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Volume XXV, No. 8

November 2011

The Independent Medical Business Newspaper

Building on partnerships Harnessing technology, community perspectives By Lacey Hart, MBA, PMP; Daniel Jensen, MPH; Terrance Donnal, MD; Erin Knoebel, MD; and Linda Williams, MD

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[Editor’s note: The Society for the Arts in Healthcare has designated November as Arts and Health Month. This is the first in a series of four articles about medicine and the arts that will appear in Minnesota Physician over the next six months.]

Healing

characteristic of the struggle to get better. However, as physicians, we have both an interest and obligation to keep these discomforts to a minimum. HealThe intersection ing deals as much with the between the arts delivery as in the treatment. The challenges and health care facing patients are but a subset of the By Gary A.-H. ospitals and clinics challenges of life Christenson, MD are by nature itself. We all deal frightening and with daily obstabrutal places. Patients cles, uncertainty, and discomwould avoid them if they could. The experifort, not only in our individual ence could easily be characterized as a conlives, but also as members of stellation of interrogations, physical and society. So how do we manage social isolation, invasion of privacy, and these discomforts? What makes assaults upon the body. The truth is that

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Detriot Lakes, MN Permit No. 2655

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HEALING POWER to page 10

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some mental and physical discomfort is

n Southeast Minnesota, efforts are underway to deploy new models of patient-centered care with a community focus. Southeast Minnesota Beacon Community (SE MN Beacon) is one of 17 Beacon community programs funded by the U.S. Department of Health and Human Services and directed by the Office of the National Coordinator of Health Information Technology to highlight best practices for improving health and health care delivery in the United States. The $12 million grant is being used to build a modern health information network as a means of improving efficiency and effective patient care. The hope is that this model can be developed, studied, and duplicated across the U.S. SE MN Beacon is organized into communities of practice, with part-

PARTNERSHIPS to page 12

IN THIS ISSUE: Rural health Page 20


Ar re e y ad o y? u

Version 5010 Deadline:

JAN 1st, 2012 ICD-10 Deadline:

OCT 1st, 2013

Official CMS Industry Resources for the ICD-10 Transition

www.cms.gov/ICD10


CONTENTS

NOVEMBER 2011 Volume XXV, No. 8

FEATURES Healing power The intersection between the arts and health care

1

MINNESOTA HEALTH CARE ROUNDTABLE

By Gary A.-H. Christenson, MD

Building on partnerships Harnessing technology, community perspectives

1

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

SESSION

By Lacey Hart, MBA, PMP; Daniel Jensen, MPH; Terrance Donnal, MD; Erin Knoebel, MD; and Linda Williams, MD

DEPARTMENTS 4

MEDICARE/MEDICAID Program integrity

MEDICUS

7

By Jesse Berg, JD, MPH

INTERVIEW

8

PROFESSIONAL UPDATE: DIABETES Systemic disease, system interventions 34

CAPSULES

Chad Robbins, DO, FACOS

30

By Tai J. Mendenhall, PhD, LMF, CFT, and Max Zubatsky, MA, LAMFT

Glencoe Regional Health Services

Specialty pharmacy Controlling the cost of care Thursday, April 19, 2012 1:00 – 4:00 PM • Duluth Room Downtown Mpls. Hilton and Towers

RESEARCH Starting a clinical research program

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By Pamela J. Wolfe and Joy L. Frestedt, PhD

SPECIAL FOCUS: RURAL HEALTH A virtual hospital experience

Forgotten no longer

26

20

By Sarah Kappel, RN, CCRN

By Daniel A. Nikcevich, MD, PhD, and Jane Brissett

Palliative care initiatives 22

Sowing seeds of change 28

By Janelle Shearer, RN, BSN, MA, and Karla Weng, MPH

By Terry Hill, MPA

The Independent Medical Business Newspaper

Background and focus: Medications treating chronic and/or life-threatening diseases are frequently new products, which are often more expensive than generic or older, branded products that treat similar conditions. The term specialty pharmacy has come to be associated with these medications. Exponents claim the new technology improves quality of life and lowers the cost of care by reducing hospitalizations. Opponents claim the higher per-dose cost spread over larger populations does not justify the expense.

The cost of research, both failed and successful, is reflected in product pricing. Current federal guidelines allow generic equivalents marketplace access based on the patent date, not the release date, of a product. This considerably narrows the window in which costs of advances may be recovered. A further complicating dynamic involves the payers. Physician reimbursement policies sometimes reward utilizing lower-cost “proven” products and cast those prescribing highercost products as “over-utilizers,” placing them in lower-tiered categories of reimbursement and patient access. Objectives: We will discuss the issues that guide the early adoption of new pharmaceutical therapies and how they relate to medical devices. We will examine the role of pharmacy benefit management in dealing with the costs of specialty pharmacy. We will explore whether it is penny-wise but pound-foolish to restrict access to new therapies and what level of communication within the industry is necessary to address these problems. With the baby boomers reaching retirement age, more people than ever will be taking prescription medications. As new products come down the development pipeline, costs and benefits will continue to escalate. We will provide specific examples of how specialty pharmacy is at the forefront of the battle to control the cost of care.

www.mppub.com PUBLISHER Mike Starnes mstarnes@mppub.com EDITOR Donna Ahrens dahrens@mppub.com ASSOCIATE EDITOR Mary Scarbrough Hunt mshunt@mppub.com ASSISTANT EDITOR Scott Wooldridge swooldridge@mppub.com ART DIRECTOR Elaine Sarkela esarkela@mppub.com OFFICE ADMINISTRATOR Juline Birgersson jbirgersson@mppub.com

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ACCOUNT EXECUTIVE Iain Kane ikane@mppub.com Minnesota Physician is published once a month by Minnesota Physician Publishing, Inc. Our address is 2812 East 26th Street, Minneapolis, MN 55406; phone (612) 728-8600; fax (612) 728-8601; email mpp@mppub.com. We welcome the submission of manuscripts and letters for possible publication. All views and opinions expressed by authors of published articles are solely those of the authors and do not necessarily represent or express the views of Minnesota Physician Publishing, Inc., or this publication. The contents herein are believed accurate but are not intended to replace legal, tax, business or other professional advice and counsel. No part of this publication may be reprinted or reproduced without written permission of the publisher. Annual subscriptions (12 issues) are $48.00. Individual issues are $5.00.

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CAPSULES

HFA in Talks to Merge With Hennepin Healthcare System Hennepin Faculty Associates (HFA), the independent medical group that contracts with Hennepin County Medical Center (HCMC), is discussing a merger with the health system that owns HCMC. HFA has nearly 400 provider members. It provides medical services at HCMC’s hospital and clinics, and owns the Minneapolis Medical Research Foundation. HCMC has seen a number of changes since the creation of Hennepin Healthcare System in 2007. At that time, the health system took over day-to-day governance of HCMC and its clinics from Hennepin County, which continues to own the health system and its assets. In a statement released Sept. 22, Gina Flak, manager of HFA corporate communication and marketing, says, “Hennepin Faculty Associates is exploring with Hennepin

4

Healthcare System, Inc. the possibility of integrating Hennepin Faculty Associates into Hennepin Healthcare System. At this stage in the discussions, a confidentiality agreement is in place that prohibits us from releasing additional details.”

Competitive Bidding Begins to Change Plan Enrollment The state’s new competitive bidding process will have a major impact on at least one local health plan and will result in approximately 70,000 metroarea enrollees of public health insurance plans being required to switch plans. Private health insurers that administer public programs such as Medical Assistance and MinnesotaCare have come under fire in recent years as analysts have noted that such programs are among the most profitable ones for health insurance companies. As part of its effort to hold down health care

MINNESOTA PHYSICIAN NOVEMBER 2011

costs, the Dayton administration announced last spring that it would open up public plans to competitive bidding. Initial results of that process are beginning to emerge, with enrollees of both Metropolitan Health Plan (MHP) and Medica receiving letters telling them they will need to switch plans during the next open enrollment period. The loss of public program enrollees is especially significant for MHP, which serves mostly poor populations and is owned by Hennepin County. MHP will lose 16,000 of its 20,000 members, officials say. It will, however, continue to serve seniors and people with disabilities. Cynthia McDonald, CEO of MHP, says the plan is disappointed, but that it’s too early to say exactly how the change will affect the HMO. “It’s fair to say we’re in the process of taking a look at what MHP’s role will be in the future,” McDonald says. “Our anticipation is that MHP will continue because we’ll have a contract for seniors and dis-

abled [people], and that’s a growing population.” Press reports have listed Minnetonka-based Medica as another health plan that will lose enrollees because of the competitive bidding system, but Medica officials have declined comment. State officials say they cannot comment on specific plans until the bidding process is complete, which was expected by the end of October. According to Scott Leitz, assistant commissioner at the Minnesota Department of Human Services (DHS), the change to competitive bidding is an effort to make the best use of public dollars. Leitz says five plans submitted bids for administering public programs in the metro area. DHS is required by federal law to offer at least two health plan options to public program enrollees, and it may offer more, he adds. Currently, the agency is working with plans to make sure that enrollees have access to services and providers.


State Gets an “A” For Palliative Care Minnesota is one of seven states, along with the District of Columbia, to rank an “A” grade in a new report on palliative care in hospitals. The Center to Advance Palliative Care released its stateby-state report card on palliative care last week, finding that the nation is improving in the area, but that too many patients still do not have access to this type of care and availability varies by region and state. The report, which was delivered to Congress, notes that palliative care is one of the fastest-growing areas of health care in the country, but says that changes in health care policy are needed, such as more emphasis on palliative care training and research. “The good news is that, over the last 10 years, [the number of] hospital palliative care teams have more than doubled,” says Diane Meier, MD, director of the center and co-author of the study. “The bad news is that, despite its enormous benefits to patients and caregivers, millions of seriously ill Americans still do not have access to palliative care.” Officials with the group note that palliative care helps patients facing serious illness by alleviating pain, treating symptoms, and focusing on quality of life. They say that approximately 90 million Americans are living with serious and chronic conditions such as cancer, heart disease, and Alzheimer’s. Overall, they say, delivery of palliative care in the United States has improved, with the country as a whole getting a “B” grade, compared to a “C” in 2008, when the center’s first report was released. Minnesota’s “A” rating is based on the finding that 89 percent of the state’s hospitals have palliative care teams. In Minnesota, 100 percent of large and public hospitals report having palliative care programs; 89 percent of mid-sized hospitals have palliative care programs; and 37 percent of small hospitals have such programs.

Employer-Sponsored Insurance Drops Nationwide The number of Minnesotans who do not have employersponsored health insurance has increased 10 percent since 2000, according to a new study by the University of Minnesota’s State Health Access Data Assistance Center (SHADAC). The trend is greater in Minnesota than it is nationally, the report finds. The overall number of Americans who have employer-sponsored insurance has dropped by 8 percent in the past decade. The report says that even with the changes brought about by health care reform, employer-sponsored insurance is the foundation of how health care is delivered in the U.S. and so this nationwide trend raises concerns, SHADAC officials add. In Minnesota, 70 percent of all residents have employerbased insurance, down from 80 percent 10 years ago. Smaller businesses saw more of a decrease in the number of companies offering insurance, with an almost 7 percent decrease. Large businesses saw only a 2 percent decrease in the number of firms offering insurance. “Minnesota was one of 12 states nationally that experienced a decline in employersponsored insurance of 10 percentage points or more. But in Minnesota, we think that a key part of this story is really an economic story,” says Julie Sonier, deputy director of SHADAC. “We had a pretty substantial shift in the last decade in the income distribution of our population. So we have a lot more people who are earning in the low-wage category than we did at the beginning of the decade. People in low-wage jobs are much less likely to have access to employer insurance.”

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MINNESOTA PHYSICIAN

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FluSafe Program Helps Facilities Vaccinate Staff More than 100 hospitals and nursing homes across Minnesota achieved flu vaccination rates of at least 70 percent among their staff under a new program from the Minnesota Department of Health (MDH). MDH officials noted the first official flu case in the state on Oct. 13. The FluSafe program was launched with the goal of 100 percent vaccination coverage of all health care personnel in participating facilities. In its inaugural 2010–2011 season, 137 hospitals and nursing homes enrolled in the program. Of those, 109 facilities had vaccination rates of at least 70 percent, and 27 of the 109 facilities reached vaccination levels of 90 percent or greater. “We’re extremely pleased with the number of facilities that participated in this first year of the program,” says

SEE 3 OPERAS FOR AS LITTLE AS

Kristen Ehresmann, director of the Infectious Disease Epidemiology Prevention and Control Division at MDH. “We’re making progress in getting more health care workers vaccinated. Even among those facilities that didn’t reach 70 percent, many showed significant improvement in their coverage rates.” Under the FluSafe program, health care facilities receive guidance and access to tools and promotional materials from MDH and CDC to help them increase their rates. The facilities record and document their vaccination rates through MDH’s electronic immunization information system. Officials note that health care workers can pass on influenza to patients, many of whom may be at high risk for complications from flu. The U.S. Department of Health and Human Services has set a standard of vaccinating 90 percent of health care personnel nationwide, but national rates are estimated at 63.5 percent. In Minnesota, the rate of vaccination of health care

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workers is approximately 72 percent overall. MDH is working to increase participation in the FluSafe program for next year. “The program benefits facilities,” says program coordinator Jennifer Heath. “It shows patients and their families that the facility’s employees are committed to patient safety by actively fighting influenza infection. Annual vaccination keeps workers and their families healthier, too.” MDH officials say flu season is off to a somewhat early start this year, but supplies of flu vaccine are expected to be sufficient.

Federal Funds Will Help State Monitor Premium Increases Minnesota will receive nearly $4 million from the federal government to establish a system to monitor health insurance premium increases. The funding is part of $109 million in grants to 28 states, a

move that federal officials say will hold down premium increases and improve transparency. The new program is part of the Affordable Care Act (ACA), and requires health insurers seeking to increase their rates by 10 percent or more in the individual and small group markets to undergo an evaluation to determine if the rate increases are reasonable. Prior to this announcement, the U.S. Department of Health and Human Services (HHS) had already given $48 million to 42 states to help set up rate review systems. “We’re committed to fighting unreasonable premium increases and we know rate review works,” said HHS Secretary Sebelius. “States continue to have the primary responsibility for reviewing insurance rates and these grants give them more resources to hold insurance companies accountable.”


MEDICUS

Caleb H. Creswell, MD, has joined Dermatology Specialists, PA, and is seeing patients at the practice’s Edina and Eden Prairie locations. Creswell graduated from the University of Wisconsin Medical School and served as chief resident at the University of Minnesota Department of Dermatology. He received several teaching awards at the University of Minnesota and was elected to the Alpha Omega Alpha Honor MedCaleb H. Creswell, MD ical Society and the Gold Humanism Honor Society. Creswell is a clinical assistant professor of dermatology at the University of Minnesota and is a member of the American Academy of Dermatology and the Minnesota Dermatological Society. Essentia Health recently added several physicians to its staff. Grace Totoe, MD, an internal medicine physician, will care for hospitalized patients at Essentia Health-St. Mary’s Medical Center and Essentia Health-Duluth. Totoe completed her residency at St. Mary’s Hospital in Waterbury, Conn., and completed her fellowship at the University of Minnesota. Jared Broadway, MD, has joined the neurosurgery department at Essentia Health-Duluth Clinic. Broadway completed a residency and internship at the University of Tennessee in Memphis. He received his medical diploma at the University of Arkansas in Little Rock. Sinisa Vujkovic, MD, has taken on a new role as a hospitalist at Essentia Health-St. Mary’s Medical Center and Essentia Health-Duluth. Vujkovic previously was medical director at St. Mary’s Hospital-Superior and Essentia Health’s Superior Clinic. Elmer Calica, MD, has joined the emergency medicine department at Essentia Health’s Northern Pines Medical Center in Aurora. Calica, who is board-certified in family medicine, received his medical diploma from Far Eastern University of the Philippines in Manila and completed his residency in family practice at the University of Minnesota’s St. Joseph’s Hospital in St. Paul. Robert Meisterling, MD, was inducted into the St. Croix Valley Sports Hall of Fame at the organization’s annual banquet in Stillwater on Sept. 14. Meisterling, a founding doctor at St. Croix Orthopaedics, PA, and acting medical director of the practice, spent 20 years providing care and expertise for the Stillwater High School sports teams. He has also served as team physician/consultant for college and professional athletic teams, including the St. Paul Saints and the Kansas City Chiefs. James E. Hartert, MD, has joined Fairview Range as vice president and medical director. He has more than 25 years of experience in the health care field and has held management Robert Meisterling, MD positions in a variety of large, complex health systems. Most recently, he served as president and chief medical officer for Hartert Healthcare Consulting, LLC in Eden Prairie. Fairview Range, based in Hibbing, includes Fairview University Medical Center–Mesabi, Fairview Mesaba Clinic (with locations in Hibbing, Nashwauk, and Mountain Iron), and Fairview HealthLine, a home care, hospice, and medical-supply provider. Saurav Paul, PhD, MS, JD, has been named director of the Innovation Fellows Program at the University of Minnesota’s Medical Devices Center. He will lead the intensive, year-long educational and intellectual property development program for medical devices sponsored by the University’s College of Science and Engineering and the Academic Health Center. Paul had been a research scientist with the Minnesota medical device company St. Jude Medical since 2002 and was instrumental in creating minimally invasive catheter-based technology platforms for diagnosis and treatment of atrial fibrillation. He received his doctorate in biomedical engineering and a master’s degree in civil engineering from the University of Minnesota. He also received a master’s degree in mechanical engineering from the Indian Institute of Science in Bangalore and has a law degree from William Mitchell College of Law in St. Paul, with a focus on intellectual property law.

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NOVEMBER 2011

MINNESOTA PHYSICIAN

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INTERVIEW

Rural health faces a general surgery crisis ■ What led you to a career as a general surgeon?

