Minnesota Physician November 2012

Volume XXVll, No. 8

November 2012

The Independent Medical Business Newspaper

A change in culture Principles support safer care

By Steven Mulder, MD

A

The intersection of art and medicine patient is seen in a family practice clinic or s clinicians, we know that practicing a specialist’s office, mental illnesses can medicine involves a delicate blend of complicate treatment in ways that science and art. Beyond the challenge clinicians. medications and other therapies Med ed Mood disorders, in addition to we rely on each day, effectively goes to the taking a severe toll on the patient, treating a particular patient strongly ripple through his or her requires that we draw on a broad theater family, friends, and set of emotional intangibles, such community in ways as empathy, compassion, and an

By Mark A. that other illnesses do ability to connect on a deeply perFrye, MD not. Also, these disorsonal level. We also need to look to ders are sometimes not well the closest, most important people in a understood by patients or patient’s life and recruit them as a support families, perhaps because they system. are misrepresented in popular This is particularly true when it comes culture—or at least poorly to treating depression, bipolar disorder, and defined and delineated. other psychiatric conditions, as therapy

A

Detriot Lakes, MN Permit No. 2655

PAID

ART to page 10

PRSRT STD U.S. POSTAGE

often involves a significant dose of “art” that’s tailored to each patient. Whether the

bout 25 years ago, I was practicing family medicine in rural Minnesota. I was on call for the hospital, and having a very busy day—five admissions by noon. That evening, as I was pausing to take a breath, I was paged urgently to the medical floor. One of my admissions had suffered a seizure. The RN on duty told me a glucometer reading was “less than 40.” She had given the patient glucagon and the seizure had resolved after three to four minutes.

Save for some brief postictal symptoms, the patient had no observable residual effects.

I reviewed the chart and discovered to my horror that I had prescribed an oral hypoglycemic agent, and the patient was not diabetic.

As I sorted things out, it became clear what had happened. Two of my morning admits were elderly gentlemen of similar age and presenting

CULTURE to page 12

RURAL HEALTH Page 20

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CONTENTS

NOVEMBER 2012 Volume XXVII, No. 8

FEATURES The intersection of art and medicine Med ed goes to the theatre

1

MINNESOTA HEALTH CARE ROUNDTABLE

By Mark A. Frye, MD

A change in culture Principles support safer care

1

By Steven Mulder, MD

T H I R T Y- N I N T H

DEPARTMENTS CAPSULES

4

MEDICINE AND THE LAW Sunshine and scrutiny 14

MEDICUS

7

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

INTERVIEW

8 WOUND CARE Venous disease

Charles Stephens, MD

28

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

The Heart of New Ulm Project

HEALTH INSURANCE Medicare in 2013

34

By Kelli Jo Greiner

SPECIAL FOCUS: RURAL HEALTH Health care reform and rural health

Forging connections 20

By Terry Hill, MPA

A call to duty

24

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

22

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

The Independent Medical Business Newspaper

SESSION

Background and focus: The next step in health care reform involves the patient becoming more actively engaged with staying healthy.

New physician reimbursement models reward improved population health but bring new dynamics into the exam room.

Incorporating patient attitude and lifestyle Creating measures that work choices into health care delivery is Thursday, April 25, 2013 necessary, but how 1:00 – 4:00 PM • Duluth Room Downtown Mpls. Hilton and Towers should it be done?

Creating conceptual and empirical clarity around this question may be best addressed by the term Patient Activation Measure (PAM).

Patient engagement

Objectives: We will examine the development of PAM, what it means and how it works. We will explore patient engagement methods that have been successful and the role of health insurance companies and employers in this process. We will explore how PAM may be used across the continuum of care and whose job it will be to implement and track these measures.

We will discuss the challenges that are inherent within the concept of PAM and how it may realize its best potential.

www.mppub.com PUBLISHER Mike Starnes mstarnes@mppub.com EDITOR Donna Ahrens dahrens@mppub.com ASSOCIATE EDITOR Janet Cass jcass@mppub.com ASSISTANT EDITOR Scott Wooldridge swooldridge@mppub.com

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3

CAPSULES

Mayo Study Looks at Cancer Drugs’ Value Manufacturers of cancer drugs enjoy a “virtual monopoly� in the marketplace, which plays a role in the relatively high cost of those drugs, according to a new article in Mayo Clinic Proceedings.

The commentary, by oncologist Mustaqeem Siddiqui, MD, and hematologist Vincent Rajkumar, MD, points out that a recently introduced cancer drug was judged to extend the life of a cancer patient by 3.7 months. The cost for the drug was $120,000. “Sadly, the benefit of these new drugs is typically shortlived, and many of these drugs are very expensive,� says Siddiqui.

The authors acknowledge that discussion of the value of such drugs can be provocative, but add that the debate is necessary at a time when high drug costs are contributing to rising insurance premiums and increased costs for government programs such as Medicare.

“The absolute cost to society will become increasingly unaffordable if every drug with statistically significant but clinically unimportant benefit is approved,� they write.

The article says that there are many causes behind the high cost of cancer drugs, including regulatory costs, drug development costs, and the tendency to want the newest and best treatments for a life-threatening disease such as cancer.

Because of these and other factors, the authors write, drug manufacturers have a kind of monopoly when it comes to cancer drugs. With other medical conditions, there are a variety of treatments and competition holds down costs.

Cancer drugs, on the other hand, often only work for a limited time, and the use of one drug does not preclude the use of another drug. “Most of these drugs provide benefit for a short duration, typically measured in weeks or months, and then the tumor begins not to respond to the therapy. In this scenario, physicians really do not choose

the most cost-effective option; they only decide the timing at which each option is used,� the authors write. “Thus, each drug is an effective monopoly because each one will be indicated at some point during the course of a patient’s illness.�

The authors call for “valuebased pricing� as one means of addressing this situation. Such a system would create metrics for estimating the number of years added to a patient’s life by a drug, adjusted for quality of life.

New Guidelines Met with Caution New national guidelines for Pap tests recommend that women get tested less often, but a local physician who recently was recognized for his cancer-screening efforts reacted with caution to the new guidelines.

Bradley Linzie, MD, FCAP, is a pathologist at Hennepin County Medical Center (HCMC) in Minneapolis and recently received the College of American Pathologists (CAP) Foundation 2012 Gene and Jean Herbek

Humanitarian Award for helping to provide free cervical and breast cancer screenings at NorthPoint Health and Wellness Center, an affiliate of HCMC. Linzie says frequency of Pap tests depends on each individual’s health history. “This [new recommendation] is mostly for people who have never had an abnormal reading,� Linzie notes. “Age, prior Pap test history, and sexual history [can affect] when you need your next Pap test.�

The new guidelines, released by the American Congress of Obstetricians and Gynecologists, say that most women should be screened for cervical cancer via Pap tests every three to five years. For many, this will replace an annual Pap test. Women ages 30–65, however, are advised to go five years between Pap tests and to be screened for human papilloma virus (HPV) at the same time as their Pap tests.

Linzie says that false positive Pap tests can result in intrusive follow-up procedures for women, so he understands the reasons for the new guidelines. “We’re not going to know until

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we try it,” he says. “I think the intentions are good.” His concern, he adds, is whether patients will be able to keep track of the three- or five-year gap between tests and know when it is time to be retested.

“The things that should help are universal coverage and electronic medical records (EMRs) that help remind everyone when they need their next tests,” he says. But underserved populations and immigrant populations, like the patients he has worked with at NorthPoint, sometimes don’t have EMRs and are not as aware of the need for screenings, Linzie says.

Substance Abuse Is Focus of Statewide Strategy by DHS The Minnesota Department of Human Services (DHS) has launched a statewide strategy to address substance abuse and addiction. Included in the strategy is a focus on prescription of opiates and the abuse of such drugs—which officials describe as a pressing concern.

The new approach emphasizes coordination between agencies and a multifaceted approach to preventing and reducing substance abuse. The state departments of corrections, education, health, and public safety are all involved, as well as the state judicial board, the Minnesota National Guard, and the Minnesota Board of Pharmacy.

“Substance abuse is a serious and costly issue that affects us all,” says DHS Commissioner Lucinda Jesson. “The long-term and immediate steps recommended in this comprehensive strategy will help save lives and dollars by making our prevention and treatment efforts more efficient and effective.”

The coalition will seek to balance public safety, prevention, intervention, and treatment and recovery services in an effort to reduce substance abuse.

Officials are recommending integration of screening services in all health care settings and expanded use of recovery centers throughout the state.

Grant Will Help U of M Lead Effort in Medical Education The University of Minnesota Academic Health Center has been chosen to lead a $4 million effort to improve coordination of medical education and practice, particularly in medically underserved areas.

The grant was announced by the Health Resources and Services Administration (HRSA) on Sept. 14. Officials with HRSA say the U of M will create a Coordinating Center for Interprofessional Education and Collaborative Practice, which will partner with other training and health delivery sites around the country.

“Health care delivered by well-functioning coordinated teams leads to better patient and family outcomes, more efficient health care services, and higher levels of satisfaction among health care providers,” says HRSA Administrator Mary Wakefield, PhD, RN. “We all share the vision of a U.S. health care system that engages patients, families, and communities in collaborative, teambased care. This coordinating center will help us move forward to achieve that goal.”

Officials say the center will aid in the development of health reform innovations such as accountable care organizations, patient-centered medical homes, and transitional care models.

Meningitis Concerns Rising Due to Contamination Public health officials have expanded their monitoring of health care facilities as a meningitis outbreak linked to injectable drugs continues to claim victims.

The Minnesota Department of Health (MDH) said on Oct. 16 that 129 clinics in the state have received injectable drugs from New England Compounding Center (NECC).

Since Oct. 4, state and federal agencies have been investigat-

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CAPSULES to page 6 NOVEMBER 2012

MINNESOTA PHYSICIAN

5

CAPSULES Capsules from page 5 ing NECC and the outbreak of fungal infections linked to contaminated products from that company.

Nearly 250 cases of meningitis have been documented by the Centers for Disease Control and Prevention (CDC) nationwide. That agency, along with the Food and Drug Administration (FDA), is working with state governments to track the outbreak and advise patients and physicians on treatment.

There have been 19 deaths linked to the outbreak, though none had been reported in Minnesota as of Nov. 5. Seven cases of meningitis have been reported in this state. Public health officials stress that this type of meningitis is not contagious.

Originally, the concern was limited to patients who had had steroid injections due to orthopedic conditions, and in Minnesota, only two facilities were known to use the NECC drug for those kinds of treatments. However, the CDC and

FDA have announced a possible case of meningitis associated with a second steroid produced

by NECC and that a NECC drug used in open heart surgery has been associated with a patient who developed a fungal infection.

MDH officials say that they attempted to contact nearly 1,000 patients about the original concern over the orthopedic steroid linked to the meningitis outbreak. State officials were able to contact nearly all of those patients by mid-October.

In a statement, MDH noted the FDA is now asking health care providers to follow up on other drugs manufactured by NECC, and to check patients who received NECC products for symptoms of meningitis.

C. Difficile Linked To Antibiotic Use A serious gastrointestinal condition is linked to antibiotic use, concludes a study by researchers at Mayo Clinic in Rochester.

In a study led by Sahil Khanna, MBBS, a Mayo Clinic gastroenterologist, researchers found that infections caused by the bacterium Clostridium difficile, also known as C. difficile, are becoming more common and more severe in hospitalized children and the elderly. The study says this is due in large part to greater use of antibiotics.

C. difficile is the most common cause of diarrhea in hospitals and can lead to life-threatening inflammation of the colon. The condition is linked to 14,000 U.S. deaths annually.

The study analyzed five years of data from the National Hospital Discharge Survey and found that of an estimated 13.7 million hospitalized children, the 46,176 with C. difficile infections had significantly longer hospital stays, more instances of colon surgery, increased admission to long- or short-term care facilities, and a higher risk of death.

“Despite increased awareness of C. difficile in children

and advancements in management and prevention, this remains a major problem in hospitalized children,” says Khanna. The study also found that elderly patients also have a greater risk of complications from C. difficile and of dying from the infection.

Researchers say increased use of antibiotics is a primary reason for the increasing infection rates. When a person takes antibiotics, good bacteria that protect against infection are destroyed. When these bacteria are destroyed, patients are vulnerable to C. difficile picked up from contaminated surfaces or spread from a health care provider’s hands.

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MINNESOTA PHYSICIAN

NOVEMBER 2012

©2012, UCare.

MEDICUS

Cardiologist John Lesser, MD, has been named president of the Society of Cardiovascular Computer Tomography. Lesser serves as director of cardiovascular CT and MRI at the Minneapolis Heart Institute at Abbott Northwestern Hospital. He is also an adjunct associate professor of medicine at the University of Minnesota.

