 70 percent of thetotal, versus 60 percent a few years ago), he isnot sure it is because of this particular lawbecause there are so many variables at play.

tively assess whether his or herprescribing habits could appearto be influenced by any sucharrangements.

As with many state and federal laws, a Sunshine Actcompliance policy can be a mitigating factor if a violationoccurs. But merely having a policy is not enough. If, duringthe course of an investigation,an employee cannot describe the policy—or, worse, does notknow of the policy—the practicemay as well not have one at all.Practice managers and physi-cians must set the tone from the top; employees should betrained on the policy when they are hired, and trained andtested on it periodically there-after. The behavior of the entirestaff either implicates or pro-tects physicians from liabilityunder these statutes.

Although employee satisfac-tion is often overlooked as anissue relating to compliance,creating a positive atmospherewhere employees feel supportedand appreciated is a smart com-pliance strategy for physicians toemploy. If employees do leave,

exit interviews should be con-ducted and any concerns imme-diately addressed. Other-wise,disgruntled employees canbecome qui tam plaintiffs.

Designating a single pointof contact to control and moni-tor practice interaction withdrug and device companies isanother practical way to facili-tate compliance with theSunshine Act. This person canpolice interactions and trackremuneration passing to eachphysician. For example,although physicians have 45days after data is re ported toHHS to submit corrections,physicians should request andreview this data well before it is reported. This will allowphysicians more time to evalu-ate the data before it is madepublic and immediately addressinaccuracies.

Kickbacks from sales repre-sentatives historically have beenproblematic and will be evenmore so under the Sunshine Act.Physicians must be brutally hon-est in assessing relationshipswith sales representatives, andmust be careful to avoid kick-backs or the appearance of akickback. For example, a med-ical education conference in Las Vegas may be legitimatelyaimed at education, and LasVegas may be the most cost-effective location for the drug or device company to hold theconference. But if it looks inap-propriate, physicians shouldeither step away or clearly docu-ment why it is in compliancewith federal law.

Take control now

The Sunshine Act’s reportingrequirements do create addi -tional risks for physicians.Physicians should not rely onthe reports by the drug anddevice companies, but shouldverify that the information beingsupplied is correct before thereports are even published.Physicians should take controlnow, by arming themselves withknowledge, evaluating theirarrangements with covered man-ufacturers, and taking practicalsteps to ensure their compliancewith federal law.

David M. Aafedt, JD, is a shareholderat Winthrop & Weinstine, PA, where hepractices in the areas of health care regu-latory law and health care litigation. As aformer Assistant Attorney General, he rep-resented the Minnesota departments ofcommerce and health. Christianna L.Finnern, JD, is a shareholder atWinthrop & Weinstine, PA, and focusesher practice on health care regulatorycompliance and complex commercial andhealth care litigation.

The authors acknowledge and thankElizabeth R. Malay for her valuable assis-tance with this article.


Physicians must take practical steps now to prepare for more “sunlight” and to navigate the still-evolving

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

The recent Supreme Courtdecision to uphold theAccountable Care Act was

significant, but the transforma-tion of health care in the UnitedStates is already underway.Accountable care organizationsalready cover most of Minne-sota, and there has been a mas -sive investment in infrastruc-ture, data warehouses, and newmodels of care. We will notreturn to paper records, nor willwe stop the momentum towardpayment for value rather thanpay for volume. In short, thereform ship has already sailed,and it will not be sunk or turnedback by the Supreme Court,politicians, or the outcome ofthe 2012 presidential election.

For the past several decades,the American health system hasbeen plagued by major break-downs in quality, cost, access,and population health. Butdespite the hard work and dedi-cation of physicians, nurses, andother health care workers, theAmerican health system isfalling farther and farther be -hind other countries in terms ofhealth care value. The problemhas not been about the pro -viders; the real problem hasbeen about the design of thecurrent system.

Peter Senge, the preeminentexpert on system theory, hasremarked, “Every system is ide-ally designed to achieve the out-comes it is achieving.” Since thepassage of the Medicare andMedicaid bill in 1965, the U.S.has been paying for volume: themore medical procedures per-formed, the more revenue pro-duced. That business model/system was ideally designed to produce too much, at too littlequality, at too much cost. It was not designed to keep peoplehealthy or to manage theirchronic illnesses, or even to giveeveryone access to basic healthservices. In 2012, approximately50 million people lack healthinsurance; quality and patientsafety are inconsistent; healthcare costs are the leading causeof bankruptcy; and, if diabetesgrowth rates continue, one-thirdof our population may have thedisease in 20 years. The healthsystem that produced theseresults cannot be adequatelytweaked; instead, it requires fundamental redesign.

A new model: pay for value

While the 2012 Supreme Courtdecision basically upheld thefederal government’s ability totax individuals or companiesthat fail to buy or provide healthinsurance, the Court struck

down the mandate for stateMedicaid programs to expandtheir coverage to every familywith income lower than 138 per-cent of the federal poverty level.This gives states the option oftaking the federal money forMedicaid at a matching ratio ofapproximately 20 to 1, or refus-ing to participate. Minnesota hasalready chosen to opt into theprogram, but other states haveexpressed a refusal to partici-pate. The money for the ex -panded insurance program tocover 32 million new peoplecomes from the health insurancemandates and the expandedMedicaid coverage.

The new U.S. health caremodel, called Pay for Value, isbased on this formula: V (value)= Q (quality) plus S (Service)divided by C (cost). Physicians,hospitals, and other providerswill be paid for documentedquality scores, documentedpatient satisfaction scores, anddocumented cost. They will befinancially rewarded for high-quality, low-cost care and will bepenalized for poor, high-costcare and hospital readmissions.

The role of ACOs

Accountable care organizations(ACOs) are at the core of theAmerican reform movement,and will be evaluated andrewarded by the new criteriamentioned above. The primarytargets for these ACOs will bethe Institute for Health Improve-ment’s Triple Aim: better quality,better population health, and ata lower cost. This systemredesign will ultimately trans-form the American health caresystem, but it will proveextremely challenging for bothurban and rural providers.

To date, more than 150ACOs have been certified by the Center for Medicare andMedicaid Innovation (CMMI),with approximately 50 more inthe pipeline. (Minnesota alonehas at least seven.) Not one ofthe certified ACOs has been ledby rural health providers, eventhough at least a dozen networksof rural providers applied forcertification. Problems withCMMI’s interpretation of whichclinics got credit for Medicarepatients led to rural ACO

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Like providers every-

where, rural health

physicians and organi-

zations face enormous

changes in care delivery,

reimbursement, and

quality measurement,

driven by the need to

drive down health care

costs. But rural health

presents special chal-

lenges related to demo-

graphics, geography,

financial realities, and

workforce issues, among

others. This month’s

special focus articles

look at how rural

providers can address

these challenges.

wannabes failing to achieve the5,000 Medicare patients neces-sary for ACO eligibility. In short,in the CMMI formula, Medicarepatients were assigned to themedical clinic where Medicarehad reimbursed the most dollarsin care. This meant urban spe-cialty clinics generally got creditfor the patients rather than theprimary care clinics, preventingthe rural ACOs from getting ade-quate numbers for certification.

CMMI may eventually alterthe ACO formula enabling ACOcreation. In the interim, ruralhospitals and rural providershave at least three basic options.

In the first option, ruralproviders can refuse to partici-pate in the reform and hope itsomehow goes away. If theabove assumptions are correct,however, that would leave themunprepared for the future. Itwould be like continuing todrive a horse-and-buggy wagonin the 1920s, while competitorswere all purchasing automo-biles. This option would lead tothe closing of rural hospitals andclinics and would severely hurt

rural communities across thenation.

Rural providers might alsochoose to immediately try tobecome part of an urban-basedACO. This, of course, would be predicated on the ACOs’agreeing to accept them, and on the rural providers’ abil ity to meet the ACO requirementsfor documented efficiency andoutcomes, patient satisfaction,effective transitions of care, andelec tronic health records. NewACOs, because of their fin an -cially risky situation and thecontinuing uncertainty aboutthe new care model, will proba-bly be extremely careful inchoos ing which rural providersthey include in their new models.