I guess the best answer is that I like the idea of being a mechanic of the body. There’s something very gratifying about seeing a problem and being able to fix it, and see that it’s been fixed. You don’t have to wait for a medication to take effect days or perhaps weeks later. It’s a really exciting thing to be able to effect change in a very quick fashion. ■ What are some of the most common procedures

you perform?

Chad Robbins, DO, FACOS Glencoe Regional Health Services Chad Robbins, DO, FACOS, is a general surgeon and an expert on rural health care delivery. He is chief of surgery and director of trauma at Glencoe Regional Health Services. He is a member of the Minnesota Department of Health’s rural general surgery committee and a board member of the Minnesota State Trauma Advisory Council. In 2010, Robbins was named a fellow of the American College of Osteopathic Surgeons.

8

In the military you hear of surgeons being able to perform surgery in other locations through robotic surgery. Right now, what we do know is there are ways to assess patients at least through a history over distances, and that’s a real exciting thing. ■ You’ve described the general surgery situation

in rural areas as a crisis. What leads you to this conclusion?

It comes down to simple math. There are 132 hospitals in Minnesota. Of these, 79 are critical access Like a lot of general surgeons, I perform a lot of hospitals, meaning that they have 25 beds or less gallbladder surgeries, hernia surgeries, appendix and they serve underserved areas of the state. So if procedures, breast surgeries, colon cancers, etc. you just take those numbers, you’ve got 60 to 70 Being in a rural area, I also have the option to percent of your hospitals that are in rural areas. practice a lot of endoscopic procedures such as Yet only 20 percent of the general surgeons in colonoscopies and gastroscopies. I also get the the state practice in rural areas. Of that 20 percent, opportunity to do thyroid procedures. Because we half of them plan on retiring in the next 10 years. don’t have the wide breadth of subspecialists out This will mean shortages in a large portion of the here, you have to do a little bit more, and I think state’s hospitals that already that’s a great thing. You really have a difficult time recruiting get to do the things you want It’s all fine and good to surgeons. to do—with the understandOf my patients here in ing that you have limitations, say patients need to Glencoe, most of them don’t given the size of the facility want to travel into the Twin come to us, but really we you’re working with and the Cities. They don’t the trafhelp that you have around should be treating them fic; they don’t like like the hassle; you. they don’t necessarily like to in their communities. ■ What are some recent have to sit in a lobby with 50 advances in your specialty? other patients and wait maybe 30, 40, 50 minutes, or wait two to three weeks or For the last 15 to 20 years it’s been all about minilonger to be seen. They’re used to being able to get mally invasive surgery. It probably started with the seen within five to 10 minutes, and only having to laparoscopic gall bladder surgeries, and now travel maybe a mile. And a lot of my older patients laparoscopy has worked its way into just about don’t necessarily drive at all; they have to have every aspect of general surgery. family members pick them up even to come to our There’s a lot being done right now in telemedifacility. cine, which I think is an exciting area, especially So being able to keep patients in the communifor facilities like ours where it’s hard to recruit ty that they’re familiar with and have their families some subspecialists because they might not be available to help out with care if, God forbid, they needed on a daily basis. But if a patient doesn’t have to be admitted to the hospital, is a very have to travel into the cities to see a neurologist or important thing. a psychologist or one of those other areas, and they Another thing that leads to the problem is can come into our clinic and talk to somebody [that] the majority of residents going into general through the computer and use that technology—I surgery aren’t staying in general surgery. I think the think that’s great. numbers are anywhere from 60 to 70 percent of Then there’s been a lot of talk recently about general surgery residents right now going on to what’s called “NOTES” surgery, which stands for subspecialties. They’re going into plastic surgery, natural orifice translumenal endoscopic surgery. cardiothoracic surgery, or urology or neurosurgery. It’s basically incisionless surgery. It’s not standard Those are definitely areas of need, but when of care at this point, but it is kind of exciting to you’re trying to serve as many people as you can, consider that we might be able to do surgery somehaving a general surgeon is really your best bet day without having to make external scars on a because of the scope of procedures that they can patient’s body. perform, especially in that small rural area where patients really need it. ■ Is surgery a field where telemedicine is more difficult? ■ So what’s being done to address the problem? Surgery has challenges because so much of what Well, right now it’s in the discussion phase—just we do is tactile—being able to palpate patients, to realizing there is a problem, and making sure that feel what’s going on with them. There are limitaeveryone’s talking about it, so we can start figuring tions with telemedicine in the general surgery field. out some solutions.

MINNESOTA PHYSICIAN NOVEMBER 2011


Some of the solutions we’ve talked about include, first and foremost, trying to get students and residents out to rural areas and educate them about what life can be like and what a practice can be like out in those areas. There are studies that say if you can get students out into rural areas, they’re more likely to practice in rural areas. There should be incentives to get surgeons to work at these smaller facilities. Financial support can help on a lot of different levels. Technology is not cheap, and there’s a mandate for every facility to have an electronic medical record system. That’s obviously costing facilities a lot of money. In surgery, there’s so much technology: for example, we work with a lot of different types of mesh and equipment that can cost up to five figures. So it’s important to make sure that the facility has the ability to cope with those types of financial situations. Another idea I’ve had is that it’d be really nice to have some type of incentive for surgeons to stay in rural practice at the same facilities. I’ve worked here at Glencoe now for seven and a half years. During that time, one of the other hospitals in the area has had seven different general surgeons. I’ve seen a study that said that 50 percent of general surgical residents coming out of residency to work at a hospital aren’t at the same hospital two years later. That can really devastate a rural hospital when it

can sometimes take years to recruit a general surgeon. Obviously it would be nice if there were some kind of incentive to keep the surgeons in those facilities so that the patients could get the continuity of care that they deserve. ■ Insurance companies in some cases are

shifting costs to patients. What impact does this have on surgical practices? I don’t know the numbers or statistics on this one, but I can give you some clinical observations. If a patient is in dire economic straits, most of the time he or she will put off some type of procedure until it becomes an emergency. Unfortunately, that can lead to a lot of problems: increased costs, problems for the patient, and problems for the patient’s family. When you talk about prophylactic procedures like a colonoscopy, it’s my opinion [that] if you do your screening colonoscopies when you’re supposed to and how you’re supposed to, you can eliminate 90 percent of the colon cancers out there. But if people don’t get them done and they wait for polyps to turn into cancers and wait for those cancers to start giving them problems, ... often it becomes too late to do anything about it. Statistically, most colon cancers are found at stage three or stage four.

■ In rural health care delivery, what do you

see as some of the biggest ongoing challenges to address? I would say really trying to understand, first and foremost through the patient’s eyes, what is best for the community. I think small, rural hospitals have a very vital role. It’s all fine and good to say patients need to come to us, but really we should be treating them in their communities, at their level. The demands on patients when you put them into a car and try to get them to a facility that’s two to three hours away; the demands on the family to try and visit their loved ones who are in facilities two to three hours away—these can be challenging. I’ve actually had trauma cases in our emergency room, patients who need to have neurosurgical procedures that we’re not equipped to take care of, and their first concern isn’t, “How am I going to do?” or ”What’s going to happen?” It’s “How am I going to get home?” And the family will say, “How am I going to get down there to visit?” So to be able to first, provide good care, and second, keep patients within their community, are two of the big things we should focus on when we’re talking about any of the changes in health care.

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Healing power from cover life palatable? I would argue that a good deal of our individual and societal ability to cope with the myriad challenges of life is through utilization of the arts. We arrange and design our living spaces, decorate our walls, listen to music, read, write, dance, recite stories, joke, delve

to be human. And if they are essential to human nature, then we as physicians need to recognize the arts as an additional avenue for healing, as much as we recognize diet, exercise, pharmaceuticals, and surgery. But how can the arts benefit health care?

sterility of the hospital ward nearly matched the necessary clinical sterility. In this context, patients, captive and immobile, not only were constantly reminded where they were and what they faced, but also were forced to sacrifice their sense of control. Increased patient fear and anxiety were natural outcomes.

Further exposure to the arts may produce better physicians.

into creative hobbies and pastimes, adorn our bodies with styles that we find fashionable, and prepare our food in creative ways. The arts are not confined to museums, concert halls, and coffee books. They are woven into the very fabric of what it is

The arts in the health care environment

Until fairly recently, health care environmental design has emphasized efficiency, practicality, and technology from the perspective of health care providers and administrators, with less attention to the patient and family experience. The aesthetic

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Studies have demonstrated that the use of design and visual art not only improves the patient experience, but can also positively influence both clinical outcomes and medical expenditures. Several studies have revealed that rooms designed with views of nature decrease anxiety, physical discomfort, and the requirement for pain medication, compared to rooms without such elements. Other studies have suggested that artwork depicting nature can achieve similar results, although many have argued that soothing abstract artwork can be equally effective. Realizing the subjective nature of art appreciation, more and more hospitals are developing art carts that visit patients’ rooms and allow patients to personally select the artwork that will grace their rooms. Art is also being installed in procedure rooms, particularly on ceilings, to provide a more soothing, less threatening environment and/or to serve as a pleasant distraction. Similarly, live music is being used in procedure rooms as well as at the bedside. Music is not just an acoustic pleasantry. One study demonstrated remarkable financial savings when music was played for children undergoing diagnostic procedures. Cost reductions related to a decreased need for nursing support, decreased need for sedation, and greater success of the diagnostic procedure itself.

Active participation in the arts has also proved useful in assisting patients and families endure the long confinement of dialysis and other lengthy medical treatments. And applications of the arts are not confined to the interior of medical facilities: Meditative and healing gardens, labyrinths, and sculpture gardens are increasingly being recognized as valuable for providing a welcomed respite for patients, families, and staff alike. The arts and medical treatments

The arts also play a role in the active treatment of medical conditions. Dance and movement therapies are being used to increase the mobility of patients with Parkinson’s disease and other conditions that diminish movement. Singing allows aphasic patients an avenue toward speech recovery. Museum visits and art-making are being used as adjunctive approaches in treating patients with Alzheimer’s disease. Art, music, dance, drama, and poetry therapies have all been used to help patients express, reflect on, and respond to their experiences. Although these creative arts therapies were initially applied as variants of psychotherapy, their use has expanded to treatment of numerous medical conditions. This should come as no surprise; what patient dealing with chronic disease is immune from the psychological challenges that derive from physical, social, and occupational impairments? The arts and prevention

The field of medicine has increasingly emphasized the importance of efforts aimed at disease prevention, and the arts have a tremendous ability to address this goal. Dancing has been recognized as one of the best ways to fend off cognitive decline, and has been proposed as one approach to increase exercise and address the growing obesity epidemic. An interesting variation on the theme, called Conductorcise, is a particularly enjoyable way to combine music appreciation and exercise in a group format. In England, the Get Healthy, Get Singing


program uses song and dance to improve self-esteem, combat bullying, and promote healthy eating and exercise in schools. In Africa, art murals educate about disease prevention, and here in Minnesota, painted sidewalks have emphasized safe sex and HIV prevention. Clearly, these efforts have great potential to help individuals and communities alike. But art is not limited to addressing the physical needs of the population. Disease trends are often associated with a lack of social cohesion and community health. The arts have a tremendous ability to pull communities together, as exemplified by beaded dollmaking in AIDs-ridden villages in Africa and lantern-making in the north of England. The arts and physicians

Most physicians entered medical school with some experience in the arts, such as participation in choirs, orchestras, garage bands, theater, dance, art classes, poetry, or story writing. Medical school matriculation is often associated with an abrupt end to

Art, music, dance, drama, and poetry therapies have all been used to help patients express, reflect on, and respond to their experiences. these creative endeavors in the face of new demands for rigorous study. However, the sacrifice of these creative pursuits may reflect the sacrifice of skills that made these students good candidates for medicine in the first place. Indeed, further exposure to the arts may produce better physicians. For example, training in observational skills and art appreciation has been demonstrated to improve clinical observational skills. Instruction in music appreciation has been shown to improve auscultation skills. Narrative medicine is being used to improve the ability of medical students to better understand, appreciate, and articulate their patients’ stories. Theatrical skills are being used to improve communication skills, empathy, and resilience in

medical students. Locally, the University of Minnesota offers a program that encourages medical students to continue in previous creative endeavors or to explore new artistic avenues in recognition of the value that the arts play in producing wellrounded physicians. Physicians face exciting yet challenging careers. The personal costs of burnout, compassion fatigue, and decision fatigue are gaining increasing attention in our field, and discussions of what contributes to physician resilience are becoming more relevant. The arts provide tools to reflect upon our own demanding lives, engage our creativity, and discover a respite from our challenging and hectic lives. There is value in reconnecting with our artistic roots and/or

developing new ones. The arts are a valuable adjunct to our care for patients as well as ourselves. Physicians should be encouraged to learn more about the multifaceted arts-in-healthcare movement, which recognizes the power that the arts can play as an adjunctive approach to healing. Two useful resources are the Society for the Arts in Healthcare (www.thesah.org), the largest international organization representing the interests of all who share an interest in arts and health care approaches, and the local Midwest Arts and Healthcare Network (www.maihn.org). Gary A.-H. Christenson, MD, is director of mental health at the University of Minnesota’s Boynton Health Service, an adjunct associate professor of psychiatry at the University of Minnesota Medical School, and a Distinguished Fellow of the American Psychiatric Association. He is president of the Society for the Arts and Healthcare and former co-chair of the Midwest Arts in Healthcare Network.

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Partnerships from cover nerships in 11 counties and their public health departments (Dodge, Fillmore, Freeborn, Goodhue, Houston, Mower, Olmsted, Rice, Steele, Wabasha, and Winona); all 47 public school districts; long-term care facilities; and several health care providers, including Mayo Clinic Health System, Mayo Clinic, Olmsted Medical Center, and Winona Health. The SE MN Beacon program focuses on two chronic health conditions: childhood asthma and adult-type 2 diabetes. In addition, immunizations have become a primary initiative of the program. Southeast Minnesota has a long history of working collaboratively within communities of practice; examples include the SE MN Tobacco initiative, Rochester Epidemiology Project, SE MN Immunization Connection, SE MN Statewide Health Improvement Program, SE Local Public Health Association, and Healthcare System Preparedness Program Southeast MN. So it was natural to

develop a community of practice to focus on the Beacon work. While a large focus of the program is the health techno logy foundation, electronic records and electronic health information exchange will not, of themselves, improve the health of patients. Rather, im proving how the data are used at the point of care will allow health professionals to make better-informed decisions. Therefore, patient and community preferences will also be essential in developing new community care-delivery models.

quickly access valuable information about patients (e.g., allergies, medications, relevant health conditions), allowing them to offer the patient the right care at the right time. It will also reduce costs by avoiding test and procedure duplication and unintended consequences such as adverse medication reactions. The HIE will incorporate technologies and processes safeguards and protections to ensure that all health care information in any exchange complies with HIPAA regulations.

Information technology

Telemedicine

All of the primary care and local public health providers involved in the Beacon project have adopted EHR systems. The Beacon grant will help them move toward adopting a standards-based Health Information Exchange (HIE). The region is deploying national IT standards to facilitate access to and retrieval of clinical data across the disparate health care information systems. This will enable health care professionals to

Winona has been designated as the community in the SE MN Beacon program to implement an expanded use of broadband technologies for a communitywide telemedicine network, through its partnership with Hiawatha Broadband Communications. This network provides a secure, HIPAA-compliant, highcapacity system that will provide and connect telemedicine stations at public and private schools, public subsidized housing, assisted-living and nursing home facilities, the county jail, group homes for the disabled, and county agencies that serve these populations. Each location will be given a shared access multimedia telemedicine station that allows live, encrypted video conferencing. These stations will support remote medical data collection, patient assessment, confidential access to personal health records, and communications to all health care services on the network. The goal is to determine how best to deploy appropriate technology to help better connect the entire community to the Winona health system and enhance the patient experience.

