Minnesota Physician July 2011

We all strive to provide quality health care to ourpatients and families. But what exactly is qualityhealth care? The Institute of Medicine defines it as

care that is timely, efficient, effective, safe, patient-centered,and equitable. Here we examine equity in health care, specifi-cally for black Americans.

While many factors affect health care equity, disparitiesbased on race that target communities of colorare consistently reported in the management ofmany diseases. For example, blacks receive alower standard of care than whites when beingtreated for breast cancer, orthopedic problems,cardiovascular disease, pain, and end-of-lifecare, among other conditions. According tothe 2009 National Healthcare Disparities Reportproduced by the Agency for HealthcareResearch and Quality, many of these discrepan-cies are not decreasing. Blacks receive worse

EQUITY to page 10

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Volume XXV, No. 4

July 2011

Small steps,long journeyAchieving “meaningful use”

By Paul McGinnis, MD

On April 18, 2011, the Centersfor Medicare & MedicaidServices (CMS) opened its

website for health care practitionersto attest to meeting electronic healthrecord (EHR) meaningful use goals(see sidebar and EHR IncentivePrograms information at www.cms.gov/ehrincentiveprograms/). Twelvephysicians from Western WisconsinMedical Associates (WWMA) wereamong the first 100 physicians toattest on that site. Our accomplish-ment resulted not from a sponta-neous, Friday-afternoon decision,but rather from months of decision-making, planning, study, monitoring,and evaluation.

Achieving meaningful use is bestunderstood in the context of focusingon the quality of care we deliver toour patients. While initially there arefinancial incentives—and, later, finan-cial disincentives—for achievingmeaningful use goals, the incentivescannot be the only driving factor. If

MEANINGFUL USE to page 12

The Independent Medical Business Newspaper

Equityin health careExamining theimpact of racial bias

By StephenNelson, MD

IN THIS ISSUE: Health Care Roundtable Page 20

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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.

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CAPSULES 4

MEDICUS 7

INTERVIEW 8

PEDIATRICSFetal alcoholsyndrome disorders 14By Mary Meland, MD

DEPARTMENTS

C O N T E N T S JULY 2011 Volume XXV, No. 4

JULY 2011 MINNESOTA PHYSICIAN 3

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;e-mail [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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TheIndependentMedicalBusinessNewspaper

Equity in health care 1Examining the impact of racial biasBy Stephen Nelson, MD

Small steps, long journey 1Achieving “meaningful use”By Paul McGinnis, MD

Minnesota Health Care Roundtable 20The Wellness Revolution

FEATURES

www.mppub.com

Ron LatzState Senator

Quantum leap 28By Cally Vinz, RN,and Melissa Marshall, MBA

Proton beam therapy 30By Robert L. Foote, MD

Breast cancer care 32By Madeline Gartner, MD

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MINNESOTA HEALTH CARE ROUNDTABLEMINNESOTA HEALTH CARE ROUNDTABLE

Background and focus:Created as part of nation-al health care reform,accountable care organi-zations (ACOs) are nowpart of every health carepolicy discussion. Asdefined by the 111thCongress, ACOs areorganizations that includephysicians, hospitals, andother health care organi-zations with the legalstructure to receive anddistribute payments to par-ticipating physicians andhospitals to provide carecoordination, invest ininfrastructure and redesigncare processes, andreward high-quality andefficient services.

Exactly what this meansis unclear, and a confusing

array of levels and qualifications for ACOs has been proposed. With2012 as a start date for Medicare reimbursement through ACOs,Congress is developing firm definitions at this time. Some say ACOsturn physicians into insurance companies; others say they are a wayfor physicians to take a leadership role in fixing a broken system. Ashealth care organizations race to join, create, or redefine themselvesas ACOs, they all face more questions than answers.

Objectives: We will review the history, goals, and rationale behindthe ACO model. We will review the latest federal guidelines definingwhat an ACO can be. We will discuss how the ACO will affect healthinsurance companies, employers, and the pharmaceutical industry.We will illustrate what must not be allowed to happen if the modelis expected to succeed. We will examine who decides if ACOs aresuccessful and how those decisions will be made. We will explore whyso many people, representing very different perspectives on healthcare, are opposed to the idea and what can be done for it to achieveits best potential.

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4 MINNESOTA PHYSICIAN JULY 2011

Mayo Re-brandsHealth SystemA new branding effort recentlytook place in health facilities inMinnesota, Wisconsin, andIowa, as Mayo Health Systembecomes Mayo Clinic HealthSystem. The Rochester-basedhealth system first announcedplans for the change lastOctober, and the new namebecame official on May 20.

The change may seem subtleat first glance, but it will bemore noticeable in communitieswhose hospitals and clinics haveoperated under locally familiarnames that in many cases havehad the words “Mayo HealthSystem” added on.

With the new branding,for example, Franciscan SkempHealthcare in LaCrosse, Wis.,becomes Mayo Clinic HealthSystem in La Crosse. St.Joseph’s Mayo Health Systemin Mankato will now be knownas Mayo Clinic Health Systemin Mankato. Fairmont MedicalCenter becomes Mayo ClinicHealth System in Fairmont.

Officials say all 70 commu-nities that are served by MayoClinic Health System facilitieswill now see a common, uni-form name for health caredelivery.

“Mayo Clinic Health Systemhas evolved over time, andtoday our sites work togethermore closely with each otherand Mayo Clinic than everbefore,” says Rob Nesse, MD,chief executive officer, MayoClinic Health System. “We oper-ate as one system and worktogether to provide our patientswith the care they need, wherethey need it—whether that’s intheir hometown, a neighboringcommunity, or in Rochester.Our new name reflects that.”

Report RanksMinnesota 2nd inHealth Care QualityMinnesota ranks second in thenation in a state-by-state reporton health care quality by theAgency for Healthcare Researchand Quality (AHRQ). The fed-eral agency, part of the U.S.

Department of Health andHuman Services, issues theannual report based on datadrawn from more than 30sources, including governmen-tal and private surveys.

New Hampshire rankedfirst in the report, followed byMinnesota, Maine, Massachu-setts, and Rhode Island.

The study found thatMinnesota was one of the topstates for showing overallimprovement in health carequality. Nationally, AHRQ offi-cials say, states are seeingimprovements, but disparitiesin care for minority and low-income residents persist.

“Every American shouldhave access to high-quality,appropriate, and safe healthcare, and we need to increaseour efforts to achieve that goalbecause our slow progress isnot acceptable,” says AHRQDirector Carolyn M. Clancy,MD. “These AHRQ 2010 StateSnapshots not only providestates with a benchmark onhow they are doing in theseareas, but they also provideresources that states can use to

make improvements.”The AHRQ report called

Minnesota’s overall care“strong” and ranked it high in anumber of areas, including firstin the nation for timely care forheart attacks, first for lowestnumber of deaths due to HIV,fourth for ambulatory care, fifthin nursing home care, andeighth for hospital care.

The report says Minnesota’sweakest areas came in measure-ments of mobility and bathingwith home health care, fecaloccult blood tests, the numberof anxious or depressed nursinghome residents, and obstetrictrauma in cesarean births.

Diabetes WizardApplication to HelpPatients, ProvidersHealthPartners is providing anew “Diabetes Wizard” as partof its electronic health record(EHR). The new applicationwill help diabetes patients andtheir providers customize atreatment plan for each individ-ual patient, officials say.

C A P S U L E S

Geoffrey J. Service, M.D.

Gregory L. Barth, M.D.Merrill A. Biel, M.D., Ph.D.

Carl A. Brown, M.D.Thomas E. Christenson, M.D.

Karin E. Evan, M.D.William J. Garvis, M.D.

Matthew S. Griebie, M.D.Michael B. Johnson, M.D.Nissim Khabie, M.D.

Richard M. Levinson, M.D.Stephen L. Liston, M.D.Jeffrey C. Manlove, M.D.Darren R. McDonald, M.D.Michael P. Murphy, M.D.Ilya Perepelitsyn, M.D.Julie C. Reddan, M.D.

Benhoor Soumekh, M.D.Jon V. Thomas, M.D.Rolf F. Ulvestad, M.D.Larry A. Zieske, M.D.


The Diabetes Wizard appli-cation was developed by theHealthPartners ResearchFoundation in collaborationwith the HealthPartnersMedical Group, and has beentested in a number of clinicsthroughout the health system.The app will be expanded foruse in all HealthPartners clinicsthis summer, officials say.

Officials say the applicationtakes much more patient detailinto account than previouslyavailable in “prompts” providedby EHR systems. The detailsinclude data on patient age,current medications, smokingstatus, kidney function, and his-tory of heart disease or conges-tive heart failure. The systemcan also identify gaps in care,such as the need for a screeningtest for kidney disease

The application will behelpful to primary care physi-cians, who provide much of thecare for patients with diabetes,by providing additionalresources through the EHR,officials say.

“Because much diabetescare is provided in primary caresettings, EHRs truly have thepotential to meaningfullyimprove the health of patientswith diabetes,” says PatrickO’Connor, MD, MPH, seniorclinical research investigator ofthe HealthPartners ResearchFoundation. “The EHR canpresent personalized patientinformation in a single screento the physician and patient inan instant. This allows physi-cians and patients to have com-plete information at the officevisit when they are makingchoices about their care.”

MDH Says GrowthIn Health SpendingSlowed in 2009A new report by the MinnesotaDepartment of Health (MDH)finds the lowest level of growthin health care spending in morethan a decade.

The report says total healthcare spending in the state roseto $36 billion in 2009, but therecession led many to put offelective and other types of care,resulting in a 3.8 percent rate of

growth in health care spending.That’s the slowest rate ofgrowth since 1997, officialsnote.

The Health EconomicsProgram at MDH created thereport using data from publicprograms, Medicare, privatehealth plans, and out-of-pocketspending. The study found thatMinnesota continues to spendless on health care per personthan the country as a whole. In2009, per-person spending inMinnesota was $6,913, com-pared to $7,590 nationally. Inaddition, health care spendingin Minnesota accounts for asmaller share of the economythan nationally: 14.1 percent,compared to 16.5 percent.

The recession hit Minne-sota hard in 2009, resulting inchanges in utilization of healthcare, MDH officials say. “Thereis evidence that during therecession Minnesotans reducedtheir use of elective and evenroutine care, a trend that mir-rors national patterns in 2009,”says Stefan Gildemeister, assis-tant director of the HealthEconomics Program. “Severalfactors contribute to thischange, such as the loss of pri-vate coverage, the expectationto pay more in premiums orout-of-pocket costs, anddeclines in income in 2009.”

Even with the slow recov-ery, health care spending is pro-jected to grow at a rate of 7.6percent in Minnesota through2019. MDH Commissioner EdEhlinger, MD, says the reportshows the importance of stick-ing with the state’s health carereform law passed in 2008,which uses a range of tools toaddress rising health care costs.MDH officials note that amongthose tools are provisions suchas provider peer grouping,health care homes, and invest-ments in public health.

“Health care spendingmakes up an ever-increasingshare of our economic re-sources in Minnesota, and wehave to find a way to restrainthat cost growth,” Ehlingersays. “One important way to dothat is to invest upstream, tomake fundamental, long-lasting

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changes that improve healthand help prevent Minnesotansfrom being pulled into thehealth care system in the firstplace.”

Without the state reforms,MDH officials say, health carespending would more thandouble over the next 10 years,to $78 billion.

Mayo, AllinaNamed as TopHealth SystemsMayo Clinic in Rochester hasbeen named one of the top10 health systems in the coun-try by Thomson Reuters. Theannual report looks at a rangeof independent research andpublic data sources to identifyhigh-quality health systems,officials say.

The report says top healthsystems have better short- andlong-term survival rates, havefewer complications, closely fol-low care protocols and patientsafety standards, and garner

better patient satisfactionresults than other hospitals.

The report also listsMinneapolis’ Allina Hospitalsand Clinics as being in the top20 percent of the 285 U.S.health systems analyzed.

Klobuchar,Paulsen LaunchWellness CaucusTwo Minnesota lawmakersrecently helped launch a newWellness Caucus in Congress tolobby for policies that promotehealthy lifestyles and workplacewellness programs.

Sen. Amy Klobuchar andRep. Erik Paulsen say the newcaucus will be a bipartisangroup in both the House andSenate that will investigate andshare best practices andresources to help businessessupport employee health andwellness.

The new caucus wasannounced on June 13 atBloomington-based ApogeeEnterprises, a window-makingcompany that has promoted a

wide range of wellness pro-grams at its worksites. SeveralMinnesota health care leaderswere at the event, includingCommissioner of HealthEdward Ehlinger, MD; BlueCross and Blue Shield of Minn-esota chief prevention officerMark Manley, MD; and TomMason, president of Alliance fora Healthier Minnesota, whichsponsored the event.

Klobuchar and Paulsenpraised the efforts of businesseslike Apogee that are leading theway in wellness efforts, sayingthat employers are coming tounderstand the importance ofaddressing employees’ health ina proactive way.

In her remarks, Klobucharnoted that congressional leadersfrom both parties see wellnessas an issue where they canfind agreement in the often-contentious area of health carereform. “Staying healthy is notan issue of Democrats versusRepublicans or business versuslabor, it’s an issue where peoplecan find common ground,” shesays. “Fundamentally this isabout empowering people, so

they can get better information,so that they can have access toworkplace wellness programs,and so that they can have thetools and the resources to stayactive and live healthy lives.”

Paulsen also praised thebipartisan nature of the caucusand said he would work tobring more members ofCongress into the effort andeducate lawmakers by showcas-ing employer success stories.

Paulsen added that workingon prevention and wellness willbe key to bringing down healthcare costs. “This is a win-winfor everyone in the work place.Employers see lower healthcare costs. Employees see thebenefits of better health, lowerout-of-pocket costs for healthcare, better access to healthcare resources, and also work-ing in that safer, healthier envi-ronment,” he says. “I think thedays of eating clubs and goingto happy hour are slowly dimin-ishing, and now we’re going tosee more fitness clubs and 5Kruns.”

Capsules from page 5

Two physicians have joined Lakeview Health and will practice atStillwater Medical Group’s Curve Crest Clinic in Stillwater. JessicaMacrie, DO, MPH, received her doctor of osteopathy degree fromthe University of New England College of Osteopathic Medicine andcompleted her residency at Cabarrus Family Medicine in North Car-olina. She is board-certified in family medicine. Nicolas Krawczyk,MD, received his medical degree from the University of Minnesota

Medical School and completed his residencyin family medicine at the U of M/North Memo-rial Hospital. He is board-certified in familymedicine.

Suja Roberts, MD, has joined Clinic Sofia,an Edina-based ob-gyn clinic. She had prac-ticed for the past four years at Fairview HealthServices. Roberts completed medical school inIndia before completing her residency trainingat Loyola University in Chicago. She is board-

certified by the American College of Obstetrics and Gynecology.Essentia Health has hired several new physicians. Kunal Shah,

MD, has joined Essentia Health’s Duluth Clinic in the pulmonary andcritical care section as a critical care intensivist. Shah attendedMaharaja Sayajirao University in Baroda, India. He completed hisresidency in internal medicine at Beth Israel Medical Center in NewYork and a fellowship in critical care at the University of PittsburghMedical Center. He is certified by the American Board of MedicalSpecialties in internal medicine. Steven Sutherland, MD, has joinedEssentia Health’s Behavioral Health Department. He is certified inpsychiatry and neurology as well as child and adolescent psychiatryby the American Board of Medical Specialties. Sutherland’s medicaldegree is from Mayo Medical School in Rochester, Minn. He com-pleted his residency in psychiatry at the University of WisconsinHospital and Clinics in Madison, where he also completed a fellow-ship in child and adolescent psychiatry. He will be involved in thenew Amberwing project, a $5 million mental health facility beingdeveloped by the Miller-Dwan Foundation. Jeffrey Rengel, MD, hasjoined the anesthesiology department at Essentia Health–St. Mary’sMedical Center. Rengel received his medical degree from TulaneUniversity School of Medicine in New Orleans. He completed hisresidency in anesthesiology at the San Antonio Uniformed ServicesHealth Education Consortium in Texas. Rengel is certified by theAmerican Board of Medical Specialties in Anesthesiology.

The American Society for Laser Medicine and Surgery (ASLMS)has named Brian Zelickson, MD, president of the professionalorganization. Zelickson, who is director of Zel Skin & Laser Special-ists, Edina, received his medical degree from Mayo Medical Schoolin Rochester, Minn., and completed postgraduate medical training atHennepin County Medical Center and at the Mayo Clinic GraduateSchool of Medicine, and the University of North Carolina, ChapelHill. He has published more than 30 medical journal articles on lasermedicine and surgery and currently serves on the GovernmentLiaison/Blue Ribbon Committee for the ASLMS.

Didima Mon-Sprehe, MD, MPH, hasjoined Children’s Respiratory and Critical CareSpecialists, PA. She had been a pediatric inten-sivist at Sanford Children’s Specialty Clinic inSioux Falls, S.D., since 2006. She received hermedical degree and master’s of public healthat the Tufts University School of Medicine inBoston and completed a fellowship at Children’sHospital in San Diego, Calif.

William C. Vincent, MD, has joined themedical staff of Fairview Mesaba Clinics, where he is practicing asa full-time general surgeon at Fairview University Medical Center–Mesabi and seeing patients in the Fairview Mesaba Clinic–Hibbing.He received his medical degree from the University of Minnesotaand completed his residency in general surgery at the Iowa Metho-dist Medical Center in Des Moines.

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� Tell us about the anti-cloning bill.

The bill was introduced under the guise of banninghuman cloning. The key to the bill was in the defi-nition of human cloning. The definition that thebill’s authors used is far broader than what thescientific community or the average person under-stands human cloning to mean.

The process here is that scientists take anunfertilized egg and replace its nucleus with anucleus from a living individual’s skin cell. Theyput the egg in a Petri dish and allow it to grow forthree or four days. So it divides 16 times, or 32times, or 64 times. Technically, it’s an embryo atthat point. And it has developed stem cells, andthose stem cells are pluripotent: They can developinto any more specialized kind of cell.

When they put these cells back into the donor’sbody they will not be seen as a foreign body, andthe immune system will not attack and destroythem. Essentially what you have is the abilityto personalize the treatment for someone whois sick. And there have been some instances inwhich it’s been demonstratedto be successful.

What the bill’s supportersare saying is, “You can’t dothat.” Because when you’reremoving the stem cells fromthe embryo, you’re destroyingit and therefore destroying ahuman life. That’s the theoryof those who would ban this[process]. And it is consistent with their definitionof life, within the pro-life movement.

However, from my perspective it’s not a humanlife at that point. I’m not belittling the sincerityof their position or the religious views that alsoinform that position. But they’re calling it humancloning because they know the public objects tohuman cloning. And almost all scientists objecton ethical and moral grounds to actual humancloning. But the way they’ve defined this now, ithas a much broader reach.

� What are some of the implications this legisla-tion could have for health care delivery?

There are a lot of implications. This bill goesfurther than just prohibiting a particular scientifictechnique. It says you cannot “participate” in anattempt to perform this technique. Participationcould include simply donating your own skin cell.Quoting from the bill, “you cannot ship, import,or receive for any purpose an embryo producedby this technique or any product derived from suchan embryo.”

So if you are a patient and you go to Wisconsinand receive a treatment with stem cells derivedfrom using this technique, and you return toMinnesota, you are committing a crime. If you area doctor and you import stem cells that have beencreated with this method in another state or coun-

try, you are committing a crime. If you receive it inthe mail, you are committing a crime.

In addition to affecting clinical treatment, thishas a business impact. The Biobusiness Alliancecame out opposing this bill, and for good reason.We have an enormous medical research businesscommunity in Minnesota. This kind of law couldhave a specific effect on some of their research.

But more importantly, it sends a message tothe rest of the county that we’re not open for thiskind of business. That the political climate here issuch, that if you were to invest in Minnesota busi-nesses doing this, you might find that the Legisla-ture will pass a law prohibiting you from doing it.

That has a huge potential impact—not only forbiobusiness, but also for the University of Minne-sota and for Mayo Clinic’s efforts to recruit scien-tists who might do research and clinical work thathas any relation to this. It’s a terrible message.

� Is this really just a pro-life issue?

I think it is, although I wouldn’t characterize it thatway. Pro-life has two meaningsto me. Yes, the movement thatis generally referred to as thepro-life movement, sometimesalso known as the antiabortionmovement, for them this is asignificant issue. MinnesotaCitizens Concerned for Life(MCCL) for example, testifiedat every hearing for this. They

were the principal movers behind this. Their execu-tive director, Scott Fischbach, is the husband ofSen. Michelle Fischbach, the president of theSenate and the author of the bill.