The American Society of Hematology has John Lesser, MD honored University of Minnesota Medical School blood and marrow transplant specialist Bruce Blazar, MD, with the 2012 Ernest Beutler Lecture and Prize for his significant advances in the field of bone marrow transplantation (BMT) and adoptive immunotherapy. Blazar is a Regents professor of pediatrics, chief of the Pediatric Blood and Marrow Transplantation Program, and Andersen Chair in Transplantation Immunology at the U of M. He is internationally Bruce Blazar, MD recognized as a foremost physician-scientist in the field of BMT and also serves as founding director of the university’s Clinical and Translational Science Institute and the Center for Translational Medicine. Blazar also was recently elected to membership in the Institute of Medicine. This is one of the highest honors in the medical field, given to individuals who have demonstrated outstanding professional accomplishments and commitment to service.

Saravana Balaraman, MD, has joined RiverView Health and will practice on the main campus in Crookston, where he will specialize in family medicine. Balaraman previously was chief resident of family medicine at Stamford (Conn.) Hospital. Prior to that, he completed a year of specialty training in general surgery at Saravana Providence Hospital in Southfield, Mich. He Balaraman, MD also worked as a research scholar in otology.

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

Essentia Health has added several physicians to its clinics in Minnesota. Theresa Weerts, MD, has joined the Family Medicine Department at Essentia Health St. Mary’s–Superior Clinic. Weerts attended medical school at Stritch School of Medicine at Loyola University in Maywood, Ill. She completed a family medicine residency at Adventist Hinsdale Hospital in Hinsdale, Ill., and is boardcertified in family medicine. Kristin Lusian, DO, has joined the Family Medicine Department at Essentia Health–Ashland Clinic.

Lusian received her doctorate in osteopathic medicine from Des Moines University. Brian Junnila, MD, has joined the Emergency Medicine Department at Essentia Health–St. Mary’s Medical Center.

He completed an emergency medicine residency at Detroit Medical Center and received his medical degree from Ross University School of Medicine in Roseau, West Indies. Antonio Laudito, a cardiothoracic surgeon, has joined the Essentia Health–St. Mary’s Heart and Vascular Center. Laudito graduated from University of Turin (Italy) Medical School and completed his general surgery residency at Mount Sinai Hospital in New York. Following his cardiothoracic surgical residency at University of Miami–Jackson Memorial Hospital in Florida, he completed a pediatric cardiac surgical residency at University of California, San Francisco. Ifeyinwa Igwe, MBBS, has joined the pain management team at Essentia Health–Duluth Clinic. Igwe completed a residency at St. Luke’s–Roosevelt Hospital Center in New York and a fellowship in pain and palliative care at Metropolitan Hospital in New York, as well as an internship and residency at North General Hospital in New York. Igwe received her bachelor of medicine, bachelor of surgery degree at the University of Nigeria in Enugu.

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MINNESOTA PHYSICIAN

7

INTERVIEW

Embracing better health ■ How did Hearts Beat Back—The Heart of New

Ulm Project get started?

Charles Stephens, MD The Heart of New Ulm Project Hearts Beat Back— The Heart of New Ulm Project is a campaign to reduce the number of heart attacks in the New Ulm area over a period of 10 years.

The project is sponsored

by Allina Health, which owns the community’s hospital, the New Ulm Medical Center.

The Minneapolis Heart Institute is another partner in the project.

As the project’s medical director, Charles Stephens, MD, helps with the design of clinical interventions and serves as a liaison between the project planners and front-line practitioners at New Ulm Medical Center.

Stephens, a family practice physician, is a graduate of the University of California, San Francisco School of Medicine.

8

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

Dick Pettingill, who was CEO of Allina at that time, challenged the organization about what they were doing to help communities. Two giant projects were born out of Pettingill’s challenge; one of them ■ The project is in its fifth year now. What are was the Backyard Initiative in the area around you finding?

Allina headquarters in Minneapolis, and the other This program started with a free public screening one was The Heart of New Ulm Project. in 2009. Over the course of about six to eight Kevin Graham, MD, head of the Minneapolis months we had a free screening program for everyHeart Institute at the time, was a cardiologist who body in the community over 18, and we have over started coming down here to New Ulm more than 5,000 people out of our adult population of 10,000 20 years ago. New Ulm had become really, really who came through the screening. good at treating acute MIs. The issue became, We found that like much of “What can we do to push the Minnesota and much of America, treatment upstream a little bit, to I see this as people were too overweight, too actually try to prevent early heart inactive, and smoked too much. attacks and to prevent earlytrying to create We used that as the initial data onset disease?” pool to look at what we set out New Ulm got in the mix a critical mass, to do here.

The idea was to because of Dr. Graham’s famila change in norms rescreen every two years, so we iarity with the community here, did another screening in 2011. but also because it’s a town of of behavior.

We found that we have been 13,000 to 14,000, and over 90 able to make an impact on how percent of the people here had a many people are smoking, how many people are medical chart. When the project started in 2009, taking an aspirin a day, how many people at least we were already three or four years into an elecare involved in doing some kind of thing—whether tronic medical record, which tied into Abbott it is increasing their activity, or increasing the Northwestern Hospital and to the whole Allina sysnumber of fruits and vegetables in their daily diet, tem, so that we had an excellent ability to catch or things like that. data on people. With a relatively small town that One of the things that surprised me has been had a high percentage of people involved in our awareness of the project. We had a phone survey a medical center here and who all had data on a cencouple of years ago, and 94 percent of people in tralized medical record, it seemed like a great place our area knew about the program. to step in and try to do a project like this.

I see this as trying to create a critical mass, a ■ What can you tell us about your role in change in norms of behavior, be that smoking, genthe project? eral physical activity, choices in eating—both what you eat and how much you eat—to try to push The idea definitely came from Minneapolis and back the big glacier of what seems like the inevitfrom Allina, but from the get-go there was a ability of rolling toward increased obesity and tremendous amount of community involvement higher cardiovascular risk. here. Before I even got involved, there was a lot of planning with about 30-some people on the community steering committee.

Then I was asked to join the project. What I am charged to do is take what goes on at the research office, which is located at the Heart Institute in Abbott Hospital in Minneapolis, and help coordinate that with the primary care and other provider staff here in New Ulm. We also have a staff of four to five people on the ground here who are interacting with businesses, the schools, restaurant folks, and the community at large.

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

MINNESOTA PHYSICIAN NOVEMBER 2012

■ The name of the community is on the project.

Do people buy into it because of that?

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

I think this is an ideal place to try this program. Racially, New Ulm is not a diverse community, but on the socioeconomic spectrum, it really is quite diverse. We have only one hospital and medical facility and most of the people have come here at some point.

I think in a bigger community, where there are lots of hospitals and lots of different clinic entities and lots of different employers, you’re probably going to be working at finding groups that naturally coalesce, whether that’s a neighborhood community or some other group that somehow identi-

fies itself, where there is already some community closeness.

One other surprising thing that I saw in our community was from the person who works specifically with stores and restaurants. With convenience stores, when people come and grab their coffee on the way to work, just making a little change at the checkout helps, having healthy options right there, so that they have apples and bananas that are priced the same or cheaper than the candy bars and power bars.

We’re doing these things so that as you’re there pulling your money out of your wallet, you have a chance to grab an apple that costs 50 cents instead of $1.50, the same price [as a candy bar] or less; giving you a choice. The convenience stores have been really receptive to that and their sales of those things have significantly improved.

I think things like that are easily exportable to a community anywhere. â– From the medical provider point of

view, how do you encourage their involvement?

Our program has been offering grand rounds, educational sessions every three to six months, talking sometimes about the bread-and-butter stuff having to do with diabetes treatments, guidelines for lipids and blood pressure, sometimes stretching it a bit further, looking at far-flung ideas in

epidemiology, and things like that. This is just to keep people up on the subject. On the ground, our group has incentive goals, some financial and some performance goals.

It’s the same critical mass phenomenon here. We have had a lot more people who are more comfortable pushing patients to do things like take another antihypertensive medication or to increase their dose of a statin to get the cholesterol level down, to take their aspirin when they’re in one of the demographic groups.

There has definitely been a shift in how people see it, and I think people have been surprised and gratified after taking a bit more of an aggressive stance on the preventive treatment side. â– What has been the most rewarding

aspect of working on this project?

The most heartening for me has been the project’s effect on people. You look at patients who you’re afraid are walking time bombs, who you’re never going to do anything to help, and then they show up out of the blue and say, “Did you notice that I lost 10, 20, 50, 80 pounds?� You just look at them and say, “Wow.�

I have a great story. This fellow, who was maybe in his late 40s, went to one of the screenings and was shocked to find his blood pressure and cholesterol were way out of whack and he was overweight. I saw him

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

I got a note from him saying, “I’m doing well with my weight loss. I’m going to quit taking the medicines and then I want to get retested and see how I’m doing.� In one year, he had lost 98 pounds, he had gone off his cholesterol-lowering medicine and one of his blood pressure pills, his cholesterol numbers were perfect, and his blood pressure was well controlled on one low dose of an inexpensive daily blood pressure medication.

I said, “How’d you do it?� And he said, “You know, I just realized I needed to change, so I eat less when I eat, and I don’t eat between meals, and I just make sure I do something every day.�

You hear so many stories of, “Doc, it’s just impossible.� And that’s probably true for some people, but then you find a story like that where somebody loses 100 pounds and he loses the need for two medications and says I feel better, and I don’t feel like I’ve had to make any huge sacrifices. To me, that’s what it’s all about, just having people be able to go about their lives and feel a little bit better and not need to have so much interaction with medications.

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Art from cover While sometimes making the healing process challenging, these characteristics of mood disorders also create new opportunities as we think about how we educate medical and mental health professionals, patients, and the public.

Is there a better way?

In 2011, our Department of Psychiatry and Psychology began planning a distinctive continuing medical education experience in collaboration with the Mayo School of Continuous Professional Development and Mayo Clinic Center for Humanities in Medicine. The latter is a unique group that brings music, dance, art, and theater to Mayo and offers various humanities-related selectives for Mayo Medical School students.

As every physician knows, CME courses traditionally include a lot of talks and presentations in large, impersonal lecture hall atmospheres. To

10

to present the aging-focused play “I and I: The Sense of Self.”

The Guthrie has also worked with Mayo Medical School and the Center for Humanities in Medicine on the weeklong selective course “Telling the Patient’s Story,” which has been held twice now for Mayo medical students and once for residents. In the When stories are brought to life course, Guthrie proin the theater, we often get swept fessionals teach acting and storytelling up in the moment, emerging skills to participants, emotionally charged and with a fresh aiming to help them master the art of perspective on the topic at hand. effective and empathetic patient interaction. Students sharpen their ability to listen spective on the topic at hand.

By thinking outside the lecture more effectively to patients and hall, might we connect with Mayo Clinic and the theater home in on key points, then mental health providers on a Within Mayo Clinic’s long hisreflect on that information and more human—and more effectory of weaving the arts and use it to guide the next steps in tive—level? humanities into medicine are the patient’s diagnosis or treatWe arrived at the idea of many instances of theater ment plan. Most importantly, bringing psychiatry and psybeing used as a medium. they become better at sharing chology, particularly mood disorders, into the theater. Theater During the 1980s, Mayo had an that plan with the patient in a ongoing series that brought way that makes sense and seemed to fit well with mood well-known actors to Rochester motivates him or her to stick for an evening performance, to it. This has been a very such as Jason Robards Jr. presuccessful collaboration, with senting staged readings from students saying they’ve found “The Iceman Cometh” and it very easy to put their new Elaine Stritch presenting passkills into practice with actual sages from “Love Letters.” patients.

One relationship that parBut for our mood disorders ticularly stands out is Mayo course, we knew we had to do Clinic’s link to the Guthrie more than bring the theater to Theater in Minneapolis. This Mayo Clinic. Mayo Clinic had connection goes back more to go to the theater. than a decade to 2001, when Mood disorders take the stage veteran Guthrie actor Nathaniel Fuller came to Mayo Depression and bipolar disorfor a staged reading of “Molly der met theater in May when Sweeney,” a play about a blind our department presented woman, her husband, and her “Windows into Mood: Stories eye surgeon that touches on of Depression and Mania” at the complexities inherent in the Guthrie. In putting the daythe doctor-patient relationship. long CME course together, we In 2006, Mayo Clinic and aimed to combine the science the Guthrie presented a readand art of mood disorders for a ing of the critically acclaimed broad audience. play “Miss Evers’ Boys,” which For medical and mental recounts the infamous health professionals interested Tuskegee syphilis experiment. in learning more about the illAfter the reading, a panel disnesses, there were conventional cussion explored the serious scientific talks on mania, mindbioethical issues the study fulness and depression, family raised. A similar reading-andsupport strategies, mood disordiscussion format was used in ders in children and teens, and 2008 when British actor the need for earlier intervenCharles Keating visited Mayo tion and prevention. be sure, such courses certainly have their place, especially when teaching the “science” of medicine. But what about when focusing on the “art” of medicine?