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Satisfying conversations

Ensuring that the preferences and values of the community, patients, and health care professionals are integrated into the Beacon program has been a critical value since the program’s inception. Toward that end, we held community engagement sessions early in the SE MN Beacon initiative. We asked area residents about their hopes and

concerns regarding the Beacon effort to improve electronic information exchange in order to improve community health. We also asked what trade-offs they would be willing to make as the technology is developed (e.g., what level-of-access trade-off— light vs. restricted—is appropriate for allowing a school nurse to care for a child?). This structured conversation method proved so valuable that a formal focus-group engagement process, involving additional surveys and advisory groups, was built into the program as a best practice for each project initiative. Many of the project teams have found that the focus groups and surveys provided direct feedback on issues directly affecting the new care-delivery models. In the case of patients with diabetes, for example, a model of shared decision-making was created and is being deployed across the region. The model encourages patients and families to share their values through direct conversation with health care providers in the health decision-making process. This aspect of the care-delivery model is based on the premise that engaging patients directly in their care has a direct and positive correlation to adherence. New models of care

Based on the health data exchange foundation, and with processes informed by community and patient conversations, new models of community care are already emerging. Asthma. One community care model focuses on asthma care in school-aged children. Research has shown that chronic asthma affects a student’s ability to exercise and take part in school activities, as well as self-esteem and school attendance and performance. The goal of the asthma project is to collaboratively develop a “cocoon of care” for children with chronic asthma by coordinating health education and care for students at their home, provider, and school. As a first step, primary care providers, public health, school PARTNERSHIPS to page 38


NOVEMBER 2011

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Victoza® (liraglutide [rDNA origin] injection) Rx Only BRIEF SUMMARY. Please consult package insert for full prescribing information. WARNING: RISK OF THYROID C-CELL TUMORS: Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice. It is unknown whether Victoza® causes thyroid C-cell tumors, including medullary thyroid 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 insulin has not been studied. CONTRAINDICATIONS: Victoza® is contraindicated in patients with a personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). WARNINGS AND PRECAUTIONS: Risk of Thyroid C-cell Tumors: Liraglutide causes dosedependent and treatment-duration-dependent thyroid C-cell tumors (adenomas and/or carcinomas) at clinically relevant exposures in both genders of rats and mice. Malignant thyroid C-cell carcinomas were detected in rats and mice. A statistically significant increase in cancer was observed in rats receiving liraglutide at 8-times clinical exposure compared to controls. It is unknown whether Victoza® will cause thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as the human relevance of liraglutide-induced rodent thyroid C-cell tumors could not be determined by clinical or nonclinical studies [see Boxed Warning, Contraindications]. In the clinical trials, there have been 4 reported cases of thyroid C-cell hyperplasia among Victoza®-treated patients and 1 case in a comparator-treated patient (1.3 vs. 0.6 cases per 1000 patient-years). One additional case of thyroid C-cell hyperplasia in a Victoza®-treated patient and 1 case of MTC in a comparator-treated patient have subsequently been reported. This comparator-treated patient with MTC had pre-treatment serum calcitonin concentrations >1000 ng/L suggesting pre-existing disease. All of these cases were diagnosed after thyroidectomy, which was prompted by abnormal results on routine, protocol-specified measurements of serum calcitonin. Four of the five liraglutide-treated patients had elevated calcitonin concentrations at baseline and throughout the trial. One liraglutide and one non-liraglutide-treated patient developed elevated calcitonin concentrations while on treatment. Calcitonin, a biological marker of MTC, was measured throughout the clinical development program. The serum calcitonin assay used in the Victoza® clinical trials had a lower limit of quantification (LLOQ) of 0.7 ng/L and the upper limit of the reference range was 5.0 ng/L for women and 8.4 ng/L for men. At Weeks 26 and 52 in the clinical trials, adjusted mean serum calcitonin concentrations were higher in Victoza®-treated patients compared to placebo-treated patients but not compared to patients receiving active comparator. At these timepoints, the adjusted mean serum calcitonin values (~ 1.0 ng/L) were just above the LLOQ with between-group differences in adjusted mean serum calcitonin values of approximately 0.1 ng/L or less. Among patients with pre-treatment serum calcitonin below the upper limit of the reference range, shifts to above the upper limit of the reference range which persisted in subsequent measurements occurred most 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 ontreatment 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 placebotreated 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 were 7 cases of pancreatitis among Victoza®-treated patients and 1 case among comparator-treated patients (2.2 vs. 0.6 cases per 1000 patient-years). Five cases with Victoza® were reported as acute pancreatitis and two cases with Victoza® were reported as chronic pancreatitis. In one case in a Victoza®-treated patient,

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MINNESOTA PHYSICIAN

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pancreatitis, with necrosis, was observed and led to death; however clinical causality could not be established. One additional case of pancreatitis has subsequently been reported in a Victoza®-treated patient. Some patients had other risk factors for pancreatitis, such as a history of cholelithiasis or alcohol abuse. There are no conclusive data establishing a risk of pancreatitis with Victoza® treatment. After initiation of Victoza®, and after dose increases, observe patients carefully for signs and symptoms of pancreatitis (including persistent severe abdominal pain, sometimes radiating to the back and which may or may not be accompanied by vomiting). If pancreatitis is suspected, Victoza® and other 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) may have an increased risk of hypoglycemia. In the clinical trials of at least 26 weeks duration, hypoglycemia requiring the assistance of another person for treatment occurred in 7 Victoza®-treated patients and in two comparator-treated patients. Six of these 7 patients treated with Victoza® were also taking a sulfonylurea. The risk of hypoglycemia may be lowered by a reduction in the dose of sulfonylurea or other insulin secretagogues [see Adverse Reactions]. Renal Impairment: Victoza® has not been found to be directly nephrotoxic in animal studies or clinical trials. There have been postmarketing reports of acute renal failure and worsening of chronic renal failure, which may sometimes require hemodialysis in Victoza®-treated patients [see Adverse Reactions]. Some of these events were reported in patients without known underlying renal disease. A majority of the reported events occurred in patients who had experienced nausea, vomiting, diarrhea, or dehydration [see Adverse Reactions]. Some of the reported events occurred in patients receiving one or more 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. 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® was evaluated in a 52-week monotherapy trial and in five 26-week, add-on combination therapy trials. In the monotherapy trial, patients were treated with Victoza® 1.2 mg daily, Victoza® 1.8 mg daily, or glimepiride 8 mg daily. In the add-on to metformin trial, patients were treated with Victoza® 0.6 mg, Victoza® 1.2 mg, Victoza® 1.8 mg, placebo, or glimepiride 4 mg. In the add-on to glimepiride trial, patients were treated with Victoza® 0.6 mg, Victoza® 1.2 mg, Victoza® 1.8 mg, placebo, or rosiglitazone 4 mg. In the add-on to metformin + glimepiride trial, patients were treated with Victoza® 1.8 mg, placebo, or insulin glargine. In the add-on to metformin + rosiglitazone trial, patients were treated with Victoza® 1.2 mg, Victoza® 1.8 mg or placebo. Withdrawals: The incidence of withdrawal due to adverse events was 7.8% for Victoza®-treated patients and 3.4% for comparatortreated patients in the five controlled trials of 26 weeks duration or longer. This difference was driven by withdrawals due to gastrointestinal adverse reactions, which occurred in 5.0% of Victoza®-treated patients and 0.5% of comparator-treated patients. The most common adverse reactions leading to withdrawal for Victoza®-treated patients were nausea (2.8% versus 0% for comparator) and vomiting (1.5% versus 0.1% for comparator). Withdrawal due to gastrointestinal adverse events mainly occurred during the first 2-3 months of the trials. Tables 1, 2 and 3 summarize the adverse events reported in ≥5% of Victoza®-treated patients in the six controlled trials of 26 weeks duration or longer. Table 1: Adverse events reported in ≥5% of Victoza®-treated patients or ≥5% of glimepiride-treated patients: 52-week monotherapy trial All Victoza® N = 497 Glimepiride N = 248 (%) (%) Adverse Event Term Nausea 28.4 8.5 Diarrhea 17.1 8.9 Vomiting 10.9 3.6 Constipation 9.9 4.8 Upper Respiratory Tract Infection 9.5 5.6 Headache 9.1 9.3 Influenza 7.4 3.6 Urinary Tract Infection 6.0 4.0 Dizziness 5.8 5.2 Sinusitis 5.6 6.0 Nasopharyngitis 5.2 5.2 Back Pain 5.0 4.4 Hypertension 3.0 6.0 Table 2: Adverse events reported in ≥5% of Victoza®-treated patients and occurring more frequently with Victoza® compared to placebo: 26-week combination therapy trials Add-on to Metformin Trial All Victoza® + Placebo + Glimepiride + Metformin N = 724 Metformin N = 121 Metformin N = 242 (%) (%) (%) Adverse Event Term 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 All Victoza® + Placebo + Glimepiride Rosiglitazone + Glimepiride N = 695 N = 114 Glimepiride N = 231 (%) (%) (%) Adverse Event Term Nausea 7.5 1.8 2.6 Diarrhea 7.2 1.8 2.2


Victoza® (liraglutide [rDNA origin] injection) Rx Only BRIEF SUMMARY. Please consult package insert for full prescribing information. WARNING: RISK OF THYROID C-CELL TUMORS: Liraglutide causes dose-dependent and 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 insulin has not been studied. CONTRAINDICATIONS: Victoza® is contraindicated in patients with a personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). WARNINGS AND PRECAUTIONS: Risk of Thyroid C-cell Tumors: Liraglutide causes dosedependent and treatment-duration-dependent thyroid C-cell tumors (adenomas and/or carcinomas) at clinically relevant exposures in both genders of rats and mice. Malignant thyroid C-cell carcinomas were detected in rats and mice. A statistically significant increase in cancer was observed in rats receiving liraglutide at 8-times clinical exposure compared to controls. It is unknown whether Victoza® will cause thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as the human relevance of liraglutide-induced rodent thyroid C-cell tumors could not be determined by clinical or nonclinical studies [see Boxed Warning, Contraindications]. In the clinical trials, there have been 4 reported cases of thyroid C-cell hyperplasia among Victoza®-treated patients and 1 case in a comparator-treated patient (1.3 vs. 0.6 cases per 1000 patient-years). One additional case of thyroid C-cell hyperplasia in a Victoza®-treated patient and 1 case of MTC in a comparator-treated patient have subsequently been reported. This comparator-treated patient with MTC had pre-treatment serum calcitonin concentrations >1000 ng/L suggesting pre-existing disease. All of these cases were diagnosed after thyroidectomy, which was prompted by abnormal results on routine, protocol-specified measurements of serum calcitonin. Four of the five liraglutide-treated patients had elevated calcitonin concentrations at baseline and throughout the trial. One liraglutide and one non-liraglutide-treated patient developed elevated calcitonin concentrations while on treatment. Calcitonin, a biological marker of MTC, was measured throughout the clinical development program. The serum calcitonin assay used in the Victoza® clinical trials had a lower limit of quantification (LLOQ) of 0.7 ng/L and the upper limit of the reference range was 5.0 ng/L for women and 8.4 ng/L for men. At Weeks 26 and 52 in the clinical trials, adjusted mean serum calcitonin concentrations were higher in Victoza®-treated patients compared to placebo-treated patients but not compared to patients receiving active comparator. At these timepoints, the adjusted mean serum calcitonin values (~ 1.0 ng/L) were just above the LLOQ with between-group differences in adjusted mean serum calcitonin values of approximately 0.1 ng/L or less. Among patients with pre-treatment serum calcitonin below the upper limit of the reference range, shifts to above the upper limit of the reference range which persisted in subsequent measurements occurred most 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 ontreatment 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 placebotreated 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 were 7 cases of pancreatitis among Victoza®-treated patients and 1 case among comparator-treated patients (2.2 vs. 0.6 cases per 1000 patient-years). Five cases with Victoza® were reported as acute pancreatitis and two cases with Victoza® were reported as chronic pancreatitis. In one case in a Victoza®-treated patient,

pancreatitis, with necrosis, was observed and led to death; however clinical causality could not be established. One additional case of pancreatitis has subsequently been reported in a Victoza®-treated patient. Some patients had other risk factors for pancreatitis, such as a history of cholelithiasis or alcohol abuse. There are no conclusive data establishing a risk of pancreatitis with Victoza® treatment. After initiation of Victoza®, and after dose increases, observe patients carefully for signs and symptoms of pancreatitis (including persistent severe abdominal pain, sometimes radiating to the back and which may or may not be accompanied by vomiting). If pancreatitis is suspected, Victoza® and other 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) may have an increased risk of hypoglycemia. In the clinical trials of at least 26 weeks duration, hypoglycemia requiring the assistance of another person for treatment occurred in 7 Victoza®-treated patients and in two comparator-treated patients. Six of these 7 patients treated with Victoza® were also taking a sulfonylurea. The risk of hypoglycemia may be lowered by a reduction in the dose of sulfonylurea or other insulin secretagogues [see Adverse Reactions]. Renal Impairment: Victoza® has not been found to be directly nephrotoxic in animal studies or clinical trials. There have been postmarketing reports of acute renal failure and worsening of chronic renal failure, which may sometimes require hemodialysis in Victoza®-treated patients [see Adverse Reactions]. Some of these events were reported in patients without known underlying renal disease. A majority of the reported events occurred in patients who had experienced nausea, vomiting, diarrhea, or dehydration [see Adverse Reactions]. Some of the reported events occurred in patients receiving one or more 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. 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® was evaluated in a 52-week monotherapy trial and in five 26-week, add-on combination therapy trials. In the monotherapy trial, patients were treated with Victoza® 1.2 mg daily, Victoza® 1.8 mg daily, or glimepiride 8 mg daily. In the add-on to metformin trial, patients were treated with Victoza® 0.6 mg, Victoza® 1.2 mg, Victoza® 1.8 mg, placebo, or glimepiride 4 mg. In the add-on to glimepiride trial, patients were treated with Victoza® 0.6 mg, Victoza® 1.2 mg, Victoza® 1.8 mg, placebo, or rosiglitazone 4 mg. In the add-on to metformin + glimepiride trial, patients were treated with Victoza® 1.8 mg, placebo, or insulin glargine. In the add-on to metformin + rosiglitazone trial, patients were treated with Victoza® 1.2 mg, Victoza® 1.8 mg or placebo. Withdrawals: The incidence of withdrawal due to adverse events was 7.8% for Victoza®-treated patients and 3.4% for comparatortreated patients in the five controlled trials of 26 weeks duration or longer. This difference was driven by withdrawals due to gastrointestinal adverse reactions, which occurred in 5.0% of Victoza®-treated patients and 0.5% of comparator-treated patients. The most common adverse reactions leading to withdrawal for Victoza®-treated patients were nausea (2.8% versus 0% for comparator) and vomiting (1.5% versus 0.1% for comparator). Withdrawal due to gastrointestinal adverse events mainly occurred during the first 2-3 months of the trials. Tables 1, 2 and 3 summarize the adverse events reported in ≥5% of Victoza®-treated patients in the six controlled trials of 26 weeks duration or longer. Table 1: Adverse events reported in ≥5% of Victoza®-treated patients or ≥5% of glimepiride-treated patients: 52-week monotherapy trial All Victoza® N = 497 Glimepiride N = 248 (%) (%) Adverse Event Term Nausea 28.4 8.5 Diarrhea 17.1 8.9 Vomiting 10.9 3.6 Constipation 9.9 4.8 Upper Respiratory Tract Infection 9.5 5.6 Headache 9.1 9.3 Influenza 7.4 3.6 Urinary Tract Infection 6.0 4.0 Dizziness 5.8 5.2 Sinusitis 5.6 6.0 Nasopharyngitis 5.2 5.2 Back Pain 5.0 4.4 Hypertension 3.0 6.0 Table 2: Adverse events reported in ≥5% of Victoza®-treated patients and occurring more frequently with Victoza® compared to placebo: 26-week combination therapy trials Add-on to Metformin Trial All Victoza® + Placebo + Glimepiride + Metformin N = 724 Metformin N = 121 Metformin N = 242 (%) (%) (%) Adverse Event Term 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 All Victoza® + Placebo + Glimepiride Rosiglitazone + Glimepiride N = 695 N = 114 Glimepiride N = 231 (%) (%) (%) Adverse Event Term Nausea 7.5 1.8 2.6 Diarrhea 7.2 1.8 2.2

NOVEMBER 2011

MINNESOTA PHYSICIAN

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RESEARCH

M

edical practice leaders are often drawn to the potential benefits of starting a clinical research program, including: • Access to cutting-edge medical devices or pharmaceutical products not available elsewhere • Access to alternative treatments for those of your patients who might have limited options for treatment or are unable to afford expensive treatments • Increased number of patients seeking care in your clinical practice • added prestige and peer recognition for your practice • Increased knowledge base, expanded professional development opportunities, and intellectual stimulation for your staff. Though it may seem like a natural evolution for a practice to create a clinical research arm to capture these potential benefits, conducting good clinical research in a busy clinical practice is a real challenge since sub-

Starting a clinical research program Is it a natural evolution to your practice? By Pamela J. Wolfe and Joy L. Frestedt, PhD

tle, but fundamental, differences exist between clinical care and research. Consider, for example, how the mindset of the clinical investigator treating a research subject differs from the mindset of a clinician treating a patient. Within a clinical practice, physicians treat patients with the desire to improve their health and well-being. In research, clinical investigators must follow a written clinical trial protocol and treat study subjects in a specific way to evaluate if the study product is safe, effective, and performs as intended (compared to a control product). Clinicians must fully understand their role as researchers if they plan to participate in a clinical study.

Public Health Certificate in Clinical Research The University of Minnesota School of Public Health offers a program for people who work with research clinical applications on human beings but who do not have an advanced degree in clinical research. Coursework is conveniently offered online and the program can be completed in six terms.

www.sph.umn.edu/programs/certificate/cr 16

MINNESOTA PHYSICIAN NOVEMBER 2011

Take stock of resources

When assessing the feasibility of a clinical research program, you must consider many factors, including (but not limited to) staff availability, education/training, experience, documentation practices, and infrastructure. Although similarities exist between the research and clinical practices needed to execute a research program, care must be taken to address the specialized needs and requirements that are unique to a research program. Staff: To run research trials, you’ll need to designate a current staff member or hire a new staff member as a clinical research coordinator (CRC). This person must have the interpersonal skills, management abilities, and self-initiative to interact well with research subjects, sponsors, and monitoring personnel, as well as the institutional review board and/or ethics committee. The CRC will coordinate these complex projects with the other staff in your practice while managing all the varied tasks required during a clinical trial. A strong coordinator— someone who can deftly manage the detailed day-to-day aspects of running a trial while working with subjects, staff, and sponsors, all at the same time—is essential to the success of the project. The CRC works under the direct guidance of the principal investigator (PI), who delegates responsibility for many requirements of the clinical trial site management (e.g., study documentation, subject consenting and enrollment). The CRC serves as the PI’s liaison to the sponsor as well as to legal and regulatory agencies. A trained and experienced CRC, particularly one certified by a nationally reputable professional society like the Asso-

ciation of Clinical Research Professionals or the Society of Clinical Research Professionals, can be an invaluable asset to your practice. If you designate a current staff member to become a CRC, simply adding research responsibilities to that person’s already full list of job responsibilities is not recommended. A better plan is to offload certain clinical duties so that the designated CRC can dedicate sufficient time to complete the research responsibilities. Research documentation tends to be much more intensive than is typical in a routine clinical practice, and the documentation practices are highly regulated, so ensuring your staff has adequate time for documentation is of paramount importance. Education/training: To conduct a clinical trial in compliance with ethical and regulatory requirements, staff members need to be educated and experienced in following good clinical practice (GCP) during research activities. In addition to GCP and human subjects protection (HSP) training, the staff will need training on specific regulations that apply to the trials you intend to run. The principal investigator will need to have GCP and HSP training as well as protocolspecific training and will need to invest time in learning the specific requirements for the role of PI. Many courses are designed to provide busy practitioners with the knowledge and training required for managing a clinical trial. In addition, consultants may be able to tailor a training program to meet specific needs. Experience: Another regulatory requirement is that the PI and staff must have experience running a clinical trial before starting a trial at their location. If you’ve never conducted a clinical trial before, you may want to bring in consultants and a few temporary staff members to help you get started and train your future research team. The goal is to create a well-organized, efficient team that can manage both clinical and research responsibilities.