To me, pro-life has a much broader meaning.It seems to me that lives can be saved, diseases canbe cured or prevented, or potentially so, by usingthis kind of scientific research and techniques, andthat is very much pro-life.

� How did this bill reach the point that it tooka veto from the governor to stop it frombecoming state law?

A couple of ways. One is that the MCCL hastremendous influence in the Legislature. The newRepublican majorities in the House and Senateare particularly susceptible to the influence of theMCCL. So they had the numbers this year thatthey hadn’t had in the past. And they had chairsof the committees that were willing to hear thebills and pursue them.

Part of it, at least initially, was that it wasintroduced and scheduled for committee hearingsvery, very fast. It was introduced on a Friday, andalready on the committee agenda on Tuesday. Sothe broader array of interest groups that mighthave mobilized to oppose it didn’t have the abilityor the time to do that, certainly not quicklyenough.

Ron LatzMinnesota Senate

Senator Ron Latz wasfirst elected to theMinnesota Senate in2006. He representsDistrict 44, which

includes St. Louis Park,Hopkins, and two-thirdsof Golden Valley. Priorto being elected to theSenate, Latz served for

four years in theMinnesota House of

Representatives and fornine years on the St.

Louis Park City Council.This spring, Latz helpedlead the opposition toanti-cloning legislationin the 2011 Session. Thebills, which were passedby the Legislature aspart two omnibusspending bills, weredefeated when Gov.

Mark Dayton vetoed allmajor spending billsin May. The governorsingled out the anti-cloning provisionsas being harmful to

medical research and jobcreation in Minnesota.

A controversial bill galvanizes legislative action


I N T E R V I E W

This bill goes furtherthan just prohibitinga particular scientific

technique.

I’m talking about the disease-orientedgroups, the American Diabetes Association,the American Cancer Society, the MuscularDystrophy Association—you can runthrough the long list, all these health-relatedorganizations that raise money and fundresearch to cure particular diseases—theywere practically absent from the legislativeprocess. They, as organizations, just can’tmove quickly enough to be responsive tothis kind of fast-track legislative process.

Mayo Clinic, by the way, sat on the side-lines for quite a while. I finally called Mayodirectly and said, “We need a letter fromyou, a letter that says this is bad. We knowthat’s where you’re at, but we need you onrecord.” They came up with a letter that putthem on record as opposing this legislation,and that just infuriated Sen. Fischbach, whowas carrying the bill as the chief author.

� Why was anti-cloning language includedin a number of bills, including two majorbudget bills?

I can’t state for certain what their legislativestrategy was. I would suggest that probablythey figured they could get somethingthrough in one bill or another. If it getsburied in a big bill, a lot of times peoplewill vote for it even if they don’t like certainprovisions in it.

� The University of Minnesota was veryvocal in mobilizing opposition to thisbill. What can you tell us about theirperspectives?

They were caught flat-footed too, at first.Eventually the U of M galvanized a broaderarray of opponents and held a big press con-ference on the topic with a lot of familieswith kids who had been treated this way.

Mayo, on the other hand, I’m not surewhy it took them a while to get on board.At first they told the Senate leadership theywere going to stay out of it. They eventuallyput a letter together. They don’t specificallydo this technique, but they’re partners withthe U of M on a lot of research. And certain-ly from the scientific standpoint, theyobjected to these kinds of statutory restric-tions. I suspect earlier they made a politicaldecision that they were not going to getinvolved, but eventually the heat got turnedup. I know I leaned on them a bit. Theyprobably heard from other places as welland eventually decided to put out a letter.

� You mentioned that Sen. Fischbach ismarried to the executive director ofthe MCCL. How common is this sortof situation?

I think it’s pretty uncommon. They’re obvi-ously a family involved in politics. It’s beenmostly a non-issue over the years. But the

MCCL has been a very powerful lobbyingorganization at the Capitol for many years.It just happens they’ve now got a senator ina very high place who has a very uniqueconnection to them. With her as Senatepresident, if there were any members of themajority who were inclined to vote againstthe bill for whatever reason, they wouldhave that much added incentive to toe theparty line and vote for the bill.

I think it raises some questions. Theydidn’t shy away from it—the MCCL staff wassitting right up there next to the Senatepresident who was the author of the bill.

� What can physicians do to help elevatethe public understanding of the natureof medical research as it applies to theseissues?

One thing they ought to do is embolden theMinnesota Medical Association to be activein these kinds of questions at the Capitol.Doctors can write letters to the editor orop-ed pieces, and they will be credible voiceson this topic.

I don’t know if it would have changedthe outcome in this case, due to the policypositions of the legislators now in the major-ity. But in terms of public opinion, it’simportant, and in the long run that doeshave an impact on positions that legislatorstake. It only takes a few votes on the floorto change the outcome of a bill.


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care than whites for half of thecore measures studied, and onlyabout 20 percent of measuresof disparities in quality of careimproved over the study periodof 2000–2007. Being uninsuredwas the single strongest predic-tor of quality of care. However,when correcting for uninsuranceand socioeconomic status,blacks still receive worse carethan whites.

Locally, a recent WilderFoundation study reported simi-lar results. Blacks in the TwinCities have significantly shorterlife expectancy than whites, evenafter correcting for socioeco-nomic status. (“The unequal dis-tribution of health in the TwinCities: a study commissioned bythe Blue Cross and Blue Shieldof Minnesota Foundation,”October 2010)

These discrepancies raise thequestion: In what ways does ra-cism shape disparities in healthcare, especially for blacks?

Background

For 18 years I have had thehonor of caring for the majority

of children with sickle cell dis-ease (SCD) in Minnesota. About100,000 Americans, includingapproximately 600 Minnesotans,are living with SCD. I have onlyrecently begun to consider how,as a white male physician, myrace may affect the health caredelivery to our patients of color.This consideration is long over-due. Barriers to racial healthcare equity include the healthcare system (insurance, funding,white domination in provision ofcare), the patient (poor healthliteracy, fear, mistrust), the com-munity (awareness, advocacy),and we the providers (bias, atti-tudes, expectations).

The vast majority ofAmericans with SCD are black.This might not be a concern ifthere were not significant gapsin private and public funding forclinical care and researchbetween diseases affecting

blacks and whites in our coun-try. In 2004, the National Insti-tutes of Health spent $90 millionon SCD and $128 million dollarson cystic fibrosis (CF), a diseasethat predominantly affectswhites—despite the fact thatthere are three times as manyAmericans with SCD. Whenphilanthropic support from theCF Foundation and the SickleCell Disease Association ofAmerica is considered, the per-capita support for patients withCF is $5,074, compared to $6per person with SCD. Thesegaps are even more disconcert-ing when we consider that SCDis the most commonly detecteddisease in newborn screeningprograms in the U.S.

Patient perspective

From early medical experimen-tation on slaves, starting in the17th century, to the Tuskegeeexperiments (1932–1972), tocoerced sterilization of youngblack women (which was legaluntil 1974 in areas of theSouth), to present-day attitudesabout AIDS contraction, thehistory of racism in medicine(and health care overall) towardblack Americans has undoubt-edly shaped this community’slack of trust in the health caresystem. This legacy of racismand the resultant mistrust maypartially explain racial dispari-ties, as it may decrease blackpatients’ willingness to followevidence-based recommenda-tions made by (predominantlywhite) physicians.

Another patient-related issuereflecting this history and therace-class connection in the U.S.is decreased access to care basedon socioeconomic status. Forexample, access issues such ashealth care literacy, time andphysical availability to optimizethe most rigorous treatmentplan, and even transportation toand from a clinic can dramati-cally affect the patient’s perspec-tive on and experience of care.

Provider perspective

Medical staffs’ perceptions andawareness levels also affect thecare patients receive. Severalstudies have shown race and sexto influence physicians’ manage-ment decisions. With respect toprovider bias, SCD patients areperceived as being opioid-dependent at twice the rate ofother patients with pain. In onestudy, both staff and families ina sickle cell center perceivedwhites getting better servicethan blacks. A larger study ofmore than 200 providers in asickle cell center showed differ-ing perceptions of the effect ofrace on the quality of healthcare delivery: Providers of colorand women providers perceivedrace as an issue, whereas whitemale providers tended not to seerace as a factor in health caredelivery. In a recent study, whiteproviders prescribed hydroxy-urea (the only FDA-approveddrug to treat SCD) less frequent-ly than did black providers.

Identifying perceptionsof race and racism

According to the 2000 U.S.Census Bureau data, our nation’spopulation was 75.1 percentwhite and 12.3 percent black.However, Minnesota’s popula-tion was 89.4 percent white andonly 3.5 percent black. In 2010,the Minnesota black populationhad increased to 5.2 percent.Given the overwhelming major-ity of white providers in thehealth care system, the effectsof institutional racism may besignificant.

Lack of provider awarenessof institutional racism and theresultant structural barriers thatpatients of color face are areasour center felt were important toexamine. In 2009, we initiatedresearch with the goal of identi-fying perceptions of race andracism among our staff andpatients, with particular atten-tion to provider attitudes as apotential contributor to racialhealth care disparities.

Methods. An 11-item surveywas adapted from the Centersfor Disease Control’s 2008Behavioral Risk Factor Sur-veillance System and the SickleCell Transfer Questionnaire,with specific questions regardingrace, racism, and health care

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Blacks receive worsecare than whites

for half of the coremeasures studied.

delivery. The target populationwas staff, patients, and familiesfrom the Sickle Cell Center atChildren's Hospitals & Clinics ofMinnesota.

Demographic data obtainedincluded age, race, ethnicity, andgender. For staff, data were alsocollected about work positionand work location (inpatient vs.outpatient). The survey wasgiven to all patients with sicklecell disease >12 years of age andtheir families upon arrival toclinic. The survey was madeavailable online to all staff in thehematology/oncology program.

Results. We receivedcompleted surveys from 112patients/families. Surveys weremade available to 158 staffmembers and 135 were complet-ed (85 percent return rate). Thisvery high return rate speaks tothe deep interest in this topic.Not surprisingly, 92.6 percent ofpatients/families identified asblack, while 94.1 percent of staffidentified as white (P<0.001).

Among the significant find-ings were the following:• More patients/families thanstaff felt that race affects the

quality of health care for sicklecell patients (50 percent vs.31.6 percent, P=0.003, OR 2.1).

• More staff than patients/fami-lies perceived unequal treat-ment of patients at our institu-tion, especially in the inpatientsetting (20.9 percent vs. 10.9percent, P=0.03, OR 0.46).

• Patients/families showed agreater awareness of race thanstaff, as measured by self-reports of emotional responsesbecause of race while at thehospital (56.6 percent vs. 27.5percent, P<0.001, OR 3.43).

• Patients/families perceivedrace affecting interpersonalrelationships with caregiversmore than did staff (47.5 per-cent vs. 29.2 percent, P=0.005,OR 2.13).

• Though the majority of staffand patients/families agreedthat racism is a problem inthe U.S., most respondents feltthis was not an issue at ourinstitution.

• More staff than patients/fami-lies perceived racism as a pro-blem nationally (83.9 percentvs. 72 percent, P=0.02, OR0.49).

• Of respondents who felt therewas racism at our hospital,more staff than patients/fami-lies perceived this to be anissue (23.7 percent vs. 9 per-cent, P=0.002, OR 0.31).

Discussion of results

As expected, patients/familiesshowed a greater awareness ofrace than did staff and felt thatrace affected the quality of carethey received. This was less ofan issue with our more recentWest African immigrant familiesas compared to our AfricanAmerican families.

More staff than patients/families perceived racism as aproblem in our institution. Staffalso perceived unequal treat-ment of sickle cell patientsbased on race, especially in theinpatient setting. We were sur-prised to find perceptions ofracial issues being more preva-lent among staff. Perhaps thefemale-majority staff is moresensitive to discrimination ofany kind because of personalexperiences with sexism. Otherfactors that may have con-tributed to these findings:

• Our staff was significantlyolder than patients/families.

• Health care workers may bemore sensitive than those inother fields.

• Our work in healing fellowhumans may help make usmore aware of inequities.

• Perhaps because of the natureof their daily experiences withracism, patients and familiesperceive our institution as lessracist when compared to otherareas of their lives. It mighthave been better to ask howChildren’s compares to theirexperiences with racism inother areas of their lives.The survey gave us insight

into how provider attitudes maycontribute to continued racialhealth care disparities. For ex-ample, one provider commentedthat “[sickle cell] patients arechallenging because of their lackof support systems, not becauseof race.” This provider’s separa-tion of systemic issues such assupport structures from the real-ities of race and racism in theU.S. is a powerful indicator ofthe lack of knowledge and


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the criteria established formeaningful use are viewed inthe context of improving pro-cess, efficiency, and ultimately,quality for the patient, thenmeaningful use becomes a goalworth striving for. This is themost important lesson learnedfrom our experience: Ultimately,what we do needs to focus onthe patient by providing high-quality, efficient care.

Putting the process in motion

The planning process to achievemeaningful use started morethan eight months before wewere able to attest to reachingthat goal. An organization-widedecision was made that mean-ingful use standards would beused to evaluate all providers,regardless of their ability to par-ticipate in the federal incentiveprogram. [Participation isdependent on the percentage ofthe physician’s patients in gov-ernment programs or throughprofessional title—medical andosteopathic physicians qualifyfor the program, but physicianassistants, nurse practitioners,

and midwives do not.] In addi-tion, it was understood early onthat this needed to be a teameffort. As such, it included ourreceptionists, patient care staff,clinical assistants, providers,medical records, informationtechnology, and many othersupport staff.

WWMA established an over-all electronic health record com-mittee and committees at eachof our three sites. This was animportant piece in achieving fulladoption of an electronic healthrecord, as these committeesbecame the groups charged withachieving meaningful use. Thecommittees spent extensive time

studying each measure andunderstanding the elements thatcompose each numerator anddenominator. Attention was thendirected to the EHR and thecapabilities it brought to achiev-ing each of the 15 core and fiveof the 10 menu measures.

Finally, the committeesevaluated workflow in order tounderstand how to adapt tomeet the standard for eachmeasure. We took care to iden-tify the level at which the taskcould be accomplished and whowould be responsible for eachtask. For example, patient demo-graphics are recorded by ourfront-desk personnel, and vitalsigns such as blood pressure,temperature, height, and weightare all entered by clinical assis-tants. We wanted to be carefulnot to add to a provider’s alreadygrowing workload. We thenselected a number of measuresthat we felt were low-hangingfruit and worked to accomplishthese first. In one case, a one-on-one discussion and demon-stration by a colleague helped aphysician begin to e-prescribe;the physician soon discoveredhow much faster it is than paperprescribing.

At the same time, we iden-tified significant barriers toachieving more difficult meas-ures and determining how toovercome them. In some cases,it meant working closely withour EHR vendor, Cerner Corpor-ation, and pushing them toadjust or improve their electron-ic health record to make it moreefficient, enabling physicians tomore easily meet the measure.Cerner’s assistance was criticalas we captured the data neededto attest to meaningful use. Insome situations we found our-selves working closely with ourproviders and staff individually

or as a group around individualresponsibilities. Key areas wefocused on with providersincluded e-prescribing, medicalreconciliation, and providingvisit summaries to patients.

We came to understand thata consistent, regular presenta-tion to the providers and to thestaff, focused on tips and toolswithin Cerner’s AmbulatoryEHR, would be quite beneficial.EHR committee members havepresented tips twice monthlyover the past six months. Often,tips came from what our col-leagues were doing. Providersshared functionality andprocesses. We quickly learnedmany providers had not consid-ered or realized what was withinthe EHR’s capabilities. Forexample, many providers strug-gled with maintaining medica-tion lists, only to find thatMedication Reconciliation was atool that not only greatlyreduces the number of stepsinvolved, but also achieves ameaningful use goal.

Early in the quest for mean-ingful use, we developed reportsutilizing data from the EHR,sorting it by practitioner firstand then presenting that infor-mation to the entire group sothat we could see and monitorour own progress and the pro-gress of our peers. WWMA hashad a tradition of open, unblind-ed presentation of qualityresults, so this was not a diffi-cult transition for providers andother staff members. We haveconsistently found this open-ness, rather than being punitive,has provided an opportunity forthose not performing at a levelthey would like, to seek out andtalk to those who demonstratehigher levels of performance.

It also helped the meaning-ful use team to identify systemand process problems on a con-sistent basis. For example, wediscovered early on that we werenot recording and chartingchanges in vital signs in waysthat successfully met the attesta-tion goal. We worked with theclinical assistants to reinforcethe critical importance ofrecording all vital signs at everyvisit. Now, with everyone under-standing the expectation, weconsistently perform well abovethe 50 percent set target. In a


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What Is “meaningful use”?

The American Recovery and Reinvestment Act of 2009 specifies threemain components of meaningful use:1. The use of a certified EHR in a meaningful manner, such as e-pre-

scribing.2. The use of certified EHR technology for electronic exchange of health

information to improve quality of health care.3. The use of certified EHR technology to submit clinical quality and

other measures.Simply put, “meaningful use” means providers need to show they'reusing certified EHR technology in ways that can be measured signifi-cantly in quality and in quantity.Source: Centers for Medicare & Medicaid Services website,www.cms.gov/ehrincentiveprograms/

couple of situations, this processenabled us to work with specificproviders one-on-one to helpthem adapt their practice andworkflows to achieve thesegoals.

Significantly, there are anumber of the EHR measuresthat are dependent upon the ITdepartment and the practice’sspecific electronic health recordand less on the practitioner’sinvolvement. Several of thosemeasures were very easy toaccomplish; some required “add-on” EHR modules; and a coupleof measures required coopera-tion and assistance from outsideorganizations. Measures in thiscategory are shown in the side-bar. They include:• Implementing drug interactionchecks

• Implementing decision sup-port rules

• Performing a security riskassessment

• Exchanging electronic infor-mation with other providers

• Implementing drug formularychecks

• Incorporating laboratoryresults

• Submitting electronic data toimmunization registries

• Providing timely electronicaccess to records

• Providing patient education• Submitting electronic syn-dromic surveillance data topublic health agencies

An exercise in quality

In short, achieving meaningfuluse becomes a classic exercise inquality, systems, and processimprovement. It involves focus-ing on the big picture, beginningwith sound, broad-based deci-sions that understand the chal-lenge and opportunities of yourinternal workflows, having an

in-depth understanding of yourelectronic health record, a goodworking relationship with yourelectronic health record vendor,and working closely with yourstaff. Meaningful use is not justdoing one thing well, but doinga lot of little things better toachieve a large impact overall.

While today we cannot saythat every single meaningful userequirement has contributed toincreasing the quality of ourpatient care, engagement in thisprocess has led to a moresophisticated understanding ofour electronic health record andour own workflows. As a result,we are able to make changesthat improve the quality and theefficiency of the care we deliverto our patients.

It is said that every journeybegins with a single step. In ourexperience, the journey to mean-ingful use is hundreds, if notthousands, of small steps lead-ing to 21st-century medicine.

Paul McGinnis, MD, practices familymedicine with Hudson Physicians, adivision of Western Wisconsin MedicalAssociates.


Sample task lists for achieving meaningful use goals

Provider/clinical assistant team:• CPOE for medication orders• Maintain active medication

allergy list• Maintain active medication list• Maintain up-to-date problem list• Perform medication reconcilia-

tion• Provide clinical summary• Provide patient education• Provide summary of care at

transition• Record and chart changes in

vital signs• Record smoking status• Transmit prescriptions electroni-

callyCare coordinators/quality team:• Generate patient lists• Report quality measures to CMS• Send appropriate patient

reminders

Front-desk staff:• Record patient demographicsMedical records staff:• Provide electronic health infor-

mation on patient requestInformation technology staff:• Exchange electronic information

with other providers• Implement drug formulary

checks• Implement drug interaction

checks• Implement one decision-support

rule• Incorporate laboratory results• Perform security risk assessment• Provide timely electronic access• Submit electronic data to

immunization registries• Submit electronic syndromic

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P E D I A T R I C S

Whyare infants born inMinnesota still beingdamaged by prenatal

alcohol exposure when the causeis well known and completelypreventable? And why are chil-dren growing up with the effectsof this exposure and strugglingwithout recognition of their dis-ability? There are many reasons,and some of them involve us ashealth care providers.

