Minnesota Physician August 2013

Page 1

Volume XXVll, No. 5

August 2013

The Independent Medical Business Newspaper

Chronic illness and patient satisfaction Examining the links between them By Caroline S. Carlin, PhD, Jon B. Christianson, PhD, and Michael Finch, PhD

I

t has been more than a decade since the Institute of Medicine’s “Crossing the Quality Chasm” identified patient satisfaction as a component of quality in health care, and interest in improving patient satisfaction has been growing ever since. Comparative reports of provider quality increasingly include patient satisfaction measures, and services such as Angie’s List and HealthGrades report consumer ratings of health care providers accompanied by consumer comments. Patient satisfaction scores also have been used in computing pay-for-performance (P4P) bonuses and in constructing “tiered” benefit designs that encourage consumers to seek care from higherranking providers. SPECIAL FOCUS: Because improving Physician care for patients with Reimbursement chronic illnesses is a Page 20 primary focus for P4P plans and public reporting, an under-

When less is more

ILLNESS to page 12

LESS IS MORE to page 10

PAID

T

he overuse of health care services is a significant contributor to rising health care costs in the United States. While some health care utilization is driven by changing demographics, the Institute of Medicine estimates that as much as 30 percent of health care spending is wasted on unnecessary services, excessive administrative costs, fraud, and other problems. Also referred to as clinical waste, unnecessary services is the largest factor in this type of wasteful spending. Clinical waste is estimated to have accounted for $5.8 billion of the $37.7

PRSRT STD U.S. POSTAGE

By Tim Hernandez, MD, Kris Soegaard, and Howard Epstein, MD, FHM

billion spent on health care services in Minnesota in 2010. Unfortunately, more care does not necessarily equate with better care, and may actually be harmful. Two examples are nuclear imaging for coronary disease and the general use of CT scans. Both procedures are associated with significant radiation exposure. In fact, many experts agree that patients are exposed to excess radiation through procedures like non-indicated CT scans and nuclear imaging with stress test. In a study of CT scans in the emergency room published in Emergency

Detriot Lakes, MN Permit No. 2655

The issue of clinical waste


NEW ICD-10 DEADLINE:

OCT 1, 2014

2014 COMPLIANCE DEADLINE FOR ICD-10 The ICD-10 transition is coming October 1, 2014. The ICD-10 transition will change every part of how you provide care, from software upgrades, to patient registration and referrals, to clinical documentation, and billing. Work with your software vendor, clearinghouse, and billing service now to ensure you are ready when the time comes. ICD-10 is closer than it seems. CMS can help. Visit the CMS website at www.cms.gov/ICD10 for resources to get your practice ready.

Official CMS Industry Resources for the ICD-10 Transition

www.cms.gov/ICD10


CONTENTS

AUGUST 2013 Volume XXVII, No. 5

FEATURES

MINNESOTA HEALTH CARE ROUNDTABLE When less is more “Choosing Wisely”: the issue of clinical waste

1

By Tim Hernandez, MD, Kris Soegaard, and Howard Epstein, MD, FHM

Chronic illness and patient satisfaction 1 Examining the links between them By Caroline S. Carlin, PhD, Jon B. Christianson, PhD, and Michael Finch, PhD

DEPARTMENTS 4

PATIENT PERSPECTIVE The guiding hand

MEDICUS

7

By Bruce Ario

INTERVIEW

8

DERMATOLOGY Treating hyperhidrosis

CAPSULES

18 FORTIETH

24

By Brian Zelickson, MD Kathleen Sibelius U.S. Department of Health and Human Services

LAW AND POLICY Growing deeper roots

NEUROSURGERY Spinal metastasis

By Rep. Kim Norton

GASTROENTEROLOGY Celiac disease

30

SPECIAL FOCUS: PHYSICIAN REIMBURSEMENT

By Maria Christu, JD

20

Bundled payment for colonoscopy

Thursday, October 24, 2013 1:00 – 4:00 PM • Symphony Ballroom Downtown Mpls. Hilton and Towers

By Vandana Nehra, MD, and Joseph A. Murray, MD

Minnesota’s Medicaid experiment

Advance care planning Addressing end-of-life issues

26

By Charles R. Watts, MD, PhD

16

SESSION

22

By Scott R. Ketover, MD, AGAF

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

Objectives: We will discuss the significant infrastructure that supports end-of-life care. We will examine the roles of long-term care/assisted living, palliative care, gerontology, and hospice. We will review the elements that go into creating advanced directives, including societal issues that make having them necessary, and the difficulties encountered in bringing them to their current state. We will present a potential road map to optimal utilization of end-of-life support today and how it may best be improved in the future. Panelists include: Ed Ratner, MD, University of Minnesota Center for Bioethics Suzanne M. Scheller, Esq., Scheller Legal Solutions, LLC Cheryl Stephens, PhD, MBA, President, CEO, Community Health Information Collaborative Tomás Valdivia, MD, MS, CEO, Luminat

The Independent Medical Business Newspaper

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

Sponsors: Community Health Information Collaborative Luminat • Scheller Legal Solutions

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

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AUGUST 2013 MINNESOTA PHYSICIAN

3


CAPSULES

HealthPartners to Help Administer New Iowa Co-op Bloomington-based HealthPartners will provide important administrative services for a new health insurance co-op being launched this fall in Iowa and Nebraska. CoOportunity Health, based in Des Moines, will be one of 24 health insurance cooperatives launched nationwide under the Affordable Care Act (ACA). Working with the University of Iowa Health Alliance (UIHA), CoOportunity Health will offer two insurance plans in Iowa and one in Nebraska as part of ACA health insurance exchanges. CoOportunity Health contacted HealthPartners early on in the process, looking for a business partner with experience in community-based health insurance, officials say. Although not technically a co-op, HealthPartners is a member-governed organization that drew national attention as health reformers looked for

models on which to base ACA legislation. HealthPartners will provide essential administrative services to the new co-op, including claims processing, product development, underwriting, and customer service. The arrangement creates a thirdparty administrator-like role for HealthPartners, with CoOportunity Health handling the marketing, regulatory, member education, and outreach functions. “They’re really a super-TPA, because they’re doing more than simply paying the claims,” says Cliff Gold, chief operating officer of CoOportunity Health, about HealthPartners’ role. “They are the running gear from a systems standpoint for the co-op … they have really done a great job in getting ready for the implementation this fall.” Gold says CoOportunity Health aims to enroll 25,000 to 30,000 members in the first five years. “We anticipate a relatively slow adoption of the ACA for the first couple years, and

then it will start to ramp up as people become more familiar with the law and the exchanges become functionally better,” he says. Delays in rolling out the employer mandate of the ACA have made headlines recently, but Scott Aebischer, HealthPartners’ senior vice president of customer service and product innovation, says work on CoOportunity Health has gone smoothly. “It’s going very well, people are working really hard, and it’s exciting to be part of something like this,” he says. “The co-op has been a great partner in the whole process.”

Disparities Gaps Are Shrinking, DHS Report Finds A new report on health care disparities in Minnesota finds that gaps in health care delivery are shrinking, but officials say more improvements are needed. The sixth annual Health Care Disparities Report, pub-

lished by the Minnesota Department of Human Services (DHS), brings together statewide data from providers tracked by MN Community Measurement. The report looks at data for patients in the managed care component of Medicaid programs, including Medical Assistance and MinnesotaCare. Minnesota public health officials say that the gap in care delivery between people covered by Medicaid and those who have commercial insurance is one of the state’s top health care issues. The report finds that despite progress, gaps remain: 11 of 13 health care measurements show significantly lower outcomes for people covered by state programs, compared with those on private insurance. But officials also see improvement in addressing disparities. The report finds that disparities are being reduced in the areas of children’s asthma care; childhood immunizations; sore throat care; and cervical and breast cancer screening. “The progress made in

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asthma care and other areas is encouraging, but it also shows how critical it is to keep our focus on reducing health care disparities,” said Human Services Commissioner Lucinda Jesson. “This annual report gives us an important update on where we stand.”

HCMC Research Uses Exception from Informed Consent Hennepin County Medical Center (HCMC) is conducting research this summer that has a different standard of patient consent than is provided with most research. The study, conducted by the hospital’s Department of Emergency Medicine, relies on a process called “exception from informed consent.” Hospital officials say since the study focuses on drugs used with endotracheal intubation, in which a tube is placed in a patient’s throat to help with breathing, there will not be an opportunity for the normal process of informed consent. Researchers are exploring the differences between the two main drugs used to relax patients being intubated. The two most common medications used for this procedure are ketamine and etomidate. Both are known to work well, but it’s not known whether one of the medications is more effective than the other—that question is what the researchers will be studying. HCMC officials say under normal circumstances, medical researchers would explain a study and get informed consent from a patient. However, patients being intubated must be treated quickly in an emergency room situation, and will not be able to discuss the research and make an informed decision. The decision to enroll the patient in the study will be made by a physician on the scene. After the patient is medically stable, officials say, researchers will talk to the patient or a family member to receive consent to continue to participate in the study.

UnitedHealthcare Doubling Number Of ACO Contracts UnitedHealthcare, the Minnetonka-based health plan division of UnitedHealth Group, says it will more than double the number of its contracts with accountable care organizations (ACOs) by 2017. The health insurance giant says it is placing much greater emphasis on contracts that reward quality rather than quantity of care. Currently, more than $20 billion of UnitedHealthcare’s reimbursements to providers are based on contracts that link reimbursement to performance in quality and cost-efficiency measures. The company expects that number to increase to $50 billion by 2017. “We are improving health outcomes for patients at lower costs by moving even more broadly to value-based payment models and integrating those with our care provider network, product, and clinical strategies,” says Austin Pittman, president of UnitedHealthcare Networks. “Our unparalleled experience with accountable care models—and there are many—demonstrates that they can work better for everyone in health care, from patients to payers to care providers.” Although UnitedHealthcare does a relatively small amount of business in Minnesota, it is seen as an industry leader. Its embrace of performance-based care delivery models such as accountable care organizations and medical homes mirrors trends underway in Minnesota, which has made medical homes a key part of state health care reforms.

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“As physicians, we have so many unknowns coming our way... One thing I am certain about is my malpractice protection.” Medicine is feeling the effects of regulatory and legislative changes, increasing risk, and profitability demands—all contributing to uncertainty and lack of control. What we do control as physicians: our choice of a liability partner. I selected ProAssurance because they stand behind my good medicine. In spite of the maelstrom, I am protected, respected, and heard. I believe in fair treatment—and I get it.

Minnesota Facilities Do Well in “Best Hospitals” Rankings Minnesota hospitals once again placed highly in the latest U.S. News and World Report “Best Hospitals” rankings. Mayo Clinic continued its tradition of being one of the

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CAPSULES to page 6 AUGUST 2013

MINNESOTA PHYSICIAN

5


CAPSULES

Capsules from page 5 top three hospitals in the nation in the annual rankings, this year coming in at No. 3 overall. The clinic’s Rochester site ranked in the top five nationally in 15 specialty areas and ranked No. 15 in ophthalmology. In all, Mayo Clinic was nationally ranked in 26 specialty areas. Allina Health’s Abbott Northwestern Hospital, in Minneapolis, ranked among the nation’s top-50 hospitals for 10 specialty areas, with its highest ranking at No. 13 for orthopedics. Allina’s Mercy Hospital in Coon Rapids also received a national ranking, at No. 34 in gastroenterology. Minneapolis-based University of Minnesota Medical Center, Fairview, received top50 rankings in one adult specialty area (No. 37, cancer) and the University of Minnesota Amplatz Children’s Hospital, also at the U of M Minneapolis campus, received top rankings for four pediatric specialty areas. Children’s Hospitals and Clinics of Minnesota, based in

Minneapolis, received top-50 rankings in three specialty areas. Gillette Children’s Specialty Healthcare in St. Paul was ranked among the top 50 in two areas. St. John’s Hospital in St. Paul was ranked No. 36 in the ear, nose, and throat specialty. In all, U.S. News recognized 19 hospitals in Minnesota for either ranking among the nation’s top 50, or receiving a “high performing” designation, in at least one specialty area.

Report Says HMOs Amassing Reserves Minnesota HMOs are continuing to amass large cash reserves, a new study by analyst Allan Baumgarten says, as premium revenues continue to outpace medical spending. Baumgarten’s twice-yearly reports on Minnesota’s health care marketplace focuses on insurers in its latest release. According to Baumgarten’s data, Minnesota’s nonprofit HMOs have added $769 million to their reserves since 2008 and

2013 CME Activities

have $1.3 billion more than what is required by law. HMOs are required by law to keep financial reserves to protect the companies and their enrollees. However, Baumgarten has tracked higher and higher reserves by Minnesota plans. His latest report finds that plans in the state now have more than $1.9 billion in reserves, or surplus funds, as the report calls them. That would allow HMOs to pay 3.2 months in claims with no additional income, up from 2.4 months in 2009. The report says that state HMOs recorded a net income of $241 million in 2012, the fourth year in a row that health plans in Minnesota have recorded a profit. The plans had an overall margin of 3.3 percent for 2012. Baumgarten notes that one reason that Minnesota HMOs are showing large reserves may be because they are nonprofits and not part of larger, for-profit corporations. “One key difference is that if you go to a state like Colorado, the largest health

plans are UnitedHealth Group and Kaiser Permanente,” he says. “The major HMOs in those states are national companies, so when Colorado health plan surpluses get very high, they transfer the money to the corporate level.” After the HMO study was released, the Minnesota Council of Health Plans executive director Julie Brunner released a statement saying that the minimum level of reserves set by the state are not actually adequate and that much of the reserves are on paper only. “State contracts with HMOs allow the state to delay, withhold, and shift payments due to the plans,” she says. “For the HMOs this year, it’s nearly $1 billion in costs they have to cover until the state pays the money owed.” Baumgarten does not disagree that such problems exist, but he still questions the size of the reserves. “If you say to me health plans need adequate reserves, great—but I think we need to have a discussion of what constitutes adequate,” he says.

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

(All courses in the Twin Cities unless noted)

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

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

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

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

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

Promoting a lifetime of outstanding professional practice

6

MINNESOTA PHYSICIAN

AUGUST 2013


MEDICUS

Gunda Georg, PhD, professor and head of the Department of Medicinal Chemistry at the University of Minnesota, has received the Volwiler Research Achievement Award for 2013, from the American Association of Colleges of Pharmacy. She was chosen by her peers for outstanding contributions to the field. Georg is the co-inventor of Lusedra, a commercial anesthetic; a co-inventor of Gamendazole, a Gunda Georg, PhD male contraceptive agent in preclinical development; and a co-inventor of Minnelide, awaiting FDA approval for use in clinical trials against pancreatic cancer as this issue went to press. Georg is the director of the Institute for Therapeutics Discovery and Development at the university. Paul Gigante, MD, a neurosurgeon who specializes in movement disorders, has joined Central Minnesota Neurosciences in St. Cloud. Gigante graduated from Harvard Medical School, completed a neurological surgery residency at Columbia University, and was a clinical instructor of stereotactic and functional neurosurgery at Stanford University from 2012 to 2013. Adnan Qureshi, MD, has joined St. Cloud-based CentraCare as chair of cerebrovascular diseases and interventional neurology for CentraCare Health. Qureshi, an interventional neurologist, earned his medical degree from Quaid-e-Azam University, Islamabad, Pakistan. He completed a neurology residency at Emory University School of Medicine, Atlanta; a neurocritical care fellowship at Johns Hopkins Hospital, Baltimore; and an endovascular neurosurgery fellowship at State University of New York, Buffalo. Previously, he was the associate head of neurology at the University of Minnesota Medical School. Barbara N. Malone, MD, a board-certified otolaryngologist, has joined Children’s ENT and Facial Plastic Surgery, part of Children’s Hospitals and Clinics of Minnesota. Malone earned a medical degree from the University of Michigan, Ann Arbor; completed a residency in otolaryngology at the University of Minnesota; and com- Barbara Malone, MD pleted a fellowship in pediatric otolaryngology at Children’s Hospital of Michigan, Detroit. Malone will practice at both the Minneapolis and St. Paul campuses, each of which has full-service ENT clinics. She has served at Children’s for nearly 25 years. Amy L. McNally, MD, has joined the gynecologic oncology/surgery practice at Minnesota Oncology’s St. Paul Cancer Center. Board-certified in obstetrics and oncology and in gynecologic oncology, McNally formerly practiced at the University of Minnesota Department of Gynecologic Oncology and as a research member of the university’s Masonic Cancer Center. She earned a medical degree Amy McNally, MD from Creighton University School of Medicine, Omaha and completed residency and a fellowship in gynecologic oncology at the University of Minnesota. Thomas Scott, MD, has been awarded the 2013 Distinguished Service Award by the Minnesota Chapter of the American Academy of Pediatrics (MNAAP). Scott, a clinical professor and interim residency director for the Developmental-Behavioral Pediatrics Program in the Department of Pediatrics at the University of Minnesota, has a long history of program development to support youth and their families. He currently serves on the Minnesota Governor’s Task Force on the Prevention of School Bullying. MNAAP also announced the addition of two board members effective July 1: L. Read Sulik, MD, FAAP, senior vice president of Behavioral Health Services for Sanford Health; and Anupam B. Kharbanda, MD, MSc, FAAP, director of research for Emergency and Trauma Services at Children’s Hospitals and Clinics of Minnesota.

