Minnesota Physician June 2013 by Minnesota Physician Publishing

Volume XXVll, No. 3

June 2013

The Independent Medical Business Newspaper

Genetic research and cystic fibrosis Targeted drug development leads to improved treatment By Warren Regelmann, MD

It’s not easy being green

our waste invades landfills; hese days, we hear a lot Why should tion; our dependence on disposable about “greening,” as supplies is staggering. The irony health care communities, businesses, is, health care professionals recschools, and government organicare? ognize the essential truth that zations are swept up into an environmental health emerging eco-revolution. As a By Crystal Saric and patient health are society, we are realizing that if Fashant, MPNA interconnected. We we begin reducing our waste, understand that when lessening our energy consumpwe promote healthy environtion, and valuing product stewardship, we ments—what we breathe, what can enjoy an improved natural environwe eat, what we expose our bodment. But what does “green” have to do ies to—we will promote healthy with health care specifically? Read on. communities. And healthy comThe truth is that health care, as an munities are what we “do” in industry, takes an enormous toll on the health care. environment. Our energy creates air pollu-

n January 2012, treatment of inherited diseases took a giant leap forward when the Food and Drug Administration approved Kalydeco (ivacaftor), a drug that improves the lives of people with cystic fibrosis (CF) by restoring function to one variant of the protein that causes CF. CF affects about 30,000 children and adults in the United States and is the most common inherited life-limiting disease among Caucasians, but it occurs in most other races as well. Ivacaftor will very likely improve and prolong the lives of patients who have a rare mutation in their cystic fibrosis transmembrane conductance regulator (CFTR). For them, this drug represents a major SPECIAL FOCUS: advance. However, this new drug is exciting MEDICAL not only because it FACILITY offers CF patients an DESIGN improved quality of life Page 22 but also because it

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CONTENTS

JUNE 2013 Volume XXVII, No. 3

FEATURES It’s not easy being green Why should health care care?

MINNESOTA HEALTH CARE ROUNDTABLE

By Crystal Saric Fashant, MPNA

Genetic research and cystic fibrosis Targeted drug development leads to improved treatment

1 FORTIETH

SESSION

By Warren Regelmann, MD

Health care architecture honor roll

DEPARTMENTS CAPSULES

MEDICINE AND THE LAW HIPAA update 16

MEDICUS

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

INTERVIEW

8 PROFESSIONAL UPDATE: NEPHROLOGY Chronic kidney disease 18

Beverly Yashar, MS, PhD

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

American Board of Genetic Counseling

Advanced care planning Addressing end-of-life issues Thursday, October 24, 2013 1:00 – 4:00 PM • Symphony Ballroom Downtown Mpls. Hilton and Towers

SPECIAL FOCUS: MEDICAL FACILITY DESIGN Freestanding “urgency Moving? Growing? room” facilities 20 By Nancy Doyle, AIA, By Gary Gosewisch, MD

and Jessica Anderson

The doctor’s advocate By Louis Suarez, CCIM

Building a chorus of voices

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

Background and focus: For the majority, end-of-life is the most medically managed part of life. With it come complex issues that involve economics, ethics, politics, medical science, resources and more. Advances in technology are extending life expectancies and require a redefinition of the term “end-of-life.” It now entails a longer time frame than one’s final weeks or hours and debate as to when life is really over. Mechanisms exist to facilitate personal direction around this topic, but there is a need for improved coordination among the entities that provide end-of-life support.

Objectives: We will discuss the significant infrastructure that supports end-of-life care. We will examine the roles of long-term care/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 current state. 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: Ed Ratner, MD, University of Minnesota Center for BioEthics

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JUNE 2013 MINNESOTA PHYSICIAN

CAPSULES

HHS Releases Data On Hospital Charges The news that hospitals have widely varying costs for procedures may not be a shock to many in the health care industry, but a move by the federal government to publicize that range of costs recently generated headlines across the nation. On May 8, the U.S. Department of Health and Human Services (HHS) released cost data from hospitals across the country for the 100 most common Medicare inpatient stays. HHS Secretary Kathleen Sebelius says the data will help make the nation’s health care system more affordable and accountable. “Currently, consumers don’t know what a hospital is charging them or their insurance company for a given procedure, like a knee replacement, or how much of a price difference there is at different hospitals, even within the same city,” Secretary Sebelius said. “This data and new data centers will help fill that gap.”

The data show dramatic variation in what hospitals charge for services. From the Medicare data, charges for major lower joint replacement could range from $21,000 to $88,000, depending on the hospital. In Minnesota, charges also varied significantly. At the University of Minnesota Medical Center, Fairview, a major cardiovascular procedure would cost $65,886, according to HHS data. Less than a mile away, at Abbott Northwestern Hospital, a similar procedure would cost $88,877. Health care experts say hospitals factor in a wide range of expenses when pricing any one procedure, and that prices can be different from the listed Medicare charges due to discounts negotiated with health plans. One analysis of the HHS data shows that Minnesota hospitals have lower costs for many major procedures than the national average. The analysis, published in the Washington Post, looked at 10 common medical procedures for Medicare

patients and found that Minnesota’s average cost was lower than the national average in every instance.

Dayton Announces MNsure Board Gov. Mark Dayton has appointed seven Minnesotans to oversee MNsure, the state’s health insurance exchange. State officials say the board members were chosen from 112 candidates. Members will serve four-year terms, and with the exception of the DHS commissioner, are limited to two terms of service. “The individuals chosen to serve on this board represent a broad diversity of experience and expertise,” says Gov. Dayton. “Their collective breadth of knowledge, and each board member’s shared commitment to the successful development and delivery of this new health care marketplace, will serve the best interests of all Minnesotans.” Board members include: Thompson Aderinkomi, founder and CEO, RetraceHealth, a

health-data analytics firm; Pete Benner, a consultant on health care, labor relations, and public policy; Brian Beutner, CEO of mPay Gateway, a health-care software company, and a former general counsel of UnitedHealthcare; Kathryn Duevel, a retired ob-gyn physician from Willmar; Tom Forsythe, vice president of global communications at General Mills; Lucinda Jesson, Commissioner of the Minnesota Department of Human Services; and Phil Norrgard, director of human services, Fond du Lac Reservation.

Blue Cross Delays New Payment System Blue Cross and Blue Shield of Minnesota has agreed to delay implementation of a new payment system for rural hospitals. The new system, which Blue Cross had been rolling out in different parts of the state this spring, caused the Minnesota Hospital Association (MHA) to publicly call for the Bloomington-based insurer to slow down implementation of the change.

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MHA officials said rural hospitals had complained they could not comply with the changes in time, and some were at risk to lose their contracts with Blue Cross. The issue raised enough outcry that Minnesota Attorney General Lori Swanson and Minnesota Health Commissioner Ed Ehlinger, MD, met with Blue Cross officials to discuss the matter. State officials seemed particularly concerned about how the new system would affect critical access hospitals, which are small, rural hospitals that serve outstate areas. After discussion with state officials, Blue Cross announced it was delaying the changes. Blue Cross released a statement on May 1, saying that it was moving the implementation date for the new payment system to Jan. 1, 2014. The statement added that Blue Cross values critical access hospitals and that it would work with them to implement the new system, including sharing costs of software needed for new reimbursement models. On May 1, MHA officials welcomed the announcement that Blue Cross had moved back the implementation date, saying the hospital association agrees that payment models need to change. “A delay provides a window of opportunity for Blue Cross and hospitals to work through the issues before attempting to implement payment changes that could have jeopardized access to care in some communities,” the statement said. “MHA appreciates that Blue Cross has heard the concerns of our members and that it is willing to respond to those concerns.”

MMA Considers Changes to Governance Structure The Minnesota Medical Association (MMA) is considering changes to its governance structure. On May 4, the MMA board of trustees voted to submit a resolution to the group’s House of Delegates at its annual

meeting in September that would replace the House of Delegates with a policy council. MMA officials say if passed, the changes would mean the group’s annual meetings would continue but policy would be determined by the council, which would meet at least twice a year. The policy council membership would be appointed by medical societies that are part of the MMA, and the council would gather member input throughout the year at listening sessions and policy forums. The board of trustees is also in the process of downsizing itself. Working from recommendations of an MMA leadership committee, the board will be reduced by five positions this year. At the MMA’s annual meeting in 2012, the house of delegates voted to reduce the board’s size from 32 trustees to 12–14 members over a three-year period. The reduction of five positions would be the first step in that process. MMA leaders say a 32-member board has proven to be unwieldy and inefficient. According to David Thorson, MD, chair of the MMA’s board of trustees, the House of Delegates has seen a decline in participation and there are concerns that it does not represent a true cross-section of Minnesota physicians. “We’ve noticed a dwindling attendance and it was not tending to bring in new people,” Thorson says. “It was not a very diverse population, ethnically, racially, or age-wise.” The physicians’ association has already held some preliminary policy forums, and Thorson says the results are encouraging. He notes that at the three forums held so far, more than half of physician participants had never attended an MMA House of Delegates meeting. “We’re getting people involved who have never been involved before,” Thorson says. “That’s exciting to me, to see newer people, younger people coming in.”

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CAPSULES to page 6

JUNE 2013

MINNESOTA PHYSICIAN

CAPSULES Capsules from page 5

U of M, Fairview Plan Management Systems Integration The University of Minnesota and Fairview Health Services have agreed to a new management structure and increased funding for U of M health services, education, and research. The announcement, which was approved by the U of M board of regents on May 10, came approximately one month after Fairview and the university publicly revealed merger talks with South Dakota-based Sanford Health. However, that proposal quickly fell apart, and officials with the University and Fairview noted that the two organizations have been negotiating this deal for some time. Under the agreement, Fairview will provide $90 million to the U of M over the next 10 years, which the university will invest in academic medical services, research, and education. If certain performance goals are met, the amount of

funding Fairview provides the university could increase. The new agreement is not a merger or acquisition, officials with the two organizations say, but rather, an integration of management systems that will allow Fairview and the U of M to coordinate patient care and plan for future changes in health care education and delivery. Officials say that Fairview and the University will now have a joint management structure, with a new board over the integrated system, which will replace boards at the university’s medical center and at U of M’s Amplatz Children’s Hospital. “We envision this as a way of breaking down silos that exist between the organizations,” says Bobbi Daniels, CEO of University of Minnesota Physicians (UMPhysicians). “Integration of inpatient and outpatient services is a national trend. Because so many of our patients are so complex, that coordination is even more critical.” Daniels and Carolyn Wilson, president of the University of Minnesota Medical Center,

Fairview, will lead the new, integrated system. They will oversee a system that has 700,000 patient clinic visits and 35,000 hospital admissions each year. The combined organizations employ 7,500 staff and 800 physicians with UMPhysicians. The integrated structure will bring in an estimated $1.9 billion in revenues annually.

CMS Announces Funds for Medical Assistance Expansion The Centers for Medicare & Medicaid Services (CMS) has told Minnesota officials that the state could get an additional $13 to $14 million annually as part of expanding public health insurance programs under the Affordable Care Act. Officials with the Minnesota Department of Human Services (DHS) say CMS has announced that the federal match for services associated with new Medical Assistance enrollment will increase from 50 percent to 75 percent.

The enhanced match will be available starting in October 2013. DHS recently sent out materials to county human services directors in Minnesota to inform them how the increased funding will affect counties. The funding will help counties handle the increased number of public program enrollees, funding services such as intake, determination of eligibility, case maintenance, computer support, and customer service. “Thanks to the Affordable Care Act, more than 200,000 more Minnesotans will receive health care through our public programs,” says DHS Commissioner Lucinda Jesson. “Counties will be an important partner in helping those Minnesotans get coverage. We would like to thank the U.S. Health and Human Services Department for providing the counties with the resources they need to make health care available to more people.”

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MEDICUS Patrick J. Flynn, MD, received the David King Community Clinical Scientist Award at the 39th national meeting of the Association of Community Cancer Centers in Washington, D.C. Flynn is a medical oncologist and medical director for the Cancer Research Program at Minnesota Oncology, where he has practiced since 1985. Award winners are physicians who have demonstrated leadership in the developPatrick J. Flynn, MD 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 for many Metro-Minnesota Community Clinical Oncology Program and National Cancer Institute clinical trials. Donald Hughes, MD, a family physician practicing at Riverwood Healthcare Center, Aitkin, has received the 2013 Family Physician of the Year Award from the Minnesota Academy of Family Physicians. In addition to his Donald Hughes, MD practice, Hughes works with the Rural Physician Associate Program each year, travels to Duluth monthly to teach in the Family Practice Residency Program, and is very active in the community, providing medical services at local sporting events and helping to educate athletes and parents about health. Robert Lavey, MD, MPH, has joined the staff of HealthEast as medical director of radiation oncology. Lavey earned his medical degree from Stanford University and his MPH from University of California, Berkeley; he completed his radiation oncology residency at Duke University and his fellowship at Stanford University. Prior to joining HealthEast, Lavey was a professor of oncology at the University of South Robert Lavey, MD, MPH Florida. He specializes in stereotactic radiosurgery; 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 in 2001, 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 the Department of Laboratory Medicine and Pathology at the University of Minnesota and a researcher in the Carcinogenesis and Chemoprevention Program at the university’s Masonic Cancer Center, has been named an American Association for Cancer Research Academy FelLee Wattenberg, MD low. The Academy honors distinguished scientists whose scientific contributions have resulted in significant innovation and progress in the fight against cancer. Wattenberg is considered the ‘father of chemoprevention,’ having pioneered that field by identifying the protective effects of vitamins A, C, and E and chemicals found in certain vegetables. He continues research to identify agents that can prevent carcinogen-induced lung cancer. Mark Werner, MD 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 integration officer for Fairview Health Services.

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MINNESOTA PHYSICIAN

INTERVIEW

Cracking the code ■ Genetic counseling is a relatively new field;

what can you tell us about its history?

Beverly Yashar, MS, PhD American Board of Genetic Counseling Beverly Yashar, MS, PhD, is president of the American Board of Genetic Counseling (ABGC) and program director for the University of Michigan’s Genetic Counseling Program. Yashar obtained her PhD in genetics from the University of North Carolina–Chapel Hill and her MS in genetic counseling from the University of Michigan. She has worked in a wide variety of genetics settings, including basic research labs, clinical genetics clinics, and a family studies core. ABGC is the national credentialing body for genetic counselors. There are currently more than 3,000 ABGC-accredited genetic counselors in the United States.

genetic counseling—you would then be referred to pediatric genetics. Then we move into adult-onset diseases. I think the one that people think of easily is Huntington’s disease, but that’s certainly rarer than cardiomyopathies or hereditary cardiomyopathies or hereditary neuromuscular conditions. People who have early-onset cancers or high-recurrence cancers or multiple occurrences, for example breast cancer, those individuals also would come and see a genetic counselor.