Our department began to wonder: Is there a better way to deliver some aspects of psychiatry and psychology CME?

MINNESOTA PHYSICIAN NOVEMBER 2012

disorders because the stage has always been a place to explore life stories—stories of hope and sadness, success and failure, love and hate, triumph and struggle. When stories are brought to life in the theater, we often get swept up in the moment, emerging emotionally charged and with a fresh per-

family’s struggle with addictimes chilling fight with The “art” came by way of tions, another key focus area in depression, an illness that patient stories and performanour Department of Psychiatry pushed him to the brink of suices that were interspersed and Psychology. cide. As he sat with a loaded throughout the course. For My colleague Timothy gun in his mouth one night, it most of the clinicians, this was Lineberry, MD, is directing was his baby daughter’s loud a first in all their years of cries that pulled him back from the Mayo Clinic CME event attending CME courses. These “Windows into Hope: Stories of the edge, opening the door for stories and performances also Addiction and Recovery” him to start his path to recovgave the patients in attendance on Saturday, Jan. 26, 2013. ery. Today, in addition to leada fresh outlook on their ongoing recovery, while inspiring families and friends to see their What seemed to work particularly well loved one’s mood diswas the way that the latest science, order in a new light.

Bringing bipolar disorder to life

including new imaging and clinical trial data, was linked to intimately personal perspectives and testimonials.

Kay Redfield Jamison, PhD, the Dalio Family Professor in Mood Disorders and co-director of the Mood Disorders Center at Johns Hopkins Hospital in Baltimore, gave the keynote talk on creativity and mood disorders. As she detailed the complex interplay between creativity and madness, she highlighted several famous writers, poets, and artists who exhibited signs of mood disorders, including Edgar Allan Poe, Ernest Hemingway, Virginia Woolf, and Vincent van Gogh.

Jamison brought a unique perspective to the course, as she both studies these illnesses as a clinician-researcher and has personally battled bipolar disorder since her late 20s. She has chronicled her experience with the illness in “An Unquiet Mind: A Memoir of Moods and Madness,” one of her several books.

We also welcomed actress and writer Mary Pat Gleason, a Minnesota native who channeled her struggle with bipolar disorder into “Stopping Traffic,” a one-woman play she performed during the course.

The play’s title comes from a life event, in which her bipolar disorder once led her to believe she could step into Los Angeles traffic—and stop it.

Attendees also heard from Mark Meier, executive director of the Face It Foundation, a Minneapolis-based organization that helps men recognize and address their depression.

The foundation grew out of Meier’s own long and some-

ing Face It, Meier is a licensed clinical social worker, an adjunct faculty member and researcher at the University of Minnesota, and a frequent speaker on depression.

Looking ahead

Participant feedback told us that “Windows into Mood” was a well-received and effective course. What seemed to work particularly well was the way that the latest science, including new imaging and clinical trial data, was linked to intimately personal perspectives and testimonials. One medical professional called it “the best CME course I have ever been to.”

Another attendee, a woman who had been successfully treated for bipolar disorder, really connected with Mary Pat Gleason’s play. In the questionand-answer session after the performance, this attendee stood up and relayed her personal experience with bipolar disorder to the entire audience.

This was after not feeling comfortable enough to share her story with a few fellow attendees during lunch.

So where do we go from here? Recognizing the success of “Windows into Mood,” our department will again collaborate with the Guthrie when the theater brings Eugene O’Neill’s “Long Day’s Journey into Night” to the stage in January 2013. This Pulitzer Prizewinning play chronicles a

National experts will provide fast-paced education before the matinee performance, and after the show they’ll discuss the impact and treatment of addictions through the lens of the play. Also joining us will be actress Melissa Gilbert, who has successfully overcome addiction.

As with “Windows into Mood,” course participants can expect a blend of science and art aimed at a wide audience, from updates on the neurobiology and treatment of addiction to patient stories and experiences. Addictions, like mood disorders, often carry a certain social stigma, so we see an addictions-focused CME event tied to “Long Day’s Journey into Night” as an excellent opportunity to continue exploring the benefits and possibilities of theater-based continuing medical education in psychiatry and psychology.

Mark A. Frye, MD, is chair of the Department of Psychiatry and Psychology at Mayo Clinic in Rochester.

He is also director of the Mayo Clinic Depression Center, a member of the National Network of Depression Centers.

The author wishes to acknowledge the assistance of Matthew Sluzinski in the preparation of this article.

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Culture from cover complaint. One was diabetic, the other was not; I had ordered the hypoglycemic agent for the wrong patient.

As I changed the order to the correct patient, the nurse politely averted her gaze. I shared with the patient that he had had a “little spell,� but that he would be fine. I did not communicate with his family. I ruefully shared my experience with a trusted colleague, whose response was, “Been there, done that!� I did not consider sharing my experience more widely; the culture of the time led me to believe that could have resulted in an uncomfortable and potentially punitive response for me and the nursing staff.

Fast-forward 22 years. I’m serving as the director of medical affairs at another rural Minnesota hospital. A patient is dealing with a frustrating, chronic problem that is defying resolution. By chance, we discover that the normal range we had calculated for a lab test was off by a factor of 10. The patient ultimately does well, but her

course is affected due to this error.

The staff member who had performed the calculation was mortified. Investigation revealed the action to be simple human error within a system that was not designed to deal with the inevitability of such errors. After reviewing the event, we changed our process so that all such calculations must be independently performed by two people, confirming matching results. We met with the patient and spouse and explained what had happened and what we had done to minimize the risk of it happening again.

The two very different responses to these error events demonstrate a profound culture change—one that stresses learning and accountability over punishment and blame.

A perspective of shared responsibility

Historically, health care has been a punitive culture. Twentyfive years ago, sharing my experience so that others could learn and improve didn’t occur to me.

The way we addressed such incidents was to minimize or discount them as aberrations, or to discipline those involved, as a cautionary tale to others. Over time, however, we realized that that approach was resulting in the loss of invaluable learning opportunities. We then migrated to a “blame-free� culture, in which all errors were assumed to be system-based and individual accountability assumed less importance. But in fact, people do make choices about their behavior, and a level of accountability is necessary.

Enter Just Culture, a risk model for dealing with error within organizations. At Hutchinson Area Health Care, we began learning about this model of care eight years ago when we joined two other Minnesota health care organizations in a collaborative with David Marx, JD, a systems engineer who was working to translate Just Culture from the aerospace and transportation industries to health care.

Many people think this approach to safe care is simply

“doing the right thing.� It is that and much more. Rather than being simply a reset of where we are on the “punitive� to “blameless� continuum, this model looks at issues of risk and error from the perspective of shared accountability for patient safety and risk reduction. The organization is responsible for creating a safe system; the individual is responsible for the quality of the choices he or she makes.

System improvement is addressed through the organizational quality improvement process, such as our organization’s PDSA (Plan-Do-Study-Act) model.

Individual choices are dealt with in a prescribed, rigorous process. The Just Culture “algorithm� identifies three categories of behaviors that breach the organization’s policies: Human Error, At Risk, and Reckless.

Response to Human Error behavior, unless it occurs repeatedly, is to console the employee and address system issues. At Risk behavior, which in some instances may be justified, generally requires additional coach-

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ing and, sometimes, remedial action. Reckless behavior requires discipline or termination. For example: • Pulling a lab report from a printer and placing it on the wrong chart would be an example of a Human Error.

• Drawing up a parenteral pediatric medication and not double-checking it with another RN before administration, per organizational policy, would be At Risk behavior (potentially justified in rare instances).

• Performing an act intended to injure a patient is Reckless behavior.

Adopting the model

Telephone Equipment Distribution (TED) Program

Our organizational leadership group was fairly quick to grasp these principles; looking at incidents and errors through that lens has become nearly second nature for this group. Moving those principles into our medical staff and peer review processes has been more challenging and remains a work in progress.

One challenge is that physician peer review has long suf-

fered from outcome bias; the severity of an error and the culpability of a physician traditionally have been determined by the ultimate impact on a patient.

For example, if a surgeon refuses to participate in a “time out” protocol and an error occurs but there is no adverse outcome (as will be the case at least 99.9 percent of the time), the natural tendency for the medical staff is to deal with it quite differently than if the outcome is a wrongsite surgery. Under the Just Culture model, both scenarios would constitute at-risk behavior and would be dealt with by coaching the physician and potentially disciplining him or her if there was continued noncompliance. This approach runs counter to the medical community’s historical cultural and intuitive response.

If these concepts are challenging in our medical staff context, they are even more so in external environments such as the media and the law, where outcome bias is also alive and well. Malpractice allegations, especially as they are played out

in the media and the courtroom, starkly reveal that the principles of Just Culture are not universally accepted. It can be difficult to hold to these principles within our organizations in the face of such outside pressures. We can do our best to try to educate these constituencies, but often we must just accept that the rules in these arenas are different and are unlikely to change any time soon.

Impact on care

Learning these principles and embedding them in our organization and medical staff has required commitment and resources, but it has been worth the effort. Now, staff and physicians more often see their work through the lens of risk awareness and reduction, rather than one of self-preservation and fear.

As the concepts of Just Culture have become more widely accepted in medicine, this organizational model is having an impact. Recently, a colleague related an experience with a patient he had referred to a tertiary center. As the patient was

being prepared for discharge, the attending physician at the referral hospital called to update the referring physician on the patient’s hospital course and follow-up plans. He also related that the patient’s stay had been prolonged due to a medical error. As the attending was entering admission orders into the electronic health record, he had added an extra digit to an insulin order, resulting in hypoglycemia, a seizure, and transfer to the ICU. This error had been disclosed to the patient and family, as well as to my colleague, and a root cause analysis was initiated to learn how to prevent or mitigate the impact of an inevitable human error like this.

What a poignant bookend to my experience from 25 years ago! On the one hand, humans haven’t changed—we still make errors. On the other hand, we’ve come such a long way in learning from those errors and reducing their frequency and impact.

It is our responsibility to do no less.

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

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MEDICINE

14

THE

LAW

Sunshine and scrutiny

T

he “Sunshine Act” certainly sounds pleasant, but don’t be fooled by the name. It is a powerful tool for prosecutors. The Physician Payments Sunshine Act was signed into law by President Obama in March 2010 as part of the Patient Protection and Affordable Care Act (ACA), and will take effect Jan. 1, 2013.

The act requires drug and device companies to report almost any payment or transfer of value to physicians of over $10. These reports will be made publicly available on a government website, and recipients of such payments will be identified by name. There are large fines for each unreported payment, so drug and device companies have incentive to be thorough in their reporting. The Sunshine Act also makes it much easier for prosecutors to identify transactions that violate these federal statutes, including the federal Anti-Kickback Statute (AKS), the False Claims Act, and Stark Laws.

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Managing compliance with the ACA’s Sunshine provisions from a provider perspective

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

The Sunshine Act is a game changer

With unprecedented breadth and transparency, the Sunshine Act requires pharmaceutical, device, biological, and other medical

ments or transfers of value to physicians or teaching hospitals for consulting, nonconsulting services, honoraria, gifts, entertainment, travel, food, research, charitable contributions, royal-

The act requires drug and device companies to report almost any payments or transfer of value to physicians of over $10. supply companies whose products are paid for by government health care programs (“covered manufacturers”) to report pay-

MINNESOTA PHYSICIAN NOVEMBER 2012

ties or licenses, ownership or investment interests, faculty or speaker compensation, grants, and anything else required by Health and Human Services (HHS). There are several exceptions to the reporting requirements, including payments under $10 (or $100 aggregated annually), product samples, educational materials for patients, certain medical device loans, warranties, discounts or cash rebates, transfers of value to physician patients, charity care items, dividends from a publicly traded security fund, employee health care coverage, nonmedical professional services, and legal services. HHS will make this reported data publicly available on a government website.

The first report is due March 31, 2013. The reports will identify the covered recipient by name, and both covered manufacturers and covered recipients have 45 days to correct any information provided to HHS before it is made public.

Covered manufacturers face large fines for each unreported payment—up to $100,000 for each instance, meaning that drug and device manufacturers are unlikely to be noncompliant.

Nevertheless, physicians should guard themselves against inac-

curate reports; but, more importantly, they should identify and eliminate risky transactions with drug and device manufacturers.

Though physicians are not subject to fines under the Sunshine Act, they are subject to civil and even criminal penalties under the AKS, the False Claims Act, and the Stark Law. Increased transparency under the Sunshine Act may allow prosecutors to identify transactions that violate these federal statutes.

Now that federal prosecutors will have easy access to the details of almost every payment made to physicians from covered manufacturers, physicians who intentionally or inadvertently walk the line in their relationships with these companies may end up on the wrong side of the law. Beyond being armed with knowledge and honestly identifying risky arrangements, physicians must also take practical steps now to prepare for more “sunlight” and to navigate the still-evolving rules of the game.