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AUGUST 2013

MINNESOTA PHYSICIAN

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INTERVIEW

Improving health through care delivery reforms ■ How are you working to improve health care

quality and patient safety while reducing the growth of health care costs?

Kathleen Sebelius U.S. Department of Health and Human Services Kathleen Sebelius is secretary of the U.S. Department of Health and Human Services. She is a former governor of Kansas and served as Kansas insurance commissioner from 1995 to 2003. She also served as a member of the Kansas House of Representatives from 1987 to 1995. Sebelius has overseen implementation of the Affordable Care Act, the largest federal health reform measure to be enacted since Medicare and Medicaid were signed into law nearly 50 years ago. As HHS secretary, Sebelius is overseeing a range of new regulations and taxes, expanded coverage through Medicaid and insurance exchanges, and sweeping new consumer protections. The health care law aims to bring health care coverage to 34 million previously uninsured Americans.

8

Under the health care law, we’re changing the incentives to reward providers who deliver the best quality of care, instead of just a higher quantity of care, and these changes are already making a difference. We’ve seen changes in care delivery on a broad scale. Accountable care organizations (ACOs) were once outliers in our health care system, but now more than 250 health organizations have formed ACOs under the health care law, serving more than 4 million Medicare beneficiaries, and similar care models are spreading rapidly in states and the private market. These kinds of delivery reforms have led to real health improvements for the American people. For example, after holding steady for years, hospital readmissions in Medicare have fallen significantly in the past year, resulting in an estimated 70,000 fewer return trips to the hospital with dangerous and costly complications. We’re starting to see health care costs slow because of the Affordable Care Act and that’s something we’re going to continue to build on. ■ Prevention and wellness are topics at the top of

HHS agendas. What are some of the outcomes of this focus? We know a focus on prevention will offer the opportunity to improve the health of Americans and control health care spending. To improve our health outcomes, the healthy choice should be the easy choice. Opportunities to eat right and exercise should be readily available to all Americans. Economic, social, and physical factors are all leading too many Americans to engage in behaviors that lead to poor health—such as tobacco use, poor diet, and physical inactivity. That is why we’re investing in prevention programs that meet Americans where they live, work, learn and play. The Affordable Care Act creates a new Prevention and Public Health Fund designed to expand and to sustain the necessary infrastructure to prevent disease, detect it early, and manage conditions before they become severe. Through the Fund’s Community Transformation Grants, communities nationwide are supporting core public health activities and implementing community-based strategies to address chronic diseases, such as heart disease, diabetes, and cancer. Current projects are expected to improve the health of more than 40 percent of our citizens—about 130 million Americans. Projects supported by the fund include the “Tips from Former Smokers” campaign, which features people discussing the health effects they’ve experienced as a result of smoking. In 2012, calls to state quitlines went up by 132 percent. The Fund also supports the National Diabetes Prevention Program, a public-private partnership connecting people at risk of developing type 2 diabetes with a

MINNESOTA PHYSICIAN AUGUST 2013

lifestyle coach in a group setting offered through community-based organizations, wellness centers, and faith-based organizations. The program’s goal is to reach 15 million people with prediabetes by 2020 and to prevent them from developing type 2 diabetes or to diagnose them early in order to avoid long-term health complications. ■ Tell us about some of the public-private collab-

oration you are promoting. One great example is Million Hearts, which was launched in 2011 with the goal of preventing 1 million heart attacks and strokes by 2017. It’s a national initiative that brings together communities, health systems, nonprofit organizations, federal agencies, and private-sector partners to fight heart disease and stroke. We also have Partnership for Patients, a program working to improve the quality, safety, and affordability of health care for all Americans. This is a collaboration among hospitals, providers, patients, advocates, and the federal and state governments. There are over 3,700 participating hospitals in the program that are focused on goals like preventing hospital-acquired conditions and reducing readmission rates. ■ What are the most important things being

done to promote the adoption and meaningful use of health information technology? Health IT is critical to improving efficiency, promoting health, and, especially, lowering costs. Smart data and analytics help providers streamline care and avoid errors. Four years ago, just two in 10 doctors and one in 10 hospitals used electronic health records, even though they’ve been around for years. Now, more than half of all doctors and other eligible providers have received Medicare or Medicaid incentive payments for adopting or meaningfully using electronic health records. HHS has met and exceeded its goal for 50 percent of doctor offices and 80 percent of eligible hospitals to have EHRs by the end of 2013. ■ As health care reform moves forward, what are

the most important things you want physicians to know? Physicians can play a critical role in educating their patients and their communities about the health care law. In particular, a new Health Insurance Marketplace will open on October 1, giving millions of Americans who are uninsured, or who buy coverage on their own, a new way to shop for health plans in which they can enroll for coverage starting on January 1. However, for many patients to understand and fully benefit in this new environment, they will need guidance and assistance from trusted sources. We know that having health coverage leads to better health. By educating themselves, physicians can be armed with the information they’ll need to help those around them get covered this fall.


Physician opinion survey August 2013 7. If a proxy is unavailable, and the patient is unable to express his or her wishes, how do you think written preferences in a health care directive should be weighed against family requests? 80 Percentage of total responses

We are pleased to present the results from our most recent physician opinion survey. Through a number of sampling methods, we received a total of 110 responses. If you would like to be included in future surveys, please contact us via email at comments@mppub.com or call 612-728-8600. The surveys are online, take less than two minutes to complete, and are completely anonymous and confidential.We welcome your suggestions for future surveys. Our thanks to those who participated.

70 60 50 40 30 20 10 0

40

Percentage of total responses

Percentage of total responses

50

30 20 10 0

Strongly agree

Agree

No opinion Disagree

Strongly disagree

40 30 20 10 0

Very Important No opinion Somewhat Not important important important

70 60 50 40 30 20 10

40

50

30 20 10

Regularly

Often

No opinion Sometimes

Rarely

30 20

3. I would recommend advance care planning more often if a standardized, validated, self-directing tool was available.

25 20 15 10

Strongly agree

Agree

No opinion Disagree

Strongly agree

Agree

No opinion Disagree

Strongly disagree

Strongly disagree

10. I recommend care (diagnostic procedures, treatment, etc.) that may have minimal effect on patients’ terminal conditions due to concern over potential legal action.

80 Percentage of total responses

Percentage of total responses

30

0

6. How useful are patient preferences on health care directives when a patient can no longer express what he or she wants?

50 40 30 20 10

50

70 60 50 40 30 20 10

0

No opinion Interpret Conference instance in colleagues individually

5

10 0

Follow requests

35

Percentage of total responses

0

40

Follow directive

9. I believe Medicare recipients should be required to file advance care directives.

Percentage of total responses

5. One of my concerns about advance directives is that unwanted care may be provided in health care facilities that are not aware a patient has an advance directive. Percentage of total responses

Percentage of total responses

50

No opinion Interpret Conference instance in colleagues individually

80

0

2. How frequently do you discuss advance care planning with patients?

Follow requests

4. How important is it for a physician to be involved 8. If a patient is unable to communicate and in helping a patient understand the issues covered the wishes expressed in his or her health in advance care planning documents? care directive differ from a proxy’s requests, how do you weigh written 50 requests compared with proxy requests?

Percentage of total responses

1. I feel comfortable talking about end-oflife care with my patients.

Follow directive

Strongly agree

Agree

No opinion Disagree

Strongly disagree

0

Very Useful

Useful

No opinion Somewhat

40 30 20 10

Not

0

Strongly agree

Agree

No opinion Disagree

Strongly disagree

To participate in future surveys or make comments, please contact us at comments@mppub.com. AUGUST 2013

MINNESOTA PHYSICIAN

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Less is more from cover Medicine International in 2011, as many as 34 percent of CT scans, other imaging studies, and diagnostic tests—whether appropriately ordered or not— were associated with false-positive and incidental findings (“incidentalomas”), which often

Now, three Minnesota health care organizations have joined forces to address the overuse of medical services in our state. These organizations, the Minnesota Health Action Group, the Institute for Clinical Systems Improvement (ICSI), and the Minnesota Medical Association (MMA), have come

services that are frequently used but may not be necessary. The campaign was publicly announced in April 2012. At the time, nine medical societies each released a list of five medical tests or procedures for their area of care that may be unnecessary. The ABIM Foundation engaged Consumer Reports to

At its most basic level, Choosing Wisely is an educational effort. lead to further studies or procedures, as well as anxiety for patients. And, according to a report published by Heart International in 2012, some studies estimate that as many as one-fifth of all nuclear cardiac scans are positive when the patient has no obstructive coronary disease. The consequence is often an angiogram that may lead to potentially more significant complications and great expense.

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together to support an initiative called Choosing Wisely, which was developed by the ABIM (American Board of Internal Medicine) Foundation. What Is Choosing Wisely?

Choosing Wisely is a national campaign that is designed to address the problem of overuse of health care services by helping physicians, patients, and other health care stakeholders discuss health care

MINNESOTA PHYSICIAN AUGUST 2013

develop easy-to-understand information about these tests and procedures that would facilitate conversations between patients and doctors. Consumer Reports also is coordinating the efforts of 16 regional communication partners, including the Minnesota Health Action Group. As part of the Choosing Wisely campaign, 26 specialty societies (representing more than 725,000 physicians) have each identified five tests and procedures that might warrant additional conversations between doctors and patients for their area of specialty. At its most basic level, Choosing Wisely is an educational effort. The education process focuses on a few key areas, and addresses both physicians and individual patients: • Specific tests or procedures that are often overused and unnecessary • The potential danger to the patient when health care services are performed unnecessarily • Tips for patients to help them ask the right questions of their doctors when in the process of deciding on an appropriate test or treatment • Tips for physicians to help them communicate with patients about tests and procedures, including the indication, potential side effects, and possible alternatives

Initial focus of Choosing Wisely in Minnesota

The Minnesota Health Action Group and ICSI received a grant from the ABIM Foundation to serve together as a regional collaborative for Choosing Wisely. They are leading a process to identify a potential list of tests and procedures that may serve as an initial focus for targeted improvement in Minnesota. The MMA received a separate grant from the ABIM Foundation. Its work on Choosing Wisely will focus on generating physician awareness about the campaign and establishing a learning network of clinics interested in implementing recommendations. In a unique partnership with the Guthrie Theater, the MMA will develop communication-skills training to support conversations with patients about appropriate care. A group of stakeholders that included the Action Group, ICSI, physicians, employer purchasers, and consumers used pre-established selection criteria to evaluate the 135 Choosing Wisely recommendations for their potential to positively impact appropriateness of care in Minnesota. Ultimately, 11 tests and procedures were selected (see sidebar on page 11). The Minnesota Chartered Value Exchange (CVE) subsequently endorsed this process, as well as future efforts to use the “Top 11” list to further the goals of the Choosing Wisely campaign. The CVE is an alliance of five Minnesota organizations—The Action Group, ICSI, Stratis Health, Minnesota Community Measurement, and the Department of Human Services—that was formed in 2008 to support health information technology; quality improvement and measurement; price transparency and public reporting; incentives to promote high-quality, efficient care; and consumer engagement and education.


Choosing Wisely—the initial list of recommendations in Minnesota: • Don’t do imaging for low back pain within the first few weeks unless red flags are present. • CT scans are not necessary in the immediate evaluation of minor head injuries; PECARN (Pediatric Emergency Care Applied Research Network) criteria should be used to determine whether imaging is indicated. • Don’t do imaging for uncomplicated headache. • Don’t schedule elective, non-medically indicated inductions of labor or C-sections before 39 weeks. • Avoid elective, non-medically indicated inductions of labor before 41 weeks, unless the cervix is deemed favorable. • Don’t routinely prescribe antibiotics for acute mild-to-moderate sinusitis unless symptoms last for seven or more days, or symptoms worsen after initial clinical improvement. • Do not repeat colonoscopy for at least five years for patients who have one or two small (<1 cm) adenomatous polyps, without high-grade dysplasia, completely removed via a high-quality colonoscopy. • Don’t recommend percutaneous feeding tubes in patients with advanced dementia; instead, offer oral assisted feeding. • Don’t recommend more than a single fraction of palliative radiation for an uncomplicated bone metastasis. • Don’t perform stenting of non-culprit lesions during percutaneous coronary artery intervention (PCI) for uncomplicated hemodynamically stable ST-segment myocardial infarction (STEMI). • Avoid routine preoperative testing for low-risk surgeries without a clinical indication. Benefits of supporting Choosing Wisely in Minnesota

The value of the campaign for all the stakeholders is that the recommendations have been developed by specialty medical societies, based on clinical evidence, and focused on improved quality and safety. Choosing Wisely has the potential to truly engage providers and patients in conversations that can help achieve the Triple Aim goals of better health, better care, and improved costs. Minnesota physicians can benefit from Choosing Wisely because it provides evidencebased support and guidance from a variety of specialty societies that complement existing ICSI health care guidelines. Of particular help are the patientcentered communication materials developed by Consumer Reports for Choosing Wisely and its website (consumer healthchoices.org). They can be used in the clinic or hospital, and in external communications to educate consumers on health conditions, testing, and treatments, and to encourage patients to discuss appropriate use and necessary care with their providers.

Choosing Wisely tools can also be used to educate clinical staff so they understand the goals of the broader initiative, the specific tests and procedures called out by their medical specialty, alternative care options, and potential overuse. This is important because patients often question clinic staff members after they leave the exam room. The Choosing Wisely materials were developed by organizations like Consumer Reports in partnership with consumers, so they address the consumer concern that needed care is being withheld from patients. Staff education allows physicians and other health care clinicians to maintain their role as advocates for their patients, while the patient-friendly materials help to simplify what can be lengthy and complex conversations. Some of the materials are also available in easy-to-read and Spanish versions. The partner organizations involved in Choosing Wisely believe that as physicians become more comfortable with the campaign, they will begin to appreciate that it can help them “do no harm,” play a role in

Medical societies supporting Choosing Wisely recommendations: • American Geriatrics Society • American College of Cardiology • American Academy of Ophthalmology • American Society for Clinical Pathology • American Society of Echocardiography • American Society of Nuclear Cardiology • Society of Cardiovascular Computed Tomography • Society of Thoracic Surgeons • Society for Vascular Medicine

• American Academy of Family Physicians • American College of Physicians • American Academy of Pediatrics • American College of Radiology • American College of Obstetricians and Gynecologists • American Gastroenterological Association • American Academy of Hospice and Palliative Medicine reducing waste, and perhaps redeploy some resources into areas of health care that might result in better care and health. At the same time, the Choosing Wisely campaign and materials will help physicians communicate the importance of appropriate use to their pa-tients and to the communities they serve. Tim Hernandez, MD, is a family physician working with Entira Family Clinics and serves as the medical

director for quality improvement for Entira. Kris Soegaard is chief operating officer of the Minnesota Health Action Group and oversees the Action Group’s role as a communications partner for Consumer Reports and a regional collaborative partner for the ABIM Foundation’s Choosing Wisely Campaign. Howard Epstein, MD, FHM, is an internal medicine hospitalist and palliative care physician at Regions Hospital and chief health systems officer at the Institute for Clinical Systems Improvement. (ICSI).

American Diabetes Association EXPO Healthcare Professional Breakfast Saturday, October 12, 2013 at 7:00am Minneapolis Convention Center Meeting Room 103 DEF *Exhibitors feature the latest products, services and medications Healthcare Reform: What does this mean for Diabetes Care in MN? *Ask the Expert: Questions answered by medical professionals *Exciting speakers on diabetes topics Presentation by Manny Munson-Regala, JD, Assistant to the *Healthy Eating cooking and Active Living fitness demo’s Commissioner of the Minnesota Department of Health. *FREE health screenings *FREE Admission The Affordable Care Act will have a significant impact on access to health insurance, *For more information call1-888-DIABETES insurance consumer reforms, payment reforms, prevention activities and work force or visitLearn www.diabetes.org/minneapolisEXPO changes. how MNsure (the new Minnesota health insurance marketplace),

insurance reforms and other provisions of the Affordable Care Act will impact diabetes prevention, diagnosis and management. Objectives:

Describe the impact the Affordable Care Act will have on patients with diabetes and prediabetes. Learn about the impact of MNsure and insurance reforms on access, care delivery and prevention. Learn about diabetes prevention initiatives that could be included in future healthcare reform.