Defining fetal alcoholsyndrome disorder

Alcohol is the only known tera-togen with the potential to causedeath, malformation, growthdeficiency, and functionaldeficits in the developing fetus.French researcher Paul Lemoineobserved the teratogenic effectsof alcohol on the developingfetus in 1968, and research inthe following decade confirmedhis findings. In 1973, the namefetal alcohol syndrome (FAS)was used by researchers atthe University of WashingtonMedical School to describethe pattern of “craniofacial,limb, and cardiovascular defectsassociated with prenatal onset

growth deficiency and develop-mental delay” in children bornto alcoholic mothers. Over time,the term fetal alcohol spectrumdisorder (FASD) was developedto include FAS as well as otherconditions resulting from prena-tal alcohol exposure. FASD is anumbrella term describing therange of effects that can occur inan individual whose motherdrank alcohol during pregnancy.In FAS, facial abnormalities

are present along with growthfailure and neurodevelopmentaldeficits. In FASD, milder effectsof confirmed prenatal alcoholexposure may include only facialanomalies or developmental dis-abilities. FASD is one of theleading causes of intellectualimpairment in the Westernworld. It is also one of the most

preventable causes.Nationally, Centers for

Disease Control and Prevention(CDC) studies show the preva-lence of FAS as one per 1,000births and of the more inclusiveFASD as one per 100 births.Based on the 2009 NationalSurvey on Drug Use & Healthconducted by the SubstanceAbuse and Mental Health Ser-vices Administration (SAMHSA),an estimated 8,500 babies areborn each year in Minnesotashowing some effects of intra-uterine exposure to alcohol.These effects may include facialanomalies, cardiac defects,growth failure, limb deformity,or abnormalities of brain devel-opment. Statistics from the 2009SAMHSA survey show that 12percent of mothers in Minnesotaconsume five or more drinks permonth in pregnancy and 5 per-cent binge drink, defined as con-suming five or more drinks dur-ing a four-hour period of time.

The effects of drinkingduring pregnancy

The timing of maternal use ofalcohol determines the type ofdamage seen, with facial andcardiac anomalies occurringduring the first trimester andgrowth retardation later in ges-tation. Brain development canbe impaired at any stage of thepregnancy. These are permanentchanges.Each mother and each preg-

nancy is different, and many fac-tors determine whether and howmaternal use of alcohol willharm the fetus. A recent Britishstudy by Kelly et al., publishedin the October 2010 issue of theJournal of Epidemiology andCommunity Health, suggestedthat mothers can safely drinksmall amounts of alcohol duringpregnancy without causing rec-ognizable abnormalities in theirchildren. Each of us can recallmothers we know who drank to

excess during several pregnan-cies and had healthy children.Clearly, there are poorly

understood correlations betweentiming and amounts of alcoholuse and protective features ofpregnancies. Because the safethreshold for alcohol exposurein a given pregnancy is un-known, the only certain way toprevent damage to the fetus is toavoid all alcohol use duringpregnancy. To that end, in 2005the Office of the SurgeonGeneral issued an advisory rec-ommending no alcohol use dur-ing pregnancy.

Prenatal care and counseling

Providers are often the firsttouch point for pregnantwomen and among the mostinfluential sources for moms-to-be. It is important that pro-viders give women consistentmessages about alcohol useduring pregnancy.The Minnesota Organization

for Fetal Alcohol Syndrome(MOFAS) promotes “049”—meaning zero alcohol for thenine months of pregnancy—asthe safest recommendation. TheMOFAS website at www.mofas.org has further information onthis recommendation.Obtaining a history of drug

or alcohol use during pregnancyrequires sensitive, nonjudgmen-tal questioning. Often, asking awoman about her alcohol useprior to becoming pregnant isperceived as less threatening, asis finding out when the motherdetermined that she was preg-nant. Asking about prior use andwhen the mother found out thatshe was pregnant may revealalcohol exposure during the firsttrimester. Because 50 percent ofpregnancies are unplanned, awoman may expose the fetus toalcohol unknowingly in earlygestation.Inquiring about current use

of alcohol during the pregnancymay help providers identifywomen who are alcohol depend-ent and will need referral fortreatment. The MOFAS websitehas links to a variety of treat-ment centers under the heading“Women.” Other women can becounseled that the safest choiceto protect their developing fetusis to abstain from alcohol during

Fetal alcoholsyndrome disorders

Working toward full prevention

By Mary Meland, MD


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EFFICACY ENCAPSULATED

Primary end point1:Primary end point1:

Initiation of GILENYA treatment results in a decrease in heart rateand has resulted in transient (AV) conduction delays. Obtain baselineelectrocardiogram before first dose if not recently available in those athigher risk for bradyarrhythmia. Observe all patients for signs and symptomsof bradycardia for 6 hours after the first dose. Patients receiving Class Ia orClass III antiarrhythmics, beta-blockers, calcium channel blockers, thosewith low heart rate, history of syncope, sick sinus syndrome, second degreeor higher conduction block, ischemic heart disease, or congestive heartfailure are at increased risk of developing bradycardia or heart blocks. Firstand second degree AV blocks following first dose have occurred. Theseconduction abnormalities were usually transient, asymptomatic, and resolvedwithin the first 24 hours, but occasionally required treatment with atropine orisoproterenol. If GILENYA is discontinued for >2 weeks, the effects on heartrate and AV conduction may recur on reintroduction of treatment and the sameprecautions for initial dosing should apply.GILENYA may increase the risk of infections. A recent complete blood count should be available before initiating GILENYA. Suspension of GILENYAshould be considered if a patient develops a serious infection. Monitor forsigns and symptoms of infection during treatment and up to 2 months afterdiscontinuation. Do not start GILENYA in patients with active acute or chronic infections. Two patients receiving a higher dose of GILENYA(1.25 mg) in conjunction with high-dose corticosteroid therapy died of herpeticinfections. Concomitant use with antineoplastic, immunosuppressive or immune modulating therapies would be expected to increase the risk ofimmunosuppression. Before initiating GILENYA, patients without a history ofchickenpox or without vaccination against varicella zoster virus (VZV) shouldbe tested for antibodies to VZV. VZV vaccination of antibody-negative patientsshould be considered prior to commencing GILENYA treatment, following whichGILENYA initiation should be postponed for 1 month.Macular edema can occur, with or without visual symptoms. An ophthalmologicevaluation should be performed before starting GILENYA and at 3 to 4 monthsafter initiation. Monitor visual acuity at baseline and during routine patientevaluations. Patients with diabetes mellitus or history of uveitis are at increasedrisk and should have regular ophthalmologic evaluations.Decreases in pulmonary function tests can occur. Dose-dependent reductionsin forced expiratory volume over 1 second (FEV1) and diffusion lung capacity for

carbon monoxide (DLCO) were observed in GILENYA patients as earlyas 1 month after initiation. The changes in FEV1 appear to be reversible afterdiscontinuing GILENYA; however, there is insufficient information to determinethe reversibility of DLCO. Obtain spirometry and DLCO when clinically indicated.Liver transaminases may increase. Recent liver transaminase and bilirubinlevels should be available before initiating GILENYA. Elevations 3- and5-fold the upper limit of normal occurred with GILENYA. Recurrence of livertransaminase elevations occurred with rechallenge in some patients. Themajority of elevations occurred within 3 to 4 months and returned to normalwithin 2 months after discontinuing GILENYA. Assess liver enzymes if symptomssuggestive of hepatic injury develop. Discontinue GILENYA if significant liverinjury is confirmed.GILENYA may cause fetal harm. Women of childbearing potential shoulduse effective contraception during and for 2 months after stopping GILENYA.A registry for women who become pregnant during GILENYA treatmentis available.Blood pressure should be monitored during treatment with GILENYA. An average increase of 2 mm Hg in systolic and 1 mm Hg in diastolicblood pressure was observed.GILENYA remains in the blood, and has pharmacodynamic effects, includingdecreased lymphocyte counts, for up to 2 months following the last dose.Lymphocyte counts generally return to normal range within 1 to 2 months ofstopping therapy. Initiating other drugs during this period warrants the sameconsiderations needed for concomitant administration.Carefully monitor patients concomitantly receiving Class Ia or Class IIIantiarrhythmics, beta-blockers or systemic ketoconazole. The use of liveattenuated vaccines should be avoided during and for 2 months afterstopping GILENYA.The most common adverse reactions with GILENYA (incidence >10%and >placebo) compared with placebo were headache (25% vs 23%),influenza (13% vs 10%), diarrhea (12% vs 7%), back pain (12% vs 7%),liver transaminase elevations (14% vs 5%), and cough (10% vs 8%).

INDICATIONGILENYA is a sphingosine 1-phosphate receptor modulatorindicated for the treatment of patients with relapsing formsof multiple sclerosis (MS) to reduce the frequency of clinicalexacerbations and to delay the accumulation of physical disability.IMPORTANT SAFETY INFORMATION

Novartis Pharmaceuticals Corporation

East Hanover, New Jersey 07936-1080 ©2011 Novartis Printed in the USA 01/11 C-GYA-100006

GILENYA is a trademark of Novartis AG.

EDSS=Expanded Disability Status Scale. FREEDOMS=FTY720 Research Evaluating Effects of Daily Oral Therapy in Multiple Sclerosis. IM=intramuscular. RRMS=relapsing-remitting MS. TRANSFORMS=Trial Assessing Injectable Interferon vs FTY720 Oral in Relapsing-Remitting Multiple Sclerosis.

Please see Brief Summary of Prescribing Information on adjacent pages.Reference: 1. GILENYA [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; 2010.

Key secondary end points:in mean number

of new or newly enlarged T2 lesions comparedwith interferon beta-1a IM (1.6 vs 2.6; P=0.002)

in the time to3-month confirmed disability progression betweenGILENYA and interferon beta-1a IM at 1 year (hazardratio [95% CI]: 0.71 [0.42-1.21]; P=0.21)

vs interferon beta-1a IM (0.16 vs 0.33; P<0.001)

TRANSFORMS: A 1-year, randomized, double-blind, double-dummy,active-controlled (interferon beta-1a IM) phase III study in 1292 peoplewith RRMS. At baseline, patients had a diagnosis of RRMS with atleast 1 documented relapse during the previous year or at least 2 documented relapses during the previous 2 years. They had a scoreof 0.0 to 5.5 on the EDSS with a median score at baseline of 2.0. Previous therapy with either any type of interferon beta or glatirameracetate was not a criterion for exclusion.

Key secondary end point:in the risk of 3-month confirmed

disability progression as measured by the EDSScompared with placebo (hazard ratio of disabilityprogression [95% CI]: 0.70 [0.52-0.96]; P=0.02)

rate vs placebo (0.18 vs 0.40; P<0.001)

FREEDOMS: A 2-year, randomized, double-blind, placebo-controlled phase III study in 1272 people with RRMS.At baseline, patients had a diagnosis of RRMS with at least1 documented relapse during the previous year or at least2 documented relapses during the previous 2 years.They had a score of 0.0 to 5.5 on the EDSS with a medianscore at baseline of 2.0. Patients did not receive anyinterferon beta or glatiramer acetate for at leastthe previous 3 months and had not receivedany natalizumab for at least theprevious 6 months.


GILENYA™ (fingolimod) capsulesInitial U.S. Approval: 2010BRIEF SUMMARY: Please see package insert for full prescribing information.1 INDICATIONS AND USAGE

GILENYA is indicated for the treatment of patients with relapsing forms ofmultiple sclerosis (MS) to reduce the frequency of clinical exacerbationsand to delay the accumulation of physical disability.

4 CONTRAINDICATIONSNone

5 WARNINGS AND PRECAUTIONS5.1 Bradyarrhythmia and Atrioventricular BlocksReduction in heart rateInitiation of GILENYA treatment results in a decrease in heart rate [seeClinical Pharmacology (12.2) in the full prescribing information]. Observe allpatients for a period of 6 hours for signs and symptoms of bradycardia.Should post-dose bradyarrhythmia-related symptoms occur, initiate appro-priate management and continue observation until the symptoms haveresolved.To identify underlying risk factors for bradycardia and atrioventricular (AV)block, if a recent electrocardiogram (i.e., within 6 months) is not available,obtain one in patients using anti-arrhythmics including beta-blockers andcalcium channel blockers, those with cardiac risk factors, as describedbelow, and those who on examination have a slow or irregular heart beatprior to starting GILENYA.Experience with GILENYA in patients receiving concurrent therapy with betablockers or in those with a history of syncope is limited. GILENYA has notbeen studied in patients with sitting heart rate less than 55 bpm. GILENYAhas not been studied in patients with second degree or higher AV block,sick sinus syndrome, prolonged QT interval, ischemic cardiac disease, orcongestive heart failure. GILENYA has not been studied in patients witharrhythmias requiring treatment with Class Ia (e.g., quinidine, procainamide)or Class III (e.g., amiodarone, sotalol) antiarrhythmic drugs. Class Ia andClass III antiarrhythmic drugs have been associated with cases of torsadesde pointes in patients with bradycardia.After the first dose of GILENYA, the heart rate decrease starts within anhour and the Day 1 decline is maximal at approximately 6 hours. Followingthe second dose a further decrease in heart rate may occur when comparedto the heart rate prior to the second dose, but this change is of a smallermagnitude than that observed following the first dose. With continued dos-ing, the heart rate returns to baseline within one month of chronic treat-ment. The mean decrease in heart rate in patients on GILENYA 0.5 mg at6 hours after the first dose was approximately 13 beats per minute (bpm).Heart rates below 40 bpm were rarely observed. Adverse reactions of brady-cardia following the first dose were reported in 0.5% of patients receivingGILENYA 0.5 mg, but in no patient on placebo. Patients who experiencedbradycardia were generally asymptomatic, but some patients experiencedmild to moderate dizziness, fatigue, palpitations, and chest pain thatresolved within the first 24 hours on treatment.Atrioventricular blocksInitiation of GILENYA treatment has resulted in transient AV conductiondelays. In controlled clinical trials, adverse reactions of first degree AV block(prolonged PR interval on ECG) following the first dose were reported in0.1% of patients receiving GILENYA 0.5 mg, but in no patient on placebo.Second degree AV blocks following the first dose were also identified in0.1% of patients receiving GILENYA 0.5 mg, but in no patient on placebo.In a study of 698 patients with available 24-hour Holter monitoring dataafter their first dose (N=351 on GILENYA 0.5 mg and N=347 on placebo),second degree AV blocks, usually Mobitz type I (Wenckebach) were reportedin 3.7% (N=13) of patients receiving GILENYA 0.5 mg and 2% (N=7) ofpatients on placebo. The conduction abnormalities were usually transientand asymptomatic, and resolved within the first 24 hours on treatment, butthey occasionally required treatment with atropine or isoproterenol. Onepatient developed syncope and complete AV block following the first doseof fingolimod 1.25 mg (a dose higher than recommended) in an uncon-trolled study.Re-initiation of therapy following discontinuationIf GILENYA therapy is discontinued for more than two weeks the effects onheart rate and AV conduction may recur on reintroduction of GILENYA treat-ment and the same precautions as for initial dosing should apply.5.2 InfectionsRisk of infectionsGILENYA causes a dose-dependent reduction in peripheral lymphocytecount to 20-30% of baseline values because of reversible sequestration oflymphocytes in lymphoid tissues. GILENYA may therefore increase the risk

of infections, some serious in nature [see Clinical Pharmacology (12.2) inthe full prescribing information].Before initiating treatment with GILENYA, a recent CBC (i.e., within 6 months)should be available. Consider suspending treatment with GILENYA if apatient develops a serious infection, and reassess the benefits and risksprior to re-initiation of therapy. Because the elimination of fingolimod afterdiscontinuation may take up to two months, continue monitoring for infec-tions throughout this period. Instruct patients receiving GILENYA to reportsymptoms of infections to a physician. Patients with active acute or chronicinfections should not start treatment until the infection(s) is resolved.Two patients died of herpetic infections during GILENYA controlled studiesin the premarketing database (one disseminated primary herpes zoster andone herpes simplex encephalitis). In both cases, the patients were receivinga fingolimod dose (1.25 mg) higher than recommended for the treatmentof MS (0.5 mg), and had received high dose corticosteroid therapy for sus-pected MS relapse. No deaths due to viral infections occurred in patientstreated with GILENYA 0.5 mg in the premarketing database.In MS controlled studies, the overall rate of infections (72%) and seriousinfections (2%) with GILENYA 0.5 mg was similar to placebo. However,bronchitis and, to a lesser extent, pneumonia were more common inGILENYA-treated patients.Concomitant use with antineoplastic, immunosuppressive or immunemodulating therapiesGILENYA has not been administered concomitantly with antineoplastic,immunosuppressive or immune modulating therapies used for treatmentof MS. Concomitant use of GILENYA with any of these therapies would beexpected to increase the risk of immunosuppression [see Drug Interactions(7)].Varicella zoster virus antibody testing/vaccinationAs for any immune modulating drug, before initiating GILENYA therapy,patients without a history of chickenpox or without vaccination againstvaricella zoster virus (VZV) should be tested for antibodies to VZV. VZV vac-cination of antibody-negative patients should be considered prior to com-mencing treatment with GILENYA, following which initiation of treatmentwith GILENYA should be postponed for 1 month to allow the full effect ofvaccination to occur.5.3 Macular EdemaIn patients receiving GILENYA 0.5 mg, macular edema occurred in 0.4% ofpatients. An adequate ophthalmologic evaluation should be performed at base-line and 3-4 months after treatment initiation. If patients report visual distur-bances at any time while on GILENYA therapy, additional ophthalmologicevaluation should be undertaken.In MS controlled studies involving 1204 patients treated with GILENYA 0.5 mgand 861 patients treated with placebo, macular edema with or without visualsymptoms was reported in 0.4% of patients treated with GILENYA 0.5 mgand 0.1% of patients treated with placebo; it occurred predominantly in thefirst 3-4 months of therapy. Some patients presented with blurred vision ordecreased visual acuity, but others were asymptomatic and diagnosed onroutine ophthalmologic examination. Macular edema generally improved orresolved with or without treatment after drug discontinuation, but somepatients had residual visual acuity loss even after resolution of macularedema.Continuation of GILENYA in patients who develop macular edema has notbeen evaluated. A decision on whether or not to discontinue GILENYA ther-apy should include an assessment of the potential benefits and risks for theindividual patient. The risk of recurrence after rechallenge has not beenevaluated.Macular edema in patients with history of uveitis or diabetes mellitusPatients with a history of uveitis and patients with diabetes mellitus are atincreased risk of macular edema during GILENYA therapy. The incidence ofmacular edema is also increased in MS patients with a history of uveitis.The rate was approximately 20% in patients with a history of uveitis vs.0.6% in those without a history of uveitis, in the combined experience withall doses of fingolimod. MS patients with diabetes mellitus or a history ofuveitis should undergo an ophthalmologic evaluation prior to initiatingGILENYA therapy and have regular follow-up ophthalmologic evaluationswhile receiving GILENYA therapy. GILENYA has not been tested in MSpatients with diabetes mellitus.5.4 Respiratory EffectsDose-dependent reductions in forced expiratory volume over 1 second(FEV1) and diffusion lung capacity for carbon monoxide (DLCO) wereobserved in patients treated with GILENYA as early as 1 month after treat-ment initiation. At Month 24, the reduction from baseline in the percent ofpredicted values for FEV1 was 3.1% for GILENYA 0.5 mg and 2% forplacebo. For DLCO, the reductions from baseline in percent of predictedvalues at Month 24 were 3.8% for GILENYA 0.5 mg and 2.7% for placebo.