Getting funded to do clinical research Documentation practices: Although health care practitioners are required to document all patient interactions, clinical research requirements take the concept of documentation to a whole new level. The importance of good documentation practices (GDPs) canâ&#x20AC;&#x2122;t be stressed enough, since GDP and full compliance with the requirements of the study protocol are required for all clinical research programs. The study documents specified in the regulations may not be part of your basic medical record or practice management system. Filling out all of the required study documents and ensuring that accurate information is recorded on these documents takes time and dedication. All data/documentation must be forwarded to the sponsor, the data must all be analyzed and cleaned, and all questions must be answered. The research site staff and PI need to be prepared for this time commitment and plan for this work to ensure they have enough time to complete all the

Here are a few potential funding ideas for your site: Sign on for a corporate-sponsored trial. You will need to market your site to sponsors, so you will need to know what they want to hear about your practice and what is possible at your site for clinical trial activities. Sponsors will assess your suitability for their trials based upon your facilities, staff, and patient demographics. In Minnesota, more than 1,400 clinical trials currently are enrolling subjects (see www.clinicaltrials.gov and type in â&#x20AC;&#x153;Minnesotaâ&#x20AC;?). A caveat: Donâ&#x20AC;&#x2122;t assume that your site should become an investigative site just because a sponsor brings a trial to your attention. Fund your own investigator-initiated trial (IIT). You will need to show the return on investment for yourself or your business to make the expense of an IIT worthwhile. Seek funding from a sponsor or other agency to run an IIT. To make this work, you must know how to write grants and market your practice for research. Although more than 450 NIH and federally sponsored clinical trials are enrolling in Minnesota, most grants are not funded. If you decide to apply for a grant, be prepared for a lack of revenue to cover the writingâ&#x20AC;&#x201D;and expect to write about 10 grants before you get funded. Partner with another institution or cooperative group to work on trials selected by the group (typically funded by a sponsor or the sites within the cooperative group). Examples in oncology are the North Central Cancer Trials Group, the Community Clinical Oncology Program, and the Radiation Therapy Oncology Group. paperwork in a timely fashion. Infrastructure: Although your existing facility may have sufficient space for your clinical activities, you may need to have a separate space for the follow-

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ing research activities: â&#x20AC;˘ A locked room with limited access to store the investigational product â&#x20AC;˘ A storage location for study binders, regulatory binders,

and subject files (kept separate from your clinical records) â&#x20AC;˘ A relatively private space for study monitors to conduct their monitoring visits â&#x20AC;˘ A dedicated research desk so the research coordinator has all the appropriate office technology (phone, fax, computer, Internet) to work on the trial. These may seem like simple issues, but in essence, the research practice should be designed in parallel with your clinical practiceâ&#x20AC;&#x201D;not incorporated into it. Patient recruitment: For good patient recruitment, you will need to define a process to ensure strong coordination between your clinical practice team and your clinical research team. Identifying subjects who meet the study inclusion criteria from your existing practice is a critical first step. Research subject flow and billing: On the front end, you will need to develop a process allowing patients to flow through the practice and into PROGRAM to page 18

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NOVEMBER 2011

MINNESOTA PHYSICIAN

17


Program from page 17 the research area in a manner that does not compromise their identity as research subjects and does not upset the flow of patients for clinic care. The back office must implement procedures to ensure study subjects are billed appropriately without billing third-party payers for any charges paid by the sponsor. Double-billing for research services can lead to serious legal problems for the practice. Legal issues (contracts, agreements, etc.): You may need a legal representative with clinical trial experience to help you work through the legal issues. For example, knowing whether indemnification is appropriate and whether you should be paid for start-up fees are just two of the many legal issues you may encounter. Technology: Having the right technology is important to make a clinical trial run smoothly. Most sponsors communicate by email and many use electronic data capture, so having up-to-date computers and convenient access for your

research staff is required. Finances/budget: Can you afford to run this trial? Budget planning is a critical step, and practices new to clinical research may find it helpful to bring in an expert in the planning stages to ensure all hidden costs are clear and are addressed in the site budget. Before negotiating the final agreements with the research sponsor, a thorough budgeting process is required to ensure that all procedures and overhead costs are accounted for in the site budget. The need to secure funding to run a clinical trial is not always well understood. (Some common misconceptions: The research will not cost money, or should be “really easy to do.”) The costs to your practice require careful consideration. The sidebar provides ideas for securing funding for a clinical trial. Too daunting, or a good fit?

discussion, here are some questions to consider: • Is this trial a good fit with your practice and your interest in clinical research? (For example, if your practice is entirely focused on noninvasive pain management but you are considering a trial for a surgically implanted device, this is probably not a good fit.) Always keep in mind your patients and the value of the research to those patients. • Do you have enough study subjects available within your practice to make it feasible to run the study? • Does your staff have the training, experience, and time available to do the work? • Are your facilities sufficient for conducting the study? • Do your clinic’s finances make it feasible to run the study without losing too much money? If these (or other) research issues present major roadblocks, then clinical research is likely not a good fit for your practice. If the possibility of engaging in clinical research seems

appealing, we suggest reviewing the current trials being run in your area of expertise (www.clinicaltrials.gov) and discussing next steps with a reputable consultant to help you prepare. If you feel your practice is ready to start conducting research, begin a thoughtful, planful approach to make this evolution as smooth as possible. Review the resources needed— including staff, education, space, technology, and finances —and take the time necessary to make this new research practice into a natural extension of the treatment options your patients can expect from a cutting-edge, dynamic, prestigious practice. Pamela J. Wolfe is strategic project manager and Joy L. Frestedt, PhD, is president and CEO at Frestedt Inc., a clinical research consulting group.

Come Listen! As with any new venture, your due diligence is required in determining whether or not to conduct a clinical research study. Summarizing the above

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MINNESOTA PHYSICIAN NOVEMBER 2011


For more information: Partnerships from page 12 nurses, and parents together created an asthma toolkit to help nurses and other staff members in the region’s public schools deal effectively with children’s chronic asthma symptoms in school. This means that all the participating schools (representing 47 school districts) will have the information and resources they need to develop their own asthma management plans to help their students. The final toolkit has been distributed to all stakeholders and made available online. Health care professionals in the Beacon communities are creating asthma action plans for their patients and, with consent from parents/guardians, are sending these plans to schools. In focus groups and surveys, health care professionals said they felt it would be valuable to their care for patients with asthma if they could hear from school nurses how their patients are doing in school. This effort to coordinate the asthma action plan, parent/guardian permission, and resources will help health care professionals and school nurses work together more closely in caring for schoolchildren with asthma. Immunization. By expanding school-based care, the SE MN Beacon Immunization Initiative promotes vaccinating school-aged youth against influenza in school. The overall goal of the initiative is to enhance the existing Minnesota Immunization Information Connection system of immunization records and to improve processes for vaccination administration in the community. Collaborating with the Olmsted County School Immunization project, partners with Olmsted County Public Health, Olmsted Medical Center, and Mayo Clinic are providing influenza vaccination administration for Southeast Minnesota’s pediatric population in schools. The goal is to increase the influenza vaccination rate for juvenile patients by enhancing processes in pre-existing school-based clinics. Nurses will set up clinics for pre-registered children to receive their flu shot

• Southeast Minnesota Beacon Program: www.semnbeacon.org • Office of the National Coordinator for Health Information Technology/Beacon: http://healthit.hhs.gov/portal/server.pt/ community/healthit_hhs_gov__hitech_programs/1487 (click on “Beacon Community Program”) during the school day, eliminating the need for parents to take time off work and pull their children out of school to be immunized. This partnership aims to improve the pre-existing systems and expand the processes into other schools across the Southeast Minnesota community. Diabetes. For people with diabetes, a new model brings each patient’s perspective on well-being to real-time clinical treatment. This model of care uses technology to include patient-reported outcomes, with minimum burden to the patient, clinicians, and affiliated systems. Allowing diabetic patients to gauge their quality of life triggers real-time suggestions in clinical pathways for supportive care, treatment changes, or community care. Asking patients to complete a brief questionaire that indicates the most pressing/urgent/first-mentioned needs of the patient prior to their visit provides health professionals with cues to probe further, take clinical action, or engage appropriate referral/supportive ser vices. When patients are able to address their high-priority socioeconomic issues, they become better able to focus on addressing their health issues. Quality-of-life measures also allow tracking over time of patient well-being and treatment outcomes in primary and secondary care. Hospital discharge. The SE MN Beacon is also working on a care model to improve communication and planning around hospital discharge. Many patients use care providers and case managers from the community. These individuals possess knowledge of the patient’s home environment that is not easily assessed during a hospitalization. With a patient’s permission, local public health systems will update hospital EMRs with names of clients served by public health nurses in the community. Hospital systems will then match these clients to admission records and electronically notify

the appropriate public health department when one of their clients has been hospitalized. This will allow communitybased public health nurse case managers to share their assessments of patients’ home environments with treating physicians and hospital staff, resulting in a coordinated, community-inclusive plan of care. Practice improvement

Clearly, the ability to electronically exchange health information within a community of practice opens up a wide range of practice improvement op tions. Leveraging existing partnerships across the community while including the patient and community perspectives will allow unique care improvement designs to emerge. And coupling regional experience with community involvement in designing new community-inclusive care

models is expected to improve population health. This starts with a commitment to bring people to the table to initiate discussions. Consider existing partnerships or colleagues you have worked with as the place to begin new models of patient-centered care with a community focus. Lacey A. Hart, MBA, PMP, is program director of the Mayo Clinic’s Project Management Office for Health Sciences Research and is program manager of the SHARP and Beacon grants. Daniel Jensen, MPH, is associate director of public health for Olmsted County and is project manager of the Ph-DOC Beacon Project for Olmsted County Public Health. Terrance Donnal, MD, practices primary care, specializing in allergy and asthma, with Winona Health and is the family medicine physician lead for asthma schoolbased care and telemedicine for Beacon projects. Erin Knoebel, MD, is a practicing primary care pediatrician in community pediatric and adolescent medicine at the Mayo Clinic, and is the physician lead for asthma and school-based care for Beacon projects. Linda Williams, MD, practices primary care and family medicine at Olmsted Medical Center and is the physician lead for the diabetes and patient portal Beacon projects.

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SPECIAL

Rural health care faces unique challenges posed by geography, limited resources, and an aging

FOCUS:

RURAL

H E A LT H

A virtual hospital experience Telehealth expands beyond traditional offerings

population served by a dwindling supply of

By Sarah Kappel, RN, CCRN

health care practitioners. The four articles in this month’s special focus explore different ways of meeting the needs of patients in rural Minnesota: through hospital telemedicine systems; community palliative care services; accessible clinical trials; and collaborative approaches to a changing health care environment as health care reforms take hold.

heart disease, cancer, and chroninnesota is a land of ic obstructive pulmonary disextremes—100-degree ease. These complex patients are summer days and most often treated by primary subzero winter nights; large care physicians because they do cosmopolitan centers and prisnot have the time or the resourtine wilderness; and, notably, ces to travel to a specialist. world-class health care centers Diminishing rural populaand medically underserved tions and professional isolation communities. make physician and nursing Much of Minnesota is rural recruitment a —small communiFor more information challenge in rural ties populated by regarding telehealth program communities. aging citizens development, contact the Often, a rural hoswith complex Great Plains Telehealth pital is supported health care needs. Resource and Assistance by only one or Statistically, rural Center at www.gptrac.org. two family-praccitizens in the tice physicians, Upper Midwest are more likely who are expected to take call than their urban counterparts to one in every two days. Long suffer from chronic health conditions such as hypertension and clinic hours and frequent call

M

responsibilities, along with a lack of collegial support, contribute to high rates of burnout and difficulty with physician retention. In the 1980s and 1990s, telehealth (also known as telemedicine) began to emerge as an alternative to traditional patient care. Over time, expanded technology use and accessibility to lightning-fast Internet connections have established telehealth as a reliable and cost-effective way to share clinical expertise across a wide geographic area. Telehealth technology has advanced drastically over the past decade. Today, integrated electronic medical records (EMRs) and picture archiving and communications systems (PACs) allow telemedicine providers to access all of the information needed to accurately assess and diagnosis a patient. Telemedicine interactions are conducted through the use of two-way audio and video equipment. These video units allow the telemedicine staff a firsthand view of the patient, with images so exact a clinician can

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MINNESOTA PHYSICIAN NOVEMBER 2011


eCare services in action in Minnesota assess a patient’s wound, IV infusion rate, and even pupil size. Audio interaction allows clinicians to speak to the patient, family, and any providers in the room at the same time, just as though they were standing together at the bedside. Telemedicine technology provides rural facilities a unique opportunity to access the specialist services available at larger urban centers. By sharing one specialist among a multitude of smaller hospitals, this technology can help ensure that every patient receives the highest quality, most appropriate care every time. Now, rural hospitals are adding telemedicine models to cover intensive care unit, pharmacy, and emergency care services to support patients across the care continuum. The eCare model

One model that is demonstrating the promise of telehealth in serving the needs of rural communities is Avera eCare, a suite of telehealth services that leverages the specialty care resources of tertiary care facilities across the Upper Midwest. Using eCare’s two-way audio and video technology, providers in one location can assess and manage patients hundreds of miles away. Avera, a health-care system based in Sioux Falls, S.D., developed the eCare model to meet the needs of rural communities across South Dakota, Minnesota, Iowa, Nebraska, North Dakota, and Wyoming. Avera eCare is currently available in 77 hospitals and clinics throughout the upper Midwest and has touched the lives of more than 90,000 patients to date. Since the inception of traditional telemedicine consults in 1994 (now called eConsult), Avera has expanded its telemedicine offerings to include Avera eICU Care, eEmergency, and ePharmacy. Specialist consultation services

eConsult, the first of Avera’s telehealth models, makes it possible for patients to receive a specialist consult in their home community, rather than traveling to an urban center. Using two-way audio and video equipment and

Those hearing about the benefits of telehealth may be skeptical of the benefits. This was true of the medical team in Madison, Minn., who agreed to a trial of the Avera eCare service in their hospital. Following is a retelling of one of their experiences. eEmergency provides a vital service to our facility and many smaller hospitals without an in-house variety of specialties. Recently, we received a patient in the Emergency Department with a major laceration and arterial bleed. Besides the immediate risk of major blood loss, the patient was at significant risk of long-term disability and needed rapid transport and surgery for muscle, tendon, and vascular repair. The eEmergency nurse and physician assessed the patient via the camera and used the same camera to consult with a surgeon. The eEmergency staff called for helicopter transport and organized pickup by the local ambulance to reach the helicopter. When the surgeon decided that the level of injury to the patient would be best treated at the Mayo Clinic in Rochester, Minn., eEmergency staff made all of the arrangements for fixed-wing transport. During this Emergency Department visit, the hospital floor (including the Emergency Department) was staffed with two nurses, one who remained with the patient and one who assisted and cared for the inpatients. Another LPN was assisting the physician with sutures and hemorrhage control. The eEmergency service was vital to the rapid transport of the patient. Furthermore, without visualization of the injury by the accepting physician, the patient would have been transferred to Sioux Falls, S.D., and then to Rochester, significantly increasing the cost to the patient and the risk of long-term disability to the limb. With the push of a button, our hospital has access to the resources of the eEmergency physician and nurse who coordinate the specialty care needed to provide optimal care for our patients. In a situation where time is of the essence, this resource can make a critical difference in patient outcomes. — Ruth DeWeerd, RN (trauma coordinator, Madison, Minn.)

from a dedicated intensivist, and this disparity is predicted to worsen in the coming years. Through the use of advanced monitoring software and an integrated EMR system, Avera eICU Care provides 24hour-a-day remote monitoring of the region’s most critically ill patients. The eICU center is staffed by an intensivist and an experienced critical care nurse who monitor trends in patient vital signs and lab values, identifying and preventing potential complications before they occur. Through eICU Care, more than 60 percent of the ICU patients in South Dakota receive care oversight provided by an intensivist. Avera calculates that 714 patients who were predicted to die have left the hospital alive since the inception of its eICU technology service in September 2004. Emergency care

When a critically ill patient presents to the emergency department of a small rural hospital, two nurses and an aide are often TELEHEALTH to page 25

specialized stethoscopes, otoscopes, and examination cameras, a specialty provider can assess the patient just as if provider and patient were faceto-face. For more than 5,000 patients each year, eConsult eliminates the need for costly travel and increases compliance with follow-up visits by simplifying the process for patients and providers. More than 20 specialties currently provide care using eConsult, including infectious disease, oncology, pediatric cardiology and pediatric GI services.