7:00 am - 8:15am Breakfast, Networking, Presentation and Discussion RSVP on-line at http://diabetesmn.wufoo.com/forms/hcp-breakfast-rsvp/ Space is limited. Please RSVP by Friday, October 4, 2013 Event is free of charge and open to all healthcare professionals to attend AUGUST 2013

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Illness from cover standing of the impact of chronic illness on patient satisfaction is important. Those with chronic illnesses are also a growing focus of population health management activities by health care systems managing total cost of care under shared-savings contracts between providers and public and private insurers. Effective population health management relies on patient retention, which is sensitive to patient satisfaction. Concern has been expressed about the possibility that some physicians might avoid including people with multiple chronic conditions in their patient panels in an effort to improve their patient satisfaction measures. While there is little empirical evidence to support or refute this notion, it is possible that providers might avoid hard-tomanage patients because low scores on technical measures of quality might translate to lower rankings in public reports and lower P4P compensation. For all these reasons, we

Our results suggest that patients who are more satisfied with their communications with their physicians have higher overall satisfaction with their care. used data from the Aligning Forces for Quality (AF4Q) initiative to examine the links between chronic illness and patient satisfaction. Research study methods

AF4Q is a major programmatic effort of the Robert Wood Johnson Foundation to improve the treatment of chronic illnesses in 14 geographic areas through the actions of multistakeholder health care alliances. Through the AF4Q initiative, a random digit-dial telephone survey was conducted between June 2007 and June 2008 to identify adults with chronic illnesses across 14 geographic areas and ask them about their health care experiences. In our analysis, we focused on respondents with diabetes, hypertension, and heart disease, because these con-

Healthcare Planning and Design

Ophthalmology - Essentia Health

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MINNESOTA PHYSICIAN AUGUST 2013

ditions have received the greatest attention in P4P initiatives and in public reports of physician performance. In modeling the relationship between patient satisfaction and severity of chronic illness, we assume that patient satisfaction is affected by three underlying characteristics of the patientprovider relationship: (1) patients’ perceptions of the quality of interaction with providers; (2) patients’ perceptions of provider support for self-management of their illness(es); and (3) patients’ understanding of their medical conditions and treatment options. There may be interactions among these three characteristics of patient-provider relationships. For example, if patients feel they have good support for self-management of their illness, this may improve their perception of their interac-

tion with their provider. The AF4Q survey included a general question asking respondents to rate their satisfaction with their provider on a scale of 1 to 10, similar to the questions used to measure patient experience for public reports. Interestingly, a simple comparison of health status and the satisfaction measure showed that patients with more chronic illnesses tend to have higher satisfaction with their physicians. The survey also included a series of questions that captured the three underlying characteristics described above. Patients’ perceptions of the quality of interactions with their physicians were indicated by questions about the clarity of physician explanations, the time physicians spent with their patients, and the respect with which physicians treated patients. Patients’ perceptions of support for self-management of their illness(es) were measured by questions about support for diet and exercise goal-setting;

Illness to page 29

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

Indications and Usage Victoza® (liraglutide [rDNA origin] injection) is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Because of the uncertain relevance of the rodent thyroid C-cell tumor findings to humans, prescribe Victoza® only to patients for whom the potential benefits are considered to outweigh the potential risk. Victoza® is not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exercise. Based on spontaneous postmarketing reports, acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victoza®. Victoza® has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for pancreatitis while using Victoza®. Other antidiabetic therapies should be considered in patients with a history of pancreatitis. Victoza® is not a substitute for insulin. Victoza® should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis, as it would not be effective in these settings. Victoza® has not been studied in combination with prandial insulin.

Important Safety Information Liraglutide causes dose-dependent and treatment-durationdependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice. It is unknown whether Victoza® causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as human relevance could not be ruled out by clinical or nonclinical studies. Victoza® is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Based on the findings in rodents, monitoring with serum calcitonin or thyroid ultrasound was performed during clinical trials, but this may have increased the number of unnecessary thyroid surgeries. It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate Victoza® is a registered trademark of Novo Nordisk A/S. © 2013 Novo Nordisk All rights reserved.

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

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AUGUST 2013

June 2013

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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 treatmentduration-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. Based on spontaneous postmarketing reports, acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victoza®. Victoza® has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for pancreatitis while using Victoza®. Other antidiabetic therapies should be considered in patients with a history of pancreatitis. Victoza® is not a substitute for insulin. Victoza® should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis, as it would not be effective in these settings. The concurrent use of Victoza® and prandial insulin has not been studied. CONTRAINDICATIONS: Do not use in patients with a personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Do not use in patients with a prior serious hypersensitivity reaction to Victoza® or to any of the product components. WARNINGS AND PRECAUTIONS: Risk of Thyroid C-cell Tumors: Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors (adenomas and/or carcinomas) at clinically relevant exposures in both genders of rats and mice. Malignant thyroid C-cell carcinomas were detected in rats and mice. A statistically significant increase in cancer was observed in rats receiving liraglutide at 8-times clinical exposure compared to controls. It is unknown whether Victoza® will cause thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as the human relevance of liraglutide-induced rodent thyroid C-cell tumors could not be determined by clinical or nonclinical studies. In the clinical trials, there have been 6 reported cases of thyroid C-cell hyperplasia among Victoza®-treated patients and 2 cases in comparator-treated patients (1.3 vs. 1.0 cases per 1000 patient-years). One comparator-treated patient with MTC had pre-treatment serum calcitonin concentrations >1000 ng/L suggesting pre-existing disease. All of these cases were diagnosed after thyroidectomy, which was prompted by abnormal results on routine, protocol-specified measurements of serum calcitonin. Five of the six Victoza®-treated patients had elevated calcitonin concentrations at baseline and throughout the trial. One Victoza® and one non-Victoza®-treated patient developed elevated calcitonin concentrations while on treatment. Calcitonin, a biological marker of MTC, was measured throughout the clinical development program. The serum calcitonin assay used in the Victoza® clinical trials had a lower limit of quantification (LLOQ) of 0.7 ng/L and the upper limit of the reference range was 5.0 ng/L for women and 8.4 ng/L for men. At Weeks 26 and 52 in the clinical trials, adjusted mean serum calcitonin concentrations were higher in Victoza®-treated patients compared to placebo-treated patients but not compared to patients receiving active comparator. At these timepoints, the adjusted mean serum calcitonin values (~1.0 ng/L) were just above the LLOQ with between-group differences in adjusted mean serum calcitonin values of approximately 0.1 ng/L or less. Among patients with pre-treatment serum calcitonin below the upper limit of the reference range, shifts to above the upper limit of the reference range which persisted in subsequent measurements occurred most frequently among patients treated with Victoza® 1.8 mg/day. In trials with on-treatment serum calcitonin measurements out to 5-6 months, 1.9% of patients treated with Victoza® 1.8 mg/day developed new and persistent calcitonin elevations above the upper limit of the reference range compared to 0.8-1.1% of patients treated with control medication or the 0.6 and 1.2 mg doses of Victoza®. In trials with on-treatment serum calcitonin measurements out to 12 months, 1.3% of patients treated with Victoza® 1.8 mg/day had new and persistent elevations of calcitonin from below or within the reference range to above the upper limit of the reference range, compared to 0.6%, 0% and 1.0% of patients treated with Victoza® 1.2 mg, placebo and active control, respectively. Otherwise, Victoza® did not produce consistent dose-dependent or time-dependent increases in serum calcitonin. Patients with MTC usually have calcitonin values >50 ng/L. In Victoza® clinical trials, among patients with pre-treatment serum calcitonin <50 ng/L, one Victoza®-treated patient and no comparator-treated patients developed serum calcitonin >50 ng/L. The Victoza®-treated patient who developed serum calcitonin >50 ng/L had an elevated pre-treatment serum calcitonin of 10.7 ng/L that increased to 30.7 ng/L at Week 12 and 53.5 ng/L at the end of the 6-month trial. Follow-up serum calcitonin was 22.3 ng/L more than 2.5 years after the last dose of Victoza®. The largest increase in serum calcitonin in a comparator-treated patient was seen with glimepiride in a patient whose serum calcitonin increased from 19.3 ng/L at baseline to 44.8 ng/L at Week 65 and 38.1 ng/L at Week 104. Among patients who began with serum calcitonin <20 ng/L, calcitonin elevations to >20 ng/L occurred in 0.7% of Victoza®-treated patients, 0.3% of placebo-treated patients, and 0.5% of active-comparator-treated patients, with an incidence of 1.1% among patients treated with 1.8 mg/day of Victoza®. The clinical significance of these findings is unknown. Counsel patients regarding the risk for MTC and the symptoms of thyroid tumors (e.g. a mass in the neck, dysphagia, dyspnea or persistent hoarseness). It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate the potential risk of MTC, and such monitoring may increase the risk of unnecessary procedures, due to low test specificity for serum calcitonin and a high background incidence of thyroid disease. Patients with thyroid nodules noted on physical examination or neck imaging obtained for other reasons should be referred to an endocrinologist for further evaluation. Although routine monitoring of serum calcitonin is of uncertain value in patients treated with Victoza®, if serum calcitonin is measured and found to be elevated, the patient should be referred to an endocrinologist for further evaluation. Pancreatitis: Based on spontaneous postmarketing reports, acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, has been observed in patients treated with Victoza®. After initiation of Victoza®, 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® should promptly be discontinued and appropriate management should be initiated. If pancreatitis is confirmed, Victoza® should not be restarted. Consider antidiabetic therapies other than Victoza® in patients with a history of pancreatitis. In clinical trials of Victoza®, there have been 13 cases of pancreatitis among Victoza®-treated patients and 1 case in a comparator (glimepiride) treated patient (2.7 vs. 0.5 cases per 1000 patient-years). Nine of the 13 cases with Victoza® were reported as acute pancreatitis and four were reported as chronic pancreatitis. In one case in a Victoza®-treated patient, pancreatitis, with necrosis, was observed and led to death; however clinical causal-

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ity could not be established. Some patients had other risk factors for pancreatitis, such as a history of cholelithiasis or alcohol abuse. Use with Medications Known to Cause Hypoglycemia: Patients receiving Victoza® in combination with an insulin secretagogue (e.g., sulfonylurea) or insulin may have an increased risk of hypoglycemia. The risk of hypoglycemia may be lowered by a reduction in the dose of sulfonylurea (or other concomitantly administered insulin secretagogues) or insulin 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. 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. Some of the reported events occurred in patients receiving one or more medications known to affect renal function or hydration status. Altered renal function has been reversed in many of the reported cases with supportive treatment and discontinuation of potentially causative agents, including Victoza®. Use caution when initiating or escalating doses of Victoza® in patients with renal impairment. Hypersensitivity Reactions: There have been postmarketing reports of serious hypersensitivity reactions (e.g., anaphylactic reactions and angioedema) in patients treated with Victoza®. If a hypersensitivity reaction occurs, the patient should discontinue Victoza® and other suspect medications and promptly seek medical advice. Angioedema has also been reported with other GLP-1 receptor agonists. Use caution in a patient with a history of angioedema with another GLP-1 receptor agonist because it is unknown whether such patients will be predisposed to angioedema with Victoza®. Macrovascular Outcomes: There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Victoza® or any other antidiabetic drug. ADVERSE REACTIONS: Clinical Trials Experience: Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of Victoza® has been evaluated in 8 clinical trials: A double-blind 52-week monotherapy trial compared Victoza® 1.2 mg daily, Victoza® 1.8 mg daily, and glimepiride 8 mg daily; A double-blind 26 week add-on to metformin trial compared Victoza® 0.6 mg once-daily, Victoza® 1.2 mg once-daily, Victoza® 1.8 mg once-daily, placebo, and glimepiride 4 mg once-daily; A double-blind 26 week add-on to glimepiride trial compared Victoza® 0.6 mg daily, Victoza® 1.2 mg once-daily, Victoza® 1.8 mg once-daily, placebo, and rosiglitazone 4 mg once-daily; A 26 week add-on to metformin + glimepiride trial, compared double-blind Victoza® 1.8 mg once-daily, double-blind placebo, and open-label insulin glargine once-daily; A doubleblind 26-week add-on to metformin + rosiglitazone trial compared Victoza® 1.2 mg once-daily, Victoza® 1.8 mg once-daily and placebo; An open-label 26-week add-on to metformin and/or sulfonylurea trial compared Victoza® 1.8 mg once-daily and exenatide 10 mcg twice-daily; An open-label 26-week add-on to metformin trial compared Victoza® 1.2 mg once-daily, Victoza® 1.8 mg once-daily, and sitagliptin 100 mg once-daily; An open-label 26-week trial compared insulin detemir as add-on to Victoza® 1.8 mg + metformin to continued treatment with Victoza® + metformin alone. Withdrawals: The incidence of withdrawal due to adverse events was 7.8% for Victoza®-treated patients and 3.4% for comparator-treated patients in the five double-blind controlled trials of 26 weeks duration or longer. This difference was driven by withdrawals due to gastrointestinal adverse reactions, which occurred in 5.0% of Victoza®-treated patients and 0.5% of comparator-treated patients. In these five trials, the most common adverse reactions leading to withdrawal for Victoza®-treated patients were nausea (2.8% versus 0% for comparator) and vomiting (1.5% versus 0.1% for comparator). Withdrawal due to gastrointestinal adverse events mainly occurred during the first 2-3 months of the trials. Common adverse reactions: Tables 1, 2, 3 and 4 summarize common adverse reactions (hypoglycemia is discussed separately) reported in seven of the eight controlled trials of 26 weeks duration or longer. Most of these adverse reactions were gastrointestinal in nature. In the five double-blind clinical trials of 26 weeks duration or longer, gastrointestinal adverse reactions were reported in 41% of Victoza®-treated patients and were dose-related. Gastrointestinal adverse reactions occurred in 17% of comparator-treated patients. Common adverse reactions that occurred at a higher incidence among Victoza®-treated patients included nausea, vomiting, diarrhea, dyspepsia and constipation. In the five double-blind and three open-label clinical trials of 26 weeks duration or longer, the percentage of patients who reported nausea declined over time. In the five double-blind trials approximately 13% of Victoza®-treated patients and 2% of comparator-treated patients reported nausea during the first 2 weeks of treatment. In the 26-week open-label trial comparing Victoza® to exenatide, both in combination with metformin and/or sulfonylurea, gastrointestinal adverse reactions were reported at a similar incidence in the Victoza® and exenatide treatment groups (Table 3). In the 26-week open-label trial comparing Victoza® 1.2 mg, Victoza® 1.8 mg and sitagliptin 100 mg, all in combination with metformin, gastrointestinal adverse reactions were reported at a higher incidence with Victoza® than sitagliptin (Table 4). In the remaining 26-week trial, all patients received Victoza® 1.8 mg + metformin during a 12-week run-in period. During the run-in period, 167 patients (17% of enrolled total) withdrew from the trial: 76 (46% of withdrawals) of these patients doing so because of gastrointestinal adverse reactions and 15 (9% of withdrawals) doing so due to other adverse events. Only those patients who completed the run-in period with inadequate glycemic control were randomized to 26 weeks of add-on therapy with insulin detemir or continued, unchanged treatment with Victoza® 1.8 mg + metformin. During this randomized 26-week period, diarrhea was the only adverse reaction reported in ≥5% of patients treated with Victoza® 1.8 mg + metformin + insulin detemir (11.7%) and greater than in patients treated with Victoza® 1.8 mg and metformin alone (6.9%). Table 1: Adverse reactions reported in ≥5% of Victoza®-treated patients in a 52-week monotherapy trial All Victoza® N = 497 Glimepiride N = 248 (%) (%) Adverse Reaction Nausea 28.4 8.5 Diarrhea 17.1 8.9 Vomiting 10.9 3.6 Constipation 9.9 4.8 Headache 9.1 9.3 Table 2: Adverse reactions reported in ≥5% of Victoza®-treated patients and occurring more frequently with Victoza® compared to placebo: 26-week combination therapy trials Add-on to Metformin Trial All Victoza® + Metformin Placebo + Metformin Glimepiride + Metformin N = 724 N = 121 N = 242 (%) (%) (%) Adverse Reaction Nausea 15.2 4.1 3.3 Diarrhea 10.9 4.1 3.7 Headache 9.0 6.6 9.5 Vomiting 6.5 0.8 0.4 Add-on to Glimepiride Trial Placebo + Glimepiride Rosiglitazone + All Victoza® + Glimepiride N = 695 N = 114 Glimepiride N = 231 (%) (%) (%) Adverse Reaction Nausea 7.5 1.8 2.6 Diarrhea 7.2 1.8 2.2