Genetic counseling was first formally established as a profession back in 1969. What occurred on that date was the founding of the first genetic counseling program, which was at Sarah Lawrence College in New York City. Discussions about genetic counseling go back to the 1940s. There were three clinical centers in the U.S. that are considered to be the start of genetic medicine. They were here at the University of Michigan in Ann Arbor, Wake Forest in North Carolina, and ■ What are some of the recent scientific advances then at the University of Minnesota, but the forin your field? malization of genetic counseling as a profession We have been identifying genes for syndromes or really occurred in New York in the late 1970s. diagnoses that we didn’t have before rapidly, Technology emerged that allowed us to screen almost on a monthly basis. And we’re developing for genetic disorders so that we could provide a the ability to think about platform from which individugenetic risk for common disals and families could begin to Now we’re thinking eases—like diabetes or cardiothink about their risk for a conabout genetic testing vascular disease, and we rapdition—both for themselves idly will start to see the ability personally and for children that of the healthy. to offer susceptibility testing they may be either carrying for a host of common diseases. during a pregnancy or might be Historically, genetics and genetic counseling contemplating in the future. have been driven by clinical presentation or phenoThat growth arose from collaboration among type before doing genetic testing. We’re moving physicians in the New York area and social workinto an era where people are starting to look at ers and genetic specialists who were working with genetic testing or genotyping first and then looking those physicians. They recognized the need for the to see what could be the clinical issues that could development of this niche; genetic counseling. arise out of that. I think a lot of the discussion at that time was That’s a new paradigm for us. We’re struggling the realization that there was a need for a peer prowith it. It changes the equation a little bit about fessional who would have the genetic expertise and genetic counseling. It means that now we’re thinkwould be able to have conversations on how to ing about genetic testing of the healthy. translate genetics information into language that makes sense for individuals and their families, so ■ Talk a little about biomedical ethics issues raised that they could then make very specific decisions. by the field of genetic counseling. The American Board of Genetics Counseling For us there are always issues around the idea of was then incorporated in 1993 and the mission of who gets the information from a genetic test result. the board is the certification and recertification of Certainly, it’s critical for your patient to get that genetic counselors. information, but the nature of genetics is such that We want everybody to be clear about the the laws of inheritance mean multiple people could genetic service they’re receiving. Given the comhave that same genetic change. Thinking about plexity of the knowledge, it needs to be provided how you move beyond your patient to the family of by experts in the field. the patient is certainly one of our large challenges. ■ What are some of the reasons a person would When we sequence the whole genome, we have see a genetic counselor? information on genes that could be relevant to a person’s health five, 10, 20, and 30 years down the If we start from the beginning, prenatal counseling pike, and thinking about who gets that information certainly is where genetic counseling started as and when they get it has been quite challenging. a profession. A couple might be referred to genetic If we have an adult who might come into a counseling because of concerns about the pregcancer clinic for very specific testing, because of nancy. the new technology we’re moving away from testWe know that certain conditions are more ing single genes to testing panels of genes—or it common in individuals of different ethnicities, so could be cheaper just to do the whole exome. they may be referred to genetic counseling to have Let’s say we then discover there is a genetic a discussion about those risks. change that leads to a condition that has nothing We then move forward to pediatrics. If a child to do with the reason they were referred, let’s say is born with multiple congenital anomalies or is later found to have developmental delay, if multiple Huntington’s disease. Should we share that information, even if it wasn’t relevant to the clinical systems were involved—certainly autism has question that led them into our clinic? started to move into a discussion of genetics and

MINNESOTA PHYSICIAN JUNE 2013

I think we can get our heads around that relatively easily in an adult population. But now let’s push it back and think about prenatal testing or pediatric testing. Our current guidelines recommend that genetic testing in a pediatric population for a condition in which the age of onset would be as an adult should be deferred until that child has the opportunity to decide whether or not they want that information. Who would keep that information? There’s a tension, as you might imagine, within the field about what we should share and who to share it with. For a parent to know, “Oh, I’ve got a child who has a high risk of breast cancer when they’re in their 30s or 40s,”—is that appropriate? That is certainly one of the major issues right now. ■ What are some of the challenges with

direct-to-consumer (DTC) testing? The problem with DTC is that it’s not regulated nor is any genetic testing well regulated. You have to be really clear what type of technology a company is using, how good the coverage is, how much of an effort they make to ensure that people who are participating in the DTC really understand what they’re getting into. Even if we carry things that can be associated with disease, not everybody who has a mutation is going to develop that disease. Now think about moving that into a DTC

2013 CME Activities

One of the major issues is that the development of genetic medicine and genetic counseling is very tightly tied to technology, and countries that don’t have the resources are going to have a very different look at genetic counseling.

format where there’s nobody who’s educating and then interpreting. They’re going to sequence 25,000+ genes. They’re definitely going to find that you’re a carrier for something. Patients get this information and they have no idea what it means. DTC is an incredibly powerful idea, but it needs to be in a format where appropriate education, counseling, and informed consent are obtained before testing is initiated and then appropriate education, counseling, and support are provided once the test results come back.

■ What does the future of genetic

counseling hold?

■ Genetic counseling is an international

field—how do approaches to these ethical issues differ globally? That’s a very good question. I am the coeditor of an upcoming edition of the Journal of Genetic Counseling, looking at genetic counseling beyond the Americas. Certainly in Australasia, there is a very large and very active genetics and genetic counseling community. Europe certainly has a large community. How genetic counseling looks in those communities is not drastically different 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 practitioners were trained in the U.S. follow a model that may be closer to a U.S.-based model.

I think the future holds expansion into basically all areas of medicine. That’s the power of being able to map our genome and then utilize that information, not just in a reactive way, but a preventive way. We’re already starting to see genetic counseling as part of cardiology, neurology, ophthalmology, ENT, you name it. As we think about the genetic basis of common complex disease, we’re going to see more and more genetic counselors in that area, and they’re going to be working not just in the traditional roles of being in front of a patient; that’s still going to be critical, but certainly also serving as consultants to physicians, to groups of physicians. As always, we’re looking for where the next new discoveries are coming from the bench—what’s going to be discovered in terms of new ways of genetic testing, new ways of explaining genetic disease. As those come out, we’re very savvy and quite nimble at following new developments and new discoveries.

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

(All courses in the Twin Cities unless noted)

SEPTEMBER – NOVEMBER Lillehei Symposium: Cardiovascular Care for Primary Care Practitioners September 5-6, 2013 Care Across the Continuum: A Trauma & Critical Care Conference September 27, 2013 NPHTI/Pediatric Clinical Hypnosis October 3-5, 2013 Twin Cities Sports Medicine October 4-5, 2013 Maintenance of Certiﬁcation in Anesthesiology (MOCA) Training October 5, 2013

Psychiatry Review October 7-8, 2013 Got Your Shots? 2013 Immunization Conference October 10-11, 2013 Transplant Immunosuppression 2013 October 16-19, 2013 Practical Dermatology October 25-26, 2013 Donald Gleason Conference on Prostate & Urologic Cancers October 25, 2013 Pediatric Trauma Summit November 1-2, 2013

ONLINE COURSES (CME credit available) www.cme.umn.edu/online U Fetal Alcohol Spectrum Disorders (FASD) - Early Identiﬁcation & Intervention U Global Health - 7 Modules to include Travel Medicine, Refugee & Immigrant Health

Internal Medicine Review & Update November 13-15, 2013 Emerging Infections in Clinical Practice & Public Health: New Developments November 22, 2013

Ofﬁce of Continuing Medical Education 612-626-7600 or 1-800-776-8636 email: cme@umn.edu

Promoting a lifetime of outstanding professional practice JUNE 2013

MINNESOTA PHYSICIAN

Being green from cover We might say that the health care industry has an obligation to be more concerned about— and to serve as a model for— responsible environmental management. Many health care organizations have stepped up to the plate. In 2010, Infection Control Today reported that 54 percent of the 5,000+ hospitals in the United States have “green teams,” and that number is growing. But let’s be careful and not sugarcoat this: Health care has a long way to go in its efforts to be environmentally sustainable. As a physician, how can you help? Physicians exert sizable influence within the workplace, and this can go a long way in encouraging a culture of sustainability within health care. This doesn’t necessarily mean you bring granola in your lunch box, wear hemp sweaters, and chain yourself to oak trees in the park. For the mainstream or even weekend environmentalist, this article suggests three topics for potential advocacy: waste reduc-

tion, energy and climate, and toxic chemical reform. Advocacy for waste reduction

According to the Environmental Protection Agency and the American Hospital Association, U.S. hospitals generate about 6,600 tons of waste each day. As much as 80 percent of this is nonhazardous solid waste, offering clinics and hospitals many opportunities for waste reduction. Just stop and think for a moment about how many consumables are used in a clinic or hospital. Questioning the status quo is the best way a physician can

tion to what is being prepared for your procedures; if you don’t use it and don’t need it, please take a moment to tell someone to remove it. At just one hospital, we saved $104,658 and reduced annual waste by 7,792 pounds with tiny tweaks to the physician custom packs. Impact on patients? Zero. This line of thinking can bode well for other reductions, too, such as office paper. One physician recounted that her clinic was faxing her several printed, paper files each day, simply because that’s “how they’d always done it.” She requested electronic delivery and reduced her personal paper consumption dramatically. Physician advocacy opportunity #2: Recycling. Health care facilities toss cans, bottles, glass, newspaper, office paper, cardboard, and more—every day. Do you a have recycling program? Could it be more robust? Many organizations and businesses offer consultant services to aid you in these efforts. Your building management depart-

act on the issue of waste reduction. For example, in working with surgeons at the University of Minnesota Medical Center to reduce disposable items in surgical custom packs, we discovered that nurses were routinely throwing away clean, unused supplies such as plastic basins, gauze, and plastic tubing. When we asked surgeons about the necessity of these supplies, they frequently answered that they were simply unaware that those items were in the pack. Indeed, they had no objections whatsoever to removing them. Physician advocacy opportunity #1: Reduction. Pay atten-

Health care has a long way to go in its efforts to be environmentally sustainable.

BEING GREEN to page 38

You can. Gray Plant Mooty Health Law Group Where others see legal barriers, we see possibilities. Join us at our Health Law Conference on July 11. Visit gpmhealthlaw.com for more details.

MINNESOTA PHYSICIAN JUNE 2013

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*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.

Indications and Usage Victoza® (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 Information Liraglutide causes dose-dependent and treatment-durationdependent 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 Victoza® is a registered trademark of Novo Nordisk A/S. © 2013 Novo Nordisk All rights reserved.

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. 0113-00013301-1

JUNE 2013

May 2013

MINNESOTA PHYSICIAN

Victoza® (liraglutide [rDNA origin] injection) Rx Only BRIEF SUMMARY. Please consult package insert for full prescribing information. WARNING: RISK OF THYROID C-CELL TUMORS: Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice. It is unknown whether Victoza® causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as human relevance could not be ruled out by clinical or nonclinical studies. Victoza® is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Based on the findings in rodents, monitoring with serum calcitonin or thyroid ultrasound was performed during clinical trials, but this may have increased the number of unnecessary thyroid surgeries. It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate human risk of thyroid C-cell tumors. Patients should be counseled regarding the risk and symptoms of thyroid tumors [see Contraindications and Warnings and Precautions]. INDICATIONS AND USAGE: Victoza is indicated as an adjunct to diet and exercise to improve 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 pancreatitis. Victoza is not a substitute for insulin. Victoza should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis, as it would not be effective in these settings. The concurrent use of Victoza and prandial insulin has not been studied. CONTRAINDICATIONS: Do not use in patients with a personal or family history of medullary thyroid 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-dependent and treatment-duration-dependent thyroid C-cell tumors (adenomas and/or carcinomas) at clinically relevant exposures in both genders of rats and mice. Malignant thyroid C-cell carcinomas were detected in rats and mice. A statistically significant increase in cancer was observed in rats 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 liraglutideinduced 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 hyperplasia among Victoza®-treated patients and 2 cases in comparator-treated patients (1.3 vs. 1.0 cases per 1000 patient-years). One comparator-treated patient with MTC had pre-treatment serum calcitonin concentrations >1000 ng/L suggesting pre-existing disease. All of these cases were diagnosed after thyroidectomy, which was prompted by abnormal results on routine, protocol-specified measurements of serum calcitonin. Five of the six Victoza®-treated patients had elevated calcitonin concentrations at baseline and throughout the trial. One Victoza® and one non-Victoza®-treated patient developed elevated calcitonin concentrations while on treatment. Calcitonin, a biological marker of MTC, was measured throughout the clinical development program. The serum calcitonin assay used in the Victoza® clinical trials had a lower limit of quantification (LLOQ) of 0.7 ng/L and the upper limit of the reference range was 5.0 ng/L for women and 8.4 ng/L for men. At Weeks 26 and 52 in the clinical trials, adjusted mean serum calcitonin concentrations were higher in Victoza®-treated patients compared to placebo-treated patients but not compared to patients receiving active comparator. At these timepoints, the adjusted mean serum calcitonin values (~1.0 ng/L) were just above the LLOQ with between-group differences in adjusted mean serum calcitonin values of approximately 0.1 ng/L or less. Among patients with pre-treatment serum calcitonin below the upper limit of the reference range, shifts to above the upper limit of the reference range which persisted in subsequent measurements occurred most frequently among patients treated with Victoza® 1.8 mg/day. In trials with on-treatment serum calcitonin measurements out to 5-6 months, 1.9% of patients treated with Victoza® 1.8 mg/day developed new and persistent calcitonin elevations above the upper limit of the reference range compared to 0.8-1.1% of patients treated with control medication or the 0.6 and 1.2 mg doses of Victoza®. In trials with on-treatment serum calcitonin measurements out to 12 months, 1.3% of patients treated with Victoza® 1.8 mg/day had new and persistent elevations of calcitonin from below or within the reference range to above the upper limit of the reference range, compared to 0.6%, 0% and 1.0% of patients treated with Victoza® 1.2 mg, placebo and active control, respectively. Otherwise, Victoza® did not produce consistent dose-dependent or time-dependent increases in serum calcitonin. Patients with MTC usually have calcitonin values >50 ng/L. In Victoza® clinical trials, among patients with pre-treatment serum calcitonin <50 ng/L, one Victoza®-treated patient and no comparator-treated patients developed serum calcitonin >50 ng/L. The Victoza®-treated patient who developed serum calcitonin >50 ng/L had an elevated pre-treatment serum calcitonin of 10.7 ng/L that increased to 30.7 ng/L at Week 12 and 53.5 ng/L at the end of the 6-month trial. Follow-up serum calcitonin was 22.3 ng/L more than 2.5 years after the last dose of Victoza®. The largest increase in serum calcitonin in a comparator-treated patient was seen with glimepiride in a patient whose serum calcitonin increased from 19.3 ng/L at baseline to 44.8 ng/L at Week 65 and 38.1 ng/L at Week 104. Among patients who began with serum calcitonin <20 ng/L, 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