Existing federal law interaction with the Sunshine Act

The state and federal reporting requirements are sure to garner heightened scrutiny, not only by the press and public, but also regulators and prosecutors. The AKS prohibits any remuneration to physicians for speaking, travel, consulting, or other services if the payment is intended to induce the physician to prescribe a medication or device that is paid for by Medicare or Medicaid. If a physician knowingly or willfully solicits or receives payments, it is a felony under the AKS and carries civil penalties. Under the ACA, AKS violations can result in False Claims Act violations, which carry criminal and civil penalties of $5,000–$10,000 per violation.

Physicians should take steps to insulate themselves from liability by understanding and strictly adhering to these requirements, including the AKS “safe harbors” described by the Office of Inspector General (OIG), which protect certain payments and business arrangements from criminal and civil SUNSHINE to page 18

NOVEMBER 2012

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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,

16

MINNESOTA PHYSICIAN NOVEMBER 2012

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 2012

MINNESOTA PHYSICIAN

17

Highlights from an interview with Minnesota’s “Physician Gift-Ban” regulator Sunshine from page 14 prosecution. This applies equally to the Stark Law, which prohibits referrals by physicians to entities in which they or their immediate family members have a financial interest. [The Sunshine Act could implicate Stark because it requires public disclosure of physician investment or ownership interests in drug or device companies.]

These federal laws mean that the increased transparency required by the Sunshine Act carries big implications for physicians.

Minnesota’s Physician Gift-Ban Act and federal law

Practitioners in Minnesota already have experience with sunshine laws. In 1993, Minnesota became the first state to enact laws regulating gifts to providers from pharmaceutical manufacturers or wholesale drug distributors. The law defines “practitioner” to include doctors of medicine, doctors of osteopathy duly licensed to practice medicine, as well as doctors of dentistry, optometry, podiatry,

We recently had the opportunity to interview the person responsible for administering and enforcing Minnesota’s “Physician Gift-Ban,” Cody Wiberg, PharmD, the executive director of the Minnesota Board of Pharmacy (Board). Here are key takeaways from the interview: • Minnesota has never taken action against anyone for improper or inadequate reporting, or for failure to report. To Dr. Wiberg’s knowledge, there have not been any major reporting issues warranting discipline.

• The Legislature has not provided the Board with resources to audit the reports and compare them with the actual payments made by regulated companies, so it is possible that some reports are inaccurate.

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

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

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

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

Stat. §151.01, subd. 23, 2011).

The Physician Gift-Ban Act bans gifts from manufacturers or wholesale drug distributors, or

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

• Dr. Wiberg believes the partial gift ban and the publicity surrounding it has changed the behavior of companies within the state. He believes that companies are no longer providing dinners to physicians at educational/promotional events and are no longer providing lunches.

• After an article appeared in the Journal of the American Medical Association, the Board received numerous requests for the payment reports from doctors, clinics, and hospitals all the way back to the date the law took effect. Dr. Wiberg said that physicians were concerned to see what was publicly reported about their relationships with companies.

• Dr. Wiberg is often asked whether the partial gift ban and reporting requirements led to an increased use of generic drugs. He said that while the state Medicare agency has seen increased prescriptions for generic drugs (he said generic drugs make up 70 percent of the total, versus 60 percent a few years ago), he is not sure it is because of this particular law because there are so many variables at play.

their agents, to “practitioners,” excluding such things as drug samples, items with a combined retail value of less than $50 (per calendar year), payments to medical conference sponsors, and reasonable honoraria.

Under the law, companies must file a publicly available annual report to the Board of Pharmacy (Board), detailing payments to identified recipients totaling over $100 per year to sponsors of educational programs, for honoraria, or for professional or consulting services.

Requests for access to the data have been few, and Minnesota’s reporting requirements are far less stringent than the Sunshine Act, meaning that Minnesota physicians who receive payments from device manufacturers will face a new level of scrutiny when the federal Sunshine Act reports are published (see Joseph S. Ross et al., Pharmaceutical company payments to physicians: early experiences with disclosure laws in Vermont and Minnesota, JAMA 2007; 297(11):1216, 1218).

Prepare to face the light

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MINNESOTA PHYSICIAN NOVEMBER 2012

Physicians must prepare for the Sunshine Act’s implementation by understanding the specifics of their interactions with cov-

ered manufacturers and identifying all areas of potential risk, including consulting agreements, purchasing deals, research funding, speaker honoraria, and the like. High-volume providers or physicians on formulary committees should be especially vigilant because they are enticing targets for prosecutors looking to make headlines.

In addition, physicians should take practical steps now to prepare for the new disclosure rules.

Practices should prepare a Sunshine Act compliance policy, including, for example, a hard dollar limit on payments from covered manufacturers, recognizing that patients, competitors, and prosecutors now have access to the records of these payments. If the physician is confident that all arrangements with a covered manufacturer are legitimate and represent fair market value, existing arrangements may be safe. Substantial consulting agreements and purchasing contracts for drugs and equipment must be evaluated for fairness. A legal opinion may be advisable for large contracts. A copy of the compliance program should be attached to consulting agreements, and, most importantly, a physician should objec-

tively assess whether his or her prescribing habits could appear to be influenced by any such arrangements.

As with many state and federal laws, a Sunshine Act compliance policy can be a mitigating factor if a violation occurs. But merely having a policy is not enough. If, during the course of an investigation, an employee cannot describe the policy—or, worse, does not know of the policy—the practice may as well not have one at all.

Practice managers and physicians must set the tone from the top; employees should be trained on the policy when they are hired, and trained and tested on it periodically thereafter. The behavior of the entire staff either implicates or protects physicians from liability under these statutes.

Although employee satisfaction is often overlooked as an issue relating to compliance, creating a positive atmosphere where employees feel supported and appreciated is a smart compliance strategy for physicians to employ. If employees do leave,

Physicians must take practical steps now to prepare for more “sunlight” and to navigate the still-evolving rules of the game. exit interviews should be conducted and any concerns immediately addressed. Other-wise, disgruntled employees can become qui tam plaintiffs.

Designating a single point of contact to control and monitor practice interaction with drug and device companies is another practical way to facilitate compliance with the Sunshine Act. This person can police interactions and track remuneration passing to each physician. For example, although physicians have 45 days after data is reported to HHS to submit corrections, physicians should request and review this data well before it is reported. This will allow physicians more time to evaluate the data before it is made public and immediately address inaccuracies.

Kickbacks from sales representatives historically have been problematic and will be even more so under the Sunshine Act. Physicians must be brutally honest in assessing relationships with sales representatives, and must be careful to avoid kickbacks or the appearance of a kickback. For example, a medical education conference in Las Vegas may be legitimately aimed at education, and Las Vegas may be the most costeffective location for the drug or device company to hold the conference. But if it looks inappropriate, physicians should either step away or clearly document why it is in compliance with federal law.

Take control now

The Sunshine Act’s reporting requirements do create additional risks for physicians.

Physicians should not rely on the reports by the drug and device companies, but should verify that the information being supplied is correct before the reports are even published.

Physicians should take control now, by arming themselves with knowledge, evaluating their arrangements with covered manufacturers, and taking practical steps to ensure their compliance with federal law.

David M. Aafedt, JD, is a shareholder at Winthrop & Weinstine, PA, where he practices in the areas of health care regulatory law and health care litigation. As a former Assistant Attorney General, he represented the Minnesota departments of commerce and health. Christianna L. Finnern, JD, is a shareholder at Winthrop & Weinstine, PA, and focuses her practice on health care regulatory compliance and complex commercial and health care litigation.

The authors acknowledge and thank Elizabeth R. Malay for her valuable assistance with this article.

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MINNESOTA PHYSICIAN

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SPECIAL

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Health care reform and rural health Preparing for the value-based future

reimbursement, and

By Terry Hill, MPA

quality measurement, driven by the need to drive down health care costs. But rural health presents special challenges related to demographics, geography, financial realities, and workforce issues, among others. This month’s special focus articles look at how rural providers can address these challenges.

T

he recent Supreme Court decision to uphold the Accountable Care Act was significant, but the transformation of health care in the United States is already underway.

Accountable care organizations already cover most of Minnesota, and there has been a massive investment in infrastructure, data warehouses, and new models of care. We will not return to paper records, nor will we stop the momentum toward payment for value rather than pay for volume. In short, the reform ship has already sailed, and it will not be sunk or turned back by the Supreme Court, politicians, or the outcome of the 2012 presidential election.

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MINNESOTA PHYSICIAN NOVEMBER 2012

For the past several decades, the American health system has been plagued by major breakdowns in quality, cost, access, and population health. But despite the hard work and dedication of physicians, nurses, and other health care workers, the American health system is falling farther and farther behind other countries in terms of health care value. The problem has not been about the providers; the real problem has been about the design of the current system.

Peter Senge, the preeminent expert on system theory, has remarked, “Every system is ideally designed to achieve the outcomes it is achieving.” Since the passage of the Medicare and Medicaid bill in 1965, the U.S. has been paying for volume: the more medical procedures performed, the more revenue produced. That business model/ system was ideally designed to produce too much, at too little quality, at too much cost. It was not designed to keep people healthy or to manage their chronic illnesses, or even to give everyone access to basic health services. In 2012, approximately 50 million people lack health insurance; quality and patient safety are inconsistent; health care costs are the leading cause of bankruptcy; and, if diabetes growth rates continue, one-third of our population may have the disease in 20 years. The health system that produced these results cannot be adequately tweaked; instead, it requires fundamental redesign.

A new model: pay for value

While the 2012 Supreme Court decision basically upheld the federal government’s ability to tax individuals or companies that fail to buy or provide health insurance, the Court struck

down the mandate for state Medicaid programs to expand their coverage to every family with income lower than 138 percent of the federal poverty level.

This gives states the option of taking the federal money for Medicaid at a matching ratio of approximately 20 to 1, or refusing to participate. Minnesota has already chosen to opt into the program, but other states have expressed a refusal to participate. The money for the expanded insurance program to cover 32 million new people comes from the health insurance mandates and the expanded Medicaid coverage.

The new U.S. health care model, called Pay for Value, is based on this formula: V (value) = Q (quality) plus S (Service) divided by C (cost). Physicians, hospitals, and other providers will be paid for documented quality scores, documented patient satisfaction scores, and documented cost. They will be financially rewarded for highquality, low-cost care and will be penalized for poor, high-cost care and hospital readmissions.

The role of ACOs

Accountable care organizations (ACOs) are at the core of the American reform movement, and will be evaluated and rewarded by the new criteria mentioned above. The primary targets for these ACOs will be the Institute for Health Improvement’s Triple Aim: better quality, better population health, and at a lower cost. This system redesign will ultimately transform the American health care system, but it will prove extremely challenging for both urban and rural providers.

To date, more than 150 ACOs have been certified by the Center for Medicare and Medicaid Innovation (CMMI), with approximately 50 more in the pipeline. (Minnesota alone has at least seven.) Not one of the certified ACOs has been led by rural health providers, even though at least a dozen networks of rural providers applied for certification. Problems with CMMI’s interpretation of which clinics got credit for Medicare patients led to rural ACO

wannabes failing to achieve the 5,000 Medicare patients necessary for ACO eligibility. In short, in the CMMI formula, Medicare patients were assigned to the medical clinic where Medicare had reimbursed the most dollars in care. This meant urban specialty clinics generally got credit for the patients rather than the primary care clinics, preventing the rural ACOs from getting adequate numbers for certification.

CMMI may eventually alter the ACO formula enabling ACO creation. In the interim, rural hospitals and rural providers have at least three basic options.

In the first option, rural providers can refuse to participate in the reform and hope it somehow goes away. If the above assumptions are correct, however, that would leave them unprepared for the future. It would be like continuing to drive a horse-and-buggy wagon in the 1920s, while competitors were all purchasing automobiles. This option would lead to the closing of rural hospitals and clinics and would severely hurt

The reform ship has already sailed, and it will not be sunk or turned back by the Supreme Court, the politicians, or the outcome of the 2012 presidential election. rural communities across the nation.

Rural providers might also choose to immediately try to become part of an urban-based ACO. This, of course, would be predicated on the ACOs’ agreeing to accept them, and on the rural providers’ ability to meet the ACO requirements for documented efficiency and outcomes, patient satisfaction, effective transitions of care, and electronic health records. New ACOs, because of their financially risky situation and the continuing uncertainty about the new care model, will probably be extremely careful in choosing which rural providers they include in their new models.

A third option for rural health providers is to actively

position themselves for success in the new value-based system.

Whether they become part of an ACO or not, they can work to maximize their value by recognizing and building their assets, while acknowledging and addressing their weaknesses.

ACOs place much greater value on primary care, a rural asset.