Constipation Dyspepsia

5.3 0.9 1.7 5.2 0.9 2.6 Add-on to Metformin + Glimepiride Victoza® 1.8 + Metformin Placebo + Metformin + Glargine + Metformin + + Glimepiride N = 230 Glimepiride N = 114 Glimepiride N = 232 (%) (%) (%) Adverse Reaction Nausea 13.9 3.5 1.3 Diarrhea 10.0 5.3 1.3 Headache 9.6 7.9 5.6 Dyspepsia 6.5 0.9 1.7 Vomiting 6.5 3.5 0.4 Add-on to Metformin + Rosiglitazone ® Placebo + Metformin + Rosiglitazone All Victoza + Metformin + Rosiglitazone N = 355 N = 175 (%) (%) Adverse Reaction Nausea 34.6 8.6 Diarrhea 14.1 6.3 Vomiting 12.4 2.9 Headache 8.2 4.6 Constipation 5.1 1.1 Table 3: Adverse Reactions reported in ≥5% of Victoza®-treated patients in a 26-Week Open-Label Trial versus Exenatide Victoza® 1.8 mg once daily + Exenatide 10 mcg twice daily + metformin and/or sulfonylurea metformin and/or sulfonylurea N = 235 N = 232 (%) (%) Adverse Reaction Nausea 25.5 28.0 Diarrhea 12.3 12.1 Headache 8.9 10.3 Dyspepsia 8.9 4.7 Vomiting 6.0 9.9 Constipation 5.1 2.6 Table 4: Adverse Reactions in ≥5% of Victoza®-treated patients in a 26-Week Open-Label Trial versus Sitagliptin All Victoza® + metformin Sitagliptin 100 mg/day + N = 439 metformin N = 219 (%) (%) Adverse Reaction Nausea 23.9 4.6 Headache 10.3 10.0 Diarrhea 9.3 4.6 Vomiting 8.7 4.1 Immunogenicity: Consistent with the potentially immunogenic properties of protein and peptide pharmaceuticals, patients treated with Victoza® may develop anti-liraglutide antibodies. Approximately 50-70% of Victoza®-treated patients in the five double-blind clinical trials of 26 weeks duration or longer were tested for the presence of anti-liraglutide antibodies at the end of treatment. Low titers (concentrations not requiring dilution of serum) of anti-liraglutide antibodies were detected in 8.6% of these Victoza®-treated patients. Sampling was not performed uniformly across all patients in the clinical trials, and this may have resulted in an underestimate of the actual percentage of patients who developed antibodies. Cross-reacting antiliraglutide antibodies to native glucagon-like peptide-1 (GLP-1) occurred in 6.9% of the Victoza®-treated patients in the double-blind 52-week monotherapy trial and in 4.8% of the Victoza®-treated patients in the double-blind 26-week add-on combination therapy trials. These cross-reacting antibodies were not tested for neutralizing effect against native GLP-1, and thus the potential for clinically significant neutralization of native GLP-1 was not assessed. Antibodies that had a neutralizing effect on liraglutide in an in vitro assay occurred in 2.3% of the Victoza®-treated patients in the double-blind 52-week monotherapy trial and in 1.0% of the Victoza®-treated patients in the double-blind 26-week add-on combination therapy trials. Among Victoza®-treated patients who developed anti-liraglutide antibodies, the most common category of adverse events was that of infections, which occurred among 40% of these patients compared to 36%, 34% and 35% of antibody-negative Victoza®-treated, placebo-treated and active-control-treated patients, respectively. The specific infections which occurred with greater frequency among Victoza®-treated antibody-positive patients were primarily nonserious upper respiratory tract infections, which occurred among 11% of Victoza®-treated antibody-positive patients; and among 7%, 7% and 5% of antibody-negative Victoza®-treated, placebo-treated and active-control-treated patients, respectively. Among Victoza®-treated antibody-negative patients, the most common category of adverse events was that of gastrointestinal events, which occurred in 43%, 18% and 19% of antibody-negative Victoza®-treated, placebo-treated and active-control-treated patients, respectively. Antibody formation was not associated with reduced efficacy of Victoza® when comparing mean HbA1c of all antibody-positive and all antibody-negative patients. However, the 3 patients with the highest titers of anti-liraglutide antibodies had no reduction in HbA1c with Victoza® treatment. In the five double-blind clinical trials of Victoza®, events from a composite of adverse events potentially related to immunogenicity (e.g. urticaria, angioedema) occurred among 0.8% of Victoza®-treated patients and among 0.4% of comparator-treated patients. Urticaria accounted for approximately one-half of the events in this composite for Victoza®-treated patients. Patients who developed anti-liraglutide antibodies were not more likely to develop events from the immunogenicity events composite than were patients who did not develop anti-liraglutide antibodies. Injection site reactions: Injection site reactions (e.g., injection site rash, erythema) were reported in approximately 2% of Victoza®-treated patients in the five double-blind clinical trials of at least 26 weeks duration. Less than 0.2% of Victoza®-treated patients discontinued due to injection site reactions. Papillary thyroid carcinoma: In clinical trials of Victoza®, there were 7 reported cases of papillary thyroid carcinoma in patients treated with Victoza® and 1 case in a comparator-treated patient (1.5 vs. 0.5 cases per 1000 patient-years). Most of these papillary thyroid carcinomas were <1 cm in greatest diameter and were diagnosed in surgical pathology specimens after thyroidectomy prompted by findings on protocol-specified screening with serum calcitonin or thyroid ultrasound. Hypoglycemia: In the eight clinical trials of at least 26 weeks duration, hypoglycemia requiring the assistance of another person for treatment occurred in 11 Victoza®-treated patients (2.3 cases per 1000 patient-years) and in two exenatidetreated patients. Of these 11 Victoza®-treated patients, six patients were concomitantly using metformin and a sulfonylurea, one was concomitantly using a sulfonylurea, two were concomitantly using metformin (blood glucose values were 65 and 94 mg/dL) and two were using Victoza® as monotherapy (one of these patients was undergoing an intravenous glucose tolerance test and the other was receiving insulin as treatment during a hospital stay). For these two patients on Victoza® monotherapy, the insulin treatment was the likely explanation for the hypoglycemia. In the 26-week open-label trial comparing Victoza® to sitagliptin,

the incidence of hypoglycemic events defined as symptoms accompanied by a fingerstick glucose <56 mg/ dL was comparable among the treatment groups (approximately 5%). Table 5: Incidence (%) and Rate (episodes/patient year) of Hypoglycemia in the 52-Week Monotherapy Trial and in the 26-Week Combination Therapy Trials Victoza® Treatment Active Comparator Placebo Comparator None Monotherapy Victoza® (N = 497) Glimepiride (N = 248) Patient not able to 0 0 — self−treat Patient able to self−treat 9.7 (0.24) 25.0 (1.66) — Not classified 1.2 (0.03) 2.4 (0.04) — Glimepiride + Placebo + Metformin Add-on to Metformin Victoza® + Metformin (N = 724) Metformin (N = 121) (N = 242) Patient not able to 0.1 (0.001) 0 0 self−treat Patient able to self−treat 3.6 (0.05) 22.3 (0.87) 2.5 (0.06) Continued Victoza® None Add-on to Victoza® + Insulin detemir + Metformin Victoza® + Metformin + Metformin alone (N = 163) (N = 158*) Patient not able to 0 0 — self−treat Patient able to self−treat 9.2 (0.29) 1.3 (0.03) — Add-on to Victoza® + Glimepiride Rosiglitazone + Placebo + Glimepiride (N = 695) Glimepiride (N = 231) (N = 114) Glimepiride Patient not able to 0.1 (0.003) 0 0 self−treat Patient able to self−treat 7.5 (0.38) 4.3 (0.12) 2.6 (0.17) Not classified 0.9 (0.05) 0.9 (0.02) 0 Placebo + Metformin Add-on to Metformin Victoza® + Metformin + Rosiglitazone None + Rosiglitazone + Rosiglitazone (N = 355) (N = 175) Patient not able to 0 — 0 self−treat Patient able to self−treat 7.9 (0.49) — 4.6 (0.15) Not classified 0.6 (0.01) — 1.1 (0.03) Add-on to Metformin Victoza® + Metformin Insulin glargine Placebo + Metformin + Glimepiride + Metformin + + Glimepiride + Glimepiride (N = 230) Glimepiride (N = 232) (N = 114) Patient not able to 2.2 (0.06) 0 0 self−treat Patient able to self−treat 27.4 (1.16) 28.9 (1.29) 16.7 (0.95) Not classified 0 1.7 (0.04) 0 *One patient is an outlier and was excluded due to 25 hypoglycemic episodes that the patient was able to self-treat. This patient had a history of frequent hypoglycemia prior to the study. In a pooled analysis of clinical trials, the incidence rate (per 1,000 patient-years) for malignant neoplasms (based on investigator-reported events, medical history, pathology reports, and surgical reports from both blinded and open-label study periods) was 10.9 for Victoza®, 6.3 for placebo, and 7.2 for active comparator. After excluding papillary thyroid carcinoma events [see Adverse Reactions], no particular cancer cell type predominated. Seven malignant neoplasm events were reported beyond 1 year of exposure to study medication, six events among Victoza®-treated patients (4 colon, 1 prostate and 1 nasopharyngeal), no events with placebo and one event with active comparator (colon). Causality has not been established. Laboratory Tests: In the five clinical trials of at least 26 weeks duration, mildly elevated serum bilirubin concentrations (elevations to no more than twice the upper limit of the reference range) occurred in 4.0% of Victoza®treated patients, 2.1% of placebo-treated patients and 3.5% of active-comparator-treated patients. This finding was not accompanied by abnormalities in other liver tests. The significance of this isolated finding is unknown. Vital signs: Victoza® did not have adverse effects on blood pressure. Mean increases from baseline in heart rate of 2 to 3 beats per minute have been observed with Victoza® compared to placebo. The long-term clinical effects of the increase in pulse rate have not been established. Post-Marketing Experience: The following additional adverse reactions have been reported during post-approval use of Victoza®. Because these events are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to drug exposure: Dehydration resulting from nausea, vomiting and diarrhea; Increased serum creatinine, acute renal failure or worsening of chronic renal failure, sometimes requiring hemodialysis; Angioedema and anaphylactic reactions; Allergic reactions: rash and pruritus; Acute pancreatitis, hemorrhagic and necrotizing pancreatitis sometimes resulting in death. OVERDOSAGE: Overdoses have been reported in clinical trials and post-marketing use of Victoza®. Effects have included severe nausea and severe vomiting. In the event of overdosage, appropriate supportive treatment should be initiated according to the patient’s clinical signs and symptoms. More detailed information is available upon request. For information about Victoza® contact: Novo Nordisk Inc., 800 Scudders Mill Road, Plainsboro, NJ 08536, 1−877-484-2869 Date of Issue: April 16, 2013 Version: 6 Manufactured by: Novo Nordisk A/S, DK-2880 Bagsvaerd, Denmark Victoza® is covered by US Patent Nos. 6,268,343, 6,458,924, 7,235,627, 8,114,833 and other patents pending. Victoza® Pen is covered by US Patent Nos. 6,004,297, RE 43,834, RE 41,956 and other patents pending. © 2010-2013 Novo Nordisk 0513-00015681-1 5/2013

AUGUST 2013

MINNESOTA PHYSICIAN

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LAW

I

n May, the Minnesota Legislature voted to support a unique public-private partnership that will enable Mayo Clinic to grow in Minnesota and further establish our state as a global medical destination. This opportunity, called Destination Medical Center (DMC), is slated to present significant direct benefits to the state, including thousands of jobs and billions in new tax revenues, and to anchor Minnesota’s status and leadership in the health and biosciences field for generations to come. Founded in 1854 by Dr. William W. Mayo, the Mayo Clinic has deep roots in Minnesota. As the state’s largest private employer, with 43,000 Minnesota workers, Mayo Clinic is responsible for $9.8 billion in economic impact and $1.5 billion in tax revenues for our state annually. After conducting an extensive analysis of emerging opportunities and challenges in health care, Mayo officials determined that in the coming years, two or three institutions around the

POLICY

Growing deeper roots Destination Medical Center initiative looks to Minnesota’s future By Rep. Kim Norton

world will emerge as global destinations for the highest quality health care. Mayo competitors such as Cleveland Clinic, Johns Hopkins, and Massachusetts General, as well as foreign entities in Europe and Asia, are making significant strategic moves and investments in order to replicate the “Mayo model� and attempt to surpass Mayo as a global destination medical center in order to capture the significant economic benefits generated by “high-value� medical spending. In many cases, government is partnering with the medical institutions to accelerate and help finance their expansion in order to generate the significant direct and indirect economic benefits of high-quality jobs, imported spending, and

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MINNESOTA PHYSICIAN AUGUST 2013

new tax revenues. Mayo Clinic has made the strategic business decision to defend its global position and be one of those destination medical centers. More importantly, Mayo has decided that its global DMC will be right here in Minnesota. The Destination Medical Center plan

The Destination Medical Center plan includes approximately $3.5 billion in new Mayofinanced capital investments on its Rochester campus over the next 20 years. Mayo Clinic is prepared to make a massive private investment in additional physicians and staff, new medical buildings, technology, clinical and wellness services, and the other enhancements needed to meet the growing needs of its patients and effectively compete and retain its position as one of the world’s top medical centers. These capital improvements will require state and local support to improve the public infrastructure that supports the level of patient, visitor, and employee growth created by this major expansion. The initiative is expected to create 35,000 to 45,000 new jobs in Rochester and statewide over 20 years, including 14,000 to 16,000 new jobs at Mayo Clinic alone. Many of the jobs created by the DMC initiative will be high paying and sustainable, including positions in medicine, medical research, and biomedical engineering. In addition, a broad spectrum of jobs will be created when private investors bring in businesses to complement the growth. The DMC plan is expected to spark an additional $2 billion in private investment to support the additional patient traffic and visitor experience in Rochester and generate approximately $3 billion in new tax revenues to

the state and local governments over 20 years. Additionally, the plan will aggressively work to retain, in Minnesota, the new businesses and jobs that emerge from Mayo Clinic’s extensive medical research. The DMC plan has five core objectives: • Sustaining Rochester and Minnesota as a global medical destination that offers patients a welcoming, comfortable, and engaging environment in which to receive the most advanced medical care in the world • Establishing Rochester as a magnet community that will attract the most promising students and sophisticated health care professionals, thinkers, and educators from around the globe • Leveraging Mayo Clinic’s presence in Minnesota to ignite institutional and commercial research in an environment that encourages shared knowledge, partnerships, medical advancements, and innovation • Creating experiences of hope, health, and hospitality for every patient, every day • Providing the ideal patient, companion, visitor, citizen, and community experience to become the international premier destination medical community The initiative offers significant benefits to Rochester, southeast Minnesota, and the state. The economic impact from drawing new patients and visitors to Rochester and Minnesota each year will benefit Olmsted County and the state as a whole, significantly boosting our state’s economy by creating thousands of new jobs and billions in new tax revenues. This initiative also means that medical professionals who relocate to Rochester will have the opportunity to practice medicine in a cuttingedge setting with an even higher quality of life. For visiting patients, Mayo Clinic’s investment still will mean great medical care, but with an improved experience. For the community, it will mean sustainable, carefully planned growth that will continue to provide jobs, yet


keep our cost of living within reason for lifetime residents. In addition, the DMC initiative supports the continued growth and development of the University of Minnesota– Rochester. In recent years UMR, with its unique niche approach to education, has developed into a major partner for the city of Rochester and the Mayo Clinic. These new investments, in combination with the increases in state investments in pre–K, K–12, and higher education, will help educate a quality workforce focused on science, technology, engineering, and math and train health care employees for the future. From vision to reality

Taking the Destination Medical Center concept from vision to reality in Minnesota will require a modest level of public investment for infrastructure and other public facilities to support this significant private investment. The city of Rochester alone simply could not finance the necessary infrastructure, and the private market simply

wouldn’t assume the burden of these costs. A large group of stakeholders, including Mayo Clinic, developed the DMC downtown master plan in concert with local government and identified what improvements will be needed to accommodate this growth. Based on this concept, state and local resources would be harnessed to support road and highway improvements, public transportation investments, wastewater treatment facilities designed to handle an influx of new taxpayers and visitors, storm water management, and electrical utility enhancements. The DMC finance plan outlined in the bill is very low risk for the state, but offers a high return to Minnesota. The plan does not direct public dollars to pay for Mayo Clinic’s buildings or facilities. Instead, a formula based on new private capital investments will be used to determine the release of direct state support and local taxing opportunities for public infrastructure, but only after the private investment is made. The

plan requires proof of investment by Mayo Clinic and the private sector before financing of any public investments is approved. There are investments we leave to the private markets and those we rightfully expect government to make on the behalf of everyone. Mayo Clinic came to the Capitol during the 2013 legislative session not asking for a check, but rather seeking commitment from the State of Minnesota to provide support for a strong, long-term partnership with city of Rochester and Olmsted County to provide normal government services that could accommodate significant private growth. The city of Rochester already has committed to spending $339 million during this period to help improve infrastructure in the city—a significant investment for a community its size. The city of Rochester and Mayo Clinic are committed to moving Minnesota’s economy forward. Making investments in projects like Destination Medical Center will drive our state’s

high-tech, modern economy. The Minnesota Legislature approved a $585 million funding package for Mayo’s Destination Medical Center plan on May 20. The state’s long-term investment in Rochester will complement Mayo Clinic’s offer of unprecedented private investment and the strong commitment from local business and government partners. The legislative debate about the Destination Medical Center initiative was not simply about whether we supported Mayo Clinic’s future in Minnesota, but whether we wanted a Minnesota that invests in a skill-based economy and high-quality jobs. All in all, it was not such a tough decision. Rep. Kim Norton represents District 25B (Rochester) in the Minnesota House of Representatives. She is vice-chair of the House Health and Human Services Finance committee.