A third option for ruralhealth providers is to actively

position themselves for successin the new value-based system.Whether they become part of anACO or not, they can work tomaximize their value by recog-nizing and building their assets,while acknowledging andaddressing their weaknesses.ACOs place much greater valueon primary care, a rural asset.ACOs also value medical homes(which we find in isolated ruralsettings) and cost-effective care,which are other rural assets. Onthe other hand, rural providerslack patient volume, access toneeded expertise, access to capi-tal, and, often, technology. Theseare weaknesses that will have tobe addressed. For those choos-ing this third option, it is imper-ative to begin as soon as possi-ble to forge strategies to preparefor the value-based future.

Challenges and strategies for meeting them

In late 2011 and early 2012, theLouisiana Hospital Associationbrought a core group of ruralhealth providers together to con-sider the impact of health carereform on rural America. Aftermonths of study and discussion,they issued a report summariz-ing the current environment, themajor challenges, and recom-mended strategies. They com-mented: “Besides the historicchallenges, the current environ-ment driven by health carereform and market realities nowoffers a new set of challenges.Many rural health care providershave not considered either themagnitude of the changes or therequired strategies to addressthe changes.”

The Louisiana group furtheridentified a core set of new chal-lenges: 1) payment systems tran-sitioning from volume to value;2) increased emphasis on qualityas payment and market differen-tiators; and 3) reduced paymentsthat are real this time (e.g., pen -


REFORM to page 27

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One out of every fourdying Americans is aveteran, yet 96 percent

of veterans are cared for outsideof the Veterans Affairs (VA)health care network, accordingto the National Hospice andPalliative Care Organization.This means that the majority of veterans are cared for by hospice and health care profes-sionals in their hometown. How can we best serve theunique end-of-life care needs of these veterans?

As health care providers, we work diligently to assesseach patient as an individualand deliver high-quality, cus-tomized care. No time is morecrucial to provide this level ofcustomized service than hos-pice, where treatment isdesigned to relieve symptomsand provide comfort and sup-port to individuals with life-lim-iting illnesses.

Veterans’ unique end-of-life care needs

It has been pointed out timeand again that when people

reach the last chapter of theirlife journey, there is a naturaltendency to reminisce, resolveissues, and reference previousexperiences of emotional inten-sity—which, for veterans,

includes their history in the military.

Both research and evi-denced-based practice havedemonstrated that a person’smilitary history can exacerbatephysical, psychological, social,

and spiritual symptoms towardthe end of life. The Departmentof Veterans Affairs notes, forexample, that Vietnam veteransmay still suffer from “trenchfoot,” a fungal infection of the

feet from walking in wet condi-tions; that symptoms of post-traumatic stress disorder maysurface; that social isolationand distrust of authority maydevelop (or redevelop) in veter-ans who have felt a lack of sup-port in the adjustment frommilitary to civilian life; and thatspiritual questions may arise asindividuals encounter deathoutside of the battlefield.

The VA also cites the follow-ing contributing factors thatmay influence a veteran’sbehavior and responses to end-of-life issues: • Entry status: enlisted or

drafted. Drafted veterans mayexperience higher levels ofdistrust of authority than vet-erans who enlisted.

• Branch of service and rank:Each branch of service has itsown distinct culture. Veteransdo not always share their rankwith friends and loved onesyet sometimes reactions to lifeevents are better understoodwhen this status is revealed.Regardless of rank, each vet-eran carries a responsibilityfor fellow soldiers although heor she cannot ensure theirwell-being and safe return.

• Combat or noncombat experi-ence: Veterans who weredirectly exposed to the effectsof combat may experience ele-vated levels of anxiety and

posttraumatic stress disorder,but noncombat veterans canexperience these symptoms as well.

• Type of war or time served:Each war or conflict carriedits own significant burdens,which may be re-experiencedby veterans at the end of their lives.

• Prisoner of war experience:We cannot begin to imaginewhat our POW veterans haveexperienced physically, men-tally, and emotionally. At theend of life, these experiencesmay be the ones that colortheir memories.

For health care providers,being aware of an individual’smilitary history and the ele-ments to which the veteran wasexposed can assist in properdiagnosis and intervention.Establishing a process toinquire about an individual’smilitary history has proven suc-cessful for numerous healthcare providers. The VA, in col-laboration with the NationalHospice and Palliative CareOrganization, has developed a simple Military HistoryChecklist that reviews the abovefactors for each patient toenable providers to best serveveterans’ unique health careneeds. The Military HistoryChecklist is available online atwww.wehonorveterans.org andthrough numerous electronichealth record platforms.

In addition, it is importantto invite veterans approachingthe end of life to tell their sto-ries, to celebrate their accom-plishments, and to expressappreciation for their service to our county.

Challenges of meeting veterans’ needs

There are many challenges inmeeting the unique end-of-lifecare needs of veterans, not onlyfrom a clinical standpoint butalso from a system-wide per-spective. Some examples:• Accessing care at a VA facility

often is difficult for rural vet-erans, as the distance andtravel time can make accesscostly and laborious.

• If inpatient care is provided atthe VA, rural veterans may notbe surrounded by family and

A call to dutyTransforming veterans’ end-of-life care

By Kami Norland, MA, ATR, and Julie Benson, MD


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A person’s military history can exacerbatephysical, psychological, social, and

spiritual symptoms toward the end of life.

friends during their remainingmonths.

• Navigating the VA system andthe correct entry point of con-tact can be confusing.

• Understanding VA benefitsand enrollment procedures iscomplicated.

• Care coordination and transi-tions between the VA andlocal providers are not wellestablished in many areas.

• For providers, receiving timely, accurate VA reimburse-ment for services can be acumbersome process.

Palliative care rural initiativefor veterans

To respond to these challenges,the Duluth-based NationalRural Health Resource Center,in partnership with AtlasResearch of Washington D.C., is working with five communityhospice organizations in theUpper Midwest on a palliativecare rural initiative to developand implement care coordina-tion models that serve thehealth care needs of rural veter-ans requiring end-of-life care.The project is funded by a con-tract awarded by theDepartment of Veterans HealthAdministration (VA), VeteransIntegrated Service Network 23.

The five hospice organiza-tions selected for the projectare:• HealthConnect at Home—

Grand Island, Neb.• Hospice of Siouxland—

LeMars, Ia.• Hospice of Southwest Iowa—

Council Bluffs, Ia.• Lakewood Health System—

Staples, Minn.• Regional Hospice Services,

Inc.—Ashland, Wis.These facilities are building

replicable and sustainablemethods of collaborationbetween the VA and rural com-munity hospice providers toaddress the challenges of meet-ing veterans’ hospice needs.

Lakewood Health System(LHS), in Staples, Minn., sawthe rural palliative care initia-tive as an opportunity toenhance services to a popula-tion it knows is underserved inrural central Minnesota. Thecare coordination model it

developed consists of two pri-mary components.

The first component isaimed at raising awareness ofveterans’ unique end-of-life careneeds, training staff to assessindividual veteran needs, anddeveloping relationships withlocal County Veteran ServiceOfficers (CVSOs), who are theentry points of contact for anyveteran enrolling in VA services.The VA provided much of thematerial for these trainings.LHS also purchased End-of-LifeNursing Education Consortium(ELNEC) modules specific toveterans to begin training staff.In addition, LHS has begunusing the Military HistoryChecklist not just on new hos-pice admissions, but on all pal-liative care patients. As the staffhas become more knowledge-able about the VA and its ser -vices, LHS has been exploringways to help nonenrolled veter-ans access services, to breakdown some of the barriers tocare, and to help veterans navi-gate through and between thetwo health systems.

The second component ofthe care coordination modelexamined ways to provide abroader spectrum of palliativecare to rural veterans and offermore care to those who are notyet hospice-appropriate butwho have serious life-threaten-ing illnesses. LHS and the VAhave collaborated and exploredoptions for the VA to pay for in-home palliative care servicesprovided by LHS.