The changes in FEV1 appear to be reversible after treatment discontinua-tion. There is insufficient information to determine the reversibility of thedecrease of DLCO after drug discontinuation. In MS controlled trials, dysp-nea was reported in 5% of patients receiving GILENYA 0.5 mg and 4% ofpatients receiving placebo. Several patients discontinued GILENYA becauseof unexplained dyspnea during the extension (uncontrolled) studies.GILENYA has not been tested in MS patients with compromised respiratoryfunction.Spirometric evaluation of respiratory function and evaluation of DLCOshould be performed during therapy with GILENYA if clinically indicated.5.5 Hepatic EffectsElevations of liver enzymes may occur in patients receiving GILENYA.Recent (i.e., within last 6 months) transaminase and bilirubin levels shouldbe available before initiation of GILENYA therapy.During clinical trials, 3-fold the upper limit of normal (ULN) or greaterelevation in liver transaminases occurred in 8% of patients treated withGILENYA 0.5 mg, as compared to 2% of patients on placebo. Elevations5-fold the ULN occurred in 2% of patients on GILENYA and 1% of patientson placebo. In clinical trials, GILENYA was discontinued if the elevationexceeded 5 times the ULN. Recurrence of liver transaminase elevationsoccurred with rechallenge in some patients, supporting a relationship todrug. The majority of elevations occurred within 3-4 months. Serumtransaminase levels returned to normal within approximately 2 monthsafter discontinuation of GILENYA.Liver enzymes should be monitored in patients who develop symptomssuggestive of hepatic dysfunction, such as unexplained nausea, vomiting,abdominal pain, fatigue, anorexia, or jaundice and/or dark urine. GILENYAshould be discontinued if significant liver injury is confirmed. Patients withpre-existing liver disease may be at increased risk of developing elevatedliver enzymes when taking GILENYA.Because GILENYA exposure is doubled in patients with severe hepaticimpairment, these patients should be closely monitored, as the risk ofadverse reactions is greater [see Use in Specific Populations (8.5) and Clin-ical Pharmacology (12.3) in the full prescribing information].5.6 Fetal RiskBased on animal studies, GILENYA may cause fetal harm. Because it takesapproximately 2 months to eliminate GILENYA from the body, women ofchildbearing potential should use effective contraception to avoid preg-nancy during and for 2 months after stopping GILENYA treatment.5.7 Blood Pressure EffectsIn MS clinical trials, patients treated with GILENYA 0.5 mg had an averageincrease of approximately 2 mmHg in systolic pressure, and approximately1 mmHg in diastolic pressure, first detected after approximately 2 monthsof treatment initiation, and persisting with continued treatment. In con-trolled studies involving 854 MS patients on GILENYA 0.5 mg and 511 MSpatients on placebo, hypertension was reported as an adverse reaction in5% of patients on GILENYA 0.5 mg and in 3% of patients on placebo. Bloodpressure should be monitored during treatment with GILENYA.5.8 Immune System Effects Following GILENYA DiscontinuationFingolimod remains in the blood and has pharmacodynamic effects, includingdecreased lymphocyte counts, for up to 2 months following the last dose ofGILENYA. Lymphocyte counts generally return to the normal range within1-2 months of stopping therapy [see Clinical Pharmacology (12.2) in the fullprescribing information]. Because of the continuing pharmacodynamiceffects of fingolimod, initiating other drugs during this period warrants thesame considerations needed for concomitant administration (e.g., risk ofadditive immunosuppressant effects) [see Drug Interactions (7)].

6 ADVERSE REACTIONSThe following serious adverse reactions are described elsewhere in labeling:• Bradyarrhythmia and atrioventricular blocks [see Warnings and Precau-

tions (5.1)]• Infections [see Warnings and Precautions (5.2)]• Macular edema [see Warnings and Precautions (5.3)]• Respiratory effects [see Warnings and Precautions (5.4)]• Hepatic effects [see Warnings and Precautions (5.5)]The most frequent adverse reactions (incidence ≥10% and > placebo) forGILENYA 0.5 mg were headache, influenza, diarrhea, back pain, liverenzyme elevations, and cough. The only adverse event leading to treatmentinterruption reported at an incidence >1% for GILENYA 0.5 mg was serumtransaminase elevations (3.8%).6.1 Clinical Trials ExperienceA total of 1703 patients on GILENYA (0.5 or 1.25 mg once daily) constitutedthe safety population in the 2 controlled studies in patients with relapsingremitting MS (RRMS) [see Clinical Studies (14) in the full prescribinginformation].

Study 1 was a 2-year placebo-controlled clinical study in 1272 MS patientstreated with GILENYA 0.5 mg (n=425), GILENYA 1.25 mg (n=429) orplacebo (n=418).

Table 1. Adverse Reactions in Study 1 (occurring in ≥1% of patients, andreported for GILENYA 0.5 mg at ≥1% higher rate than for placebo)

Primary System Organ Class GILENYA 0.5 mg PlaceboPreferred Term N=425 N=418

% %Infections

Influenza viral infections 13 10Herpes viral infections 9 8Bronchitis 8 4Sinusitis 7 5Gastroenteritis 5 3Tinea infections 4 1

Cardiac disordersBradycardia 4 1

Nervous system disordersHeadache 25 23Dizziness 7 6Paresthesia 5 4Migraine 5 1

Gastrointestinal disordersDiarrhea 12 7

General disorders and administrationsite conditions

Asthenia 3 1Musculoskeletal and connective tissuedisorders

Back pain 12 7Skin and subcutaneous tissue disorders

Alopecia 4 2Eczema 3 2Pruritus 3 1

InvestigationsALT/AST increased 14 5GGT increased 5 1Weight decreased 5 3Blood triglycerides increased 3 1

Respiratory, thoracic and mediastinal disordersCough 10 8Dyspnea 8 5

Psychiatric disordersDepression 8 7

Eye disordersVision blurred 4 1Eye pain 3 1

Vascular disordersHypertension 6 4

Blood and lymphatic system disordersLymphopenia 4 1Leukopenia 3 <1

Adverse reactions in Study 2, a 1-year active-controlled (vs. interferon beta-1a,n=431) study including 849 patients with MS treated with fingolimod, weregenerally similar to those in Study 1.Vascular EventsVascular events, including ischemic and hemorrhagic strokes, peripheralarterial occlusive disease and posterior reversible encephalopathy syn-drome were reported in premarketing clinical trials in patients who receivedGILENYA doses (1.25-5 mg) higher than recommended for use in MS. Novascular events were observed with GILENYA 0.5 mg in the premarketingdatabase.LymphomasCases of lymphoma (cutaneous T-cell lymphoproliferative disorders or dif-fuse B-cell lymphoma) were reported in premarketing clinical trials in MSpatients receiving GILENYA at, or above, the recommended dose of 0.5 mg.Based on the small number of cases and short duration of exposure, therelationship to GILENYA remains uncertain.

7 DRUG INTERACTIONSClass Ia or Class III antiarrhythmic drugsGILENYA has not been studied in patients with arrhythmias requiring treat-ment with Class Ia (e.g., quinidine, procainamide) or Class III (e.g., amio-darone, sotalol) antiarrhythmic drugs. Class Ia and Class III antiarrhythmicdrugs have been associated with cases of torsades de pointes in patientswith bradycardia. Since initiation of GILENYA treatment results in decreasedheart rate, patients on Class Ia or Class III antiarrhythmic drugs should beclosely monitored [see Warnings and Precautions (5.1)].


KetoconazoleThe blood levels of fingolimod and fingolimod-phosphate are increased by1.7-fold when coadministered with ketoconazole. Patients who use GILENYAand systemic ketoconazole concomitantly should be closely monitored, asthe risk of adverse reactions is greater.VaccinesVaccination may be less effective during and for up to 2 months after dis-continuation of treatment with GILENYA [see Clinical Pharmacology (12.2)in the full prescribing information]. The use of live attenuated vaccinesshould be avoided during and for 2 months after treatment with GILENYAbecause of the risk of infection.Antineoplastic, immunosuppressive or immunomodulating therapiesAntineoplastic, immunosuppressive or immune modulating therapies areexpected to increase the risk of immunosuppression. Use caution whenswitching patients from long-acting therapies with immune effects such asnatalizumab or mitoxantrone.Heart rate-lowering drugs (e.g., beta blockers or diltiazem)Experience with GILENYA in patients receiving concurrent therapy with betablockers is limited. These patients should be carefully monitored during ini-tiation of therapy. When GILENYA is used with atenolol, there is an addi-tional 15% reduction of heart rate upon GILENYA initiation, an effect notseen with diltiazem [see Warnings and Precautions (5.1)].Laboratory test interactionBecause GILENYA reduces blood lymphocyte counts via redistribution insecondary lymphoid organs, peripheral blood lymphocyte counts cannot beutilized to evaluate the lymphocyte subset status of a patient treated withGILENYA. A recent CBC should be available before initiating treatment withGILENYA.

8 USE IN SPECIFIC POPULATIONS8.1 PregnancyPregnancy Category CThere are no adequate and well-controlled studies in pregnant women. Inoral studies conducted in rats and rabbits, fingolimod demonstrated devel-opmental toxicity, including teratogenicity (rats) and embryolethality, whengiven to pregnant animals. In rats, the highest no-effect dose was less thanthe recommended human dose (RHD) of 0.5 mg/day on a body surfacearea (mg/m2) basis. The most common fetal visceral malformations in ratsincluded persistent truncus arteriosus and ventricular septal defect. Thereceptor affected by fingolimod (sphingosine 1-phosphate receptor) isknown to be involved in vascular formation during embryogenesis. Becauseit takes approximately 2 months to eliminate fingolimod from the body,potential risks to the fetus may persist after treatment ends [see Warningsand Precautions (5.7, 5.8)]. GILENYA should be used during pregnancyonly if the potential benefit justifies the potential risk to the fetus.Pregnancy RegistryA pregnancy registry has been established to collect information aboutthe effect of GILENYA use during pregnancy. Physicians are encouraged toenroll pregnant patients, or pregnant women may enroll themselves in theGILENYA pregnancy registry by calling 1-877-598-7237.Animal DataWhen fingolimod was orally administered to pregnant rats during theperiod of organogenesis (0, 0.03, 0.1, and 0.3 mg/kg/day or 0, 1, 3, and10 mg/kg/day), increased incidences of fetal malformations and embryo-fetal deaths were observed at all but the lowest dose tested (0.03 mg/kg/day),which is less than the RHD on a mg/m2 basis. Oral administration to preg-nant rabbits during organogenesis (0, 0.5, 1.5, and 5 mg/kg/day) resultedin increased incidences of embryo-fetal mortality and fetal growth retarda-tion at the mid and high doses. The no-effect dose for these effects in rab-bits (0.5 mg/kg/day) is approximately 20 times the RHD on a mg/m2 basis.When fingolimod was orally administered to female rats during pregnancyand lactation (0, 0.05, 0.15, and 0.5 mg/kg/day), pup survival was decreasedat all doses and a neurobehavioral (learning) deficit was seen in offspring atthe high dose. The low-effect dose of 0.05 mg/kg/day is similar to the RHDon a mg/m2 basis.

8.2 Labor and DeliveryThe effects of GILENYA on labor and delivery are unknown.8.3 Nursing MothersFingolimod is excreted in the milk of treated rats. It is not known whetherthis drug is excreted in human milk. Because many drugs are excreted inhuman milk and because of the potential for serious adverse reactions innursing infants from GILENYA, a decision should be made whether to dis-continue nursing or to discontinue the drug, taking into account the impor-tance of the drug to the mother.8.4 Pediatric UseThe safety and effectiveness of GILENYA in pediatric patients with MSbelow the age of 18 have not been established.8.5 Geriatric UseClinical MS studies of GILENYA did not include sufficient numbers of patientsaged 65 years and over to determine whether they respond differently thanyounger patients. GILENYA should be used with caution in patients aged65 years and over, reflecting the greater frequency of decreased hepatic, orrenal, function and of concomitant disease or other drug therapy.8.6 Hepatic ImpairmentBecause fingolimod, but not fingolimod-phosphate, exposure is doubledin patients with severe hepatic impairment, patients with severe hepaticimpairment should be closely monitored, as the risk of adverse reactionsmay be greater [see Warnings and Precautions (5.5) and Clinical Pharma-cology (12.3) in the full prescribing information].No dose adjustment is needed in patients with mild or moderate hepaticimpairment.8.7 Renal ImpairmentThe blood level of some GILENYA metabolites is increased (up to 13-fold)in patients with severe renal impairment [see Clinical Pharmacology (12.3)in the full prescribing information]. The toxicity of these metabolites has notbeen fully explored. The blood level of these metabolites has not beenassessed in patients with mild or moderate renal impairment.

10 OVERDOSAGENo cases of overdosage have been reported. However, single doses up to80-fold the recommended dose (0.5 mg) resulted in no clinically significantadverse reactions. At 40 mg, 5 of 6 subjects reported mild chest tightnessor discomfort which was clinically consistent with small airway reactivity.Neither dialysis nor plasma exchange results in removal of fingolimod fromthe body.

16 STORAGEGILENYA capsules should be stored at 25°C (77°F); excursions permitted to15-30°C (59-86°F). Protect from moisture.

Issued September 2010 Printed in the USA T2010-81Manufactured by:Novartis Pharma Stein AGStein, SwitzerlandDistributed by:Novartis Pharmaceuticals CorporationEast Hanover, New Jersey 07936©Novartis


the remainder of the pregnancy.Diagnosing fetal alcohol

syndrome disorders. Signs thatan infant or child has beenaffected by prenatal alcoholexposure can be subtle or quiteobvious. Making an early diag-nosis will enable the child to getspecific intervention if needed.Physical effects of prenatal

alcohol exposure may includegrowth deficiency with length,weight, or head circumferencebelow the 10th percentile. Aunique facial phenotype with asmooth philtrum, thin upper lip,and short palpebral fissures ischaracteristic of FASD. At-riskpopulations such as children infoster care can be screened byfacial photographs using a soft-ware measurement program.Cardiac and forearm anomaliesmay also occur but are less spe-cific to FASD.More significant but invisi-

ble are malformations in thebrain, including the cerebralcortex, cerebellum, corpus callo-sum, and other areas. Althoughspecific periods in gestation areassociated with specific vulnera-

bilities, the central nervous sys-tem begins to develop in thethird week and continues to de-velop throughout the pregnancy.Alcohol exposure at any timehas the potential to cause injuryto the immature nervous system.Research using MRI and fMRI isbeing done to assess focal andglobal central nervous systemdamage in children with FASD.A diagnosis of fetal alcohol

syndrome (FAS) requires allthree facial anomalies, alongwith growth deficits and centralnervous system abnormality.Other diagnoses on the spec-trum include alcohol-relatedneurodevelopmental disorder(ARND), alcohol-related birthdefects (ARBD), and partial fetalalcohol syndrome (pFAS).Milder involvement is calledfetal alcohol spectrum disorder(FASD). If any of these condi-tions is suspected, referral for aneurodevelopmental evaluationis warranted.As the child becomes a tod-

dler and a preschooler, behav-ioral and learning problems mayappear. Attention problems andhyperactivity are hallmarks,

though nonspecific ones, of pre-natal alcohol exposure, and theresponse to stimulant medica-tion is often poor. Memory andlearning impairments are alsocommonly seen. Executive func-tions such as judgment, plan-ning, and organizing are weak,making problem-solving diffi-cult. Not surprisingly, secondarydisabilities—including mentalhealth issues, trouble with thelaw, inappropriate sexual behav-ior, and drug and alcohol prob-lems—occur more frequently inyoung adults who were exposedto alcohol in utero. A goal ofearly diagnosis and interventionis to prevent these secondarydisabilities. Support for familiesliving with FASD is available atthe MOFAS website.

Prevention is the answer

Although early intervention canimprove outcomes for children,those with the full fetal alcoholsyndrome seldom achieve inde-pendent living as adults. Clearly,the answer lies in prevention.In addition to the frustra-

tion and heartache caused bydisabilities in individuals with

fetal alcohol spectrum disorders,the costs for their health care inMinnesota total an estimated$131 million dollars per year,according to the L. HurdPrevalence and Cost Calculator.Preventing a single case of full-blown fetal alcohol syndromecan save our community $1 mil-lion over the person's lifetimefor services such as health care,disability services, occupationaland physical therapy, juvenilejustice. All of these costs are pre-ventable if mothers abstain fromalcohol throughout pregnancy.Minnesota health care

providers must do their utmostto educate all women of child-bearing age and their partnersabout the dangers of consumingalcohol during pregnancy. Thetoxic effects of alcohol on thedeveloping fetus have beenknown for more than 40 years.It is time that all Minnesotainfants are protected from thisteratogen and allowed to leadhealthy productive lives.

Mary Meland, MD, is a pediatrician atSouth Lake Pediatrics and a board memberof MOFAS.


FASD from page 14

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MR. CHRISTENSON: How do you definewellness?

DR. LAWSON:Wellness is really about fullyembodied health from a holistic standpoint.All the perspectives—mental, emotional,physical, environmental, relational—need tobe involved. If you are just talking aboutwellness from a physical standpoint, you aremissing three-fourths of the boat. The secondpart of it is that wellness does not excludedisease or disability or injuries. Many, manypeople who are suffering from some kind ofdiagnosis or injury can still pursue theirhighest level of wellness and well-being forthemselves—that is important. The thirdthing is that it is not a set place that any ofus are ever going to arrive at. It is a movingtarget, an ongoing evolution, and a commit-ment to a conscious participation in a well-lived life.

DR. RADCLIFFE: As someone who sees patientsevery day, I see wellness as a balance. It is away to meet people where they are, withtheir experience, their heredity, their labora-tory tests, and their resources, and then find-ing out what they are willing to do and howwe can make a difference in their lives.

MS. SARGENT: Health is about individualstruly understanding what is happening intheir lives and developing a path and aplan to best achieve wellness at it relatesto what they are experiencing. Expanded tothe employer, it is the same thing. Everyemployer needs to have an understanding ofwhere they are and where they want to beand customize that plan for wellness fortheir organization.

MR. CHRISTENSON: Bill, how do you distinguishbetween wellness and preventive medicine?

DR. LITCHY: Some people confuse preventiveservices and preventive medicine and well-ness. Preventive services are those things weprovide—at first-dollar coverage—to peopleto make sure they do not have or are not sus-ceptible to certain diseases. Preventive careis about how you maintain health and some-times even restore health. Wellness to me is aphilosophy. All of those things go together. Asallopathic physicians, we have been taught tocure disease. We should be thinking abouthow we restore health.

MR. CHRISTENSON: Tom, what do you see asthe generator of this wellness revolution?

MR. HENKE: One big piece is that the finan-

cials of health care have changed dramati-cally. The plan designs offered to consumersthrough employers have radically changedover the last five or six years. Now the major-ity of consumers have high-deductibleplans—or if they do not have a high-de-ductible plan, they have much more personalaccountability for the amount they spend inhealth care. With that, they have decidedthey spend too much. One of the drivers hereis the consumer saying, “If this is going tocost me a lot, what could I do to avoid that?”

The other part that put this in a super-charged position is that the government pay-ment model changed to encourage account-able care organizations and to make rewardsor payment to the care providers. It is muchmore beneficial for a care provider to get up-stream and work on wellness to avoid thecost that will follow patients who are out ofcompliance or not at their optimal wellnessstate. Also, in the past, employers and healthplans did not know what things had a goodreturn on investment (ROI) in terms of well-ness. We all knew that we should eat right,exercise, should not smoke or drink. But howdo we best influence consumers to do thatinexpensively, efficiently? The data is finallycoming in.

MR. CHRISTENSON: Not so long ago, healthcare insurance had no deductibles, no copays—it covered everything. Now—with copays, de-ductibles, et cetera—people are beginning toask: Do I pay $20 or $30 to go to a physicianwhen I can go to a wellness practitioner andpay the same amount for a whole-service visit?

MR. HENKE: There has been a trend to cover-ing less traditional or nontraditional practi-tioners over the last 15 years. One piece tothis is that some employers are taking a veryaggressive approach, using biometric screen-ing—cholesterol levels, body mass index,weight measurement. It’s a first step in con-necting to whether an individual is doing thework he or she needs to do. Employers aredriving that because it comes back to cost.An overweight patient is much more likelyto have additional health care costs, and em-ployers just cannot afford it anymore.

DR. LAWSON: Cost is by no means the onlydriver for consumer behavior. Twenty yearsago, American consumers were spendingsignificantly more out-of-pocket dollars tosee complementary and alternative (CA)medicine providers. There were more visitsto CA providers than to primary careproviders in the United States at that time—and that was before those economic changeswith payment policies and stuff with thirdparties. There has also been a growing grass-roots hunger from the American populationto the effect that “this is not enough, wewant more.”

DR. ZEIGLER: If you look at public policy on anational level as well as a local level, it isturning itself upside down—and with goodreason. We are a country that per capita paysjust about the most in dollars per person buthas overall outcomes that are only moderateor worse. Looking at Third World countriesin comparison to our own, we do not havemuch to brag about. We are a rich nation.We have generally a high standard of living.We have access to a lot of care, yet we tendnot to change our health care behaviors. Sohow do we effect change in a society that isvery much oriented to the here and now? Itcomes down to creating value-based systemsthat consumers are willing to purchase. Weare seeing, as Karen said, consumers movingto other areas of health care because of itscost-effectiveness, because of their prefer-ences, because of their outcomes. We need totake a step back and look at how we design

About the RoundtableMinnesota Physician Publishing’s

35th Minnesota Health Care Roundtableexamined wellness as the centerpieceof a changing focus in health care.Seven panelists and our moderatormet on April 28 to discuss this topic.The next roundtable, on Oct. 13, willexplore the role of accountable careorganizations in health care reform.