MINNESOTA PHYSICIAN JUNE 2013

lowered by a reduction in the dose of sulfonylurea (or other concomitantly administered insulin secretagogues) 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 experienced 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 discontinuation 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 angioedema with Victoza®. Macrovascular Outcomes: There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Victoza® or any other antidiabetic drug. ADVERSE REACTIONS: Clinical Trials Experience: Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of Victoza® has been evaluated in 8 clinical trials: A double-blind 52-week monotherapy trial 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 oncedaily, 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 summarize common adverse reactions (hypoglycemia is discussed separately) reported in seven of the eight controlled trials of 26 weeks duration or longer. Most of these adverse reactions were gastrointestinal in nature. In the five double-blind clinical trials of 26 weeks duration or longer, gastrointestinal adverse reactions were reported in 41% of Victoza®-treated patients and were dose-related. Gastrointestinal adverse reactions occurred in 17% of comparator-treated patients. Common adverse reactions that occurred at a higher incidence among Victoza®-treated patients included nausea, vomiting, diarrhea, dyspepsia and constipation. In the five double-blind and three open-label clinical trials of 26 weeks duration or longer, the percentage of patients who reported nausea declined over time. In the five double-blind trials approximately 13% of Victoza®-treated patients and 2% of comparator-treated patients reported nausea during the first 2 weeks of treatment. In the 26-week open-label trial comparing Victoza® to exenatide, both in combination with metformin and/or sulfonylurea, gastrointestinal adverse reactions were reported at a similar incidence in the Victoza® and exenatide treatment groups (Table 3). In the 26-week open-label trial comparing Victoza® 1.2 mg, Victoza® 1.8 mg and sitagliptin 100 mg, all in combination with metformin, gastrointestinal adverse reactions were reported at a higher incidence with Victoza® than sitagliptin (Table 4). In the remaining 26-week trial, all patients received Victoza® 1.8 mg + metformin during a 12-week run-in period. During the run-in period, 167 patients (17% of enrolled total) withdrew from the trial: 76 (46% of withdrawals) of these patients doing so because of gastrointestinal adverse reactions and 15 (9% of withdrawals) doing so due to other adverse events. Only those patients who completed the run-in period with inadequate glycemic control were randomized to 26 weeks of add-on therapy with insulin detemir or continued, unchanged treatment with Victoza® 1.8 mg + metformin. During this randomized 26-week period, diarrhea was the only adverse reaction reported in ≥5% of patients treated with Victoza® 1.8 mg + metformin + insulin detemir (11.7%) and greater than in patients treated with Victoza® 1.8 mg and metformin alone (6.9%). Table 1: Adverse reactions reported in ≥5% of Victoza®-treated patients in a 52-week monotherapy trial All Victoza® N = 497 Glimepiride N = 248 (%) (%) Adverse Reaction Nausea 28.4 8.5 Diarrhea 17.1 8.9 Vomiting 10.9 3.6 Constipation 9.9 4.8 Headache 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 Trial All Victoza® + Metformin Placebo + Metformin Glimepiride + Metformin N = 724 N = 121 N = 242 (%) (%) (%) Adverse Reaction Nausea 15.2 4.1 3.3 Diarrhea 10.9 4.1 3.7 Headache 9.0 6.6 9.5 Vomiting 6.5 0.8 0.4 Add-on to Glimepiride Trial Placebo + Glimepiride Rosiglitazone + All Victoza® + Glimepiride N = 695 N = 114 Glimepiride N = 231 (%) (%) (%) Adverse Reaction Nausea 7.5 1.8 2.6 Diarrhea 7.2 1.8 2.2 Constipation 5.3 0.9 1.7 Dyspepsia 5.2 0.9 2.6

Add-on to Metformin + Glimepiride Victoza® 1.8 + Metformin Placebo + Metformin + Glargine + Metformin + + Glimepiride N = 230 Glimepiride N = 114 Glimepiride N = 232 (%) (%) (%) Adverse Reaction Nausea 13.9 3.5 1.3 Diarrhea 10.0 5.3 1.3 Headache 9.6 7.9 5.6 Dyspepsia 6.5 0.9 1.7 Vomiting 6.5 3.5 0.4 Add-on to Metformin + Rosiglitazone Placebo + Metformin + Rosiglitazone All Victoza® + Metformin + Rosiglitazone N = 355 N = 175 (%) (%) Adverse Reaction Nausea 34.6 8.6 Diarrhea 14.1 6.3 Vomiting 12.4 2.9 Headache 8.2 4.6 Constipation 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 + Exenatide 10 mcg twice daily + metformin and/or sulfonylurea metformin and/or sulfonylurea N = 235 N = 232 (%) (%) Adverse Reaction Nausea 25.5 28.0 Diarrhea 12.3 12.1 Headache 8.9 10.3 Dyspepsia 8.9 4.7 Vomiting 6.0 9.9 Constipation 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 Sitagliptin 100 mg/day + N = 439 metformin N = 219 (%) (%) Adverse Reaction Nausea 23.9 4.6 Headache 10.3 10.0 Diarrhea 9.3 4.6 Vomiting 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 antiliraglutide 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 antibody-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 exenatidetreated 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 treatment 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 Comparator None Monotherapy Victoza® (N = 497) Glimepiride (N = 248) Patient not able to 0 0 — self−treat Patient able to self−treat 9.7 (0.24) 25.0 (1.66) — Not classified 1.2 (0.03) 2.4 (0.04) — Glimepiride + Placebo + Metformin Add-on to Metformin Victoza® + Metformin (N = 724) Metformin (N = 121) (N = 242) Patient not able to 0.1 (0.001) 0 0 self−treat Patient able to self−treat 3.6 (0.05) 22.3 (0.87) 2.5 (0.06) Continued Victoza® None Add-on to Victoza® + Insulin detemir + Metformin Victoza® + Metformin + Metformin alone (N = 163) (N = 158*) Patient not able to 0 0 — self−treat Patient able to self−treat 9.2 (0.29) 1.3 (0.03) — Add-on to Victoza® + Glimepiride Rosiglitazone + Placebo + Glimepiride (N = 695) Glimepiride (N = 231) (N = 114) Glimepiride Patient not able to 0.1 (0.003) 0 0 self−treat 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) 0 ® Placebo + Metformin Add-on to Metformin Victoza + Metformin + Rosiglitazone None + Rosiglitazone + Rosiglitazone (N = 355) (N = 175) Patient not able to 0 — 0 self−treat 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 Victoza + Metformin Insulin glargine Placebo + Metformin + Glimepiride + Metformin + + Glimepiride + Glimepiride (N = 230) Glimepiride (N = 232) (N = 114) Patient not able to 2.2 (0.06) 0 0 self−treat Patient able to self−treat 27.4 (1.16) 28.9 (1.29) 16.7 (0.95) Not classified 0 1.7 (0.04) 0 *One patient is an outlier and was excluded due to 25 hypoglycemic episodes that the patient was able to self-treat. This patient had a history of frequent hypoglycemia prior to the study. In a pooled analysis of clinical trials, the incidence rate (per 1,000 patient-years) for malignant neoplasms (based on investigator-reported events, medical history, pathology reports, and surgical reports from both blinded and open-label study periods) was 10.9 for Victoza®, 6.3 for placebo, and 7.2 for active comparator. After excluding papillary thyroid carcinoma events [see Adverse Reactions], no particular cancer cell type predominated. Seven malignant neoplasm events were reported beyond 1 year of exposure to study 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 population 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, sometimes 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, 1−877-484-2869 Date 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

JUNE 2013

MINNESOTA PHYSICIAN

Cystic fibrosis from cover shows that research targeting a specific genetic defect can lead to more effective treatment of other inherited diseases, too. The nature of the problem

CF is caused by mutations in any of the several loci in the CFTR gene that produce variant CFTR proteins. Mutation produces a defective CFTR protein that causes the body to produce extremely thick, sticky mucus. CF mucus clogs the lungs and leads to life-threatening lung infections. It obstructs the pancreas and stops natural enzymes from helping the body break down and absorb food, which leads to an inability to maintain a healthy weight. Until the discovery of ivacaftor, CF treatment focused on controlling the disease’s hallmark symptoms of cough, mucus production, shortness of breath, and pancreatic insufficiency that causes weight loss. We expend great effort controlling airway infections, which are very common because of the abnormal mucus clearance. We’ve

done pretty well with this, and improved survival significantly. But these are downstream effects of a defective CFTR protein that has lost much of its function. Ivacaftor is the first drug to restore function to that protein. How does CFTR function and how does its dysfunction cause disease? In most people, CFTR functions as a channel that opens and closes to allow chloride to pass from the inside to the outside of the cells lining the airways and other ducts. These chloride ions balance the sodium ions pumped into the airway that together attract water onto the tops of airway-lining cells. A normal depth of the water above the airway-lining cells allows their cilia to move mucus, along with bacteria, molds, and other inhaled particles trapped in the mucus up to the mouth where it is swallowed. When CFTR fails to function, the chloride cannot get through the cell membrane to balance the sodium pumped to the cell surface; there is less sodium chloride to draw water to the cell surface; the depth of the

periciliary fluid layer diminishes; cilia-driven mucus clearance slows or ceases; and bacteria and molds trapped in the mucus have time to grow in the airway. Growing microbes release proteins that attract inflammatory cells to the airway. These cells release enzymes that kill some of these microbes but also injure airway tissue. For patients who have the defective CFTR protein that responds to ivacaftor, this oral drug restores the defective CFTR chloride channel function and presumably the normal movement of mucus out of the airway. As a result, microbes trapped in CF mucus have less time in the airway to reproduce and therefore attract fewer inflammatory cells. This decreases coughing, mucus production, and shortness of breath, allowing patients to gain and maintain much-needed weight. Unraveling the mystery

How was it determined that this particular CFTR protein was abnormal in some CF patients,

and how did we find a drug to fix it? This story starts in the 1900s with Sir William Lawrence and Charles Darwin, who first understood that reproduction produced slight variations in offspring; and with Gregor Mendel’s discovery that different traits were inherited in different, but predictable, patterns. In the 1940s, Avery, McCloud, and McCarty found that deoxyribonucleic acid (DNA) was the chemical that transmitted these inherited patterns from one generation to the next in higher organisms. From their experiments, scientists learned that DNA is the molecular basis of the patterns of inheritance that Mendel discovered; and that variation in DNA transmitted to offspring causes most variation in organ form and function in offspring. These findings provide the basis for our current work to generate more safe and effective treatments of inherited diseases in people. In the 1950s, CF patients were found to have a much higher concentration of sodium

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Savvy and practical legal solutions by attorneys with decades of health care experience

chloride in their sweat than unaffected people. Studying families affected by CF revealed the autosomal recessive pattern of inheritance described by Mendel. This research allowed Francis Collins, Lap-Chee Tsui, and John Riordan and their collaborators to identify the specific DNA that varied in CF patients. The protein predicted from the DNA sequence was a good candidate for regulating salt movement across cells. This was later confirmed by microinjecting the CFTR DNA sequence into a cultured cell line that normally lacked a transmembrane chloride channel and by showing that expression of the CFTR protein in these cells produced such a channel. These experiments demonstrated that both copies of the CFTR gene were mutated in individuals with CF and not in their relatives. Subsequent research confirmed that cells from the lining of CF patientsâ&#x20AC;&#x2122; sweat ducts, airways, or gut showed abnormal functioning of the mutated CFTR protein. Normally, this protein moves chloride from

inside the airway-, gut-, and duct-lining cells to outside the cells. However, in CF patients the cells from the lining of the airways or gut have abnormal function of the CFTR channel that allows chloride to move from inside these cells to the outside. Consequently, in those patients chloride stays in the sweat ducts, resulting in the overly salty sweat characteristic of CF. From research to drug

Once the defective chloride-moving CFTR protein was identified, drugs that could theoretically make it behave more normally could be synthesized. Using a high-throughput screening method, it was now possible to test thousands of drugs already available for treatment of other diseases for their effectiveness on cells that contained a CFTR gene with the most common CFcausing mutation cultured under two different conditions. This testing was accomplished by Vertex Pharmaceuticals with start-up funding from the Cystic Fibrosis Foundation.

Vertex tested the already synthesized drugs for their effect on chloride flow from inside these cells to outside the cells (potentiator drugs). The first drug to be found was ivacaftor, a potentiator drug that increased the transfer rate of chloride from these cells. After preliminary safety testing in laboratory animals, ivacaftorâ&#x20AC;&#x2122;s effect was tested for safety and effectiveness in humans at the University of Minnesota Cystic Fibrosis Center and at other institutions around the world. These tests showed that ivecaftor effectively increased the chloride flow in certain CF patients (those who have the G551D mutation in the CFTR gene) and brought their sweat chloride concentrations down toward normal. Of greatest importance, it increased the flow of air through their airways and they gained weight compared with placebo treatment. Improved treatment today, hope for the future

What sets the discovery and development of ivacaftor apart

from the usual path of drug development is that it focused on a specific protein whose role in disease was discovered based on an understanding of genes and how they are inherited. It is the way more drugs will be discovered and developed for inherited diseases that today are poorly treatable. We are currently testing another drug that may produce similar improvement in more CF patients. With the help of patients with CF who participate in these clinical trials, we are on the verge of slowing and possibly stopping the progression of the lung disease that shortens the lives of most CF patients. Warren Regelmann, MD, is an associate professor of pediatric pulmonology and infectious diseases at the University of Minnesota, where he is co-director of the Pediatric Pulmonary Division and director of the Pediatric CF Program of the Minnesota CF Center, which is supported by grants from the Cystic Fibrosis Foundation and is one of 13 Translational and Therapeutic Development Centers funded to carry out early-phase clinical trials of new therapies.