LHS is also working towardcompleting level four of the WeHonor Veterans Partnership, aneducational recognition pro-gram for hospices to buildawareness of veterans’ end-of-life needs and establish collabo-rative partnerships with the VA.LHS plans to start a Veteran-to-Veteran volunteer program thatoffers peer support to meet thesocial and emotional needs of

vets receiving hospice care. Inaddition, the health systemhopes to implement pinningceremonies to recognize andhonor veterans for their service.LHS leaders note that their par-ticipation in this initiative withthe National Rural ResourceCenter and the VA has raisedawareness of veterans’ uniqueneeds and has restored a senseof patriotism among the healthcare staff.

The five community hos-pices participating in this initia-tive are on a “call to duty” toserve those who have served ourcountry, and are transformingveterans’ end-of-life care needsthrough respectful inquiry, com-passionate listening, and grate-ful acknowledgment to comfortpatients with a history of mili-tary service.

Kami Norland, MA, ATR, is a commu-nity specialist with the National RuralHealth Resource Center, in Duluth. Julie Benson, MD, is medical directorfor hospice and palliative care atLakewood Health System, in Staples.


Tips to serve veterans in your community

• Implement the Military History Checklist upon intake.

• Utilize resources from We Honor Veterans, a program of theNational Hospice and Palliative Care Organization in collaborationwith the Department of Veterans Affairs (www.wehonorveterans.org).

• Encourage local hospices to become a “We Honor Veterans” partner.

• Connect with the VA’s entry point of contact, County Veteran ServiceOfficers, to seek eligibility criteria for enrolling a veteran in the VA.

• Build professional and organizational capacity to provide qualitycare for veterans.

• Develop and/or strengthen partnerships with the VA and otherorganizations serving veterans.

• Increase access to end-of-life services for veterans in your community.

• Network with other providers to learn about best practices and models.

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Picture this: Clinicians in ahospital emergency roomin Aurora, Minn., are

working to stabilize a 14-year-old boy who has been in an ATVaccident. They are preparinghim for transfer to a Duluth hos-pital, where he will receive spe-cialty care. While they check theboy’s vitals and administer oxy-gen, a trauma surgeon located inDuluth looks on. She makes rec-ommendations for initiating achest tube while examining thepatient’s injuries more closely,along with the Aurora provider.

This scenario is possiblethanks to a recent project thathas connected the emergencydepartment (ED) at EssentiaHealth–St. Mary’s Medical Cen-ter (SMMC) with the NorthernPines Medical Center–Aurora, an Essentia Health criticalaccess hospital (CAH) located in Aurora, 90 minutes north ofDuluth. Telehealth connectionsare helping to provide support to the emergency care in theAurora community and the surrounding rural area.

Similar scenes are unfoldingin outlying communities across

the country today. Equippedwith a two-way video monitor, ahand-held zoom camera, stellarsound microphone, and a digitalstethoscope, providers in ruralcommunities are using tele-health technology to connectthem and their patients to spe-

cialists located virtually any-where in the world.

Theresa Gunnarson, MD,chief of hospital-based servicesand a board-certified emergencymedicine physician at Essentia

Health–SMMC in Duluth, isusing telehealth technology toassist doctors in remote emer-gency rooms. “They simply log on to remotely connect,”Gunnarson says, “and I can helpmanage the patient care orprocess the paperwork. The

technology allows me to be avaluable help as if I am on-site.Plus, if a patient is transferredhere to Duluth, we already knowtheir medical situation and canbe prepared to help them imme-diately when they arrive.”

Gunnarson adds, “It’s easyto get caught up in the techno lo -gy, but telehealth works be causeit’s a way for everyone to providebetter care for all patients.”

A redesign initiative

The ED redesign and subsequentintroduction of the telehealthsystem reflect the realities ofAurora’s demographics, whichare very similar to those of otherrural areas across the country.Here is a snapshot of ruraldemographics across EssentiaHealth’s service area:• 51 percent of our 50,990-

square-mile service area isclassified as rural.

• 45.2 percent of our populationlives in areas where there is aninadequate supply of healthcare providers, defined by theU.S. Health Resources andServices Administration asHealth Professional ShortageAreas (HPSAs).

• Five of our 14 hospitals and 27of our 62 clinics are located inHPSAs.

The consequences of thesedemographics for rural critical

access hospitals include staffingproblems (such as workforceshortages when attempting tohave physicians cover all deliv-ery of care), fragmented emer-gency care, and quality con-cerns. Meanwhile, sustainabilityissues threaten the very future ofthe entire hospital. In Aurora, ithad become clear that the highcost of the all-physician deliveryof care model was unaffordableand unsustainable.

The solution involved twomajor changes: • The medical center in Aurora

replaced its all-physicianmodel of care delivery with amodel that primarily usesadvance practice clinicians(APCs)—nurse practitioners(NPs) and physician assistants(PAs)—who receive telehealthsupport from board-certifiedphysicians in the SMMC–Duluth ED.

• Essentia implemented a tele-health system to connect theEssentia Health–NorthernPines Medical Center inAurora (the sending site,where the patient arrives foremergency care) with EssentiaHealth–St. Mary’s MedicalCenter’s emergency depart-ment in Duluth (the receivingsite for the videoconferencing).

By August 2012, three full-time NP/PAs were employed inthe ED, replacing the rotating,independently contracted emer-gency room physicians at therural hospital. The section chairfor the Aurora ER, a board-certi-fied emergency medicine physi-cian, covers shifts in the ER atAurora on a set rotation, andalso conducts quality improve-ment activities for the ER.

The APCs are supported by board-certified emergencymedicine physicians at SMMC–Duluth via the telehealth con-nection.

A two-way emergency service

The TeleEmergency Department(TeleED) service links two-wayvideo conferencing equipment ina rural emergency room toboard-certified emergency medi-cine physicians and nurses at acentral station hub, 24 hours aday, seven days a week. Thecomputer access and connec-tions are immediate.

Forging connections Intersection of

emergency departments and telehealth

By Maureen Ideker, MBA, BSN, RN; Cindy Loe, RN; Michelle Oman, DO; and Nancy Tario, MA


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In Essentia’s system, wall-mounted, two-way, interactivevideo units equipped withmicrophones allow theSMMC–ED to see the patient inthe rural ER and to support thecare being delivered. Theprovider in Aurora initiates thecall, and always serves as theprimary provider. The connec-tion continues until the ruralprovider signals the end of theconsultation and disconnects.

Patients are not billed forthese telehealth services.Essentia pays an annual sub-scriber fee based on use by therural site. Privileging and cre-dentialing for the APCs (NP andPA) making video connectionsare governed by guidelinesdefined by the medical staff.Examples include requiring connections during STEMIs,strokes, intubations, trauma,and when treating a newborn upto 3 months old.

TeleED technology

Essentia Health’s secure high-speed broadband network sup-ports the telehealth connections.

This advanced e-health networkconnects all Essentia Healthhospitals and clinics inMinnesota, Wisconsin, andNorth Dakota (Essentia’s othertelehealth services are listed inthe sidebar). Providers in bothlocations not only can conductlive, interactive videoconfer-ences, but also can access APCs’images and make notes on thesame electronic medical recordsimultaneously. The micro-phones and the wall-mountedcamera and monitor at the footof the patient cart in the emer-gency room bay can beenhanced with additional cam-eras and a digital stethoscopefor listening to heart and lungsounds simultaneously.

Telehealth education

To prepare for using the TeleEDsystem, the nurses, doctors, andother clinicians in the two loca-tions participated in live, inter-active in-service education aweek before going live. Using acase study scenario, the ruraland metro providers, nurses,and ancillary staff all receive in-service training together. ASTEMI case study was usedwith a volunteer “patient” tosimulate a real situation. Allstaff members were required topractice with and demonstrateproficiency in operating theequipment.