M I N N E S O T A H E A L T H C A R E R O U N D T A B L E

The WellnessRevolution

A changing focus in health care

A B O U T T H E PA N E L I S T S


Julia Halberg, MD, MPH, MS, is vice president of global healthservices and chief medical officer of General Mills. Halberg earned hermedical degree from the University of Connecticut. She received a mas-ter’s degree in biology/ecology and a master’s of public health degree inepidemiology from the University of Minnesota. She is board-certified inoccupational medicine. Halberg has published extensively on several

topics, including shift work and blood pressure. At the University of Minnesota, she is anadjunct assistant professor in the department of environmental and occupational health.Halberg serves on the Occupational Medical Residency and the Midwest Center for Occupa-tional Health and Safety (MCOHS) advisory boards.

Tom Henke, MBA, is president and CEO of QuickCheck Health.Henke’s 25 years in health insurance include 15 years of executiveexperience with Medica Health Plans as chief innovation officer, seniorvice president and general manager of commercial markets, and vicepresident of sales and account management. In these roles, Henke hadoverall responsibility for Medica’s largest segment, representing 1 mil-lion members and more than $2 billion of revenue. He successfully launched many newproducts in many new markets and delivered market-leading growth. Henke has an MBA infinance from the University of St. Thomas.

Karen Lawson, MD, is an assistant professor in the Department ofFamily Medicine and Community Health at the University of MinnesotaMedical School and director of health coaching at the university’s Centerfor Spirituality and Healing. She is board-certified in both family medi-cine and integrative and holistic medicine, and was a founding diplomatof the American Board of Integrative Holistic Medicine. Lawson is the

co-leader and initiator of the National Team for Standards, Certification, and Research forProfessional Health and Wellness Coaches. At the university, Lawson is active in undergradu-ate and graduate medical education, and in the center’s graduate program.

William Litchy, MD, is chief medical officer of MMSI, the Mayo Clinichealth plan administrator. With graduate degrees from Saint Louis Uni-versity (MS, Anatomy), the University of Minnesota Medical School, andthe Mayo Graduate School of Medicine (Neurology), Litchy initiallyjoined the Mayo Clinic staff in 1982 and currently is a consultant in neu-rology. He also is the chair of Mayo Health Plan Operations Committee,which is responsible for the oversight of Mayo Clinic employee health plans. With MMSI andthe health plan, he has been involved in the development of wellness and care managementprograms for Mayo Clinic employees as well as other commercial and government-basedcompanies.

Noël Radcliffe, MD, is a family medicine physician at Edina SportsHealth & Wellness, PA. Within her practice, she includes alternative,holistic, and spiritual care. A board-certified, active member of the Amer-ican Holistic Medical Association, she began pursuing this area of interestwhen constraints of the managed-care system threatened the values ofmedicine she felt were important, namely caring and compassion. Rad-

cliffe lectures locally and nationally on topics such as consciousness and healing, depression,and forgiveness. She received her MD from the University of Wisconsin Medical School, withspecialty training in family medicine at Hennepin County Medical Center.

Jennifer A. Sargent, MS, is vice president of corporate wellness formyHealthCheck. Prior to joining Life Time and myHealthCheck, Sargentwas senior vice president of sales for U.S. Preventive Medicine. Hercareer also includes time at Matria Healthcare as vice president of salesand at Medica Health Plans as fitness program manager, as well as man-aging health enhancement programs for 3M and the University of NorthDakota. A graduate of the University of Minnesota Duluth, Sargent has a master’s of science inkinesiology and is pursuing her MBA at the Carlson School of Management.

Mark T. Zeigler, DC, a graduate of Northwestern College of Chiro-practic, was named president of Northwestern Health Sciences Universityin 2006. Prior to that, he was in private practice for 26 years in Sturgis,S.D., and was the city’s mayor from 2001 to 2006. Under his leadership,Northwestern completed a major 2008 campus expansion; attained a10-year re-accreditation; established clinical education partnerships with

the University of Minnesota, the Mayo Clinic, and HealthPartners; and founded the Center forHealth Care Policy and Innovation. Zeigler is vice president of the Associ-ation of Chiropractic Colleges and is on the board of the Minnesota Cam-pus Compact and Foundation for Chiropractic Progress.

Robert Christenson has 40 years of experience in health care policyand consulting. He helps solo and small-group practitioners build a fullpractice of ideal clients and improve their net revenue.


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these systems and address those ob-vious shifts in what consumers aredoing today.

DR. RADCLIFFE: From the perspectiveof the consumer, there are a couplethings that drive this strong interestin wellness. One is the change in ourconsciousness and awareness of howwe see health and wellness. I see itas being driven by the availability ofinformation from other traditions—Eastern philosophy and how otherpeople are living their lives and howthey are thinking about theirhealth—and also from access to theInternet. Suddenly you are awarethat there are all these other options.

DR. LITCHY:With regard to ROI, thereare issues that are very difficult toaddress. People struggle to find ROIin a variety of programs, whether itis health and wellness programs, dis-ease management programs, what-ever. But one issue that we alwayshave to keep in mind is that it is notjust the health care dollar that isbeing spent. It is—for employers—the absenteeism and presenteeismthat is well beyond the dollars theyspend for health care.

DR. HALBERG: At General Mills, wehave not been measuring absen-teeism/presenteeism, but seeingthe loyalty and the morale that leadto increased productivity. Ourdepartment of global health is aboutadvocacy and helping employeesunderstand their health and improveon it. We look at loyalty and morale—and thereby productivity.

MR. CHRISTENSON: While new possi-bilities for cross-disciplinary partner-ships are clear, much of the progress isstymied by the reimbursement system.What are the major causes of thisproblem?

DR. RADCLIFFE:We have been stuck inthe idea that we need to have a cer-tain type and quantity of studies thatprove efficacy. Though science is im-portant, we need to be able to take abigger-picture look. For instance,menopause. A patient has meno-pausal symptoms and can’t take hor-mones, so she wants a differentsolution. I have had really good luckhaving people do Chinese medicineand acupuncture. Knowing thatthere is a good response, I can referher to get a treatment that may bebeneficial for her. We need moredata that shows that it is beneficial.I am looking for that as I try to findout where I can send people to doother alternatives.

I also think that a lot of times

when we send people for alternativetreatments, we are also empoweringthem and they are making otherchanges that then impact other areasof their health. When we send peo-ple for Chinese medicine andacupuncture, they don’t need to stayon it for the rest of their lives. Wecreate a change, and they are in-structed in some health-changinglifestyle techniques that also play arole. There is a bigger picture to nothaving just science.

DR. ZEIGLER: Our third-party payersystem has historically reimbursedfor disease management versushealth promotion. Now there is atrend by third-party payers to lookat how can we save dollars and movepatient populations to providers whogive care with the best evidence andthe best cost-efficiency that im-proves patient satisfaction. Take low-back pain, for instance. I am awareof some third-party payers who aretrying to move those patients toproviders who they know are goingto prevent low-back surgeries ormore expensive procedures that aregoing to drive up the cost. Secondly,as you look at the movement towardmedical homes and the encourage-ment to bundle payments, it doesnot matter when you have a collabo-ration of providers in the medicalneighborhood, so to speak. It isabout getting the patient as well asyou possibly can in order to save themost dollars. It is a driver we aregoing to see being explored inMinnesota and across the countryover the next two to three years.

MR. CHRISTENSON: Why havehealth plans been hesitant to get intowellness?

MR. HENKE: It is important to notethat I don’t speak for a health plan atthe moment, but have in the past.One piece of it is the way in whichall systems are paid. Right now theyare paid dominantly in this marketby transactions. So every time some-thing is done, a payment is made.That is starting to evolve withaccountable care organizations(ACOs). In that world, we havecoaching that is intangible—it’s verydifficult to code exactly what conver-sation just occurred. That coachingtime was pressed down as all thecare delivery systems went to pro-duction models that required fasterand faster visits. One statistic I findfascinating: There is a recent RANDstudy that showed that the 10 mostcommon things done in the retail


clinic—Minute Clinic or Target Clinic—rep-resent 10 percent of its revenue. Those same10 things also represent 18 percent of all pri-mary care visits and 12 percent of all emer-gency room visits. In a world where we arespending enormous resources, $25 billionspent in clinics and emergency rooms forthings that can be done in a Minute Clinic isnot an efficient use of human capital. So youhave a large, clogged-up health system. Wehave insurers that are paying the way they’vealways paid and, because of that, every por-tion is optimized in their piece. It does notallow for new thought processes.

Since 1975 health plans, at least inMinnesota, all have covered preventive medi-cine and they have covered large numbers ofwellness services, but they are not alwayswell known. The nursing coach lines havebeen in place. We have also had chiropracticservices that have been covered for manyyears in the local health plans. Acupuncturehas been covered for quite a while. It isevolving, but to a great degree consumers didnot know what they could use within thehealth plans.

MR. CHRISTENSON: How well do third-party payers reimburse chiropractors?

DR. ZEIGLER: The chiropractic pro-fession, by and large, is covered by

all third-party payers. It’s not the cov-erage, really—it’s how you drive patients tothe right providers. In South Dakota theyjust had a legislative war on copays. The in-surance industry, in particular Blue Shield,raised copays for a chiropractic visit to morethan $50; for medical providers, it remained$15. So they introduced a bill in the Legisla-ture saying that you cannot discriminate co-pays for the same services. It passed both theHouse and the Senate, but was vetoed by thegovernor. Both chambers overrode his veto.In the industry today it is all about eliminat-ing barriers and getting the patient to theright provider. What we need to do in the fu-ture is watch the General Mills and the LifeTimes, as purchasers of health care designsystems that will be value-based. They willlook at leveraging and driving consumersand their employees to areas that ultimatelysave money. It will be business, not the pub-lic arena, that will change the way healthcare is going to go.

MR. CHRISTENSON: What is the role of integra-tive health care and integrative medicine inhelping to advance this wellness revolution?

DR. LAWSON: The two big pieces of integra-tive health care are that it takes a holistic

perspective to get us looking at all the com-ponents and all the perspectives of a personor a family or the system, and that it is opento and available to the best therapeutic inter-ventions and resources that are available forthat person’s situation and resources—whether those are things that may be per-ceived as conventional or things that havebeen outside the mainstream. Prior to the’90s, we had alternative medicine—peoplewere doing [either] that or this. Then we hadcomplementary medicine. People were doingboth things, but often they were not commu-nicating between providers or telling one docwhat the other was doing. With integrativehealth care, if you are, for example, an oncol-ogy patient, you may be receiving chemo-therapy and seeing a naturopath forsupplements and an acupuncturist for acu-puncture. As you are doing that, everybodyknows about everything. What that can bringto this movement has always been, tosome extent, about wellness and well-being. It has always been about opti-mizing a way of living and the abilityto live and do as one wants. A philos-ophy and focus that that movementhas held for 25 to 30 years is nowmoving into the mainstream.

MR. CHRISTENSON: Much of integra-tive care is happening in a teamenvironment. If we lookat medical homes,who should beincluded on theteam that isworking withthe patient?

DR. HALBERG:You have to beopen and inclu-sive. I use the integrative approach with ouremployees when I see someone who is nothealing. They have been diagnosed, theyhave a condition and it is being medicallytreated, but their mind is not there. We arevery fortunate to have high-quality integra-tive care in the Twin Cities. The holistic ap-proach is what we need to look at with themedical home as well. Rather than sayingwho should be included, I think most peopleshould be and you can pick from them all.

DR. ZEIGLER: It depends on the condition andthe situation. Certainly in a number of envi-ronments there are providers who excel be-cause of their experiences and their training.The collaboration of providers takes into ac-count patient preferences, the best evidence

that exists for the condition, and the clinicalexperience. At our institution we have achiropractic program, an acupuncture andoriental medicine program, and a massagetherapy program. We concentrate on thewhole person and try to deliver care withnatural components and in a natural setting.We understand that there is a fit for allproviders and a need for different deliverysystems. That is why we seek out models ofcare that are integrated—whether it be withour Woodwinds Clinic in HealthEast, withour students at Abbott Northwestern, withour massage therapy students at RegionsHospital, with our chiropractor program atMethodist. We work with the Center for Spir-ituality and Healing. We put these youngstudents together in an integrative settingand they go through diagnosis, the processof developing treatment plans, and then theyallow patients to decide which route of care

they would like to take.

MR. CHRISTENSON: One of the most interestinginnovations has been a new team membercalled a health coach.

DR. LAWSON: For years we called it the miss-ing provider. When you see an MD or a chi-ropractor or a naturopath, that providersays, “This is what you need to do.” Out inthe parking lot, you ask yourself, “How am Igoing to do that in my life? What do I starton first? What are my barriers?” There wasnot a professional to help people navigatethat. It’s the health coach or the health andwellness coach; the definition is still evolv-ing. A national team is working on settingthe standards for this. Team members havedefined certified health and wellness coachesas “professionals from diverse backgrounds


M I N N E S O T A H E A L T H C A R E R O U N D T A B L E sponsored by

M

There comes apoint where per-sonal accountabilityhas to step in.Tom Henke, MBA


in education that work with individualsand/or groups, in a client-centered process,to facilitate and empower a client to achieveself-determined goals related to health andwellness. Successful coaching occurs whencoaches apply clearly defined knowledge andskills so that the clients mobilize their owninternal strengths and external resources forsustainable life change.” The movement iscoming from everywhere—fitness, recre-ation, wellness, mainstream medicine, psy-chology, behavior change, and everything inbetween.

MR. CHRISTENSON: What type of training andoversight should be given to a health coach?

DR. LAWSON:We are still working on that,but there is agreement that it is not a week-end class. This is not something that justanybody should be able to write on their

business card. It will probably settle out be-tween 130 and 150 hours of education in ad-dition to a bachelor’s degree. There will needto be a requirement for four to six months ofclinical supervision. There will be a nationalboard-certification testing process that willidentify knowledge in areas around lifestyleand lifestyle medicine.

MR. CHRISTENSON: Should there be a processto certify wellness programs?

DR. HALBERG: I am a little nervous about that.The more certifications you acquire, themore barriers you put up. Wellness programsneed to be individualized; one size does notfit all. I think certification would take awayinnovation, as well as putting up barriers.

DR. LITCHY: I am also concerned about certifi-

cation of a program when we still are tryingto define what everything really means. As itmatures, there may be a time in the future,but I don't think the time is now. Programcertification would more likely hinderprogress at this time, because certification ingeneral does that.

MR. CHRISTENSON: When did you begin yourwellness programs at Mayo, Bill?

DR. LITCHY: There has been a long history inthe wellness programs we offer commercialclients, starting with health assessments andidentifying how you can use them and thengoing into providing information throughwebsites, books, and a variety of things.Mayo has a whole series of books, even oneon complementary medicine. Now there is astrong move to approach all these thingsfrom multimodalities. Each person learns

differently, each person will work differ-ently. If you have only one tool to usewith people, you will lose a lot of them.

MR. HENKE: As Karen mentioned, con-sumers have been paying for thingsoutside the health care insuranceworld all along, and we are not tak-ing advantage of that. Winningmodels will win—period. Rightnow, even on the insurance-

covered things, a typical de-ductible is between $1,000

and $3,000. That meanssomething on the order of

50 percent or more of allpatients will not reach

their out-of-pocketmaximum. So, inessence, they havezero coverage forthe current sys-

tem. That means that anything that is notcovered by insurance is on an equal footingwith covered things because it is 100 percentpaid by consumers. The question is whetherthe world really is ready for this—and Iwould suggest it is. Then I would suggest wefocus on adding value directly to the con-sumer. If it is there, employers will pay for it,insurers will pay for it. If it is not there, itwon’t be paid for. It is about getting con-sumers what they need.

DR. ZEIGLER: It goes deeper than just thehealth care system. Wellness needs to be partof our public policy. We have to take a standon how we feed our children in school, howwe promote good food, how we promotehealthy living. It is changing perspectives ofconsumers and changing behaviors. Look athow we buy our food, how we cook it, how

we prepare it. Look at tobacco use and howwe continue to abuse alcohol in certainsocioeconomic areas. Obesity still tends to beone of the largest problems within the UnitedStates. Look at cardiovascular disease anddiabetes. The debate really is a public policydebate.

DR. HALBERG: I would take it one step furtherfrom a business standpoint, and say healthand wellness have to be part of strategicvision for companies to be successful goingforward. We have a senior leadership believ-ing in that and that helps a lot to make amore open environment where we work.

DR. LITCHY: Until senior leadership takes therole of wanting it and talking about it, it justdoes not happen. When we work with newcompanies, that is the biggest thing we em-phasize. The stronger a company’s seniorleadership, the more successful wellnessprograms are. That’s simply the way it is.

MS. SARGENT: One of the biggest reasons wehave seen employer wellness programs fail isbecause they don’t change their culture. Theywill put a wellness program in place, theymay have a health risk assessment, dosome biometric screening—buttheir cultural aspect does notchange. They are still serving un-healthy foods and they do not havean environment that is conducive forpeople to exercise and manage stress. It doesnot become a part of what they do as an or-ganization. It is more than just putting a pro-gram in place and hoping that it works. Youhave to have it be a part of your strategy andchange your organization, your culture, andwho you are.

MR. CHRISTENSON: Many chronic conditionsare linked to unhealthy lifestyle choices. Whatare some examples of how our society encour-ages people to make the wrong choices?

MS. SARGENT:We have a society of conven-ience and a little bit of entitlement. We as asociety have this “I want it and I want it nowand I should have it now” kind of feeling—because we have such high-stress, busylives and unhealthy things are convenient.Because healthy behaviors are much lessconvenient, it makes it easier to choose theunhealthy over the healthy.

DR. RADCLIFFE: One thing that concerns meis advertising. How many ads [like this] dowe see: “If you have the symptoms, see yourdoctor”? There is no empowerment, and verylittle public health information out there.

DR. ZEIGLER: I read an article about a study atthe University of North Carolina–Greens-



MinnesotaPhysicianPublishing, Inc.

People come to thetable with not justlabs, but with theirwhole historyand experiences.Noël Radcliffe, MD




M

boro. Two economists studied WalmartSupercenter openings in almost 1,600 loca-tions nationwide. They demonstrated over10 years, from 1996 to 2005, that when aWalmart Supercenter enters a county, onaverage the residents of that county gainabout a pound and a half and the county’sobesity rate goes up by about two percentagepoints. So, fundamentally, our society is try-ing to make choices for us. It comes back toconsumers making healthy decisions. It isthe obligation of our educational institutionsto talk to our future providers about chang-ing behaviors, shifting consumer choices thatconsumers are making, and providing good,sound information that can change thosebehaviors.

MR. HENKE: The alignment centers in healthcare are very, very difficult to put in place.Let me use this silly example. If I am notdriving with my seatbelt on, I can get ar-rested. But my brother-in-law can get on hismotorcycle without a helmet. That is a verysimple example of an odd choice for societyto make. Health plans struggle with notbeing able to say they won’t cover a statin if

you haven’t stopped eating fats. Wecan’t do that. There comes a pointwhere personal accountability hasto step in. I would suggest that,

rather than complain about the sys-tem and society, we just go after the tar-

geted areas and win in those markets wherethere is interest. Rather than mandate thateveryone has to eat right, let’s reward thepeople who are eating right. We are going tohave to break down some of the insuranceregulations to have that flow-through to theconsumer. Right now consumers do not getrate cuts for following the right practices—even if they are following doctors’ orders.

DR. HALBERG:With regard to responsibility, Ivetoed a requirement that you had to fill outa health questionnaire before using our fit-ness center. I could not see instituting an-other barrier for liability purposes. Peopleask what small employers can do. There areso many things you can do, even at smallcompanies: Join with the American Heart As-sociation, American Cancer Society, Ameri-can Diabetes Association. They have walksand runs all the time. You can buy T-shirtsand get your people involved. To feel goodabout ourselves and to feel healthy, we needto engage. Volunteering is one way.

MR. CHRISTENSON: If a significant portion ofwellness involves making healthy choices, whatare some examples of successful programs?