ACOs also value medical homes (which we find in isolated rural settings) and cost-effective care, which are other rural assets. On the other hand, rural providers lack patient volume, access to needed expertise, access to capital, and, often, technology. These are weaknesses that will have to be addressed. For those choosing this third option, it is imperative to begin as soon as possible to forge strategies to prepare for the value-based future.

Challenges and strategies for meeting them

In late 2011 and early 2012, the Louisiana Hospital Association brought a core group of rural health providers together to consider the impact of health care reform on rural America. After months of study and discussion, they issued a report summarizing the current environment, the major challenges, and recommended strategies. They commented: “Besides the historic challenges, the current environment driven by health care reform and market realities now offers a new set of challenges.

Many rural health care providers have not considered either the magnitude of the changes or the required strategies to address the changes.”

The Louisiana group further identified a core set of new challenges: 1) payment systems transitioning from volume to value; 2) increased emphasis on quality as payment and market differentiators; and 3) reduced payments that are real this time (e.g., penREFORM to page 27

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ne out of every four dying Americans is a veteran, yet 96 percent of veterans are cared for outside of the Veterans Affairs (VA) health care network, according to the National Hospice and Palliative Care Organization.

This means that the majority of veterans are cared for by hospice and health care professionals in their hometown.

How can we best serve the unique end-of-life care needs of these veterans?

As health care providers, we work diligently to assess each patient as an individual and deliver high-quality, customized care. No time is more crucial to provide this level of customized service than hospice, where treatment is designed to relieve symptoms and provide comfort and support to individuals with life-limiting illnesses.

Veterans’ unique end-of-life care needs

It has been pointed out time and again that when people

FOCUS:

H E A LT H

A call to duty Transforming veterans’ end-of-life care

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

reach the last chapter of their life journey, there is a natural tendency to reminisce, resolve issues, and reference previous experiences of emotional intensity—which, for veterans,

and spiritual symptoms toward the end of life. The Department of Veterans Affairs notes, for example, that Vietnam veterans may still suffer from “trench foot,” a fungal infection of the

A person’s military history can exacerbate physical, psychological, social, and spiritual symptoms toward the end of life. includes their history in the military.

Both research and evidenced-based practice have demonstrated that a person’s military history can exacerbate physical, psychological, social,

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RURAL

MINNESOTA PHYSICIAN NOVEMBER 2012

feet from walking in wet conditions; that symptoms of posttraumatic stress disorder may surface; that social isolation and distrust of authority may develop (or redevelop) in veterans who have felt a lack of support in the adjustment from military to civilian life; and that spiritual questions may arise as individuals encounter death outside of the battlefield.

The VA also cites the following contributing factors that may influence a veteran’s behavior and responses to endof-life issues: • Entry status: enlisted or drafted. Drafted veterans may experience higher levels of distrust of authority than veterans who enlisted.

• Branch of service and rank: Each branch of service has its own distinct culture. Veterans do not always share their rank with friends and loved ones yet sometimes reactions to life events are better understood when this status is revealed.

Regardless of rank, each veteran carries a responsibility for fellow soldiers although he or she cannot ensure their well-being and safe return.

• Combat or noncombat experience: Veterans who were directly exposed to the effects of combat may experience elevated levels of anxiety and

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

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

• Prisoner of war experience: We cannot begin to imagine what our POW veterans have experienced physically, mentally, and emotionally. At the end of life, these experiences may be the ones that color their memories.

For health care providers, being aware of an individual’s military history and the elements to which the veteran was exposed can assist in proper diagnosis and intervention.

Establishing a process to inquire about an individual’s military history has proven successful for numerous health care providers. The VA, in collaboration with the National Hospice and Palliative Care Organization, has developed a simple Military History Checklist that reviews the above factors for each patient to enable providers to best serve veterans’ unique health care needs. The Military History Checklist is available online at www.wehonorveterans.org and through numerous electronic health record platforms.

In addition, it is important to invite veterans approaching the end of life to tell their stories, to celebrate their accomplishments, and to express appreciation for their service to our county.

Challenges of meeting veterans’ needs

There are many challenges in meeting the unique end-of-life care needs of veterans, not only from a clinical standpoint but also from a system-wide perspective. Some examples: • Accessing care at a VA facility often is difficult for rural veterans, as the distance and travel time can make access costly and laborious.

• If inpatient care is provided at the VA, rural veterans may not be surrounded by family and

Tips to serve veterans in your community

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•

•

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friends during their remaining months.

Navigating the VA system and the correct entry point of contact can be confusing.

Understanding VA benefits and enrollment procedures is complicated.

Care coordination and transitions between the VA and local providers are not well established in many areas.

For providers, receiving timely, accurate VA reimbursement for services can be a cumbersome process.

Palliative care rural initiative for veterans

To respond to these challenges, the Duluth-based National Rural Health Resource Center, in partnership with Atlas Research of Washington D.C., is working with five community hospice organizations in the Upper Midwest on a palliative care rural initiative to develop and implement care coordination models that serve the health care needs of rural veterans requiring end-of-life care.

The project is funded by a contract awarded by the Department of Veterans Health Administration (VA), Veterans Integrated Service Network 23.

The five hospice organizations selected for the project are: • HealthConnect at Home— Grand Island, Neb. • Hospice of Siouxland— LeMars, Ia. • Hospice of Southwest Iowa— Council Bluffs, Ia. • Lakewood Health System— Staples, Minn.

• Regional Hospice Services, Inc.—Ashland, Wis. These facilities are building replicable and sustainable methods of collaboration between the VA and rural community hospice providers to address the challenges of meeting veterans’ hospice needs.

Lakewood Health System (LHS), in Staples, Minn., saw the rural palliative care initiative as an opportunity to enhance services to a population it knows is underserved in rural central Minnesota. The care coordination model it

• Implement the Military History Checklist upon intake.

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

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

• Connect with the VA’s entry point of contact, County Veteran Service Officers, to seek eligibility criteria for enrolling a veteran in the VA. • Build professional and organizational capacity to provide quality care for veterans.

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

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

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

developed consists of two primary components.

The first component is aimed at raising awareness of veterans’ unique end-of-life care needs, training staff to assess individual veteran needs, and developing relationships with local County Veteran Service Officers (CVSOs), who are the entry points of contact for any veteran enrolling in VA services.

The VA provided much of the material for these trainings.

LHS also purchased End-of-Life Nursing Education Consortium (ELNEC) modules specific to veterans to begin training staff.

In addition, LHS has begun using the Military History Checklist not just on new hospice admissions, but on all palliative care patients. As the staff has become more knowledgeable about the VA and its services, LHS has been exploring ways to help nonenrolled veterans access services, to break down some of the barriers to care, and to help veterans navigate through and between the two health systems.

The second component of the care coordination model examined ways to provide a broader spectrum of palliative care to rural veterans and offer more care to those who are not yet hospice-appropriate but who have serious life-threatening illnesses. LHS and the VA have collaborated and explored options for the VA to pay for inhome palliative care services provided by LHS.

LHS is also working toward completing level four of the We Honor Veterans Partnership, an educational recognition program for hospices to build awareness of veterans’ end-oflife needs and establish collaborative partnerships with the VA. LHS plans to start a Veteran-toVeteran volunteer program that offers peer support to meet the social and emotional needs of

vets receiving hospice care. In addition, the health system hopes to implement pinning ceremonies to recognize and honor veterans for their service.

LHS leaders note that their participation in this initiative with the National Rural Resource Center and the VA has raised awareness of veterans’ unique needs and has restored a sense of patriotism among the health care staff.

The five community hospices participating in this initiative are on a “call to duty” to serve those who have served our country, and are transforming veterans’ end-of-life care needs through respectful inquiry, compassionate listening, and grateful acknowledgment to comfort patients with a history of military service.

Kami Norland, MA, ATR, is a community specialist with the National Rural Health Resource Center, in Duluth.

Julie Benson, MD, is medical director for hospice and palliative care at Lakewood Health System, in Staples.

Read us online

wherever you are!

www.mppub.com NOVEMBER 2012

MINNESOTA PHYSICIAN

23

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icture this: Clinicians in a hospital emergency room in Aurora, Minn., are working to stabilize a 14-yearold boy who has been in an ATV accident. They are preparing him for transfer to a Duluth hospital, where he will receive specialty care. While they check the boyâ&#x20AC;&#x2122;s vitals and administer oxygen, a trauma surgeon located in Duluth looks on. She makes recommendations for initiating a chest tube while examining the patientâ&#x20AC;&#x2122;s injuries more closely, along with the Aurora provider.

This scenario is possible thanks to a recent project that has connected the emergency department (ED) at Essentia Healthâ&#x20AC;&#x201C;St. Maryâ&#x20AC;&#x2122;s Medical Center (SMMC) with the Northern Pines Medical Centerâ&#x20AC;&#x201C;Aurora, an Essentia Health critical access hospital (CAH) located in Aurora, 90 minutes north of Duluth. Telehealth connections are helping to provide support to the emergency care in the Aurora community and the surrounding rural area.

Similar scenes are unfolding in outlying communities across

FOCUS:

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H E A LT H

Forging connections Intersection of emergency departments and telehealth

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

the country today. Equipped with a two-way video monitor, a hand-held zoom camera, stellar sound microphone, and a digital stethoscope, providers in rural communities are using telehealth technology to connect them and their patients to spe-

Healthâ&#x20AC;&#x201C;SMMC in Duluth, is using telehealth technology to assist doctors in remote emergency rooms. â&#x20AC;&#x153;They simply log on to remotely connect,â&#x20AC;?

Gunnarson says, â&#x20AC;&#x153;and I can help manage the patient care or process the paperwork. The

Telehealth works because itâ&#x20AC;&#x2122;s a way for everyone to provide better care for all patients. cialists located virtually anywhere in the world.

Theresa Gunnarson, MD, chief of hospital-based services and a board-certified emergency medicine physician at Essentia

technology allows me to be a valuable help as if I am on-site.

Plus, if a patient is transferred here to Duluth, we already know their medical situation and can be prepared to help them immediately when they arrive.â&#x20AC;?

Gunnarson adds, â&#x20AC;&#x153;Itâ&#x20AC;&#x2122;s easy to get caught up in the technology, but telehealth works because itâ&#x20AC;&#x2122;s a way for everyone to provide better care for all patients.â&#x20AC;?

A redesign initiative

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MINNESOTA PHYSICIAN NOVEMBER 2012

The ED redesign and subsequent introduction of the telehealth system reflect the realities of Auroraâ&#x20AC;&#x2122;s demographics, which are very similar to those of other rural areas across the country.

Here is a snapshot of rural demographics across Essentia Healthâ&#x20AC;&#x2122;s service area: â&#x20AC;˘ 51 percent of our 50,990square-mile service area is classified as rural. â&#x20AC;˘ 45.2 percent of our population lives in areas where there is an inadequate supply of health care providers, defined by the U.S. Health Resources and Services Administration as Health Professional Shortage Areas (HPSAs). â&#x20AC;˘ Five of our 14 hospitals and 27 of our 62 clinics are located in HPSAs. The consequences of these demographics for rural critical

access hospitals include staffing problems (such as workforce shortages when attempting to have physicians cover all delivery of care), fragmented emergency care, and quality concerns. Meanwhile, sustainability issues threaten the very future of the entire hospital. In Aurora, it had become clear that the high cost of the all-physician delivery of care model was unaffordable and unsustainable.

The solution involved two major changes: â&#x20AC;˘ The medical center in Aurora replaced its all-physician model of care delivery with a model that primarily uses advance practice clinicians (APCs)â&#x20AC;&#x201D;nurse practitioners (NPs) and physician assistants (PAs)â&#x20AC;&#x201D;who receive telehealth support from board-certified physicians in the SMMCâ&#x20AC;&#x201C; Duluth ED. â&#x20AC;˘ Essentia implemented a telehealth system to connect the Essentia Healthâ&#x20AC;&#x201C;Northern Pines Medical Center in Aurora (the sending site, where the patient arrives for emergency care) with Essentia Healthâ&#x20AC;&#x201C;St. Maryâ&#x20AC;&#x2122;s Medical Centerâ&#x20AC;&#x2122;s emergency department in Duluth (the receiving site for the videoconferencing).

By August 2012, three fulltime NP/PAs were employed in the ED, replacing the rotating, independently contracted emergency room physicians at the rural hospital. The section chair for the Aurora ER, a board-certified emergency medicine physician, covers shifts in the ER at Aurora on a set rotation, and also conducts quality improvement activities for the ER. The APCs are supported by board-certified emergency medicine physicians at SMMCâ&#x20AC;&#x201C; Duluth via the telehealth connection.

A two-way emergency service

The TeleEmergency Department (TeleED) service links two-way video conferencing equipment in a rural emergency room to board-certified emergency medicine physicians and nurses at a central station hub, 24 hours a day, seven days a week. The computer access and connections are immediate.