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MINNESOTA PHYSICIAN

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PAT I E N T

W

ith a drink of water from a filthy pool, I kissed goodbye my tenuous grip on reality. It was a symbolic act, a Biblical drinking from the well. (Why I had drunk dirty water rather than clean water made sense only to me.) I opened my eyes to the cosmos, to Jesus—and, then, to the mental health system. It was simply a matter of time until I snapped. I had been living with an untreated traumatic brain injury from a car accident for more than nine months. I hadn’t sought treatment when the accident occurred because I had been drinking, and the mental health system scared me, and it wasn’t cool or safe in my eyes to get help. I didn’t want a stranger asking me questions, especially when I was so full of negative emotions. So I grimly made my way through the days until I didn’t even know who I was. Others had serious concerns, but I was adamant: I wasn’t “a mental case.” My parents got the call from my boss saying that “Bruce has lost control.” They arranged for

18

PERSPECTIVE

The guiding hand Straightening out the roller-coaster track of mental illness By Bruce Ario a bed at one of the city’s psych wards, came and got me at my apartment, and drove me to the hospital, where I signed the papers admitting myself into the mental health system. It was a life-changing decision, made while in the worst condition I’ve ever been in. Even before my first visit to the psych ward, I had been under the delusion that the whole world was dependent on my relationship with God. By the time I entered the hospital, it seemed to me that the only one who offered me real hope was my Grannie, in the form of an angel. The angel had touched the divine spark within me. But I didn’t feel I could tell people about this directly; if I wanted to share my divine experience, I was required to share my deep-

MINNESOTA PHYSICIAN AUGUST 2013

est being through acts of love and kindness, like giving my love to strangers or money to the homeless. I treated everyone with great love and respect. It felt like parceling out my heart. A diagnosis

“You’re schizophrenic.” That was the declaration of my psychiatrist, two minutes after seeing me. The words I was expecting to hear stemmed from my grandiosity; they were more on the order of, “Welcome my brother. We’ve been waiting for you and your angel. How can we serve you?” Obviously, he hadn’t understood about the angel and my divine connection with God. The psychiatrist’s hasty diagnosis erected a barrier between us during the rest of my stay on the psych ward. I left there 10

days later, not much better than when I came in; the psychiatrist released me, saying, “You are medically stable,” although we both knew I was not healed. In fact, I had fought his authority more than I had accepted his help. Yet, he had laid the foundation for me to be in charge of my own recovery by allowing me many choices, despite my limited capacity to make good decisions. He had put up with me at times refusing medication, using foul language, and in general rebelling against him. After being discharged I went back to my old lifestyle, using alcohol and marijuana to help me disregard all that had happened, including the angel. I had minimal contact with my parents because I was mad at them for taking me to the hospital. Among my friends, my stay on the psych ward was spoken of in hushed tones. I was very uptight, and they didn’t know how to loosen me up. Unsurprisingly, I needed help within a few months. This time was different, though. For one thing, I felt comfortable


talking to a new psychiatrist who came highly recommended by a friend of my parents. He conveyed a contagious confidence and a strong sense of empathy. We initially met in a comfortable office, where we warmly discussed things for over an hour (though later we both acknowledged that I was quite confused at the time). We came to the decision that it would be best if I went into the hospital under his care. This hospital stay lasted three weeks, with daily contacts with my psychiatrist as the highlight of my day. Over the next two years, with his help, I made great progress. I got a job that was in line with my college degree and held that job for a year and a half. A disconnect in recovery

In 1981 I was accepted at the U of M law school. Though this sounds like significant progress, there was still a major disconnect in my recovery: I carried a diagnosis of schizophrenia, but my friends and family still thought the head injury in the

car accident was the cause of the condition that had plagued me. I regarded the head injury from my car accident as a “just a bump�; I didn’t understand that it could alter my thinking. I had no perspective on my condition. I thought my main problem was connected to my huge religious burden; I believed my angel was real, though it wasn’t easy trying to interpret what I believed God (via the angel) was telling me to do. I do know that throughout this time, when I was on the medication to treat schizophrenia, I did better and could start to get a handle on my religious struggle. My first year of law school went well. My second year was a disaster, mostly because I stopped taking my meds and began drinking heavily. I was unable to go back for my third year. I plummeted into homelessness, having been off medication for over a year. I had some contact with my family, friends, and doctor, all of whom urged me to get help and take my meds, but their words fell on deaf ears.

Eventually I was arrested for a misdemeanor and taken to jail, where the plan was to send me to the workhouse. However, an astute and kind nurse intervened. She coaxed from me my name and the information that I had been treated for mental illness, and contacted my parents. My mother called the doctor with whom I had had such a successful relationship. He told her that because I had lost my insurance and would be on government assistance, “He is no longer one of mine.� I came to regard this statement as a type of betrayal. In any case, the wheels turned, and I was diverted to the mental health system—which turned out to be the best break of my life. Choosing a road of recovery

I was committed to my third psych ward. The psychiatrist took my case even though I was on welfare and he wouldn’t be paid his full fee. I’ll never forget our first meeting; he limped into my room in a cast (skiing accident), looked me squarely in the

eyes, and said he would start treatment immediately. He was serious, tough, direct, compassionate, and caring, with a sense of urgency that caused me to nearly jump up in my bed. I felt I had found someone who could truly help me. He was treating the illness and not simply reacting to my symptoms; he saw a worthwhile person with a diseased mind. I began to stabilize while in the hospital, and we continued to meet weekly for a couple of years, when I was living in a group home. With his help and that of the group home psychologist, I achieved some understanding of my illness. I became more conventional in my religious beliefs, making a decision to cut way back on what I felt God had asked of me through the angel. Everyone who knew and cared about me supported this development. In part, this progress reflected a change in my attitude toward therapy. In the past, I had prided myself on “keeping ’em guessing� and maintaining a sense of humor, in part as a way GUIDING HAND to page 36

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AUGUST 2013

MINNESOTA PHYSICIAN

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SPECIAL

As health reforms alter the health care marketplace, providers are exploring innovations in payment systems. This month’s special

FOCUS:

Fixing the disconnect between high-value care and payment models By Maria Christu, JD

Minnesota providers high-quality health care while bringing down costs. The first describes the state’s Health Care Delivery Systems demonstration project with the Medicaid program; the second, a gastroenterology group’s partnership with a selfinsured employer to improve colonoscopy screening.

REIMBURSEMENT

Minnesota’s Medicaid experiment

focus looks at two seeking to deliver

PHYSICIAN

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o one knows better than those of us working in health care that our industry is in the midst of unprecedented change. Policymakers, regulators, businesses, and patients are asking important questions about how we deliver care, how it is paid for, and whether the current system is designed to meet our future needs. In response to these pressures, Minnesota has embarked on a pilot project (with the state’s public programs) that is designed to answer the most fundamental question: Can we create a health-care delivery model that leads to better health outcomes at lower costs? Answering this question is

critical to the future of health care. In Minnesota alone, we spend more than $6 billion every year on public health-care programs. The Medicaid program alone accounts for 18 percent of the state’s entire annual budget. Recent budget pressures, coupled with continued growth in the number of Medicaid enrollees, left state leaders with two distinct options―continue to cut reimbursement rates or develop new, innovative models for delivering and paying for care. Minnesota leaders chose the latter with an experiment that represents another example of our state offering nation-leading ideas to address the most pressing challenges facing our health care system. Guiding principles

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MINNESOTA PHYSICIAN AUGUST 2013

In 2011, Gov. Mark Dayton’s Department of Human Services (DHS) brought forward the idea of the Health Care Delivery System (HCDS) demonstration project with the stated intention of testing “alternative and innovative health care delivery systems.” Eager for a new way to tackle a big challenge, the Legislature put it into law. The guiding principles of the HCDS are: • Encourage providers to innovate to deliver highervalue care • Focus on desired health outcomes rather than the type and number of services provided • Support robust primary care and improve care coordination • Test payment models that advance the Triple Aim goals (improving the patient experience of care, improving the health of populations, and reducing the per capita cost of health care) • Allow for flexibility and innovation within a framework of accountability

While budget pressures are a clear driving force for new models, there are other factors motivating these efforts. We all know that there is no one-sizefits-all approach to health care. Care is influenced and directed by the complexity of each patient’s health needs and conditions, cultural background, age, and socioeconomic factors. We need a system that works as well for the child who comes into the clinic for well-child visits and the occasional mishaps as it does for the child with several comorbidities that require multiple health care interactions each week. In other words, care needs to be flexible and patient-driven. This is not news to most of us. For years, there has been discussion about and implementation of approaches that put patients and their health at the center of care delivery. Children’s Hospitals and Clinics of Minnesota was a pioneer in the adoption of the medical home concept when we established our model of care coordination for special health-care needs in 2004. We have seen the positive results of a model that places outcomes ahead of services. By effectively coordinating and managing care for these patients with complex needs, Children’s saw outpatient clinic visits reduced by more than half and inpatient admissions reduced by more than 60 percent in the first 200 patients served by the model. Those changes represent significant cost savings and, more importantly, better outcomes for our patients. As good as those results are, there is a downside. For those of us investing in these innovative models, we put our own organizations at financial risk because changes to the payment system have not kept up with innovations in care delivery. The current payment model does not focus incentives on outcomes, value, or coordination of care. It penalizes providers who invest in prevention and does nothing to encourage patients to be involved in their own health care choices. This disconnect has real consequences for providers who are incorporating different care models into the existing structure: We can do ourselves finan-


cial harm by doing the right thing. That is the paradigm the HCDS project seeks to change. It is also why, under a voluntary program, DHS was able to attract some of Minnesota’s leading health care systems as participants in this pilot project. In the first phase of the pilot, six health systems―Children’s Hospitals and Clinics of Minnesota, Essentia Health, CentraCare Health System, North Memorial Health Care, Federally Qualified Health Center Urban Health Network, and Northwest Metro Alliance (a partnership between Allina Health and HealthPartners)―have stepped up to explore new methods for caring for 100,000 Minnesotans. Again, this probably is not a surprise to those of us working in health care in Minnesota. Health care providers are perhaps the most eager to test a system that will allow us to take the lessons we have learned and our creative ideas and apply them more broadly, without the constraints of an outdated payment model. Collectively, the

physicians, nurses, nurse practitioners, social workers, care coordinators, and other professionals who are part of a care team know we can deliver care better when we focus intently on the needs of each unique patient. The HCDS project is a powerful public-private partnership that utilizes the roles of government and health care systems. As the largest payer of health care services in Minnesota, state government has a vested interest in pushing for better results. Through the HCDS project, the state has created a structure that fosters health systems’ innovation and creativity in a framework of accountability. It is not risk-free for either partner, and there are rigorous expectations in this model, including: • A total-cost-of-care model on which risk or reward will be determined • Driving rapidly toward increasing levels of integration of care both within and outside a health care system • A focus on measurable quality metrics

Charting a new path

So what does this type of care delivery look like? The honest answer is that we do not know yet. That is exactly what each participant in this project will explore. Participation in the project requires that we deliver the full scope of primary care services, coordinate with specialty providers and hospitals, and demonstrate an approach to partnering with community and social services organizations that integrates their services into the patient’s care experience. At Children’s, we view this as an opportunity to take a fresh look at how we support and transition services and resources from a hospital focus to a community and primary care focus. We are creating a model that will build on our past experiences and new forward-looking ideas. The model will include expanded primary care capacity and improved care coordination and care management, as well as investments in information technology and electronic medical record enhancements. The methods for providing more patient-

centered care will range from scheduling changes to introducing new care team members to real-time data sharing. The hope is that by exploring a combination of approaches, Children’s, along with the other health systems trying out their own approaches, will create a model that can serve as the template for a new way of paying for and delivering care. The HCDS project will not generate a magic solution to our health care challenges. In fact, it may yield as many failures as successes. That is the beauty of experimentation; it allows us the opportunity to try new ideas and narrow in on strategies that demonstrate results. Those who are scrutinizing our industry should be proud that Minnesota and its health care providers are yet again willing to lead and take risks in the interest of charting a new path for the future of health care. Maria Christu, JD, is general counsel and vice president of advocacy and health policy at Children’s Hospitals and Clinics of Minnesota.

All About Access: Health Reform and the Safety Net Join us for the 8th Annual Conference • Thursday & Friday, October 24 - 25, 2013

The conference will cover clinical, public policy, and management topics that impact quality improvement and health disparities in primary care settings. The conference emphasizes sharing practical tools, tips, and resources, as well as providing useful information, inspiration, and networking opportunities.

Eugene and Mildred Lipitz Professor in the Department of Health Policy and Management and Director of the Roger C. Lipitz Center for Integrated Health Care at the Bloomberg School Keynote: Karen Davis, PhD of Public Health at National Perspectives on the Johns Hopkins Safety Net Under ACA University.

AUGUST 2013

MINNESOTA PHYSICIAN

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SPECIAL

T

he most pressing issue concerning health care in the United States is cost. For the last 25 years, all increases in workers’ wages have been consumed by increasing costs of medical care. Payers attempt to mitigate cost trends by “managed care” techniques such as pre-authorization requirements, limits on coverage, “medical necessity” reviews, patient copays and deductibles, restricted networks, and capitation, to name a few examples. An emerging payment trend aims to replace traditional fee-for-service with “value-based” reimbursement. Across the health care spectrum, provider groups are developing new strategies to bring down costs while delivering high-quality care. This article describes one such strategy, involving bundled payment for colonoscopy. Background

Colonoscopy has become one of the primary modalities used for colorectal cancer (CRC) screening, prevention, and detection, and has become so common

FOCUS:

REIMBURSEMENT

Bundled payment for colonoscopy Collaborating with employers to save costs, improve screening By Scott R. Ketover, MD, AGAF

that it has moved from the realm of medical literature into popular culture. There are even greeting cards available for those who reach their 50th year, reminding them to celebrate— and look forward to their colonoscopy examination. And while colonoscopy is a common procedure for colorectal cancer screening, the Agency for Healthcare Research and Quality reports that approximately 50 percent of those eligible for screening colonoscopy have not yet had this procedure. There are other accepted methods of CRC screening, but colonoscopy remains the only method available to simultaneously screen, diagnose, remove, and cure a

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PHYSICIAN

MINNESOTA PHYSICIAN AUGUST 2013

patient of suspicious lesions. Similarly, employers have discovered that having a large population of employees who are noncompliant with CRC screening results in future risk to their wellness plans. Health plan costs are driven by catastrophic health events such as cancer, resulting in employer concerns about future claims and lost productivity with a cancer occurrence. For that reason, employers are looking for ways to increase compliance with recommended screenings. The good news: Early screening can prevent colorectal cancer and, if detected early enough, the disease is both treatable and beatable. The bad news: The cost of a colonoscopy can vary greatly by physician and, more specifically, by facility where the test is performed, adding expense for patients, health plans, and, ultimately, employers. Against this backdrop, Minnesota Gastroenterology sought to create and trial a local example of bundled payment for care with a “Pay-One-Price” Colonoscopy program. A bundled payment program for colonoscopy was formed based on the knowledge that: • There is material price variation for the colonoscopy procedure, based on place of service and physician, but a limited amount of variation in resources used • The procedure can result in multiple bills from multiple providers and facilities • There is variation in insurance benefits and out-of-pocket expense, based on screening benefits versus diagnostic with pathology • The procedure is definable to a single encounter with a rec-

ognized beginning and end • It is an elective/non-urgent service that allows for direction of care • The service can be performed at alternative locations (hospital/ambulatory surgery center (ASC)/clinic) In planning a bundled payment program, the best partners seemed to be: • A provider group interested in having strong partnerships with all parties involved in the delivery of service and willing to accept some risk, competing on the total package • Patients looking for a guaranteed out-of-pocket expense and willing to go to a recommended provider • Self-funded employers that have a true incentive to control costs and are open to steering patients to high-value care Program

The Pay-One-Price Colonoscopy program seeks to increase the compliance rate for high-quality colorectal cancer screening by collaborating directly with employers seeking the same outcome. The strategy aimed to create a program that provided both procedural savings and budget control for employers while educating and motivating their plan participants to be screened. These are areas where employers previously have been limited by a lack of options, and this program represents a changed model of care and reimbursement (i.e., direct payment agreement between the medical practice and the employer). The program bundles the cost of the procedure—including professional and facility fees, lab tests, biopsies, and more—into one package and a fixed price, when performed in the practiceowned ASC. The employer supports the program through employee incentives (deductible savings, wellness programs, etc.) to motivate plan participants to complete the cancer screening. Additionally, employees who choose to use the designated program for their colonoscopy are assured of zero personal outof-pocket costs.


