minnesota physician june 2013

Volume XXVll, No. 3

June 2013

Genetic researchand cystic fibrosisTargeted drug development leads toimproved treatment

By Warren Regelmann, MD

In January 2012, treatment ofinherited diseases took a giantleap forward when the Food and

Drug Administration approvedKalydeco (ivacaftor), a drug thatimproves the lives of people with cys-tic fibrosis (CF) by restoring functionto one variant of the protein thatcauses CF. CF affects about 30,000children and adults in the UnitedStates and is the most commoninherited life-limiting disease amongCaucasians, but it occurs in mostother races as well.

Ivacaftor will very likely improveand prolong the lives of patients whohave a rare mutation in their cysticfibrosis transmembrane conductanceregulator (CFTR). For them, this drug

represents a majoradvance. However, thisnew drug is excitingnot only because itoffers CF patients animproved quality of lifebut also because it

CYSTIC FIBROSIS to page 14

The Independent Medical Business Newspaper

These days, we hear a lotabout “greening,” as communities, businesses,

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The truth is that health care, as anindustry, takes an enormous toll on theenvironment. Our energy creates air pollu-

tion; our waste invades landfills;our dependence on disposablesupplies is staggering. The ironyis, health care professionals rec-ognize the essential truth thatenvironmental healthand patient health areinterconnected. Weunderstand that when

we promote healthy environ-ments—what we breathe, whatwe eat, what we expose our bod-ies to—we will promote healthycommunities. And healthy com-munities are what we “do” inhealth care.

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JUNE 2013 MINNESOTA PHYSICIAN 3

CAPSULES 4

MEDICUS 7

INTERVIEW 8

MEDICINE AND THE LAW HIPAA update 16By Timothy Johnson, JD, and Jesse Berg, JD, MPH

PROFESSIONAL UPDATE:NEPHROLOGYChronic kidney disease 18 By Nathan T. Blake, PharmD, andWendy L. St. Peter, PharmD

It’s not easy being green 1Why should health care care?By Crystal Saric Fashant, MPNA

Genetic research and cystic fibrosis 1Targeted drug development leads to improved treatmentBy Warren Regelmann, MD

Health care architecture honor roll 22

DEPARTMENTS

C O N T E N T S JUNE 2013 Volume XXVII, No. 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; email [email protected]. We welcome the submission of manuscripts and letters for possible pub-lication. All views and opinions expressed by authors of published articles are solely those of theauthors and do not necessarily represent or express the views of Minnesota PhysicianPublishing, Inc., or this publication. The contents herein are believed accurate but arenot intended to replace legal, tax, business or other professional advice and counsel. Nopart of this publication may be reprinted or reproduced without written permission ofthe publisher. Annual subscriptions (12 issues) are $48.00. Individual issues are $5.00.

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Beverly Yashar,MS, PhDAmerican Board ofGenetic Counseling

Freestanding “urgencyroom” facilities 20By Gary Gosewisch, MD

The doctor’s advocate 30By Louis Suarez, CCIM

Moving? Growing? 32By Nancy Doyle, AIA, and Jessica Anderson

Building a chorus of voices 34By Don Thomas, CD, and ScottHolmes, AIA, ACHA, LEED AP

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Background andfocus: For the majority,end-of-life is the mostmedically managed part oflife. With it come complexissues that involve eco-nomics, ethics, politics,medical science,resources and more.Advances in technologyare extending lifeexpectancies and requirea redefinition of the term“end-of-life.” It now entailsa longer time frame thanone’s final weeks or hoursand debate as to when lifeis really over. Mechanismsexist to facilitate personaldirection around this topic,but there is a need forimproved coordinationamong the entities thatprovide end-of-life support.

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

Panelists include:

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4 MINNESOTA PHYSICIAN JUNE 2013

HHS Releases Data On Hospital ChargesThe news that hospitals havewidely varying costs for proce-dures may not be a shock tomany in the health care indus-try, but a move by the federalgovernment to publicize thatrange of costs recently generatedheadlines across the nation.

On May 8, the U.S.Department of Health andHuman Services (HHS) releasedcost data from hospitals acrossthe country for the 100 mostcommon Medicare inpatientstays. HHS Secretary KathleenSebelius says the data will helpmake the nation’s health caresystem more affordable andaccountable.

“Currently, consumers don’tknow what a hospital is charg-ing them or their insurancecompany for a given procedure,like a knee replacement, or howmuch of a price difference thereis at different hospitals, evenwithin the same city,” SecretarySebelius said. “This data andnew data centers will help fillthat gap.”

The data show dramaticvariation in what hospitalscharge for services. From theMedicare data, charges formajor lower joint replacementcould range from $21,000 to$88,000, depending on the hos-pital.

In Minnesota, charges alsovaried significantly. At theUniversity of Minnesota MedicalCenter, Fairview, a major cardio-vascular procedure would cost$65,886, according to HHS data.Less than a mile away, at AbbottNorthwestern Hospital, a similarprocedure would cost $88,877.

Health care experts say hospitals factor in a wide rangeof expenses when pricing anyone procedure, and that pricescan be different from the listed Medicare charges due to discounts negotiated withhealth plans.

One analysis of the HHSdata shows that Minnesota hos-pitals have lower costs for manymajor procedures than thenational average. The analysis,published in the WashingtonPost, looked at 10 common med-ical procedures for Medicare

patients and found that Minne-sota’s average cost was lowerthan the national average inevery instance.

Dayton AnnouncesMNsure BoardGov. Mark Dayton has appointedseven Minnesotans to overseeMNsure, the state’s health insur-ance exchange.

State officials say the boardmembers were chosen from 112candidates. Members will servefour-year terms, and with theexception of the DHS commis-sioner, are limited to two termsof service.

“The individuals chosen toserve on this board represent abroad diversity of experienceand expertise,” says Gov. Dayton.“Their collective breadth ofknowledge, and each boardmember’s shared commitment tothe successful development anddelivery of this new health caremarketplace, will serve the bestinterests of all Minnesotans.”

Board members include:Thompson Aderinkomi, founderand CEO, RetraceHealth, a

health-data analytics firm; PeteBenner, a consultant on healthcare, labor relations, and publicpolicy; Brian Beutner, CEO ofmPay Gateway, a health-caresoftware company, and a formergeneral counsel of UnitedHealth -care; Kathryn Duevel, a retiredob-gyn physician from Willmar;Tom Forsythe, vice president ofglobal communications atGeneral Mills; Lucinda Jesson,Commissioner of the MinnesotaDepartment of Human Services;and Phil Norrgard, director ofhuman services, Fond du LacReservation.

Blue Cross DelaysNew Payment System Blue Cross and Blue Shield ofMinnesota has agreed to delayimplementation of a new pay-ment system for rural hospitals.

The new system, which Blue Cross had been rolling outin different parts of the state thisspring, caused the MinnesotaHospital Association (MHA) topublicly call for the Blooming-ton-based insurer to slow downimplementation of the change.

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MHA officials said rural hospi-tals had complained they couldnot comply with the changes in time, and some were at riskto lose their contracts with Blue Cross.

The issue raised enoughoutcry that Minnesota AttorneyGeneral Lori Swanson andMinnesota Health Commiss-ioner Ed Ehlinger, MD, metwith Blue Cross officials to dis-cuss the matter. State officialsseemed particularly concernedabout how the new systemwould affect critical access hos-pitals, which are small, ruralhospitals that serve outstateareas. After discussion withstate officials, Blue Crossannounced it was delaying thechanges.

Blue Cross released a state-ment on May 1, saying that itwas moving the implementationdate for the new payment sys-tem to Jan. 1, 2014. The state-ment added that Blue Cross val-ues critical access hospitals andthat it would work with them toimplement the new system,including sharing costs of soft-ware needed for new reimburse-ment models.

On May 1, MHA officialswelcomed the announcementthat Blue Cross had moved backthe implementation date, sayingthe hospital association agreesthat payment models need tochange. “A delay provides a win-dow of opportunity for BlueCross and hospitals to workthrough the issues beforeattempting to implement pay-ment changes that could havejeopardized access to care insome communities,” the state-ment said. “MHA appreciatesthat Blue Cross has heard theconcerns of our members andthat it is willing to respond tothose concerns.”

MMA ConsidersChanges toGovernance StructureThe Minnesota MedicalAssociation (MMA) is consider-ing changes to its governancestructure. On May 4, the MMAboard of trustees voted to sub-mit a resolution to the group’sHouse of Delegates at its annual

meeting in September thatwould replace the House ofDelegates with a policy council.

MMA officials say if passed,the changes would mean thegroup’s annual meetings wouldcontinue but policy would bedetermined by the council,which would meet at least twicea year. The policy council mem-bership would be appointed bymedical societies that are part of the MMA, and the councilwould gather member inputthroughout the year at listeningsessions and policy forums.

The board of trustees is alsoin the process of downsizingitself. Working from recommen-dations of an MMA leadershipcommittee, the board will bereduced by five positions thisyear. At the MMA’s annual meet-ing in 2012, the house of dele-gates voted to reduce the board’ssize from 32 trustees to 12–14members over a three-year per -iod. The reduction of five posi-tions would be the first step inthat process. MMA leaders say a32-member board has proven tobe unwieldy and inefficient.

According to DavidThorson, MD, chair of theMMA’s board of trustees, theHouse of Delegates has seen adecline in participation andthere are concerns that it doesnot represent a true cross-sec-tion of Minnesota physicians.“We’ve noticed a dwindlingattendance and it was not tend-ing to bring in new people,”Thorson says. “It was not a verydiverse population, ethnically,racially, or age-wise.”

The physicians’ associationhas already held some prelimi-nary policy forums, andThorson says the results areencouraging. He notes that atthe three forums held so far,more than half of physician par-ticipants had never attended anMMA House of Delegates meet-ing. “We’re getting peopleinvolved who have never beeninvolved before,” Thorson says.“That’s exciting to me, to seenewer people, younger peoplecoming in.”

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U of M, Fairview PlanManagementSystems Integration The University of Minnesota andFairview Health Services haveagreed to a new managementstructure and increased fundingfor U of M health services, edu-cation, and research.

The announcement, whichwas approved by the U of Mboard of regents on May 10,came approximately one monthafter Fairview and the universitypublicly revealed merger talkswith South Dakota-basedSanford Health. However, thatproposal quickly fell apart, andofficials with the University andFairview noted that the twoorganizations have been negoti-ating this deal for some time.

Under the agreement,Fairview will provide $90 mil-lion to the U of M over the next10 years, which the universitywill invest in academic medicalservices, research, and educa-tion. If certain performancegoals are met, the amount of

funding Fairview provides theuniversity could increase.

The new agreement is not amerger or acquisition, officialswith the two organizations say,but rather, an integration ofmanagement systems that willallow Fairview and the U of Mto coordinate patient care andplan for future changes in healthcare education and delivery.Officials say that Fairview andthe University will now have ajoint management structure,with a new board over the inte-grated system, which willreplace boards at the university’smedical center and at U of M’sAmplatz Children’s Hospital.

“We envision this as a wayof breaking down silos that existbetween the organizations,” saysBobbi Daniels, CEO of Univer-sity of Minnesota Physicians(UMPhysicians). “Integration ofinpatient and outpatient servicesis a national trend. Because somany of our patients are socomplex, that coordination iseven more critical.”

Daniels and Carolyn Wilson,president of the University ofMinnesota Medical Center,

Fairview, will lead the new, inte-grated system. They will overseea system that has 700,000patient clinic visits and 35,000hospital admissions each year.The combined organizationsemploy 7,500 staff and 800physicians with UMPhysicians.The integrated structure willbring in an estimated $1.9 bil-lion in revenues annually.

CMS AnnouncesFunds for MedicalAssistance ExpansionThe Centers for Medicare &Medicaid Services (CMS) hastold Minnesota officials that thestate could get an additional $13to $14 million annually as partof expanding public healthinsurance programs under theAffordable Care Act.

Officials with the MinnesotaDepartment of Human Services(DHS) say CMS has announcedthat the federal match for servic-es associated with new MedicalAssistance enrollment willincrease from 50 percent to 75percent.

The enhanced match will be available starting in October2013. DHS recently sent outmaterials to county human serv-ices directors in Minnesota toinform them how the increasedfunding will affect counties. Thefunding will help counties han-dle the increased number ofpublic program enrollees, fund-ing services such as intake,determination of eligibility, casemaintenance, computer support,and customer service.

“Thanks to the AffordableCare Act, more than 200,000more Minnesotans will receivehealth care through our publicprograms,” says DHS Commiss-ioner Lucinda Jesson. “Countieswill be an important partner inhelping those Minnesotans getcoverage. We would like tothank the U.S. Health andHuman Services Department forproviding the counties with theresources they need to makehealth care available to morepeople.”

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Patrick J. Flynn, MD, received the David KingCommunity Clinical Scientist Award at the39th national meeting of the Association ofCommunity Cancer Centers in Washington,D.C. Flynn is a medical oncologist and medicaldirector for the Cancer Research Program atMinnesota Oncology, where he has practicedsince 1985. Award winners are physicians whohave demonstrated leadership in the develop-ment, participation, and evaluation of clinical

studies and/or who are active in developing new screening, risk assessment, treatment, or supportive care programs for cancer patients. Flynn has engaged in clinical research for many years,having served as principal investigator formany Metro-Minnesota Community ClinicalOncology Program and National Cancer Institute clinical trials.

Donald Hughes, MD, a family physicianpracticing at Riverwood Healthcare Center,Aitkin, has received the 2013 Family Physicianof the Year Award from the Minnesota Acad-emy of Family Physicians. In addition to hispractice, Hughes works with the Rural Physi-cian Associate Program each year, travels to Duluth monthly toteach in the Family Practice Residency Program, and is very activein the community, providing medical services at local sportingevents and helping to educate athletes and parents about health.

Robert Lavey, MD, MPH, has joined thestaff of HealthEast as medical director of radia-tion oncology. Lavey earned his medical degreefrom Stanford University and his MPH fromUniversity of California, Berkeley; he completedhis radiation oncology residency at Duke Uni-versity and his fellowship at Stanford Univer-sity. Prior to joining HealthEast, Lavey was aprofessor of oncology at the University of SouthFlorida. He specializes in stereotactic radio-

surgery; sarcomas; and brain, liver, pancreas, and pediatric tumors. Jon V. Thomas, MD, MBA, has been elected chair of the

Federation of State Medical Boards’ (FSMB) board of directors.First appointed to the Minnesota Board of Medical Practice in2001, Thomas has served in multiple capacities within the FSMB.He practices otolaryngology with Ear, Nose &Throat SpecialtyCare of Minnesota in St. Paul.

Lee Wattenberg, MD, a professor in theDepartment of Laboratory Medicine andPathology at the University of Minnesota and a researcher in the Carcinogenesis and Chemo-prevention Program at the university’s MasonicCancer Center, has been named an AmericanAssociation for Cancer Research Academy Fel-low. The Academy honors distinguished scien-

tists whose scientific contributions haveresulted in significant innovation and progressin the fight against cancer. Wattenberg is con-sidered the ‘father of chemoprevention,’ havingpioneered that field by identifying the protec-tive effects of vitamins A, C, and E and chemi-cals found in certain vegetables. He continuesresearch to identify agents that can preventcarcinogen-induced lung cancer.

Mark Werner, MD, has joined Medica as its senior vice president and chief clinical and innovation officer.Most recently, he was a senior vice president and chief clinical inte-gration officer for Fairview Health Services.

M E D I C U S

Donald Hughes, MD

Robert Lavey, MD, MPH

Lee Wattenberg, MD

Mark Werner, MD

Patrick J. Flynn, MD


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■ Genetic counseling is a relatively new field;what can you tell us about its history?

Genetic counseling was first formally establishedas a profession back in 1969. What occurred onthat date was the founding of the first geneticcounseling program, which was at Sarah LawrenceCollege in New York City. Discussions about ge netic counseling go back to the 1940s.

There were three clinical centers in the U.S.that are considered to be the start of genetic medi-cine. They were here at the University of Michiganin Ann Arbor, Wake Forest in North Carolina, andthen at the University of Minnesota, but the for-malization of genetic counseling as a professionreally occurred in New York in the late 1970s.

Technology emerged that allowed us to screenfor genetic disorders so that we could provide aplatform from which individu-als and families could begin tothink about their risk for a con-dition—both for themselvespersonally and for children thatthey may be either carryingduring a pregnancy or might becontemplating in the future.

That growth arose from collaboration amongphysicians in the New York area and social work-ers and genetic specialists who were working withthose physicians. They recognized the need for thedevelopment of this niche; genetic counseling.

I think a lot of the discussion at that time wasthe realization that there was a need for a peer pro-fessional who would have the genetic expertise andwould be able to have conversations on how totranslate genetics information into language thatmakes sense for individuals and their families, sothat they could then make very specific decisions.

The American Board of Genetics Counselingwas then incorporated in 1993 and the mission ofthe board is the certification and recertification ofgenetic counselors.

We want everybody to be clear about the ge netic service they’re receiving. Given the com-plex ity of the knowledge, it needs to be provided by experts in the field.

■ What are some of the reasons a person wouldsee a genetic counselor?

If we start from the beginning, prenatal counselingcertainly is where genetic counseling started as a profession. A couple might be referred to geneticcounseling because of concerns about the preg -nancy.

We know that certain conditions are morecommon in individuals of different ethnicities, sothey may be referred to genetic counseling to havea discussion about those risks.