In addition, each NP and PAemployed in the Aurora ERspent a mandatory residency in

the SMMC–Duluth ED, averag-ing three months. During thattime they also conducted intuba-tions with anesthesiology in sur-gery, and followed the pediatricspecialist rotation for admis-sions. Each residency was indi-vidualized based on the APC’spast clinical experience andassessed strengths and weak-nesses. Additionally, the APC jobdescriptions for the NorthernPines Medical Center–Aurorarequired at least five years ofexperience in a critical carearea. Although the time spent ontraining delayed putting the newstaffing model into place, it notonly helped these providersdevelop necessary skills but alsoallowed the ED physicians andAPCs to build respect and trustover time and reduced the EDphysicians’ concerns about lia-bility and sharing risk.

Key considerations for project success

The telehealth director receivedstrong staff support at severallevels. Rapid cycle, six sigma,


CONNECTIONS to page 26

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• Maternal/fetal health• Medical weight loss• Medication therapy management• Mental health• Nutrition therapy• Stroke care • Wound care

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and lean management andimprovement processes wereused to meet the scheduled go-live date at Aurora and Duluthwithin six months. Physicianchampions and nurse leadersfrom both Northern Pines andSMMC were vital to moving theproject forward and supportingthe telehealth teams. Crucialtechnology expertise includedproblem-solving and educatingstaff.

Other key considerations inthe redesign project establishinga new delivery model of careand telehealth in the NorthernPines–Aurora ER were: • Internal communication• Rural ED technology, location,

and design• Hub station technology loca-

tion and design at the SMMCemergency department

• Equipment/information sys-tems

• NP/PA hiring• Risk management• Credentialing and privileging• Documentation/information

systems • Training development—cur-

riculum, outcomes• Policy and procedure develop-

ment for both facilities• Resource manual for both

facilities• Marketing and public rela-

tions/external communications• Outcome measures/bench-

markingMeasurements of project

success will include financial,clinical, and quality indicators,such as the overall impact onAurora’s admissions; length ofstay; telehealth usage; transfersand avoided transfers; mortalityand morbidity; provider reten-tion and patient satisfaction;and clinical outcomes withSTEMIs, strokes, and trauma. A formal dashboard for measur-

ing, reporting, and evaluation isin place.

Challenges with the rapid-cycle process included therequirement for cross-functionalteams at both the rural Auroraand Duluth facilities. Com -pleting the project preparationtasks in six months requiredcommitment from all ED andproject staff. Attendance at teammeetings was important forshared decision-making.Scheduling was complicated,but routine videoconferencingexpedited attendance and erasedtravel time.

From April 2012 throughAugust 2012, 27 TeleED connec-tions were made between thetwo emergency rooms, based onguidelines and the rural clini-cians’ requests for support,assistance, and second opinions.

During the month of September2012, when all three APCs wereemployed full time, sevenTeleED connections took place.

Results to date show thatpatient satisfaction at Aurora is excellent. Both EDs agree that the TeleED service hasmade the patient transfer pro-cess run much more smoothly;ED staff at SMMC say they feelthey “already know” thesepatients before they even arrive.The Aurora community’s confi-dence in the local ER has grownand utilization has increased.Over the next two years,Essentia Health plans to addTeleED connections to all of itscritical access hospitals.

Maureen Ideker, MBA, BSN, RN, is telehealth director at Essentia Health.Cindy Loe, RN, is director of nurses atNorthern Pines Medical Center–Aurora.Michelle Oman, DO, is chief medicalofficer at Northern Pines MedicalCenter–Aurora. Nancy Tario, MA, is senior process expert at Essentia Health.


Connections from page 25 The TeleED service has made the patienttransfer process run much more smoothly;

ED staff at SMMC say they feel they “alreadyknow” these patients before they even arrive.

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alties for high rates of hospitalreadmissions).

The group then laid out alist of recommended strategiesfor rural providers to considermoving forward:• Increase leadership awareness

of the new environment reali-ties. This includes boards,physicians, and hospital leaders.

• Improve operational efficien-cies of provider organizations.This can be done with toolssuch as Lean and processimprovement methodologies.

• Adopt effective quality meas-urement and improvement sys-tems as a strategic priority.

• For hospitals, align/partnerwith medical staff contractu -ally, functionally, and throughgovernance where appropriate.Under ACOs, primary carephysicians in particular havegreater influence.

• Seek interdependent relation-ships with developing regionalsystems and ACOs. In otherwords, find the win-win propo-sition, and don’t underestimate

the rural provider value.• Maintain alignment between

delivery system models andpayment systems, buildingflexibility into the delivery sys-tem model for the changingpayment system.

Though they come from theopposite end of the country,these observations and recom-mendations have value nation-wide and should be seriouslyconsidered by rural providers inMinnesota. Organizations andindividuals don’t have to addressall the recommended activitiesat the same time, but it’s impor-tant to lay out a plan for takingaction at the appropriate time.

Managing change: Don’t just sit there

The transformation of healthcare is already happening and

will not be stopped or signifi-cantly altered by political events.We will move from the volume-based system of the past to thevalue-based system of the futurebecause the old model producedlow-value outcomes and is nolonger financially sustainable.

Urban and rural healthproviders have the immediatechallenge of preparing for suc-cess in the value-based paymentsystem while still being paid inthe old volume-based system.This challenge is already clear tothose building the new ACOs.They may not have figured outthe answers, but they’re acutelyaware of the problem.

Rural providers must actnow to increase their awarenessand begin to map out strategiesthat will make them successfulin the future. Becoming part of

an ACO, or positioning the hos-pital or clinic to be successful inan ACO-like environment, areboth viable options that ruralproviders should consider care-fully. Hoping the reform will allgo away or that the politicianswill eventually kill it, however, isprobably not a desirable option.

As is the case in almostevery industry, change is in -evitable, and managing changehas become the greatest chal-lenge of the 21st century. WillRogers recognized this evenback in the 1930s, when thenation faced the immense chal-lenge of the last great depres-sion, in this comment: “Even ifyou’re on the right track, you’llget run over if you just sitthere.”

Terry Hill, MPA, is director of theDuluth-based National Rural HealthResource Center. In that capacity, he isleading adviser to the Department ofHealth and Human Services, leads twonational quality initiatives, and has worked with rural health providers in more than 40 states.


Reform from page 21 To date, more than 150 ACOs have been certified by the Center for Medicare and

Medicaid Innovation (CMMI). Not one hasbeen led by rural health providers.

Minneapolis VA Health Care SystemThe Minneapolis VA Health Care System is a 341-bed tertiary-care facility affiliated with the University of Minnesota. Our patient population and case mix is challenging and exciting, providing care to veterans and active-duty personnel. The Twin Cities offers excellent living and cultural opportunities. License in any state required. Malpractice provided. Applicants must be BE/BC.

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

• Cardiac Anesthesiologist

• Chief of Surgery/Specialty Care Director

• Compensation & Pension Examiner

• Gastroenterologist

• Internal Medicine or Family Practice

o General Medicine Clinic

o Women’s Clinic

o Post Deployment Clinic

• Hematology/Oncology

• Hospitalist

• Outpatient Clinics: Internal Medicine or Family Practice

o Maplewood, MN

o Ramsey, MN

o Rochester, MN

o Chippewa Falls, WI

o Rice Lake, WI

o Superior, WI

• Rheumatologist

• Women’s Health

Competitive salary and benefits with recruitment/relocation incentive and performance pay possible.For more information:

Visit www.usajobs.govor email [email protected]

EEO employer

P R O F E S S I O N A L U P D A T E : W O U N D C A R E

Chronic venous insuffi -ciency (CVI) is a progres-sive disease affecting

approximately 60 percent of thepopulation in varying degrees.