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MEDICINE

n January 2013, Health and Human Services (HHS) published the long-awaited final rule (the “Final Rule”) implementing changes to HIPAA from 2009’s Health Information Technology for Economic and Clinical Health (HITECH) Act. The 130-plus pages of regulations and corresponding commentary clearly demonstrate that HHS is more committed than ever before to expanding both patients’ privacy rights and the obligations of providers to be proactive in protecting patients’ protected health information (PHI). While the Final Rule provides significant detail on numerous patient privacy and security issues, those of immediate concern to physicians and other providers are in the areas of business associate relationships, breach notification, and notices of privacy practices.

Business associate relationships

Telephone Equipment Distribution (TED) Program

One of the primary areas addressed in the Final Rule concerns business associates and

THE

LAW

HIPAA update Final security and privacy regulations will significantly affect physician practices By Timothy Johnson, JD, and Jesse Berg, JD, MPH

their relationship with physicians and other providers. Expanded definition of “business associate.” The Final Rule expands the definition of “business associate” to include any party that “creates, receives, maintains, or transmits” PHI on behalf of a covered entity. HHS clarified that an entity that maintains or stores PHI, regardless of whether it ever accesses the information, would be considered a business associate. Similarly, the Final Rule includes in the definition of business associates entities that primarily transmit PHI, but are provided “routine access” to PHI such as health information organizations and e-prescribing gateways. The Final Rule continues to exclude from the defini-

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tion of business associates those entities that act as mere conduits for the transport of PHI but do not access the information, such as the U.S. Postal Services and courier services. Historically, business associates were only those entities that had access to PHI and contracted directly with covered entities. However, the Final Rule expands the definition of business associate to include downstream entities that perform typical business associate functions involving PHI but have no direct relationship with the covered entity and instead only perform those services on behalf of the business associate that has a direct relationship with the covered entity. Not only are these direct subcontractors to a business associate considered business associates; so are parties that contract with those subcontractors and create, receive, maintain, or transmit PHI on behalf of those subcontractors. Under the Final Rule, this expansion of parties that are considered business associates (to the party with which they contract as a subcontractor) continues as far down as the chain of relationships goes. This expansion of the definition of business associates has important implications for covered entities, business associates, and, especially, those “subcontractors” that in the past may not have been very focused on HIPAA compliance. For example, by including each party that creates, receives, maintains, or transmits PHI downstream as a business associate, the Final Rule requires a party in the chain to have a business associate agreement with each of the subcontractors with which it contracts to perform services on that party’s behalf involving PHI. Furthermore, as a business associate, each subcontractor will be subject to the Final Rule’s

HIPAA compliance obligations for enhanced business associates discussed below. Given this expanded definition of business associates, physician groups will need to re-evaluate which of their vendors are business associates and put updated business associate agreements in place. HIPAA compliance and direct business associates. Prior to the Final Rule, physicians and other providers were required to have business associate agreements with their business associates that required the business associates to be contractually liable to the group in order to comply with many of the Privacy Rule and Security Rule requirements. With the passage of the Final Rule, in addition to being contractually liability to the covered entities, business associates will now be directly responsible for compliance with many provisions of the HIPAA rules. For example, under the Final Rule, business associates will be required to comply with the HIPAA Security Rule in the same manner as a “covered entity.” Likewise, business associates will be required to comply with some, but not all, of the provisions of the Privacy Rule. Being directly responsible for compliance with the Security Rule, and many provisions of the Privacy Rule, means that business associates, including the subcontractors who will themselves be regulated as business associates, can be potentially liable for civil and criminal penalties for noncompliance with such requirements. Updates to business associate agreements. The Final Rule makes it clear that its various changes to the definition and obligations of business associates, along with their relationships with providers, will require the providers to amend and update existing business associate agreements. Fortunately, the Final Rule gives some latitude on the timetable for providers to update existing agreements. Generally, business associate agreements that were in effect as of Jan. 25, 2013, will not have to be updated until Sept. 22, 2014. However, for all new business associate agreements that are

executed after Jan. 25, 2013, and for any modification or renewal of existing business associate agreements, the business associate agreements must comply with the Final Rule requirements by Sept. 23, 2013. Breach notification rule

The Final Rule also issues new guidance about when covered entities are required to notify their patients in the event of a breach (defined as an unauthorized acquisition, access, use, or disclosure, of patients’ PHI). Historically, HIPAA provided that a covered entity was required to notify the patients only if the patients’ PHI was unsecured and the breach of the PHI presented a significant risk of financial, reputational, or other harm to the patient. However, the Final Rule replaces that standard with a much stricter one. Specifically, any incident involving the unauthorized acquisition, access, use, or disclosure of PHI is presumed to be a breach and the affected patients must be notified unless the covered entity performs a

risk assessment and is able to demonstrate that there is a low probability that the patients’ PHI was compromised. Revisions to notices of privacy practices

As a result of modifications to various Privacy and Security Rule provisions included in the Final Rule, all covered entities will be required to update their notices of privacy practices (NPP) to reflect the new changes. For example, in addition to describing the breach notification process discussed above, the NPP must disclose the Final Rule’s expansion of a patient’s right to restrict disclosures and the types of uses and disclosures of PHI that require individual authorization. The Final Rule requires that physician groups begin providing the updated NPP to patients prior to Sept. 23, 2013. Preparing for new HIPAA requirements

The Final Rule provides that covered entities that breach the Privacy Rule can be fined up to

$1.5 million per each occurrence. However, the Final Rule also provides that in assessing penalties for HIPAA violations, the HHS Secretary may take into consideration the practice’s efforts in complying with the HIPAA requirements. To help demonstrate a practice’s compliance, it is recommended that physicians groups initially focus on the following four areas: 1. Business associate relationships. Given the Final Rule’s expansion of both who is a business associate and enhanced legal HIPAA exposure for business associates, physician practices should ensure that they have updated business associate agreements with all applicable business associates and that the practice’s business associates are aware of their HIPAA obligations and are operating accordingly. 2. Notice of privacy practices. Physician practices should amend and modify their NPP to comply with the new Final Rule requirements.

3. Security assessment. Given the enhanced obligation under the Final Rule to report HIPAA breaches, practices should perform an assessment of their operations and make changes to minimize the risk of reportable HIPAA breaches. Such changes could include encrypting PHI when possible, performing workforce training on the need to keep PHI secure, and changing practices that present risk of HIPAA breaches, such as prohibiting everyone, including practice physicians, from removing patient PHI from the office or placing electronic PHI on personal computers. 4. Policies and procedures. Update practice HIPAA policies and procedures to comply with the requirements under the Final Rule. Timothy Johnson, JD, and Jesse Berg, JD, MPH, are principals at Gray Plant Mooty, specializing in health care law. They will discuss the new HIPAA requirements at their annual Health Law Seminar at the Metropolitan on Thursday, July 11.

Thursday, July 18, 2013 9:00 am - 4:00 pm

Participants will: • Learn current progress, findings, and best practices from Minnesota's advance care planning 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 • Plus much more

Ramada Plaza Minneapolis Hotel

This year's conference promises to be a special day of exploration and discovery . . . one you will not want to miss.

For more informaton: ksnow@mnmed.org

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

PLAN TO ATTEND... Honoring Choices Minnesota 4th Annual Sharing the Experience Conference

JUNE 2013

MINNESOTA PHYSICIAN

PROFESSIONAL

ver the past decade, physicians and other health care providers have referenced the 2002 “Kidney Disease: Outcomes Quality Initiative (KDOQI) Clinical Practice Guidelines for Chronic Kidney Disease (CKD): Evaluation, Classification, and Stratification” to help direct the care of patients with kidney dysfunction. The 2012 “Kidney Disease: Improving Global Outcomes (KDIGO) Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease” updates the original KDOQI guidelines. The new guidelines may be downloaded at www.kdigo.org/clinical_practice_ guidelines/ckd.php. We present a patient case and a summary of the new guidelines to assist primary care physicians in identifying, classifying, and treating patients with non-dialysis-dependent CKD with or without diabetes. A multidisciplinary approach (primary care, nephrology, pharmacy) to managing CKD progression and complications can help improve

NEPHROLOGY

Chronic kidney disease An updated approach to identification, classification, and management By Nathan T. Blake, PharmD, and Wendy L. St. Peter, PharmD

patient understanding and clinical outcomes. A common patient case

Bob, a 79-year-old non-Hispanic Caucasian man, is seen at a local chain pharmacy for a comprehensive medication review. Comprehensive medication review is part of medication therapy management (MTM), a health care service often provided by specially trained pharmacists to optimize medication regimens. Bob and the pharmacist discuss Bob’s prescriptions and over-thecounter medications. Bob’s medical conditions include: • CKD (stage unknown) • Hypertension • Congestive heart failure (CHF) • Dyslipidemia

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• Atrial fibrillation • History of myocardial infarction (stent placement, four years ago) • Asthma • Gastroesophageal reflux disease • Macular degeneration Bob has no questions or concerns about his medication regimen. When he recently saw his primary care practitioner (PCP), his systolic blood pressure was elevated to 180 mmHg, and the PCP mentioned labored breathing and mild edema. His PCP made no medication changes. Though Bob’s electronic medical record lists CKD as a problem, Bob does not recall ever seeing a nephrologist or receiving an angiotensin-converting enzyme-inhibitor (ACE-I) or angiotensin receptor blocker (ARB). Bob and the pharmacist discuss benefits and risks of ACE-I/ARB therapies for reducing risk of CKD progression and other medical conditions. With Bob’s consent, the pharmacist contacts the PCP to discuss whether ACE-I/ARB therapy would be beneficial for Bob’s hypertension, CHF, and kidney function. From the PCP, the pharmacist learns that Bob was hospitalized last year for CHF and subsequent acute kidney injury (AKI); a nephrology consult note indicated a decision not to initiate ACE-I/ARB therapy at that time. Given this history, the PCP was hesitant to initiate ACE-I/ ARB therapy despite Bob’s recovery from the AKI episode. The pharmacist provides the PCP with a rationale for initiating ACE-I/ARB therapy, and discusses monitoring parameters and potential benefits and risks. The PCP decides not to initiate ACE-I/ARB therapy due to concerns about potential hyperkalemia and the possibility of fur-

ther decreasing kidney function. Although the KDIGO guidelines are not intended as an exclusive prescribing template, they can aid in the decisionmaking process for patients like Bob by providing graded recommendations based on best available evidence. Updated CKD guideline summary

The KDIGO definition of CKD is the same as in the original KDOQI guidelines: abnormalities in kidney structure or function, present for more than three months, with implications for health. However, the new guidelines enhance classification, identification, and prognostication of kidney function through the CGA classification system, which identifies cause (C), glomerular filtration rate (GFR) category (G), and albuminuria category (A). KDOQI highlighted the pitfalls of using serum creatinine alone to assess kidney function and set a standard for physicians to use GFR estimating equations to obtain more accurate estimates of GFR. The two equations advocated were the Modification of Diet in Renal Disease Study and the Cockcroft-Gault equations; both take into account additional patient factors that influence GFR. The new KDIGO guidelines recommend using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation for staging CKD for better accuracy in patients with higher GFRs. Electronic versions of these equations can be found at www.kidney.org/professionals /kdoqi/gfr_calculator.cfm, and printed versions on pages 7–8 of the KDIGO guidelines. KDIGO guidelines further define the GFR categories (see Table 1 on page 42). Albumin, as the primary component of urinary protein in kidney diseases, serves as an early indicator of glomerular damage, often before a decrease in kidney function can be appreciated. Albuminuria classification is based on the albumin excretion rate (AER; see Table 2 on page 42).

Guidelines on blood pressure goals for CKD patients By collectively considering GFR and AER (and cause of kidney disease), physicians can determine classification, treatment priorities, and prognostication of kidney disease (refer to the figure on page 21 of the KDIGO guidelines). Managing blood pressure in patients with CKD

New blood pressure (BP) goals and treatment guidelines can help providers select appropriate treatment regimens. KDIGO encourages providers to individualize BP goals and treatment based on age, cardiovascular disease, other comorbidity, risk of CKD progression, retinopathy (for patients with diabetes), and treatment tolerance. The BP target is generally ≤140/90 mmHg for patients with non-dialysisdependent CKD with or without diabetes and AER <30 mg/24 hours. If AER ≥30 mg/24 hours, the target BP recommendation is ≤130/80 mmHg (for both diabetic and nondiabetic patients). Guidelines now recommend initiating ACE-I/ARB therapy for diabetic and nondiabetic patients with non-dialysis-dependent CKD in whom BP-lowering agents are indicated if AER ≥30 mg/24 hours. Decisions regarding choice of BP-lowering agent for patients with AER <30 mg/24 hours should be individualized. The renin-angiotensin system (RAS) plays a significant role in BP regulation in CKD patients; it can increase intraglomerular pressure by constricting the efferent arteriole via increasing angiotensin II. Blocking angiotensin II with an ACE-I or ARB relaxes the efferent arteriole, reduces intraglomerular pressure and albuminuria, and protects kidney function over time. Therefore, medications that target the RAS system (most evidence is with ACE-I/ ARBs) should be considered in CKD treatment regimens. ACE-I/ARBs are indicated for patients with AER ≥30 mg/24 and can be combined with other BP-lowering medications. Close monitoring upon initiation and dose escalations is prudent due to the potential for hyperkalemia and initial GFR decreases, especially in patients with renalartery stenosis or intravascular