We then move forward to pediatrics. If a childis born with multiple congenital anomalies or islater found to have developmental delay, if multiplesystems were involved—certainly autism has started to move into a discussion of genetics and

genetic counseling—you would then be referred topediatric genetics.

Then we move into adult-onset diseases. I think the one that people think of easily isHuntington’s disease, but that’s certainly rarer thancardiomyopathies or hereditary cardiomyopathiesor hereditary neuromuscular conditions. Peoplewho have early-onset cancers or high-recurrencecancers or multiple occurrences, for examplebreast cancer, those individuals also would comeand see a genetic counselor.

■ What are some of the recent scientific advancesin your field?

We have been identifying genes for syndromes ordiagnoses that we didn’t have before rapidly,almost on a monthly basis. And we’re developing

the ability to think about ge netic risk for common dis-eases—like diabetes or cardio-vascular disease, and we rap -idly will start to see the abilityto offer susceptibility testingfor a host of common diseases.

Historically, genetics and genetic counselinghave been driven by clinical presentation or pheno-type before doing genetic testing. We’re movinginto an era where people are starting to look atgenetic testing or genotyping first and then lookingto see what could be the clinical issues that couldarise out of that.

That’s a new paradigm for us. We’re strugglingwith it. It changes the equation a little bit aboutgenetic counseling. It means that now we’re think-ing about genetic testing of the healthy.

■ Talk a little about biomedical ethics issues raisedby the field of genetic counseling.

For us there are always issues around the idea ofwho gets the information from a genetic test result.Certainly, it’s critical for your patient to get thatinformation, but the nature of genetics is such thatthe laws of inheritance mean multiple people couldhave that same genetic change. Thinking abouthow you move beyond your patient to the family ofthe patient is certainly one of our large challenges.

When we sequence the whole genome, we haveinformation on genes that could be relevant to aperson’s health five, 10, 20, and 30 years down thepike, and thinking about who gets that informationand when they get it has been quite challenging.

If we have an adult who might come into acancer clinic for very specific testing, because ofthe new technology we’re moving away from test-ing single genes to testing panels of genes—or itcould be cheaper just to do the whole exome.

Let’s say we then discover there is a geneticchange that leads to a condition that has nothingto do with the reason they were referred, let’s sayHuntington’s disease. Should we share that infor-mation, even if it wasn’t relevant to the clinicalquestion that led them into our clinic?

Beverly Yashar, MS, PhDAmerican Board of Genetic

Counseling

Beverly Yashar, MS, PhD,is president of theAmerican Board ofGenetic Counseling

(ABGC) and programdirector for the

University of Michigan’sGenetic Counseling

Program. Yashar obtained her PhD in genetics from

the University of NorthCarolina–Chapel Hill

and her MS in geneticcounseling from the

University of Michigan.She has worked in a

wide variety of geneticssettings, including basic

research labs, clinicalgenetics clinics, and afamily studies core.ABGC is the national

credentialing body forgenetic counselors.There are currently

more than 3,000 ABGC-accredited

genetic counselors in the United States.

Cracking the code


I N T E R V I E W

Now we’re thinkingabout genetic testing

of the healthy.

I think we can get our heads aroundthat relatively easily in an adult population.But now let’s push it back and think aboutprenatal testing or pediatric testing. Ourcurrent guidelines recommend that genetictesting in a pediatric population for a condi-tion in which the age of onset would be asan adult should be deferred until that childhas the opportunity to decide whether ornot they want that information. Who wouldkeep that information?

There’s a tension, as you might imagine,within the field about what we should shareand who to share it with. For a parent toknow, “Oh, I’ve got a child who has a highrisk of breast cancer when they’re in their30s or 40s,”—is that appropriate? That iscertainly one of the major issues right now.

■ What are some of the challenges withdirect-to-consumer (DTC) testing?

The problem with DTC is that it’s not regu-lated nor is any genetic testing well regu -lated. You have to be really clear what typeof technology a company is using, how goodthe coverage is, how much of an effort theymake to ensure that people who are partici-pating in the DTC really understand whatthey’re getting into.

Even if we carry things that can be asso-ciated with disease, not everybody who hasa mutation is going to develop that disease.Now think about moving that into a DTC

format where there’s nobody who’s educat-ing and then interpreting. They’re going tosequence 25,000+ genes. They’re definitelygoing to find that you’re a carrier for some-thing. Patients get this information and theyhave no idea what it means.

DTC is an incredibly powerful idea, butit needs to be in a format where appropriateeducation, counseling, and informed con-sent are obtained before testing is initiatedand then appropriate education, counseling,and support are provided once the testresults come back.

■ Genetic counseling is an internationalfield—how do approaches to these ethical issues differ globally?

That’s a very good question. I am the coedi-tor of an upcoming edition of the Journal of Genetic Counseling, looking at geneticcounseling beyond the Americas.

Certainly in Australasia, there is a verylarge and very active genetics and geneticcounseling community. Europe certainly hasa large community. How genetic counselinglooks in those communities is not drasticallydifferent from the way it looks in the U.S.How it looks in Turkey or Saudi Arabia,Taiwan, China is a very, very different game.I think those countries in which the practi-tioners were trained in the U.S. follow amodel that may be closer to a U.S.-basedmodel.

One of the major issues is that thedevelopment of genetic medicine and ge -netic counseling is very tightly tied totechno logy, and countries that don’t have theresources are going to have a very differentlook at genetic counseling.

■ What does the future of genetic counseling hold?

I think the future holds expansion into basically all areas of medicine. That’s thepower of being able to map our genome andthen utilize that information, not just in areactive way, but a preventive way.

We’re already starting to see geneticcounseling as part of cardiology, neurology,ophthalmology, ENT, you name it. As wethink about the genetic basis of commoncomplex disease, we’re going to see moreand more genetic counselors in that area,and they’re going to be working not just inthe traditional roles of being in front of apatient; that’s still going to be critical, butcertainly also serving as consultants tophysicians, to groups of physicians.

As always, we’re looking for where thenext new discoveries are coming from thebench—what’s going to be discovered interms of new ways of genetic testing, newways of explaining genetic disease. As thosecome out, we’re very savvy and quite nimbleat following new developments and new discoveries.


For a full activity listing, go to www.cmecourses.umn.edu2013 CME Activities(All courses in the Twin Cities unless noted)

SEPTEMBER – NOVEMBER

Lillehei Symposium: Cardiovascular Care for Primary Care PractitionersSeptember 5-6, 2013

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

NPHTI/Pediatric Clinical HypnosisOctober 3-5, 2013

Twin Cities Sports Medicine October 4-5, 2013

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

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

Fetal Alcohol Spectrum Disorders (FASD) - Early Identification & Intervention

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

Psychiatry ReviewOctober 7-8, 2013

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

Transplant Immunosuppression 2013October 16-19, 2013

Practical DermatologyOctober 25-26, 2013

Donald Gleason Conference on Prostate & Urologic CancersOctober 25, 2013

Pediatric Trauma SummitNovember 1-2, 2013

Internal Medicine Review & UpdateNovember 13-15, 2013

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

Office of Continuing Medical Education612-626-7600 or 1-800-776-8636

email: [email protected]

Promoting a lifetime of outstanding professional practice

We might say that the healthcare industry has an obligationto be more concerned about—and to serve as a model for—responsible environmental man-agement. Many health careorganizations have stepped up tothe plate. In 2010, InfectionControl Today reported that 54 percent of the 5,000+ hospi-tals in the United States have“green teams,” and that numberis growing. But let’s be carefuland not sugarcoat this: Healthcare has a long way to go in itsefforts to be environmentallysustainable. As a physician, howcan you help?

Physicians exert sizableinfluence within the workplace,and this can go a long way inencouraging a culture of sustain-ability within health care. Thisdoesn’t necessarily mean youbring granola in your lunch box,wear hemp sweaters, and chainyourself to oak trees in the park.For the mainstream or evenweekend environmentalist, thisarticle suggests three topics forpotential advocacy: waste reduc-

tion, energy and climate, andtoxic chemical reform.

Advocacy for waste reduction

According to the EnvironmentalProtection Agency and theAmerican Hospital Association,U.S. hospitals generate about6,600 tons of waste each day. Asmuch as 80 percent of this isnonhazardous solid waste, offer-ing clinics and hospitals manyopportunities for waste reduc-tion. Just stop and think for amoment about how many con-sumables are used in a clinic orhospital.

Questioning the status quois the best way a physician can

act on the issue of waste reduc-tion. For example, in workingwith surgeons at the Universityof Minnesota Medical Center toreduce disposable items in surgi-cal custom packs, we discoveredthat nurses were routinelythrowing away clean, unusedsupplies such as plastic basins,gauze, and plastic tubing. Whenwe asked surgeons about thenecessity of these supplies, theyfrequently answered that theywere simply unaware that thoseitems were in the pack. Indeed,they had no objections whatso-ever to removing them.

Physician advocacy oppor-tunity #1: Reduction. Pay atten-

tion to what is being preparedfor your procedures; if you don’tuse it and don’t need it, pleasetake a moment to tell someoneto remove it. At just one hospi-tal, we saved $104,658 and red uced annual waste by 7,792pounds with tiny tweaks to thephysician custom packs. Impacton patients? Zero. This line ofthinking can bode well for otherreductions, too, such as officepaper. One physician recountedthat her clinic was faxing herseveral printed, paper files eachday, simply because that’s “howthey’d always done it.” Sherequested electronic delivery andreduced her per sonal paper con-sumption dramatically.

Physician advocacy oppor-tunity #2: Recycling. Healthcare facilities toss cans, bottles,glass, newspaper, office paper,cardboard, and more—every day.Do you a have recycling pro-gram? Could it be more robust?Many organizations and busi-nesses offer consultant servicesto aid you in these efforts. Yourbuilding management depart-

Being green from cover


BEING GREEN to page 38

Health care has a long way

to go in its efforts to be

environmentallysustainable.

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Victoza® is a registered trademark of Novo Nordisk A/S.© 2013 Novo Nordisk All rights reserved. 0113-00013301-1 May 2013

Indications and UsageVictoza® (liraglutide [rDNA origin] injection) is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.Because of the uncertain relevance of the rodent thyroid C-cell tumor findings to humans, prescribe Victoza® only to patients for whom the potential benefits are considered to outweigh the potential risk. Victoza® is not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exercise.In clinical trials of Victoza®, there were more cases of pancreatitis with Victoza® than with comparators. Victoza® has not been studied sufficiently in patients with a history of pancreatitis to determine whether these patients are at increased risk for pancreatitis while using Victoza®. Use with caution in patients with a history of pancreatitis.Victoza® is not a substitute for insulin. Victoza® should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis, as it would not be effective in these settings.Victoza® has not been studied in combination with prandial insulin.

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

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

Please see brief summary of Prescribing Information on adjacent page.

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

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

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

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

INDICATIONS AND USAGE: Victoza is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Important Limitations of Use: Because of the uncertain relevance of the rodent thyroid C-cell tumor findings to humans, prescribe Victoza only to patients for whom the potential benefits are considered to outweigh the potential risk. Victoza is not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exercise. In clinical trials of Victoza, there were more cases of pancreatitis with Victoza than with comparators. Victoza has not been studied sufficiently in patients with a history of pancreatitis to determine whether these patients are at increased risk for pancreatitis while using Victoza. Use with caution in patients with a history of pan-creatitis. Victoza is not a substitute for insulin. Victoza should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis, as it would not be effective in these settings. The concurrent use of Victoza and prandial insulin has not been studied.

CONTRAINDICATIONS: Do not use in patients with a personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Do not use in patients with a prior serious hypersensitivity reaction to Victoza or to any of the product components.

WARNINGS AND PRECAUTIONS: Risk of Thyroid C-cell Tumors: Liraglutide causes dose-depen-dent and treatment-duration-dependent thyroid C-cell tumors (adenomas and/or carcinomas) at clinically relevant exposures in both genders of rats and mice. Malignant thyroid C-cell carcinomas were detected in rats and mice. A statistically significant increase in cancer was observed in rats receiving liraglutide at 8-times clinical exposure compared to controls. It is unknown whether Victoza® will cause thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as the human relevance of liraglutide-induced rodent thyroid C-cell tumors could not be determined by clinical or nonclinical studies [see Boxed Warning, Contraindications]. In the clinical trials, there have been 6 reported cases of thyroid C-cell hyper-plasia among Victoza®-treated patients and 2 cases in comparator-treated patients (1.3 vs. 1.0 cases per 1000 patient-years). One comparator-treated patient with MTC had pre-treatment serum calcitonin concen-trations >1000 ng/L suggesting pre-existing disease. All of these cases were diagnosed after thyroidectomy, which was prompted by abnormal results on routine, protocol-specified measurements of serum calcito-nin. Five of the six Victoza®-treated patients had elevated calcitonin concentrations at baseline and throughout the trial. One Victoza® and one non-Victoza®-treated patient developed elevated calcitonin concentrations while on treatment. Calcitonin, a biological marker of MTC, was measured throughout the clinical development program. The serum calcitonin assay used in the Victoza® clinical trials had a lower limit of quantification (LLOQ) of 0.7 ng/L and the upper limit of the reference range was 5.0 ng/L for women and 8.4 ng/L for men. At Weeks 26 and 52 in the clinical trials, adjusted mean serum calcitonin concentra-tions were higher in Victoza®-treated patients compared to placebo-treated patients but not compared to patients receiving active comparator. At these timepoints, the adjusted mean serum calcitonin values (~1.0 ng/L) were just above the LLOQ with between-group differences in adjusted mean serum calcitonin values of approximately 0.1 ng/L or less. Among patients with pre-treatment serum calcitonin below the upper limit of the reference range, shifts to above the upper limit of the reference range which persisted in subsequent measurements occurred most frequently among patients treated with Victoza® 1.8 mg/day. In trials with on-treatment serum calcitonin measurements out to 5-6 months, 1.9% of patients treated with Victoza® 1.8 mg/day developed new and persistent calcitonin elevations above the upper limit of the refer-ence range compared to 0.8-1.1% of patients treated with control medication or the 0.6 and 1.2 mg doses of Victoza®. In trials with on-treatment serum calcitonin measurements out to 12 months, 1.3% of patients treated with Victoza® 1.8 mg/day had new and persistent elevations of calcitonin from below or within the reference range to above the upper limit of the reference range, compared to 0.6%, 0% and 1.0% of patients treated with Victoza® 1.2 mg, placebo and active control, respectively. Otherwise, Victoza® did not produce consistent dose-dependent or time-dependent increases in serum calcitonin. Patients with MTC usually have calcitonin values >50 ng/L. In Victoza® clinical trials, among patients with pre-treatment serum calcitonin <50 ng/L, one Victoza®-treated patient and no comparator-treated patients developed serum calcitonin >50 ng/L. The Victoza®-treated patient who developed serum calcitonin >50 ng/L had an elevated pre-treatment serum calcitonin of 10.7 ng/L that increased to 30.7 ng/L at Week 12 and 53.5 ng/L at the end of the 6-month trial. Follow-up serum calcitonin was 22.3 ng/L more than 2.5 years after the last dose of Victoza®. The largest increase in serum calcitonin in a comparator-treated patient was seen with glimepiride in a patient whose serum calcitonin increased from 19.3 ng/L at baseline to 44.8 ng/L at Week 65 and 38.1 ng/L at Week 104. Among patients who began with serum calcitonin <20 ng/L, calcitonin elevations to >20 ng/L occurred in 0.7% of Victoza®-treated patients, 0.3% of placebo-treated patients, and 0.5% of active-comparator-treated patients, with an incidence of 1.1% among patients treated with 1.8 mg/day of Victoza®. The clinical significance of these findings is unknown. Counsel patients regarding the risk for MTC and the symptoms of thyroid tumors (e.g. a mass in the neck, dysphagia, dyspnea or persistent hoarseness). It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate the potential risk of MTC, and such monitoring may increase the risk of unnecessary procedures, due to low test specificity for serum calcitonin and a high background incidence of thyroid disease. Patients with thyroid nodules noted on physical examination or neck imaging obtained for other reasons should be referred to an endocrinologist for further evaluation. Although routine monitoring of serum calcitonin is of uncertain value in patients treated with Victoza®, if serum calcitonin is measured and found to be elevated, the patient should be referred to an endocrinologist for further evaluation. Pancreatitis: In clinical trials of Victoza®, there have been 13 cases of pancreatitis among Victoza®-treated patients and 1 case in a comparator (glimepiride) treated patient (2.7 vs. 0.5 cases per 1000 patient-years). Nine of the 13 cases with Victoza® were reported as acute pancreatitis and four were reported as chronic pancreatitis. In one case in a Victoza®-treated patient, pancreatitis, with necrosis, was observed and led to death; however clinical causality could not be established. Some patients had other risk factors for pancreatitis, such as a history of cholelithiasis or alcohol abuse. There are no conclusive data establishing a risk of pancreatitis with Victoza® treatment. After initiation of Victoza®, and after dose increases, observe patients carefully for signs and symptoms of pancreatitis (including persistent severe abdominal pain, sometimes radiating to the back and which may or may not be accompanied by vomiting). If pancreatitis is suspected, Victoza® and other potentially suspect medications should be discontinued promptly, confirmatory tests should be performed and appropriate management should be initiated. If pancreatitis is confirmed, Victoza® should not be restarted. Use with caution in patients with a history of pancreatitis. Use with Medications Known to Cause Hypoglycemia: Patients receiving Victoza® in combination with an insulin secretagogue (e.g., sulfonylurea) or insulin may have an increased risk of hypoglycemia. The risk of hypoglycemia may be

lowered by a reduction in the dose of sulfonylurea (or other concomitantly administered insulin secreta-gogues) or insulin [see Adverse Reactions]. Renal Impairment: Victoza® has not been found to be directly nephrotoxic in animal studies or clinical trials. There have been postmarketing reports of acute renal failure and worsening of chronic renal failure, which may sometimes require hemodialysis in Victoza®-treated patients [see Adverse Reactions]. Some of these events were reported in patients without known underlying renal disease. A majority of the reported events occurred in patients who had experi-enced nausea, vomiting, diarrhea, or dehydration [see Adverse Reactions]. Some of the reported events occurred in patients receiving one or more medications known to affect renal function or hydration status. Altered renal function has been reversed in many of the reported cases with supportive treatment and dis-continuation of potentially causative agents, including Victoza®. Use caution when initiating or escalating doses of Victoza® in patients with renal impairment. Hypersensitivity Reactions: There have been postmarketing reports of serious hypersensitivity reactions (e.g., anaphylactic reactions and angioedema) in patients treated with Victoza®. If a hypersensitivity reaction occurs, the patient should discontinue Victoza® and other suspect medications and promptly seek medical advice. Angioedema has also been reported with other GLP-1 receptor agonists. Use caution in a patient with a history of angioedema with another GLP-1 receptor agonist because it is unknown whether such patients will be predisposed to angio-edema with Victoza®. Macrovascular Outcomes: There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Victoza® or any other antidiabetic drug.