CVI most frequently affectsthe superficial venous systemand is a product of vascularhypertension resulting from veinwall weakness and valvularincompetence. Dysfunction orincompetence of the valves inthe superficial venous systempromotes retrograde blood flowand increased hydrostatic pres-sures. This failure in valve com-petency may be the result of pre-existing weakness in the vesselwall or valve leaflets, superficialphlebitis, or excessive venousdistention resulting from hor-monal effects or high pressure.Failure of valves located at thejunctions of the deep and super-ficial system allows high pres-sure to enter the superficialveins, causing venous dilatationand varicose veins to form andpropagate from the proximaljunction site down into thelower extremities. When thisoccurs, normal backflow ofperivascular fluid is disrupted,

resulting in molecular changescausing inflammation, skinchanges, pain, edema, deep veinthrombosis, and, ultimately,ulcerations.

The prevalence of CVI in the population is far more wide-spread than secondary post-thrombotic syndrome. The in -cidence of CVI is marginallyhigher in women than in menand significantly increases withage. Other associated factorsinclude a family history of vari-cose veins, obesity, pregnancy,phlebitis, and previous leginjury. Environmental or behav-ioral factors, such as prolongedstanding or sitting posture atwork, may also be associatedwith CVI.

The CEAP system for classi-fication of venous disease wasfirst developed in 1994 by the

American Venous Forum. Theacronym’s letters stand for:C—Clinical state: symptomaticvs. asymptomaticE—Etiology: congenital, pri-mary, or secondaryA—Anatomy: superficial, deep,or perforator P—Pathophysiology: reflux orobstruction

This classification standardhas been adopted worldwide andis the endorsed method for re-porting data in the U.S. Venousdisease is complex; CEAP classi-fication helps determine thepresence or absence of symp-toms, as well as prognostic eval-uation and treatment guidelines.

Venous ulcerations

Venous ulcerations are amongthe more serious consequences

of CVI and have an estimatedprevalence of 0.06 percent to 2 percent, affecting nearly 1 per-cent of the adult population.Approximately 60 percent to 70 percent of all lower extremityulcerations are the result ofchronic venous insufficiency.

Disabilities related to venousulceration have a tremendoussocioeconomic impact. Venousulcerations result in an impairedability to engage in social andoccupational activities, therebyreducing quality of life andimposing financial constraints.An estimated $3 billion is spentannually on venous ulcer care inthe U.S.

The link between CVI andvenous ulceration is thought tobe the result of many factorsand is the end-stage manifesta-tion of chronic venous insuffi-ciency. One common scenario inthe formation of venous ulcera-tions is an abnormal increase inplasma and erythrocyte diffu-sion into the extra vascularspace, followed by fibrinogenpassing into the interstitial fluidat a faster than normal rate,

Venous diseaseThe link between venous ulceration and

chronic venous insufficiency

By Dana Matthews BSN, MBA, and Dan Morehouse MD, RVT


VENOUS DISEASE to page 30

Qualifications:• Licensed to practice medicine in the state of MN• Knowledge of chemical dependency

Duties and responsibilities:• Provides 24-hour call coverage• On site two times per week for 1 to 2 hours • Evaluate and provide written documentation (supporting

statement) for clients involved in the civil commitment process• Annual review of policies as mandated by MN Rule 32 licensure• The medical director reports directly to the program director

Medical Director

Mission Detox CenterMaking Change Possible By Never Giving Up On Anyone

Opened in 1978, Mission Detox Center provides medically supervised detoxificationservices for suburban Hennepin County and Anoka County. Admission to Mission DetoxCenter is frequently the first professional intervention in a destructive pattern of chem-ical use, and a difficult point in any chemically dependent person's journey. Each clientis welcomed with respect and provided professional and compassionate care by thestaff of nurses, counselors and trained technicians.

If interested, contact the Program Director at (763) 559-1402 or to apply, send a cover letter and resume to:

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Or check out our website at: www.missionsinc.org

Spine Surgeons, join our team and set thestandards for patient care.Orthopaedic Associates of Duluth is seeking a highly motivated

passionate and experienced SPINE SURGEON to provide

outstanding orthopaedic care to its patients. The successful candidate

will be part of our expanding and growing, well-respected team that

serves patients from Duluth to northern Minnesota.

Orthopaedic Associates of Duluth is a group of nine orthopaedic

surgeons that provide comprehensive orthopaedic services ranging

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

OCTOBER 2012 MINNESOTA PHYSICIAN 29

EOE/AA/LEP

A landscape of opportunities

PhysiciansGundersen Lutheran Health System, based in LaCrosse, Wis., offers you the opportunity to practice cutting-edge medicine. But we also believe that medicine is about people and that’s why our medical outcomes are among the nation’s best (gundluth.org/accomplishments).

Currently seeking physicians for the following:

• Family Medicine• Neurology• General Surgery• Emergency Physician• Dermatology• Endocrinology• Psychiatry• Otolaryngology

We are a physician-led health system,where teaching and research are possible with competitive salary, benefits, CME and loan forgiveness.

Cathy Mooney (608)[email protected]/MedCareers

which then creates a fibrotic tissue depo-sition. The resulting inflammation andlipodermatosclerosis ultimately lead tovenous ulcer formation.

Venous ulcerations make up themajority of chronic wounds treated inoutpatient settings. These wounds haveclassic characteristics, including a loca-tion along the medial and lateral malleoli;surrounding dermatitis with scaling,weeping, crusting, and erythema causingintense pruritus; hyperpigmentation, lipo-dermatosclerosis, and beefy red granula-tion tissue. Venous ulcerations are oftenassociated with superficial fibrinousnecrosis, displaying healthy granulationtissue underneath. Most commonly, thereis little or no pain associated with thesewounds unless an underlying inflamma-tion is present.

Evaluation and treatment of ulcerations

Differentiation of the various types ofchronic ulcers and their pathophysiologyprovides a clear distinction among charac-teristics associated with ischemic, venous,and neuropathic ulcers. Clinical evalua-tion and diagnostic studies are importantin identifying and treating these variousforms of ulcerations. Etiology of venousulcerations is indicative of chronic venous

disease and valve incompetency resultingin reflux.

The accepted diagnostic standard forassessing venous reflux in the great andsmall saphenous veins, deep veins, andperforator veins is color duplex ultra-sound. This imaging combines real-timeB-mode imaging of the deep and superfi-cial veins with pulsed Doppler assessmentof blood flow. Pulsed or color Doppleridentifies vessels as well as the presenceand direction of blood flow, and is used to detect venous reflux or venous obstruc-tion. Duplex imaging identifies thosepatients with superficial venous refluxwho may benefit from correction of theunderlying venous disease throughendovascular treatments using laser,radiofrequency ablation, and chemicalfoam sclerotherapy. These treatmentshave shown promise in controlling vein-related symptoms and decreasing the incidence of recurrent ulcerations.

Conservative treatment is based on thereduction of venous hypertension andabatement of the inflammatory response.Compression is the most widely prescribedconservative treatment, reducing edemaand preventing venous distention. Com-pression also improves function in the calfmuscle pump by decreasing vein wall ten-sion. Pharmacologic intervention such as


VENOUS DISEASE to page 32

Venous disease from page 28

TABLE 1. Basic CEAP classification.

Clinical classification:C 0 No visible evidence of venous diseaseC 1 Superficial spider veins

(telangectasias or reticular veins)C 2 Simple varicose veins onlyC 3 Ankle edema or venous originC 4a Skin pigmentation in the ankle area

and/or dermatitis/eczemaC 4b LipodermatosclerosisC 5 Healed venous ulcerC6 Open (active) venous ulcerS SymptomaticA AsymptomaticEtiologic classification:Ec CongenitalEp PrimaryEs SecondaryEn No venous etiologyAnatomic classification:As Superficial veinsAp Perforating veinsAd Deep veinsAn No venous anatomy involvedPathophysiology classification:Pr RefluxPo ObstructionPr, o Reflux and obstructionPn No venous pathologyCEAP = Clinical-Etiologic-Anatomic-Pathophysiology.Modified from Meissner M, Gloviczki P, Bergan J, et al. Primary chronic venous disorders. J Vasc Surg. 2007;46(suppl S):54S-67S.