• A BP goal of ≤130/80 mmHg may be reasonable for many patients with CKD and AER ≥30 mg/24 hours, but a higher goal (e.g., ≤140/90 mmHg) may be appropriate for elderly patients or those with significant cardiovascular disease; individualize the BP goal for patients with AER <30 mg/24 hours (or equivalent). • Consider use of ACE-Is or ARBs as single-agent primary therapy in CKD patients with AER ≥30 mg/24 hours (or equivalent). • Do not institute dual RAS therapy except under the care or recommendation of a specialist (endocrinologist, nephrologist, diabetologist). • Do not initiate RAS therapy in patients with potassium >5.5 mEq/L or with diagnosed or suspected bilateral renal artery stenosis. • Assess serum creatinine and serum potassium before ACE-I/ARB initiation and with each dose increase. • Initiate using lowest ACEI/ARB doses; consider halving the lowest dose in patients at high risk for RASagent-induced AKI (elderly, diuretic use, dehydrated, atherosclerosis). • Maximize the ACE-I/ARB dose by titrating up as frequently as every 2 to 4 weeks until maximal dose is achieved or hypotension or other adverse effect occurs (see potassium and serum creatinine monitorvolume depletion (or taking diuretics), or when combined with nonsteroidal anti-inflammatory drugs (NSAIDs), COX-2 inhibitors, or potassium-sparing diuretics. No substantive evidence suggests that ACE-Is are superior to ARBs regarding BPor albuminuria-lowering effects. ACE-Is are generally initiated first due to lower costs. If a cough arises with ACE-I use, an ARB can be substituted. Combining an ACE-I and an ARB to lower BP or preserve kidney function is not recommended; combination use increases the risk of progression of kidney failure and other adverse reactions (hyperkalemia, hypotension), according to recent findings from the ONTARGET and ALTITUDE clinical trials. RAS agents are beneficial in reducing progression of kidney disease, but inappropriate dosing or lack of close monitoring can cause kidney dysfunction. The sidebar (above) provides a practical guide for safe and effective use of RAS agents in CKD patients. Medication combinations including a potassium-losing diuretic (in general, thiazide diuretic if estimated GFR is above 30 mL/min/1.73 m2 or loop diuretic if estimated GFR is below that level) may help prevent hyperkalemia and provide a

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 from baseline 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 RAS initiation, 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 of long-term alkali supplements, liberalizing salt intake, or long-term use of low-dose sodium polystyrene sulfonate may be indicated. o If potassium increases to ≥6.0–<6.5 mEq/L, stop RAS agent and reinstitute at 50% of prior dose when potassium <5.5 mEq/L. o If potassium increases to ≥6.5 mEq/L, permanently discontinue RAS agent.

concomitant BP-lowering effect. If a patient established on a RAS-blocking medication becomes acutely ill or requires short-term therapy with NSAIDs, dose reductions or temporary discontinuation of the

RAS blocking agent may be advised to reduce the risk of AKI. RAS-blocking therapy can resume upon recovery or discontinuation of the NSAID. KIDNEY DISEASE to page 42

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JUNE 2013

MINNESOTA PHYSICIAN

SPECIAL

This monthâ&#x20AC;&#x2122;s special the evolution of freestanding emergency and â&#x20AC;&#x153;urgency careâ&#x20AC;? cy role that health care real-estate pro-

medical clinics planning to relocate or expand; and the importance of including medical staff in the planning and design process for new or remodeled health-care facilities.

Everyone cares about

ALZHEIMERâ&#x20AC;&#x2122;S DISEASE.

Increasing demand for ER care cut that requires stitches, a broken arm, heart Use of emergency rooms nationattack symptoms â&#x20AC;Ś it wide has increased 26 percent used to be that anyone suffering since 1997, to these ailments about 114 million would head annually, Use of emergency patients directly to the according to the nearest hospital rooms nationwide Centers for Disemergency room ease Control and has increased (ER). But today, Prevention (CDC). the ER isnâ&#x20AC;&#x2122;t the This increased 26 percent only option for demand for ER patients. Many services gives rise since 1997. are trying a faster, to frustration for less expensive both physicians and patients option for acute care closer because of long waits in the to home: the freestanding lobby, long waits for test results, emergency/urgency room. and other inefficiencies. Emergency physicians have been saying for years that we could do better if we had operational control over the environment, and that we could work out common ER problems to make emergency care faster, better, and more efficient. This is what motivated the Emergency Physicians Professional Association (EPPA) to develop the Urgency Room (UR), the first stand-alone ER type of facility in Minnesota. EPPA is a locally based group of board-certified ER physicians who provide ER physician staffing in five Twin Cities hospitals.

At a Clare BridgeÂŽ community, communityy, we care for those who have been n touched by dementia. With home-like by Alzheimerâ&#x20AC;&#x2122;s Alzheimerâ&#x20AC;&#x2122;s and and d ementia. W ith innovative innovative activities, activities, h ome-like environments environments aand nd professional professional staff, staff, Clare Clare Bridge Bridge communities communities deliver deliver highhighquality, Wee aalso understand quality, full-time full-time care. c are . W lso ccare are eenough nough tto ou nderstand tthe he ffull ull iimpact mpact of of this this disease, disease, from from its its destruction destruction of of the the memory memory to to the the challenges challenges and and difficulties it poses for families and an nd loved ones. And we respond accordingly. acccordingly. Thatâ&#x20AC;&#x2122;s why a Clare Bridge community comm munity is special. If your family has been touched toucheed by Alzheimerâ&#x20AC;&#x2122;s, call or visit your you ur nearest www.brookdaleliving.com. Clare Bridge community or log onto o We do more than th han care. We understand.

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DESIGN

By Gary Gosewisch, MD

clinic development considerations for

FACILITY

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

fessionals can play in and management;

MEDICAL

Freestanding â&#x20AC;&#x153;urgency roomâ&#x20AC;? facilities

focus articles discuss

facilities; the advoca-

FOCUS:

MINNESOTA PHYSICIAN JUNE 2013

The need for an ER alternative

Recent health care reforms have provided a strong impetus to develop health care networks that offer more connected and comprehensive care among all physicians and patients. However, the idea of a standalone ER facility surfaced about a decade ago, initially as a way to bring ER-level treatment to towns and communities without easy access to this type of care.

The aim was, and is, to provide patients with the same care that they would find in a hospitalbased emergency room, the difference being that the time to be seen, treated, and on their way is much reducedâ&#x20AC;&#x201D;as is the cost. In late 2011, an article in the Washington Post reported there were at least 222 freestanding ER facilities in the U.S., operating in 16 states. The same article noted that Seattle has several freestanding emergency rooms, including one an hour north of the city that has more square footage than an NFL football field. The lure of stand-alone emergency departments is also rooted in a growing consumer demand for convenience in health care delivery, as evidenced by the growing number of clinics staffed by nurses in supermarkets and doctor-owned urgent care centers. In addition, many procedures have already moved out of the hospital because they can be handled more efficiently in other settings where resources for certain procedures can be dedicated in a specific way. For example, colonoscopies, which are regularly performed at gastroenterology centers today, could be performed only in hospitals just 10 years ago. Spine surgeries, LASIK, pediatric tonsillectomies, plastic surgery, and many other surgical procedures also, for the most part, are done at surgery centers now. Services delivered

Stand-alone ERs are designed to treat a variety of medical conditions. At the three Urgency Room locations in the Twin Cities, board-certified physicians and emergency medicine-trained nurses and paramedics have treated a wide range of conditions, from broken bones and serious lacerations to blood clots and heart attack symptoms. In fact, EPPAâ&#x20AC;&#x2122;s research on ER admissions in five Twin Cities hospital-based ERs since 2001 shows that in Minnesota, roughly 75 percent of patients who go to the ER for care arenâ&#x20AC;&#x2122;t admitted to the hospital and donâ&#x20AC;&#x2122;t need hospital-based services. Thereâ&#x20AC;&#x2122;s no need for those

people to endure hours of waiting, uncertainty over what is going on with their case, and anxiety about the financial costs. Going to the ER for acute and urgent medical needs is no longer the only option for patients in the Twin Cities and in many parts of the country. Instead of a mom waiting four hours to get five stitches for her child at the ER, her child can receive the same expert medical treatment much faster in an environment that is welcoming and comfortable. Urgency Room patients are treated quickly in a comforting environment by board-certified emergency physicians and avoid the hassle of an ER visit. Urgency Room facilities also provide a high level of amenities and service, in marked contrast to the atmosphere of a typical hospital-based ER. Patients are greeted by friendly, courteous staff whose priority is to put patients at ease and make them comfortable. We always keep patients informed of how long the wait will be and where they are in the process. An LCD screen in the lobby lists wait times, which are also accessible via the Urgency Room website. Patients can even go online and enter their name into the system before arriving at the facility, so staff will be ready for them. If the wait time is longer than normal, patients may leave to run errands or entertain their children outside without losing their place in line; we call or text the patient when a room is ready. The discharge process at the Urgency Room is also quick and easy; our goal is to get our patients treated, home, and on their way to recovery fast. The Urgency Room also makes arrangements with local hospitals to have expedited admissions when a trip to the operating room or a hospital stay is needed. When they get there, patients typically can go directly to their hospital bed or the operating room without having to be seen or wait in the ER. Our goal is to return our patients to their primary care provider for their regularly scheduled care post-treatment at the Urgency Room. We work

How are alternative â&#x20AC;&#x153;urgency roomâ&#x20AC;? facilities different from urgent care clinics and hospital emergency departments? Stand-alone facilities that offer emergency medical care differ from urgent care facilities because they provide ER-level care from the same doctors, nurses, and paramedics found in the ER. Urgent care facilities do not provide this level of care; rather, they basically offer the same services as a primary care clinic, except on a walk-in basis and at extended and weekend hours. The new emergency care facilities such as the EPPAâ&#x20AC;&#x2122;s Urgency Room differ from traditional hospital-based ERs in that they do not accept ambulances. with our patients and with surrounding clinics and physician groups to make sure coordination of care is fulfilled and

For example, the Urgency Room does not accept ambulances, which can alter ER wait times because ambulance-transported

Going to the ER for acute and urgent medical needs is no longer the only option for patients in the Twin Cities and in many parts of the country. patient information is transferred accordingly. Patients can return to their primary or specialty provider following their visit with any necessary records or images from their visit to the Urgency Room. Advantages of the emerging ER alternatives

Reduced cost and wait times were our goals in the creation and execution of the three Urgency Room locations in the Twin Cities. Cost is a key factor. For Urgency Room patients with major health insurance, weâ&#x20AC;&#x2122;ve negotiated for them to have an urgent care (rather than emergency care) copay. This means that these patients are getting ER-level staff and evaluations, but theyâ&#x20AC;&#x2122;re paying less for the same treatment. The Urgency Room does not have the overhead and associated costs found in a standard ER attached to a hospital. We are able to keep costs affordable for patients, providers, and insurers. Wait time is the other big draw of freestanding ERs. At the Urgency Room we have the same equipment as an ER, but weâ&#x20AC;&#x2122;re dedicated only to the patients in the building, so we donâ&#x20AC;&#x2122;t have the kind of delays that result when resources are dedicated to the hospital overall.

it. Since our first facility, in Woodbury, opened in October 2010, our patient satisfaction rate has been 99 percent. Based on that success, we have since opened locations in Eagan and in Vadnais Heights, and we will continue to expand this innovative concept to communities across the metro area. In the meantime, other urgency care facilities have sprung up in the Twin Cities area. As health care professionals, organizations, and patients look ever more closely at ways to reduce costs while improving care, efficiency, and the patient experience, we can expect this model to be adopted more widely nationwide. Gary Gosewisch, MD, is board-certified in emergency medicine and is an emergency physician at the Urgency Rooms and at Fairview Southdale Hospital.

patients often receive priority care based on the severity of their condition. Our freestanding ER alternative has been very well received by those who have used

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MINNESOTA PHYSICIAN

health care architecture honor roll

innesota Physician’s 2013 Health Care Architecture Honor Roll recognizes eight outstanding projects completed in the past year. This year’s Honor Roll projects include new clinic and hospital construction, remodeled spaces, and facility expansions in urban, suburban, and greater Minnesota. The medical services range from routine clinic visits to specialized care. Populations served include the standard patient rosters typically seen in family medicine clinics, as well as specialized groups—such as new mothers and their babies, and children and adolescents needing individualized 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 elements from nature and feature eye-catching artwork. Minnesota Physician Publishing thanks all those who participated in the 2013 honor roll.

MINNESOTA PHYSICIAN

JUNE 2013

St. Luke’s Medical Office Building A Type of facility: Medical office building/parking structure Location: Duluth Client: Ventas, Inc. Architect/Interior design:

Amberwing Type of facility: Child, adolescent, and young adult mental health 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 Square feet: 25,883 sf Amberwing–Center for Youth & Family Well-Being, built by the Miller-Dwan Foundation with more than $6 million in charitable gifts, provides individualized psychotherapeutic care for 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 the welcoming warmth of a North Woods lodge. Each wing is anchored by a family-friendly kitchen and gathering area surrounded by separate rooms for educational therapy, talk therapy, play therapy, a classroom, and a living room-like space for family meetings. A separate wing designed for alternative therapies offers music, art, drama, occupational therapy, recreation, and movement therapy to enhance therapeutic outcomes.

An imaginative lobby, a community meeting area, a spiritual center, a treatment space for infant and toddlers, and a professionally staffed parent and family resource center make up the heart of Amberwing, encouraging the community to enter. The wooded outdoors, which is connected to a 16-acre federal park, allows for nature walks in the spring and summer, outdoor games, and snowshoeing in the winter. The building includes an outdoor deck and a strategically designed outdoor gathering space to integrate nature into Amberwing’s treatment programming. Left: A wooden, ribbed canoe suspended from the ceiling of the lobby, 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 a 16-acre federal park.

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 A was built for the fast-changing climate of health care, with an eye to the future. The top floor of the fivefloor medical office building is home to six of St. Luke’s specialty 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 waiting areas 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 offer beautiful 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 feet of the total 175,000-square-foot structure. The lower three levels offer enclosed, climate-controlled parking for 219 patient and employee vehicles.

Top: Nurses’ station Right: Lobby Bottom: Entrance to Medical Building A

HONOR ROLL

2 013 Mother Baby Center Type of facility: Hospital Location: Minneapolis Client: Joint venture between Children’s Hospital and Clinics of Minnesota and Abbott Northwestern Hospital Architect/Interior design: HDR Architecture, Inc. Engineer: Palanisami & Associates, Inc., structural; HDR Architecture, Inc., mechanical/electrical Contractor: Knutson Construction Completion date: January 2013 Total cost: $36.7 million Square feet: 75,000 sf, new; 22,000 sf, remodeled

Left: The signature entrance allows for a celebratory family experience.

Left Inset: Rooms with a birthing tub provide moms with a variety of birthing options. Top: The exterior façade captures the welcoming spirit of the Mother Baby program through color and creative forms.

The Mother Baby Center combines Children’s Hospitals and Clinics of Minnesota’s excellence in neonatal care with Abbott Northwestern Hospital’s renowned obstetrical program, enabling mothers, babies, and families to stay together and experience the highest level of coordinated care. The four-story facility is nestled between Abbott Northwestern and Children’s with a skyway that connects the two. The new facility has capacity for 5,000 births each year. It offers a comprehensive approach to care, beginning at prenatal care and continuing through obstetrics, perinatology, labor and delivery, neonatology, and pediatrics. Combining a comforting spa-like atmosphere with state-of-the-art clinical technology, the Mother Baby Center achieves an environment that balances function with the needs of families before, during, and after childbirth. The facility includes a maternal assessment center; 13 labor 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 integrated operating 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 its expertise beyond its physical location and advise providers at other birth centers in the region.