DR. LAWSON: One of the most groundbreak-ing is Dean Ornish’s work with reversingheart disease. He put together a multidimen-sional team approach that was not usinghigh-cost interventions. Many, many practi-tioners said, “You are never going to get peo-ple to eat that way, to exercise, to do groupsupport.” And now it is reimbursed byMedicare because the cost of reversing heartdisease by a lifestyle-change program at$5,000 per year versus a typical quadruplebypass, which starts and goes up from about$30,000 a year—with similar morbidity/mortality outcomes—is pretty significant.

MR. CHRISTENSON: Jennifer, when you werewith U.S. Preventive Medicine, what were someof their successful programs?

MS. SARGENT: Partnering with employerssucceeded when employers understoodthat you have to take the program pasteducation to intervention. As an in-dustry, we have done the educationpiece pretty well. But we have not hadprograms in place to intervene.The successful programsare where the employertook charge of theprogram and said,“We need to domore. We need to in-stitute walking pro-grams and we needto have a fitnesscenter. We need tohave fruits and veg-etables available toour people,” andthen incorporatedthe whole family. Kids are a big part in mak-ing a wellness program successful.

DR. HALBERG:We trademarked a real-timehealth risk assessment. Our Health Numbergives people a snapshot in time of theirhealth status. Then there are health coachesto educate, motivate, and help them chooseone thing to move forward with. We use ink-dated fingersticks to do fasting glucose andlipids. We record weight and blood pressure.And we ask six objective questions. We cate-gorize scores on a scale of zero to 100. It’s alldone anonymously. Everyone gets their ownHealth Number. Then we project what theirpeers are doing. It’s a healthy competition,totally confidential, but it motivates them totake the next step.

MR. HENKE: The employer is an importantcenterpoint for a lot of change, but it is notthe only place. People spend half their time

at home, so reaching out just to the employeris not enough. Some successes I have seenare where the stakeholder—whether a gov-ernment agency, employer, a vendor—takes awhat’s-in-it-for-me approach and aligns itand meets with immediate response. If youare an employer who wants employees to be-have differently, you have to have a carrot ora stick, and it will absolutely make a differ-ence. If you put either rewards or penaltiesin, you will see dramatic change in participa-tion. If you do it incorrectly, you can makepeople pretty unhappy as well.

DR. LAWSON:While behaviors are criticaland they are often the easiest thing to meas-ure, belief change is a huge piece of this. Too

often we minimize the impact and empower-ment of learning to think of your life differ-ently, working your life differently ineverything from reducing pain to improvingquality of life. A lot of people, when they askabout health coaching, really focus on behav-ior. We need to be thinking broader thanthat.

MR. CHRISTENSON: What are some incentivesthat will make these programs successful?

MS. SARGENT: There are a lot of ways you cando incentives—and you can take a stick andpaint it orange and call it a carrot. More andmore employers are moving away from thetraditional carrot approach—I am going topay my employee $300 because maybe theydid a few things over the course of a year—to more of an outcome-based incentive pro-gram design. This is where you look at keyindicators and tell people, “If you don’t reachcertain goals, you are going to pay more.”

It will be business—not the public arena—that will change theway health care isgoing to go.

Mark T. Zeigler, DC



Maybe that’s a long-term strategy; it’s notthat you have to get to these goals tomorrow.

DR. ZEIGLER: Tom and Jennifer are right.Incentives can create tremendous shifts inbehavior. They are taking nontraditional ap-proaches to create those levers and using re-lationships as a driver in changing behavior.In other words, it is not just the fact that Iam going to drop $100 into your HSA or Iam going to reduce your annual health cover-age by $200 if you meet these markers, but itis creating these communities of partici-pants. You create obligations of one on an-other: If you don't meet your marker, you areletting down your friend, your coworker onthe team. So I will get up at 6:30 a.m. be-

cause if I don't I am going to let down myteam. Would I get up at 6:30 on my own? No.It is this obligation they are creating to in-centivize behavior changes.

DR. LITCHY:We spend a lot of time talkingabout how we are going to help the em-ployee, but many of our employees are mar-ried and have children. Our cost for thedependents and children is more than theemployee costs. We are challenged on howwe can engage the other members of thefamily.

DR. HALBERG:We have a healthy night out wesponsor for the community at the schoolswith parents, grandparents, and providers.We introduce fun ways of looking at nutri-tion, exercise—not just for our families butthe whole community. Recently we joinedwith American Harvest: For employees whoneeded to lose weight, for every pound ofweight they pledged to lose, we would give a

pound of food to the local food bank. Thattie to the community was a great motivationfor our employees.

MR. HENKE: One thing that is happening is aretailization of health care. Consumers aremuch more involved in their own decisions—good or bad—than ever before. One examplewe are working on now at QuickCheckHealth is the question of how to monitor pre-diabetics. If someone is prediabetic, it is op-timal to measure their A1c up to two times ayear to see if it is progressing. In a perfectworld, we would have a physician spendingtime with the patient twice a year doing thatwork. That is optimal. However, to have aprediabetic come in for an A1c check mightmean two visits because the health system isnot organized to do the test first and followwith the doctor immediately thereafter. It isorganized to see the doctor, then go get yourtests, and then you won’t have your scoreuntil you come back. That needs to be re-designed.

A second piece is that it costs $200 to$300 for a typical office visit with some labs.

So now we’re saying we are going tospend $400 a year on the 25 percent of

all adults in America who are pre-diabetic. That is a huge in-

crease in health care costsacross the board. Duringa single year, only a por-tion of those will migrateupward towards dia-betes. How do we ad-dress that? An exampleof what I would con-

sider a disruptive innova-tion is a rapid test that could be sent to thehome. The patient might have a $10 gift cardfor completing the rapid test. The patientcannot see the score until the doctor seesthe score. If we could move to a world wherethat is the approach to health care ratherthan centralizing everything at the clinic,consumers win, doctors can spend less timeon patients that don’t need to be there andmore time with those who do, and the sys-tem can win.

MR. CHRISTENSON: How have medical doctorsbegun to incorporate wellness more into theirpractice?

DR. RADCLIFFE: It comes on many levels. Thefirst is personal, how we chose to live ourlives and model for patients. How do we asemployers take care of our employees? Butalso wellness in the office: We take moretime. We want to talk to patients, to look notjust at their labs or their family history, but

to understand the barriers to them living ahealthier life. Are they caring for a sickmother? Are their kids having issues thattake up a lot of their time? Is their workplaceunsupportive? What are the issues and howcan you help them so that they have the timeand energy to focus some of their energy onthemselves and their wellness? The patients Isee fall into two groups. The first group feelshelpless. How many people do we know whowould save hundreds of dollars if they quitsmoking and still they don't quit smoking? Itisn’t about money. They do not feel like theycan do it. Part of that holistic approach isunderstanding that people come to the tablenot just with labs, but with their whole his-tory and experiences. In my clinic we spenda little extra time talking about those aspectsversus just looking at their labs.

DR. ZEIGLER: I was in private practice in Stur-gis, S.D., for 26 years. When I entered prac-tice in the late ’70s, I put an ad in the localnewspaper talking about my approach to thewhole person—body, mind, and spirit—andabout eating healthy, having an active life-style, and taking care of ourselves. I remem-ber getting chastised by my medicalcounterparts. In today’s environ-ment, open up any magazine, anynewspaper and look at how theads are talking about health care.There is a remarkable generationalshift. What excites us now in education isthat we have an opportunity to build on thatand break down the barriers to create betteroutcomes.

MR. CHRISTENSON: Bill, is there a growingnumber of holistic practitioners at Mayo?

DR. LITCHY: Yes. They have formed a sectionof interactive medicine. The philosophy atMayo has always been that the patient comesfirst. Generally, the approach has been totreat the whole patient, although we as allo-pathic physicians have been constrained byour training.

DR. HALBERG: I could not agree more that weare restrained by our training. I am oldenough to say it was always about disease—we never did prevention. It was always whatkind of technology or pharmacology you aregoing to use to get the person better. It is anawakening for those of us who are older toembrace these different treatments.

MR. HENKE: But there always is this issue ofcompensation. Who is going to pay for it?

DR. LAWSON: The restraints fascinate me.Yes, your payment plan covers acupuncture,but it has to come with a referral and the



Kids are a bigpart in makinga wellnessprogramsuccessful.Jennifer A.Sargent, MS



referral specifically has to be from your pri-mary care provider. Then I have to provide apitch with research documents to my pri-mary care provider to get them to write thereferral. Or we will cover massage, but onlyif it is for a diagnosis. If I go preventivelyonce a month, then I don’t get a diagnosis.

DR. ZEIGLER: I practiced in an environmentthat was defined by patient prefer-

ence. They could come to me forlow-back pain or they could goacross the street to the osteopathor MD. Now Optum Health—

which has tens of thousands ofchiropractors, physical therapists, and occu-pational therapists as part of their network—has developed a paradigm for low-back painbecause of what they know through theirdata. They are going to shift many of theirenrollees to chiropractors because they knowthe cost savings, the cost efficiency, and thepatient satisfaction. Would they have donethat 10 to 15 years ago? No. But because ofthe numbers they have, they know exactlythe dollar amount they are going to save ifthey can get it to a certain provider before itgoes to a specialist and on to probable sur-gery. Like it or not, that drives a lot of deci-sions—good most of the time.

MR. CHRISTENSON: What are the most impor-tant things employers need to evaluate whenthey look at the myriad wellness programsavailable to them?

DR. HALBERG:We always like to look atoutcomes measurements, of course. Is theprogram going to engage people, sustain be-haviors, and how is it going to go moving for-ward? There are a lot of good programs outthere. There is no one-size-fits-all, whetherit’s nutrition or getting moving. The pro-grams also have to have management sup-

port. We have talked about senior leader-ship, which is key, but we also found outthat middle management has to kick in

too or it will not be successful.

MR. CHRISTENSON: Bill, how do you marketyour programs to employers?

DR. LITCHY: The brand opens a door, butdoes not close the deal. We are cog-

nizant that some of the things wedo simply will not work with

some organizations. We wantto make sure there is a

match. Sometimes it does not match, not be-cause we have a program that is not good orthe company is not a good company. Therecan be different philosophies. You also haveto be able to demonstrate that you can suc-ceed at what you do. Outcomes are criticaland that magic word “data” is essential.Sometimes it is hard to get the data youneed. You may not be able to show the ROI,but you can show the engagement.

MS. SARGENT: I will echo some things thathave been said. Not every program is goingto fit every employer. The program and com-pany need to be flexible and nimble to meetthe needs of the employer and build a strat-egy around it, not just put a program or aproduct in place. It also needs to offer a vari-ety of modalities for people to engage. It can-not just be telephonic. There needs to be aphysical way for people to engage, whetherat the worksite or in other ways. One key isfinding a wellness program that will inte-grate with other programs you provide.Employers may have disease manage-ment with a carrier and they may havean employee assistance program andthey may have case management andthen a wellness program. How does it allfit? How do we not confuse memberswith somebody calling from thiscompany and somebodycalling from anothercompany for the samething? We need part-ners that are willingto sit together onthe client’s behalf tointegrate the solu-tions for a seam-less memberexperience.

DR. HALBERG: One other point is to get a localchampion. If you can get one or two employ-ees to really engage people, that local cham-pion will help determine success.

MR. CHRISTENSON: What are some of thebroader environmental and cultural aspectsthat affect the general health and wellness ofemployee populations?

MS. SARGENT: There are a number of things—smoking policies, food served in the cafete-ria, lots of little up to big things that cultur-ally and environmentally can impact health.Are you willing to do the tough thing tochange your culture and deal with theimpact?

MR. CHRISTENSON: What obstacles inhibit com-panies from investing in wellness programs?

DR. LITCHY:Money—simply that and whetherpeople are willing to realize that it is an in-vestment in their organization. To be veryfrank, there are organizations where the in-vestment really is not of value. If they have aturnover of 150 percent a year, I can see whythey would choose not to invest in their pop-ulation. If you have turnover of 2 percent ayear—Mayo, for example—there is a big in-centive to take care of the population.

MR. HENKE: It is all about how the seniormanagement culture sees health care. Whenthey see a 10 percent renewal increase forhealth care and they are looking at cuttingbenefits, there is not an appetite for addingthings that cost money unless they are ab-solutely proven to have a result.

DR. ZEIGLER:We got a Blue Shield grant toapply for a wellness program. It was a god-


M

Let’s make this anevolution versus revolution.

Julia Hallberg, MD, MPH, MS

Belief changeis a huge pieceof this.

Karen Lawson, MD



send because it gave us the green light toimplement a change. It did change the workenvironment, and you have to have the sup-port of senior management to do that. Andyou have to allow these things to evolve. Thereturn on investment came quicker than weexpected. Within two years we had premiumdrops in our overall insurance that we allcollectively shared.

MR. CHRISTENSON: What are some of thefactors that inhibit wellness programs frombeing effective?

DR. RADCLIFFE: Patients often do not feel sup-ported in their workplace. Without that it isvery hard for them to implement any change.Understanding how your workplace is stress-ful or unhealthy is critical to being able tohelp people commit to these programs.

MR. HENKE: The data is really compelling onthis. If there is one thing you can do, it isabout the senior management engagementand the champions. If you do not have thelocal champion, it just won’t work.

MS. SARGENT: There is a lot of research goingon right now about intrinsic versus extrinsicmotivation. The program has to have a com-ponent of working with the individual to findout what is going to intrinsically motivatethem to make the change. That is the hardthing to do.

DR. HALBERG:We combined health andsafety; our safety managers were also ourhealth managers. Often, people say, “I’m notsure I want my employer asking me aboutmy health—that is very personal to me.” Butfrom a safety perspective, it is all about be-havior change. What do I have to do to be

the safest I can be? Zero lost time, zeroinjury, win/win. Pair the health and safetyduality and they can incorporate it easierinto their everyday lives.

MR. CHRISTENSON: What role should healthinsurance companies play in keeping the well-ness momentum going?

DR. RADCLIFFE: I would like to see them offerincentives to employers to clean up theirworkplace. Maybe they would have to dosome kind of analysis, but in the long runI think it would be a healthier workplaceand healthier employees.

MR. CHRISTENSON: There are lots of wellnessprograms where there are no medical practition-ers involved at all. What issues are posed byhow these establishments archive patient data?

DR. RADCLIFFE: Having at one time practicedas a medical professional in an environmentthat was set up for what you are describing,there is not often educational expectation ofthings such as even basic rules of HIPAA.Certainly those wellness centers are very fo-cused on client empowerment and the clientbeing responsible for his or her own issues,challenges, and medical information. Butthere needs to be a certain level of safetytriage awareness, because clients don'talways understand what the level of knowl-edge is at the different places. I have seenthose issues coming up more and more inthe last five years as coaching has reallytaken off and we are getting a lot more part-nerships among fitness facilities, communityhealth places, and medical facilities.

DR. LITCHY: On the other hand, it is critical tobe able to integrate the data from all the dif-

ferent areas from which people are seek-ing wellness, so that we can do the

evaluations that are essential to con-tinued improvement. The struggle ishow to obtain the data legallythrough HIPAA and how we cantransfer that data among groups.

Because, unfortunately, a field inone person’s data set is notthe same field in anotherdata set. We are workingright now in a consortiumof several major medicalcenters around the coun-try and trying to figureout how we can put theidentified data togetherin a single database. Weare now at 18 monthsof very rigorous work

and are still challenged.

MR. CHRISTENSON: We have come to our finalquestion of the afternoon: How do we win thewellness revolution?

DR. RADCLIFFE: I would like us just to makesome steps forward. One thing that standsout is the need to personalize any type ofwellness plan. I love the idea that it startsfrom the top, but how do we do that? Howdo we actually get owners and senior man-agers involved in championing it? I think itwill happen on its own because they them-selves will be facing their own health issues.I think that will come.

DR. LITCHY: Fifteen years ago we were wor-ried about how we were going to take care ofthe high-dollar-cost people in the plan. Thenwe went on to say, “Let’s take care of every-one.” Now we’re talking about the high-costpeople again. We talked about wellness awhile ago and then forgot about it. We arenow bringing it back again.

MS. SARGENT: In order to win and not lose—or however you want to frame that—youneed to have some common vision andcollaboration among the key stake-holders: carriers, providers, em-ployers all starting to move in thesame direction with some sort ofcommon vision.

DR. ZEIGLER:We do know that the con-sumer is purchasing health care differentlytoday than they did 10 years ago. They arespending their own dollars to purchase carethe way they want to see it. I believe we needto listen to how consumers want to see theirhealth care and use health care education toour advantage to shift those populations intodifferent behaviors and different systems.

MR. HENKE: If we focus exclusively on theconsumer, focus exactly on what their prob-lems are and what they need, and we don’tworry about the other stakeholders—whogets paid, who wins, who loses—that is howwe are going to win.

DR. LAWSON: As long as we have the mindsetthat there is a barrier, something to over-come—if there is a loser and a winner—wewill continue to flail.

MR. CHRISTENSON: The last word, Julia, isyours.

DR. HALBERG: Slow and steady, let’s make anevolution versus revolution.



The stronger acompany’s seniorleadership, the moresuccessful wellnessprograms are.

WilliamLitchy, MD

Colorectal cancer (CRC) isthe second leading causeof cancer death in the

U.S., according to the AmericanCancer Society’s “ColorectalCancer Facts & Figures 2011–2013.” The report estimated thatin 2010 in Minnesota, an esti-mated 2,410 new cases of col-orectal cancer would be be diag-nosed and 780 people would diefrom CRC. Many of these CRCcases and deaths could havebeen avoided if people had madethe most of available screeningtests and prevention strategies.

The Minnesota CancerAlliance, a coalition of morethan 100 organizations, hasbeen working over the past twoyears to improve CRC screeningrates as an important way toreduce the burden of cancer inMinnesota.

In March 2009 the Minne-sota Cancer Alliance and theAmerican Cancer Society (ACS)co-sponsored a roundtable dis-cussion entitled “Colon CancerPrevention: The Next QuantumLeap.” Attendees included repre-sentatives of care delivery sys-tems, health plans, the Institutefor Clinical Systems Improve-ment (ICSI), MN CommunityMeasurement (MNCM), theMinnesota Department of Health(MDH), and the ACS. The goalwas to explore how care deliverysystems could help achieve apopulation-wide appropriatescreening rate of at least 80 per-cent in order to reduce deathsfrom CRC in Minnesota.

According to MNCM, thescreening rate in Minnesota in2010 was 66 percent, up from58 percent of appropriatepatients screened in 2006. [Note:2010 results are not directlycomparable to those for earlieryears, because the upper agelimit was lowered to includepatients only 75 years of age, vs.80 years of age in 2006.] Whilethe overall screening rate hasclimbed, there is significantvariation in screening ratesacross the state. Screening ratesfor the 61 medical groupsincluded in MNCM’s 2010 reportranged from a high of 92 per-cent to a low of 15 percent.

Among the issues raised anddiscussed at the roundtable werehow to systematically supportpatients and care teams to:1) motivate average-risk peopleage 50–75 to opt for screening;2) identify and initiate screeningat the appropriate age and inter-val for individuals at higher risk;3) address geographic and otherdisparities in CRC screening;and 4) ensure high-qualitycolonoscopy in Minnesota.

Following the March 2009roundtable, a Colorectal CancerAdvisory Council was formed.Subgroups of this councilfocused on: 1) clarifying the

screening message for average-risk individuals to the public andproviders; 2) revising ICSI’s CRCScreening Guideline to addressscreening for people at elevatedrisk; 3) addressing the complexi-ties of billing and payment forCRC screening; and 4) workingwith MNCM to create standard-ized population measures ofappropriate screening/surveil-lance and colonoscopy proce-dural quality.

In October 2010, stakehold-ers reconvened to highlight workaccomplished since the firstroundtable and to determinehow to further leverage Minne-sota’s health systems to increaseappropriate screenings.

Highlights of work accom-plished included:

Revision of the ICSI CRCscreening guideline and its useas a statewide evidence-basedstandard. Additions/changesto the guideline include newrecommended routine screeningoptions for individuals at aver-age risk for CRC; quality indica-tors for colonoscopies; addition-al considerations for informeddecision-making regarding validand evidence-based screeningoptions; and adding customizingscreening for average-riskAfrican American and AmericanIndians to start at age 45.

A change in how CRCscreening measurement datawill be collected and reportedby MNCM to provide greaterpublic accountability and trans-parency. New Colorectal CancerScreening Direct Data Submis-sion and Colonoscopy Quality &Surveillance measures were putin place in the summer of 2010.The data for these measures willbe collected directly from med-ical groups in the fall of 2011,and will include additional infor-mation on patient’s race, ethnici-ty, and primary language.