ADVERSE REACTIONS: Clinical Trials Experience: Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in prac-tice. The safety of Victoza® has been evaluated in 8 clinical trials: A double-blind 52-week monotherapy trial compared Victoza® 1.2 mg daily, Victoza® 1.8 mg daily, and glimepiride 8 mg daily; A double-blind 26 week add-on to metformin trial compared Victoza® 0.6 mg once-daily, Victoza® 1.2 mg once-daily, Victoza® 1.8 mg once-daily, placebo, and glimepiride 4 mg once-daily; A double-blind 26 week add-on to glimepiride trial compared Victoza® 0.6 mg daily, Victoza® 1.2 mg once-daily, Victoza® 1.8 mg once-daily, placebo, and rosiglitazone 4 mg once-daily; A 26 week add-on to metformin + glimepiride trial, compared double-blind Victoza® 1.8 mg once-daily, double-blind placebo, and open-label insulin glargine once-daily; A double-blind 26-week add-on to metformin + rosiglitazone trial compared Victoza® 1.2 mg once-daily, Victoza® 1.8 mg once-daily and placebo; An open-label 26-week add-on to metformin and/or sulfonylurea trial compared Victoza® 1.8 mg once-daily and exenatide 10 mcg twice-daily; An open-label 26-week add-on to metformin trial compared Victoza® 1.2 mg once-daily, Victoza® 1.8 mg once-daily, and sitagliptin 100 mg once-daily; An open-label 26-week trial compared insulin detemir as add-on to Victoza® 1.8 mg + metformin to continued treatment with Victoza® + metformin alone. Withdrawals: The incidence of withdrawal due to adverse events was 7.8% for Victoza®-treated patients and 3.4% for comparator-treated patients in the five double-blind controlled trials of 26 weeks duration or longer. This difference was driven by withdrawals due to gastrointestinal adverse reactions, which occurred in 5.0% of Victoza®-treated patients and 0.5% of comparator-treated patients. In these five trials, the most common adverse reactions leading to withdrawal for Victoza®-treated patients were nausea (2.8% versus 0% for comparator) and vomiting (1.5% versus 0.1% for comparator). Withdrawal due to gastrointestinal adverse events mainly occurred during the first 2-3 months of the trials. Common adverse reactions: Tables 1, 2, 3 and 4 sum-marize common adverse reactions (hypoglycemia is discussed separately) reported in seven of the eight controlled trials of 26 weeks duration or longer. Most of these adverse reactions were gastrointestinal in nature. In the five double-blind clinical trials of 26 weeks duration or longer, gastrointestinal adverse reac-tions were reported in 41% of Victoza®-treated patients and were dose-related. Gastrointestinal adverse reactions occurred in 17% of comparator-treated patients. Common adverse reactions that occurred at a higher incidence among Victoza®-treated patients included nausea, vomiting, diarrhea, dyspepsia and constipation. In the five double-blind and three open-label clinical trials of 26 weeks duration or longer, the percentage of patients who reported nausea declined over time. In the five double-blind trials approxi-mately 13% of Victoza®-treated patients and 2% of comparator-treated patients reported nausea during the first 2 weeks of treatment. In the 26-week open-label trial comparing Victoza® to exenatide, both in combination with metformin and/or sulfonylurea, gastrointestinal adverse reactions were reported at a similar incidence in the Victoza® and exenatide treatment groups (Table 3). In the 26-week open-label trial comparing Victoza® 1.2 mg, Victoza® 1.8 mg and sitagliptin 100 mg, all in combination with metformin, gastrointestinal adverse reactions were reported at a higher incidence with Victoza® than sitagliptin (Table 4). In the remaining 26-week trial, all patients received Victoza® 1.8 mg + metformin during a 12-week run-in period. During the run-in period, 167 patients (17% of enrolled total) withdrew from the trial: 76 (46% of withdrawals) of these patients doing so because of gastrointestinal adverse reactions and 15 (9% of withdrawals) doing so due to other adverse events. Only those patients who completed the run-in period with inadequate glycemic control were randomized to 26 weeks of add-on therapy with insulin detemir or continued, unchanged treatment with Victoza® 1.8 mg + metformin. During this randomized 26-week period, diarrhea was the only adverse reaction reported in ≥5% of patients treated with Victoza® 1.8 mg + metformin + insulin detemir (11.7%) and greater than in patients treated with Victoza® 1.8 mg and metformin alone (6.9%).

Table 1: Adverse reactions reported in ≥5% of Victoza®-treated patients in a 52-week monotherapy trial

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

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

Add-on to Metformin TrialAll Victoza® + Metformin

N = 724Placebo + Metformin

N = 121Glimepiride + Metformin

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

Add-on to Glimepiride TrialAll Victoza® +

Glimepiride N = 695Placebo + Glimepiride

N = 114Rosiglitazone +

Glimepiride N = 231Adverse Reaction (%) (%) (%)Nausea 7.5 1.8 2.6Diarrhea 7.2 1.8 2.2Constipation 5.3 0.9 1.7Dyspepsia 5.2 0.9 2.6


Add-on to Metformin + GlimepirideVictoza® 1.8 + Metformin

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

Glargine + Metformin + Glimepiride N = 232

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

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

Rosiglitazone N = 355Placebo + Metformin + Rosiglitazone

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

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

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

N = 235

Exenatide 10 mcg twice daily + metformin and/or sulfonylurea

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

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

All Victoza® + metformin N = 439

Sitagliptin 100 mg/day + metformin N = 219

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

Immunogenicity: Consistent with the potentially immunogenic properties of protein and peptide pharma-ceuticals, patients treated with Victoza® may develop anti-liraglutide antibodies. Approximately 50-70% of Victoza®-treated patients in the five double-blind clinical trials of 26 weeks duration or longer were tested for the presence of anti-liraglutide antibodies at the end of treatment. Low titers (concentrations not requiring dilution of serum) of anti-liraglutide antibodies were detected in 8.6% of these Victoza®-treated patients. Sampling was not performed uniformly across all patients in the clinical trials, and this may have resulted in an underestimate of the actual percentage of patients who developed antibodies. Cross-reacting anti-liraglutide antibodies to native glucagon-like peptide-1 (GLP-1) occurred in 6.9% of the Victoza®-treated patients in the double-blind 52-week monotherapy trial and in 4.8% of the Victoza®-treated patients in the double-blind 26-week add-on combination therapy trials. These cross-reacting antibodies were not tested for neutralizing effect against native GLP-1, and thus the potential for clinically significant neutralization of native GLP-1 was not assessed. Antibodies that had a neutralizing effect on liraglutide in an in vitro assay occurred in 2.3% of the Victoza®-treated patients in the double-blind 52-week monotherapy trial and in 1.0% of the Victoza®-treated patients in the double-blind 26-week add-on combination therapy trials. Among Victoza®-treated patients who developed anti-liraglutide antibodies, the most common category of adverse events was that of infections, which occurred among 40% of these patients compared to 36%, 34% and 35% of antibody-negative Victoza®-treated, placebo-treated and active-control-treated patients, respectively. The specific infections which occurred with greater frequency among Victoza®-treated anti-body-positive patients were primarily nonserious upper respiratory tract infections, which occurred among 11% of Victoza®-treated antibody-positive patients; and among 7%, 7% and 5% of antibody-negative Victoza®-treated, placebo-treated and active-control-treated patients, respectively. Among Victoza®-treated antibody-negative patients, the most common category of adverse events was that of gastrointestinal events, which occurred in 43%, 18% and 19% of antibody-negative Victoza®-treated, placebo-treated and active-control-treated patients, respectively. Antibody formation was not associated with reduced efficacy of Victoza® when comparing mean HbA1c of all antibody-positive and all antibody-negative patients. However, the 3 patients with the highest titers of anti-liraglutide antibodies had no reduction in HbA1c with Victoza® treatment. In the five double-blind clinical trials of Victoza®, events from a composite of adverse events potentially related to immunogenicity (e.g. urticaria, angioedema) occurred among 0.8% of Victoza®-treated patients and among 0.4% of comparator-treated patients. Urticaria accounted for approximately one-half of the events in this composite for Victoza®-treated patients. Patients who developed anti-liraglutide antibodies were not more likely to develop events from the immunogenicity events composite than were patients who did not develop anti-liraglutide antibodies. Injection site reactions: Injection site reactions (e.g., injection site rash, erythema) were reported in approximately 2% of Victoza®-treated patients in the five double-blind clinical trials of at least 26 weeks duration. Less than 0.2% of Victoza®-treated patients discontinued due to injection site reactions. Papillary thyroid carcinoma: In clinical trials of Victoza®, there were 7 reported cases of papillary thyroid carcinoma in patients treated with Victoza® and 1 case in a comparator-treated patient (1.5 vs. 0.5 cases per 1000 patient-years). Most of these papillary thyroid carcinomas were <1 cm in greatest diameter and were diagnosed in surgical pathology specimens after thyroidectomy prompted by findings on protocol-specified screening with serum calcitonin or thyroid ultrasound. Hypoglycemia: In the eight clinical trials of at least 26 weeks duration, hypoglycemia requiring the assistance of another person for treatment occurred in 11 Victoza®-treated patients (2.3 cases per 1000 patient-years) and in two exenatide-treated patients. Of these 11 Victoza®-treated patients, six patients were concomitantly using metformin and a sulfonylurea, one was concomitantly using a sulfonylurea, two were concomitantly using metformin (blood glucose values were 65 and 94 mg/dL) and two were using Victoza® as monotherapy (one of these patients was undergoing an intravenous glucose tolerance test and the other was receiving insulin as treat-ment during a hospital stay). For these two patients on Victoza® monotherapy, the insulin treatment was the likely explanation for the hypoglycemia. In the 26-week open-label trial comparing Victoza® to sitagliptin, the incidence of hypoglycemic events defined as symptoms accompanied by a fingerstick glucose <56 mg/dL was comparable among the treatment groups (approximately 5%).

Table 5: Incidence (%) and Rate (episodes/patient year) of Hypoglycemia in the 52-Week Monotherapy Trial and in the 26-Week Combination Therapy Trials

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

0 0 —

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

(N = 724)Glimepiride +

Metformin (N = 242)

Placebo + Metformin (N = 121)

Patient not able to self−treat

0.1 (0.001) 0 0

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

Insulin detemir + Victoza® + Metformin

(N = 163)

Continued Victoza® + Metformin alone

(N = 158*)

None


0 0 —

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

Victoza® + Glimepiride (N = 695)

Rosiglitazone + Glimepiride (N = 231)

Placebo + Glimepiride (N = 114)


0.1 (0.003) 0 0

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

Victoza® + Metformin + Rosiglitazone

(N = 355)

None

Placebo + Metformin + Rosiglitazone

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

0 — 0

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

Victoza® + Metformin + Glimepiride

(N = 230)

Insulin glargine + Metformin +

Glimepiride (N = 232)

Placebo + Metformin + Glimepiride

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

2.2 (0.06) 0 0

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

*One patient is an outlier and was excluded due to 25 hypoglycemic episodes that the patient was able to self-treat. This patient had a history of frequent hypoglycemia prior to the study.

In a pooled analysis of clinical trials, the incidence rate (per 1,000 patient-years) for malignant neoplasms (based on investigator-reported events, medical history, pathology reports, and surgical reports from both blinded and open-label study periods) was 10.9 for Victoza®, 6.3 for placebo, and 7.2 for active compara-tor. After excluding papillary thyroid carcinoma events [see Adverse Reactions], no particular cancer cell type predominated. Seven malignant neoplasm events were reported beyond 1 year of exposure to study medication, six events among Victoza®-treated patients (4 colon, 1 prostate and 1 nasopharyngeal), no events with placebo and one event with active comparator (colon). Causality has not been established. Laboratory Tests: In the five clinical trials of at least 26 weeks duration, mildly elevated serum bilirubin concentrations (elevations to no more than twice the upper limit of the reference range) occurred in 4.0% of Victoza®-treated patients, 2.1% of placebo-treated patients and 3.5% of active-comparator-treated patients. This finding was not accompanied by abnormalities in other liver tests. The significance of this isolated finding is unknown. Vital signs: Victoza® did not have adverse effects on blood pressure. Mean increases from baseline in heart rate of 2 to 3 beats per minute have been observed with Victoza® compared to placebo. The long-term clinical effects of the increase in pulse rate have not been established [see Warnings and Precautions]. Post-Marketing Experience: The following additional adverse reactions have been reported during post-approval use of Victoza®. Because these events are reported voluntarily from a popula-tion of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to drug exposure: Dehydration resulting from nausea, vomiting and diarrhea [see Warnings and Precautions]; Increased serum creatinine, acute renal failure or worsening of chronic renal failure, some-times requiring hemodialysis [see Warnings and Precautions]; Angioedema and anaphylactic reactions [see Contraindications, Warnings and Precautions] OVERDOSAGE: In a clinical trial, one patient with type 2 diabetes experienced a single overdose of Victoza® 17.4 mg subcutaneous (10 times the maximum recommended dose). Effects of the overdose included severe nausea and vomiting requiring hospitalization. No hypoglycemia was reported. The patient recovered without complications. In the event of overdosage, appropriate supportive treatment should be initiated according to the patient’s clinical signs and symptoms.

More detailed information is available upon request. For information about Victoza® contact: Novo Nordisk Inc., 100 College Road West, Princeton, New Jersey 08540, 1−877-484-2869Date of Issue: December 13, 2012 Version: 5

Manufactured by: Novo Nordisk A/S, DK-2880 Bagsvaerd, Denmark

Victoza® is a registered trademark of Novo Nordisk A/S. Victoza® is covered by US Patent Nos. 6,268,343; 6,458,924; and 7,235,627 and other patents pending. Victoza® Pen is covered by US Patent Nos. 6,004,297; 6,235,004; 6,582,404 and other patents pending.© 2010-2013 Novo Nordisk 0213-00013375-1 2/2013

shows that research targeting aspecific genetic defect can leadto more effective treatment ofother inherited diseases, too.

The nature of the problem

CF is caused by mutations inany of the several loci in theCFTR gene that produce variantCFTR proteins. Mutation pro-duces a defective CFTR proteinthat causes the body to produceextremely thick, sticky mucus.CF mucus clogs the lungs andleads to life-threatening lunginfections. It obstructs the pan-creas and stops natural enz ymesfrom helping the body breakdown and absorb food, whichleads to an inability to maintaina healthy weight.

Until the discovery of iva-caftor, CF treatment focused oncontrolling the disease’s hall-mark symptoms of cough,mucus production, shortness ofbreath, and pancreatic insuffi-ciency that causes weight loss.We expend great effort control-ling airway infections, which arevery common because of the ab -normal mucus clearance. We’ve

done pretty well with this, andimproved survival significantly.But these are downstream ef -fects of a defective CFTR proteinthat has lost much of its func-tion. Ivacaftor is the first drug torestore function to that protein.How does CFTR function andhow does its dysfunction causedisease? In most people, CFTRfunctions as a channel thatopens and closes to allow chlor -ide to pass from the inside to theoutside of the cells lining the air-ways and other ducts. Thesechloride ions balance the sod -ium ions pumped into the air-way that together attract wateronto the tops of airway-liningcells. A normal depth of thewater above the airway-liningcells allows their cilia to movemucus, along with bacteria,molds, and other inhaled parti-cles trapped in the mucus up tothe mouth where it is swal-lowed. When CFTR fails to func-tion, the chloride cannot getthrough the cell membrane tobalance the sodium pumped tothe cell surface; there is less sod -ium chloride to draw water tothe cell surface; the depth of the

periciliary fluid layer dimin -ishes; cilia-driven mucus clear-ance slows or ceases; and bacte-ria and molds trapped in themucus have time to grow in theairway. Growing microbesrelease proteins that attractinflammatory cells to the airway.These cells release enzymes thatkill some of these microbes butalso injure airway tissue.