Healthcare Planning and Design

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MINNESOTA PHYSICIAN

JUNE 2013

Lakeview Health: Stillwater Medical Group Mahtomedi Clinic Type of facility: Outpatient medical clinic Location: Mahtomedi Client: Lakeview Health/HealthPartners Architect/Interior design: Mohagen Hansen Architectural Group/HealthPartners Facilities Contractor: Greiner Construction Completion date: October 2012 Total cost: $795,636 Square feet: 7,031 sf The clinic design was based on a new care delivery model being used by HealthPartners. Areas within the clinic are considered “on-stage” areas, which patients see and experience; or “off-stage” areas, which are seen and used by clinic staff. The staff areas are located in the central core of the clinic and surrounded by exam rooms. The main patient corridor runs around the perimeter of the building to give patients views to nature and the outdoors while bringing more daylight into the exam rooms. This new exam model improves staff flow by creating separate patient and provider entrances while increasing the sense of comfort by decreasing the visibility of staff work areas and medical equipment from patients. Patients appreciate the light, airy feel of this clinic. The goal of the interior concept was to design a welcoming, yet healing environment. Nature is a key element found throughout the clinic, both literally and figura-

driven by your

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

Inset: Thoughtful use of materials and finishes, along with abundant natural daylight, create a comfortable and inviting waiting area.

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

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JUNE 2013

MINNESOTA PHYSICIAN

HONOR ROLL

2 013 This medical clinic was built in the renovated space formerly occupied by a book retailer. The two-story interior underwent many renovations, including skylights and patient-friendly touches (no more weighing patients in the public hallways). The exterior was also updated to include heated sidewalks by the main entrance, so patrons don’t run the risk of slipping and falling.

HealthEast Midway Clinic Type 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 Total cost: $5.5 million Square feet: 23,000 sf

The location was very attractive to HealthEast and real estate developer MSP on many levels. Located on the corners of Hamline and University Avenues, the new Midway clinic is centrally located between Minneapolis and St. Paul. Neighbors, like Super Target, Herberger’s, and Walmart, make it a destination location for patrons. It is also located two blocks from where the Central Corridor light rail will be making it convenient 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 System extremely 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 blocks from the Central Corridor light rail (now under construction), make it convenient to patrons.

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MINNESOTA PHYSICIAN

JUNE 2013

Riverwood Healthcare Center Type 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 ownerâ&#x20AC;&#x2122;s request Square feet: 24,365 sf (renovated) Riverwood Healthcare Center is an independent, integrated hospital and clinic facility serving Aitkin county and nearby communities in northern Minnesota. Renovation in 2012â&#x20AC;&#x201C;2013 included remodeling of patient, specialty treatment, pharmacy, waiting areas, and staff amenitiesâ&#x20AC;&#x201D;all accomplished without interruption to clinic or hospital services. Included was conversion of 11 existing patient rooms to single patient rooms; new labor and delivery unit; relocated emergency room and intensive care unit; remodeled rehab space; addition of five infusion bays for chemotherapy and other medication therapies; and relocation of pharmacy, respiratory therapy, diabetes education, and wound care. In addition, renovation created a new support services addition, which houses medical records, human resources, and others services, bringing all Riverwood employees in Aitkin into one location. Infection controls were implemented in each phase. Other renovation work included utility and site improvements (grading, curb/gutter, courtyard pavers, landscaping) and additional parking. The expansion effort also facilitated an economic boost, creating 18 new positions at the hospital and generating 130 new construction jobs with a payroll of approximately $6 million for the duration of construction. A

number of subcontractors were hired from Aitkin as well as the surrounding area, providing regional economic impact. Top: Remodeled nursesâ&#x20AC;&#x2122; station Bottom: Riverwood Healthcare Center entrance at dawn

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JUNE 2013

MINNESOTA PHYSICIAN

HONOR ROLL

2 013 The Sartell Pediatrics project was unique and challenging in a number of ways. The project was a complete renovation of a building that was originally built as a drive-thru branch bank. It was later converted to a bar that featured a floor to ceiling dance pole, where the nurse’s station now stands. Also, the practice is private (owned by David Smith, MD) rather than part of a medical group. Dr. Smith wanted a very functional layout that would accommodate both patients and the staff. He also was looking for a space that would be inviting, warm, and comforting for the children who would be his patients. The exterior of the south façade was opened up to allow for new windows and abundant natural light. EIFS material was used in strategic areas to cover old brick patches and to tie in the new window openings. The existing structure and high ceilings were left open where the old bank drivethrough was located, to create a sense of openness and interest. Vibrant colors were used on the exam room walls while natural tones and stone were used in the entry and lobby areas to bring a sense of warmth and character to the patient experience.

Sartell Pediatrics Type 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) Square feet: 4,000 sf

The Sartell Pediatrics facility provides a unique environment and functional support to the important process of pediatric health care. The project has been a great success and has resulted in an abundance of community support.

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

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MINNESOTA PHYSICIAN

JUNE 2013

Hazelden Center for Youth and Families Type of facility: Addiction treatment facility Location: Plymouth Client: Hazelden Foundation Architect/Interior design: HGA Architects and Engineers Engineer: HGA Contractor: Knutson Construction Co. Completion date: October 2013 Total cost: $22,865,900 Square feet: 50,000 sf The Hazelden project consists of a 50,000square-foot expansion and a 50,000-square-foot renovation of an addiction treatment facility for teens and young adults, ages 14â&#x20AC;&#x201C;25, in Plymouth. It is nestled within a residential neighborhood surrounded by beautiful woodland along the north shore of Medicine Lake, next to Three Rivers park grounds. The expansion comprises a new, two-story 32-bed resident unit, gymnasium with rock-climbing walls and attached fitness room, a serene meditation area, a large auditorium, an outpatient clinic, and numerous group and training rooms. The existing resident units/dormitories, the medical service unit, and the kitchen/dining area also are being transformed to mirror the elegance of the newly completed addition. In January, Hazelden began serving patients in the new building with great enthusiasm. Employees and clients alike are highly satisfied with their brand-new space.

Landscaping is underway to enhance their experience even more with a beautiful water feature, labyrinth, fire pit, and amphitheater. The entire project is scheduled to be complete this fall. Top: Family waiting area Inset: Entrance to the facility, which is nestled within a residential neighbor-

hood surrounded by beautiful woodland along the north shore of Medicine Lake in Plymouth

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SPECIAL

FOCUS:

icture this: A medical group had outgrown its space, and was looking to add two new physicians. Despite their prospects for growth, they were burdened with an outdated and badly located facility. For two years, the group looked at numerous options that would fit their various requirements, which included visibility, parking, layout, and pricing, but they could find nothing within their limited geographic parameters. Finally, through some ingenuity and hard work, a retail building was repurposed to become the perfect solution for their new clinic. Though successful, this whole process and its creative solution might not have happened at all without the help of health care real-estate professionals.

What exactly is a commercial real-estate professional?

There are many types of commercial real-estate professionals with different areas of expertise; some specialize in a particular industry, like health care. These

FACILITY

DESIGN

The doctor’s advocate How commercial real-estate professionals help medical practices By Louis Suarez, CCIM

professionals act as consultants for businesses, helping them determine their real estate needs and then working to find them the best possible location and negotiating on their behalf. When finding a space, health care real-estate professionals take into account the specific requirements and regulations that apply to the health care industry, including integration and absorption of smaller clinics into larger systems. Think of it this way: General practitioners can effectively diagnose and treat many ailments, but if their patient is a special case or requires additional expertise, they most likely will refer the patient to a spe-

Read us online

wherever you are!

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MEDICAL

MINNESOTA PHYSICIAN JUNE 2013

cialist. Health care real-estate professionals serve a similar function, as they specialize in the field of commercial real estate as it relates to various health care practices. What skills do commercial real-estate specialists bring to their work with medical professionals? Market expertise. Commercial real-estate professionals know the medical office market. They act as the physician’s advocate, consulting with medical practices 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-term decisions about real estate involves analyzing many factors, including demographics, competitive evaluation, system and complementary practice alignment, branding, patient base, market shifts, and financial expenditures. Commercial realestate professionals also can analyze your current location for integration and subleasing possibilities, keeping in mind the legalities surrounding subleasing and fair market value, especially Stark laws. Through mapping and patient analysis, they can help you identify whether current trends, such as repositioning former retail space for medical practice use, are going to continue, and whether they are right for your practice. Neutrality. Working with a commercial real-estate professional provides medical profes-

sionals with a neutral third party—something that can be helpful during negotiations. They can provide conflict resolution without getting the physician involved, acting as a buffer between the building owner and the tenant. This helps keep things amiable and professional between the owner and tenant, who likely will be working together for many years. Also, when buildings are owned by health care systems and other physicians, there is the potential to run into regulatory issues like Stark law. Long-term relationships, including referrals, are often best protected and resolved by a third party. When should you start working with a commercial real-estate professional?

Commercial real-estate professionals should be part of your operational team, communicating with you annually as part of your long-term strategic and financial planning, whether or not you are considering changing spaces. When it comes to making a move, the more proactive a medical practice is, the better the chances of negotiating better lease terms or securing space in a new, highly desired medical development that is still in the planning stages. Many new medical development projects take years to fully develop, so having early knowledge about these projects enables you to make the best decisions for your practice. Even if you just signed a 10-year-lease, having an annual review can help prepare for things that may come up, such as outgrowing a space, a demographic shift in your patient base, or partnership changes. The commercial real-estate professional can help you take advantage of these situations before your lease is actually up. What to look for in a commercial-real estate professional

Choosing the right commercial real-estate professional for your medical practice will depend on your specific needs and objectives, but there are some things that all medical professionals should look for when selecting the right real estate partner.

Health care experience. How much does this individual know about the health care industry as a whole, and what can he or she tell you about typical and special real estate needs? A commercial real-estate professional who specializes in health care will understand the dynamics of relationships with affiliated systems and clinics, as well as your clinic’s referral network. Market knowledge. Good commercial real-estate professionals should have market knowledge of what is happening in the industry, current market pricing, what opportunities are available, and what forces will affect your practice’s situation. They should also keep you apprised of proposed and inprogress construction projects, to help you make the most informed decisions possible. Resources. Good commercial real-estate professionals have access to a multitude of resources, including demographic and geographic information, construction costs, project management, move costs, and building operations.

Landlord experience. While this may seem counterintuitive, commercial real-estate professionals who have also worked with and for landlords can provide a unique point of view for a physician. They can offer insight into the motivations and processes of building owners and administrators, providing you with a more advantageous perspective in the site selection and lease negotiation process. Getting down to dollars and cents

Finally, there is the ever-looming question: How much is it going to cost? While there is not a specific price, there are some factors to consider: Scope of project. Projects can vary dramatically in the size, scope, and time required. Costs for these types of services typically will be calculated differently depending on the required services and the client/broker relationship. Some brokers charge by the hour, while others may charge by the project or transaction. Who’s paying? Although

each project is different, the most common transaction is a lease or sale. In these cases, the building owner or developer usually pays the fee. Most medical buildings have fees built into their pricing as part of the cost of doing business, similar to the way the commission for a buyer’s realtor is paid within the seller’s contract on a house. This is not always the case, so it is important to discuss this with your specialist early in the process. Single transaction or longterm project. Another factor that many commercial realestate brokers take into account when calculating fees is whether this is a one-time-only transaction or a longer-term project. Many times, tenant representatives will perform various services free of charge, with the understanding that they will be receiving commissions on future transactions. Other times, a fee for a service or project can be determined and paid for upfront. Current vacancy rates in Minnesota for health care space

are the lowest of all types of office space. This means there is less space available, and the space that is available costs more. You can be sure that the landowner or developer has a broker on its side. So, who’s on your side? You don’t have time to waste fighting for available concessions like signage, tenant improvement allowances, rental rates, and lease term rates. Choosing a health care commercial real-estate professional means you have an advocate. You’ll have someone working with you every step of the way to learn about your real estate history and requirements, to find the correct type of properties for your specific needs, and to develop a plan that minimizes jostling to your practice. Have a professional do the real estate legwork, so you can focus on your practice. To download a glossary of common health-care real-estate terms, go to www.colliersmsp. com/mnphysicians. Louis Suarez, CCIM, is director of Colliers International’s Healthcare Services Group, based in Minneapolis.

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MINNESOTA PHYSICIAN

SPECIAL

f your clinic has ever considered opening a satellite location or relocating to a new facility, you know how daunting the decision-making process can be. Today, these decisions are further complicated by a host of factors, such as changes in the health care industry, technological advances, and more restrictive networks of care. The traditional approach to medicine, based on a diagnosisand-treatment model, is not well equipped to thrive in todayâ&#x20AC;&#x2122;s rapidly evolving health care environment. Today, medical groups are responsible for more covered lives than in the past, so physicians are seeing more patients. Increasingly, practices are delegating routine visits to extenders (e.g., physician assistants, nurse practitioners, advanced practice providers), allowing physicians to deal with more complex visits where their expertise is more fully utilized. All of these factors influence facility design and operations. This article examines five key aspects of health care that clinics planning to relocate or expand may want to consider.

FOCUS:

MEDICAL

DESIGN

Moving? Growing? Considerations in clinic relocation or expansion By Nancy Doyle, AIA, and Jessica Anderson Patient experience and practice image

Research indicates that patientsâ&#x20AC;&#x2122; perception of the quality of care they receive is directly linked to the physical environment where they receive care. For example, if outdated floor coverings and other poorly chosen furnishings dominate a facilityâ&#x20AC;&#x2122;s decor, a patient may question the safety of the care environment. As health care consumers become more aware of their choices, health care organizations need to attract their business with a welcoming environment. Facilities today are moving away from the traditional front desk check-in model to a concierge model where patients are greeted at the door and assisted in navigating their journey. In an effort to accommodate a diverse patient population, organizations

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FACILITY

MINNESOTA PHYSICIAN JUNE 2013

are offering more variety and choices to their patients as they move through the facility. Waiting rooms have become more home-like, with choices that include love seats for parents with small children, oversized chairs for larger patients, taller seats with sturdy arms for elderly patients, play and reading areas for children, as well as maneuvering space for wheelchairs and scooters. Patient privacy is a primary concern in the patientâ&#x20AC;&#x2122;s journey through the clinic visit, from the moment the patient checks in at a desk or kiosk until he or she leaves with follow-up instructions and appointments. Designing the desk with private checkout stations on the back side of the desk, out of the main traffic pattern, offers additional privacy to those patients scheduling follow-up appointments and procedures while maintaining staff efficiency in covering both check-in and check-out. Although the lobby and waiting/public spaces are important elements in the patient journey, the exam room is the patientâ&#x20AC;&#x2122;s principal destination. Until recently, the exam room has seen very little change. However, today we have a new understanding of how the design of the exam room can affect the patientâ&#x20AC;&#x2122;s perceived quality of care. The standard exam room today is about 50 percent larger than it has been in the past. Todayâ&#x20AC;&#x2122;s exam rooms can better accommodate large families and caregivers, patients with disabilities, and bariatric patients. In addition, research shows that the design of the physicianâ&#x20AC;&#x2122;s desk influences patientsâ&#x20AC;&#x2122; involvement in and understanding of their care. For example, mobile desks and larger monitor screens allow patients to see their medical records, X-ray images, and test results, permitting greater interaction with their care provider.