Clarification of billing andcoding practices for screeningprocedures. Health plans andprovider groups came togetherto review current billing prac-tices and to understand barriersand challenges in the currentsystem. A grid of colorectal can-cer screening codes was devel-oped as part of this work.

Decisions by five healthplans in Minnesota to work

Quantum leapSeeking to increase appropriate screening

for colorectal cancer

By Cally Vinz, RN, and Melissa Marshall, MBA

Minneapolis VA Medical CenterDirector, Spinal Cord Injury/Disorder Center

The Minneapolis Veterans Administration Health Care System (MVAHCS)is seeking a Director for its Spinal Cord Injury/Disorder (SCI/D)Center.The Center is theVA referral center for the upper Midwestand provides acute rehabilitation and lifelong care for 1200+ SCI/DVeter-ans. The SCI/D Center, a 68,000 square-foot-state-of-the art facility, has 30inpatient beds and an extensive outpatient clinic with both a urodynam-ics/special procedure and telehealth room.The Center’s therapy depart-ment is equipped with a wall-to-wall ceiling lift, a full spectrum of roboticand FES training devices, and an assistive technology lab.A dedicated ther-apy pool with adjustable depth control and computer-controlled under-water treadmill includes underwater video monitoring capability.Affiliated with the University of Minnesota, the SCI/D Center has rota-tions for both medical students and PM&R residents.

The Director is responsible for clinical care and administrative oversightof all aspects of the SCI/D Center, including leadership of Center func-tions such as continuous improvement activities,CARF and JCAHO com-pliance, oversight of satellite operations throughout the upper MidwestVA system, and direct supervision of medical staff and other clinical andadministrative staff.The SCI/D Director will also be responsible for con-tinued development of a SCI/D Home Care Program and SCI/D Fellow-ship Program.The Director reports to the Chief of Staff of the MVAHCSand participates in medical center and medical staff leadership activities.

Candidates should be board-certified in Spinal Cord Medicine.Leadership experience preferred.

Send CV and application to:

Human Resources Management ServiceMVAHCS, One Veterans Drive, Minneapolis, MN 55417Attn: Ann Bolan, HRMS or, email to [email protected]

EEO Employer


The American Cancer

Society estimates that

about 1,596,670 new

cancer cases will be

diagnosed in 2011 in

the U.S., including

27,600 new cases in

Minnesota. The articles

in this month’s special

focus address several

ways in which the

medical community

is striving to reduce the

burden of cancer—

through screeening

for colorectal cancer,

research on breast cancer

treatment, and technolog-

ical advances in radia-

tion therapy.

S P E C I A L F O C U S : O N C O L O G Y

with their provider groups toimprove colorectal cancerscreening for their perform-ance improvement project forthe Minnesota Department ofHuman Services for 2011.

Best practices

At the second roundtable, apanel with representatives ofStillwater Medical Group,CentraCare, and HealthEastCare System described the bestpractices they used to make sig-nificant improvements in theirreported screening rates from2008 to 2009. Panelists recom-mended the following practices:Plan ahead.• Standardize screening proto-cols to decrease confusion andsupport patients and providerswith appropriate options.

• Build a quality improvementand communications infra-structure to support patient/physician/care team interac-tion with regard to CRCscreening.

Identify patients/engageproviders.• Develop a process for targetedmedical chart review to figure

out which patients are mostlikely in need of a screen.

• Effectively track, and transpar-ently report, appropriatescreening rates results withinthe organization; this adds“friendly competition” amongcolleagues.

Send reminders to providersand patients.• Improve documentation andprompts—both electronic andpaper.

• Improve or initiate patient out-reach—simple postcards andletters work.The panelists also noted the

following common challengesthey encountered:• Effectively tracking and docu-menting screening proceduresnot done within their own

organization. It is important toget this information back tothe original clinic and docu-mented in the medical record.

• Tracking CRC screenings otherthan colonoscopies, as someinformation systems are notset up to do so.

• Variation and confusionregarding insurance coveragefor “screening” vs. “non-screening” colonoscopy.

• Difficulty with patient prepara-tion for a colonoscopy proce-dure and the need to havepatients’ questions regardingprep addressed in a timelymanner prior to the procedure.

Tactics to increase screening

Participants at both the 2009and 2010 roundtable discussions

also generated the followingideas to increase CRC screening.Communication/informationexchange tacticsWithin/between provider groups• Hard-wire one set of guidelinesinto the electronic healthrecord with prompts forscreening.

• Clearly communicate appro-priate CRC screening stan-dards and options to bothproviders and patients.

• Provide feedback to providerson their performance (measureand report).

• Create methods to sharepatient data between systems.

Physician/clinic to patient• Incorporate questions/provideinformation about CRC screen-ing into other health careencounters (e.g., mammo-grams, flu shots).

• Clearly communicate topatients their last preventiveexams and what is recom-mended for their age/gender.

• Develop a CRC pamphlet foruse at appropriate appoint-ments.


QUANTUM LEAP to page 36

Resources: colorectal cancer screening

• Revised ICSI CRC Screening Guideline: www.icsi.org/guidelines_and_more/gl_os_prot/preventive_health_maintenance/colorectal_cancer_screening/colorectal_cancer_screening_6.html

• New MN Community Measurement screening measurement require-ments: http://bit.ly/hvUC4S

• Information and tools to increase the quantity and quality of screensprovided to patients: www.mncanceralliance.org, www.icsi.org, andwww.mncm.org

• Additional resources: www.cancer.org/colonmd, www.nccrt.organd www.cdc.gov/screenforlife

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Move over photons.Make room for pro-tons. Photons, also

known as x-rays, have been themainstay of external beamradiotherapy for more than acentury, but a new era of radio-therapy—using charged parti-cles, such as protons—hasbegun, following pioneeringefforts in the United States,Europe, and Asia.

The beneficial effects ofx-rays for treating cancer werenoted soon after the discovery ofx-rays over 100 years ago. Signi-ficant advances over the yearshave improved their safety andefficacy, including improvedimaging of the cancer targetusing CT, MRI, and PET andmore powerful computer hard-ware and software used for dosecalculations and delivery.However, a problem with x-raysis that they pass completelythrough the body, administeringharmful effects to normal organsand tissues as they enter andexit the body on their way toand from the cancer target.

Protons, on the other hand,have a unique physical charac-

teristic called the Bragg Peak,in which there is very littleentrance dose as the protonsenter the body; then they slowdown and deposit the majorityof their energy in the canceroustissues; and then they stop, elim-inating the exit dose to normalorgans and tissues. This moretargeted form of radiotherapyallows exploration of dose esca-lation to improve tumor controland overall survival while simul-taneously lowering the risk ofacute and late side effects andcomplications of radiation onnormal organs and tissues.

The current generation ofproton beam therapy uses pas-sively scattered proton beams.This requires the use of costlydevices to shape the radiothera-py beams for every patient treat-ed, in order to reduce radiationexposure to normal tissue. These

devices are manually attached tothe treatment machine and pro-long treatment times. At present,all but one of the facilities offer-ing proton radiotherapy in theU.S. employ this technology.

The second generation ofproton radiotherapy, pencil-beam scanning proton therapy,eliminates the need for thesedevices by using intensity-modu-lated proton therapy (IMPT)to conform the radiation doseto the cancer target—much asintensity-modulated radiationtherapy (IMRT) improves preci-sion of x-ray delivery. Pencilbeam scanning proton therapyuses so-called spot scanningto embed dots of radiationthroughout a tumor—“painting”dots of protons back and forth,similar to the pointillism paint-ing style of French artist GeorgeSeurat. The protons fill thedepth and contour of the tumor,allowing greater control overradiation doses, including appli-cation of higher doses to im-prove tumor control and sur-vival, shorter and fewer treat-ment times, and fewer side ef-fects compared with convention-al photon and proton therapy.

A third iteration of protonbeam therapy is now undergoingfinal testing at the Paul ScherrerInstitute in Switzerland, whereproton pencil-beam scanningtherapy was developed. Linescanning with IMPT will be 10times faster than spot scan-ning—so fast that it can paint atumor in between a patient’sbreaths. That means this radio-therapy can be used in lung,liver, and other tumors thatmove due to respiration.

In April, design began ontwo new advanced proton unitsat Mayo Clinic’s campuses inMinnesota and Arizona (seesidebar). The health system willinstall pencil beam scanningradiotherapy and hopes to usethe third iteration as well.

The case for charged particles

The U.S., in general, has been

late to explore the use ofcharged particles to treat cancer.One reason is cost; researchersand physicians chose to examinewhether less expensive advancedx-ray technology would offersimilar benefits. Experts havespent a lot of time investigatingwhether IMRT technology couldfocus and concentrate x-rays ontumors better than conventionalx-ray treatments could.

Radiation oncologists knowthat the price paid for bathingthe body with low doses ofIMRT x-rays, which travel intothe body, through the tumor,and then out of the body, is radi-ation damage to normal tissueand development of secondarylate effects and cancers. Theradiotherapy communityremains concerned about thelong-term effects of x-rays, espe-cially when they are used inchildren and young adults.

X-ray and proton radiothera-py has limited efficacy in treat-ing some solid tumors that aredeficient in oxygen, a conditionthat occurs when these tumorsoutgrow their blood supply.Tu-mor cells in such a hypoxicenvironment are often resistantto x-ray and proton radiotherapy.

Comparatively, heaviercharged-particle therapy usingcarbon ions offers an anti-tumoreffect that does not depend ontumor oxygen content. In heav-ier charged-particle therapy, thelarge mass of the particle sup-plies directed energy that canbreak apart DNA, in a processreferred to as high-linear energytransfer. Taking advantage of thesame Bragg Peak physical char-acteristic of protons, the higherenergy from heavier chargedparticles can be deposited direct-ly within the tumor, with verylittle entrance or exit dose, thusreducing the impact on sur-rounding normal tissue andovercoming the resistance of thecancer cells to the killing effectsof radiation.

Recognizing these advan-tages, charged particle radio-therapy facilities have beenbuilt in Europe (Switzerland,Germany, England, France, Italy,and Sweden) and in Japan,China, and South Africa. Carbonion units have been used sincethe mid-1990s, primarily inJapan, where more than 4,000

Proton beam therapyPutting radiation doses where they belong

By Robert L. Foote, MD


patients have been treated.There are also carbon ion facili-ties in Germany, Italy, andChina.

In the past few years, anumber of commercial equip-ment vendors have begun tooffer proton therapy, thus lower-ing the price of the equipment.Carbon ion therapy is consider-ably more costly than protonbeam therapy, but it also offers adose that is at least three timesas powerful as protons or x-rays.

There is much yet to beresolved regarding use of carbonions in the U.S. The federalFood and Drug Administrationhas not approved the equipmentfor its use in this country; noone has applied for approval.And there is no mechanism yetfor insurance reimbursement forthis future therapy. The strategyMayo Clinic has adopted is tobuild two units of the mostadvanced proton pencil-beamscanning therapy possible, at acost of about $400 million, andto explore development of a“next-generation” carbon ionfacility in the future.

Mayo radiation oncologists

foresee a future in which amenu of charged particles—pro-tons, carbon ions, and otherheavier charged particles suchas helium, oxygen, neon, lithi-um, and beryllium ions—will beoffered to cancer patients. Thechoice of particles will dependon characteristics of the tumor(such as its anatomical locationand genetic profile), in muchthe same way as biologically tar-geted chemotherapeutic agentsfor cancer, and antibiotics basedon specific strains for bacteria.

The need for research

Pencil beam scanning is veryeffective in treating tumors that

are deep-seated, close to critical,radiation-sensitive organs andbody structures. These includesome head and neck, breast, gas-trointestinal, lung, spine, andprostate cancers, and tumors inor near the brain and eye.

Even though it is knownthat patients benefit from put-ting radiation doses where theybelong and nowhere else, thenewness of proton therapymeans that randomized, clinicalproof that proton beam therapyin adults offers superior out-comes compared to advancedx-ray technology is still evolving.The benefit to children, however,is clear. The pediatric radiation

oncology community alreadyhas determined that protonbeam therapy should be usedwhenever possible in preferenceto x-ray therapy.

Researchers at the twoMayo Clinic proton beam facili-ties are planning on conductingjoint prospective clinical studiesas a unified program. Standard-ized treatment factors and clini-cal outcomes for all Mayopatients will be entered into onecentral database to improve caremodels and services for cancerpatients. Mayo also plans to fos-ter collaborative research withother centers worldwide.

The goal is to minimize theharmful effects of the entranceand exit dose of radiation onnormal organs and tissues andincrease the beneficial effects onthe cancer target by increasingthe dose. This will give us agreater chance to cure morecancers and help people to livelonger, free of the harmful acuteand late effects of radiation.

Robert L. Foote, MD, is chairman ofthe Radiation Oncology Department at theMayo Clinic, Rochester.


While some first-generation proton treatment facilities are up and run-ning in the United States, Mayo Clinic has announced plans to build twonew advanced proton units at its campuses in Minnesota and Arizona, aspart of Mayo’s three-site cancer center (the other campus is in Florida).

With multi-site facilities, which are now in the design phase, MayoClinic’s commitment to proton beam radiotherapy is perhaps, at thispoint, among the strongest in the country. Eight rooms will be equippedwith “pencil beam scanning” proton beam therapy that will use spotscanning to “paint” dots of protons back and forth through a tumor.

Design of the proton beam facilities began in April, and constructionis slated to begin in September in Rochester and in December in Arizona.The first patient will be treated in Rochester in mid-2015, and in early2016 in Arizona.

The proton beam therapy program will be fully integrated into MayoClinic's three-site cancer center in Minnesota, Arizona, and Florida.

9533 0611 ©2011 ALLINA HEALTH SYSTEM. ®A REGISTERED TRADEMARK OF ALLINA HEALTH SYSTEM

Allina Hospitals & Clinics inMinnesota/Western Wisconsin

AllergyDermatology

Hospitalist

Hospitalist

Allina offers a competitive bene�ts and salary package.For more information, please contact:

Kaitlin Osborn, Allina Physician Recruitment Toll-free: 1-800-248-4921 | Fax: 612-262-4163

Email: [email protected] Website: allina.com/jobs

EOE

Allina Hospitals & Clinics is known for its clinical quality, and an award-winning EMR. At Allina, physician leadership and involvement drive our success.The Clinic and Community Division features the Allina Medical Clinic, Aspen Medical Group, and Quello Clinics, as well as Home and Community Services. Our clinics, as well as our 11 hospitals, are located in the Twin Cities metro area, throughout Minnesota, and in western Wisconsin.Full- or part-time urban, suburban, and rural openings are available inthe following specialties:

Minneapolis VA Medical CenterChief of Imaging Services

The Minneapolis VA Health Care System (MVAHCS),affiliated with the University of Minnesota, is seeking adynamic leader for the position of Chief of ImagingServices.MVAHCS provides comprehensive inpatient andoutpatient care and serves as a tertiary referral center forVISN 23 and other medical centers across the country.TheVA has state of the art equipment including all digitaldepartment with 3T and 1.5T MRI, 3 CT scanners, PET/CTand 2 angiographic suites.

A full-time Chief is needed to assume clinical and aca-demic leadership of the Imaging Service Line, and to serveas a member of the management team of the medical cen-ter. This position would include an academic appointmentat the University of Minnesota and would oversee researchand resident training at theVA.Applicants must be board-certified in diagnostic radiology, have clinical, administra-tive, and teaching experience, and preferably experienceworking in aVA hospital. Competitive salary and benefitswith recruitment incentive and performance pay possible.

SSeenndd CCVV aanndd aapppplliiccaattiioonn ttoo::Human Resources Management ServiceAttention: Ann BolanMVAHCSOne Veterans Drive, Minneapolis MN 55417or, email [email protected].

EEO Employer


An article in the February2011 issue of the Journalof the American Medical

Association made national newsin reporting the results of theAmerican College of SurgeonsOncology Group Z0011 trial(JAMA 2011; 305(6):569–575).

The study findings haveimplications for current surgicalpractice. Researchers comparedsentinel lymph node (SLN)biopsy alone versus axillarylymph node dissection (ALND)for positive SLN. They carefullychose nearly 900 patients,selected for small, invasivebreast cancers with no palpableadenopathy, who were under-going lumpectomy and post-lumpectomy radiation. Eachpatient’s physician determinedwhether she should receivechemotherapy. Approximatelyhalf of the women did.

Based on the literature, theresearchers hypothesized over-all survival at about 80 percentat five years for optimally treat-ed women with positive axillarylymph nodes. Surprisingly, aftersix years, survival for bothgroups was considerably higher.

The SLN-alone group demon-strated a five-year survival rateof 92.5 percent; the ALNDgroup, at 91.8 percent, showedno statistical difference fromthe SLN-alone group. The

improved survival rate likely isthe result of better radiationtechniques and improvedchemotherapy drugs.

The SLN-alone groupreached a disease-free survivalrate of 83.9 percent, and theALND group topped 82.2 per-

cent—again, showing no com-parative statistical difference.Further, the SLN-alone groupdemonstrated a five-year localrecurrence rate of 1.6 percent,while the ALND group demon-

strated a 3.1 percent rate(P=0.11). Results point to alocoregional recurrence-free sur-vival at five years of 96.7 percentin the SLN-alone group and 95.7percent in the ALND group.

Should we changestandard practice?

Axillary lymph node dissectionin the setting of breast cancerhas long been controversial.Nodal sampling was at one timethought to be therapeutic, butmore recently the consensus hasbeen that it is diagnostic. Breastsurgery, as a whole, has becomemuch less radical, moving fromthe Halsted radical mastectomy,to various versions of the modi-fied radical mastectomy, tolumpectomy. These changes insurgery have been accompaniedby advances in adjuvant treat-ments including breast irradia-tion and chemotherapy/hormonetherapy.

Similarly, axillary lymphnode surgery has become lessinvasive. The sentinel lymphnode biopsy, associated with farless morbidity than axillary dis-section, has become the stan-dard. The accepted SLN biopsyprocedure involves sending thesentinel node(s) to pathologyduring surgery for frozen sec-tion. If the SLN is positive, thesurgeon performs an ALND andoften places a drain. The risks ofALND include wound infection,

seroma, paresthesias, and lym-phedema. No study has demon-strated a survival benefit associ-ated with ALND when metastat-ic cancer is identified in an SLN.

In light of the AmericanCollege of Surgeons OncologyGroup Z0011 trial results,should surgeons change theirprotocols and standard practice?The data are good and the num-ber of patients is fairly large(420 and 436 in the respectivegroups). The follow-up period—six years, so far—is not thatlong, but the data appear validas they are compared with five-year survival and recurrencenumbers. If we apply this studyto clinical practice, surgeonsshould adhere to the patientselection criteria as outlined(see sidebar).

Also, because radiationtreatment is important, a patientwho will not need post-surgicalradiation, such as a womanundergoing mastectomy, shouldhave ALND if the SLN is posi-tive. The surgeon should removeany palpably abnormal lymphnodes, regardless of procedure.Avoiding ALND in select patientswill decrease the associatedmorbidity and post-operativediscomfort, as well as save thetime and money associated withperforming a frozen section onthe lymph node during surgery.

The ACOSOG Z0011 studysupports the idea that lymphnode biopsy for breast cancerserves a diagnostic purpose, andthat further dissection of lymphnodes does not improve survivalas long as the patient receivesradiation to include the inferioraxilla.

Questions remain

Although the study’s findingsprovide important guidance tosurgeons, a number of questionsremain about lymph node proce-dures and their interpretationfor treatment.

For example, does removingonly one or two positive nodesaffect the oncologist’s treatmentselection? Typically, oncologistsconsider the number of affectedlymph nodes when making deci-sions about chemotherapy. Anoncologist may offer chemother-apy to a healthy woman in her

Breast cancer careNew study highlights issues of

surgical protocols, standard practice

By Madeline Gartner, MD


Sioux Falls VA Medical Center“A Hospital for Heroes”

Working 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,

theVA offers an incomparable benefits package.They all come

together at the Sioux Falls VA Medical Center.

www.siouxfalls.va.gov

To be a part of our proud tradition, contact:

Human Resources Mgmt. ServiceP O Box 5046Sioux Falls SD 57117605-333-6852

• Pulmonologist

• Orthopedic Surgeon

• Emergency Department Physician

BREAST CANCER to page 34

Although the study’s findings provide impor-tant guidance to surgeons, a number of

questions remain about lymph node proce-dures and their interpretation for treatment.


The perfect match ofcareer and lifestyle.