For patients who have thedefective CFTR protein thatresponds to ivacaftor, this oraldrug restores the defective CFTRchloride channel function andpresumably the normal move-ment of mucus out of the air-way. As a result, microbestrapped in CF mucus have lesstime in the airway to reproduceand therefore attract fewerinflammatory cells. Thisdecreases coughing, mucus pro-duction, and shortness ofbreath, allowing patients to gainand maintain much-neededweight.

Unraveling the mystery

How was it determined that thisparticular CFTR protein wasabnormal in some CF patients,

and how did we find a drug tofix it?

This story starts in the 1900swith Sir William Lawrence andCharles Darwin, who first under-stood that reproduction pro-duced slight variations in off-spring; and with GregorMendel’s discovery that differenttraits were inherited in different,but predictable, patterns. In the1940s, Avery, McCloud, andMcCarty found that deoxyri-bonucleic acid (DNA) was thechemical that transmitted theseinherited patterns from one gen-eration to the next in higherorganisms. From their experi-ments, scientists learned thatDNA is the molecular basis ofthe patterns of inheritance thatMendel discovered; and thatvariation in DNA transmitted tooffspring causes most variationin organ form and function inoffspring. These findings providethe basis for our current work togenerate more safe and effectivetreatments of inherited diseasesin people.

In the 1950s, CF patientswere found to have a muchhigher concentration of sodium


Cystic fibrosis from cover

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chloride in their sweat thanunaffected people. Studyingfamilies affected by CF revealedthe autosomal recessive patternof inheritance described byMendel. This research allowedFrancis Collins, Lap-Chee Tsui,and John Riordan and their collaborators to identify thespec ific DNA that varied in CFpatients. The protein predictedfrom the DNA sequence was agood candidate for regulatingsalt movement across cells. Thiswas later confirmed by microin-jecting the CFTR DNA sequenceinto a cultured cell line that nor-mally lacked a transmembranechloride channel and by show-ing that expression of the CFTRprotein in these cells producedsuch a channel. These experi-ments demonstrated that bothcopies of the CFTR gene weremutated in individuals with CFand not in their relatives.

Subsequent research con-firmed that cells from the liningof CF patients’ sweat ducts, air-ways, or gut showed abnormalfunctioning of the mutatedCFTR protein. Normally, thisprotein moves chloride from

inside the airway-, gut-, andduct-lining cells to outside thecells. However, in CF patientsthe cells from the lining of theairways or gut have abnormalfunction of the CFTR channelthat allows chloride to movefrom inside these cells to theoutside. Consequently, in thosepatients chloride stays in thesweat ducts, resulting in theoverly salty sweat characteristicof CF.

From research to drug

Once the defective chloride-mov-ing CFTR protein was identified,drugs that could theoreticallymake it behave more normallycould be synthesized. Using ahigh-throughput screeningmethod, it was now possible totest thousands of drugs alreadyavailable for treatment of otherdiseases for their effectivenesson cells that contained a CFTRgene with the most common CF-causing mutation cultured undertwo different conditions. Thistesting was accomplished byVertex Pharmaceuticals withstart-up funding from the CysticFibrosis Foundation.

Vertex tested the alreadysynthesized drugs for their effecton chloride flow from insidethese cells to outside the cells(potentiator drugs). The firstdrug to be found was ivacaftor, apotentiator drug that increasedthe transfer rate of chloridefrom these cells.

After preliminary safety test-ing in laboratory animals, iva-caftor’s effect was tested for safe-ty and effectiveness in humansat the University of MinnesotaCystic Fibrosis Center and atother institutions around theworld. These tests showed thativecaftor effectively increasedthe chloride flow in certain CFpatients (those who have theG551D mutation in the CFTRgene) and brought their sweatchloride concentrations downtoward normal. Of greatestimportance, it increased the flowof air through their airways andthey gained weight comparedwith placebo treatment.

Improved treatment today,hope for the future

What sets the discovery anddevelopment of ivacaftor apart

from the usual path of drugdevelopment is that it focusedon a specific protein whose rolein disease was discovered basedon an understanding of genesand how they are inherited. It isthe way more drugs will be dis-covered and developed for inher-ited diseases that today arepoorly treatable.

We are currently testinganother drug that may producesimilar improvement in more CFpatients. With the help of pat -ients with CF who participate inthese clinical trials, we are onthe verge of slowing and possi-bly stopping the progression ofthe lung disease that shortensthe lives of most CF patients.

Warren Regelmann, MD, is an associ-ate professor of pediatric pulmonology andinfectious diseases at the University ofMinnesota, where he is co-director of thePediatric Pulmonary Division and directorof the Pediatric CF Program of the Minne-sota CF Center, which is supported bygrants from the Cystic Fibrosis Foundationand is one of 13 Translational andTherapeutic Development Centers fundedto carry out early-phase clinical trials ofnew therapies.


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

In January 2013, Health andHuman Services (HHS) pub-lished the long-awaited final

rule (the “Final Rule”) imple-menting changes to HIPAA from2009’s Health InformationTechnology for Economic andClinical Health (HITECH) Act.The 130-plus pages of regula-tions and corresponding com-mentary clearly demonstratethat HHS is more committedthan ever before to expandingboth patients’ privacy rights andthe obligations of providers tobe proactive in protectingpatients’ protected health infor-mation (PHI).

While the Final Rule pro-vides significant detail onnumerous patient privacy andsecurity issues, those of immedi-ate concern to physicians andother providers are in the areasof business associate relation-ships, breach notification, andnotices of privacy practices.

Business associate relationships

One of the primary areasaddressed in the Final Rule con-cerns business associates and

their relationship with physi-cians and other providers.

Expanded definition of“business associate.” The FinalRule expands the definition of“business associate” to includeany party that “creates, receives,maintains, or transmits” PHI onbehalf of a covered entity. HHSclarified that an entity thatmaintains or stores PHI, regard-less of whether it ever accessesthe information, would be con-sidered a business associate.Similarly, the Final Ruleincludes in the definition ofbusiness associates entities thatprimarily transmit PHI, but areprovided “routine access” to PHIsuch as health informationorganizations and e-prescribinggateways. The Final Rule contin-ues to exclude from the defini-

tion of business associates thoseentities that act as mere con-duits for the transport of PHIbut do not access the informa-tion, such as the U.S. PostalServices and courier services.

Historically, business associ-ates were only those entities thathad access to PHI and contrac -ted directly with covered enti-ties. However, the Final Ruleexpands the definition of busi-ness associate to include down-stream entities that perform typ-ical business associate functionsinvolving PHI but have no directrelationship with the coveredentity and instead only performthose services on behalf of thebusiness associate that has adirect relationship with the cov-ered entity. Not only are thesedirect subcontractors to a busi-ness associate considered busi-ness associates; so are partiesthat contract with those subcon-tractors and create, receive,maintain, or transmit PHI onbehalf of those subcontractors.Under the Final Rule, thisexpansion of parties that areconsidered business associates(to the party with which theycontract as a subcontractor)continues as far down as thechain of relationships goes.

This expansion of the defini-tion of business associates hasimportant implications for cov-ered entities, business associ-ates, and, especially, those “sub-contractors” that in the past maynot have been very focused onHIPAA compliance. For exam-ple, by including each party thatcreates, receives, maintains, ortransmits PHI downstream as abusiness associate, the FinalRule requires a party in thechain to have a business associ-ate agreement with each of thesubcontractors with which itcontracts to perform services onthat party’s behalf involving PHI.Furthermore, as a business asso-ciate, each subcontractor will besubject to the Final Rule’s

HIPAA compliance obligationsfor enhanced business associatesdiscussed below. Given thisexpanded definition of businessassociates, physician groups willneed to re-evaluate which oftheir vendors are business asso-ciates and put updated businessassociate agreements in place.

HIPAA compliance anddirect business associates.Prior to the Final Rule, physi-cians and other providers wererequired to have business associ-ate agreements with their busi-ness associates that required thebusiness associates to be con-tractually liable to the group inorder to comply with many ofthe Privacy Rule and SecurityRule requirements. With thepassage of the Final Rule, inaddition to being contractuallyliability to the covered entities,business associates will now bedirectly responsible for compli-ance with many provisions ofthe HIPAA rules. For example,under the Final Rule, businessassociates will be required tocomply with the HIPAA SecurityRule in the same manner as a“covered entity.” Likewise, busi-ness associates will be requiredto comply with some, but notall, of the provisions of thePrivacy Rule. Being directlyresponsible for compliance withthe Security Rule, and manyprovisions of the Privacy Rule,means that business associates,including the subcontractorswho will themselves be regula -ted as business associates, canbe potentially liable for civil andcriminal penalties for noncom-pliance with such requirements.

Updates to business associ-ate agreements. The Final Rulemakes it clear that its variouschanges to the definition andobligations of business associ-ates, along with their relation-ships with providers, will requirethe providers to amend andupdate existing business associ-ate agreements. Fortunately, theFinal Rule gives some latitudeon the timetable for providers toupdate existing agreements.Generally, business associateagreements that were in effect asof Jan. 25, 2013, will not have tobe updated until Sept. 22, 2014.However, for all new businessassociate agreements that are

HIPAA updateFinal security and privacy regulations will

significantly affect physician practices

By Timothy Johnson, JD, and Jesse Berg, JD, MPH


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executed after Jan. 25, 2013, andfor any modification or renewalof existing business associateagreements, the business associ-ate agreements must complywith the Final Rule require-ments by Sept. 23, 2013.

Breach notification rule

The Final Rule also issues newguidance about when coveredentities are required to notifytheir patients in the event of abreach (defined as an unautho-rized acquisition, access, use, ordisclosure, of patients’ PHI).Historically, HIPAA providedthat a covered entity wasrequired to notify the patientsonly if the patients’ PHI wasunsecured and the breach of thePHI presented a significant riskof financial, reputational, orother harm to the patient.However, the Final Rule replacesthat standard with a muchstricter one. Specifically, anyincident involving the unautho-rized acquisition, access, use, ordisclosure of PHI is presumed tobe a breach and the affectedpatients must be notified unlessthe covered entity performs a

risk assessment and is able todemonstrate that there is a lowprobability that the patients’ PHIwas compromised.

Revisions to notices of privacy practices

As a result of modifications tovarious Privacy and SecurityRule provisions included in theFinal Rule, all covered entitieswill be required to update theirnotices of privacy practices(NPP) to reflect the newchanges. For example, in addi-tion to describing the breachnotification process discussedabove, the NPP must disclosethe Final Rule’s expansion of apatient’s right to restrict disclo-sures and the types of uses anddisclosures of PHI that requireindividual authorization. TheFinal Rule requires that physi-cian groups begin providing theupdated NPP to patients prior toSept. 23, 2013.

Preparing for new HIPAArequirements

The Final Rule provides thatcovered entities that breach thePrivacy Rule can be fined up to

$1.5 million per each occur-rence. However, the Final Rulealso provides that in assessingpenalties for HIPAA violations,the HHS Secretary may takeinto consideration the practice’sefforts in complying with theHIPAA requirements. To helpdemonstrate a practice’s compli-ance, it is recommended thatphysicians groups initially focuson the following four areas:1. Business associate relation-

ships. Given the Final Rule’sexpansion of both who is abusiness associate andenhanced legal HIPAA expo-sure for business associates,physician practices shouldensure that they have updatedbusiness associate agreementswith all applicable businessassociates and that the prac-tice’s business associates areaware of their HIPAA obliga-tions and are operatingaccordingly.

2. Notice of privacy practices.Physician practices shouldamend and modify their NPPto comply with the new FinalRule requirements.

3. Security assessment. Giventhe enhanced obligation underthe Final Rule to reportHIPAA breaches, practicesshould perform an assessmentof their operations and makechanges to minimize the riskof reportable HIPAA breaches.Such changes could includeencrypting PHI when possible,performing workforce trainingon the need to keep PHIsecure, and changing prac-tices that present risk ofHIPAA breaches, such as pro-hibiting everyone, includingpractice physicians, fromremoving patient PHI fromthe office or placing electronicPHI on personal computers.

4. Policies and procedures.Update practice HIPAA poli-cies and procedures to complywith the requirements underthe Final Rule.

Timothy Johnson, JD, and JesseBerg, JD, MPH, are principals at GrayPlant Mooty, specializing in health carelaw. They will discuss the new HIPAArequirements at their annual Health LawSeminar at the Metropolitan on Thursday,July 11.


Participants will:

• Learn current progress, findings, and best practices from Minnesota's advance careplanning programs

• Learn from experts in the field about professional and community perspectives in advance care planning

• Be inspired with collective ACP stories and testimonies

• Gain additional knowledge on ACP evaluation and outcome measurement

• Have the opportunity to develop new professional relationships with other health,human service and community-based professionals

• Hear keynotes Penny Wheeler, MD, CCO, Allina Hospitals and Clinics and Michele Kimball, Director, AARP Minnesota

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Registration opens June 3rd(www.metrodoctors.com)Registration Fee: $150

PLAN TO ATTEND...Honoring Choices Minnesota 4th AnnualSharing the Experience ConferenceThursday, July 18, 20139:00 am - 4:00 pm

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

Over the past decade,physicians and otherhealth care providers

have referenced the 2002“Kidney Disease: OutcomesQuality Initiative (KDOQI)Clinical Practice Guidelines forChronic Kidney Disease (CKD):Evaluation, Classification, andStratification” to help direct thecare of patients with kidney dys-function. The 2012 “KidneyDisease: Improving GlobalOutcomes (KDIGO) ClinicalPractice Guideline for theEvaluation and Management ofChronic Kidney Disease”updates the original KDOQIguidelines. The new guidelinesmay be downloaded atwww.kdigo.org/clinical_practice_guidelines/ckd.php.

We present a patient caseand a summary of the newguidelines to assist primary carephysicians in identifying, classi-fying, and treating patients withnon-dialysis-dependent CKDwith or without diabetes. A mul-tidisciplinary approach (primarycare, nephrology, pharmacy) tomanaging CKD progression andcomplications can help improve

patient understanding and clini-cal outcomes.

A common patient case

Bob, a 79-year-old non-HispanicCaucasian man, is seen at a localchain pharmacy for a compre-hensive medication review. Com -prehensive medication review ispart of medication therapy man-agement (MTM), a health careservice often provided by speci -ally trained pharmacists to opti-mize medication regimens. Boband the pharmacist discussBob’s prescriptions and over-the-counter medications.

Bob’s medical conditionsinclude: • CKD (stage unknown)• Hypertension• Congestive heart failure (CHF)• Dyslipidemia

• Atrial fibrillation• History of myocardial

infarction (stent placement,four years ago)

• Asthma• Gastroesophageal reflux

disease• Macular degeneration

Bob has no questions orconcerns about his medicationregimen. When he recently sawhis primary care practitioner(PCP), his systolic blood pres-sure was elevated to 180 mmHg,and the PCP mentioned laboredbreathing and mild edema. His PCP made no medicationchanges. Though Bob’s elect -ronic medical record lists CKDas a problem, Bob does not re call ever seeing a nephrologistor receiving an angiotensin-con-vert ing enzyme-inhibitor (ACE-I)or angiotensin receptor blocker(ARB).

Bob and the pharmacist discuss benefits and risks ofACE-I/ARB therapies for reduc-ing risk of CKD progression andother medical conditions. WithBob’s consent, the pharmacistcontacts the PCP to discusswhether ACE-I/ARB therapywould be beneficial for Bob’shypertension, CHF, and kidneyfunction.

From the PCP, the pharma-cist learns that Bob was hospi-talized last year for CHF andsubsequent acute kidney injury(AKI); a nephrology consult noteindicated a decision not to initi-ate ACE-I/ARB therapy at thattime. Given this history, the PCPwas hesitant to initiate ACE-I/ARB therapy despite Bob’s re -covery from the AKI episode.The pharmacist provides thePCP with a rationale for initiat-ing ACE-I/ARB therapy, and dis-cusses monitoring parametersand potential benefits and risks.The PCP decides not to initiateACE-I/ARB therapy due to con-cerns about potential hyperkal -emia and the possibility of fur-

ther decreasing kidney function. Although the KDIGO guide-

lines are not intended as anexclusive prescribing template,they can aid in the decision-making process for patients likeBob by providing graded recom-mendations based on best avail-able evidence.

Updated CKD guideline summary

The KDIGO definition of CKD is the same as in the originalKDOQI guidelines: abnormali-ties in kidney structure or func-tion, present for more than threemonths, with implications forhealth. However, the new guide-lines enhance classification,identification, and prognostica-tion of kidney function throughthe CGA classification system,which identifies cause (C),glomerular filtration rate (GFR)category (G), and albuminuriacategory (A).

KDOQI highlighted the pit-falls of using serum creatininealone to assess kidney functionand set a standard for physi-cians to use GFR estimatingequations to obtain more accu-rate estimates of GFR. The two equations advocated werethe Modification of Diet inRenal Disease Study and theCockcroft-Gault equations; bothtake into account additionalpatient factors that influenceGFR. The new KDIGO guide-lines recommend using theChronic Kidney DiseaseEpidemiology Collaboration(CKD-EPI) equation for stagingCKD for better accuracy inpatients with higher GFRs.Electronic versions of theseequations can be found atwww.kidney.org/professionals/kdoqi/gfr_calculator.cfm, andprin ted versions on pages 7–8 ofthe KDIGO guidelines.

KDIGO guidelines furtherdefine the GFR categories (seeTable 1 on page 42).

Albumin, as the primarycom ponent of urinary proteinin kidney diseases, serves as an ear ly indicator of glomerulardamage, often before a decreasein kidney function can beappreciated. Albuminuria clas-sification is based on the albu-min excretion rate (AER; seeTable 2 on page 42).