Analyzing demographics to help build referral networks

Demographic data can guide practitioners in pinpointing potential geographic locations for clinic expansion or relocation and in identifying opportunities to build referral networks that can create greater access to specific patient populations. Most patient accounting and electronic health record systems allow practices to capture and monitor patient demographics, payer classes, referring physician data, and other pertinent information that can help determine a business case for expansion or relocation to a new market. For example, a specialty practice that is centrally located may begin to see a large portion of its patient population shifting to the west metro area due to population growth, new referral sources from affiliated physician practices, or new health care facilities. The demographic data may indicate that the practice likely would have sufficient patient volume to open a new practice with a new or established practitioner. Health system alignment opportunities

More and more medical group practices are aligning themselves with hospitals and integrated health systems that are increasingly focused on population health management. These health systems need physicians of all specialty types in their networks to provide comprehensive care for their patient populations. When considering relocating or expanding, practices may want to consider new ambulatory care facilities that are affiliated with large health systems so they can secure their participation within the provider network. Gaining workflow efficiencies through space programming

Planning for a new location should involve assessing practice patterns, anticipated future growth, and recruitment plans to determine the total number of exam and procedure rooms the practice needs. The assessment should include an analysis of the daily provider schedule so that exam rooms are fully utilized, even when individual physicians

and providers are caring for patients in the hospital or other practice locations. Incorporating utilization factors will help prevent “over-building” of a new practice location, and can provide opportunities to sublet space to unaffiliated physicians on a part-time basis. Practices also may consider designing offices and support spaces so they can easily be converted to clinical use in the future. Incorporating principles of “lean” design into space programming involves an objective evaluation of the practice to identify opportunities to reduce waste and redundancy in practice operations. The most effective design will aim to minimize provider travel distances, maximize access to materials and supplies, and eliminate nonessential or duplicative functions. Consideration should be given to designing larger exam rooms so that they can accommodate additional provider staff, office-based procedures, and greater involvement of family members and patient caretakers during office visits.

Planning for collaborative care

The delivery of care increasingly has been shifting to patientfocused models that support the best possible state of wellness for each patient over the long term. This shift from an episodic mindset to a holistic approach requires greater collaboration among all participants in the care delivery process for primary care and specific disease conditions. Accommodating this model in the practice setting may require a different approach to the organization of the clinical care environment. In the traditional care model, the patient ventures from one clinical space to another to receive specialty care. In contrast, collaborative care often allows the medical team to care for the patient in one clinical space or room. In this new design, providers flow in a tight pattern of movement among their patients while the patient remains in one exam room. Ultimately, this approach to care should reduce the cost of space per patient encounter because the rooms are used more effi-

ciently than in the traditional one-room/one-provider system of care. Often this type of planning is an integral part of changing physician work patterns from the existing norm to a more efficient system that will yield higher productivity and lower overhead. The objective of the medical home model is to create a universal clinic module that facilitates multi-use by an expanded team of providers. Because there are no customized, private spaces built into the module, it can be used by any specialty needing space. With this care model, utilization of the exam rooms has the potential to increase to 10–12 half-day sessions per week, allowing the system to build fewer rooms and use the space more efficiently. The central team space provides a collaborative work environment for the multifaceted care team supporting a provider with an increased patient population. The care team of case managers, dieticians, mental health providers, medical assistants,

and other care professionals allows the provider to focus on the medical tasks critical to patient health and wellness. Interlocking factors in facility planning

In today’s health care environment, decisions about relocating or opening a satellite location cannot be made based solely on the availability of space at the right price. Physician practices should consider this type of planning as an opportunity to lower overall practice costs, adapt to new delivery models, align with a preferred health system partner and referral sources, and increase patient loyalty. If these factors are incorporated into the planning process, the practice should be well positioned for the changing health care landscape. Nancy Doyle, AIA, is vice president of development and programming; and Jessica Anderson is director of physician services at Frauenshuh HealthCare Real Estate Solutions, Minneapolis.

Building a Direct-Pay Independent Practice Thrive, Not Just Survive Workshop for Physicians, Surgeons, and Other Health Care Professionals Saturday, August 10, 2013 8:30 am-4:00 pm Lunch provided Humphrey School of Public Affairs Conference Room University of Minnesota Minneapolis, MN

Sponsored by the Association of American Physicians and Surgeons (AAPS) and the Minnesota Physician Patient Alliance (MPPA)

• To present real-life stories of practicing physicians and surgeons who have transitioned from third-party paid practices to a direct-pay model. • To provide tools and guidance for physicians, surgeons, and other health care professionals considering transitioning to a direct-pay practice. • $99 for Physicians and Health Care Professionals and $49 for Professional Staff

Learn first hand from the MDs who are already in Direct Pay Practice: Jane Orient, MD Tucson, AZ

Chris Foley, MD Minneapolis, MN

Gerard Gianoli, MD Baton Rouge, LA

Juliette Madrigal, MD Marble Falls, TX

Robert Sewell, MD Dallas, TX

James Eelkema, MD Burnsville, MN

Lee Beecher, MD St. Louis Park, MN

Adam Harris, MD San Antonio, TX

Lee Hieb, MD Lake City, IA

Susan Wasson, MD Osakis, MN

Merlin Brown, MD Edina, MN

Plus Authors: Lee Kurisko, MD, Ralph Weber, & Dave Racer, MLitt To Register go to: http://tinyurl.com/lajk4uo Or Call Dave Racer at 651.705.8583, Ext. 1 Residents, Interns, & Medical Students Are Invited to Attend At No Cost JUNE 2013

MINNESOTA PHYSICIAN

SPECIAL

ow do you feel today?” This seems like a good question for a physician to ask a patient during an exam, to better understand what is on the patient’s mind and begin a dialogue. For architects and designers helping organizations create new spaces, this question also seems like a good way to begin a discussion when embarking on a design project. Yet, ask a physician, “How do you want your new facility to feel?”, and it’s not unusual to get a blank, if not irritated, stare. “What do you do?” Again, it seems like a straightforward question for a patient to answer. But the question “How would you like to work?” is often an eye-opener for busy nurses when they begin to consider the variety of different things they do, how their activities rank in importance, and how their activities shape their care teams. Just as the patient typically is the best source of relevant information and perspective in conducting a meaningful physi-

FOCUS:

MEDICAL

FACILITY

DESIGN

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 cal exam and developing a healing partnership, the input of medical staff is key in creating successful health-care facility projects. The institutional knowledge, history, and extensive, hands-on experience that medical staff bring to the table are invaluable in seeing the reality behind the vision for new projects. And the interactive engagement and committed participation of medical staff help build a collaborative, creative, and energized planning team in the facility design process. By engaging this group early in the design process and in a thoughtful manner, medical organizations can find an inspi-

MINNESOTA PHYSICIAN JUNE 2013

rational vision, define a functional program, and shape an innovative medical model that guides a successful project. Bringing necessary voices to the table

On paper, the idea for a new or remodeled medical facility appears both visionary and grand: to create a space that brings together the talent and technology that will make an organization a provider of choice for patients who, more and more, are shopping around for health care services. But bringing a visionary idea to reality involves much more than bricks and mortar. While materials can put a face on the services medical staff provide, the real heart of a new facility is how it operates: the flow of patients, staff, and families; the flexibility of rooms to adapt to changing practices; durability; and the efficiency of the spaces. Successful new facilities are those that architects and designers uncover through both business models and medical models. That dual approach to facility planning and design underscores the need for representation from all levels of a care organization, especially the medical staff. A project team that embodies effective leadership can galvanize an organization’s resources to begin painting a vision that is comprehensive and collective. A team that represents both a cross-section of staff members and the demographics of the organization will offer the diversity of views and ideas needed to develop a clear, inspiring vision that the whole organization can rally around.

In developing a solid vision, project teams must be curious and able to leave preconceptions at the door. Often, providers show up wanting newer, bigger versions of what they currently have. Teams should be empowered to seize the opportunity for innovation and change, and to re-imagine how their organizations can serve their communities and deliver care. By bringing together the multiple facets of an organization—from direct care to marketing, radiology to environmental services, and including both new and seasoned employees—planning teams can do more than react to current conditions; they can paint a picture that excites coworkers and the community about the next generation of care. Accommodating needs, managing expectations

Bringing a new project to life is a complex and expensive process. The steps in designing a project are complicated and require deliberate scheduling and purposeful staff inclusion, to ensure that those who are involved on the team have a voice. To that end, it’s important that meetings be scheduled at times when medical staff can attend; that a schedule be established for meetings; and that meetings be organized so that staff who are attending know what to expect and come prepared to participate. The aim is to create a satisfying experience for participants—one that can uncover new and unexpected ideas by welcoming fruitful discussions to help the team clarify the goals of the project and set priorities. Encouraging open dialogue and clearly defining project scope, budget, and parameters early in the process allow the discussions to be immersive and focused. This approach is intended to elicit the most useful input on the issues that are driving the project and to avoid the detours that can sidetrack teams and frustrate members. Issues like improving patient privacy and staff safety or creating more efficient spaces can then drive the discussions about

how to design a new space rather than where certain rooms may be placed or how large the rooms will be—discussions that are usually influenced by singular voices or perceptions about traditional care delivery. Health care professionals whose day-to-day duties tend toward the more analytic and linear often find that participating in the design of a facility can be both exhilarating and intimidating. The creativity required in the design of a new facility can unleash insights and reasoning not always accessed in the routines of care delivery. However, discussions of details, such as materials and finishes, can disengage providers whose interest in such matters is not at the level of others on the care team who will be using the space on a daily basis. Understanding the team members’ differing levels of interests and when to excuse them from certain discussions will help create a satisfying experience for all team members.

Medical staff play a strategic role as advocates for and practitioners of patient-focused care. They are essential partners helping design these complex, high-stakes facilities. A measured and deliberate process

While there can be many steps to a new or remodeled space, creating a clear and inspiring vision at the start of the process will keep teams engaged and focused. A solid vision will drive the project team’s discussions and help establish the guiding principles for developing effective spaces. These guiding principles then act as a bit of a promise statement, reminding team members why the organization is pursuing new or remodeled spaces. For this reason, the principles exist on a high level: “The hospital will put patients at the center of the care experience.” “The hospital will enhance staff and the care they provide.” “The hospital will create a destination for healthy

Emergency Room Physicians Looking for leisure work hours?

lifestyles.” With these principles in place, medical staff and their coworkers can begin to execute a future-oriented, functional space program—taking a broad view to respond to the question, “How would you like to be practicing medicine tomorrow?” In planning a new facility, the medical staff can explore changing care models and begin to anticipate the steps needed to execute those models, such as medications stocked at the bedside or shifting waiting periods in emergency departments from waiting rooms to patient rooms. Building flexibility into the details—for example, designing nurse servers to accommodate bedside medications in the future—then allows organizations to adopt new models in a

more efficacious manner. For the designers, this part of the planning process requires an understanding of the organization’s history and facility data—information that teams can provide, identifying their strengths and opportunities for change. Questions that designers might ask: What is the staff doing now that works? How does the staff want to operate in the future? How will the market forces, shifting demographics, and policy changes shape the way staff is delivering care? In this era of rapid change in health care, it’s difficult to predict the future with certainty. But raising these types of questions with staff will help the design team formulate a functional space program identifying the types and size of spaces, as well as departmental adjacencies and patient and staff flow for the care environment that will allow staff to transition successfully through changes (whether predicted or unexpected). And when medical staff are VOICES to page 36

Physician Practice Opportunities Avera Marshall Regional Medical Center is part of the Avera system of care. Avera encompasses 300 locations in 97 communities in a five-state region. The Avera brand represents system strength and local presence, compassionate care and a Christian mission, clinical excellence, technological sophistication, an array of specialty care and industry leadership. Currently we are seeking to add the following specialists:

• Set your own hours

General Surgery

Pediatrics

Orthopedic Surgery

Obstetrics/Gynecology

• No contract

Radiology/Oncology

Family Practice

Internal Medicine

Emergency Medicine

Psychiatry

Ophthalmology

• No obligations

Optometry

Attention Physicians • Immediate openings • Casual weekend or evening shift coverage

• Choose from 12 or 24 hour shifts • Competitive rates • Paid malpractice

Great Emergency Department in Southern Minnesota

For details on these practice opportunities go to http://www.avera.org/marshall/physicians/ For more information, contact Dave Dertien, Physician Recruiter, at 605-322-7691. Dave.Dertien@avera.org Avera Marshall Regional Medical Center 300 S. Bruce St. Marshall, MN 56258

763-682-5906 • 1-800-876-7171 F-763-684-0243 michelle@whitesellmedstaff.com

www.averamarshall.org JUNE 2013

MINNESOTA PHYSICIAN

Voices from page 35 involved in the design and planning process, staff outside of the design group are more receptive to the changes, because those changes have evolved from their colleagues’ deliberations and recommendations. The next stage in facility planning and design shifts the discussions from what kind of services staff envision for the future to how the new facility can support those services. The goal during this stage is to discover options that staff can evaluate and then collectively decide what best fits the needs of the departments and the organization. Mock-ups and simulation rooms can help medical staff evaluate room configurations, such as inboard versus outboard bathrooms, location of charting areas, and family zones in rooms. Finally, the team can put a feel and image to the spaces and align with an organization’s brand by offering design ideas for aesthetics and feel. The decisions made during this part of the planning process carry sig-

The real heart of a new facility is how it operates: the flow of patients, staff, and families; the flexibility of rooms to adapt to changing practices; durability; and the efficiency of the spaces. nificant weight, as they will have a direct impact on the organization’s perceived reputation and the workplace culture. Working together with an interior designer who specializes in health care interiors, teams can explore materials, finishes, and sense of light that will affect the feel of the space. Creating ownership

When an organization opens a new facility, it’s never the end of the journey, but only the start down a new path. And the staff’s impressions of the process leading up to the opening can directly affect how they perceive the functionality and usability of the new space. As architects and designers facilitate the process shaping

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 diane.m.collins@healthpartners.com or call Diane at: 952-883-5453; toll-free: 1-800-472-4695 x3. EOE

healthpartners.com 36

MINNESOTA PHYSICIAN JUNE 2013

the new spaces that will enhance an organization’s business and care models, physicians and medical staff are integral to process. Creating an inspirational vision, providing the definition for functional space programming, innovating and shaping new medical models—the opinions and insights that the medical staff contribute to these critical pieces improve the process of implementing the ideas. Coming to consensus on options rather than adopting a prescribed design allows staff to take greater ownership and experience a higher degree of success with the final design solutions. Medical staff play a strategic role as advocates for and practitioners of patient-focused

care. They are essential partners helping design these complex, high-stakes facilities. When engaged early in the design process, they also become ambassadors for the enhancements that new projects will bring to an organization and the community. New projects have farreaching effects on the day-today duties of medical staff. They go to the heart of staff satisfaction, which drives patient satisfaction. Asking staff how they want to feel and work in their new space is more than a pleasantry—it’s an indispensable part of the process that explores and discovers the models of care that staff envision and intend to deliver for years to come. Don Thomas, CID, is a certified interior designer and principal, and Scott Holmes, AIA, ACHA, LEED AP, is a senior medical planner at BWBR, a St. Paul-based design solutions firm with practices in architecture, interior design, and master and strategic planning. Holmes is also a member of the American College of Healthcare Architects.