In Essentia’s system, wallmounted, two-way, interactive video units equipped with microphones allow the SMMC–ED to see the patient in the rural ER and to support the care being delivered. The provider in Aurora initiates the call, and always serves as the primary provider. The connection continues until the rural provider signals the end of the consultation and disconnects.

Patients are not billed for these telehealth services.

Essentia pays an annual subscriber fee based on use by the rural site. Privileging and credentialing for the APCs (NP and PA) making video connections are governed by guidelines defined by the medical staff.

Examples include requiring connections during STEMIs, strokes, intubations, trauma, and when treating a newborn up to 3 months old.

TeleED technology

Essentia Health’s secure highspeed broadband network supports the telehealth connections.

Essentia Health’s Minnesota Telehealth Network provides the following specialty services: • • • • • • •

Cardiology Dermatology Diabetes care Elder care Emergency services Internal medicine Kidney care

This advanced e-health network connects all Essentia Health hospitals and clinics in Minnesota, Wisconsin, and North Dakota (Essentia’s other telehealth services are listed in the sidebar). Providers in both locations not only can conduct live, interactive videoconferences, but also can access APCs’ images and make notes on the same electronic medical record simultaneously. The microphones and the wall-mounted camera and monitor at the foot of the patient cart in the emergency room bay can be enhanced with additional cameras and a digital stethoscope for listening to heart and lung sounds simultaneously.

• • • • • • •

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

Telehealth education

To prepare for using the TeleED system, the nurses, doctors, and other clinicians in the two locations participated in live, interactive in-service education a week before going live. Using a case study scenario, the rural and metro providers, nurses, and ancillary staff all receive in-service training together. A STEMI case study was used with a volunteer “patient” to simulate a real situation. All staff members were required to practice with and demonstrate proficiency in operating the equipment.

In addition, each NP and PA employed in the Aurora ER spent a mandatory residency in

the SMMC–Duluth ED, averaging three months. During that time they also conducted intubations with anesthesiology in surgery, and followed the pediatric specialist rotation for admissions. Each residency was individualized based on the APC’s past clinical experience and assessed strengths and weaknesses. Additionally, the APC job descriptions for the Northern Pines Medical Center–Aurora required at least five years of experience in a critical care area. Although the time spent on training delayed putting the new staffing model into place, it not only helped these providers develop necessary skills but also allowed the ED physicians and APCs to build respect and trust over time and reduced the ED physicians’ concerns about liability and sharing risk.

Key considerations for project success

The telehealth director received strong staff support at several levels. Rapid cycle, six sigma, CONNECTIONS to page 26

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25

Connections from page 25 and lean management and improvement processes were used to meet the scheduled golive date at Aurora and Duluth within six months. Physician champions and nurse leaders from both Northern Pines and SMMC were vital to moving the project forward and supporting the telehealth teams. Crucial technology expertise included problem-solving and educating staff.

Other key considerations in the redesign project establishing a new delivery model of care and telehealth in the Northern Pines–Aurora ER were: • Internal communication • Rural ED technology, location, and design • Hub station technology location and design at the SMMC emergency department • Equipment/information systems • NP/PA hiring • Risk management • Credentialing and privileging • Documentation/information

The TeleED service has made the patient transfer process run much more smoothly; ED staff at SMMC say they feel they “already know” these patients before they even arrive. systems • Training development—curriculum, outcomes • Policy and procedure development for both facilities • Resource manual for both facilities • Marketing and public relations/external communications • Outcome measures/benchmarking Measurements of project success will include financial, clinical, and quality indicators, such as the overall impact on Aurora’s admissions; length of stay; telehealth usage; transfers and avoided transfers; mortality and morbidity; provider retention and patient satisfaction; and clinical outcomes with STEMIs, strokes, and trauma.

A formal dashboard for measur-

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26

ing, reporting, and evaluation is in place.

Challenges with the rapidcycle process included the requirement for cross-functional teams at both the rural Aurora and Duluth facilities. Completing the project preparation tasks in six months required commitment from all ED and project staff. Attendance at team meetings was important for shared decision-making.

Scheduling was complicated, but routine videoconferencing expedited attendance and erased travel time.

From April 2012 through August 2012, 27 TeleED connections were made between the two emergency rooms, based on guidelines and the rural clinicians’ requests for support, assistance, and second opinions.

During the month of September 2012, when all three APCs were employed full time, seven TeleED connections took place.

Results to date show that patient satisfaction at Aurora is excellent. Both EDs agree that the TeleED service has made the patient transfer process run much more smoothly; ED staff at SMMC say they feel they “already know” these patients before they even arrive.

The Aurora community’s confidence in the local ER has grown and utilization has increased.

Over the next two years, Essentia Health plans to add TeleED connections to all of its critical access hospitals.

Maureen Ideker, MBA, BSN, RN, is telehealth director at Essentia Health.

Cindy Loe, RN, is director of nurses at Northern Pines Medical Center–Aurora.

Michelle Oman, DO, is chief medical officer at Northern Pines Medical Center–Aurora. Nancy Tario, MA, is senior process expert at Essentia Health.

Minnesota Web Recruitment Search for practice opportunity postings throughout greater Minnesota

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The National Rural Health Resource Center offers Minnesota Web Recruitment which allows physicians, residents, fellows, advanced practice nurses, physician assistants and students to search for practice opportunities throughout greater Minnesota via the National Rural Recruitment and Retention Network (3RNet).

Postings are always current, include detailed opportunity descriptions and direct employer contact information.

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MINNESOTA PHYSICIAN NOVEMBER 2012

(Phone: 218-727-9390 Ext. 222 or Email: alaflamme@ruralcenter.org)

To date, more than 150 ACOs have been certified by the Center for Medicare and Medicaid Innovation (CMMI). Not one has been led by rural health providers.

Reform from page 21 alties for high rates of hospital readmissions).

The group then laid out a list of recommended strategies for rural providers to consider moving forward: • Increase leadership awareness of the new environment realities. This includes boards, physicians, and hospital leaders.

• Improve operational efficiencies of provider organizations.

This can be done with tools such as Lean and process improvement methodologies.

• Adopt effective quality measurement and improvement systems as a strategic priority.

• For hospitals, align/partner with medical staff contractually, functionally, and through governance where appropriate.

Under ACOs, primary care physicians in particular have greater influence.

• Seek interdependent relationships with developing regional systems and ACOs. In other words, find the win-win proposition, and don’t underestimate

the rural provider value.

• Maintain alignment between delivery system models and payment systems, building flexibility into the delivery system model for the changing payment system.

Though they come from the opposite end of the country, these observations and recommendations have value nationwide and should be seriously considered by rural providers in Minnesota. Organizations and individuals don’t have to address all the recommended activities at the same time, but it’s important to lay out a plan for taking action at the appropriate time.

Managing change: Don’t just sit there

The transformation of health care is already happening and

will not be stopped or significantly altered by political events.

We will move from the volumebased system of the past to the value-based system of the future because the old model produced low-value outcomes and is no longer financially sustainable.

Urban and rural health providers have the immediate challenge of preparing for success in the value-based payment system while still being paid in the old volume-based system.

This challenge is already clear to those building the new ACOs. They may not have figured out the answers, but they’re acutely aware of the problem.

Rural providers must act now to increase their awareness and begin to map out strategies that will make them successful in the future. Becoming part of

an ACO, or positioning the hospital or clinic to be successful in an ACO-like environment, are both viable options that rural providers should consider carefully. Hoping the reform will all go away or that the politicians will eventually kill it, however, is probably not a desirable option.

As is the case in almost every industry, change is inevitable, and managing change has become the greatest challenge of the 21st century. Will Rogers recognized this even back in the 1930s, when the nation faced the immense challenge of the last great depression, in this comment: “Even if you’re on the right track, you’ll get run over if you just sit there.”

Terry Hill, MPA, is director of the Duluth-based National Rural Health Resource Center. In that capacity, he is 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.

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MINNESOTA PHYSICIAN

27

PROFESSIONAL

C

hronic venous insufficiency (CVI) is a progressive disease affecting approximately 60 percent of the population in varying degrees.

CVI most frequently affects the superficial venous system and is a product of vascular hypertension resulting from vein wall weakness and valvular incompetence. Dysfunction or incompetence of the valves in the superficial venous system promotes retrograde blood flow and increased hydrostatic pressures. This failure in valve competency may be the result of preexisting weakness in the vessel wall or valve leaflets, superficial phlebitis, or excessive venous distention resulting from hormonal effects or high pressure.

Failure of valves located at the junctions of the deep and superficial system allows high pressure to enter the superficial veins, causing venous dilatation and varicose veins to form and propagate from the proximal junction site down into the lower extremities. When this occurs, normal backflow of perivascular fluid is disrupted,

U P D AT E :

WOUND

CARE

Venous disease The link between venous ulceration and chronic venous insufficiency

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

resulting in molecular changes causing inflammation, skin changes, pain, edema, deep vein thrombosis, and, ultimately, ulcerations.

The prevalence of CVI in the population is far more widespread than secondary postthrombotic syndrome. The incidence of CVI is marginally higher in women than in men and significantly increases with age. Other associated factors include a family history of varicose veins, obesity, pregnancy, phlebitis, and previous leg injury. Environmental or behavioral factors, such as prolonged standing or sitting posture at work, may also be associated with CVI. The CEAP system for classification of venous disease was first developed in 1994 by the

American Venous Forum. The acronym’s letters stand for: C—Clinical state: symptomatic vs. asymptomatic E—Etiology: congenital, primary, or secondary A—Anatomy: superficial, deep, or perforator P—Pathophysiology: reflux or obstruction This classification standard has been adopted worldwide and is the endorsed method for reporting data in the U.S. Venous disease is complex; CEAP classification helps determine the presence or absence of symptoms, as well as prognostic evaluation and treatment guidelines.

Venous ulcerations

Venous ulcerations are among the more serious consequences

of CVI and have an estimated prevalence of 0.06 percent to 2 percent, affecting nearly 1 percent of the adult population.

Approximately 60 percent to 70 percent of all lower extremity ulcerations are the result of chronic venous insufficiency.

Disabilities related to venous ulceration have a tremendous socioeconomic impact. Venous ulcerations result in an impaired ability to engage in social and occupational activities, thereby reducing quality of life and imposing financial constraints.

An estimated $3 billion is spent annually on venous ulcer care in the U.S. The link between CVI and venous ulceration is thought to be the result of many factors and is the end-stage manifestation of chronic venous insufficiency. One common scenario in the formation of venous ulcerations is an abnormal increase in plasma and erythrocyte diffusion into the extra vascular space, followed by fibrinogen passing into the interstitial fluid at a faster than normal rate, VENOUS DISEASE to page 30

Medical Director Duties and responsibilities: • Provides 24-hour call coverage • On site two times per week for 1 to 2 hours • Evaluate and provide written documentation (supporting statement) for clients involved in the civil commitment process • Annual review of policies as mandated by MN Rule 32 licensure • The medical director reports directly to the program director Mission Detox Center Making Change Possible By Never Giving Up On Anyone Opened in 1978, Mission Detox Center provides medically supervised detoxification services for suburban Hennepin County and Anoka County. Admission to Mission Detox Center is frequently the first professional intervention in a destructive pattern of chemical use, and a difficult point in any chemically dependent person's journey. Each client is welcomed with respect and provided professional and compassionate care by the staff of nurses, counselors and trained technicians.

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

If interested, contact the Program Director at (763) 559-1402 or to apply, send a cover letter and resume to: Mission Detox Center, 3409 East Medicine Lake Blvd., Plymouth, MN 55441 or fax to (763)559-1195 Or check out our website at: www.missionsinc.org

28

MINNESOTA PHYSICIAN NOVEMBER 2012

Spine Surgeons, join our team and set the standards for patient care.

Orthopaedic Associates of Duluth is seeking a highly motivated passionate and experienced SPINE SURGEON to provide outstanding orthopaedic care to its patients. The successful candidate will be part of our expanding and growing, well-respected team that serves patients from Duluth to northern Minnesota.

Orthopaedic Associates of Duluth is a group of nine orthopaedic surgeons that provide comprehensive orthopaedic services ranging from specialty specific exams and diagnosis to state-of-the-art inoffice MRI and imaging and surgery at their physician-owned surgery center.

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

A landscape of opportunities

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

Currently seeking physicians for the following: • Family Medicine • Neurology • General Surgery • Emergency Physician • Dermatology • Endocrinology • Psychiatry • Otolaryngology We are a physician-led health system, where teaching and research are possible with competitive salary, benefits, CME and loan forgiveness.

Cathy Mooney (608)775-3637 camooney@gundluth.org gundluth.org/MedCareers

EOE/AA/LEP

OCTOBER 2012

MINNESOTA PHYSICIAN

29

TABLE 1. Basic CEAP classification.