Chronic kidney diseaseAn updated approach to identification,

classification, and management

By Nathan T. Blake, PharmD, and Wendy L. St. Peter, PharmD


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By collectively consideringGFR and AER (and cause of kid-ney disease), physicians candetermine classification, treat-ment priorities, and prognostica-tion of kidney disease (refer tothe figure on page 21 of theKDIGO guidelines).

Managing blood pressure in patients with CKD

New blood pressure (BP) goalsand treatment guidelines canhelp providers select appropriatetreatment regimens. KDIGOencourages providers to individ-ualize BP goals and treatmentbased on age, cardiovascular dis-ease, other comorbidity, risk ofCKD progression, retinopathy(for patients with diabetes), andtreatment tolerance. The BP tar-get is generally ≤140/90 mmHgfor patients with non-dialysis-dependent CKD with or withoutdiabetes and AER <30 mg/24hours. If AER ≥30 mg/24 hours,the target BP recommendationis ≤130/80 mmHg (for both dia-betic and nondiabetic patients).

Guidelines now recommendinitiating ACE-I/ARB therapy fordiabetic and nondiabetic pati -ents with non-dialysis-dependentCKD in whom BP-lowering ag -ents are indicated if AER ≥30mg/24 hours. Decisions regard-ing choice of BP-lowering agentfor patients with AER <30 mg/24hours should be individualized.

The renin-angiotensin sys-tem (RAS) plays a significantrole in BP regulation in CKDpatients; it can increase intra-glomerular pressure by const ri c -ting the efferent arteriole viaincreasing angiotensin II. Block -ing angiotensin II with an ACE-Ior ARB relaxes the efferent arte-riole, reduces intraglom erularpressure and albuminuria, andprotects kidney function overtime. Therefore, medicationsthat target the RAS system(most evidence is with ACE-I/ARBs) should be considered in CKD treatment regimens.

ACE-I/ARBs are indicatedfor patients with AER ≥30 mg/24and can be combined with otherBP-lowering medications. Closemonitoring upon initiation anddose escalations is prudent dueto the pot ential for hyperkalemiaand initial GFR decreases, espe-cially in patients with renal-artery stenosis or intravascular

volume depletion (or takingdiuretics), or when combinedwith nonsteroidal anti-inflam-matory drugs (NSAIDs), COX-2inhibitors, or potassium-sparingdiuretics. No substantive evi-dence suggests that ACE-Is aresuperior to ARBs regarding BP-or albuminuria-lowering effects.ACE-Is are generally initiatedfirst due to lower costs. If acough arises with ACE-I use, anARB can be substituted. Com -bining an ACE-I and an ARB tolower BP or preserve kidneyfunction is not recommended;combination use increases therisk of progression of kidneyfailure and other adverse reac-tions (hyperkalemia, hypoten-sion), according to recent find-ings from the ONTARGET andALTITUDE clinical trials.

RAS agents are beneficial inreducing progression of kidneydisease, but inappropriate dos-ing or lack of close monitoringcan cause kidney dysfunction.The sidebar (above) provides apractical guide for safe andeffective use of RAS agents inCKD patients.

Medication combinationsincluding a potassium-losingdiuretic (in general, thiazidediuretic if estimated GFR isabove 30 mL/min/1.73 m2 orloop diuretic if estimated GFR isbelow that level) may help pre-vent hyperkalemia and provide a

concomitant BP-lowering effect. If a patient established on

a RAS-blocking medicationbecomes acutely ill or requiresshort-term therapy withNSAIDs, dose reductions or tem-porary discontinuation of the

RAS blocking agent may beadvised to reduce the risk ofAKI. RAS-blocking therapy canresume upon recovery or discon-tinuation of the NSAID.

KIDNEY DISEASE to page 42

• A BP goal of ≤130/80 mmHg may be reasonablefor many patients with CKD and AER ≥30 mg/24hours, but a higher goal (e.g., ≤140/90 mmHg)may be appropriate for elderly patients or thosewith significant cardiovascular disease; individualizethe BP goal for patients with AER <30 mg/24 hours(or equivalent).

• Consider use of ACE-Is or ARBs as single-agent pri-mary therapy in CKD patients with AER ≥30 mg/24hours (or equivalent).

• Do not institute dual RAS therapy except under thecare or recommendation of a specialist (endocrinol-ogist, nephrologist, diabetologist).

• Do not initiate RAS therapy in patients with potass -ium >5.5 mEq/L or with diagnosed or suspectedbilateral renal artery stenosis.

• Assess serum creatinine and serum potassium beforeACE-I/ARB initiation and with each dose increase.

• Initiate using lowest ACEI/ARB doses; consider halv-ing the lowest dose in patients at high risk for RAS-agent-induced AKI (elderly, diuretic use, dehydra -ted, atherosclerosis).

• Maximize the ACE-I/ARB dose by titrating up asfrequently as every 2 to 4 weeks until maximal doseis achieved or hypotension or other adverse effectoccurs (see potassium and serum creatinine monitor-

ing guidelines below).• Reassess potassium and serum creatinine within 2

weeks of initiating a RAS agent or dose increase.- Regarding change in serum creatinine levels:

o If dose is tolerated with ≤30% increase frombaseline serum creatinine or ≤30% increase from baseline estimated GFR, then consider dose increase.

o If serum creatinine increases >30% from baseline or estimated GFR is reduced >30% from baseline anytime within 4 months of RASinitiation, decrease dose (or stop RAS agent if at lowest dose).

- Regarding serum potassium levels:o If potassium level is at or increases to 5.0

mEq/L, prescribe a low-potassium diet.o If potassium increases to 5.5 mEq/L, measures

such as adjustment in diuretics, administration oflong-term alkali supplements, liberalizing saltintake, or long-term use of low-dose sodiumpolystyrene sulfonate may be indicated.

o If potassium increases to ≥6.0–<6.5 mEq/L, stopRAS agent and reinstitute at 50% of prior dosewhen potassium <5.5 mEq/L.

o If potassium increases to ≥6.5 mEq/L, perma-nently discontinue RAS agent.

Guidelines on blood pressure goals for CKD patients

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

Acut that requires stitches,a broken arm, heartattack symptoms … it

used to be that anyone sufferingthese ailmentswould headdirectly to thenearest hospitalemergency room(ER). But today,the ER isn’t theonly option forpatients. Manyare trying a faster,less expensiveoption for acute care closer to home: the freestanding emergency/urgency room.

Increasing demand for ER care

Use of emergency rooms nation-wide has increased 26 percent

since 1997, toabout 114 millionpatients annually,according to theCenters for Dis-ease Control andPrevention (CDC).This increaseddemand for ERservi ces gives riseto frustration for

both physicians and patientsbecause of long waits in thelobby, long waits for test results,and other inefficiencies.

Emergency physicians havebeen saying for years that wecould do better if we had opera-tional control over the environ-ment, and that we could workout common ER problems tomake emergency care faster, bet-ter, and more efficient. This iswhat motivated the EmergencyPhysicians ProfessionalAssociation (EPPA) to developthe Urgency Room (UR), thefirst stand-alone ER type offacility in Minnesota. EPPA is alocally based group of board-cer-tified ER physicians who pro-vide ER physician staffing infive Twin Cities hospitals.

The need for an ER alternative

Recent health care reforms haveprovided a strong impetus todevelop health care networksthat offer more connected andcomprehensive care among allphysicians and patients.However, the idea of a stand-alone ER facility surfaced abouta decade ago, initially as a wayto bring ER-level treatment totowns and communities withouteasy access to this type of care.

The aim was, and is, to providepatients with the same care thatthey would find in a hospital-based emergency room, the dif-ference being that the time to beseen, treated, and on their wayis much reduced—as is the cost.

In late 2011, an article inthe Washington Post reportedthere were at least 222 free-standing ER facilities in theU.S., operating in 16 states. Thesame article noted that Seattlehas several freestanding emer-gency rooms, including one anhour north of the city that hasmore square footage than anNFL football field.

The lure of stand-aloneemergency departments is alsorooted in a growing consumerdemand for convenience inhealth care delivery, as evi-denced by the growing numberof clinics staffed by nurses insupermarkets and doctor-ownedurgent care centers. In addition,many procedures have alreadymoved out of the hospitalbecause they can be handledmore efficiently in other settingswhere resources for certain pro-cedures can be dedicated in aspecific way. For example,colonoscopies, which are regu-larly performed at gastroenterol-ogy centers today, could be per-formed only in hospitals just 10 years ago. Spine surgeries,LASIK, pediatric tonsillectomies,plastic surgery, and many othersurgical procedures also, for themost part, are done at surgerycenters now.

Services delivered

Stand-alone ERs are designed to treat a variety of medical con-ditions. At the three UrgencyRoom locations in the TwinCities, board-certified physiciansand emergency medicine-trainednurses and paramedics havetreated a wide range of condi-tions, from broken bones andserious lacerations to blood clotsand heart attack symptoms. Infact, EPPA’s research on ERadmissions in five Twin Citieshospital-based ERs since 2001shows that in Minnesota, roughly 75 percent of patientswho go to the ER for care aren’tadmitted to the hospital anddon’t need hospital-based ser -vices. There’s no need for those

Freestanding“urgency room”

facilitiesA new option for acute-care services, at reduced cost, and closer to home

By Gary Gosewisch, MD


Everyonecares about

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nearest ur

re,e at om

This month’s special

focus articles discuss

the evolution of free-

standing emergency

and “urgency care”

facilities; the advoca-

cy role that health

care real-estate pro-

fessionals can play in

clinic development

and management;

considerations for

medical clinics plan-

ning to relocate or

expand; and the

importance of includ-

ing medical staff

in the planning and

design process for

new or remodeled

health-care facilities.

Use of emergencyrooms nationwide

has increased 26 percent since 1997.

people to endure hours of wait-ing, uncertainty over what isgoing on with their case, andanxiety about the financial costs.

Going to the ER for acuteand urgent medical needs is nolonger the only option forpatients in the Twin Cities andin many parts of the country.Instead of a mom waiting fourhours to get five stitches for herchild at the ER, her child canreceive the same expert medicaltreatment much faster in anenvironment that is welcomingand comfortable. Urgency Roompatients are treated quickly in acomforting environment byboard-certified emergency physi-cians and avoid the hassle of anER visit.

Urgency Room facilities alsoprovide a high level of amenitiesand service, in marked contrastto the atmosphere of a typicalhospital-based ER. Patients aregreeted by friendly, courteousstaff whose priority is to putpatients at ease and make themcomfortable. We always keeppatients informed of how longthe wait will be and where theyare in the process. An LCDscreen in the lobby lists waittimes, which are also accessiblevia the Urgency Room website.Patients can even go online andenter their name into the systembefore arriving at the facility, sostaff will be ready for them. Ifthe wait time is longer than nor-mal, patients may leave to runerrands or entertain their chil-dren outside without losing theirplace in line; we call or text thepatient when a room is ready.

The discharge process at theUrgency Room is also quick andeasy; our goal is to get our pa -tients treated, home, and ontheir way to recovery fast. TheUrgency Room also makes ar -rangements with local hospitalsto have expedited admissionswhen a trip to the operatingroom or a hospital stay is needed. When they get there,patients typically can go directlyto their hospital bed or the oper-ating room without having to beseen or wait in the ER.

Our goal is to return ourpatients to their primary careprovider for their regularlyscheduled care post-treatment atthe Urgency Room. We work

with our patients and with sur-rounding clinics and physiciangroups to make sure coordina-tion of care is fulfilled and

patient information is trans-ferred accordingly. Patients can return to their primary orspecialty provider followingtheir visit with any necessaryrecords or images from theirvisit to the Urgency Room.

Advantages of the emerging ER alternatives

Reduced cost and wait timeswere our goals in the creationand execution of the threeUrgency Room locations in theTwin Cities.

Cost is a key factor. ForUrgency Room patients withmajor health insurance, we’venegotiated for them to have anurgent care (rather than emer-gency care) copay. This meansthat these patients are gettingER-level staff and evaluations,but they’re paying less for thesame treatment. The UrgencyRoom does not have the over-head and associated costs foundin a standard ER attached to ahospital. We are able to keepcosts affordable for patients,providers, and insurers.

Wait time is the other bigdraw of freestanding ERs. At theUrgency Room we have thesame equipment as an ER, butwe’re dedicated only to thepatients in the building, so wedon’t have the kind of delaysthat result when resources arededicated to the hospital overall.

For example, the Urgency Roomdoes not accept ambulances,which can alter ER wait timesbecause ambulance-transported

patients often receive prioritycare based on the severity oftheir condition.

Our freestanding ER alter-native has been very well re ceived by those who have used

it. Since our first facility, inWoodbury, opened in October2010, our patient satisfactionrate has been 99 percent. Basedon that success, we have sinceopened locations in Eagan andin Vadnais Heights, and we willcontinue to expand this innova-tive concept to communitiesacross the metro area. In themeantime, other urgency carefacilities have sprung up in theTwin Cities area. As health careprofessionals, organizations, andpatients look ever more closelyat ways to reduce costs whileimproving care, efficiency, andthe patient experience, we canexpect this model to be adoptedmore widely nationwide.

Gary Gosewisch, MD, is board-certifiedin emergency medicine and is an emer-gency physician at the Urgency Rooms andat Fairview Southdale Hospital.


How are alternative “urgency room” facilities different from urgent care clinics and

hospital emergency departments?

Stand-alone facilities that offer emergency medical care differ fromurgent care facilities because they provide ER-level care from thesame doctors, nurses, and paramedics found in the ER. Urgent carefacilities do not provide this level of care; rather, they basically offerthe same services as a primary care clinic, except on a walk-in basisand at extended and weekend hours.

The new emergency care facilities such as the EPPA’s UrgencyRoom differ from traditional hospital-based ERs in that they do notaccept ambulances.

Going to the ER for acute and urgent medical needs is no longer the

only option for patients in the Twin Citiesand in many parts of the country.

health care architecture honor roll


innesota Physician’s 2013 HealthCare Architecture Honor Roll recognizes eight outstanding

projects completed in the past year. This year’sHonor Roll projects include new clinic andhospital construction, remodeled spaces, andfacility expansions in urban, suburban, andgreater Minnesota. The medical services rangefrom routine clinic visits to specialized care.Populations served include the standardpatient rosters typically seen in family medicine clinics, as well as specializedgroups—such as new mothers and theirbabies, and children and adolescents needingindividualized psychotherapeutic care.

Several urban facilities remodeled existing spaces that previously housed a bank building, a bar, and a bakery.

Seeking to provide a welcoming environment,many of the projects incorporate elementsfrom nature and feature eye-catching artwork.

Minnesota Physician Publishing thanks allthose who participated in the 2013 honor roll.

M

Type of facility: Medical office building/parking structure

Location: Duluth

Client: Ventas, Inc.

Architect/Interior design:Erdman; DSGW Architects,design consultant

Engineer: Erdman

Contractor: Erdman

Completion date:August 2012

Total cost: $25 million

Square feet: 175,000 sf

St. Luke’s Campus Building Awas built for the fast-chang-ing climate of health care,with an eye to the future.

The top floor of the five-floor medical office building is home to six of St. Luke’s spe cialty clinics:Gastroenterology, Neurosurgery, Orthopedics and Sports Medicine, Pediatrics,Physical Medicine & Rehab, and Plastic Surgery.

Patient exam rooms, procedure rooms, casting rooms, physician offices, lab, digital tomographic X-ray suites, a physical therapy room, and separate waitingareas for the pediatric and plastic surgery clinics are found on the fifth floor.

The main patient waiting area and a number of the patient exam rooms offerbeautiful views of Lake Superior.

The fourth floor is currently unoccupied, offering room for expansion.

The clinical space on the fourth and fifth floors comprises 70,600 square feetof the total 175,000-square-foot structure.

The lower three levels offer enclosed, climate-controlled parking for 219patient and emp loyee vehicles.

Top: Nurses’ stationRight: LobbyBottom: Entrance toMedical Building A

St. Luke’s Medical Office Building A

AmberwingType of facility: Child, adolescent, and young adult mentalhealth and chemical dependency treatment center

Location: Duluth

Client: Miller-Dwan Foundation

Architect/Interior design: John Ivey Thomas Assoc., architect; Kitchi Gammi Design, interior design

Engineer: SEH, civil; Northland Consulting Engineers, LLP,structural; The Design Group, mechanical/electrical

Contractor: Johnson Wilson Constructors

Completion date: August 2012

Total cost: $6.2 million


Amberwing–Center for Youth & Family Well-Being, built by the Miller-Dwan Foundation with more than $6 million in charitable gifts, provides individualized psychotherapeutic carefor young people and their families.

Amberwing was designed specifically to reduce the stress and stigma of mental health and chemical dependency care.Located on six wooded acres in the heart of Duluth, the facility’s central atrium and four treatment wings reflect thewelcoming warmth of a North Woods lodge. Each wing isanchored by a family-friendly kitchen and gathering area sur-rounded by separate rooms for educational therapy, talk ther -apy, play therapy, a classroom, and a living room-like space forfamily meetings. A separate wing designed for alternative ther-apies offers music, art, drama, occupational therapy, recreation,and movement therapy to enhance therapeutic outcomes.

An imaginative lobby, a community meeting area, a spiritualcenter, a treatment space for infant and toddlers, and a profes-sionally staffed parent and family resource center make up theheart of Amberwing, encouraging the community to enter.