Affiliated Community Medical Centers is a physician ownedmulti-specialty group with 11 affiliate sites located in westernand southwestern Minnesota. ACMC is the perfect match forhealthcare providers who are looking for an exceptional prac-tice opportunity and a high quality of life.Current opportuni-ties available for BE/BC physicians in the following specialties:

• Family Medicine

• General Surgery• Geriatrician/OutpatientInternal Medicine

• Hospitalist

• Infectious Disease

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For additional information, please contact:

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

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

www.acmc.com

In the heart of the Cuyuna Lakes region of Minnesota, the medical campus in Crosby includes Central Lakes Medical Clinic, a 30-physician multispecialty group and Cuyuna Regional Medical Center, a critical access hospital offering superb new facilities with the latest medical technologies. Outdoor activities abound, and with the Twin Cities metropolitan area just a short drive away, you can experience the perfect balance of recreational and cultural activities.

Enhance your professional life in anenvironment that provides exciting practice opportunities in a beautiful Northwood’s setting. The Cuyuna Lakes region welcomes you.

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Minneapolis VA Medical CenterPrimary Care Provider

The Minneapolis VA Health Care System(MVAHCS) is seeking a Primary Care Provider.Applicants must be board-certified in internalmedicine.Clinical work involves taking care ofVeterans in the outpatient setting with optionsto do inpatient attending,working with internalmedicine residents.A faculty appointment inthe Department of Medicine at the Universityof Minnesota is possible.Competitive salaryand benefits with potential for a recruitmentincentive.

SSeenndd CCVV aanndd aapppplliiccaattiioonn ttoo::

Human Resources Management ServiceAttention: Brittany Buck

MVAHCSOne Veterans Drive

Minneapolis MN 55417or, email [email protected].

EEO Employer

www.mankato-clinic.com

Mankato Clinic is looking for BC/BE physicians for our Urgent CareDepartment. Urgent Care is three rotations of 3–12-hour shifts in a week,and one rotation of 2–12-hour weekday shifts plus a Satur-day 8 a.m.— 5 p.m. and Sunday 11 a.m.— 5 p.m. Thereare no Call or hospital privileges required for Urgent Care.Service lines that support our group include our own lab,sleep center, nuclear medicine, Medicare Certified endo-scopic center and radiology department with a 128 slice CTand co-ownership in an ambulatory surgery center.

Opportunity highlights:

• Market competitive compensation guarantee to start,followed by RVU based production income thereafter

• Fully integrated Allscripts electronic medical record

• 35 PTO / CME Days + paid holidays; generous CME allowance

• Practice connects to a regional, 270 bed, not-for-profit Mayo-affiliatedhospital, Level 3 Trauma Center

• State university with 14k students; 150 undergraduate / 100 graduate /4 PhD programs; 1800 Faculty / Staff

• Named one of America’s Promise “100 of the Best Places for Youth”

• Essential retail in the community; Target, Best Buy, Lowe’s, Sears, Old Navy

• Affordable housing: 4-bed, 4.5 bath, 3,572 Sq/Ft. home - $264,900

• 50 miles of local, paved trails / hundreds of acres of community parks

Contact Dennis Davito,Director of Physician Placement,Mankato Clinic, 1230 East Main Street,P.O. Box 8674, Mankato, MN, 56002-8674;phone: 507-389-8654; fax: 507-625-4353;email: [email protected]

URGENT CARE

60s or 70s who has one or twopositive lymph nodes and anER-positive breast cancer, butmay not push for it, since estro-gen blockade alone may be com-parable treatment. However, theoncologist would be more likelyto encourage a patient to acceptchemotherapy if there werethree or more positive nodes.

Additionally, the stage of thecancer is based, in part, on thenumber of positive lymph nodes.Ten or more positive lymphnodes place the patient in stageIIIc. Furthermore, the OncotypeDX test—a diagnostic test thatanalyzes the expression of 21genes within a tumor to deter-mine a recurrence score thatindicates the likelihood of dis-tant (i.e., lungs, bones, liver, etc.)breast cancer recurrence within10 years of the initial diagnosisif the patient was treated withTamoxifen alone—is approvedfor use in patients with one tothree positive nodes. If weremove only one or two nodesand they are positive, how do weknow that the patient has threeor fewer positive nodes? Can we

still use the Oncotype DX test ina case where we remove oneSLN and it is positive, but weremove no further lymph nodes?

I have cared for patients inwhom one of two sentinel lymphnodes is positive and anothertwo or three nodes are found tobe positive in the subsequentaxillary dissection. The oncolo-gist would not be aware of theadditional positive nodes if theALND were not performed. Nottoo long ago, I cared for apatient in her 60s with multiplecomorbidities (diabetes, obesity,hypertension) who had a posi-tive SLN and one additional pos-itive node in the ALND. The

oncologist was not eager to givethis patient chemotherapy, andbecause he knew that the totalnumber of positive nodes wastwo, he was able to order theOncotype DX test. The OncotypeDX recurrence score was verylow for this patient, whichgave the oncologist confidencethat estrogen blockade alonewas a reasonable treatment inthis case.

An oncologist would notorder an Oncotype DX test for apatient who had four positivelymph nodes, but might orderthe test if there was one positivenode. If we stopped doing ALNDwith a positive SLN, would the

oncologists assume that thereare more positive nodes andbe more likely to bypass theOncotype DX test in favor ofgiving chemotherapy? Or wouldthey assume that there is one, orno, further positive lymph nodeand order the Oncotype DX testto help with decision-makingregarding chemotherapy?

The study showed that sur-geons found additional positivenodes on ALND only 27 percentof the time. The authors arguethat the additional informationgained from ALND is unlikelyto change systemic therapy deci-sions, while the cost is signifi-cantly increased morbidity.

Clearly, we need furtherdiscussion among physicianstreating breast cancer beforethe medical community canaccept a new standard of SLNalone in node-positive patientsundergoing lumpectomy andsubsequent radiation.

Madeline Gartner, MD, is a solo prac-titioner specializing in breast surgery, withoffices in Plymouth and Edina. She com-pleted her general surgery training atBrown University/Rhode Island Hospitaland the University of Minnesota.


Breast cancer from page 32

Lymph node study: criteria for breast cancer

American College of Surgeons Oncology Group Z0011 trial com-pared sentinel lymph node (SLN) biopsy alone, versus axillary nodedissection (ALND), for positive SLN.* The results showed that ALNDwas unnecessary for some patients who met the following criteria:• Tumors were at an early clinical stage, T1 or T2 (<5 cm in greatestdimension).

• Sentinel node biopsies (i.e., 1–4 axillary lymph nodes are removedthat are identified by pooling of radioactivity that was injected intothe breast preoperatively) found cancer, but the positive nodes werenot enlarged enough to be palpated during an exam.

• The cancer had not metastasized to distant organs.• The patient would be undergoing post-lumpectomy radiation.*The study was published in the Journal of the American MedicalAssociation (JAMA 2011; 305(6):569–575).

www.olmstedmedicalcenter.org

Olmsted Medical Center,a 150-clinician multi-specialty

clinic with 10 outlyingbranch clinics and a 61 bed

hospital, continues to experiencesignificant growth.

Olmsted Medical Centerprovides an excellent opportunityto practice quality medicine in a

family oriented atmosphere.

The Rochester communityprovides numerous cultural,

educational, and recreationalopportunities.

Olmsted Medical Centeroffers a competitive salary

and comprehensivebenefit package.

Send CV to:

OlmstedMedical Center

Administration/Clinician Recruitment

1650 4th Street SE

Rochester, MN 55904

email: [email protected]

Phone: 507.529.6610

Fax: 507.529.6622

EOE

Opportunities availablein the following specialty:

Family MedicineRochester Northwest ClinicRochester Southeast Clinic

St.Charles Clinic

Internal MedicineSoutheast Clinic

Occupational MedicineSoutheast Clinic

DermatologySoutheast Clinic

Current Opportunities in:OB/GYN

Occupational MedicineFamily MedicineInternal Medicine

Pediatrics & Adolescent MedicineHospitalist Program


CardiologyDermatologyENTEmergency MedicineFamily MedicineGastroenterologyHospitalistsInternal MedicineNeurologyOccupational MedicineOncologyOrthopedic SurgeryPediatric SpecialtiesPsychiatryPulmonology (Sleep)RheumatologyUrology

Come home.Where organizational strength lies in the diversity of peoplewho call SANFORD HEALTH – home.

Sanford Health – Fargo Regionis redefining health care. Servingnorthwestern Minnesota andeastern North Dakota,we offerinnovative technology, support ofa multi-specialty organization, anddependable colleagues.

Excellent practice opportunitiesexist in family-oriented communitiesthat offer year-round outdooractivities, cultural events, andsuperior education districts thatwill allow you to balance yourwork & life.

Our employment model featurescompetitive salaries, a comprehensivebenefits package, paid malpracticeinsurance, and a generous relocationallowance.Contact:

Jean KellerPhysician RecruiterPhone: (701) [email protected]

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

Urgent CareMinneapolis /St. Paul

©

We have part-time and on-call positions available at a variety ofTwin 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 paidmalpractice.

For consideration, apply online at healthpartners.jobs and followthe Search Physician Careers link to view our Urgent Careopportunities. For more information, please contact [email protected] or call Diane at: 952-883-5453; toll-free: 1-800-472-4695 x3. EOE

Growing multi-specialty group practicein Northern Minnesota is looking fora BC/BE Family Practice Physician,Internal Medicine Physician,Emergency Room Physician,OB/GYN Physician, Urologist as well asan Orthopaedic Surgeon. Join an existinggroup practice and take over existingpractices from departing physicians. GrandItasca Clinic & Hospital in Grand Rapids,Minnesota has recently opened a new stateof the art clinic & hospital. Excellent salaryguarantee with outstanding incomepotential, full benefits and sign-on bonus.Community located in the beautifulnorthern Minnesota lakes area.

Contact: Gail Anderson(218) [email protected].

• Internal Medicine• Pediatrics

• Family Medicine

• General Surgery

Lake Region Healthcare is located in a magnificent, rural, andfamily-friendly setting in Minnesota lakes country where weaim to be the state’s preeminent regional health care partner.

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

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

Practice Well.Live Well.

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

For more information contact

Barb Miller, Physician [email protected] • (218) 736-8227

Lake Region Healthcare is an Equal Opportunity Employer. EOE

• Internal Medicine • Family Medicine • Urology

• Pediatrics • General Surgery • Psychiatrist

• Provide all screening choicesto patients: colonoscopy, CTcolonography, flexible sigmoi-doscopy, fecal occult blood test(FOBT), and fecal immuno-chemical test (FIT).

Population-wide communications• Develop a marketing campaignaimed at high-risk individuals.

• Develop an interactive web-site/videos to engage public.

• Provide all screening choices—not just colonoscopy—topatients.

• Increase use of free screens(FOBT, FIT).

System improvement tactics• Standardize screening ques-tions to effectively identifyhigh-risk patients and initiatescreening at appropriate ageand interval.

• Schedule screening beforepatient leaves office.

• Provide incentives to high-riskpatients to get screening.

• Emphasize team approach atthe provider level.

• Make CRC screening a strate-gic quality improvement goal

at the board/senior leadershiplevel for providers, systems,and plans.

• Achieve consistent prepara-tions to avoid variation inoutcomes.

• Reduce complexity of cover-age, waive copay, and deter-mine cost to patients beforethey have the test.

Public policy and regulatorytactics• Expand educational and out-reach efforts to the broadercommunity (faith community,social service agencies, etc.).

• Develop a statewide screening(and cancer) registry to opti-mize tracking of data for infor-mation exchange.

• Create consistent benefitcoverage/reimbursement andsimplify coding options andrequirements.

• Develop measurement andreporting systems to encouragetransparency in reportingrates.

More discussion needed

Participants at the 2010 round-table indicated that more discus-sion is needed to address twoareas.

First, since insurancecoverage and cost sharing forcolonoscopy vary depending onwhether a colonoscopy is codedas “screening” or as “diagnostic,”steps should be taken in advanceof the procedure to clarify the

indication and inform patientsahead of time. Higher thanexpected out-of-pocket costs canbe a disincentive for colono-scopy screening.

Second, if the ultimate goalof screening is to reduce deathsfrom colorectal cancer, attentionmust be paid to the quality andeffectiveness of current screen-ing procedures with an eyetoward screening innovationsthat may be more cost-effective,less invasive, and more useful indetecting early cases of colorec-tal cancer.

What providers can do

Medical groups are encouragedto help support this effort toincrease screenings and reducedeaths from colorectal cancer inMinnesota. See the sidebar onpage 29 for website resourcesrelated to CRC screening.

Cally Vinz, RN, is vice president forclinical products and strategic initiatives,and Melissa Marshall, MBA, is a clini-cal systems improvement facilitator at theInstitute for Clinical Systems Improvement.


St. Cloud VA Medical Centeris accepting applications for the following full or part-time positions:

• Internal Medicine(Nursing Home—Alexandria,Brainerd, St. Cloud)

• Family Practice(Alexandria, Brainerd,St. Cloud)

• Psychiatrist (Brainerd,St. Cloud)

• ENT (St. Cloud)

• Geriatrician(Nursing Home—St. Cloud)

• Hematology/Oncology(St. Cloud)

• Neurology (St. Cloud)

• Dermatology (St. Cloud)

• Disability Examiner(IM or FP) (St. Cloud)

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

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

Physician applicants should be BC/BE. Applicant(s) selected for aposition 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: 320-255-6436 orTelephone: 320-252-1670, extension 6618

Favorable lifestyle26 days vacationCME days

Competitive salary13 days sick leaveLiability insurance

Interested applicants can mail or email your CV to VAMC

Quantum leap from page 29 The Minnesota Cancer Alliance,a coalition of more than 100 organizations,has been working over the past two years

to improve CRC screening ratesas an important way to reduce the

burden of cancer in Minnesota.

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.

1495 Highway 101 North, Plymouth, MN 55447763-504-6600 • Fax 763-504-6622

Visit our website at www.NWFPC.com


Come to the Alexandria Lakes Area...• Dermatology • Emergency Medicine

• Family Medicine • Internal Medicine • Pediatrics

Broadway Medical Center is a rapidly growing, independent,physician-owned multi-specialty group practice with over35 caregivers in 10 different medical specialties. We arelocated in Alexandria, MN; a beautiful and growing commu-nity with tremendous recreational opportunities. Welcome!

Contact Daniel J. Jones, MHA atBroadway Medical Center1527 Broadway Street, Alexandria, MN 56308(320) 762-6841 or [email protected]

To learn more about our practice,please visit our website atwww.broadwaymedicalcenter.com

1527 Broadway Street,Alexandria, MN 56308

ONAMIA • ISLE • HILLMAN • GARRISON • MILACA

Please send inquiries to;

Rob Stiles; 320-532-2606 [email protected] orDr. Tom Bracken; [email protected]

Mille Lacs Health System isseeking a Family Physician tojoin their rural practice on thesouthern tip of Lake Mille Lacsin Onamia, Minnesota. Our 7Family Physicians, 8 PAs, anda Gen Surgeon provide a uniquerural health opportunity with 4outreach clinics, a 25-bed CriticalAccess Hospital, and attachedGeriatric Psych Unit and LTCfacility. We also provide servicesto the Mille Lacs Band of Ojibwe.

Minimum qualifications: Musthave an MD/DO in medicinefrom an accredited school andbe licensed to practice in thestate of Minnesota.

• ER is staffed 24/7 by skilled PAs

• OB is required; C-sectiontraining is a bonus

• Guaranteed competitive salary

Mille Lacs Health System isan integrated healthcare organi-zation that tends to the lifelonghealthcare needs of all itspatients. Come live where thereis excellent hunting, fishing, andcross-country skiing. Practicemedicine where your skills andexperience can be fully utilized,and where you can make adifference.

Caring for mind, body and spirit.

Two BC/BE Orthopaedic Surgeonswanted to join four orthopaedic sur-geons at Sanford Bemidji OrthopaedicsClinic in Bemidji, Minnesota. Part ofan 85-physician, multi-specialty grouppractice and 118 bed acute care hospi-tal. 1:6 call anticipated. Competitivecompensation/benefits package, paidmalpractice, relocation assistance andmore. Sanford Health of NorthernMinnesota has 1,450+employees andis part of Sanford Health system basedin Fargo, ND and Sioux Falls, SD.

Bemidji, Minnesota, located in north-western Minnesota, is a beautifulresort community offering exceptionalschools, a state university, and year-round cultural activity as well as greataccess to the outdoors for year-roundrecreation activity. To learn moreabout this excellent practiceopportunity contact:

Kathie Lee,Director Physician PlacementPhone: 701-280-4887Fax: 701-280-4136Email: [email protected]

AA/EOE

OrthopaedicSurgery

OpportunityLive in Beautiful

MinnesotaResort Community

EOEAn equal opportunity employer and provider

Signing bonus

insurance

Wadena, MN 56482Tri-County

Health CareHealth CareTri-County

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awareness of how racism oper-ates in our country.

Given that typically there isno intentional or direct trainingregarding racism in nursing ormedical schools, and given thatthere has been no direct trainingat our institution about theseissues to mitigate the presenceof societal racism, it is not sur-prising that providers have verylittle understanding of the com-plexities of racism and its mani-festations in provision of healthcare or in society as a whole. Arecent survey of physicians atChildren’s revealed that they hadreceived an average of 5.3 hoursof “racism training” during1,200 person-years of practice.Further questioning revealedthat this training actually repre-sented diversity and culturalcompetency training, and nottraining specific to issues ofrace, racism, and whiteness.

Next steps

Clearly, health care provider atti-tudes must change in order toreduce health care disparitiesassociated with race. In 2009,

the U.S. Department of Healthand Human Services recom-mended that in order to acceler-ate the pace of improvement, wemust train providers.

Diversity and cultural com-petency trainings are already inplace at many institutions,including our own. While theyhave been shown to be success-ful in fostering an appreciationand awareness of difference, aswell as developing tools forcross-cultural communication,they have not addressed the coreof racism and, therefore, fallshort of being able to truly effectchange in racial disparity inpatient care.

After analyzing the results ofour survey, we recommendedsocial justice/anti-racist train-ings in addition to the diversityand cultural competency train-ings. To that end, we have devel-oped a training module for staffto help providers address indi-vidual racial bias, the role ofracism in evidence-based med-ical protocols, and the realitiesof systemic racism and itsimpact on patients. The ultimategoal is to improve provider atti-

tudes and provider confidence incaring for patients and familiesof color.

We hope to take the trainingmodule hospital-wide followingour initial pilot study, and thenoffer it to other institutions. Wehave developed a half-day and afull-day workshop, dependingupon the needs of the organiza-tion. The training module will:• Address the definition ofrace/racism and history of thesocial construction of race

• Differentiate among diversity,cultural competency, andsocial justice

• Explore our current healthcare system (racial make-up ofproviders, how insurancebecame tied to employment,what we’re taught/not taughtin school, evidence-based med-icine, racial disparities)

• Examine racism/whiteness inour society, including exam-ples of racism/whiteness inmedicine

• Examine how race affects eachof the Institute of Medicine'ssix measures of quality care,and provide trainees tools forunderstanding these effects

• Introduce critical thinkingtools for improving medicalproviders’ comfort and skills incaring for patients of colorWe are currently developing

a longer training experience (sixhalf-day sessions over four to sixmonths) for those who desiremore in-depth exploration.

Although our study focusedon white providers and blackpatients, the findings and futuredirections can be applied acrossall aspects of health care deliv-ery. Dismantling racism andprovider bias will remove atleast one of the barriers to racialequity in health care. We physi-cians have the greatest ability toaffect change in this area. Untilracial issues are addressed hon-estly by members of the healthcare team, it is unlikely that wewill see significant improve-ments in racial health-care dis-parities for Americans.

Stephen Nelson, MD, practices pedi-atric oncology/hematology and pediatricsand directs the HemoglobinopathyProgram at Children’s Hospitals and Clinicsof Minnesota. He is also an adviser to theMinnesota Department of Health NewbornScreening Program.

Equity from page 11


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Pediatric Conferences • Best Practices – Managing the Pediatric Patient in the Urgent Care Setting October 28, 2011

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11th Annual Women’s Health Conference November 4, 2011

Emergency Medicine and Trauma Update: Beyond the Golden Hour November 17, 2011

Otolaryngology for Primary Care November 18, 2011

33rd Annual Cardiovascular Conference December 1- 2, 2011

continuing medical education

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

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Minnesota Physician July 2011