The Pay-One-Price Colonoscopy program The program is designed to be flexible, providing benefit to employees beyond CRC screening. For example, employees with a prior history of polyps or with active symptoms can be included in the same bundled price structure. The flexibility of the program also allowed for a second bundled payment option that the employer could make available to employees needing a combined procedure of upper endoscopy and colonoscopy in the same visit. Pilot program

The program, which was trialed with one self-funded employer in 2012, detected potential medical concerns in approximately half of the patients. The employer has a high proportion of male employees who had been noncompliant with CRC screening recommendations, and uses an on-site clinic and provider for referral. Cancer was found in the youngest patient screened, and precancerous polyps were removed from many of the employees. Screening compliance has improved, and the employer has budget control over the costs. The program’s success, in combination with a 16 percent increase in employees over the age of 50 since the program began, has resulted in the employer rolling out a full continuation of the program. The financial and health outcomes of the program (based on financial and productivity data from the pilot program, provided by the employer) are summarized below: Financial outcomes:

• Colonoscopies performed for pilot: 29 • Total cost for direct program: $47,850 • Cost savings for procedures through the direct program: approx. $30,450 • Average employee out-ofpocket costs were $1,096 in 2010 and dropped to $197 in 2012 (some employees chose to be screened outside of the program) • Produced an annual productivity savings of $25,201 by providing the wellness incen-

The bundled payment includes the following: • Pre-procedure telephone assessment • Colonoscopy prep kit and detailed instructions • 24-hour nurse phone support before and after the procedure • Colonoscopy procedure in a practice-owned ASC (all facility and professional fees, including sedation and biopsies) • All pathology technical and professional services • Final procedure report and follow-up to the patient and referring physician with online access to pathology findings within 72 hours of procedure • Guideline-compliant follow-up recommendations and intervals to next examination • A 14-day warranty on professional services • Fixed fee (one bill sent directly to employer) with no intermediaries The value-added benefits are: • High quality/value; employees are steered to nationally recognized leaders in GI diagnosis and care and provided with assurance of no out-ofpocket costs • Procedural savings for employer by removing price variations of physician and place of service • The Pay-One-Price bundle total cost of care is one-third to one-half the cost of these services when purchased under conventional payer relationships in the hospital setting. • Budget control and streamlined billing with a predictable cost; no surprise charges or risk of reclassification from preventive to diagnostic because of symptoms or pathology • Increased screening compliance within employer’s pool of plan participants • Customized tools for employer’s program launch • Educational materials and expert medical support continually available to employer • Convenient ASC locations with free parking • The possibility of preventing a colon cancer occurrence or reduction of overall treatment costs by detecting it at an earlier stage

tive for 29 participants • Provided an undetermined significant cost savings by identifying level of risk for participants Health outcomes:

• 22 males and 7 females screened • Ages 42 to 82 • 6 employees under age 50 • 11 preventive screening colonoscopy with no pathology • 18 colonoscopies with biopsy and/or polyp removal – 3 employees with benign polyps or tissue samples only – 10 employees with precancerous polyp(s) removed – 4 employees with “advanced” and/or multiple precancerous polyps removed – 1 colorectal cancer diagnosed, in the youngest participant Moving ahead

Working directly with employers as a new model of care and reimbursement was successful

MORE THAN

and all parties are motivated for the program to be of benefit. The impact to the gastroenterology practice was manageable, and access for these patients (and other patients) was not adversely affected. Other employer groups have since been added, and the practice is well positioned for additional and larger employers to use the program. Media coverage and external interest in the bundled payment program have drawn the attention of health plans, and there is optimism for productive and renewed discussions about how to incorporate bundled programs into the traditional model. Lastly, there is interest in collaborating with other specialty medical groups to provide a broader menu of bundled payment programs to employers. Scott R. Ketover, MD, AGAF, is president and CEO of Minnesota Gastroenterology, PA.

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Liver disease, liver cancer, and deaths from Hepatitis C are on the rise. Testing can lead to lifesaving care and treatment for your patients. For more information, go to: www.health.state.mn.us/hepatitis AUGUST 2013

MINNESOTA PHYSICIAN

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D E R M AT O L O G Y

H

Telephone Equipment Distribution (TED) Program

yperhidrosis is a condition characterized by abnormally increased sweating, in excess of that required for regulation of body temperature. Hyperhidrosis is classified as either primary or secondary based upon the etiology. The condition can be focal, regional or generalized, and can be either symmetric or asymmetric. General hyperhidrosis is secondary to a variety of conditions while focal hyperhidrosis can be primary, or idiopathic, or secondary, associated with a neuropathy or spinal disease or injury. Secondary hyperhidrosis generally starts in adulthood, affects a large surface area, and may be linked to any of the following: • Drugs, toxins, or substance abuse • Cardiovascular disorders • Respiratory failure • Infections • Malignancies such as myeloproliferative disorders or cancers with increased metabolism • Endocrine/metabolic disorders

Treating hyperhidrosis A new solution for excessive underarm sweating By Brian Zelickson, MD such as thyroid disease, acromegaly, carcinoid tumors, hypoglycemia, menopause, Parkinson’s disease, stroke • Rarely, idiopathic or primary hyperhidrosis Localized hyperhidrosis is most commonly idiopathic. It also can be a result of anxiety, gustatory sweating, Frey syndrome, eccrine nevus, or a neurologic lesion or injury. Primary focal hyperhidrosis, which involves excessive sweating of the palmar, plantar, and axillary regions, affects 2 percent to 3 percent of the population. Symptoms typically emerge in childhood or adolescence, and most cases indicate no cause but do follow a familial pattern. Though primary hyperhidrosis may have serious social, emotional, and professional consequences, 40 percent of affected individuals fail to seek medical

Do you have patients with trouble using their telephone due to hearing loss, speech or physical disability? If so…the TED Program provides assistive telephone equipment at NO COST to those who qualify. Please contact us, or have your patients call directly, for more information.

1-800-657-3663 www.tedprogram.org Duluth • Mankato • Metro Moorhead • St. Cloud The Telephone Equipment Distribution Program is funded through the Department of Commerce Telecommunications Access Minnesota (TAM) and administered by the Minnesota Department of Human Services

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MINNESOTA PHYSICIAN AUGUST 2013

attention for it. Of the 7.8 million people in the U.S. who have axillary hyperhidrosis, 32.5 percent of them report that their condition is barely tolerable and often interferes with daily activities. This article focuses on evaluation and treatment of primary hyperhidrosis, with particular attention to a new long-term treatment for the axillary region. Evaluation of primary hyperhidrosis

The diagnosis of primary focal hyperhidrosis is made primarily when the patient has had excessive sweating lasting more than six months without an apparent cause and at least two of the following measures apply: • Sweating is bilateral and symmetric • Sweating impedes daily activity • Episodes occur at least once per week • Onset before 25 years of age • Family history of hyperhidrosis • Focal sweating does not occur during sleep Other important elements of the history include the location, trigger factors, and a complete review of symptoms with a thorough physical examination. A very good tool to assess the severity of sweating is the Hyperhidrosis Disease Severity Scale (HDSS), which is used for patients to assess their sweating and also can be used to confirm improvement of treatments. The HDSS asks patients to rate the severity of their hyperhidrosis on four measures of severity: 1. My sweating is never noticeable and never interferes with my daily activities. 2. My sweating is tolerable but sometimes interferes with my daily activities. 3. My sweating is barely tolerable and frequently interferes with my daily activities. 4. My sweating is intolerable and always interferes with my

daily activities. It has been shown that a decrease in one HDSS score after treatment correlates to a 50 percent reduction in sweating, and a decrease in two scores is associated with an 80 percent reduction. Laboratory evaluation to confirm areas of increased sweating includes a starch iodine test, which can define the areas of sweating; and a gravimetric test, which is primarily a research tool, to define the degree of hyperhidrosis. These tests can also be used to assess response to therapy. Medical treatment of hyperhidrosis

Treatment options for axillary sweating include antiperspirants, medication, iontophoresis, Botox injections, endoscopic thoracic sympathectomy (ETS), and surgical gland removal. Antiperspirants containing 10 percent to 20 percent aluminum chloride hexahydrate are typically used to treat the axillary region. Antiperspirants need to be applied three to seven times per week initially and then reduced to one to three times per week once the condition begins to normalize. These products may induce skin irritation and may damage clothing. Occasional use of steroid creams may provide relief. Medications such as glycopyrrolate (Robinul, RobinulForte) are helpful in reducing the stimulation of sweat glands, but side effects include dry mouth, dizziness, and difficulty with urination. Beta-blockers or benzodiazepines may help reduce generalized sweating induced by stress; however, they are rarely used due to their side effects. Iontophoresis—using water to conduct a mild electrical current through the skin’s surface, to temporarily occlude the glands in the treated area—can be efficacious in treating sweating of the underarms, hands and feet. Several treatments (six to 10 sessions), each lasting 10 to 20 minutes, may be needed. Treatments may need to be maintained at one- to four-week intervals. This modality has no


Key points significant or serious side effects, though cracking and blistering of the skin may result. Botox is FDA-approved for the treatment of primary axillary hyperhidrosis. Injection-site pain and flu-like symptoms may result. Injection-site edema typically resolves within a few weeks, and results may last several months. Some patients may warrant additional treatments. Injections in the hands may result in mild, but temporary, weakness and/or intense pain. Treatments are often, but not always, covered by insurance. Endoscopic thoracic sympathectomy (ETS) is a minimally invasive surgical approach to treating severe sweating of the palms or the face, but is not successful in the axillary region. ETS turns off the signal that tells the body to release excessive sweat. Potential side effects include bradycardia and compensatory sweating. Treatments are often, but not always, covered by insurance. A new treatment for

• Primary focal hyperhidrosis involves excessive sweating of the palmar, plantar, and axillary regions. • Primary focal hyperhidrosis affects 2 percent to 3 percent of the population and can have serious social, emotional, and professional consequences. • Treatment options for axillary sweating include antiperspirants, medication, iontophoresis, Botox injections, endoscopic thoracic sympathectomy, and surgical gland removal. • A new, FDA-approved, noninvasive procedure treats excess underarm sweating on a long-term basis, using microwave energy to eliminate sweat glands. axillary hyperhidrosis

In 2012, Miramar Labs introduced the miraDry system, an FDA-approved, noninvasive procedure for treatment of excessive underarm sweating. In this procedure, microwave energy is delivered (via a hand piece) to the axillary region and thermally injures the sweat glands, which the body then resorbs. The treatment involves little or no patient downtime, offers lasting dryness (because the sweat glands do not regenerate after being eliminated), and has a strong safety profile. In controlled trials, up to 90 percent of the patients reported significant reduction of axillary sweat following two miraDry treatments. The treatment is done in a

clinic setting and the protocol consists of two treatments at a three-month interval. The treatment is painful, so it requires anesthesia. The patient has local infiltration of anesthetic and then each underarm requires 15–20 minutes to treat. Patients can expect edema, erythema, and tenderness to the treatment area that may last up to 14 days. In addition, they may have bruising at the injection sites, partial hair loss, temporary uticaria, and altered sensation in or around the area. Rarer side effects include hyperpigmentation, edema of the adjacent arm or shoulder, numbness or tingling of the arm due to anesthesia, increased odor, and small blisters.

Since the treatment is relatively new, the longest reported response is two years; however, given the mechanism of action, the durability should be maintained for much longer. Longerterm studies are currently underway. While the treatment is FDA-approved for treating axillary hyperhidrosis, there is no CPT code and it is not covered by insurance. The cost of the treatment ranges from $2,500 to $4,000. Prior to the miraDry treatment, there were no noninvasive options for long-term axillary sweat reduction. As there are multiple issues to address while evaluating patients with axillary hyperhidrosis, we now have another noninvasive, long-term modality to offer for treatment. Brian Zelickson, MD, is the director of Skin Specialists in Minneapolis and Wayzata and Zel Skin & Laser Specialists in Edina. He is a clinical associate professor in the Department of Dermatology at the University of Minnesota Medical School and is director of the department’s Electron Microscopy Laboratory.

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MINNESOTA PHYSICIAN

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NEUROSURGERY

T

ime is shortening, but every day that I challenge this cancer and survive is a victory to me.” –Ingrid Bergman (1915–1982), Swedish actress, breast cancer patient

With an aging population as well as improvements in cancer screening and treatment, the incidence of spinal metastasis (SM) is likely to increase in the coming years. Data from the Centers for Disease Control and Prevention and the American Cancer Society indicate approximately 1.66 million individuals in the United States will receive a new diagnosis of cancer in 2013. Autopsy data suggests that one-third of these patients will have evidence of spinal metastasis (SM) at the time of their death. The most common primary tumors to metastasize to the vertebral column are breast (16–37 percent), prostate (9–15 percent), lung (12–15 percent), renal (3–6 percent), and thyroid (4 percent). The incidences of metastasis by spinal region are: thoracic (68-70 percent), lumbar

Spinal metastasis Multidisciplinary approach, advances in treatment improve outcomes By Charles R. Watts, MD, PhD

and sacral (16–22 percent), and cervical (8–15 percent). The most common region of the vertebral body affected by SM is the middle column (posterior onethird of the body and pedicles).

Most spinal metastases are discovered at the time of initial diagnosis

Not only is the diagnosis of SM a poor prognostic sign (median survival 3–18 months), but the occurrence of a significant skeletal-related event (SRE)—pain, pathologic fracture, hypercalcemia, spinal cord compression, or neurologic

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deficit—decreases the median life expectancy to 3–6 months and significantly increases the cost of associated care (median cost $28,000–$48,000 per event). Management of SM patients

MINNESOTA PHYSICIAN AUGUST 2013

should focus on the prevention of further SREs, maintenance of quality of life and independence, reducing the morbidities of SREs, and improving survival. Diagnosis

Despite efforts to improve and disseminate cancer screening, most spinal metastases are discovered at the time of initial diagnosis. Pain is the most common presenting symptom. It is often well localized along the spinal axis and is exacerbated with palpation of the effected region. Pain tends to increase with axial loading and movement and improves with recumbence. There should be a strong index of suspicion in any patient with a known history of malignancy presenting with pain that is well localized to the spine. Although plain X-rays are useful for evaluating spinal alignment and deformity, their role in screening and following disease progression is limited. Bone scans are very sensitive, capable of discovering lesions as small as 2 mm, but have a high rate of false positives from osteoarthritic disease as well as potential false negatives from aggressive osteolytic lesions. MRI with contrast is the gold standard with the highest sensitivity (98.5 percent) and specificity (98.9 percent) and is superior for evaluation of the neural elements (spinal cord, nerve

roots, and leptomeninges). CT is useful for the evaluation of bony integrity but has a lower sensitivity (66 percent) than MRI. For treatment planning, particularly surgery and radiation therapy, it is usual to obtain both MRI and CT of the spinal axis. Patients need a thorough history and exam. Particular attention should be given to complaints of pain (especially radicular and neuropathic types), weakness, incontinence, and gait instability. Neurological examination should focus on strength of the upper and lower extremities and trunk; sensory deficits; alteration in reflexes or presence of pathologic reflexes; and the patient’s ability to ambulate with or without assistance (gait). The presence of a neurological deficit, particularly an evolving motor deficit should prompt urgent surgical evaluation by a neurosurgeon or orthopedic spine surgeon familiar with the treatment of SM. For those patients with SM without a neurological deficit, the Spinal Instability Neoplastic Score (SINS), has been developed to help clinicians determine a patient’s need for surgical evaluation (see Table 1). Patients with a SINS score of 7 or greater should receive prompt consultation. Medical management

The development of a metastatic lesion is a complex biological process. Tumor cells must invade the basement membrane entering the blood stream, adhere to the vascular endothelium of the host organ, extravasate through the blood vessel, and enter the tissues. If conditions are suitable, the cells will undergo growth and stimulate angiogenesis forming a new tumor. The formation of metastasis is highly dependent on the biologic behavior of the primary tumor and the microenvironment of the host tissue. This codependence explains the predilection of certain tumors to invade specific organs. The most thoroughly investigated mechanisms of SM are those of breast and non-smallcell lung cancers. Tumor cells release either parathyroid hor-