The wooded outdoors, which is connected to a 16-acre fed -eral park, allows for nature walks in the spring and summer,outdoor games, and snowshoeing in the winter. The buildingincludes an outdoor deck and a strategically designed outdoorgathering space to integrate nature into Amberwing’s treat-ment programming.

Left: A wooden, ribbed canoe suspended from the ceiling of thelobby, along with earth tones and comfortable design touches,carries out the facility’s theme of a welcoming North Woods lodge.

Top: The fireplace room provides a cozy space for youth and families to relax.

Bottom inset: The facility, built in a restful wooded area, is near a16-acre federal park.

Mother Baby CenterType of facility: Hospital

Location: Minneapolis

Client: Joint venture between Children’s Hospital and Clinics of Minnesota and AbbottNorthwestern Hospital

Architect/Interior design: HDR Architecture, Inc.

Engineer: Palanisami & Associates, Inc., structural; HDR Architecture, Inc., mechanical/electrical

Contractor: Knutson Construction

Completion date: January 2013


Square feet: 75,000 sf, new; 22,000 sf, remodeled

The Mother Baby Center combines Children’s Hospitalsand Clinics of Minnesota’s excellence in neonatal care with Abbott Northwestern Hospital’srenowned obstetrical program, enabling mothers, babies, and families to stay together and experi-ence the highest level of coordinated care.

The four-story facility is nestled between Abbott Northwestern and Children’s with a skyway thatconnects the two. The new facility has capacity for 5,000 births each year. It offers a compre-hensive approach to care, beginning at prenatal care and continuing through obstetrics, peri-natology, labor and delivery, neonatology, and pediatrics.

Combining a comforting spa-like atmosphere with state-of-the-art clinical technology, theMother Baby Center achieves an environment that balances function with the needs of fami-lies before, during, and after childbirth. The facility includes a maternal assessment center; 13labor and delivery rooms; two 24-bed postpartum units; an 11-bed high-risk antepartum unit;a 24-room/31-bed special care nursery; and three operating rooms, including an integratedoperating room for highly complex cases that is 150 feet from Children’s level III/IV NICU.

The Mother Baby Center has live telemedicine capabilities, allowing the center to extend itsexpertise beyond its physical location and advise providers at other birth centers in the region.

H O N O R R O L L 2013

Left: The signature entrance allows for a celebratory family experience.Left Inset: Rooms with a birthing tub provide moms with a variety of birthingoptions.Top: The exterior façade captures thewelcoming spirit of the Mother Baby pro-gram through color and creative forms.


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Healthcare Planning and Design

Ophthalmology - Essentia Health


Lakeview Health:Stillwater Medical GroupMahtomedi ClinicType of facility: Outpatient medical clinic

Location: Mahtomedi

Client: Lakeview Health/HealthPartners

Architect/Interior design: Mohagen HansenArchitectural Group/HealthPartners Facilities

Contractor: Greiner Construction

Completion date: October 2012

Total cost: $795,636


The clinic design was based on a new care delivery model being used byHealthPartners. Areas within the clinic areconsidered “on-stage” areas, which patientssee and experience; or “off-stage” areas,which are seen and used by clinic staff.The staff areas are located in the centralcore of the clinic and surrounded by examrooms. The main patient corridor runsaround the perimeter of the building to give patients views to nature andthe outdoors while bringing more daylight into the exam rooms. Thisnew exam model improves staff flow by creating separate patient andprovider entrances while increasing the sense of comfort by decreasingthe visibility of staff work areas and medical equipment from patients.Patients appreciate the light, airy feel of this clinic. The goal of the inter -ior concept was to design a welcoming, yet healing environment. Natureis a key element found throughout the clinic, both literally and figura -

tively. The artwork provides photographic images of nature, and naturalwood, stone, and metal add texture and warmth to the reception andwaiting areas, as well as the exam rooms. Also found in the exam roomsis a resin material containing real grasses, wood-look paneling, and stone-look resilient flooring. The clean lines and simple shape configurationsseen throughout the clinic also enhance the freshness and appeal of the clinic.

Top: In the X-ray room, the use of warm finishes andnature images provide a welcome distraction for patients.

Inset: Thoughtful use of materials and finishes, alongwith abundant natural daylight, create a comfortableand inviting waiting area.

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HealthEast Midway ClinicType of facility: Outpatient internal medical clinic

Location: St. Paul

Client: MSP/University Medical, LLC

Architect/Interior design:HGA Architects and Engineers

Engineer: Anderson-Urlacher PA

Contractor: Welsh Construction

Completion date: April 2012



This medical clinic was built in therenovated space formerly occupiedby a book retailer. The two-storyinterior underwent many renova-tions, including skylights andpatient-friendly touches (no moreweighing patients in the publichallways). The exterior was alsoupdated to include heated side-walks by the main entrance, sopatrons don’t run the risk of slip-ping and falling.

The location was very attractive toHealthEast and real estate developerMSP on many levels. Located on thecorners of Hamline and UniversityAvenues, the new Midway clinic is

centrally located between Minneapolis and St. Paul.Neighbors, like Super Target, Herberger’s, andWalmart, make it a destination location for patrons.It is also located two blocks from where theCentral Corridor light rail will be making it conven-ient for those patrons reliant on public transit.

This successful conversion of a retail space into a medical building will serve the needs of patients, providers, and HealthEast Care Systemextremely well.

Top: Floor-to-ceiling windows provide plenty of light in the waiting room.

Inset: The new facility’s location, near a number of retail stores and two blocksfrom the Central Corridor light rail (now under construction), make it conven-ient to patrons.



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Riverwood Healthcare CenterType of facility: Critical access hospital (renovation)

Location: Aitkin

Client: Riverwood Healthcare Center

Architect/Interior design: HDR Architecture

Engineer: Paulson & Clark Engineering, Inc.

Contractor: Kraus-Anderson Construction Co.

Completion date: June 2013

Total cost: Withheld at owner’s request

Square feet: 24,365 sf (renovated)

Riverwood Healthcare Center is an independent, integrated hos-pital and clinic facility serving Aitkin county and nearby com-munities in northern Minnesota. Renovation in 2012–2013included remodeling of patient, specialty treatment, pharmacy,waiting areas, and staff amenities—all accomplished withoutinterruption to clinic or hospital services. Included was conver-sion of 11 existing patient rooms to single patient rooms; newlabor and delivery unit; relocated emergency room and intensive careunit; remodeled rehab space; addition of five infusion bays forchemotherapy and other medication therapies; and relocation of phar-macy, respiratory therapy, diabetes education, and wound care. In addi-tion, renovation created a new support services addition, which housesmedical records, human resources, and others services, bringing allRiverwood employees in Aitkin into one location. Infection controlswere implemented in each phase.

Other renovation work included utility and site improvements (grading,curb/gutter, courtyard pavers, landscaping) and additional parking. Theexpansion effort also facilitated an economic boost, creating 18 newpositions at the hospital and generating 130 new construction jobs witha payroll of approximately $6 million for the duration of construction. A

number of subcontractors were hired from Aitkin as well as the sur-rounding area, providing regional economic impact.

Top: Remodeled nurses’ station

Bottom: Riverwood Healthcare Center entrance at dawn

From struggling to lift his newborn son to competing in triathlons, Ben Mattson’s referral to Dr. Bruce Bartie at St. Croix Orthopaedics changed his life!

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Our orthopaedic and sports medicine physicians are on-site to support you and your patients with urgent care hours at High Pointe in Lake Elmo. No appointments necessary.

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Sartell PediatricsType of facility: Pediatrics clinic

Location: Sartell

Client: David Smith, MD

Architect/Interior design: HMA Architects

Engineer: Larson Engineering, structural; Precise Refrigeration, Heating & Air Conditioning, Inc., mechanical; Augusta Electric, Inc., electrical

Contractor: R.A. Morton Construction Managers

Completion date: November 2012

Total cost: $600,000 (construction)


The Sartell Pediatrics project was unique and challeng-ing in a number of ways. The project was a completerenovation of a building that was originally built as adrive-thru branch bank. It was later converted to a barthat featured a floor to ceiling dance pole, where thenurse’s station now stands. Also, the practice is private(owned by David Smith, MD) rather than part of amedical group.

Dr. Smith wanted a very functional layout that wouldaccommodate both patients and the staff. He also waslooking for a space that would be inviting, warm, andcomforting for the children who would be his patients.The exterior of the south façade was opened up toallow for new windows and abundant natural light. EIFSmaterial was used in strategic areas to cover old brickpatches and to tie in the new window openings.

The existing structure and high ceilingswere left open where the old bank drive-through was located, to create a sense ofopenness and interest. Vibrant colors wereused on the exam room walls while naturaltones and stone were used in the entry andlobby areas to bring a sense of warmth andcharacter to the patient experience.

The Sartell Pediatrics facility provides aunique environment and functional support

to the important process of pediatric health care. The project has been agreat success and has resulted in an abundance of community support.

Top: At the Sartell Pediatrics check-in desk, natural tones and stone help con-vey a sense of warmth to the patient experience.

Bottom: Entrance to the clinic


Alcohol and drug abuse by seniors often goes unnoticed because of isolation and loneliness. As a result, the older adult continues to suffer in silence. Senior Helping Hands is a program of St. Cloud Hospital Recovery Plus and a recognized national leader providing support and services to stop the suffering. Senior Helping Hands serves individuals age 55 and older.

Services• Outreach service and consultation with family or concerned persons• Evaluation and assessment for chemical dependency and/or mental health

issues completed by qualified professionals• Volunteer support for older adults who are chemically dependent• Support from peer volunteer counselors for older adults with mental health issues

ProgramsOlder Adult Chemical Dependency Primary Treatment ProgramA comprehensive program that involves physical/psychosocial/chemical use assessments performed by professionals trained in chemical dependency and mental health, including a full time Medical Director who is an addictionist. The program provides a slow pace, holistic approach to recovery. Transportation and temporary housing are available if needed.

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Picture this: A medicalgroup had outgrown itsspace, and was looking to

add two new physicians. Despitetheir prospects for growth, theywere burdened with an outdatedand badly located facility. Fortwo years, the group looked atnumerous options that would fittheir various requirements,which included visibility, park-ing, layout, and pricing, but theycould find nothing within theirlimited geographic parameters.Finally, through some ingenuityand hard work, a retail buildingwas repurposed to become theperfect solution for their newclinic.

Though successful, thiswhole process and its creativesolution might not have hap-pened at all without the help of health care real-estate profes-sionals.

What exactly is a commercialreal-estate professional?

There are many types of com-mercial real-estate professionalswith different areas of expertise;some specialize in a particularindustry, like health care. These

professionals act as consultantsfor businesses, helping themdetermine their real estate needsand then working to find themthe best possible location andnegotiating on their behalf.When finding a space, healthcare real-estate professionalstake into account the specificrequirements and regulationsthat apply to the health careindustry, including integrationand absorption of smaller clinicsinto larger systems.

Think of it this way: Generalpractitioners can effectivelydiagnose and treat many ail-ments, but if their patient is aspecial case or requires addi -tional expertise, they most likelywill refer the patient to a spe-

cialist. Health care real-estateprofessionals serve a similarfunction, as they specialize inthe field of commercial realestate as it relates to varioushealth care practices.

What skills do commercialreal-estate specialists bring totheir work with medical profes-sionals?

Market expertise. Commer-cial real-estate professionalsknow the medical office market.They act as the physician’s advo-cate, consulting with medicalpractices on issues such as:• Patient analysis• Demographics• Current and new market

trends• Pricing and negotiating• Competitive analysis• Site evaluation• Compliance and regulatory

knowledge• Off-market deals• Future projects

Analysis. Making long-termdecisions about real estate in -volves analyzing many factors,including demographics, com-petitive evaluation, system andcomplementary practice align-ment, branding, patient base,market shifts, and financialexpenditures. Commercial real-estate professionals also cananalyze your current location forintegration and subleasing possi-bilities, keeping in mind thelegalities surrounding subleasingand fair market value, especiallyStark laws. Through mappingand patient analysis, they canhelp you identify whether cur-rent trends, such as reposition-ing former retail space for med-ical practice use, are going tocontinue, and whether they areright for your practice.

Neutrality. Working with acommercial real-estate profes-sional provides medical profes-

sionals with a neutral thirdparty—something that can behelpful during negotiations.They can provide conflict resolu-tion without getting the physi-cian involved, acting as a bufferbetween the building owner andthe tenant. This helps keepthings amiable and professionalbetween the owner and tenant,who likely will be workingtogether for many years. Also,when buildings are owned byhealth care systems and otherphysicians, there is the potentialto run into regulatory issues likeStark law. Long-term relation-ships, including referrals, areoften best protected andresolved by a third party.

When should you start working with a commercialreal-estate professional?

Commercial real-estate profes-sionals should be part of youroperational team, communicat-ing with you annually as part ofyour long-term strategic andfinancial planning, whether ornot you are considering chang-ing spaces. When it comes tomaking a move, the more proac-tive a medical practice is, thebetter the chances of negotiatingbetter lease terms or securingspace in a new, highly desiredmedical development that is stillin the planning stages. Manynew medical development proj-ects take years to fully develop,so having early knowledge aboutthese projects enables you tomake the best decisions for yourpractice.

Even if you just signed a 10-year-lease, having an annualreview can help prepare forthings that may come up, suchas outgrowing a space, a demo-graphic shift in your patientbase, or partnership changes.The commercial real-estate professional can help you takeadvantage of these situationsbefore your lease is actually up.

What to look for in a commer-cial-real estate professional

Choosing the right commercialreal-estate professional for yourmedical practice will depend onyour specific needs and objec-tives, but there are some thingsthat all medical professionalsshould look for when selectingthe right real estate partner.

The doctor’s advocate

How commercial real-estate professionalshelp medical practices

By Louis Suarez, CCIM


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Health care experience.How much does this individualknow about the health careindustry as a whole, and whatcan he or she tell you about typi-cal and special real estate needs?A commercial real-estate profes-sional who specializes in healthcare will understand the dynam-ics of relationships with affilia -ted systems and clinics, as wellas your clinic’s referral network.

Market knowledge. Goodcommercial real-estate profes-sionals should have marketknowledge of what is happeningin the industry, current marketpricing, what opportunities areavailable, and what forces willaffect your practice’s situation.They should also keep youapprised of proposed and in-progress construction projects,to help you make the mostinformed decisions possible.

Resources. Good commer-cial real-estate professionalshave access to a multitude ofresources, including demogra -phic and geographic informa-tion, construction costs, projectmanagement, move costs, andbuilding operations.

Landlord experience. Whilethis may seem counterintuitive,commercial real-estate profes-sionals who have also workedwith and for landlords can pro-vide a unique point of view for a physician. They can offerinsight into the motivations andprocesses of building ownersand administrators, providingyou with a more advantageousperspective in the site selectionand lease negotiation process.

Getting down to dollars and cents

Finally, there is the ever-loomingquestion: How much is it goingto cost? While there is not a spe-cific price, there are some fac-tors to consider:

Scope of project. Projectscan vary dramatically in thesize, scope, and time required.Costs for these types of servicestypically will be calculated dif-ferently depending on therequired services and theclient/broker relationship. Somebrokers charge by the hour,while others may charge by theproject or transaction.

Who’s paying? Although

each project is different, themost common transaction is alease or sale. In these cases, thebuilding owner or developerusually pays the fee. Most med-ical buildings have fees builtinto their pricing as part of thecost of doing business, similar to the way the commission for abuyer’s realtor is paid within theseller’s contract on a house. Thisis not always the case, so it isimportant to discuss this withyour specialist early in theprocess.

Single transaction or long-term project. Another factorthat many commercial real-estate brokers take into accountwhen calculating fees is whetherthis is a one-time-only transac-tion or a longer-term project.Many times, tenant representa-tives will perform various ser -vices free of charge, with theunderstanding that they will bereceiving commissions on futuretransactions. Other times, a feefor a service or project can bedetermined and paid forupfront.

Current vacancy rates inMinnesota for health care space

are the lowest of all types ofoffice space. This means there is less space available, and thespace that is available costsmore. You can be sure that thelandowner or developer has abroker on its side. So, who’s onyour side? You don’t have timeto waste fighting for availableconcessions like signage, tenantimprovement allowances, rentalrates, and lease term rates.

Choosing a health care com-mercial real-estate professionalmeans you have an advocate.You’ll have someone workingwith you every step of the wayto learn about your real estatehistory and requirements, tofind the correct type of proper-ties for your specific needs, andto develop a plan that minimizesjostling to your practice. Have aprofessional do the real estatelegwork, so you can focus onyour practice.

To download a glossary ofcommon health-care real-estateterms, go to www.colliersmsp.com/mnphysicians.

Louis Suarez, CCIM, is director ofColliers International’s Healthcare ServicesGroup, based in Minneapolis.


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If your clinic has ever consid-ered opening a satellite loca-tion or relocating to a new

facility, you know how dauntingthe decision-making process canbe. Today, these decisions arefurther complicated by a host offactors, such as changes in thehealth care industry, technologi-cal advances, and more restric-tive networks of care.

The traditional approach tomedicine, based on a diagnosis-and-treatment model, is not wellequipped to thrive in today’s rap-idly evolving health care environ-ment. Today, medical groups areresponsible for more coveredlives than in the past, so physi-cians are seeing more patients.Increasingly, practices are dele-gating routine visits to extenders(e.g., physician assistants, nursepractitioners, advanced practiceproviders), allowing physiciansto deal with more complex visitswhere their expertise is morefully utilized. All of these factorsinfluence facility design andoperations. This article examinesfive key aspects of health carethat clinics planning to relocateor expand may want to consider.