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n Minnesota, as elsewhere, the need for palliative careâ&#x20AC;&#x201D; which centers on relieving suffering and improving quality of life for patients who have a serious or advanced illness and their familiesâ&#x20AC;&#x201D;is increasing as people generally are living longer, often with multiple serious chronic illnesses. The need for palliative care services is especially acute in rural Minnesota, with its disproportionate and growing population of older adults: 41 percent of rural residents are over age 65, though only 30 percent of all residents live in rural communities. To foster expansion in care delivery, Stratis Health and Fairview Health Servicesâ&#x20AC;&#x2122; Palliative Care Program have teamed up to support rural communities in developing or enhancing palliative care services. Since the program was launched in 2008, 10 rural communities have participated in the Minnesota Rural Palliative Care Initiative, an 18-month learning collaborative to establish or strengthen palliative care

RURAL

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Palliative care initiatives Collaborative models enhance services in rural communities By Janelle Shearer, RN, BSN, MA, and Karla Weng, MPH

programs in their communities. Palliative care is often part of the health care services offered in urban areas, but this is not so in rural communities. In urban areas, large patient volumes allow health care staff to specialize in palliative care. The typical hospital-based palliative care team model, which includes a certified physician or advance practice nurse, is difficult to implement in rural communities. In addition, small rural hospitals designated as critical access have a per-diem, costbased reimbursement system, so they do not have the same financial benefit for earlier discharge or less intense care that other

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MINNESOTA PHYSICIAN NOVEMBER 2011

hospitals do. In its 2011 report, the National Palliative Care Research Center gave Minnesota an overall grade of â&#x20AC;&#x153;A,â&#x20AC;? but the stateâ&#x20AC;&#x2122;s rural communities with small hospitals lag behind medium and larger hospitals in offering palliative care, 39 percent versus about 89 percent. However, the challenges that rural areas face in developing palliative care services are balanced by some advantages that some of their urban counterparts lack. Because of their smaller populations, people in rural communities are more broadly interconnected than are larger cities, making partnerships across organizations easier to foster. Because resources have always been limited, rural communities bring a pull-yourselfup-by-the-bootstraps attitude to solving problems. As might be expected, Minnesotaâ&#x20AC;&#x2122;s rural communities have demonstrated creativity in finding solutions to the lack of applicable service delivery models to support their palliative care programs. Minnesota Rural Palliative Care Initiative

Ten rural Minnesota communities worked to establish or strengthen palliative care programs in their communities through the Minnesota Rural Palliative Care Initiative: Bemidji, New Ulm, Olivia, Red Wing, Roseau, Staples, Waconia, Wadena, Willmar, and Winona. The populations served in the communities ranged in size from 9,000 to 200,000, with a median of 49,000. Stratis Health led the initiative, acting as the convener and bringing expertise in rural health, quality improvement, and learning collaboratives. Fairview provided clinical and operational expertise in pallia-

tive care. UCare funded the initiative and played an advisory role. Each participating community was required to have a multi-setting, interdisciplinary team to work with Stratis Health staff and consultants on developing and/or enhancing palliative care services in their community. The 10 community teams included various combinations of nurses, physicians, social workers, chaplains, and others. Many participants had experience in caring for people with advanced illness in various settings within their communities. Participants represented hospitals, home care, hospice programs, long-term care, clinics, assisted living, a college department of nursing, parish nurses, clergy, and public health agencies. In all, 64 organizations were represented across the 10 teams. The collaborative included three in-person learning sessions and technical assistance for the community teams. The technical assistance and coaching, which were provided throughout the initiative, included three webinar conferences covering the topics of implementing family conferences, pain management, and starting a rural palliative care program. Participants in the collaborative welcomed the support and have connected across communities to provide the best care for their patients. Communities improve processes, systems

Six of the 10 communities were enrolling patients as of April 2011 and were providing interdisciplinary palliative care services at the conclusion of the collaborative. The other four communities focused on developing and/or improving processes to improve certain aspects of palliative care, such as advance care planning; implementation of common order sets across care settings to support patient transitions; and education about palliative care for health care professionals and others in their communities. All 10 of the participating communities worked toward process and system improvements related to aspects of


TABLE 1. Variables in Rural Palliative Care Program Structure Methods of Interdisciplinary palliative care. Nine service delivery team communities implemented advance care Clinic appointments All teams included planning/advance direcphysician care, Home visits tives; seven implementsocial work, Inpatient nursing ed common order sets consultation across care settings or Other disciplines Nursing home visits varying by consistent order sets among two or more Telephonic case program: settings; eight offered management Advance practice community education Volunteer support nurse in psychiatry and outreach; and eight visits/services Chaplain provided education to Nurse practitioner health care profesPharmacy sionals. The models for Rehabilitation service delivery develservices oped by the participatVolunteers ing communities vary widely. Services may be patient and family, but also psybased out of home care services chosocial, spiritual, and other or led by an RN or NP coordinatypes of support they need. tor housed in the clinic or hospiTo support advance care tal. Services may focus on planning, the team implemented patients in the hospital or nursHonoring Choices Minnesota, a ing home or on those receiving continuum of conversations home care or outpatient services aimed at helping patients, famisuch as infusion therapy. Several lies, and health care providers teams support home-based and reflect upon, discuss, and undercommunity-level support stand the patient’s goals for their through telephone contact current and future health care. and/or volunteer visits. The community team also comTable 1 and the Red Wing pleted a patient satisfaction surand Winona community examvey and conducted “Living Well ples below highlight the diverswith Chronic Conditions” workity of palliative care program shops for community members structures in rural communities. that included palliative care and advance care planning.

Patient focus

Coordinating staff

Home care with complex illness

Advance practice nurse

Hospice eligible but refused

Registered nurse Social worker

Infusion therapy Inpatient consult when requested Physician referred with complex illness Nursing home residents—triggered by Minimum Data Set criteria for complex management

Palliative care and hospice

team—a physician, nursing staff, and a social worker—meets every two weeks to discuss patient care plans. They have standard order sets to consistently manage pain and other symptoms. The nursing home has a focus on advance care planning. After the collaborative ended, the Winona team was excited about the prospect of doing the consultative work—

Both the Red Wing and Winona communities have found that their palliative care programs have enhanced their hospice programs. Referrals to hospice are made easier, and the transition from palliative care to hospice is seamless. Palliative care supports the patient and the family, so when staff see clinical changes that lead to discussing or recommending hospice care, the patient is ready and the family is ready. When patients are PALLIATIVE to page 24

NOW hear this!

Red Wing community

Through the Minnesota Rural Palliative Care Initiative, Fairview Red Wing Health Services led the Red Wing community team, which focused on service delivery in the nursing home, outpatient clinic, and community. A nurse practitioner serves as the key palliative care contact through the nursing home. An interdisciplinary team composed of a social worker, nurse, and palliative care provider has official palliative care consultations with the patient and patient’s family in the three long-term care facilities in Red Wing. They talk about the patient’s and family’s concerns and how they can develop a plan to benefit the patient and family as a whole unit, rather than focusing only on the patient. The consult team helps determine how to provide not just physical support to the

Winona community

The Winona community team, led by Winona Area Hospice, provides palliative care services through home care and the nursing home. Services, including pain and symptom management, are available to patients who qualify for the Medicare Home Care benefit. The community wanted to reduce the number of visits to the emergency room and the number of hospitalizations, and to increase care in the patient homes. It had been talking about palliative care for years and the Minnesota Rural Palliative Care Initiative provided the support to get their program off the ground. The collaborative got them organized to get started. Through Winona’s palliative care services, a nurse and a social worker interact with patients. Its interdisciplinary

helping families and patients get the services they need. They view their palliative care work as more than a program; it’s a philosophy of patient care. The “whole team” approach helps people with chronic illness, and their families, receive support, care, and resources, and allows the team to help people throughout the whole continuum of their care.

D

o you know of family members, friends or neighbors who have difficulty using their telephone? Do they have trouble hearing, speaking or have a physical disability that prevents them from using a standard telephone? The Minnesota Telephone Equipment Distribution Program can provide special telephone equipment at NO CHARGE to Minnesota residents of all ages!! The equipment includes amplified (corded and cordless) phones, speakerphones, captioned telephones, telephone ring signalers, deafblind equipment and other special equipment. To learn more about this program visit our Web site at: www.tedprogram.org or contact us at (800) 657-3663, (888) 206-6555 TTY. Eligibility requirements do apply.

The Telephone Equipment Distribution Program is administered by the Department of Commerce Telecommunication Access Minnesota (TAM) and funded by a telephone surcharge. NOVEMBER 2011

MINNESOTA PHYSICIAN

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Palliative from page 23 transitioned from palliative care to hospice, their symptoms have already been aggressively managed and treated. It’s a much smoother transition than starting someone on hospice care in the heart of a crisis.

Combining a collaborative model with community capacity-building, the Minnesota Rural Palliative Care Initiative has enhanced palliative care delivery in rural Minnesota.

Highlights of the initiative

Numerous tools are available to support patients and address barriers in care coordination and reducing hospital readmissions; the primary challenge is bringing together community teams to implement the tools, processes, and services. Combining a collaborative model with community capacitybuilding, the Minnesota Rural Palliative Care Initiative has enhanced palliative care delivery in rural Minnesota. Here are some highlights of the initiative: • A microsite, www.stratishealth. org/palcare, was developed to share palliative care information. The microsite includes resources for program development, links to national guidelines and resources, example

tools, and resources from the rural communities (e.g., action plans, descriptions of relevant quality improvement projects, clinical order sets, clinical assessment tools). • The communities established an ongoing networking group to continue discussing topics and issues related to palliative care in rural areas. • At the conclusion of the project, six of the 10 communities were enrolling patients and providing interdisciplinary palliative care services. Three of the communities expanded services beyond their initial pilot site. • All 10 communities developed a work plan to implement a

palliative care program. • Eighty-one percent of the health care professionals involved in the initiative reported increased knowledge regarding effective discussions of care and goals; 73 percent reported increased knowledge regarding pain management. Three factors have contributed in a major way to the success of the initiative: the commitment of the community team leads and team members; the increasing local and national attention given to palliative care during the course of the project; and the structure and resources provided by Stratis Health and its partners.

Although many rural communities have strong interest in developing palliative care services, as evidenced by the 35 applicants for this initiative, few communities are able to move forward without some external technical assistance and support. Stratis Health will launch another rural palliative care initiative in 2012 to provide the external resources and support needed for additional rural communities to develop palliative care services. Janelle Shearer, RN, BSN, MA, and Karla Weng, MPH, are program managers with Stratis Health, where they co-lead rural palliative care projects. Shearer also leads the Care Transitions/ Readmission Initiative and the Rural Patient Safety Culture Project, and has more than 10 years’ experience as a home health/hospice services director in rural Minnesota. Weng is program lead for Stratis Health’s rural health work and oversees coordination of health plan quality improvement.

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Telehealth from page 21 the only clinicians available to begin stabilizing treatment while the on-call physician drives in from home. Avera’s eEmergency service provides local hospitals with immediate, around-theclock access to a board-certified emergency medicine physician and an experienced emergency nurse. Using sophisticated two-way cameras, the eEmergency physician performs a complete assessment and can examine a wound, manage a resuscitation effort, or guide local providers through procedures such as intubation or chest tube insertion. The eEmergency service offers local providers the support necessary to stabilize seriously ill patients, reducing the need to transfer patients to tertiary care facilities. When patient transfer is needed, the eEmergency team makes arrangements and notifies providers at the receiving facility. Pharmacy services

Federal regulations require every medication order to be reviewed by a pharmacist prior to administration. However, the limited number of pharmacists practicing in rural communities, coupled with the high cost of pharmacist salaries, has left many rural facilities with an onsite pharmacist less than 10 percent of the time. Pharmacists play a vital role in patient safety by reviewing medication orders for potential drug-drug interactions, allergies, and correct dosing to prevent harmful adverse drug events. Avera’s ePharmacy service provides rural facilities with this vital pharmacist support 100 percent of the time. ePharmacy links a hospitaltrained pharmacist to rural facilities throughout the region. Using an integrated EMR and order management system that sorts and queues orders as they arrive, the ePharmacy staff is able to review every medication order before the drug is administered to the patient. Since 2009, ePharmacy has prevented 3,637 serious safety events and has improved remote clinicians’ knowledge of medication prescription and administration by

Above: Offsite specialists from eICU and eEmergency consult remotely via telehealth technology with rural hospitals.

assisting with pharmacokinetic dosing, anticoagulation management, and antibiotic selection.

ing the resource gap; and for bringing technology and clinicians together.

Sarah Kappel, RN, CCRN, is the eCare quality manager at Sioux Falls, S.D.-based Avera. eICU is a registered trademark of Visicu, Inc.

The future of telehealth

Since Avera’s telehealth program was launched in 1994, it has demonstrated the following results: • eEmergency has resulted in 435 avoided transfers, totaling $3,295,413 in avoided air transfer costs. • eICU Care has saved 19,023 ICU days, for more than $30 million in estimated savings. • ePharmacy oversight has resulted in $16,730,000 in costs avoided due to prevention of serious safety events. • eConsult saves patients and families $46,000 in travel expenses each month. One challenge to the expansion of telemedicine services is that reimbursement of telemedicine services has not kept pace with advances in the field. CMS has authorized reimbursement of some telemedicine services, but significant regulatory barriers inhibit widespread adoption. Telemed-icine providers and users are continuing to advocate for improving reimbursement of telemedicine services. Avera continues to develop models that support patients across the care continuum and through transitional points in care. Reducing hospital readmission rates, providing urgent care services to target populations, and encouraging home health care success are important avenues for future development. Avera, like other telemedicine providers, strongly believes that telemedicine services are a viable solution for decreasing economic shortfalls and minimizing workforce shortages; for bridg-

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ural health care providers face unique challenges when it comes to carrying out clinical trials for their patients. From monitoring patientsâ&#x20AC;&#x2122; progress from afar to transporting and tracking medications between research hubs and local sites, rural providers offering research studies must overcome different hurdles than their urban counterparts. Duluthbased Essentia Institute of Rural Health (EIRH) is tackling those challenges as it strives to bring state-of-the-art research opportunities to underserved rural populations in Minnesota, Wisconsin, North Dakota, and Idaho. A patient named Deborah, who lives in the woods near Motley, Minn., serves as a good illustration of these efforts. She is one of just 56 women in North America involved in a clinical cancer trialâ&#x20AC;&#x201D;and she participates through Essentia Healthâ&#x20AC;&#x2122;s Cancer Center in Brainerd, only a 20-mile drive from her home. Increasingly, oncology and

FOCUS:

RURAL

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Forgotten no longer Taking clinical trials to rural regions By Daniel A. Nikcevich, MD, PhD, and Jane Brissett

other clinical research is being designed to be accessible to patients who donâ&#x20AC;&#x2122;t live near urban medical centers in Minnesota and elsewhere. And researchers are beginning to seek out these rural patients to bring the latest care closer to patientsâ&#x20AC;&#x2122; homes. â&#x20AC;&#x153;The forgottenâ&#x20AC;? patients

In the United States as a whole, rural areas account for about 25 percent of the population but just 10 percent of physicians, according to the National Rural Health Association (NRHA). Nonurban regions have 40 specialists per 100,000 population, compared with about 134 specialists per 100,000 in urban areas, the NHRA reports. In addition,

rural residents are older, poorer, sicker, and less likely to be covered by private insurance than city dwellers. â&#x20AC;&#x153;For years rural patients were â&#x20AC;&#x2DC;the forgotten,â&#x20AC;&#x2122;â&#x20AC;? says Anne Forsman, RN, BSN, OCN, clinical research manager of Essentiaâ&#x20AC;&#x2122;s oncology clinical trials. But that is changing, and itâ&#x20AC;&#x2122;s good both for the patientsâ&#x20AC;&#x201D; who now have access to cuttingedge treatments, medications, and medical devices earlierâ&#x20AC;&#x201D; and for researchers, who are getting results from an increasingly diverse set of patients, she said. â&#x20AC;&#x153;One advantage that we have is the rural population,â&#x20AC;? says Larry Clifford, grants development director for EIRH. Seventy-four percent of the population in Essentiaâ&#x20AC;&#x2122;s service region is rural. The majority of its facilities, as well as patients, are in communities outside of metropolitan areas. Combined resources

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MINNESOTA PHYSICIAN NOVEMBER 2011

In the summer of 2010, Essentia began bringing together the resources of its member organizationsâ&#x20AC;&#x201D;SMDC Health System, Innovis Health, and Brainerd Lakes Health. The system now comprises 14 hospitals, 64 clinics, and about 1,500 physicians and credentialed practitioners. Access to clinical trials is a top priority for the Essentia Institute of Rural Health, which was formed to improve the health and health care for rural populations through research and education. EIRH provides the centralized administrative, financial, and clinical oversight for the systemâ&#x20AC;&#x2122;s research. In fiscal year 2010, more than 1,800 Essentia patients participated in nearly 400 clinical trials and other studies, many conducted in collaboration with Duke University, Mayo Clinic, and Cleveland Clinic. Eighty-two Essentia physicians

and health care professionals are engaged in clinical and health services research. Duluth Clinic, now part of Essentia, began conducting oncology research in 1978. Its research division has grown to 65 employees today, including investigators, biostatisticians, informatics analysts, clinical research nurses and coordinators, and other staff, and includes other specialties such as cardiovascular research. Current oncology clinical trials include studies of brain, breast, gastrointestinal, prostate, ovarian, lung, renal, and head and neck cancers, in addition to studies of lymphoma, leukemia, multiple myeloma, melanoma, symptom management and cancer prevention. Longer reach

Each year, Essentia treats 2,500 patients with new cancer diagnoses. Last year the system had 778 oncology trial participants. Until recently, the 80-plus open adult oncology studies were conducted at Essentia Health in Duluth, Hibbing, Virginia (Minn.), and Ashland, Wis., plus a few non-Essentia research sites, including one in Cloquet. Rural expansion of the trials will give Essentiaâ&#x20AC;&#x2122;s research a much longer reach. Thatâ&#x20AC;&#x2122;s important because patients who live in rural areas often canâ&#x20AC;&#x2122;t participate in studies if they must drive long distances. If a patient is required to have her blood drawn three days in a row for a study, it might be fine if she lives a few miles away from her research site. But if she lives 70 miles away, she might not comply, or even participate. As a member of the Community Clinical Oncology Program (CCOP) since 1984, Essentia is part of a national network for testing and validating National Cancer Instituteapproved clinical oncology trials. It is one of only two CCOP programs funded by the National Cancer Institute in Minnesota. Through CCOP, the Duluth Clinic participated in some large-scale cancer prevention trials, including the 13,000-woman Breast Cancer Prevention Trial and the 18,000-


man Prostate Cancer Prevention trial. Essentia Health and the Essentia Institute of Rural Health have begun collaborating with members of the HMO Research Network, a group that has accepted the EIRH into its membership. Other, larger health systems in the 19-member research network include the Marshfield Clinic in Wisconsin, Geisinger Health System in Pennsylvania, HealthPartners in Minneapolis, and Group Health of Seattle. The Duluth-based system also is affiliated with the North Central Cancer Treatment Group, Alliance for Clinical Trials, National Surgical Adjuvant Breast and Bowel Project, Eastern Cooperative Oncology Group, Children’s Oncology Group, and other national cancer networks. On the cutting edge

Belonging to those groups means researchers “suddenly have colleagues throughout the nation,” Forsman says. Essentia researchers work with academ-

ics on protocols and benefit along with the patients from trial results. “It keeps our physicians right up there in the forefront of cutting-edge knowledge,” she says. They also want to be able to use their knowledge at rural sites and to have protocols that can be used at clinics or hospitals that aren’t as well equipped as academic health centers or large urban hospitals. Essentia Health St. Joseph’s Medical Center in Brainerd recently joined the Duluth CCOP and is currently enrolling patients in 24 studies that focus on breast, lung, and gastrointestinal cancers, which are the most common cancers treated at its Cancer Center in Brainerd. The Essentia Health Cancer Center in Fargo was recently approved to join the CCOP and is expected to be operational by the end of 2011. Both the Brainerd and Fargo medical centers are community hospital cancer centers accredited by the American College of Surgeons Commission on Cancer and are medical hubs

for rural clinics in their regions. Plans call for them to extend the trials to their outreach sites once all systems are working. Fargo has participated in a few clinical trials, including industry-sponsored research. Essentia Health St. Joseph’s Medical Center has not had an active research program in the recent past. Expanding the breadth and depth of clinical trials

The Essentia Institute of Rural Health uses technology that allows clinics with patients enrolled in the trials to communicate with the research team in Duluth, so researchers visit only periodically. Duluth research staff, scientists, an institutional review board, a scientific review board, regulatory staff, biostatisticians, grants specialists, and other support staff are available to all Essentia affiliates to assist with protocols and deal with data and regulatory matters. An electronic data warehouse in Duluth is a key element, collecting information from a variety of sources at each research site.