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Urgent Care

We have part-time and on-call positions available at a variety of Twin Cities’ metro area HealthPartners Clinics. Evening and weekend shifts are currently available. 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

h e a l t h p a r t n e r s . c o m

Family PracticeUrgent Care

NEW POSITIONS:

Dynamic, independent 3 location, single-specialtypractice in northwest Minneapolis suburbs is seekingadditional associates for its Rogers site and has Full Time/Part Time shifts in the Crystal and Rogers Urgent Care.

• Partnership opportunity after 2 years

• Competitive salary with incentives

• Excellent benefits, 401k/employer paid pension

• Practice at one site/one hospital

• Physician-owned

Please contact or fax CV to:Joel Sagedahl, M.D.

5700 Bottineau Blvd., Crystal, MN 55429763-504-6600 • Fax 763-504-6622

Visit our website at www.NWFPC.com

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

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:

diuretics, aspirin, systemicantibiotics, pentoxifylline, stana-zol, escin (horse chestnut seedextract), hydroxyethylrutoside,sulodexide, and prostacyclinanalogs has also been used.These agents are thought toinhibit proteolytic enzymes thatinduce leukocyte activation,decrease capillary and venouspermeability, and increasevenous tone.

Although conservative treat-ment is a first-line defense,chronic venous insufficiency isprogressive. Patients with per-sistent symptoms (pain, aching,swelling) and signs (varicoseveins, skin changes, ulceration)of venous disease and docu-mented reflux as a source oftheir symptoms are candidatesfor saphenous ablation by chem-ical, thermal, or mechanicalmeans. This includes endove-nous laser ablation, radiofre-quency ablation, sclerotherapy,and surgical removal of affectedvessels (stripping) or, morerecently, microphlebectomy. Thechoice of modality dependsupon the size of abnormal veins,

their location, and the presenceor absence of venous reflux.

Endovenous laser ablation(EVLA) is a less invasive alterna-tive to vein stripping and is nowthought to be the gold standardin treating chronic venous insuf-ficiency. Outcomes are far supe-rior to surgical stripping, withbetter quality-of-life scores inthe postoperative period. EVLAhas been shown to correct orsignificantly improve hemody-namic abnormality in patientswith chronic venous insuffi -ciency and to dramaticallydecrease the incidence of neo-vascularization, as noted in theJournal of Vascular Surgery. Ithas been asserted that vein wallinjury is mediated both by adirect laser effect and indirectlyvia steam generated by heatingsmall amounts of blood withinthe lumen of the vessel.Advanced technology using1,320-, 1470-, and 2,078-nmlasers is thought to target water,while other wavelengths used forEVLA primarily target hemoglo-bin. This procedure is performedin outpatient settings, requiringminimal downtime. Most

patients resume normal activitywithin 24 hours.

Radiofrequency ablation gen-erates a high-frequency alternat-ing current, in the radio range offrequencies 300 kHz to 1 MHz,that is transmitted through anelectrode. The resultant energyheats the vein wall adjacent tothe probe, elevating the temper-ature, which alters the proteinstructure of the vein, inducingits closure. This is an outpatientprocedure performed underlocal tumescent anesthesia, andit similarly decreases recurrenceof venous incompetency byreducing neovascularization.

Sclerotherapy involves theinduction of a chemical agentinto the lumen of a vessel, caus-ing endothelial destruction. Thetwo main categories of scleros-ing agents are detergent andosmotic. Detergent agents causeendothelial destruction by inter-fering with cell surface lipids.Osmotic agents work throughdehydration of the endothelialcells by interfering with the elec-trostatic charge. Sclerotherapyusually is used in conjunctionwith EVLA or radiofrequency

ablation to treat smaller varicoseand nonsaphenous veins and is introduced using a visual technique or with ultrasoundguidance.

Early detection and treatmentenhance outcomes

Manifestation of venous ulcers is the end result of chronicvenous insufficiency. Mostpatients present with ongoingpain, aching, throbbing, edema,cramping, restlessness, itching,and burning long before venousulcerations appear. It is impor-tant to assess the nature of thesecomplaints and determine thepossibility of underlying venousdisease. Referral to a board-cer-tified phlebologist or practicespecializing in the diagnosis,treatment, and advanced under-standing of venous disease willpromote early detection andtreatment, enhancing clinicaloutcomes by improving thequality of care received.

Dana Matthews BSN, MBA, is director of clinic operations and DanMorehouse, MD, RVT, is a board-certified vascular surgeon at Vein Clinic PA,based in Blaine.


Venous disease from page 30

Physicians:• Let us do your scheduling

& credentialing

• Paid Malpractice

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Clients:• Prevent loss of revenue

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Look for thefriendly doctorin a MN based

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Alexandria• Dermatology• ENT• Family Medicine• Hospitalist/IM• Internal Medicine• Ob/Gyn

Detroit Lakes• Dermatology• Family Medicine• Internal Medicine• General Surgery• Pediatrics

East Grand Forks• Family Medicine• IM/Peds

Moorhead• Family Medicine

New York Mills/Perham• Family Medicine• Orthopedic

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Thief River Falls• Dermatology• Family Medicine• Hospitalist/IM• Internal Medicine• Ob/Gyn• Optometry

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Sanford Clinic North – Excellent practice opportunities in communities located in the ‘Heart of Minnesota Lakes Country.’ Good call

arrangements and modern well-managed community-owned hospitals.

Sanford Health, serving western Minnesota, eastern North Dakotaand South Dakota, is redefining health care. Sanford offers

innovative technology, support of a multi-specialty organization and dependable colleagues. Our employment model includes: market

competitive salary, comprehensive benefits, paid malpractice insur-ance and a generous relocation allowance. To learn more contact:

Heart of Minnesota Lakes CountryPractice Opportunities

Shannon Ellering, Physician RecruiterEmail: [email protected]

Phone: (701) 280-4817EOE/AA


www.lrhc.org

Practice Well. Live Well.Lake Region Healthcare is located in a magnificent, rural,and family-friendly setting in Minnesota lakes countrywhere we aim to be the state’s preeminent regional healthcare partner.

Our award winning patient care and uncommon medicalspecialties set us apart from other regional health caregroups. Lake Region’s physicians and their families alsoenjoy an unmatched quality of professional and personal life.

Current opportunities including competitive salary andbenefit packages available for BE/BC physicians are:

• Dermatologist

• Family Medicine

• Emergency Medicine

• Medical Oncologist

• Pediatrics

• Urology NP/PA

712 Cascade St. S., Fergus Falls, MN736-8000 • (800) 439-6424

Lake Region Healthcare is an Equal Opportunity Employer. EOE

For more information contactBarb Miller, Physician [email protected] • (218) 736-8227

www.olmstedmedicalcenter.org

Olmsted Medical Center, a 150-clinician multi-specialty

clinic with 10 outlying branch clinics and a 61 bed

hospital, continues to experience significant growth.

Olmsted Medical Center provides an excellent

opportunity to practice quality medicine in a family oriented

atmosphere.

The Rochester community provides numerous cultural,

educational, and recreational opportunities.

Olmsted Medical Center offers a competitive salary

and comprehensivebenefit package.

EOE

Opportunities available in the following specialties:

Adult PsychiatryChild Psychiatry

Southeast Clinic

DermatologySoutheast Clinic

Family MedicineChatfield Clinic

Pine Island ClinicPlainview Clinic

HospitalistRochester Hospital

Internal MedicineSoutheast Clinic

Sleep MedicineRochester Hospital

Sports MedicineOthopedic Surgeon

Southeast Clinic

Send CV to:Olmsted Medical Center

Administration/Clinician Recruitment102 Elton Hills Drive NW

Rochester, MN 55901email: [email protected]

Phone: 507.529.6610Fax: 507.529.6622

BREAST/GENERAL SURGEON

Minneapolis/St. Paul, Minnesota

HealthPartners Medical Group is a large, successful multi-specialty physician group based in Minneapolis/St. Paul, central Minnesota and western Wisconsin. Our busy surgical team at Level 1 trauma center Regions Hospital in St. Paul has an excellent opportunity for a full-time, BC/BE Breast/General Surgeon. This well-established, mature practice is based at Regions Breast Center, and provides best care in general and breast surgery. No night call is involved.