Patient experience and practice image

Research indicates that patients’perception of the quality of carethey receive is directly linked tothe physical environment wherethey receive care. For example,if outdated floor coverings andother poorly chosen furnishingsdominate a facility’s decor, apatient may question the safetyof the care environment.

As health care consumersbecome more aware of theirchoices, health care organiza-tions need to attract their busi-ness with a welcoming environ-ment. Facilities today are movingaway from the traditional frontdesk check-in model to a con-cierge model where patients aregreeted at the door and assistedin navigating their journey. In aneffort to accommodate a diversepatient population, organizations

are offering more variety andchoices to their patients as theymove through the facility.Waiting rooms have becomemore home-like, with choicesthat include love seats for par-ents with small children, over-sized chairs for larger patients,taller seats with sturdy arms forelderly patients, play and readingareas for children, as well asmaneuvering space for wheel-chairs and scooters.

Patient privacy is a primaryconcern in the patient’s journeythrough the clinic visit, from themoment the patient checks in ata desk or kiosk until he or sheleaves with follow-up instruc-tions and appointments. Design-ing the desk with private check-out stations on the back side ofthe desk, out of the main trafficpattern, offers additional privacyto those patients scheduling fol-low-up appointments and proce-dures while maintaining staffefficiency in covering bothcheck-in and check-out.

Although the lobby andwaiting/public spaces are impor-tant elements in the patient jour-ney, the exam room is thepatient’s principal destination.Until recently, the exam roomhas seen very little change.However, today we have a newunderstanding of how the designof the exam room can affect thepatient’s perceived quality ofcare. The standard exam roomtoday is about 50 percent largerthan it has been in the past.Today’s exam rooms can betteraccommodate large families andcaregivers, patients with disabili-ties, and bariatric patients.

In addition, research showsthat the design of the physician’sdesk influences patients’ involve-ment in and understanding oftheir care. For example, mobiledesks and larger monitorscreens allow patients to seetheir medical records, X-rayimages, and test results, permit-ting greater interaction withtheir care provider.

Analyzing demographics tohelp build referral networks

Demographic data can guidepractitioners in pinpointingpotential geographic locationsfor clinic expansion or reloca-tion and in identifying opportu-nities to build referral networksthat can create greater access tospecific patient populations.

Most patient accounting andelectronic health record systemsallow practices to capture andmonitor patient demographics,payer classes, referring physi-cian data, and other pertinentinformation that can help deter-mine a business case for expan-sion or relocation to a new mar-ket. For example, a specialtypractice that is centrally locatedmay begin to see a large portionof its patient population shiftingto the west metro area due topopulation growth, new referralsources from affiliated physicianpractices, or new health carefacilities. The demographic datamay indicate that the practicelikely would have sufficientpatient volume to open a newpractice with a new or estab-lished practitioner.

Health system alignmentopportunities

More and more medical grouppractices are aligning themselveswith hospitals and integratedhealth systems that are increas-ingly focused on populationhealth management. Thesehealth systems need physiciansof all specialty types in their net-works to provide comprehensivecare for their patient popula-tions. When considering relocat-ing or expanding, practices maywant to consider new ambula -tory care facilities that are affili-ated with large health systems sothey can secure their participa-tion within the provider network.

Gaining workflow efficienciesthrough space programming

Planning for a new locationshould involve assessing practicepatterns, anticipated futuregrowth, and recruitment plans todetermine the total number ofexam and procedure rooms thepractice needs. The assessmentshould include an analysis of thedaily provider schedule so thatexam rooms are fully utilized,even when individual physicians

Moving? Growing?Considerations in clinic relocation or expansion

By Nancy Doyle, AIA, and Jessica Anderson


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and providers are caring forpatients in the hospital or otherpractice locations. Incorporatingutilization factors will help pre-vent “over-building” of a newpractice location, and can pro-vide opportunities to subletspace to unaffiliated physicianson a part-time basis. Practicesalso may consider designingoffices and support spaces sothey can easily be converted toclinical use in the future.

Incorporating principles of“lean” design into space pro-gramming involves an objectiveevaluation of the practice toidentify opportunities to reducewaste and redundancy in prac-tice operations. The most effec-tive design will aim to minimizeprovider travel distances, maxi-mize access to materials andsupplies, and eliminate non-essential or duplicative func-tions. Consideration should begiven to designing larger examrooms so that they can accom-modate additional provider staff,office-based procedures, andgreater involvement of familymembers and patient caretakersduring office visits.

Planning for collaborative care

The delivery of care increasinglyhas been shifting to patient-focused models that support thebest possible state of wellness foreach patient over the long term.This shift from an episodicmindset to a holistic approachrequires greater collaborationamong all participants in thecare delivery process for primarycare and specific disease condi-tions. Accommodating thismodel in the practice settingmay require a different approachto the organization of the clinicalcare environment.

In the traditional caremodel, the patient ventures fromone clinical space to another toreceive specialty care. In con-trast, collaborative care oftenallows the medical team to carefor the patient in one clinicalspace or room. In this newdesign, providers flow in a tightpattern of movement amongtheir patients while the patientremains in one exam room.Ultimately, this approach to careshould reduce the cost of spaceper patient encounter becausethe rooms are used more effi-

ciently than in the traditionalone-room/one-provider systemof care.

Often this type of planningis an integral part of changingphysician work patterns fromthe existing norm to a more efficient system that will yieldhigher productivity and loweroverhead.

The objective of the medicalhome model is to create a uni-versal clinic module that facili-tates multi-use by an expandedteam of providers. Because thereare no customized, privatespaces built into the module, itcan be used by any specialtyneeding space. With this caremodel, utilization of the examrooms has the potential toincrease to 10–12 half-day ses-sions per week, allowing the sys-tem to build fewer rooms anduse the space more efficiently.The central team space providesa collaborative work environ-ment for the multifaceted careteam supporting a provider withan increased patient population.The care team of case managers,dieticians, mental healthproviders, medical assistants,

and other care professionalsallows the provider to focus onthe medical tasks critical topatient health and wellness.

Interlocking factors in facility planning

In today’s health care environ-ment, decisions about relocatingor opening a satellite locationcannot be made based solely onthe availability of space at theright price. Physician practicesshould consider this type ofplanning as an opportunity tolower overall practice costs,adapt to new delivery models,align with a preferred health system partner and referralsources, and increase patientloyalty. If these factors are incor-porated into the planningprocess, the practice should bewell positioned for the changinghealth care landscape.

Nancy Doyle, AIA, is vice president ofdevelopment and programming; andJessica Anderson is director of physicianservices at Frauenshuh HealthCare RealEstate Solutions, Minneapolis.


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How do you feel today?”This seems like a goodquestion for a physician

to ask a patient during an exam,to better understand what is onthe patient’s mind and begin adialogue.

For architects and designershelping organizations createnew spaces, this question alsoseems like a good way to begina discussion when embarkingon a design project. Yet, ask aphysician, “How do you wantyour new facility to feel?”, andit’s not unusual to get a blank, if not irritated, stare.

“What do you do?” Again, it seems like a straightforwardquestion for a patient to answer.But the question “How wouldyou like to work?” is often aneye-opener for busy nurseswhen they begin to consider the variety of different thingsthey do, how their activitiesrank in importance, and howtheir activities shape their care teams.

Just as the patient typicallyis the best source of relevantinformation and perspective inconducting a meaningful physi-

cal exam and developing a heal-ing partnership, the input ofmedical staff is key in creatingsuccessful health-care facilityprojects. The institutionalknowledge, history, and exten-sive, hands-on experience thatmedical staff bring to the tableare invaluable in seeing thereality behind the vision fornew projects. And the interac-tive engagement and committedparticipation of medical staffhelp build a collaborative, cre-ative, and energized planningteam in the facility designprocess.

By engaging this groupearly in the design process andin a thoughtful manner, medicalorganizations can find an inspi-

rational vision, define a func-tional program, and shape aninnovative medical model thatguides a successful project.

Bringing necessary voices to the table

On paper, the idea for a new or remodeled medical facilityappears both visionary andgrand: to create a space thatbrings together the talent andtechnology that will make anorganization a provider ofchoice for patients who, moreand more, are shopping aroundfor health care services. Butbringing a visionary idea toreality involves much more than bricks and mortar. Whilematerials can put a face on theservices medical staff provide,the real heart of a new facility ishow it operates: the flow ofpatients, staff, and families; the flexibility of rooms to adaptto changing practices; durabil -ity; and the efficiency of thespaces.

Successful new facilities are those that architects anddesigners uncover through bothbusiness models and medicalmodels. That dual approach tofacility planning and designunderscores the need for repre-sentation from all levels of acare organization, especially the medical staff.

A project team that embod-ies effective leadership can galvanize an organization’sresources to begin painting avision that is comprehensiveand collective. A team that rep-resents both a cross-section ofstaff members and the demo-graphics of the organizationwill offer the diversity of viewsand ideas needed to develop aclear, inspiring vision that thewhole organization can rallyaround.

In developing a solid vision,project teams must be curiousand able to leave preconcep-tions at the door. Often,providers show up wantingnewer, bigger versions of whatthey currently have. Teamsshould be empowered to seizethe opportunity for innovationand change, and to re-imaginehow their organizations canserve their communities anddeliver care. By bringing toge -ther the multiple facets of anorganization—from direct careto marketing, radiology to envi-ronmental services, and includ-ing both new and seasonedemployees—planning teams cando more than react to currentconditions; they can paint a pic-ture that excites coworkers andthe community about the nextgeneration of care.

Accommodating needs, managing expectations

Bringing a new project to life isa complex and expensiveprocess. The steps in designinga project are complicated andrequire deliberate schedulingand purposeful staff inclusion,to ensure that those who areinvolved on the team have avoice. To that end, it’s importantthat meetings be scheduled attimes when medical staff canattend; that a schedule be estab-lished for meetings; and thatmeetings be organized so thatstaff who are attending knowwhat to expect and come pre-pared to participate.

The aim is to create a satis-fying experience for partici-pants—one that can uncovernew and unexpected ideas bywelcoming fruitful discussionsto help the team clarify thegoals of the project and set pri-orities. Encouraging open dia-logue and clearly defining proj-ect scope, budget, and parame-ters early in the process allowthe discussions to be immersiveand focused. This approach isintended to elicit the most use-ful input on the issues that aredriving the project and to avoidthe detours that can sidetrackteams and frustrate members.Issues like improving patientprivacy and staff safety or creat-ing more efficient spaces canthen drive the discussions about

Building a chorus of voices

Involving medical staff in the facility planning and design process

By Don Thomas, CID, and Scott Holmes, AIA, ACHA, LEED AP


how to design a new spacerather than where certainrooms may be placed or howlarge the rooms will be—discus-sions that are usually influ-enced by singular voices or per-ceptions about traditional caredelivery.

Health care professionalswhose day-to-day duties tendtoward the more analytic andlinear often find that participat-ing in the design of a facilitycan be both exhilarating andintimidating. The creativityrequired in the design of a newfacility can unleash insights andreasoning not always accessedin the routines of care delivery.However, discussions of details,such as materials and finishes,can disengage providers whoseinterest in such matters is notat the level of others on the careteam who will be using thespace on a daily basis. Under -standing the team members’differing levels of interests andwhen to excuse them from cer-tain discussions will help createa satisfying experience for allteam members.

A measured and deliberate process

While there can be many stepsto a new or remodeled space,creating a clear and inspiringvision at the start of the processwill keep teams engaged andfocused. A solid vision will drivethe project team’s discussionsand help establish the guidingprinciples for developing effec-tive spaces. These guiding prin-ciples then act as a bit of apromise statement, remindingteam members why the organi-zation is pursuing new orremodeled spaces. For this rea-son, the principles exist on ahigh level: “The hospital willput patients at the center of thecare experience.” “The hospitalwill enhance staff and the carethey provide.” “The hospital willcreate a destination for healthy

lifestyles.” With these principles in

place, medical staff and theircoworkers can begin to executea future-oriented, functionalspace program—taking a broadview to respond to the question,“How would you like to bepracticing medicine tomor-row?” In planning a new facil -ity, the medical staff can explorechanging care models and beginto anticipate the steps needed toexecute those models, such asmedications stocked at the bed-side or shifting waiting periodsin emergency departments fromwaiting rooms to patient rooms.Building flexibility into thedetails—for example, designingnurse servers to accommodatebedside medications in thefuture—then allows organiza-tions to adopt new models in a

more efficacious manner. For the designers, this part

of the planning process requiresan understanding of the organi-zation’s history and facilitydata—information that teamscan provide, identifying theirstrengths and opportunities forchange. Questions that design-ers might ask: What is the staffdoing now that works? Howdoes the staff want to operate in the future? How will themarket forces, shifting demo-graphics, and policy changesshape the way staff is deliveringcare?

In this era of rapid changein health care, it’s difficult to predict the future with cer-tainty. But raising these types of questions with staff will helpthe design team formulate afunctional space program identi-fying the types and size ofspaces, as well as departmentaladjacencies and patient and staffflow for the care environmentthat will allow staff to transitionsuccessfully through changes(whether predicted or unexpect-ed). And when medical staff are


VOICES to page 36

Medical staff play a strategic role as advocates for and practitioners of

patient-focused care. They are essential partners helping design these

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involved in the design and plan-ning process, staff outside of thedesign group are more receptiveto the changes, because thosechanges have evolved from theircolleagues’ deliberations andrecommendations.

The next stage in facilityplanning and design shifts thediscussions from what kind ofservices staff envision for thefuture to how the new facilitycan support those services. Thegoal during this stage is to dis-cover options that staff canevaluate and then collectivelydecide what best fits the needsof the departments and theorganization. Mock-ups andsimulation rooms can helpmedical staff evaluate roomconfigurations, such as inboardversus outboard bathrooms,location of charting areas, andfamily zones in rooms.

Finally, the team can put afeel and image to the spacesand align with an organization’sbrand by offering design ideasfor aesthetics and feel. The deci-sions made during this part ofthe planning process carry sig-

nificant weight, as they willhave a direct impact on theorganization’s perceived reputa-tion and the workplace culture.Working together with an inte-rior designer who specializes inhealth care interiors, teams canexplore materials, finishes, andsense of light that will affect thefeel of the space.

Creating ownership

When an organization opens anew facility, it’s never the end of the journey, but only the start down a new path. And the staff’s impressions of theprocess leading up to the open-ing can directly affect how theyperceive the functionality andusability of the new space.

As architects and designersfacilitate the process shaping

the new spaces that willenhance an organization’s busi-ness and care models, physi-cians and medical staff are inte-gral to process. Creating aninspirational vision, providingthe definition for functionalspace programming, innovatingand shaping new medical mod-els—the opinions and insightsthat the medical staff contributeto these critical pieces improvethe process of implementing theideas. Coming to consensus onoptions rather than adopting aprescribed design allows staff totake greater ownership andexperience a higher degree ofsuccess with the final designsolutions.

Medical staff play a strate-gic role as advocates for andpractitioners of patient-focused

care. They are essential partnershelping design these complex,high-stakes facilities. Whenengaged early in the designprocess, they also becomeambassadors for the enhance-ments that new projects willbring to an organization andthe community.

New projects have far-reaching effects on the day-to-day duties of medical staff.They go to the heart of staff sat-isfaction, which drives patientsatisfaction. Asking staff howthey want to feel and work intheir new space is more than apleasantry—it’s an indispensa-ble part of the process thatexplores and discovers the mod-els of care that staff envisionand intend to deliver for yearsto come.

Don Thomas, CID, is a certified interiordesigner and principal, and ScottHolmes, AIA, ACHA, LEED AP, is asenior medical planner at BWBR, a St. Paul-based design solutions firm withpractices in architecture, interior design,and master and strategic planning.Holmes is also a member of the AmericanCollege of Healthcare Architects.


Voices from page 35 The real heart of a new facility is how itoperates: the flow of patients, staff,

and families; the flexibility of rooms toadapt to changing practices; durability;

and the efficiency of the spaces.

Please contact or fax CV to:

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

763-504-6600 Fax 763-504-6622

www.NWFPC.com

Join the top ranked clinic

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

• Family Practice

• Urgent Care

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

Urgent Care

We have part-time and on-call positions available at a variety of Twin Cities’ metro area HealthPartners Clinics. We will be opening a new Urgent Care clinic in Hugo, MN in the spring of 2013! Evening and weekend shifts are currently available. We are seeking BC/BE full-range family medicine and internal medicine pediatric (Med-Peds) physicians. We offer a competitive salary and paid malpractice.

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

hea l thpa r tne r s . com


Emergency MedicinePhysician

BC/BE Family Medicine or BC/BEEmergency Medicine Physician to work exclusively in our ED.10 patients average per 24 hrs. 24 hr. shifts-Full Time or Part Time. GRHS is a progressive 19 bedCritical Access Hospital with two clinics. Glenwood is a family oriented community with an excellentschool system. Recreational opportunities include boating, hiking, excellent fishing and hunting. We are halfway betweenFargo and the Twin Cities.