Essentia’s clinical trials at rural sites will continue to expand in the next three to five years. “We will be seeking more funding to support medical research,” Clifford says. He and his staff will hunt for funds for clinical trials in oncology, cardiology, pain management, and neurology. Essentia can’t—and doesn’t intend to—conduct clinical research in every specialty or subspecialty. But in the coming years, the system intends to be conducting clinical trials across all of its regions and at nonEssentia sites as well—ensuring that rural patients are no longer “the forgotten” in clinical research. Daniel A. Nikcevich, MD, PhD, is an oncologist with Essentia Health. Jane Brissett writes for Essentia Health.

Medical Director/Chief Health Officer Boynton Health Service has an exciting opportunity for a Medical Director/Chief Health Officer. This senior leadership position is primarily responsible for directing medical services, ensuring staff adherence to relevant regulations and highest professional and ethical standards, and collaboration with the Director in formulating long range strategic planning and policies. The ideal applicant will have strong leadership skills, and an ability to work with a diverse population. Experience in a college health setting, and knowledge of electronic health records, third party accreditation standards, and public health approaches to maintaining and improving community health would be beneficial. The Medical Director/Chief Health Officer will also provide some patient care time each week. To learn more please contact David Golden, Director, Public Health and Communications (612) 626-6738, dgolden@bhs.umn.edu Boynton Health Service offers a competitive salary and excellent benefits including CME. Apply online at https://employment.umn. edu and reference requisition number 173177. The University of Minnesota is an Equal Opportunity, Affirmative Action Educator and Employer

NOVEMBER 2011

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or the 72 million Americans currently living in rural areas, local hospitals and rural health clinics are a critically important and, often, sole source of health care. Approximately 3,800 federally designated rural health clinics, combined with 2,000 hospitals and hundreds more community health centers, constitute a fragile safety net for almost a quarter of our nation’s population. These institutions, and the physicians, nurses, and allied health professionals who work in them, face immense challenges as the provisions of the Affordable Care Act (ACA) of 2010 go into effect. Marcia Brand, former director of the federal Office of Rural Health Policy, once commented that her office should have been called the “Office of Unintended Consequences,” implying that with each major federal reform initiative, rural providers were unintentionally disadvantaged as a consequence. The ACA will be no exception. Whatever the pros and cons of the legislation, there is no question that it will bring

RURAL

H E A LT H

Sowing seeds of change Health care reform and rural providers By Terry Hill, MPA

major change—and that it may unintentionally sow the seeds of rural health destruction. The ACA presents challenges for all providers—urban and rural—but the fragile nature of the rural health infrastructure leaves little room for error. Within the ACA also reside opportunities to strengthen rural health organizations and help meet some of their historic needs. This article explores some of the major challenges for rural providers and suggests opportunities to work together and prosper in the new health care environment. Provider supply

In rural America, accessing primary care physicians and get-

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MINNESOTA PHYSICIAN NOVEMBER 2011

ting timely care are becoming increasingly difficult. More than 65 million people live in areas designated by the federal government as primary care provider shortage areas. As the baby boomer population in these areas ages and requires more health services, the demand for primary care will escalate dramatically. In addition, the new medical home and accountable care models require an adequate supply of primary care physicians, thereby increasing the demand even more. Although the ACA includes several provisions to increase the supply of rural primary care providers, there is little optimism that our medical schools and residency programs will be able to produce the supply of physicians needed in the short term. ACA provisions to expand the National Health Services Corps, provide new rural physician training grants, and increase the number of rural residency training slots will not be enough to offset the growing demand for primary physicians in large cities, nor the impact of increasing medical student debt that discourages physicians from choosing lower-paying specialties. Other predicted rural shortages include the supply of nurses, technicians, therapists, pharmacists, dentists, health information technology (HIT) professionals, and various medical specialists. Rural nurses, for example, are, on average, 10 years older than their urban counterparts, and may retire if the economy improves or if they are able to acquire alternate sources of health insurance. Experienced health information specialists will prove even more difficult to attract than physicians; they already constitute the nation’s largest professional shortage.

Rural hospitals

Since more than 60 percent of the typical rural hospital’s revenue comes from Medicare/ Medicaid payments, the current government financial crisis and the anticipated reimbursement cuts will have a disproportionately greater impact on rural hospitals than on their urban counterparts. The critical access hospital (CAH) designation and its cost-based reimbursement have been a lifeline for these hospitals, but proposals to cut both the numbers and funding for CAHs have ominous implications. We can expect an increasing number of rural hospital closures in the years ahead, even if the cuts are minimal. The new, significantly more demanding health care environment, combined with growing difficulties in accessing capital, will close the doors of the weakest hospitals, and greater federal reimbursement cuts would probably close many more. Reforms and cutbacks will pose immense challenges to rural hospitals, but they can also be a gateway to greater efficiency, innovation, and partnerships. Opportunities for rural hospitals include operating with greater efficiency; developing partnerships with other rural hospitals to produce economies of scale; and joining health systems and networks that provide access to capital and needed expertise. For example, the SISU network, a consortium of 20 hospitals in northern Minnesota, provides comprehensive HIT coverage to its members. Other hospital networks run a variety of jointly owned services, and the hospitals often jointly own diagnostic equipment. New models of health care delivery

Rural providers should remain cautious about urban-based policies and large health system programs that can potentially damage rural health care delivery. The population-based accountable care organization (ACO) model, for example, was not constructed with rural providers in mind. The requirement that ACOs have at least 5,000 Medicare-covered lives leaves


rural providers playing a secondary role, at best. But rural stakeholders must participate in ACO discussions or run the risk of being left behind. Clint MacKinney, MD, of Minnesota, along with Keith Meuler and Tim McBride of the Rural Policy Research Institute, recently wrote that two possible scenarios may play out in assessing the possible impact of ACOs: “Best: Rural health care leadership will creatively and proactively develop health care delivery innovations that serve rural people and … ensure the long-term viability of local rural health care providers. Rural providers will develop networks with other rural providers to coordinate services that improve care and reduce costs. Rural networks will then initiate mutually beneficial collaborations with … larger health systems. “Worst: Urban health systems will use their financial strength, leadership experience, market dominance, and policy clout to leverage market share from rural providers. Urban predators will shift patients out

of rural areas to support extensive urban infrastructure investments. An attitude will prevail that dismisses the need for all but the most basic rural health services, … rural provider shortages will worsen … rural hospitals will degrade … and rural access to quality health services will diminish.” (Journal of Rural Health 27(2011), 131–137, National Rural Health Association) Preventing the worst-case scenario will require assertive and effective rural health leadership and advocacy. Policymakers are generally unaware of the circumstances and the realities of rural health-care delivery, so it will be important for rural providers voices to be heard in discussions of policy alternatives. Though rural providers will find it difficult to successfully develop ACOs as currently defined, they can participate in larger system-led ACOs and provide important value in their roles as care managers and medical leaders. While physicians have not necessarily driven health care

changes in the past, they are uniquely situated to help drive health industry change in the present and future. Simply by virtue of the orders they write, physicians are responsible for 80 to 90 percent of all health care costs. Funding for pharmaceuticals, hospitals, long-term care, and almost everything else flows through medical providers. The new models therefore will be dependent on physician leadership and partnership, in both rural and urban settings. Physician-hospital relationships have not always been smooth, but these two groups will need to work together effectively in the new health system models. This will require collaborative leadership from physicians and hospitals, transparency and accountability, alignment of goals and cultures, meaningful incentives, and, ultimately, trust. The same can be said for successful collaboration between urban and rural providers. Trust will take time to build, but it will be the essential component for productive new business relationships.

Health information technology

Within the ACA is the HITECH provision that requires all hospitals and medical clinics to reach “meaningful use” of electronic health records (EHRs) by 2015. Financial incentives are available to providers reaching meaningful use by the deadline; but penalties for noncompliance, including the loss of a percentage of Medicare payments, are also included. The movement to electronic records theoretically will improve health care, save money, and lead to superior care management. EHRs are a central component of the new reform models and will increasingly be a prerequisite for recruiting young physicians and nurses. Rural clinics and rural hospitals will have to acquire and maintain expensive EHR systems as a price of doing business in the reform era. Unfortunately, rural hospitals and clinics lag behind their urban counterparts in EHR adoption. The ACA provides funding for 62 new HIT regional extension centers, which have CHANGE to page 38

A Diverse and Vital Health Service

Boynton Health Service

Psychiatrist

Welcome to Boynton Health Service >ŽĐĂƚĞĚ ŝŶ ƚŚĞ ŚĞĂƌƚ ŽĨ ƚŚĞ dǁŝŶ ŝƟĞƐ ĂƐƚ ĂŶŬ ĐĂŵƉƵƐ͕ ŽLJŶƚŽŶ ,ĞĂůƚŚ ^ĞƌǀŝĐĞ ŝƐ Ă ǀŝƚĂů ƉĂƌƚ ŽĨ ƚŚĞ hŶŝǀĞƌƐŝƚLJ ŽĨ DŝŶŶĞƐŽƚĂ ĐŽŵŵƵŶŝƚLJ͕ ƉƌŽǀŝĚŝŶŐ ĂŵďƵůĂƚŽƌLJ ĐĂƌĞ͕ ŚĞĂůƚŚ ĞĚƵĐĂƟŽŶ͕ ĂŶĚ ƉƵďůŝĐ ŚĞĂůƚŚ ƐĞƌǀŝĐĞƐ ƚŽ ƚŚĞ hŶŝǀĞƌƐŝƚLJ ĨŽƌ ŶĞĂƌůLJ ϵϬ LJĞĂƌƐ͘ /ƚ͛Ɛ ŽƵƌ ŵŝƐƐŝŽŶ ƚŽ ĐƌĞĂƚĞ Ă ŚĞĂůƚŚLJ ĐŽŵŵƵŶŝƚLJ ďLJ ǁŽƌŬŝŶŐ ǁŝƚŚ ƐƚƵĚĞŶƚƐ͕ ƐƚĂī͕ ĂŶĚ ĨĂĐƵůƚLJ ƚŽ ĂĐŚŝĞǀĞ ƉŚLJƐŝĐĂů͕ ĞŵŽƟŽŶĂů͕ ĂŶĚ ƐŽĐŝĂů ǁĞůůͲďĞŝŶŐ͘ ŽLJŶƚŽŶ͛Ɛ ŽƵƚƐƚĂŶĚŝŶŐ ƐƚĂī ŽĨ ϮϱϬ ŝŶĐůƵĚĞƐ ďŽĂƌĚ ĐĞƌƟĮĞĚ ƉŚLJƐŝĐŝĂŶƐ͕ ŶƵƌƐĞ ƉƌĂĐƟƟŽŶĞƌƐ͕ ƌĞŐŝƐƚĞƌĞĚ ŶƵƌƐĞƐ͕ DƐͬ>WEƐ͕ ƉŚLJƐŝĐŝĂŶ ĂƐƐŝƐƚĂŶƚƐ͕ ĚĞŶƟƐƚƐ͕ ĚĞŶƚĂů ŚLJŐŝĞŶŝƐƚƐ͕ ŽƉƚŽŵĞƚƌŝƐƚƐ͕ ƉŚLJƐŝĐĂů ĂŶĚ ŵĂƐƐĂŐĞ ƚŚĞƌĂƉŝƐƚƐ͕ ƌĞŐŝƐƚĞƌĞĚ ĚŝĞƟƟĂŶƐ͕ ƉŚĂƌŵĂĐŝƐƚƐ͕ ƉƐLJĐŚŝĂƚƌŝƐƚƐ͕ ƉƐLJĐŚŽůŽŐŝƐƚƐ͕ ĂŶĚ ƐŽĐŝĂů ǁŽƌŬĞƌƐ͘ KƵƌ ŵƵůƟĚŝƐĐŝƉůŝŶĂƌLJ ŚĞĂůƚŚ ƐĞƌǀŝĐĞ ŚĂƐ ďĞĞŶ ĐŽŶƟŶƵŽƵƐůLJ ĂĐĐƌĞĚŝƚĞĚ ďLJ , ƐŝŶĐĞ ϭϵϳϵ͕ ĂŶĚ ǁĂƐ ƚŚĞ ĮƌƐƚ ĐŽůůĞŐĞ ŚĞĂůƚŚ ƐĞƌǀŝĐĞ ƚŽ ŚĂǀĞ ĞĂƌŶĞĚ ƚŚŝƐ ĚŝƐƟŶĐƟŽŶ͘ ƩĞŶĚŝŶŐ ƚŽ ŽǀĞƌ ϭϬϬ͕ϬϬϬ ƉĂƟĞŶƚ ǀŝƐŝƚƐ ĞĂĐŚ LJĞĂƌ͕ ŽLJŶƚŽŶ ,ĞĂůƚŚ ^ĞƌǀŝĐĞ ƚĂŬĞƐ ƉƌŝĚĞ ŝŶ ŵĞĞƟŶŐ ƚŚĞ ŚĞĂůƚŚ ĐĂƌĞ ŶĞĞĚƐ ŽĨ h ŽĨ D ƐƚƵĚĞŶƚƐ͕ ƐƚĂī͕ ĂŶĚ ĨĂĐƵůƚLJ ǁŝƚŚ ĐŽŵƉĂƐƐŝŽŶ ĂŶĚ ƉƌŽĨĞƐƐŝŽŶĂůŝƐŵ͘

ŽLJŶƚŽŶ ,ĞĂůƚŚ ^ĞƌǀŝĐĞ ŝƐ ƐĞĞŬŝŶŐ Ă WƐLJĐŚŝĂƚƌŝƐƚ ƚŽ ǁŽƌŬ ǁŝƚŚ Ă ůĂƌŐĞ ĂŶĚ ĚŝǀĞƌƐĞ ƉŽƉƵůĂƟŽŶ ŽĨ ƐƚƵĚĞŶƚƐ Ăƚ ƚŚƌĞĞ ůŽĐĂů ĐŽůůĞŐĞƐ͕ ŝŶ ĂĚĚŝƟŽŶ ƚŽ ƚŚĞ ,ĞĂůƚŚ ^ĞƌǀŝĐĞ͕ ĂƐ Ă ƌĞƉƌĞƐĞŶƚĂƟǀĞ ŽĨ ƚŚĞ ŵĞŶƚĂů ŚĞĂůƚŚ ĐŽŶƐƵůƚĂƟŽŶͬŽƵƚƌĞĂĐŚ ƉƌŽŐƌĂŵ͘ dŚĞ WƐLJĐŚŝĂƚƌŝƐƚ ǁŝůů ĂůƐŽ ƐĞƌǀĞ ĂƐ Ă ĐŽŶƐƵůƚĂŶƚ ƚŽ ŽƚŚĞƌ ,ĞĂůƚŚ ^ĞƌǀŝĐĞ ƐƚĂī ŵĞŵďĞƌƐ͕ ĂƐ ǁĞůů ĂƐ ƚŚĞ ĨĂĐƵůƚLJ ĂŶĚ ƐƚĂī ŽĨ ƚŚĞƐĞ ŽůůĞŐĞ ĂŶĚ hŶŝǀĞƌƐŝƚLJ ĐŽŵŵƵŶŝƟĞƐ͘  ůŝŵŝƚĞĚ ĂŵŽƵŶƚ ŽĨ ƉƐLJĐŚŽƚŚĞƌĂƉLJ ǁŝůů ĂůƐŽ ďĞ ŝŶǀŽůǀĞĚ͘ ƉƉůŝĐĂŶƚ ŵƵƐƚ ďĞ WE ďŽĂƌĚ ĐĞƌƟĮĞĚͬĞůŝŐŝďůĞ ŝŶ ƉƐLJĐŚŝĂƚƌLJ͘ ŽLJŶƚŽŶ ,ĞĂůƚŚ ^ĞƌǀŝĐĞ ŽīĞƌƐ Ă ĐŽŵƉĞƟƟǀĞ ƐĂůĂƌLJ ĂŶĚ Ă ƌĞǁĂƌĚŝŶŐ ƉƌĂĐƟĐĞ ĞŶǀŝƌŽŶŵĞŶƚ͘ WƌŽĨĞƐƐŝŽŶĂů ůŝĂďŝůŝƚLJ ĐŽǀĞƌĂŐĞ ŝƐ ƉƌŽǀŝĚĞĚ͘ dŽ ůĞĂƌŶ ŵŽƌĞ ƉůĞĂƐĞ ĐŽŶƚĂĐƚ 'ĂƌLJ ŚƌŝƐƚĞŶƐŽŶ͕ D͕͘͘ DĞŶƚĂů ,ĞĂůƚŚ ůŝŶŝĐ ŝƌĞĐƚŽƌ (612) 624-1444͘ ƉƉůLJ ŽŶůŝŶĞ Ăƚ ŚƩƉƐ͗ͬͬĞŵƉůŽLJŵĞŶƚ͘ƵŵŶ͘ĞĚƵ and ƌĞĨĞƌĞŶĐĞ ƌĞƋƵŝƐŝƟŽŶ ŶƵŵďĞƌ 174055͘ dŚĞ hŶŝǀĞƌƐŝƚLJ ŽĨ DŝŶŶĞƐŽƚĂ ŝƐ ĂŶ ƋƵĂů KƉƉŽƌƚƵŶŝƚLJ͕ ĸƌŵĂƟǀĞ ĐƟŽŶ ĚƵĐĂƚŽƌ ĂŶĚ ŵƉůŽLJĞƌ͘