Venous disease from page 28 which then creates a fibrotic tissue deposition. The resulting inflammation and lipodermatosclerosis ultimately lead to venous ulcer formation.

Venous ulcerations make up the majority of chronic wounds treated in outpatient settings. These wounds have classic characteristics, including a location along the medial and lateral malleoli; surrounding dermatitis with scaling, weeping, crusting, and erythema causing intense pruritus; hyperpigmentation, lipodermatosclerosis, and beefy red granulation tissue. Venous ulcerations are often associated with superficial fibrinous necrosis, displaying healthy granulation tissue underneath. Most commonly, there is little or no pain associated with these wounds unless an underlying inflammation is present.

Evaluation and treatment of ulcerations

Differentiation of the various types of chronic ulcers and their pathophysiology provides a clear distinction among characteristics associated with ischemic, venous, and neuropathic ulcers. Clinical evaluation and diagnostic studies are important in identifying and treating these various forms of ulcerations. Etiology of venous ulcerations is indicative of chronic venous

disease and valve incompetency resulting in reflux.

The accepted diagnostic standard for assessing venous reflux in the great and small saphenous veins, deep veins, and perforator veins is color duplex ultrasound. This imaging combines real-time B-mode imaging of the deep and superficial veins with pulsed Doppler assessment of blood flow. Pulsed or color Doppler identifies vessels as well as the presence and direction of blood flow, and is used to detect venous reflux or venous obstruction. Duplex imaging identifies those patients with superficial venous reflux who may benefit from correction of the underlying venous disease through endovascular treatments using laser, radiofrequency ablation, and chemical foam sclerotherapy. These treatments have shown promise in controlling veinrelated symptoms and decreasing the incidence of recurrent ulcerations.

Conservative treatment is based on the reduction of venous hypertension and abatement of the inflammatory response.

Compression is the most widely prescribed conservative treatment, reducing edema and preventing venous distention. Compression also improves function in the calf muscle pump by decreasing vein wall tension. Pharmacologic intervention such as VENOUS DISEASE to page 32

Clinical classification: C0 No visible evidence of venous disease C1 Superficial spider veins (telangectasias or reticular veins) C2 Simple varicose veins only C3 Ankle edema or venous origin C 4a Skin pigmentation in the ankle area and/or dermatitis/eczema C 4b Lipodermatosclerosis C5 Healed venous ulcer C6 Open (active) venous ulcer S Symptomatic A Asymptomatic Etiologic classification: Ec Congenital Ep Primary Es Secondary En No venous etiology Anatomic classification: As Superficial veins Ap Perforating veins Ad Deep veins An No venous anatomy involved Pathophysiology classification: Pr Reflux Po Obstruction Pr, o Reflux and obstruction Pn No venous pathology CEAP = Clinical-Etiologic-Anatomic-Pathophysiology.

Modified from Meissner M, Gloviczki P, Bergan J, et al.

Primary chronic venous disorders.

J Vasc Surg. 2007;46(suppl S):54S-67S.

Think ““Outside” Think Outside” the C linic Clinic If yyou’re If ou’re ready ready to to expand impact exp and yyour our im pact beyond office b eyond o ffice vvisits, isits, ts ccall all us. us. You You can can make make a rreal eal difference diff ffeerence in rrural ural health medical h ealth ccare are as as a m edical leader le ader for for our our small, small, yet yet innovative health inn ovaative h ealth plan. plan.

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All rights reserved.

30

MINNESOTA PHYSICIAN NOVEMBER 2012

AIRFORCE.COM/HEALTHCARE

NEW POSITIONS:

Urgent Care

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.

• • • • •

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

Please contact or fax CV to: Joel Sagedahl, M.D. 5700 Bottineau Blvd., Crystal, MN 55429 763-504-6600 • Fax 763-504-6622

Visit our website at www.NWFPC.com

Orthopaedic Surgery Opportunity Live in Beautiful Minnesota Resort Community

An immediate opportunity is available for a BC/BE orthopedic surgeon in Bemidji, MN. Join three board certified orthopedic surgeons in this beautiful lakes community.

Enjoy practicing in a new Orthopedic & Sport Medicine Center, opening spring 2013 and serving a region of 100,000.

Live and work in a community that offers exceptional schools, a state university with NCAA Division I hockey and community symphony and orchestra. With over 500 miles of trails and 400 surrounding lakes, this active community was ranked a “Top Town” by Outdoor Life Magazine. Enjoy a fulfilling lifestyle and rewarding career. To learn more about this excellent practice opportunity contact: Celia Beck, Physician Recruiter Phone: (218) 333-5056 Fax: (218) 333-5360 Email: Celia.Beck@sanfordhealth.org

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

healthpartners.com

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

Hibbing Little Falls Park Rapids Alexandria Austin For more information contact Tina Dalton or Mike Coulter at 800-458-5003, email:

recruiting@epamidwest.com or visit our website at

www.epamidwest.com

AA/EOE - Not subject to H1B Caps

Your Emergency Practice Partner NOVEMBER 2012

MINNESOTA PHYSICIAN

31

Venous disease from page 30 diuretics, aspirin, systemic antibiotics, pentoxifylline, stanazol, escin (horse chestnut seed extract), hydroxyethylrutoside, sulodexide, and prostacyclin analogs has also been used.

These agents are thought to inhibit proteolytic enzymes that induce leukocyte activation, decrease capillary and venous permeability, and increase venous tone.

Although conservative treatment is a first-line defense, chronic venous insufficiency is progressive. Patients with persistent symptoms (pain, aching, swelling) and signs (varicose veins, skin changes, ulceration) of venous disease and documented reflux as a source of their symptoms are candidates for saphenous ablation by chemical, thermal, or mechanical means. This includes endovenous laser ablation, radiofrequency ablation, sclerotherapy, and surgical removal of affected vessels (stripping) or, more recently, microphlebectomy. The choice of modality depends upon the size of abnormal veins,

their location, and the presence or absence of venous reflux.

Endovenous laser ablation (EVLA) is a less invasive alternative to vein stripping and is now thought to be the gold standard in treating chronic venous insufficiency. Outcomes are far superior to surgical stripping, with better quality-of-life scores in the postoperative period. EVLA has been shown to correct or significantly improve hemodynamic abnormality in patients with chronic venous insufficiency and to dramatically decrease the incidence of neovascularization, as noted in the Journal of Vascular Surgery. It has been asserted that vein wall injury is mediated both by a direct laser effect and indirectly via steam generated by heating small amounts of blood within the lumen of the vessel.

Advanced technology using 1,320-, 1470-, and 2,078-nm lasers is thought to target water, while other wavelengths used for EVLA primarily target hemoglobin. This procedure is performed in outpatient settings, requiring minimal downtime. Most

patients resume normal activity within 24 hours.

Radiofrequency ablation generates a high-frequency alternating current, in the radio range of frequencies 300 kHz to 1 MHz, that is transmitted through an electrode. The resultant energy heats the vein wall adjacent to the probe, elevating the temperature, which alters the protein structure of the vein, inducing its closure. This is an outpatient procedure performed under local tumescent anesthesia, and it similarly decreases recurrence of venous incompetency by reducing neovascularization.

Sclerotherapy involves the induction of a chemical agent into the lumen of a vessel, causing endothelial destruction. The two main categories of sclerosing agents are detergent and osmotic. Detergent agents cause endothelial destruction by interfering with cell surface lipids.

Osmotic agents work through dehydration of the endothelial cells by interfering with the electrostatic charge. Sclerotherapy usually is used in conjunction with EVLA or radiofrequency

ablation to treat smaller varicose and nonsaphenous veins and is introduced using a visual technique or with ultrasound guidance.

Early detection and treatment enhance outcomes

Manifestation of venous ulcers is the end result of chronic venous insufficiency. Most patients present with ongoing pain, aching, throbbing, edema, cramping, restlessness, itching, and burning long before venous ulcerations appear. It is important to assess the nature of these complaints and determine the possibility of underlying venous disease. Referral to a board-certified phlebologist or practice specializing in the diagnosis, treatment, and advanced understanding of venous disease will promote early detection and treatment, enhancing clinical outcomes by improving the quality of care received.

Dana Matthews BSN, MBA, is director of clinic operations and Dan Morehouse, MD, RVT, is a boardcertified vascular surgeon at Vein Clinic PA, based in Blaine.

Heart of Minnesota Lakes Country Practice Opportunities

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

Sanford Clinic North – Excellent practice opportunities in communities located in the ‘Heart of Minnesota Lakes Country.’ Good call arrangements and modern well-managed community-owned hospitals.

Alexandria • Dermatology • ENT • Family Medicine • Hospitalist/IM • Internal Medicine • Ob/Gyn Detroit Lakes • Dermatology • Family Medicine • Internal Medicine • General Surgery • Pediatrics

East Grand Forks • Family Medicine • IM/Peds Moorhead • Family Medicine New York Mills/ Perham • Family Medicine • Orthopedic Surgery

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

Sanford Health, serving western Minnesota, eastern North Dakota and South Dakota, is redefining health care. Sanford offers innovative technology, support of a multi-specialty organization and dependable colleagues. Our employment model includes: market competitive salary, comprehensive benefits, paid malpractice insurance and a generous relocation allowance. To learn more contact: Shannon Ellering, Physician Recruiter Email: Shannon.Ellering@sanfordhealth.org

Phone: (701) 280-4817 EOE/AA

32

MINNESOTA PHYSICIAN NOVEMBER 2012

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

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

Growth and Opportunity

Practice Well. Live Well.

For

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.

Every Stage of Your Career

Over 700 physicians in more than 40 specialties.

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

North Memorial is seeking driven providers to be part of our 2012-2013 growth initiatives.

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 • Emergency Medicine

Opportunities exist in Family Medicine Internal Medicine Obstetrics

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

Gynecology

and in multiple surgical or medical specialties

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

Optimize your education and leadership potential.

To learn more, contact Mark A. Peterson, Physician Recruiter 763-520-1336 mark.peterson@northmemorial.com northmemorial.com

Adult Psychiatry Child Psychiatry

The Rochester community provides numerous cultural, educational, and recreational opportunities.

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

Dermatology Southeast Clinic

Family Medicine Chatfield Clinic Pine Island Clinic Plainview Clinic

Hospitalist Rochester Hospital

Internal Medicine Southeast Clinic

Sleep Medicine Rochester Hospital

Sports Medicine Othopedic Surgeon Southeast Clinic

Send CV to: Olmsted Medical Center Administration/Clinician Recruitment 102 Elton Hills Drive NW Rochester, MN 55901 email: egarcia@olmmed.org Phone: 507.529.6610 Fax: 507.529.6622

www.olmstedmedicalcenter.org

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

Southeast Clinic

Olmsted Medical Center provides an excellent opportunity to practice quality medicine in a family oriented atmosphere.

Lake Region Healthcare is an Equal Opportunity Employer. EOE

www.lrhc.org

Opportunities available in the following specialties:

Olmsted Medical Center, a 150-clinician multi-specialty clinic with 10 outlying branch clinics and a 61 bed hospital, continues to experience significant growth.

• Medical Oncologist • Pediatrics • Urology NP/PA

We offer a great group of colleagues, generous benefits and comp, opportunity for teaching and research, and the excitement of a metropolitan practice. Apply online at healthpartners.jobs or forward your CV and cover letter to sandy.j.lachman@ healthpartners.com. EO Employer

EOE

healthpartners.com NOVEMBER 2012

MINNESOTA PHYSICIAN

33

H E A LT H

Medicare in 2013

W

ith Medicare, things are always changing— and that will continue in 2013. Medicare changes affect your patients and your practice, so it is important to be aware of what is changing in the year ahead. Although not all of the 2013 information is yet available from the Centers for Medicare & Medicaid Services (CMS), what was available as of Aug. 31, 2012, is provided below. In addition, it is anticipated that Congress will revisit the physician fee schedule changes that were delayed until 2013.

Health care homes and ACOs

The Affordable Care Act allowed for the formation of accountable care organizations (ACOs), which are networks of physicians and hospitals that share responsibility for providing care to patients. The ACO agrees to manage all of the health care needs of a minimum of 5,000 Medicare beneficiaries for at least three years. In Minnesota, the formation of ACOs is in progress.

INSURANCE

Changes ahead for physicians, patients

By Kelli Jo Greiner

Health care homes, also known as medical homes, are becoming a popular option for providers to deliver care to patients in Minnesota. Health care homes are the foundation for new payment models, including ACOs. Primary care clinics transform services to meet a new set of patient- and familycentered standards that improve patient experience and quality of care and reduce costs. There were 190 certified health care homes in Minnesota when this article went to press; 25 percent of primary clinics in Minnesota have become certified health care homes. The Minnesota Department of Health is responsible for certifying health care homes. For information about health care homes in Minnesota, go to www.health.state.mn.us/ healthreform/homes/index.html.