For more informationCall Kirk Stensrud, CEO320.634.4521

Mail CV to:Kirk Stensrud, CEO 10 Fourth Ave SEGlenwood, MN 56334

Submit CV [email protected]

www.glacialridge.org

Fairview Health ServicesOpportunities to fit your life

Fairview Health Services seeks physicians to improve the health of the communities we serve. We have a variety of opportunities that allow you to focus on innovative and quality care. Shape your practice to fit your life as a part of our nationally recognized, patient-centered, evidence-based care team.Whether your focus is work-life balance or participating in clinical quality initiatives, we have an opportunity that is right for you:

Dermatology

e

fairview.org/physicians

[email protected], no J1 opportunities.

fairview.org/physicians

Applicants can apply online atwww.USAJOBS.gov

Sioux Falls VA Health Care SystemWorking with and for America’s Veterans is a privilege

and we pride ourselves on the quality of care we

provide. In return for your commitment to quality

health care for our nation’s Veterans, the VA offers an

incomparable benefits package.

The VAHCS is currently recruiting for the following

healthcare positions in the following location.

Sioux Falls VA HCS, SD

Sioux Falls VA HCS(605) 333-6858

www.siouxfalls.va.gov

Chief of Primary &

Specialty Medicine

Psychiatrist

Hospitalist

Neurologist

Endocrinology

Emergency Medicine

Primary Care (Internal

Medicine or Family Practice)

Pulmonologist

AIRFORCE.COM/HEALTHCARE

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

ment might be a great place tostart asking questions aboutrecycling. You may be pleasantlysurprised by what they say. Oryou may find an issue ripe foradvocacy.

Advocacy for energy and climate

You can hear your mother orgrandmother saying it: “Last oneout, turn out the light.” Rarelydo we hear this in our work-places. Perhaps we’re just toobusy to bother with shutting offlights. Besides, the argumentgoes, why would turning offlights matter, with all the com-puters blazing, the medicalequipment humming, and theHVAC system cranking out acomfortable 72 degrees?

Actually, it can and doesmatter. According to the U.S.Department of Energy estimatein 2012, a typical hospital con-sumes about 60,152 million Btuof energy annually. In compari-son, a typical office buildingconsumes 1,376 million Btu ofenergy annually. It’s logical that

hospitals demands greater en ergy use, but this researchsuggests that hospitals use 40times more energy than neigh-boring office buildings. The U.S.Energy Information Administra-tion tells us that it isn’t biomed-ical equipment, heating, or airconditioning that uses the singlemost energy units; lightingaccounts for fully one-third ofthe energy used in health care.Yes, your grandmother wasright, after all.

Physician advocacy oppor-tunity #3: Shut off the lights.

Ask your hospital or clinicadministrator to create a policyfor all staff to observe: “Last oneout, turn off the light.” Insistthat this policy cover conferencerooms, break rooms, supplyrooms, and empty exam rooms.Make a note when this conversa-tion occurs and invite the build-ing department to participate.They can watch for any reduc-tions in the utility bills, and staffcan be appropriately applaudedfor their efforts.

Physician advocacy oppor-tunity #4: Climate change.

From the operational perspec-tive, the health care industryaccounts for “nearly a tenth ofthe country’s carbon dioxideemissions,” according to theUniversity of Chicago (2009).From the health perspective, the World Health Organizationnotes “widespread consensusamong the scientific commun -ity” that the earth is not onlywarming, but that this is “mainly due to human activi-ties.” Climate change affectshuman health, “both throughdirect effects of extreme eventssuch as heat waves, floods andstorms, and more indirect influ-ences on the distribution andtransmission intensity of infec-tious diseases, and on the avail-ability of fresh water and food”(World Health Organization,Campbell-Lendrum andWoodruff, 2007).

Your advocacy opportunityhere is to research and under-stand (if you don’t already) thelinks between climate changeand human health, and to useyour professional standing to

Being green from page 38


BEING GREEN to page 40

“Green” health-care advocacy organizations

• Practice Greenhealth (PGH) is a membership-based, non-profit organization focused on changing the way health careoperates: www.practicegreenhealth.org

• Health Care Without Harm (HCWH) is an internationaladvocacy group that works toward specific goals for healthcare environmental reform: www.noharm.org

• Healthier Hospitals Initiative (HHI) provides free guides toimprove health care sustainability in six key areas: engagedleadership, healthier foods, leaner energy, less waste, saferchemicals, and smarter purchasing:www.healthierhospitals.org

• Physicians for Social Responsibility (PSR) is a national organization that works to slow global warming and toxicdegradation of the environment through education, researchanalysis, and policy initiatives: www.psr.org

Shar GrigsbyHealth Center - East

20 Burdick Expressway Minot ND 58702

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

Email: [email protected]

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

www.trinityhealth.org

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

Ambulatory Internal MedicineGeneral Surgery

PsychiatryUrology

Trinity Health One of the region’s premier healthcare providers.

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

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

Currently Seeking BC/BE

Contact us for a complete list of openings.


Emergency Medicine

Hibbing

Little Falls Park Rapids Alexandria Austin

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

Your Emergency Practice Partner

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

www.olmstedmedicalcenter.org

Olmsted Medical Center, a 150-clinician multi-specialty

clinic with 10 outlying branch clinics and a 61 bed

hospital, continues to experience significant growth.

Olmsted Medical Center provides an excellent

opportunity to practice quality medicine in a family oriented

atmosphere.

The Rochester community provides numerous cultural,

educational, and recreational opportunities.

Olmsted Medical Center offers a competitive salary

and comprehensivebenefit package.

EOE

Opportunities available in the following specialties:

DermatologySoutheast Clinic

Family MedicineCannon Falls Clinic

and Pine Island Clinic

HospitalistRochester Hospital

Internal MedicineSoutheast Clinic

Send CV to:Olmsted Medical Center

Administration/Clinician Recruitment102 Elton Hills Drive NW

Rochester, MN 55901email: [email protected]

Phone: 507.529.6748Fax: 507.529.6622

www.altru.org

• Dedicated Team Approach

• Competitive Salary & Benefits

• EPIC Healthcare Information System

Idylic Practice Opportunitieslocated in family friendly

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

FAMILY PRACTICE w/OB

Warroad, MNRoseau, MN

Crookston, MN

Contact:Kerri Hjelmstad, Physician Recruiter

Altru Health SystemPO Box 6003

Grand Forks, ND 58201-6003

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

St. Paul Allergy & Asthma Clinic, P.A. is seeking a highly motivated, passionate

BC/BE Allergist to provide outstanding patientcare. The successful candidate will be

part of our independent, well-respected teamthat serves patients at 4 Twin Cities

east metro locations.

Physicians are offered a competitive salarywith incentives, 4 day work weeks, partnership

opportunity, excellent benefits and profit sharing plan with 401(K).

For more information, please visit our website at www.stpaulallergy.com;

contact Cindy Stadel at [email protected]

or 651-698-0386.

www.stpaulallergy.com

speak out to your institutionsand communities about thisurgent crisis facing our planet.

Advocacy for toxic chemical reform

Chemicals play an importantand beneficial role in healthcare. However, the health careindustry also must be mindful ofthe impacts of these chemicalsand reduce their use wheneverpossible.

Physician advocacy oppor-tunity #5: Smarter purchases.You can help diminish theimpact of chemicals on patientsby advocating for policies gearedtoward phasing out certainchemicals used in industry.According to Physicians forSocial Responsibility, the worstchemicals in health care includebisphenol A (BPA), mercury, per-fluorinated compounds (PFCs),phthalates, polybrominateddiphenylethers (PBDEs), and triclosan. Two leaders in healthcare sustainability, KaiserPermanente and Dignity Health,have implemented policies topurchase products that are free

of PVC/DEHP (common phtha-lates used in IV bags), formalde-hyde (found in carpeting andother building finishes), andhalogenated flame retardants(applied to many products suchas linen and baby blankets).

Physician advocacy oppor-tunity #6: Support reform of

the TSCA. Federal legislationenacted in 1976 as the ToxicSubstances Control Act (TSCA)was an attempt to regulatechemicals on the U.S. market.However, in 2009 the President’sCancer Panel, in reviewing thetopic of environmental factors incontributing to cases of cancer,noted that very few of the morethan 80,000 chemicals currentlyin use are fully tested for long-term health safety.

The nonprofit powerhouseHealthcare without Harm (viaSafer Chemicals HealthyFamilies, a coalition of 11 mil-lion individuals and businesses)has long been advocating forrevisions to TSCA. Recently, theSafe Chemicals Act of 2013 wasintroduced in the U.S. Senate by

Sens. Frank Lautenberg (D-NJ)and Kirsten Gillebrand (D-NY).This act, if passed, would givethe EPA greater oversight ofthese chemicals, allowing theEPA to take immediate action onthe worst chemicals, requiremanufacturers to demonstratechemical safety, and promotesafer alternatives through greenchemistry. The voice of thephysicians in our community iscritical in keeping chemicals

reform on the minds of federallawmakers.

Physicians can change the status quo

Embedding “green” concepts inhealth care by reducing wasteand resource consumption canmake a difference to you, yourpatients, your community, and,ultimately, the environment as awhole. In the health care indus-try, no one has greater power tochange the status quo than you,the physician. In addition to thesix advocacy opportunities dis-cussed in this article, the sidebaron page 38 lists other resourcesfor becoming involved in theseefforts.

Crystal Saric Fashant, MPNA, is sus-tainability program manager at FairviewHealth Services in Minneapolis. She hasworked in hospital operations for 10 yearsand currently manages aggressive systemgoals to reduce Fairview’s environmentalimpact. She also is on the community fac-ulty at Metropolitan State University,teaching Topics in Sustainability to gradu-ate students.

Being green from page 38


Here to care

At Allina Health, we’re here to care, guide, inspire and comfort the millions of patients we see each year at our 90+ clinics, 11 hospitals and through a wide variety of specialty care services throughout Minnesota and western Wisconsin. We care for our employees by providing rewarding work, flexible schedules and competitive benefits in an environment where passionate people thrive and excel.

Make a difference. Join our award-winning team.Madalyn Dosch, Physician Recruitment ServicesToll-free: 1-800-248-4921 Fax: 612-262-4163 [email protected] allinahealth.org/careersEOE/AA10127 0213 ©2013 ALLINA HEALTH SYSTEM ® A TRADEMARK OF ALLINA HEALTH SYSTEM

Lighting accounts forfully one-third of the energy used in

health care.

Connecting your business to your market

Connecting your business to your market

By Robert Sweet, MD“I have prostate cancer

… and I want a robotic

prostatectomy.” This is

a common presenting“chief complaint” heard

nowadays in urologists’

offices across the state

and across the country

If you perform robotic prostatectomy, it

can be a plus in marketing your practice.

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

patient that robotic prostatectomy isn’t all

it’s cracked up to be, or you refer him t

someone who does it. To date, removin

aid of a robap

figure, given the rela-tively recent adoption

of the robot for use in

clinical applications.The rapid growth in

this field promises to permanently alter

the way surgical proce-

dures—especially mini

mally invasive surgeries—are pe f

and taught. The cu

Volume XXI, No.7October 2007


B edside manner may be

viewed as a “soft” skill these

days, and advances in medi-

cine continue to heighten the

emphasis on clinical and technical

expertise. But as medicine shifts its

focus to become more patient cen-

tered, patient experience is fast gain-

ing ground as a key measure of qual-

ity. In 2004, for example, the U.S.

Medical Licensing Examination

added a national skills test on per-

sonal interaction and communica-

tion that medical students must pass

to be eligible for licensure. And this

year, the National Committee for

Quality Assurance (NCQA) added

“shared decision-making” as one of

seven measures to assess patient

experience. Shared decision-making invol

systematic interaction

to arrive at an ibased

Talk it out Shared decision-making improves

the patient experienceBy Marcus Thygeson, MD,

and Karen Kraemer, RN, CMC

Lending ahandRobotic surgery makes inroads into the

OR and beyond

ES:MPAug06 Cover 3P-ES 10/2/07 10:54 AM Page 1

Volume XXI, No.8November 2007


Bringing a newmedical deviceto marketThe challenges of picking a winnerBy Curt Miller

in Minnesota Physician

612-728-8600

Advertise


Orthopaedic Surgery

OpportunityLive in Beautiful

Minnesota Resort Community

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

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

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

AA/EOE - Not subject to H1B Caps

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

passionate and experienced SPINE SURGEON to provide

outstanding orthopaedic care to its patients. The successful candidate

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

serves patients from Duluth to northern Minnesota.

Orthopaedic Associates of Duluth is a group of nine orthopaedic

surgeons that provide comprehensive orthopaedic services ranging

from specialty specific exams and diagnosis to state-of-the-art in-

office MRI and imaging and surgery at their physician-owned surgery

center.

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

The perfect matchof career and lifestyle.

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

For additional information, please contact:

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

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

www.acmc.com

• ENT• Family Medicine• Geriatrician/Outpatient

Internal Medicine• Hospitalist• Infectious Disease

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

• Psychology• Pediatrics• Pulmonary/

Critical Care• Radiation Oncology• Rheumatology

Family Medicine

St. Cloud/Sartell, MN

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

BE family medicine physicians to join our primary care team in

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

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

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

GYN and pediatrics. Previous electronic medical record experience

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

record system at all of our clinics and admitting hospitals.

Our HealthPartners Central Minnesota Clinics – Sartell moved

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

competitive salary, an excellent benefi t package, a rewarding

practice and a commitment to providing exceptional patient-

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

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

community with a traditional appeal.

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

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

Use of other BP-loweringagents (e.g., beta-blockers, calc -ium-channel blockers, diuretics)and combinations are reviewedin detail in the KDIGO guide-lines. Most CKD patients requiremore than one BP-loweringagent to achieve optimal control.

In patients with progressiveCKD, PCPs should work withspecialists to manage theirpatients. The figure on page 26of the KDIGO guidelines pro-vides guidance for PCPs regard-ing when to refer patients withCKD to a nephrologist.

Patient case revisited

Additional information regard-ing Bob’s CKD stage and albu-minuria level would have beenuseful in determining his CKDprognosis and treatment plan.KDIGO guidelines provide moreevidence-based direction forphysicians in weighing benefitsand risks of ACE-I/ARB therapy.

A multidisciplinaryapproach to CKD managementis re commended. In addition tonephrology referral, many pa -tients would benefit from partic-

ipating in MTM services to iden-tify, resolve, and prevent drugtherapy problems common inCKD. With diagnostic informa-tion on CKD classification, phar-macists can assist patients andphysicians in mitigating risks ofadverse drug reactions by assur-ing proper, evidence-based drugselection, dosing, and ongoingmonitoring. An MTM pharma-cist can help by educatingpatients about their entire med-ication regimen and assessingadherence to therapy for out-come success. A team appr oachcan help patients with CKD livelonger, healthier lives.

Nathan T. Blake, PharmD, is an MTMpharmacist with Target Pharmacy at multi-ple Target locations throughout the TwinCities metro area. His patient-care practiceis providing evidence for the establishmentof an MTM model of care for Target.Wendy L. St. Peter, PharmD, a professor at the University of MinnesotaCollege of Pharmacy, conducts researchwith the U.S. Renal Data System(www.USRDS.org), located at HennepinCounty Medical Center, Minneapolis. Hercurrent research includes investigating thecomparative effectiveness of various blood-pressure medications in hemodialysis andperitoneal dialysis patients.


Kidney disease from page 19

TABLE 1. Glomerular filtration rate (GFR) categories in chronic kidney disease (CKD).

TABLE 2. Albuminuria categories in chronic kidney disease.

G1* ≥90 Normal or high

G2* 60–89 Mildly decreased†

G3a 45–59 Mildly to moderately decreased

G3b 30–44 Moderately to severely decreased

G4 15–29 Severely decreased

G5 <15 Kidney failure*In the absence of evidence of kidney damage, categories G1 and G2do not fulfill the criteria for CKD.

†Relative to young-adult level.Printed with permission. Copyright ©2012 by KDIGO. All rights reserved.

Category

Category

TermMeasurement, mL/min/1.73 m2

A1 <30 <30 Normal to mildly increased

A2 <30–300 <30–300 Moderately increased†

A3 >300 >300 Severely increased‡

ACR, albumin-to-creatinine ratio; AER, albumin excretion rate. *If albuminuria measurement is not available, urine reagent strip resultscan be substituted using albumin-to-creatinine ratio.

†Relative to young-adult level.‡Including nephrotic syndrome (albumin excretion usually>2200 mg/24 hours, ACR >2200 mg/g).Adapted and printed with permission. Copyright ©2012 by KDIGO. All rights reserved.

Measurement

AER (mg/24 hours)

ACR (approximate equivalent) mg/g* Term

continuing education

Education and research to improve the health of our community HealthPartnersInstitute.org

Fundamental Critical Care Support July 18-19, 2013

Simulation Facilitator Course August 20-22, 2013

Trauma Education: The Next Generation* * Formerly Emergency Medicine and Trauma Update: Beyond the Golden Hour September 5, 2013

Managing Life Limiting Illness and End of Life Care (two-day event) October 1 and October 3, 2013

Primary Care Update: Pathways to Knowledge October 10-11, 2013

Fundamental Critical Care Support October 24-25, 2013

Simulation Facilitator Course November 6-8, 2013

Pediatric Fundamental Critical Care Support November 14-15, 2013

35th Annual Cardiovascular Conference: Current Concepts and Advancements in Cardiovascular Disease December 12-13, 2013

“Let’s Keep this Confidential”Finally, you can text and email your peers with the highest level of hipAA security

required. that’s the power of NoticeMed. the only peer-to-peer messaging network exclusively for health professionals’ day-to-day patient care collaboration.

Designed by health pros, for health pros. Join us today at NoticeMed.com...and let’s keep this confidential.

learn more and sign up at www.noticemed.com

for more information, Call toll-free 855-884-5952

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

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

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

minnesota physician june 2013

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