We offer a great group of colleagues, generous benefi ts and comp, opportunity for teaching and research, and the excitement of a metropolitan practice. Apply online at healthpartners.jobs or forward your CV and cover letter to [email protected]. EO Employer

h e a l t h p a r t n e r s . c o m

Growth and Opportunity

North Memorial is seeking driven

providers to be part of our 2012-2013 growth initiatives.

Opportunities exist in

Family Medicine

Internal Medicine

Obstetrics

Gynecology

and in multiple

surgical or

medical specialties

Over 700 physicians in more than 40 specialties.

An award-winning hospital and network of primary/urgent and specialty clinics.

To learn more, contact Mark A. Peterson, Physician Recruiter763-520-1336 [email protected]

Optimize your education and leadership potential.

For

EveryStageof Your Career

H E A L T H I N S U R A N C E

With Medicare, thingsare always changing—and that will continue

in 2013. Medicare changes affectyour patients and your practice,so it is important to be aware ofwhat is changing in the yearahead. Although not all of the2013 information is yet availablefrom the Centers for Medicare & Medicaid Services (CMS),what was available as of Aug. 31,2012, is provided below. In addi-tion, it is anticipated thatCongress will revisit the physi-cian fee schedule changes thatwere delayed until 2013.

Health care homes and ACOs

The Affordable Care Act allowedfor the formation of accountablecare organizations (ACOs),which are networks of physi-cians and hospitals that shareresponsibility for providing careto patients. The ACO agrees tomanage all of the health careneeds of a minimum of 5,000Medicare beneficiaries for atleast three years. In Minnesota,the formation of ACOs is inprogress.

Health care homes, alsoknown as medical homes, arebecoming a popular option forproviders to deliver care topatients in Minnesota. Healthcare homes are the foundationfor new payment models, includ-ing ACOs. Primary care clinicstransform services to meet anew set of patient- and family-centered standards that improvepatient experience and quality ofcare and reduce costs. Therewere 190 certified health carehomes in Minnesota when thisarticle went to press; 25 percentof primary clinics in Minnesotahave become certified healthcare homes. The MinnesotaDepartment of Health is respon-sible for certifying health carehomes. For information abouthealth care homes in Minnesota,go to www.health.state.mn.us/healthreform/homes/index.html.

E-prescribing

E- prescribing is here to stay.2012 is the first year of theElectronic Prescribing (eRx)Incentive Program that featuresboth incentive payments andadjustments (penalties). Eligibleprofessionals that successfullyreported eRx measures in 2011will receive a bonus paymentfrom Medicare in 2012 equal to1 percent of their total MedicarePart B payments in 2011.

Physicians who fail to reportone of the following will be sub-ject to a 1 percent paymentpenalty for all Medicare pay-ments in 2012, which will beassessed in 2013.• At least 25 prescribing events

via claims for at least 10unique denominator eligibleeRx events for services pro -vided Jan. 1, 2012 throughJune 30, 2012; or

• Report the G8553 code viaclaims for at least 10 uniquedenominator eligible eRxevents for services providedJan. 1, 2012 through June 30,2012; or

• Apply for an exemption.The penalty in 2012 and

assessed in 2013 is a 1 percentreduction in all Medicare reim-bursements. In 2013 andassessed in 2014, the penaltyamount increases to 1.5 percent;and in 2014, to 2 percent. Someexemptions may apply.

Providers compliant with e-prescribing receive 1 percentincentive amount in 2012 and .5 percent in 2013. Beginning2014, there is no incentive pay-ment.

Update on therapies

On Feb. 22, 2012, PresidentObama signed the Middle ClassTax Relief and Job Creation Actof 2012. The law prevented the27.4 percent cut to the MedicarePhysician Fee Schedule throughDec. 31, 2012.

Medicare in 2013Changes ahead for physicians, patients

By Kelli Jo Greiner


MEDICARE to page 36

Applicants can apply online atwww.USAJOBS.gov

VA Health Care System In South Dakota & North DakotaWorking with and for America’s Veterans is a privilege and we pride ourselves on the quality of care we provide.

In return for your commitment to quality health care for our nation’s Veterans, the VA offers an incomparable

benefits package.

The VAHCS is currently recruiting for the following healthcare positions in the following locations.

Sioux Falls VA HCS, SD

Urologist Orthopedic Surgeon

Psychiatrist Cardiologist

Hospitalist Pulmonologist

Sioux Falls VA HCS(605) 333-6858www.siouxfalls.va.gov

Black Hills VA HCS, SD

Psychiatrist

General Surgeon

Physician (Primary Care)

Hospitalist (Internal Medicine)

Urologist

Black Hills VA HCS(605) 720-7487www.blackhills.va.gov

Fargo VA HCS, ND

Psychiatrist

Hospitalist

Family Practice

Internal Medicine

Fargo VA HCS(701) 239-3700 x2353www.fargo.va.gov


Family Medicine

St. Cloud/Sartell, MN

We are actively recruiting exceptional part-time or full-time BC/

BE family medicine physicians to join our primary care team in

Sartell, MN. This is an out-patient only opportunity and does not

include labor and delivery or hospital call and rounding. Our current

primary care team includes family medicine, adult medicine, OB/

GYN and pediatrics. Previous electronic medical record experience

is preferred, but not required. We use the Epic electronic medical

record system at all of our clinics and admitting hospitals.

Our HealthPartners Central Minnesota Clinics – Sartell moved

into a new primary care clinic in the summer 2010. We offer a

competitive salary, an excellent benefi t package, a rewarding

practice and a commitment to providing exceptional patient-

centered care. St. Cloud/Sartell, MN is located just one hour

north of the Twin Cities and offers a dynamic lifestyle in a growing

community with a traditional appeal.

Apply on-line at healthpartners.jobs or contact [email protected] or call Diane at 800-472-4695 x3. EOE

h e a l t h p a r t n e r s . c o mWith Essentia Health, you’ll find a supportive group of more than 750 physicians across 55 medical specialties. Located in large and small communities across Minnesota, Wisconsin, North Dakota and Idaho, Essentia Health is emerging as a leader in high-quality, cost-effective, patient-centered care. EOE/AA

LEARN MORE

EssentiaHealth.org/Careers800.882.7310

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In addition, the law ex -tended the Medicare Part BOutpatient Therapy Cap Ex ceptions Process through Dec. 31, 2012. The combinedtherapy cap amount for physicaland occupational ther apy is$1,880. The separate capamount for occupational ther -apy is $1,880. Hospital outpa-tient therapy departments hadbeen exempt from the therapycap, but that will end for a brieftime. From Oct. 1, 2012 through Dec. 31, 2012, therapy caps willapply to all hospital outpatientdepartments on a temporarybasis.

Competitive bidding for DMEPOS

The Medicare Modernization Act of 2003 established require-ments for a new CompetitiveBidding Program for certaindurable medical equipment,prosthetics, orthotics, and sup-plies (DMEPOS). The Com -petitive Bidding Programreplaces the current fee schedulemethodology for selected

DMEPOS items with a competi-tive bid process. It will eventu -ally be implemented nationwide.In 2013, areas of Minnesota willbe part of the Round 2 DMEPOSCompetitive Bidding Program.The Round 2 area includes zipcodes in Isanti, Chisago, Sher-burne, Wright, Anoka, Washing-ton, Ramsey, Hennepin, Dakota,Scott, and Carver counties.

Changes to MedicarePrescription Drug Program(Medicare Part D)

The following changes toMedicare Part D will go intoeffect Jan. 1, 2013.

The Medicare Part D an nual deductible will increasefrom $320 to $325.

The initial coverage limitwill increase from $2,930 to$2,970. During the initial cover-age limit, the Part D plan paysfor 75 percent of the Part D pre-scription drug costs and the

enrollee pays 25 percent of thecosts.