TABLE 1. Spinal Instability Neoplastic Score (SINS) mone (PTH) or parathyroid hormone-related peptide (PTHrP). These hormones bind to the parathyroid hormone receptor of osteoblastic cells, causing the release of Receptor Activator of Nuclear factor Kappa-b Ligand (RANKL). RANKL binds to osteoclast precursor cells derived from hematopoietic stem cells, forming active osteoclasts, resulting in bone resorption. RANKL is inhibited by osteoprotegrin (OPG), which is also released by activated osteoblast cells. The complex interaction between osteoblasts (bone formation cells), osteoclasts (bone resorption cells), RANKL, and OPG varies with tumor type and results in either lytic lesions with destruction of bone, blastic lesions with the formation of chaotic poorly differentiated bone, or mixed lesions with lytic and blastic characteristics. The most significant development in the medical management of SM has been the development of drugs that interfere with osteoblast/osteoclast activation processes. Amino bisphosphonates are farensyl-diphosphate synthetase inhibitors that bind to remodeling bone, causing the apoptosis of osteoclasts. They have been demonstrated in randomized controlled studies to decrease the incidence of SREs, control the size of existing tumors, and reduce pain. The most potent of these agents is zolendronic acid (Boniva). More recently, a fully human monoclonal antibody to RANKL has been developed, denosumab (Prolia or Xgeva). This agent is a very potent inhibitor of osteoclast activation and bone resorption. It has been proven in randomized clinical trials to be superior to zolendromic acid in the treatment of breast cancer metastasis to the vertebral column and is approved for the treatment of osteoporosis and SM. Radiation therapy

Radiation therapy is the most common palliative treatment for SM. Radiation causes tumor cell death, decreases associated edema, protects neural structures from compression by decreasing tumor size, and may

SINS Component

Score

Location Junctional (Occiput-C2, C7-T2, T11-L1, L5-S1) Mobile spine (C3-C6, L2-L4) Semirigid (T3-T10) Rigid (S2-S5)

3 2 1 0

Pain Yes Occasional but not Mechanical Pain-Free lesion

3 1 0

Bone Lesion Lytic Mixed (Lytic/blastic) Blastic

2 1 0

Radiographic Spinal Alignment Subluxation/translation present De novo deformity (kyphosis/scoliosis) Normal alignment

4 2 0

Vertebral Body Collapse >50 percent collapse <50 percent collapse No collapse with > 50 percent body involvement None of the above

3 2 1 0

Posterolateral Involvement (pedicle, facet, costovertebral joint) Bilateral 3 Unilateral 1 None of the above 0 Score 0 to 6: stable. Score 7 to 12: indeterminate instability. Score 13 to 18: unstable. *Timely surgical evaluation is recommended for all patients with SINS scores 7 or greater. promote the ossification of lytic lesions. There are several treatment regimes; the most common is to administer 3,000 cGy in 10 fractions. Although a single fraction may provide significant pain control, there is an 18 percent recurrence rate with lowdose single fraction vs. a 9 percent rate with the above protocol. Traditional dose delivery systems tend to uniformly irradiate both the osseous and neural structures. Despite a long history of use, the highest fractionated or single dose that the spinal cord or nerve roots can tolerate without risk of injury is unknown. The risk of a radiation-induced myelopathy is something that will need to be considered in the future, as life expectancies improve and longterm survival becomes the rule rather than the exception. The development of highspeed computers, high-resolution imaging, and highly accurate robotic gantry systems has revolutionized the delivery of radiation therapy. Stereotactic radiosurgery (SRS) was devel-

oped using the concept that multiple converging beams of ionizing radiation (X-rays or Gamma rays) will produce a well-defined area of high radiation dose that falls off rapidly in intensity within a short distance of the target, limiting the exposure of surrounding tissues. Requirements for SRS are a small well-defined target and the ability to deliver a highly accurate and conformal dose that limits exposure to sensitive structures. A number of commercially available systems have demonstrated accuracies within 2–3 mm. SRS has efficacy in the treatment of patients with a high Karnofsky performance (KPS > 70) and limited SM disease (one to three lesions). It also allows for the possible retreatment of lesions that have previously received traditional radiation protocols, is delivered in one to three fractions, and tends not to interfere with chemotherapy. Patients treated with SRS have an increased risk of spinal compression fractures SPINAL to page 28

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MINNESOTA PHYSICIAN

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FIGURE 1: 53 y/o male with an incidentally discovered left lung nodule on plain radiographs. The lesion demonstrated growth on follow up PET/CT of chest abdomen and pelvis along with a lytic lesion within the left T8 vertebral body. Lung wedge resection and percutaneous vertebral body biopsies showed indeterminate pathology. MRI of the thoracic spine with contrast showing >50 percent vertebral body involvement, involvement of left pedicle, facets, costovertebral junction, and proximal rib, and spinal canal compromise (A). The patient underwent a posterolateral vertebral body resection with placement of a titanium cage and pedicle screw instrumentation T6 through T10 (B). Pathology was consistent with malignant schwannoma that was also confirmed in the lung wedge resection tissue. Sixth-month follow-up MRI of thoracic spine with contrast (patient received post surgical radiation therapy) showing no evidence of local recurrence (C). SPINAL from page 27

at the treated level, raising the question of whether prophylactic vertebral body augmentation (kyphoplasty or vertebroplasty) should be performed (see Table

1 on page 27). Surgical treatment

The traditional surgical treatment of patients with SM and neurologic decline was a simple decompressive laminectomy. The

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MINNESOTA PHYSICIAN AUGUST 2013

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No .7

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results for this procedure were very poor, with limited ability to restore or preserve ambulatory status and the complication of postoperative spinal instability. The advent of modern spinal instrumentation has dramatically changed these outcomes. The 2005 landmark study published by Patchell et al. in Lancet comparing surgical compression and instrumentation followed by radiation therapy to radiation therapy alone clearly demonstrated the superiority of a combined approach to treatment. The patients surgically stabilized, 84 percent remained ambulatory at 122 days vs. 57 percent of those treated with radiation therapy at 13 days, and 62 percent of the surgically treated patients regained ambulatory function from significant pre-operative motor dysfunction. The surgery cohort also remained continent for a longer period of time. Although the study has been criticized for an undemanding definition of ambulation (four steps) and an obsolete definition of spinal instability (some unstable patients were assigned to the radiation therapy arm), it has significantly changed the perspective on SM treatment. Percutaneous augmentation of a lytic vertebral body with polymethylmethacrylate

(PMMA), using either vertebroplasty or kyphoplasty, in combination with the development of minimally invasive instrumentation and surgical approaches, has decreased the morbidity and hospital length of stay associated with these procedures. In general, surgery is a preferred for patients with a life expectancy greater than three months and a SINS score >7 (Table 1). Coordinated treatment plan is key

The goals of treatment in patients with spinal metastases are the prevention of further SREs, maintenance of quality of life and independence, reducing the morbidities of SREs, and improved survival. Changing medical treatment with drugs that target the osteoclastic resorption of bone and advances in surgical and radiation therapy have improved the overall prognosis and functional outcome for these patients. A comprehensive treatment plan coordinated among the patient’s medical oncologist, radiation oncologist, and neurosurgeon/orthopedic spine surgeon will provide the best possible outcome. Charles R. Watts, MD, PhD, of University of Minnesota Physicians, practices with the Spine and Brain Clinic at Fairview Southdale Hospital in Edina.


Illness from page 12 educational activities like teaching self-monitoring, providing written materials, or referring the patient to outside resources; and outreach activities like calls to see how the patient is doing, and reminder calls. Patients’ understanding of their conditions and treatment options was measured by a subset of questions from the Patient Activation Measure, developed by Judith Hibbard and colleagues, regarding understanding of medications, knowing when to selftreat, confidence in following home-care instructions, understanding of their conditions, knowing treatment options, and knowing how to prevent future problems with their conditions. Using structural equation methods, we built a model relating these three characteristics of the patient-provider relationship and overall patient satisfaction, adjusting for characteristics of the patient (age, sex, income, race, education, employment status, insurance status), and for the complexity of their chronic conditions.

Physician-patient communication: What does the literature tell us? While our research suggests that satisfaction related to different aspects of communication with physicians is associated positively with overall patient satisfaction, it does not address whether programs to improve physician communication are effective in increasing patient satisfaction. However, two of us (Christianson and Finch) recently co-authored a comprehensive review of the peer-reviewed literature on all aspects of physician communication with patients, including what is known about the effectiveness of efforts to improve communication directed at physicians in practice (see Christianson, J. et al., “Physician Communication with Patients: Research Findings and Challenges,” The University of Michigan Press: Ann Arbor, Mich., 2012). Unfortunately, the published literature provides minimal evidence-based guidance in this respect. Nine general reviews of this literature found relatively little evidence, using a variety of outcome measures, relating to the effectiveness of communication skills-building programs directed at practicing physicians (as opposed to medical students). One review that assessed the effectiveness of four programs targeted specifically at improving patient satisfaction found positive effects for only one. Program effectiveness generally was hard to determine because of small sample sizes, lack of control groups, and limited follow-up periods, among other reasons. The Kaiser Permanente Four Habits model is perhaps the best-known physician communication skillsbuilding model for practicing physicians, but there is

very little peer-reviewed evidence of its effectiveness. A relatively comprehensive assessment of a communication intervention in the United Kingdom involving physicians who treat cancer patients, which was one of the more rigorous studies we identified in our review, found measurable changes in physician behavior but no significant impact on patient satisfaction. In part because of the paucity of empirical evidence on the impact of communication skill-building programs for practicing physicians on patients, including impact on patient satisfaction, we collected interview data from two health care organizations to better understand their approaches. Both organizations combined employed and contracted physician groups with their own insurance products, and each expressed a desire to improve physician communication with the hope of raising publicly reported patient experience scores. Although details differed, their programs combined general educational efforts, emphasizing that “service” is an important part of the medical care “product,” with targeted “coaching” for physicians who ranked low on communication skills. Both organizations reported that their approaches were continuing to evolve and, while they cited anecdotal evidence of success, they had not conducted rigorous program evaluations. Competing with other organizational priorities for program resources was a continuing challenge for the sustainability of their programs and, in one case, had led to scaling back program efforts.

Illness to page 38

Here to care At Allina Health, we’re here to care, guide, inspire and comfort the millions of patients we see each year at our 90+ clinics, 11 hospitals and through a wide variety of specialty care services throughout Minnesota and western Wisconsin. We care for our employees by providing rewarding work, flexible schedules and competitive benefits in an environment where passionate people thrive and excel. Make a difference. Join our award-winning team. Madalyn Dosch, Physician Recruitment Services Toll-free: 1-800-248-4921 Fax: 612-262-4163 Madalyn.Dosch@allina.com allinahealth.org/careers EOE/AA 10127 0213 ©2013 ALLINA HEALTH SYSTEM ® A TRADEMARK OF ALLINA HEALTH SYSTEM

Practice Well. Live Well.

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

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

• Orthopedic Surgeon • Pediatrics • Psychiatrist • Psychiatric NP or PA

For more information contact John D. Peterson, Physician Recruiter jdpeterson@lrhc.org (218) 736-8090

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

Lake Region Healthcare is an Equal Opportunity Employer. EOE

www.lrhc.org AUGUST 2013

MINNESOTA PHYSICIAN

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GASTROENTEROLOGY

Celiac disease

C

eliac disease is a systemic disease triggered by immune response to dietary ingestion of gluten in immunologically susceptible individuals. In the 1940s, Dutch pediatrician Willem Dicke established the link between gluten exposure and development of celiac disease. Gluten exposure will result in variable degrees of intestinal damage, and in most patients with celiac disease, the enteropathy will reverse on a gluten-free diet. Gluten is a storage protein found in wheat, rye, and barley. Wheat gluten is composed of gliadin, low-molecular-weight glutenin (LMW-GS), and highmolecular-weight glutenin (HMW-GS). Gliadin is further subdivided into α, β, γ, and ω subunits. The α gliadin peptides are the most toxic fraction in patients with celiac disease. This gluten-sensitive response affects people of all ages and both genders, and is more common among Caucasians. Genetics plays a large role in this response, which runs in families and can be associated with other

Incidence, symptoms, diagnosis, and treatment by Vandana Nehra, MD, and Joseph A. Murray, MD autoimmune diseases, including type 1 diabetes and autoimmune thyroid disease. Epidemiology

Though celiac disease was once thought to be uncommon, based on research conducted by the National Institutes of Health (NIH) and Mayo Clinic, published July 2012 in the American Journal of Gastroenterology, one in every 100 U.S. Caucasians is estimated to have celiac disease, which affects about 1.8 million Americans. Data from collaborative research by the Mayo Clinic, the University of Minnesota, and the Medical Follow-up Agency suggest that the prevalence of celiac disease in the U.S. has increased dramatically over the past several years. This increase is not due simply to better detec-

tion, but reflects a true increase in incidence. Another 2012 American Journal of Gastroenterology report, from the Department of Defense, confirmed this dramatically increased rate of new diagnosis of celiac disease (Riddle M, Murray JA, Porter CK, Am J Gastroenterol 2012; 107:1248–1255). The exact reason for this epidemiological change is unclear but likely reflects pervasive changes in the environment. The increase of celiac disease in children may be due in part to changes in feeding habits that include introduction of infant formula containing gluten early in life. Studies from animal models and of humans who develop gluten sensitivity after an episode of infectious diarrhea suggest that in genetically sus-

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ceptible patients, an infection may trigger the onset of celiac disease symptoms. Early childhood infections, especially those that overlap introduction of formula containing a high dose of gluten, may increase the likelihood of celiac disease. Three or more bouts of infectious diarrhea in young children around the time they start drinking formula has been found to be associated with a substantially increased risk of being diagnosed with celiac disease during childhood. Results from collaborative research by the U.S. Naval Medical Research Center and Mayo Clinic suggest that, similar to studies in infants, infectious gastroenteritis may precede diagnosis of celiac disease in active service military personnel. Another trend observed has been diagnosis of celiac disease for the first time in 30- to 50year-old adults who apparently have tolerated gluten well without any symptoms. The reason for this trend is unclear and may relate to changes in wheat genetics caused by modern wheatCELIAC to page 32


Family Medicine St. Cloud/Sartell, MN We are actively recruiting exceptional full-time BE/BC Family Medicine physicians to join our primary care team at the HealthPartners Central Minnesota Clinics - Sartell. This is an out-patient clinical position. Previous electronic medical record experience is helpful, but not required. We use the Epic medical record system in all of our clinics and admitting hospitals. Our current primary care team includes family medicine, adult medicine, OB/GYN and pediatrics. Several of our specialty services are also available onsite. Our Sartell clinic is located just one hour north of the Twin Cities and offers a dynamic lifestyle in a growing community with traditional appeal. HealthPartners Medical Group continues to receive nationally recognized clinical performance and quality awards. We offer a competitive compensation and benefit package, paid malpractice and a commitment to providing exceptional patient-centered care. Apply online at healthpartners.jobs or contact diane.m.collins@healthpartners.com. Call Diane at 952-883-5453; toll-free: 800-472-4695 x3. EOE

healthpartners.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 AA/EOE - Not subject to H1B Caps

Emergency Medicine Physician BC/BE Family Medicine or BC/BE Emergency Medicine Physician to work exclusively in our ED. 10 patients average per 24 hrs. 24 hr. shifts-Full Time or Part Time. GRHS is a progressive 19 bed Critical Access Hospital with two clinics. Glenwood is a family oriented community with an excellent school system. Recreational opportunities include boating, hiking, excellent fishing and hunting. We are halfway between Fargo and the Twin Cities. For more information Call Kirk Stensrud, CEO 320.634.4521 Mail CV to: Kirk Stensrud, CEO 10 Fourth Ave SE Glenwood, MN 56334 Submit CV Online kirk.stensrud@glacialridge.org

www.glacialridge.org

Emergency Room Physicians Looking for leisure work hours? • Set your own hours • No contract • No obligations

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

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Great Emergency Department in Southern Minnesota

763-682-5906 • 1-800-876-7171 F-763-684-0243 michelle@whitesellmedstaff.com AUGUST 2013

MINNESOTA PHYSICIAN

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Celiac from page 30 growing practices, combined with increased consumption of processed foods containing gluten. Clinical presentation

Classic disease presentation with diarrhea and malabsorption represents only the tip of the iceberg, as the greater proportion of patients have subclinical or atypical manifestations that are not apparent. Celiac disease may present with classical symptoms, atypical symptoms, or refractory disease. Typical celiac disease: Classical presentation includes symptoms of diarrhea, weight loss, steatorrhea and failure to thrive, hypoalbuminemia, and deficiencies of micronutrients and fat-soluble vitamins. Atypical celiac disease: Celiac disease may present with atypical symptoms characterized by gastrointestinal complaints suggestive of irritable bowel syndrome, unexplained iron deficiency anemia, persistently elevated serum aminotransferases (ALT, AST), osteoporosis, short

stature, peripheral neuropathy, idiopathic ataxia, and infertility or recurrent spontaneous abortions at time of diagnosis. Refractory celiac disease: These patients may have persistent gastrointestinal symptoms of diarrhea and weight loss with small bowel villus atrophy despite adhering to a strict gluten-free diet for more than 12 months. Non-celiac gluten sensitivity presents as chronic gastrointestinal symptoms, often associated with fatigue, that seem to improve on a gluten-free diet, even though the diagnosis of celiac disease has been ruled out. Associated disorders

Dermatitis herpetiformis. The classic presentation is of pruritic, papulovesicular eruption on the elbows, knees, and buttocks. The diagnosis is confirmed histologically on skin biopsy. Dermatitis herpetiformis is common among patients with celiac disease, and both diseases are associated with the same HLA-DQ heterodimers. About 85 percent of patients with dermatitis her-

Sioux Falls VA Health Care System 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 location.