ϰϭϬ ŚƵƌĐŚ ^ƚƌĞĞƚ ^ ͻ DŝŶŶĞĂƉŽůŝƐ͕ DE ϱϱϰϱϱ ͻ ;ϲϭϮͿ ϲϮϱͲϴϰϬϬ ͻ ǁǁǁ͘ďŚƐ͘ƵŵŶ͘ĞĚƵ NOVEMBER 2011

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MEDICARE/MEDICAID

U

ntil about 15 years ago, Medicare enrollment for providers meant completing the HCFA-1513 form, a document with one page of instructions and eight, mostly “yes” or “no” questions. By comparison, the current CMS-855A form is 59 pages long and includes dozens of questions and lengthy directions for answering them. This ballooning in the size of enrollment applications is just one example of the Centers for Medicare & Medicaid Services’ emphasis on ever more rigorous program integrity rules. In addition to constituting CMS’ latest and most ambitious effort in this area, 2010’s Affordable Care Act (ACA) evidences a newfound focus on Medicaid program integrity. While no one disputes the importance of stopping genuine fraud, many of the initiatives that have become effective over the past few years have had the unfortunate consequence of ensnaring honest providers in a web of complex rules. This article summarizes some of CMS’

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Program integrity Keeping the bad guys out, but making things harder for the good guys By Jesse A. Berg, JD, MPH

recent activities in the realm of program integrity. Enrollment revalidation

In 2006, CMS implemented a process known as “revalidation,” which requires providers to confirm the accuracy of their Medicare enrollment. Revalidation did not really begin on a broad scale until 2009, however. Here’s how it works: CMS contacts providers and tells them that applications and supporting documents must be provided within 60 days. Failure to respond within this timeframe can lead to loss of billing privileges for one year, effective just 30 days after CMS mails notice of its determination. Although an appeals process exists, there

MINNESOTA PHYSICIAN NOVEMBER 2011

is no guarantee that a provider will succeed in reversing CMS’ decision. Thus, quick action in response to a revalidation request is imperative. The CMS revalidation initiative has caught many providers off guard, for a number of reasons: • Because revalidation requests have not been sent via certified mail, in some cases these requests have been lost in the everyday shuffle of correspondence. • Some requests have been addressed to practice locations on file with CMS that do not receive mail (i.e., because the provider receives mail at a separate address). • There has been confusion about how revalidation requirements interact with the obligation to report changes of information, like changes in practice locations, to CMS within specified time periods. Some providers have mistakenly thought that revalidation allowed them to wait to inform CMS all at once of changes, when in fact they were obligated to inform the agency within 30 days of the change. CMS recently announced that it would be requiring all providers enrolled in Medicare before March 25, 2011 to revalidate their enrollment—even those providers who have revalidated within the past few years. Only providers that enrolled in Medicare after March 25, 2011, are exempt. Some providers might want to revalidate proactively—with the goal of taking care of this obligation while it is fresh in mind—as opposed to waiting to receive CMS’ request. This apparently is not permitted, however; providers must instead wait to receive a request from CMS.

Medicare & Medicaid provider and supplier screening

A key motivation behind the revalidation initiative is to ensure that all providers go through a new enrollment screening process. Under the ACA, provider types have been placed into three risk categories: limited, moderate, and high. These categories denote the level of screening applicable when a provider initially enrolls in Medicare, adds a new practice location, or revalidates its enrollment. The degree of screening is based on the level of risk CMS believes to be associated with the provider category at issue. CMS relegated only newly enrolling durable medical equipment and home health suppliers to the “high-risk” category. The “moderate” category includes independent diagnostic testing facilities, independent labs, and hospices. The bulk of providers, including hospitals, physician groups, and surgery centers pose “limited” risk. Providers in the high and moderate categories are subject to more rigorous screening, including unannounced site visits and, in the high-risk category, fingerprintbased criminal background checks. The relevant level of screening is not necessarily permanent, as CMS can increase the level of risk applicable to a provider. Among the situations in which CMS will increase from “limited” to “moderate” or “high” are those where a payment suspension has been imposed on the provider or where the provider has been subject to any “final adverse action,” such as a revocation of Medicare billing privileges or suspension of a license to provide health care, during the previous 10 years. When regulations implementing the screening process were proposed, observers asked that providers have a chance to conclude any litigation related to the conduct that formed the basis for CMS’ decision before the agency raised the risk level associated with a provider. CMS refused, noting that the appeals process is lengthy, which affords unscrupulous providers additional opportunity to defraud


Medicare if they can remain at lower risk levels. CMS also rejected the notion of tailoring the screening requirements to specific areas of the country that have a high incidence of fraud. A similar screening process is also required for state Medicaid agencies, although states can rely on the results of Medicare contractors’ screening for purposes of screening requirements under the Medicaid program. State agencies are to use the same risk levels and apply the same types of screening standards as those that apply under Medicare. For Medicaid provider types that are not recognized by Medicare, CMS is allowing the state agencies to assess the level of risk themselves. However, the state agencies are supposed to use the same types of risk criteria implemented on a national level under the Medicare program. Moratoria on Medicare and Medicaid enrollment

In addition to screening enrollees, CMS can also impose a moratorium on enrollment of

Many of the initiatives that have become effective over the past few years have had the unfortunate consequence of ensnaring honest providers in a web of complex rules. new providers or establishment of new practice locations, if it determines that there is a significant potential for fraud involving particular provider types, particular geographic areas, or both. Decisions to halt enrollment will be based on CMS’ review of trends that appear linked with a high risk of fraud, such as disproportionate numbers of providers in a category relative to the number of beneficiaries or a rapid increase in enrollment applications within a category. Medicaid agencies also have authority to impose temporary moratoria on enrollment of new providers or numerical caps or other limits that the agency identifies as having significant potential for fraud. Further, CMS can implement a Medicare moratorium if a state Medicaid

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program has imposed a moratorium on a group of Medicaid providers that are eligible to enroll in Medicare or imposed a moratorium in a particular geographic area or on a particular provider type. Announcement of moratoria, along with an explanation of CMS’ reasoning, will be published in the Federal Register. There will be no advance notice, however, because CMS is concerned that this would cause a rush of enrollments of the type posing the problem that the moratorium is intended to address. Enrollment moratoria under both Medicare and Medicaid will last for six months, although CMS and state agencies have the authority to extend the moratoria (in additional six-month blocks) beyond

that timeframe if they deem it necessary. Payment suspensions during fraud investigations

The ACA gave CMS expanded power to suspend reimbursement to providers if, after consultation with other agencies, CMS identifies a “credible allegation.” A “credible allegation” can come from any source, including claims from fraud hotlines and data mining, as well as from patterns identified through provider audits and law enforcement investigations. Under the regulations, allegations are considered “credible” when they have “indicia of reliability.” A major question about this suspension authority is whether there is enough clarity on the types and level of detail of allegations that can have the necessary “indicia of reliability” such that CMS can halt reimbursement. CMS received comments to its proposed regulations that the “credible allegation” standard was ambiguous and failed PROGRAM INTEGRITY to page 32

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MINNESOTA PHYSICIAN

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Among concerns with this initiative is that the regulations provide only brief windows of time to provide updated information to CMS.

Program integrity from page 31

to detail a clear, evidentiary standard that will be used in determining whether suspension is warranted. Observers also wondered if, given the anonymity of fraud hotlines, competitors or disgruntled employees would have an easy way to cause problems by lodging groundless complaints, an act that could lead to unwarranted and painful payment suspensions. CMS proved unsympathetic, noting that the statutorily required consultation with other agencies before implementing a suspension will provide opportunity for a preliminary investigation into the allegation of fraud to occur sufficient to meet a reasonable standard. Time will tell whether concerns around the broad scope of authority will be validated. Another challenge involves the length of time during which payments can be suspended. CMS is required to reevaluate, every 180 days after a suspension begins, whether there is good cause not to continue with the suspension. In doing so,

CMS must request certifications from relevant enforcement agencies that the matter under investigation warrants continuation of the suspension. Good cause not to continue will be deemed to exist if a payment suspension has been in effect for 18 months and the investigation has not reached a resolution. This 18month deadline is far from absolute, however, as CMS can continue the suspension if the case is being considered by the Office of Inspector General for administrative action or if the Department of Justice asks that the suspension be continued. State Medicaid agencies have been given similar authority and are now required to suspend payments once the agency determines that there is a credible allegation of fraud (based on the same definition used under

the Medicare program), so long as there is no good cause to avoid the suspension. State agencies are allowed to suspend payments without notifying providers of the agencyâ&#x20AC;&#x2122;s intention to take action, although the agencies are required to send notice within five days. Whatâ&#x20AC;&#x2122;s next for program integrity?

Program integrity is a high priority because CMS believes that by keeping bad actors out, many of the fraudulent activities that have long bedeviled health care programs can be stopped before they start. It is highly likely that CMSâ&#x20AC;&#x2122; already intense focus on enrollment and on ensuring that providers continue to maintain the accuracy of their enrollment information will only grow. Meanwhile, the Medicaid pro-

gram seems positioned for creation and implementation of additional program integrity initiatives, as it has been less of an enforcement priority in the past. Among concerns with this initiative is that the regulations provide only brief windows of time to provide updated information to CMS, with the failure to respond often a trigger for losing billing privileges. And if compliance alone were not enough of a burden, Congress has devised a clever way to fund CMSâ&#x20AC;&#x2122; new program integrity initiatives: Certain providers that initially enroll in Medicare, add practice locations, or revalidate must pay an application fee, set at $505 for 2011. Providers should stay tuned for further development on the Medicare and Medicaid program integrity fronts. Jesse A. Berg, JD, MPH, is a shareholder in the Gray Plant Mooty Health Law practice. He advises physicians, hospitals, and other providers on Medicare and Medicaid regulatory matters.

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MINNESOTA PHYSICIAN NOVEMBER 2011

CurrentOpportunities Opportunities in:in: Current OB/GYN OB/GYN Occupational Medicine Family Medicine Family Medicine Internal Medicine Internal Medicine Pediatrics Pediatrics & & Adolescent Adolescent Medicine Medicine Hospitalist Program


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 patient-centered care. St Cloud/Sartell, MN is located just one hour north of the Twin Cities and offers a dynamic lifestyle in a growing community with a traditional appeal. For more information, please contact diane.m.collins@ healthpartners.com or call Diane at 800-472-4695 x3. EOE

We invite you to explore our opportunities in: In the heart of the Cuyuna Lakes region of Minnesota, the medical campus in Crosby includes Central Lakes Medical Clinic, a 30-physician multispecialty group, and Cuyuna Regional Medical Center, a critical access hospital offering superb new facilities with the latest medical technologies. Outdoor activities abound, and with the Twin Cities metropolitan area just a short drive away, you can experience the perfect balance of recreational and cultural activities. Enhance your professional life in an environment that provides exciting practice opportunities in a beautiful Northwoods setting. The Cuyuna Lakes region welcomes you.

• Family Medicine • Internal Medicine

CENTRAL LAKES MEDICAL CLINIC P.A.

Contact: Todd Bymark, tbymark@cuyunamed.org (866) 270-0043 / (218) 546-4322 | www.cuyunamed.org

healthpartners.com ©

Opportunities available in the following specialty:

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.

Family Medicine Rochester Northwest Clinic Rochester Southeast Clinic St.Charles Clinic Internal Medicine Southeast Clinic Occupational Medicine Southeast Clinic Dermatology Southeast Clinic

“A Hospital for Heroes” Working with and for America’s Veterans is a privilege and we pride ourselves on the quality of care we provide. In return for your commitment to quality health care for our nation’s Veterans, the VA offers an incomparable benefits package. They all come together at the Sioux Falls VA Health Care System.

• Orthopedic Surgeon • Emergency Department Physician

Send CV to:

• Chief of Primary Care and Specialty Medicine

Olmsted Medical Center Administration/Clinician Recruitment 1650 4th Street SE

To be a part of our proud tradition, contact:

Rochester, MN 55904

Olmsted Medical Center offers a competitive salary and comprehensive benefit package.

Sioux Falls VA Health Care System

email: egarcia@olmmed.org Phone: 507.529.6610 Fax: 507.529.6622 EOE

www.olmstedmedicalcenter.org

Human Resources Mgmt. Service P O Box 5046 Sioux Falls SD 57117 605-333-6852

www.siouxfalls.va.gov NOVEMBER 2011

MINNESOTA PHYSICIAN

33


PROFESSIONAL

Working with patients and families who live with diabetes By Tai J. Mendenhall, PhD, LMFT, CFT, and Max Zubatsky, MA, LAMFT serious health problems, such as cardiovascular diseases (which represent the most common causes of death and disability in the U.S.), eye disease and blindness, kidney failure, nerve disease, and sexual dysfunctions. Family history may also serve as a hereditary risk factor for developing type 2 diabetes, in contrast to type 1 diabetes. A positive family history of diabetes confers a twofold to fourfold increased onset during one’s lifetime. Additionally, 15 to 25 percent of first-degree relatives of patients with type 2 diabetes develop impaired glucose tolerance, a prediabetic state associated with insulin resistance.

Come home. Where organizational strength lies in the diversity of people who call SANFORD HEALTH – home. Sanford Health – Fargo Region is redefining health care. Serving northwestern Minnesota and eastern North Dakota, we offer innovative technology, support of a multi-specialty organization, and dependable colleagues. Excellent practice opportunities exist in family-oriented communities that offer year-round outdoor activities, cultural events, and superior education districts that will allow you to balance your work & life. Our employment model features competitive salaries, a comprehensive benefits package, paid malpractice insurance, and a generous relocation allowance. Contact: Jean Keller Physician Recruiter Phone: (701) 280-4853 Jean.Keller@sanfordhealth.org

34

DIABETES

Systemic disease, system interventions

D

iabetes is one of the most widespread chronic diseases in the United States; current estimates of those afflicted exceed 25 million people. Prevalence estimates have increased sixfold since the 1950s, with more than 2,500 new cases diagnosed in this country each day. Last year the Centers for Disease Control and Prevention predicted that approximately one in every three Americans may develop type 2 diabetes by 2050. And while diabetes is a chronic illness that crosses all cultural, ethnic, and racial groups, considerable health disparities continue to exist: Hispanics and African Americans are two to four times more likely, and American Indians three to 10 times more likely, to be diagnosed than Caucasians. Principal reasons behind these statistics include Americans’ increasingly sedentary lifestyles, consumption of high-fat and carbohydrate-rich diets, and increased weight. This trend is alarming because diabetes can lead to a number of

U P D AT E :

Cardiology Dermatology ENT Emergency Medicine Family Medicine Gastroenterology Hospitalists Internal Medicine Neurology Occupational Medicine Oncology Orthopedic Surgery Pediatric Specialties Psychiatry Pulmonology (Sleep) Rheumatology Urology

MINNESOTA PHYSICIAN NOVEMBER 2011

The family context

Diabetes is often called a “family disease” because its effects go beyond just the person who is diagnosed with it. As the patient is required to change longstanding habits across a wide variety of areas in his or her life, others in the household will have to do the same. For example, proper diabetes management requires careful attention to diet. As families attend to patients’ ongoing disease management and medical care, their incomes may be strained as they pay for healthier foods (which can be more expensive than unhealthy foods), copays and doctor visits, bloodtesting supplies, and other expenses. Because it is easier for patients (or anyone, really) to exercise if they have someone to stay physically active with, family members are encouraged to take part—but may do so reluctantly or with resentment. Adjusting to and managing diabetes in these ways can be very hard for couples and families. For example, some family members may feel angry or indignant about having to change their own diets, especially in light of the fact that they are not the one who has the disease. When the person with diabetes asks family or friends to attend informational forums or groups with him or her, members of the support system may struggle with feelings of infringement on their own schedules or free time. Children without diabetes can sometimes feel jealous of their diabetic siblings, who are getting more attention from parents and other family members. Patients with diabetes (from children to adolescents to adults) may feel that others’ attempts to be supportive are actually harassing, and those trying to offer the help may not

know where the line is between being supportive and being a “nag.” Systemic interventions

Thinking “systemically” means conceptualizing how any one part influences other parts within a larger whole. In the case of diabetes, the health of a diagnosed patient depends on how the connections within that person’s family and social system(s) affect—and are affected by— multiple areas of his or her life. As we advance our efforts in diabetes care, we must work to bridge our conventional, individual-oriented approaches to disease management with approaches that embrace the relational contexts in which our patients reside. This broader approach translates into a messier constellation of interventions and people (e.g., providers, family members) rather than just putting all of our eggs into one basket (e.g., medication, diet, lifestyle changes). And while it would be far easier for health care providers to work strictly with a patient on his or her medications or diet, research has shown that attending to coexisting facets of patients’ lives yields better outcomes. Medical treatment for diabetes should be personalized for each patient, depending on his or her overall health and presence (or absence) of diabetesrelated conditions and other diseases. The main health considerations for diabetic patients include insulin administration to control blood sugars, oral medications, drugs to lower blood pressure and bad cholesterol, and lifestyle changes in diet and physical activity. Different types of therapy can help address a variety of biopsychosocial issues in a patient’s life. Individual therapy with psychoeducational interventions generally involves patients meeting with a physician, diabetes nurse educator, nutritionist, and/or therapist to talk about health behaviors (e.g., meal planning, exercise, regular blood sugar testing, and recordkeeping) and common feelings SYSTEMIC DISEASE to page 36