The coverage gap, alsoknown as the doughnut hole,begins once the enrollee’s Part Dprescription drug costs reach$2,970 and ends when theenrollee spends a total of $4,750.In 2013, during the doughnuthole period enrollees will receivea 52.5 percent discount onbrand-name prescription drugsand a 21 percent discount on generic prescription drugs. The full retail cost of the pre-scription drugs will apply to thedoughnut hole.

The out-of-pocket thresholdwill increase from $4,700 to$4,750. Total covered Part Dspending at out-of-pocketthreshold will increase from$6,657.50 to $6,733.75.

Every Medicare Part D planwill be required to have aMedication Therapy Manage-ment Program (MTMP) in place

for enrollees.• In 2013, the requirement

expands to include providingMTM to enrollees residing in a long-term care facility.

• In addition, each plan isrequired to include MTMinformation on the plan web-site. This includes describingthe eligibility requirements,providing a contact person,and summarizing the servicesoffered as part of the MTM.

• Annual comprehensive med-ication reviews (CMRs) will beperformed by the plan as partof medication therapy manage-ment protocol.

• In 2013, CMS will require thatstandard member materials beprovided to each enrollee fol-lowing a CMR, including apersonal medication list andmedication action plan.

• In 2014, the CMR service willbecome a focus of the STARrating performance measurethat is used to rank and pro-vide bonuses to high-perform-ing plans.


MEDICARE to page 38

Medicare from page 34

Medicare Advantage in Minnesota

There are now more than 803,000 Medicare beneficiaries inMinnesota; 389,000 are enrolled in Medicare Advantage plans toreceive all of their Medicare benefits—Part A, Part B, and Part D—from one plan. At 48 percent, Minnesota has the highest rate ofMedicare Advantage penetration in the continental United States.

www.altru.org

• Dedicated Team Approach

• Competitive Salary & Benefits

• EPIC Healthcare Information System

Idylic Practice Opportunitieslocated in family friendly

communities with close access to some of Minnesota’s most beautiful lakes.

FAMILY PRACTICE w/OB

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]

We invite you to explore our opportunities in:

Contact: Todd Bymark, [email protected](866) 270-0043 / (218) 546-4322 | www.cuyunamed.org

(866) 270-0043 / (218) Todd BymContact:

546-4322 | www.cuyunamed.omark, [email protected]

org


St. Cloud VA Health Care System

is accepting applications for the following full or part-time positions:

US Citizenship required or candidates must have proper authorization to work in the US.

J-1 candidates are now being accepted for the Hematology/Oncology positions.

Physician applicants should be BC/BE. Applicant(s) selected for a position may be eligible for an award up to the maximum limitation under the provision of the Education Debt Reduction

Program. Possible relocation bonus. EEO Employer.

Excellent benefit package including:

Sharon Schmitz ([email protected])4801 Veterans Drive, St. Cloud, MN 56303

Or fax: 320-654-7650 or Telephone: 320-252-1670, extension 6618

Favorable lifestyle

26 days vacation

CME days

Competitive salary

13 days sick leave

Liability insurance

St. Cloud VAHealth Care SystemBrainerd | Montevideo | Alexandria

Interested applicants can mail or email your CV to VAHCS

• Associate Chief, Primary& Specialty Medicine(Internist-St. Cloud)

• Dermatologist(St. Cloud)

• Director, Primary and Specialty Medicine (Internal Medicine)(St. Cloud)

• ENT(St. Cloud)

• Geriatrician(Nursing Home-St. Cloud)

• Hematology/Oncology(Part Time-St. Cloud)

• Hospice/Palliative Care(St. Cloud)

• Internal Medicine/Family Practice(Alexandria, Brainerd, St. Cloud, Montevideo)

• Medical Director-Extended Care & Rehab(IM or Geriatrics) (St. Cloud)

• Psychiatrist(Brainerd, St. Cloud)

• Radiologist(St. Cloud)

• Urgent Care Provider (MD: IM/FP/ER)(St. Cloud)

Contact Brad McDonald, MD CEO888-733-4428 or email: [email protected]

www.erstaff.com

“Connecting Quality Healthcare to Rural America”

Along with...

Be a part of the Leading Provider of outsourcedPhysician coverage

• Competitive Pay• Paid Malpractice

coverage• Boarded IM &

FP welcome

• Full and Part time workavailable

• Physician Owned, Physician Run

• Life work Balance

Wapiti Medical Group andConnect Healthcare are

looking for quality physicians to provide ER &Hospitalist coverage in our

partner facilities in MN

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• General Surgery• 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

Other Medicare matters

The CMS revalidation of physi-cians is scheduled to be com-pleted on March 25, 2013. Therevalidation is part of massiveanti-fraud effort required by theAffordable Care Act. CMS esti-mates that when the revalidationis completed, nearly 750,000physicians will have receivedrevalidation request letters.

In 2013, CMS will establisha Medicare pilot program todevelop and evaluate makingbundled payments for acute,inpatient hospital services,physician services, outpatienthospital services, and post-acutecare services for an episode ofcare.

Beginning Jan. 1, 2013,there will be an increase in theMedicare withholding tax forhigher income individuals,from 0.9 percent to 2.35 percentfor singles with adjusted grossincomes over $200,000 and mar-ried couples filing jointly whoseincome exceeds $250,000. Be -ginning in 2013, these individu-als will also pay a 3.8 percent

Medicare contribution tax onunearned income.

It appears the implemen -tation of the InternationalClassification of Diseases (ICD-10) will be delayed untilOct. 1, 2014. The switch fromICD-9 to ICD-10 for claims sub-missions for medical diagnosisand inpatient procedure codingwas scheduled to begin Oct. 1,2013.

Assistance for your patients

Perhaps you want to help yourpatients find communityresources to maintain their inde-pendence. You may have ques-tions about communityresources available for yourpatients. Often your patientsmay need additional assistance,such as connecting to commun -

ity resources; understandinglong-term care options; selectinga Medicare Prescription DrugPlan; applying for PhaRMApatient-assistance programs;finding support for caregivers;understanding Medicare bene-fits; or locating informal servicessuch as chore services, home-delivered meals, and supportgroups. One call to the SeniorLinkAge Line at (800) 333-2433does it all.

The Senior LinkAge Line: A One Stop Shop for MinnesotaSeniors is a service of theMinnesota Board on Aging andis provided locally through theArea Agencies on Aging. Assis -tance is available by phone, livechat (www.MinnesotaHelp.info),and in person in all ofMinnesota’s 87 counties. There

is no charge to you or yourpatients.

The Senior LinkAge Linedoes not sell or market anyproduct. Information provided iscomprehensive, objective, andfocused on helping your patientmeet their needs. Currently theSenior LinkAge Line is seekingoppor tunities to partner withhealth care homes and hospitalsto connect patients to the com-munity resources they need.

For additional informationabout opportunities for workingwith the Senior LinkAge Line: AOne Stop Shop for MinnesotaSeniors and the local AreaAgency on Aging, please call(800) 333-2433 and ask to speak with the Area Agency onAging director. For additionalinformation, contact Kelli JoGreiner at (651) 431-2581 or [email protected].

Kelli Jo Greiner is the ConsumerChoices team lead at the Minnesota Boardon Aging.


Medicare from page 36 E-prescribing is here to stay. 2012 is the first year of the Electronic

Prescribing (eRx) Incentive Program that features both incentive payments

and adjustments (penalties).

You wouldn’t give a 4-year-old a drink, so why would you give one to an unborn child?

As a physician, it’s your responsibility to let her know: the U.S. Surgeon General Advisory says no amount of alcohol is safe during pregnancy.

Share 049: Zero Alcohol For Nine Months.

www.mofas.org

We protect your peace of mind. And we do it in

lots of ways for physicians, facilities and hospitals.

Whatever your situation, we’ve been there, and will be

there. We’ve gotten good at it. Excellent, actually, with

a proven success rate. It’s a peace of mind movement.

And we’d love to have you along.

Join the Peace of Mind Movement at

PeaceofMindMovement.com,or contact

your independent agent or broker.

Documents

Minnesota Physician November 2012