Psychiatrist Hospitalist

Who should be tested for celiac disease?

• Patients with chronic diarrhea, malabsorption, and weight loss • All patients with dermatitis herpetiformis • Patients with type 1 diabetes mellitus who present with gastrointestinal symptoms • Patients with unexplained iron deficiency anemia, persistent elevated aminotransferases, idiopathic peripheral neuropathy, nonhereditary ataxia, epilepsy, infertility, and recurrent spontaneous abortions • Asymptomatic first-degree relatives of patient diagnosed with celiac disease Diagnosis

Testing for celiac disease should be done before the patient starts a gluten-free diet. Consumption of a gluten-free diet requires major lifestyle changes and is expensive. With recent media attention to the potential adverse effects of gluten on health, many people have switched to a gluten-free diet without any supervision. However, relief of CELIAC to page 34

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

Pediatrics

Orthopedic Surgery

Obstetrics/Gynecology

Radiology/Oncology

Family Practice

Endocrinology

Internal Medicine

Emergency Medicine

Emergency Medicine

Psychiatry

Ophthalmology

Sioux Falls VA HCS, SD Primary Care (Family Practice or Internal Medicine)

petiformis have small bowel histologic changes consistent with celiac disease. Both the skin lesions and the small bowel mucosal changes are responsive to a gluten-free diet. Dapsone is effective for treatment of the skin lesions but does not have any impact on small bowel histology. Diabetes mellitus. Celiac disease is associated with type 1 diabetes mellitus and polyglandular autoimmune syndrome with autoimmune thyroiditis. Selective IgA deficiency has been reported in 1 percent to 2 percent of patients with celiac disease, and screening in these patients is best done by using IgG-based antibody tests. Hyposplenism has been well described in association with celiac disease, thus supporting a role for prophylactic pneumococcal vaccination. Down syndrome. There is a strong association between Down syndrome and celiac disease, with biopsy-proven disease in about 16 percent of patients with Down syndrome.

Neurologist

Optometry

Pulmonologist

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

Applicants can apply online at www.USAJOBS.gov

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

www.averamarshall.org

32

MINNESOTA PHYSICIAN AUGUST 2013


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

The perfect match of career and lifestyle.

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

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

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

• Psychology • Pediatrics • Pulmonary/ Critical Care • Radiation Oncology • Rheumatology

For additional information, please contact:

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

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

www.acmc.com

healthpartners.com

Emergency Medicine Olmsted Medical Center, a 150-clinician multi-specialty clinic with 10 outlying branch clinics and a 61 bed hospital, continues to experience significant growth. Olmsted Medical Center provides an excellent opportunity to practice quality medicine in a family oriented atmosphere. The Rochester community provides numerous cultural, educational, and recreational opportunities. Olmsted Medical Center offers a competitive salary and comprehensive benefit package.

Opportunities available in the following specialties: Dermatology Southeast Clinic

Family Medicine Cannon Falls Clinic and Pine Island Clinic

Hospitalist

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

Hibbing Little Falls Park Rapids Alexandria Austin

Rochester Hospital

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

Internal Medicine Southeast Clinic

recruiting@epamidwest.com or visit our website at Send CV to: Olmsted Medical Center Administration/Clinician Recruitment 102 Elton Hills Drive NW Rochester, MN 55901 email: dcardille@olmmed.org Phone: 507.529.6748 Fax: 507.529.6622 EOE

www.epamidwest.com

Your Emergency Practice Partner

www.olmstedmedicalcenter.org AUGUST 2013

MINNESOTA PHYSICIAN

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Celiac from page 32 certain gastrointestinal symptoms on a gluten-free diet is not diagnostic of celiac disease, as gluten sensitivity may occur in the absence of celiac disease. Hence, a definitive diagnosis should be made before implementation of a gluten-free diet. Serologic tests are the initial test of choice in patients suspected of having symptoms of celiac disease. Serum IgA tissue transglutaminase antibody (IgATTG) is the initial serological test of choice in patients who do not have IgA deficiency. TTG-IgA has sensitivity and specificity of >95 percent in untreated patients. The endomysial antibody test (IgA-EMA), although highly sensitive and specific, is expensive and operator-dependent, and is used mainly as a confirmatory test. Selective IgA deficiency has been reported in 1 percent to 2 percent of patients with celiac disease. In patients with high suspicion for the diagnosis of celiac disease, total serum IgA levels should be measured and should include IgG-based tests such as

IgG-deamidated gliadin peptides (IgG DGP) or IgG tissue transglutaminase antibody test (IgG TTG). All diagnostic serologic tests should be done when patients are consuming a regular diet containing gluten. Small bowel biopsy remains the gold standard for the diagnosis of celiac disease. All patients with a positive serology should have a small bowel biopsy to diagnose celiac disease. Endoscopic features observed in patients with celiac disease include flattening of folds and scalloped or fissured appearance of the duodenum; however, these findings are unreliable in diagnosing celiac disease. The histologic features in celiac disease are described using the MarshOberhuber classification, and include total or partial villus atrophy, crypt hyperplasia, and presence of increased intraepithelial lymphocytes. HLA DQ2 and DQ8 haplotypes are present in 99 percent of patients with celiac disease. A diagnosis of celiac disease is highly unlikely in patients without these haplotypes.

FAMILY PRACTICE w/OB Warroad, MN Roseau, MN Crookston, MN • Dedicated Team Approach • Competitive Salary & Benefits • EPIC Healthcare Information System Idylic Practice Opportunities located in family friendly communities with close access to some of Minnesota’s most beautiful lakes. 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 34

MINNESOTA PHYSICIAN AUGUST 2013

Treatment

At present, the only treatment for celiac disease is a strict gluten-free diet. A definitive diagnosis of celiac disease is necessary before lifelong commitment to a gluten-free diet. All patients diagnosed with celiac disease should have a formal consultation with a dietician for instructions. Treatment with a gluten-free diet results in resolution of symptoms in the majority of patients, with restoration of small bowel histology within six to 12 months of starting the diet. Patients should be followed up annually to assess response to treatment, monitor associated conditions, and review adherence to the diet. Patients with celiac disease may have associated vitamin and micronutrient deficiencies, including deficiencies of fat-soluble vitamins. Zinc and copper deficiencies also have been described in celiac disease, and may require additional physician supervision. Studies have reported an increase in overall mortality in

patients with celiac disease. Causes of death include nonHodgkin’s lymphoma and cancer of the esophagus, stomach, pancreas, liver, and bile ducts. A gluten-free diet likely reduces the increased mortality in patients with celiac disease. Ironically, most people who have celiac disease don’t know it and are not on the gluten-free diet that would likely improve their health, whereas it’s unknown whether most people who follow a gluten-free diet need to do so. Early recognition and testing with highly sensitive serologic tests facilitates diagnosis. With recent advances in understanding the pathogenesis of celiac disease, novel alternative therapies to replace the gluten-free diet are under investigation. Vandana Nehra, MD, is an assistant professor of medicine and consultant gastroenterologist with expertise in celiac disease and small bowel disorders at the Mayo Clinic in Rochester. Joseph A. Murray, MD, is a professor of medicine and consultant gastroenterologist specializing in celiac disease at the Mayo Clinic in Rochester.

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

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

Live in the relaxed lake country of Mille Lacs and practice medicine where you will make a difference. We’re looking for a Family Physician to join us at Mille Lacs Health System in Onamia, Minnesota. Loan forgiveness options – J-1Visas considered. Contact: Fern Gershone: fgershone@mlhealth.org or Dr. Tom Bracken: tbracken@mlhealth.org

Caring for body, mind and spirit. Onamia, MN • mlhealth.org • 877 -535-3154 7 FAMILY PHYSICIANS • 9 PAs • CRITICAL ACCESS HOSPITAL ER STAFFED 24/7 • ATTACHED GERIATRIC UNIT & LTC FACILITY • 4 CLINICS

Opportunities for full-time and part-time staff are available in the following positions: • Associate Director, Primary & Specialty Medicine (IM)

• Medical DirectorExtended Care & Rehab (Geriatrics)

• Dermatologist

• Pain Specialist

• Geriatrician/Hospice/ Palliative Care

• Psychiatrist

• Internal Medicine/ Family Practice

• Urgent Care Physician (IM/FP/ER) Applicants must be BE/BC.

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

US Citizenship required or candidates must have proper authorization to work in the US. 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 recruitment bonus. EEO Employer.

Competitive salary and benefits with recruitment/ relocation incentive and performance pay possible.

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

Please contact or fax CV to:

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

763-504-6600 Fax 763-504-6622

For more information: Visit www.USAJobs.gov or contact Nola Mattson, STC.HR@VA.GOV Human Resources 4801 Veterans Drive, St. Cloud, MN 56303

(320) 255-6301 www.NWFPC.com AUGUST 2013

MINNESOTA PHYSICIAN

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Guiding hand from page 19 to dodge concerns about my mental state. Now I was required to be forthright (especially in my recovery from alcoholism) and to acknowledge that many things in my life were no laughing matter. In choosing a road of recovery, I could no longer deny the necessity of the medications I was taking to treat schizoaffective disorder. I had to admit to myself, my doctor, and others that I had been insane. However, I always was able, mostly through the help of my family and friends, to see beyond the boundaries of schizophrenia. This made me, and others, think there was something in addition to schizophrenia that was my problem. I began to reexamine the brain trauma from the car accident. Was it just my mind fooling me, or had the blow to my head caused my condition? I sought answers from many sources, but I will never know for certain. In charge of my mind

My first days in the mental health system were a roller

coaster ride and, at times, hellish, but now the track has mostly straightened out, and it’s been a smooth trip the last 10 or 15 years. When I look back to 1979, my first time in the mental health system, I can honestly say I feel lucky and grateful to have found a treatment that works for me. I see my psychiatrist for meds monitoring twice a year, and a therapist intermittently. An important part of my recovery has been my employment with a nonprofit mental health agency that has a radical outlook on mental illness: They give employees/clients the power to make our own decisions and suffer the consequences or reap the benefits. The staff monitors; they do not control. Their psychiatrists support that notion. I have been in their program for 25 years. The psychiatrist I currently see is an exceptional doctor. It is with him that I finally broached the idea of my head injury being at least a contributing factor in my illness. It’s been like an awakening to be able to fully and honestly discuss my medical concerns, as I under-

stand them, with a psychiatrist. Far and away the biggest benefit I’ve received from my doctors has been to stabilize my thinking and put me back in charge of my mind. The psychiatrists have helped me the most by treating me with medication. Along with the meds, I’ve received great spiritual and emotional help from countless support staff workers over the past 30 years. I now understand that alcohol is very detrimental to my mental health; I haven’t touched it in 30 years. I’ve learned to ask for help, and I’ve learned to be happy with less than perfection in myself and a scaled-down role—something less than the Second Coming, which I once thought I was. All these gifts would have never come to me without the car accident and the angel, which shows me that good and bad sometimes travel closely together. I’m fortunate to be able to now live a normal life for the most part. I work at a full-time job that lands me solidly in the middle class, and I have a decent social life. I am halfway

to a black belt in karate. I own a condo and am a member of a well-established Christian church. I have weekend jobs through my church, and in the past went on church-sponsored mission trips to Haiti and India. I’ve also pursued a writing career (see www.bruceario.com); when one of my psychiatrists read a book I had written, it became a bridge of understanding for me. I no longer consider myself to have an active mental illness. It’s been a very long road and I still have difficult moments, but my medical teams have been there for me. They’ve intervened when necessary with bold and decisive steps, and they’ve mostly spoken in a caring voice, which makes recovery easier. Coming out of psychosis requires a belief in a greater power than oneself. Sometimes this has been my angel; sometimes, my family, friends, and co-workers; and oftentimes, my doctors. Without their guiding hand, I surely would have had no recovery, and no angel. Bruce Ario lives in Minneapolis.

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

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

s Psychiatry s Urology

Contact us for a complete list of openings.

Based in Minot, the trade center for Northern and Western North Dakota, Trinity Health offers the opportunity to work within a dramatically growing community that offers more than just a high quality of life. Comprised of a network of nearly 200 physicians in hospitals, clinics and nursing homes, Trinity Health hosts a Level II Trauma Center, Critical Care Helicopter Ambulance, Rehab Center, Open Heart and Lung Program, Joint Replacement Center and Cancer Care Center.

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

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

www.trinityhealth.org

36

MINNESOTA PHYSICIAN AUGUST 2013

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


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)

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

AIRFORCE.COM/HEALTHCARE

AUGUST 2013

MINNESOTA PHYSICIAN

37


Illness from page 29 Study findings

We found that the three relationship characteristics described above are important, both directly and indirectly, to patient satisfaction (additional details can be found in Carlin CS, et al., Chronic illness and patient satisfaction. Health Services Research 2012;47(6):2250–2272). In particular, patients’ perceptions of the quality of their interactions with their providers are positively associated with overall satisfaction, and this is consistent across patients with different numbers of chronic conditions. Patient perceptions of practice support for self-management also have a positive relationship to patient satisfaction. Here, the effect of supporting self-management of the patients’ conditions on satisfaction got stronger as the number of chronic conditions increased. Simply improving patients’ understanding of their illnesses and treatment options had an impact that, while statistically significant, was too small to have practical significance.

38

The study also found that patients who are older, female, and insured tend to be more satisfied with care, but these effects tend to erode as the patient’s illness burden increases. Those with lower education levels tend to be more satisfied with care, consistently across illness levels. Race had no discernible impact on patient satisfaction. It is interesting that these readily observable patient characteristics have less impact than the three underlying characteristics of the patient-provider relationships described above. Conclusions

The purpose of this study was to increase knowledge concerning the relationship between patient complexity and measures of satisfaction with care typically used in physician practice performance reports or P4P programs. Our findings suggest that readily observable characteristics of patients are likely to be associated with physician practice “satisfaction with care” scores in public reports or P4P programs. For example, provi-

MINNESOTA PHYSICIAN AUGUST 2013

ders with patient mixes skewed toward older or female patients are likely to have higher scores. In contrast, practices with a higher proportion of well-educated patients are likely to have lower scores. [The relationship between education and satisfaction reported by Fan et al. (2005, J Gen Intern Med 20(5)) is in the opposite direction.] Providers seeking to improve their patient satisfaction scores could do so by considering certain patient characteristics when accepting new patients or deciding whom to refer to other providers for treatment. Although our findings suggest that scores vary with observable demographic characteristics, which creates the potential for practices to improve scores by avoiding or referring specific types of patients, we found no strong evidence that avoiding complex patients (i.e., those who have more chronic illnesses) will improve satisfaction measures. Importantly, our results suggest that patients who are more satisfied with their com-

munications with their physicians have higher overall satisfaction with their care. Patients who report that practices support them in their care management activities are also more satisfied, and this support becomes more important as patient complexity increases. Therefore, investments in activities that improve communication with patients and support patients in self-management of their illnesses have the potential to improve patient satisfaction. The challenge to physician practices, however, is identifying programs that are effective in accomplishing these objectives. Caroline S. Carlin, PhD, is a research investigator with Medica Research Instit-ute. Jon B. Christianson, PhD, is the James A. Hamilton Chair in Health Policy and Management at the University of Minnesota in the School of Public Health, Division of Health Policy & Management. Michael Finch, PhD, is an adjunct associate professor at the University of Minne-sota’s Carlson School of Management. This research was supported by a grant from the Robert Wood Johnson Foundation for the evaluation of its Aligning Forces for Quality initiative. The authors also gratefully acknowledge the input of our co-author, Patricia Keenan, and input from Dennis Scanlon in the formative stages of this work.


It’s time to see beneath the surface. September 8–10, 2013 http://www.mayo.edu/transform/


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