Join the top ranked clinic in the Twin Cities A leading national consumer magazine recently recognized our clinic for providing the best care in the Twin Cities based on quality and cost. We are currently seeking new physician associates in the areas of:

• Family Practice • Urgent Care We are independent physicianowned and operated primary clinic with three locations in the NW Minneapolis suburbs. Working here you will be part of an award winning team with partnership opportunities in just 2 years. We offer competitive salary and benefits. Please call to learn how you can contribute to our innovative new approaches to improving health care delivery.

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

Emergency Medicine Physician BC/BE Family Medicine or BC/BE Emergency 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 bed Critical Access Hospital with two clinics. Glenwood is a family oriented community with an excellent school system. Recreational opportunities include boating, hiking, excellent fishing and hunting. We are halfway between Fargo and the Twin Cities. For more information Call Kirk Stensrud, CEO 320.634.4521 Mail CV to: Kirk Stensrud, CEO 10 Fourth Ave SE Glenwood, MN 56334 Submit CV Online kirk.stensrud@glacialridge.org

Fairview Health Services Opportunities 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: t Dermatology t &NFSHFODZ .FEJDJOF t 'BNJMZ .FEJDJOF t (FOFSBM 4VSHFSZ t (FSJBUSJD .FEJDJOF t )PTQJUBMJTU t *OUFSOBM .FEJDJOF

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www.glacialridge.org

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Sioux Falls VA Health Care System Working with and for Americaâ&#x20AC;&#x2122;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 nationâ&#x20AC;&#x2122;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 Chief of Primary & Specialty Medicine Psychiatrist Hospitalist Neurologist

Endocrinology Emergency Medicine Primary Care (Internal Medicine or Family Practice) Pulmonologist

AIRFORCE.COM/HEALTHCARE

JUNE 2013

MINNESOTA PHYSICIAN

“Green” health-care advocacy organizations Being green from page 38 ment might be a great place to start asking questions about recycling. You may be pleasantly surprised by what they say. Or you may find an issue ripe for advocacy. Advocacy for energy and climate

You can hear your mother or grandmother saying it: “Last one out, turn out the light.” Rarely do we hear this in our workplaces. Perhaps we’re just too busy to bother with shutting off lights. Besides, the argument goes, why would turning off lights matter, with all the computers blazing, the medical equipment humming, and the HVAC system cranking out a comfortable 72 degrees? Actually, it can and does matter. According to the U.S. Department of Energy estimate in 2012, a typical hospital consumes about 60,152 million Btu of energy annually. In comparison, a typical office building consumes 1,376 million Btu of energy annually. It’s logical that

• Practice Greenhealth (PGH) is a membership-based, nonprofit organization focused on changing the way health care operates: www.practicegreenhealth.org • Health Care Without Harm (HCWH) is an international advocacy group that works toward specific goals for health care environmental reform: www.noharm.org • Healthier Hospitals Initiative (HHI) provides free guides to improve health care sustainability in six key areas: engaged leadership, healthier foods, leaner energy, less waste, safer chemicals, and smarter purchasing: www.healthierhospitals.org • Physicians for Social Responsibility (PSR) is a national organization that works to slow global warming and toxic degradation of the environment through education, research analysis, and policy initiatives: www.psr.org

hospitals demands greater energy use, but this research suggests that hospitals use 40 times more energy than neighboring office buildings. The U.S. Energy Information Administration tells us that it isn’t biomedical equipment, heating, or air conditioning that uses the single most energy units; lighting accounts for fully one-third of the energy used in health care. Yes, your grandmother was right, after all. Physician advocacy opportunity #3: Shut off the lights.

Ask your hospital or clinic administrator to create a policy for all staff to observe: “Last one out, turn off the light.” Insist that this policy cover conference rooms, break rooms, supply rooms, and empty exam rooms. Make a note when this conversation occurs and invite the building department to participate. They can watch for any reductions in the utility bills, and staff can be appropriately applauded for their efforts. Physician advocacy opportunity #4: Climate change.

From the operational perspective, the health care industry accounts for “nearly a tenth of the country’s carbon dioxide emissions,” according to the University of Chicago (2009). From the health perspective, the World Health Organization notes “widespread consensus among the scientific community” that the earth is not only warming, but that this is “mainly due to human activities.” Climate change affects human health, “both through direct effects of extreme events such as heat waves, floods and storms, and more indirect influences on the distribution and transmission intensity of infectious diseases, and on the availability of fresh water and food” (World Health Organization, Campbell-Lendrum and Woodruff, 2007). Your advocacy opportunity here is to research and understand (if you don’t already) the links between climate change and human health, and to use your professional standing to BEING GREEN to page 40

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

Currently Seeking BC/BE s Ambulatory Internal Medicine s General Surgery

s Psychiatry s Urology

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.

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

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.

www.trinityhealth.org

MINNESOTA PHYSICIAN JUNE 2013

Shar Grigsby Health Center - East 20 Burdick Expressway Minot ND 58702 Ph: (800) 598-1205, Ext 7860 Pager #0318 Email: shar.grigsby@trinityhealth.org

Emergency Medicine

FAMILY PRACTICE w/OB

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

Warroad, MN Roseau, MN Crookston, MN

Hibbing Little Falls Park Rapids Alexandria Austin

• Dedicated Team Approach • Competitive Salary & Benefits • EPIC Healthcare Information System Idylic Practice Opportunities located in family friendly communities with close access to some of Minnesota’s most beautiful lakes.

For more information contact Tina Dalton or Mike Coulter at 800-458-5003, email:

recruiting@epamidwest.com or visit our website at

www.epamidwest.com

Contact: Kerri Hjelmstad, Physician Recruiter Altru Health System PO Box 6003 Grand Forks, ND 58201-6003 1-800-437-5373 Fax: 701-780-6641 khjelmstad@altru.org

Your Emergency Practice Partner

St. Paul Allergy & Asthma Clinic, P.A. is seeking a highly motivated, passionate BC/BE Allergist to provide outstanding patient care. The successful candidate will be part of our independent, well-respected team that serves patients at 4 Twin Cities east metro locations. Physicians are offered a competitive salary with 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 cstadel@stpaulallergy.com or 651-698-0386. www.stpaulallergy.com

www.altru.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 comprehensive benefit package.

Opportunities available in the following specialties: Dermatology Southeast Clinic

Family Medicine Cannon Falls Clinic and Pine Island Clinic

Hospitalist Rochester Hospital

Internal Medicine Southeast Clinic

Send CV to: Olmsted Medical Center Administration/Clinician Recruitment 102 Elton Hills Drive NW Rochester, MN 55901 email: dcardille@olmmed.org Phone: 507.529.6748 Fax: 507.529.6622 EOE

www.olmstedmedicalcenter.org JUNE 2013

MINNESOTA PHYSICIAN

Being green from page 38 speak out to your institutions and communities about this urgent crisis facing our planet. Advocacy for toxic chemical reform

Chemicals play an important and beneficial role in health care. However, the health care industry also must be mindful of the impacts of these chemicals and reduce their use whenever possible. Physician advocacy opportunity #5: Smarter purchases. You can help diminish the impact of chemicals on patients by advocating for policies geared toward phasing out certain chemicals used in industry. According to Physicians for Social Responsibility, the worst chemicals in health care include bisphenol A (BPA), mercury, perfluorinated compounds (PFCs), phthalates, polybrominated diphenylethers (PBDEs), and triclosan. Two leaders in health care sustainability, Kaiser Permanente and Dignity Health, have implemented policies to purchase products that are free

of PVC/DEHP (common phthalates used in IV bags), formaldehyde (found in carpeting and other building finishes), and halogenated flame retardants (applied to many products such as linen and baby blankets). Physician advocacy opportunity #6: Support reform of

The nonprofit powerhouse Healthcare without Harm (via Safer Chemicals Healthy Families, a coalition of 11 million individuals and businesses) has long been advocating for revisions to TSCA. Recently, the Safe Chemicals Act of 2013 was introduced in the U.S. Senate by

Lighting accounts for fully one-third of the energy used in health care. the TSCA. Federal legislation enacted in 1976 as the Toxic Substances Control Act (TSCA) was an attempt to regulate chemicals on the U.S. market. However, in 2009 the President’s Cancer Panel, in reviewing the topic of environmental factors in contributing to cases of cancer, noted that very few of the more than 80,000 chemicals currently in use are fully tested for longterm health safety.

Sens. Frank Lautenberg (D-NJ) and Kirsten Gillebrand (D-NY). This act, if passed, would give the EPA greater oversight of these chemicals, allowing the EPA to take immediate action on the worst chemicals, require manufacturers to demonstrate chemical safety, and promote safer alternatives through green chemistry. The voice of the physicians in our community is critical in keeping chemicals

reform on the minds of federal lawmakers. Physicians can change the status quo

Embedding “green” concepts in health care by reducing waste and resource consumption can make a difference to you, your patients, your community, and, ultimately, the environment as a whole. In the health care industry, no one has greater power to change the status quo than you, the physician. In addition to the six advocacy opportunities discussed in this article, the sidebar on page 38 lists other resources for becoming involved in these efforts. Crystal Saric Fashant, MPNA, is sustainability program manager at Fairview Health Services in Minneapolis. She has worked in hospital operations for 10 years and currently manages aggressive system goals to reduce Fairview’s environmental impact. She also is on the community faculty at Metropolitan State University, teaching Topics in Sustainability to graduate students.

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 Services Toll-free: 1-800-248-4921 Fax: 612-262-4163 Madalyn.Dosch@allina.com allinahealth.org/careers EOE/AA 10127 0213 ©2013 ALLINA HEALTH SYSTEM ® A TRADEMARK OF ALLINA HEALTH SYSTEM

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MINNESOTA PHYSICIAN JUNE 2013

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Orthopaedic Surgery Opportunity Live in Beautiful Minnesota Resort Community

An immediate opportunity is available for a BC/BE orthopedic surgeon in Bemidji, MN. Join three board certified orthopedic surgeons in this beautiful lakes community. Enjoy practicing in a new Orthopedic & Sport Medicine Center, opening spring 2013 and serving a region of 100,000. Live and work in a community that offers exceptional schools, a state university with NCAA Division I hockey and community symphony and orchestra. With over 500 miles of trails and 400 surrounding lakes, this active community was ranked a “Top Town” by Outdoor Life Magazine. Enjoy a fulfilling lifestyle and rewarding career. To learn more about this excellent practice opportunity contact: Celia Beck, Physician Recruiter Phone: (218) 333-5056 Fax: (218) 333-5360 Email: Celia.Beck@sanfordhealth.org AA/EOE - Not subject to H1B Caps

The perfect match of career and lifestyle. Affiliated Community Medical Centers is a physician owned multispecialty group with 11 affiliate sites located in western and southwestern Minnesota. ACMC is the perfect match for healthcare providers who are looking for an exceptional practice opportunity and a high quality of life. Current opportunities available for BE/BC physicians in the following specialties: • 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

For additional information, please contact:

Kari Bredberg, Physician Recruitment karib@acmc.com, (320) 231-6366

Julayne Mayer, Physician Recruitment mayerj@acmc.com, (320) 231-5052

www.acmc.com

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 beneﬁt package, a rewarding practice and a commitment to providing exceptional patientcentered 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 diane.m.collins@ healthpartners.com or call Diane at 800-472-4695 x3. EOE

Spine Surgeons, join our team and set the standards 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 inoffice MRI and imaging and surgery at their physician-owned surgery center.

Email CV to jwaller@slhduluth.com or call 800-461-8843 (Sue) or 218-625-2731 (June)

healthpartners.com JUNE 2013

MINNESOTA PHYSICIAN

Kidney disease from page 19 Use of other BP-lowering agents (e.g., beta-blockers, calcium-channel blockers, diuretics) and combinations are reviewed in detail in the KDIGO guidelines. Most CKD patients require more than one BP-lowering agent to achieve optimal control. In patients with progressive CKD, PCPs should work with specialists to manage their patients. The figure on page 26 of the KDIGO guidelines provides guidance for PCPs regarding when to refer patients with CKD to a nephrologist. Patient case revisited

Additional information regarding Bob’s CKD stage and albuminuria level would have been useful in determining his CKD prognosis and treatment plan. KDIGO guidelines provide more evidence-based direction for physicians in weighing benefits and risks of ACE-I/ARB therapy. A multidisciplinary approach to CKD management is recommended. In addition to nephrology referral, many patients would benefit from partic-

TABLE 1. Glomerular filtration rate (GFR) categories in chronic kidney disease (CKD). Measurement, 2 mL/min/1.73 m