E-prescribing

E- prescribing is here to stay.

2012 is the first year of the Electronic Prescribing (eRx) Incentive Program that features both incentive payments and adjustments (penalties). Eligible professionals that successfully reported eRx measures in 2011 will receive a bonus payment from Medicare in 2012 equal to 1 percent of their total Medicare Part B payments in 2011.

Physicians who fail to report one of the following will be subject to a 1 percent payment penalty for all Medicare payments in 2012, which will be assessed in 2013.

• At least 25 prescribing events via claims for at least 10 unique denominator eligible eRx events for services provided Jan. 1, 2012 through June 30, 2012; or

• Report the G8553 code via claims for at least 10 unique denominator eligible eRx events for services provided Jan. 1, 2012 through June 30, 2012; or • Apply for an exemption.

The penalty in 2012 and assessed in 2013 is a 1 percent reduction in all Medicare reimbursements. In 2013 and assessed in 2014, the penalty amount increases to 1.5 percent; and in 2014, to 2 percent. Some exemptions may apply.

Providers compliant with e-prescribing receive 1 percent incentive amount in 2012 and .5 percent in 2013. Beginning 2014, there is no incentive payment.

Update on therapies

On Feb. 22, 2012, President Obama signed the Middle Class Tax Relief and Job Creation Act of 2012. The law prevented the 27.4 percent cut to the Medicare Physician Fee Schedule through Dec. 31, 2012.

MEDICARE to page 36

VA Health Care System In South Dakota & North Dakota 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.

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

Sioux Falls VA HCS, SD

Black Hills VA HCS, SD

Fargo VA HCS, ND

Urologist Psychiatrist Hospitalist

Psychiatrist General Surgeon Physician (Primary Care) Hospitalist (Internal Medicine) Urologist

Psychiatrist Hospitalist Family Practice Internal Medicine

Orthopedic Surgeon Cardiologist Pulmonologist

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

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

Fargo VA HCS (701) 239-3700 x2353 www.fargo.va.gov

Applicants can apply online at www.USAJOBS.gov

34

MINNESOTA PHYSICIAN NOVEMBER 2012

Family Medicine St. Cloud/Sartell, MN We are actively recruiting exceptional part-time or full-time BC/ BE family medicine physicians to join our primary care team in Sartell, MN. This is an out-patient only opportunity and does not include labor and delivery or hospital call and rounding. Our current primary care team includes family medicine, adult medicine, OB/ GYN and pediatrics. Previous electronic medical record experience is preferred, but not required. We use the Epic electronic medical record system at all of our clinics and admitting hospitals.

Our HealthPartners Central Minnesota Clinics – Sartell moved into a new primary care clinic in the summer 2010. We offer a competitive salary, an excellent benefit package, a rewarding practice and a commitment to providing exceptional patientcentered care. St. Cloud/Sartell, MN is located just one hour north of the Twin Cities and offers a dynamic lifestyle in a growing community with a traditional appeal.

Apply on-line at healthpartners.jobs or contact diane.m.collins@ healthpartners.com or call Diane at 800-472-4695 x3. EOE

healthpartners.com

Essentia He H alth, yyou’ll ou’ll find With Essentia Health, a supportive group more supportive gr o of mor oup e than 750 medical 750 physicians physicians across across 55 55 me dical specialties. large specialties. Located Located in lar ge and small communities communities across across Minnesota, Minnesota, Wisconsin, North Dakota Idaho, Wisconsin, Nort th D akota and Idah o, Essentia Health emerging Essentia He alth h is emer ging as a leader cost-effective, leader in high-quality, high-q quality, c ost-effectivve, patient-centered care. patient-centered c are. EOE/AA EOE//A AA

LEARN MORE

EssentiaHealth.org/Careers E ssentiaHealth.org/Careers 800.882.7310 8 00.882.7310

NOVEMBER 2012

MINNESOTA PHYSICIAN

35

Medicare Advantage in Minnesota Medicare from page 34 In addition, the law extended the Medicare Part B Outpatient Therapy Cap Exceptions Process through Dec. 31, 2012. The combined therapy cap amount for physical and occupational therapy is $1,880. The separate cap amount for occupational therapy is $1,880. Hospital outpatient therapy departments had been exempt from the therapy cap, but that will end for a brief time. From Oct. 1, 2012 through Dec. 31, 2012, therapy caps will apply to all hospital outpatient departments on a temporary basis.

Competitive bidding for DMEPOS

The Medicare Modernization Act of 2003 established requirements for a new Competitive Bidding Program for certain durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS). The Competitive Bidding Program replaces the current fee schedule methodology for selected

There are now more than 803,000 Medicare beneficiaries in Minnesota; 389,000 are enrolled in Medicare Advantage plans to receive all of their Medicare benefitsâ&#x20AC;&#x201D;Part A, Part B, and Part Dâ&#x20AC;&#x201D; from one plan. At 48 percent, Minnesota has the highest rate of Medicare Advantage penetration in the continental United States.

DMEPOS items with a competitive bid process. It will eventually be implemented nationwide.

In 2013, areas of Minnesota will be part of the Round 2 DMEPOS Competitive Bidding Program.

The Round 2 area includes zip codes in Isanti, Chisago, Sherburne, Wright, Anoka, Washington, Ramsey, Hennepin, Dakota, Scott, and Carver counties.

Changes to Medicare Prescription Drug Program (Medicare Part D)

The following changes to Medicare Part D will go into effect Jan. 1, 2013.

The Medicare Part D annual deductible will increase from $320 to $325.

The initial coverage limit will increase from $2,930 to $2,970. During the initial coverage limit, the Part D plan pays for 75 percent of the Part D prescription drug costs and the

enrollee pays 25 percent of the costs.

The coverage gap, also known as the doughnut hole, begins once the enrolleeâ&#x20AC;&#x2122;s Part D prescription drug costs reach $2,970 and ends when the enrollee spends a total of $4,750.

In 2013, during the doughnut hole period enrollees will receive a 52.5 percent discount on brand-name prescription drugs and a 21 percent discount on generic prescription drugs.

The full retail cost of the prescription drugs will apply to the doughnut hole.

The out-of-pocket threshold will increase from $4,700 to $4,750. Total covered Part D spending at out-of-pocket threshold will increase from $6,657.50 to $6,733.75.

Every Medicare Part D plan will be required to have a Medication Therapy Management Program (MTMP) in place

for enrollees. â&#x20AC;˘ In 2013, the requirement expands to include providing MTM to enrollees residing in a long-term care facility. â&#x20AC;˘ In addition, each plan is required to include MTM information on the plan website. This includes describing the eligibility requirements, providing a contact person, and summarizing the services offered as part of the MTM. â&#x20AC;˘ Annual comprehensive medication reviews (CMRs) will be performed by the plan as part of medication therapy management protocol. â&#x20AC;˘ In 2013, CMS will require that standard member materials be provided to each enrollee following a CMR, including a personal medication list and medication action plan. â&#x20AC;˘ In 2014, the CMR service will become a focus of the STAR rating performance measure that is used to rank and provide bonuses to high-performing plans.

MEDICARE to page 38

FAMILY PRACTICE w/OB Warroad, MN Roseau, MN Crookston, MN â&#x20AC;˘ Dedicated Team Approach â&#x20AC;˘ Competitive Salary & Benefits â&#x20AC;˘ EPIC Healthcare Information System Idylic Practice Opportunities located in family friendly communities with close access to some of Minnesotaâ&#x20AC;&#x2122;s most beautiful lakes.

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

www.altru.org 36

MINNESOTA PHYSICIAN NOVEMBER 2012

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

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

The perfect match of career and lifestyle.

Affiliated Community Medical Centers is a physician owned multispecialty group with 11 affiliate sites located in western and southwestern Minnesota. ACMC is the perfect match for healthcare providers who are looking for an exceptional practice opportunity and a high quality of life.

Current opportunities available for BE/BC physicians in the following specialties: • ENT • Internal Medicine • Psychology • Family Medicine • Med/Peds Hospitalist • Pediatrics • General Surgery • OB/GYN • Pulmonary/ Critical Care • Geriatrician/Outpatient • Oncology Internal Medicine • Radiation Oncology • Orthopedic Surgery • Hospitalist • Rheumatology • Psychiatry • Infectious Disease 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

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

• Medical DirectorExtended Care & Rehab (IM or Geriatrics) (St. Cloud) • Psychiatrist (Brainerd, St. Cloud)

• Geriatrician (Nursing Home-St. Cloud)

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

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

Along with...

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.

Wapiti Medical Group and Connect Healthcare are looking for quality physicians to provide ER & Hospitalist coverage in our partner facilities in MN

Excellent benefit package including:

Be a part of the Leading Provider of outsourced Physician coverage • Competitive Pay • Paid Malpractice coverage • Boarded IM & FP welcome

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

• Dermatologist (St. Cloud)

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

www.acmc.com

tĂƉŝƟ DĞĚŝĐĂů 'ƌŽƵƉ

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

• Full and Part time work available • Physician Owned, Physician Run • Life work Balance

“Connecting Quality Healthcare to Rural America” Contact Brad McDonald, MD CEO 888-733-4428 or email: brad@erstaff.com www.erstaff.com

Favorable lifestyle

Competitive salary

26 days vacation

13 days sick leave

CME days

Liability insurance

Interested applicants can mail or email your CV to VAHCS

St.Health Cloud VA Care System Brainerd | Montevideo | Alexandria

Sharon Schmitz (Sharon.schmitz@va.gov) 4801 Veterans Drive, St. Cloud, MN 56303 Or fax: 320-654-7650 or Telephone: 320-252-1670, extension 6618

NOVEMBER 2012

MINNESOTA PHYSICIAN

37

Medicare from page 36 Other Medicare matters

The CMS revalidation of physicians is scheduled to be completed on March 25, 2013. The revalidation is part of massive anti-fraud effort required by the Affordable Care Act. CMS estimates that when the revalidation is completed, nearly 750,000 physicians will have received revalidation request letters.

In 2013, CMS will establish a Medicare pilot program to develop and evaluate making bundled payments for acute, inpatient hospital services, physician services, outpatient hospital services, and post-acute care services for an episode of care.

Beginning Jan. 1, 2013, there will be an increase in the Medicare withholding tax for higher income individuals, from 0.9 percent to 2.35 percent for singles with adjusted gross incomes over $200,000 and married couples filing jointly whose income exceeds $250,000. Beginning in 2013, these individuals will also pay a 3.8 percent

E-prescribing is here to stay. 2012 is the first year of the Electronic Prescribing (eRx) Incentive Program that features both incentive payments and adjustments (penalties).

Medicare contribution tax on unearned income.

It appears the implementation of the International Classification of Diseases (ICD-10) will be delayed until Oct. 1, 2014. The switch from ICD-9 to ICD-10 for claims submissions for medical diagnosis and inpatient procedure coding was scheduled to begin Oct. 1, 2013.

Assistance for your patients

Perhaps you want to help your patients find community resources to maintain their independence. You may have questions about community resources available for your patients. Often your patients may need additional assistance, such as connecting to commun-

ity resources; understanding long-term care options; selecting a Medicare Prescription Drug Plan; applying for PhaRMA patient-assistance programs; finding support for caregivers; understanding Medicare benefits; or locating informal services such as chore services, homedelivered meals, and support groups. One call to the Senior LinkAge Line at (800) 333-2433 does it all.

The Senior LinkAge Line: A One Stop Shop for Minnesota Seniors is a service of the Minnesota Board on Aging and is provided locally through the Area Agencies on Aging. Assistance is available by phone, live chat (www.MinnesotaHelp.info), and in person in all of Minnesotaâ&#x20AC;&#x2122;s 87 counties. There

is no charge to you or your patients.

The Senior LinkAge Line does not sell or market any product. Information provided is comprehensive, objective, and focused on helping your patient meet their needs. Currently the Senior LinkAge Line is seeking opportunities to partner with health care homes and hospitals to connect patients to the community resources they need.

For additional information about opportunities for working with the Senior LinkAge Line: A One Stop Shop for Minnesota Seniors and the local Area Agency on Aging, please call (800) 333-2433 and ask to speak with the Area Agency on Aging director. For additional information, contact Kelli Jo Greiner at (651) 431-2581 or at kellijo.greiner@state.mn.us.

Kelli Jo Greiner is the Consumer Choices team lead at the Minnesota Board on Aging.

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38

MINNESOTA PHYSICIAN NOVEMBER 2012

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

We protect your peace of mind. And we do it in lots of ways for physicians, facilities and hospitals.

Whatever your situation, we’ve been there, and will be there. We’ve gotten good at it. Excellent, actually, with a proven success rate. It’s a peace of mind movement.

And we’d love to have you along.

Join the Peace of Mind Movement at PeaceofMindMovement.com,or contact your independent agent or broker.