Mankato Clinic is looking for a full-time Nurse Practitioner or Physician Assistant to work in our Mapleton satellite 20+ hours/week, and rotating weekday/every third weekend shifts in our Urgent Care Department. Qualifications include but are not limited to: NP: Masters Degree in nursing encompassing specialized classroom and experiential learning as a nurse practitioner OR grandfathered in as an NP if certified prior to 1995. Current licensure by the State of Minnesota and Advanced Practice Certification by ANCC, ACNP, National Certification Board of Pediatric Nurse Practitioner and Nurses, or other certification agencies to practice as a registered nurse and Nurse Practitioner. PA: Graduate of an approved Physician Assistant Program, Certification by the NCCPA, and current Minnesota Registration with the State Board of Medical Practice. For both: Current authorization from the MN Board of Nursing/Physician Assistants to prescribe drugs and therapeutic devices; current Basic Life Support and Advanced Cardiac Life Support certifications; three years of employment experience preferred; effective interpersonal skills necessary for providing patient/family instruction and collaboration with health team members. You will enjoy an excellent benefits package including generous CME expense and time-off allowance, 401(k) profit sharing plan; EAP; employee discounts; six paid holidays and more. Apply online at www.mankato-clinic.com, or contact: Dennis Davito, Director of Provider Services, at dennisd@mankato-clinic.com; Phone: (507) 389-8654; Fax (507) 625-4353, Mankato Clinic, 1230 E. Main St., Mankato, MN 56001. Mankato Clinic is an Affirmative Action/Equal Opportunity Employer.

family room | YLKLĂ&#x201E;ULK

Marshfield Clinic continues to redefine health care through our innovative technology and practices, but it doesnâ&#x20AC;&#x2122;t end there. Weâ&#x20AC;&#x2122;re also redefining what it means to be a physician practicing with us. Our setting in the heart of Wisconsin makes it possible for you to explore all of the lifestyle options that come with living in an environment rich in natural wonders and short on congestion. We have openings for BC/BE physicians in:

â&#x20AC;˘ Dermatology â&#x20AC;˘ Family Practice â&#x20AC;˘ IM â&#x20AC;˘ Neurosurgery â&#x20AC;˘ Orthopaedic Surgery â&#x20AC;˘ Pediatrics (general and subspecialty) â&#x20AC;˘ PM&R â&#x20AC;˘ Pulmonary Critical Care â&#x20AC;˘ Urology (please contact us if you donâ&#x20AC;&#x2122;t see your speciality listed) Marshfield Clinic is one of the largest physician-directed private group practices in the United States employing more than 800 physicians and over 6000 support personnel in 54 locations throughout northern, western and central Wisconsin. As one of the most respected and recognized names in health care delivery, Marshfield Clinic combines world class services with a solid commitment to quality of life for both patients and staff, which makes Marshfield Clinic and Wisconsin a very attractive place to get your career on the right path. To hear more about the numerous physician practice opportunities we have available and the very competitive compensation package we offer, please contact: Physician Recruitment, Marshfield Clinic, 1000 N. Oak Ave., Marshfield, WI 54449. Phone: 800-782-8581, ext. 15770; Fax #: 715-2215779; E-mail: physrec@marshfieldclinic.org; Website: www.marshfieldclinic.org/recruit; Facebook: www.facebook.com/marshfieldclinicphysrec 0DUVKĂ&#x20AC;HOG &OLQLF LV DQ $IĂ&#x20AC;UPDWLYH $FWLRQ(TXDO 2SSRUWXQLW\ HPSOR\HU WKDW YDOXHV GLYHUVLW\ 0LQRULWLHV IHPDOHV LQGLYLGXDOV ZLWK GLVDELOLWLHV DQG YHWHUDQV DUH HQFRXUDJHG WR DSSO\ 6RUU\ QRW D KHDOWK SURIHVVLRQDO VKRUWDJH DUHD

www.mankato-clinic.com

NEW POSITIONS:

Family Practice Urgent Care Dynamic, independent 3 location, single-specialty practice in northwest Minneapolis suburbs is seeking additional associates for its Rogers site and has Full Time/ Part Time shifts in the Crystal and Rogers Urgent Care. â&#x20AC;˘ â&#x20AC;˘ â&#x20AC;˘ â&#x20AC;˘ â&#x20AC;˘

Partnership opportunity after 2 years Competitive salary with incentives Excellent benefits, 401k/employer paid pension Practice at one site/one hospital Physician-owned

Please contact or fax CV to: Joel Sagedahl, M.D. 1495 Highway 101 North, Plymouth, MN 55447 763-504-6600 â&#x20AC;˘ Fax 763-504-6622

Minneapolis VA Health Care System Great place to work, great place to live. You are invited to be part of the Department of Veterans Affairs that has been leading change in the health care sector. The Minneapolis VA is a 341-bed tertiary care medical center affiliated with the University of Minnesota. Our patient population and case mix is challenging and exciting, providing care to veterans and active-duty personnel.The Twin Cities area offers excellent living and cultural opportunities. Opportunities for full-time and part-time staff are available in the following positions: â&#x20AC;˘ Rheumatologist â&#x20AC;˘ Gastroenterologist â&#x20AC;˘ Chief, Occupational Health â&#x20AC;˘ Chief, Emergency Department â&#x20AC;˘ Chief of Medicine of Outpatient Clinics â&#x20AC;˘ General Internal Medicine (Minneapolis) â&#x20AC;˘ General Internal Medicine (Chippewa Falls, WI Outpatient Clinic) Physician applicants should be BC/BE. Possible recruitment bonus.

Interested applicants should email CV to: Brittany Buck, HRMS â&#x20AC;˘ brittany.buck@va.gov Fax 612-725-2287 â&#x20AC;˘ Telephone 612-629-7873

Visit our website at www.NWFPC.com

EEO Employer

NOVEMBER 2011

MINNESOTA PHYSICIAN

35


Systemic disease from page 34 of depression, anxiety, or stress associated with the diagnosis of and living with a chronic illness. Couples therapy with psychoeducational interventions generally involves patients and their spouses or partners meeting with a mental health provider and treatment team to learn about diabetes together and to build a sense of co-ownership and teamwork into everyday relationship functioning and disease management. This intervention also provides a safe space to identify and work through commonplace challenges and difficulties associated with diabetes management. Using psychoeducation in family therapy applies similar techniques as those in couples therapy, but purposefully includes children, siblings, parents, and anybody else who is closely associated with (and affected by) the patient and his or her illness. A potential challenge addressed in this context is negotiating developmentally normal struggles between adolescents’ desire for more independence vis-à-vis parents’

Orthopaedic Surgery Opportunity Live in Beautiful Minnesota Resort Community

desire to be involved in disease management and care. Social and community interventions provide opportunities for patients and their family members to connect with other patients and families. Participating in these types of interventions allows participants to access the personal wisdom and lived experiences of people who have “been there.” For example, veteran spouses can share with spouses of newly diagnosed patients how they have achieved a balance between being supportive versus nagging. Similarly, longer-term patients can share with newly diagnosed patients how they were able to adjust their diets and lifestyles in ways that are satisfying and realistic to maintain. Tips for providers

Diabetes is most effectively man-aged when it is attended to by multiple people in the patient’s life. Family members (e.g., spouses/partners, children, parents) represent invaluable resources in diabetes care; providers can work to engage

them in the following ways: • Encourage patients to bring a spouse/partner or another family member with them to doctor appointments • Talk about and normalize the systemic impact(s) of diabetes, along with the stress on everyone in adjusting to new routines in disease management and daily living • Suggest that patients and family members take part in counseling or mental health appointments, local educational workshops, and/or support groups • Promote exercising together • Encourage shopping for and preparing foods together • Applaud patients’ and families’ teamwork, and frame improvements in health behaviors and physiological markers as collectively earned. When families come together to fight diabetes as a team, everybody wins. Research has shown that patients do better in their health when their families are supportive and collectively share in disease management.

Two BC/BE Orthopaedic Surgeons wanted to join four orthopaedic surgeons at Sanford Bemidji Orthopaedics Clinic in Bemidji, Minnesota. Part of an 85-physician, multi-specialty group practice and 118 bed acute care hospital. 1:6 call anticipated. Competitive compensation/benefits package, paid malpractice, relocation assistance and more. Sanford Health of Northern Minnesota has 1,450+employees and is part of Sanford Health system based in Fargo, ND and Sioux Falls, SD. Bemidji, Minnesota, located in northwestern Minnesota, is a beautiful resort community offering exceptional schools, a state university, and yearround cultural activity as well as great access to the outdoors for year-round recreation activity. To learn more about this excellent practice opportunity contact: Kathie Lee, Director Physician Placement Phone: 701-280-4887 Fax: 701-280-4136 Email: Kathie.Lee@sanfordhealth.org

Many families have described diabetes as actually having helped them to become a closer unit, as well as improving the health of others in addition to the identified patient. Talking about foods, cooking together, exercising together, going to doctor visits together, and so forth—all help families to grow stronger. Effective treatment of this chronic condition requires collaboration among the patient, family, health professionals, and support systems. By using this team approach, families can also serve as educational models to future generations in efforts to prevent this widespread disease. Tai J. Mendenhall, PhD, LMFT, CFT, is a faculty member in the University of Minnesota Medical School’s Department of Family Medicine and Community Health and an associate director of the university’s Citizen Professional Center. Max Zubatsky, MA, LAMFT, is a doctoral student in the University of Minnesota’s Department of Family Social Science (Marriage and Family Therapy Program) and a behavioral health intern at the Broadway Family Medicine Clinic in Minneapolis.

Look for the friendly doctor in a MN based physician staffing service ...

Physicians: • Let us do your scheduling & credentialing • Paid Malpractice • Physician Friendly • Choose where and when you want to work • Competitve Rates • Courteous Staff

Clients: • Prevent loss of revenue • BC/BE physicians • Competitive rates • Quality coverage • Malpractice coverage paid by us

AA/EOE

P-763-682-5906/F-763-684-0243 michelle@whitesellmedstaff.com www.whitesellmedstaff.com

36

MINNESOTA PHYSICIAN NOVEMBER 2011


Practice Well. Live Well.

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

Our award winning patient care and uncommon medical specialties set us apart from other regional health care groups. Lake Region’s physicians and their families also enjoy an unmatched quality of professional and personal life. Current opportunities including competitive salary and benefit packages available for BE/BC physicians are: • Dermatologist • Family Medicine • General Surgery

• Hospitalist • Internal Medicine • Pediatrics

For more information contact Barb Miller, Physician Recruiter bjmiller@lrhc.org • (218) 736-8227

712 Cascade St. S., Fergus Falls, MN 736-8000 • (800) 439-6424

Lake Region Healthcare is an Equal Opportunity Employer. EOE

www.lrhc.org

Urgent Care

The perfect match of career and lifestyle. Affiliated Community Medical Centers is a physician owned multi-specialty 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: • Family Medicine • General Surgery • Geriatrician/ Outpatient Internal Medicine • Hospitalist • Infectious Disease

• Internal Medicine • OB/GYN • Oncology • Orthopedic Surgery • Psychiatry

• 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

St. Cloud VA Health Care System is accepting applications for the following full or part-time positions:

We have part-time and on-call positions available at a variety of Twin Cities’ metro area HealthPartners Clinics. Evening and weekend shifts are currently available. We are seeking BC/ BE full-range family medicine and internal medicine pediatric (Med-Peds) physicians. We offer a competitive salary and paid malpractice. For consideration, apply online at healthpartners.jobs and follow the Search Physician Careers link to view our Urgent Care opportunities. For more information, please contact diane.m.collins@ healthpartners.com or call Diane at: 952-883-5453; toll-free: 1-800-472-4695 x3. EOE

• Internal Medicine/ Family Practice

• Disability Examiner (IM or FP) (St. Cloud) • Weekend Medical Officer of the Day (IM or FP) (fee for service

(Alexandria, Brainerd, St. Cloud, Montevideo)

• Psychiatrist (Brainerd, St. Cloud)

appointment, St.Cloud)

• ENT (St. Cloud) • Geriatrician

• Medical DirectorExtended Care & Rehab (IM or Geriatrics)

(Nursing Home—St. Cloud)

(St. Cloud)

• Hematology/Oncology (St. Cloud)

• Neurology (St. Cloud) • Dermatology (St. Cloud)

• Radiologist (St. Cloud) • NP/PA (Montevideo)

US Citizenship required or candidates must have proper authorization to work in the US. J-1 candidates are now being accepted for the Hematology/Oncology positions. Physician applicants should be BC/BE. Applicant(s) selected for a position may be eligible for an award up to the maximum limitation under the provision of the Education Debt Reduction Program. Possible relocation bonus. EEO Employer.

Excellent benefit package including: Favorable lifestyle 26 days vacation

CME days Competitive salary

13 days sick leave Liability insurance

Interested applicants can mail or email your CV to VAHCS

healthpartners.com ©

Sharon Schmitz (Sharon.schmitz@va.gov) 4801 Veterans Drive, St. Cloud, MN 56303 Or fax: 320-255-6436 or Telephone: 320-252-1670, extension 6618

NOVEMBER 2011

MINNESOTA PHYSICIAN

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Change from page 29 primary care clinics as their major target group. Through these extension centers, free or heavily subsidized technical assistance is available to clinics with fewer than 10 physicians. (In Minnesota and North Dakota, this assistance is available through REACH, a program led by Stratis Health, the College of St. Scholastica, and the National Rural Health Resource Center). Rural hospitals are considerably more complex than clinics and will need substantially more assistance. Many are also having difficulty acquiring the financing to purchase the systems. Other HIT resources and assistance are available through the major health systems as well as HIT networks such as SISU and others based in Minnesota. Since HIT adoption is generally a lengthy, resource-consuming experience that doesn’t end with going live, rural providers will need ongoing sources of expertise and assistance.

Quality and patient safety

Medical penalties for health care delivery-system failures will begin with avoidable readmissions in 2012 and expand to hospital-acquired conditions by 2015. These penalties, together with the growth of shared savings and bundled payment models, will shift more clinical and financial accountability to providers. They will also drive a greater focus on patient safety and on coordination of inpatient and outpatient care. The Centers for Medicare & Medicaid Services currently is promoting a Partnership for Patients initiative that provides $1 billion for new patient-safety initiatives, many of which are targeted for rural areas. The National Rural Health Association, in partnership with the National Rural Health Resource Center, has helped guide policy development in this initiative and has applied for funding to provide quality improvement technical assistance and support to rural providers nationally. Hospital associations also have applied for funding to provide

additional quality and patient safety support. To date, critical access hospitals have been exempted from federal quality reporting requirements and pay-for-performance in general. However, there are strong indications from policymakers that CAHs soon will be compelled to participate in both the reporting and pay-for-performance initiatives. Rural quality reporting and rural quality improvement in general suffer from low numbers. With infrequent numbers of particular medical conditions, rural hospitals can look terrible if they have even one mistake. Consequently, rural hospitals have tended to view national quality measures as inappropriate for them, and many have refused to report. As a result, in a value-based environment, rural advocates lack data to show rural hospital and rural health clinic worth. If rural hospitals and clinics fail to demonstrate quality outcomes, they are in danger of losing a significant measure of their funding in the budget-cutting processes, and could conceivably

lose their CAH and Rural Health Clinic programs altogether. Rural health is at stake

In the past, rural hospitals and clinics were generally seen as essential and were protected by strong Congressional champions. In today’s more unpredictable political environment, we can no longer be confident that the rural safety net will survive as currently structured. To survive and prosper, rural health leaders will need to explore ways to work together and forge successful hospital-hospital, clinic-clinic, and hospital-clinic partnerships. Building the necessary trust that is at the core of all good business ventures, as well as strong and persistent leadership, will take time—but the future of rural health may well be at stake. Terry Hill, MPA, is director of the Duluthbased National Rural Health Resource Center. In that capacity, he is a leading adviser to the Department of Health and Human Services, leads two national quality initiatives, and has worked with rural health providers in more than 40 states.

continuing medical education Emergency Medicine and Trauma Update: Beyond the Golden Hour

November 17, 2011

Otolaryngology for Primary Care

November 18, 2011

33rd Annual Cardiovascular Conference Fundamental Critical Care Support Dermatology for Primary Care

February 23-24 and July 19 -20, 2012 February 24, 2012

26th Annual Family Medicine Today

March 8 - 9, 2012

30th Annual OB/Gyn Update

April 12 -13, 2012

The Mind of a Child: Psychiatric Challenges for Today’s Youth

April 19, 2012

Psychiatry Update: Selected Topics for the Non-Psychiatrist

April 20, 2012

Pediatric Fundamental Critical Care Support Strategies in Primary Care Medicine

education that measurably improves patient care 38

December 1-2, 2011

MINNESOTA PHYSICIAN NOVEMBER 2011

May 3-4 and November 8 - 9, 2012 September 20- 21, 2012

healthpartnersIME.com


You wouldnâ&#x20AC;&#x2122;t give a 4-year-old a drink, so why would you give one to an unborn child? As a physician, itâ&#x20AC;&#x2122;s your responsibility to let her know: the U.S. Surgeon General Advisory says no amount of alcohol is safe during pregnancy. Share 049: Zero Alcohol For Nine Months.

www.mofas.org


Youâ&#x20AC;&#x2122;re always there for them.

Weâ&#x20AC;&#x2122;re always here for you. We have defended and supported the individual needs of health professionals for more than 30 years. And nobody is more personally committed to protecting you from the risks you face every day. To learn more, call 800-328-5532 or visit MMICGroup.com

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Minnesota Physician November 2011  

Health care infomation for Minnesota doctors Cover: Healthing power by Gary A.H. Christwison, MD Building on partnerships by Lacey Hart, M...