Minnesota Physician January 2011 by Minnesota Physician Publishing

Volume XXlV, No. 10

January 2011

The Independent Medical Business Newspaper

Sea change Just one constant: the budget deficit By H. Theodore Grindal, JD, and Nate Mussell, JD

Runaway TRAIN? a pilot project for the Minnehysicians and other Where do sota Medicaid population medical providers rely PMAP dollars go? wherein large parts of this on data in assessing program were outsourced to and managing their patients. By David Feinwachs, JD, PhD private health maintenance Vital signs, lab results, huge organizations, based on the amounts of information are theory that these HMOs could deliver better necessary to successfully manage the health health care at a lower cost. The rationale and the care of patients. So shouldn’t we was that the state of Minnesota would save have data to manage the functioning and money and be relieved of the efficiency of our health care system, particuadministrative burden of operlarly our publicly funded programs? Oddly ating these programs. enough, we lack this data—and what This pilot project was to accounts for this sorry state of affairs is an be carefully evaluated for cost interesting tale. effectiveness and health care During the past two decades, the state outcomes to demonstrate the of Minnesota has outsourced the majority soundness of the outsourcing of our tax-funded health care programs. theory. Now, nearly 20 years Before this outsourcing occurred, our health later, we know that has never care programs were administered by the occurred. state using a fee-for-service model. A little more than 20 years ago, the state undertook ACCOUNTABLE to page 10

s the 2011 legislative session begins, the November elections are a thing of the past and a new base of power has taken over at the Capitol. Republicans now have the majority in both the House and the Senate, and the governor’s office has a new occupant for the first time in eight years. The only constant remaining from last year is the sizable budget deficit facing the new governor and Legislature once again. Political posturing and philosophical differences on balancing the budget are likely to entrench the governor’s office and legislative bodies in opposite corners for what could be a long spring and summer. Can Republicans forge a budget solution entirely through cuts, or will new revenue be the only way forward? These questions, along with potential reforms to the state’s SEA CHANGE to page 12

IN THIS ISSUE: Minnesota Health Care Roundtable Page 20

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One Heart, One Mind, One Universe May 8, 2011 at Mariucci Arena, University of Minnesota Medicine Buddha Empowerment: A Tibetan Cultural and Spiritual Ceremony Promoting Personal and Societal Healing featuring His Holiness the 14th Dalai Lama 9:30 - 11:30 a.m. Peace Through Inner Peace: A Public Address featuring His Holiness the 14th Dalai Lama 2:00 - 3:30 p.m. May 9, 2011 at University Radisson Hotel Second International Tibetan Medicine Conference: Healing Mind & Body 9:00 a.m. - 7:30 p.m. (* His Holiness is not expected to be in attendance.)

2 Days Only, 3 Events

The Minnesota Visit 2011 His Holiness the 14th Dalai Lama

A special invitation to health professionals: The Second International Tibetan Medicine Conference May 9, 2011 This event will bring to the Twin Cities the foremost practitioners of Tibetan medicine from the Men-Tsee-Khang, the Tibetan Medical Institute of His Holiness the Dalai Lama, in Dharamsala, India. By the end of the conference, participants will be able to meet the following objectives involving Tibetan Medicine: Examine the relationship between ethics, spirituality, and healing. Investigate participants' own unique constitution. Determine what lifestyle choices to make, based on participants' own constitution. Explain how to heal from the source and develop health through balance. Describe research about Tibetan medicine, as well as propose additional research needed. Apply teachings of Tibetan medicine personally and professionally.

etan Ame Tib r

Minnesota of

For tickets and more information, visit www.dalailama.umn.edu or call 612-624-2345

un n Fo dation ica

CONTENTS

JANUARY 2011 Volume XXIV, No. 10

FEATURES Runaway train? Where do PMAP dollars go?

MINNESOTA HEALTH CARE ROUNDTABLE

By David Feinwachs, JD, PhD

Sea change Just one constant: the budget deficit

By H. Theodore Grindal, JD, and Nate Mussell, JD

Minnesota Health Care Roundtable Comparative effectiveness

DEPARTMENTS 4

GASTROENTEROLOGY Elevated liver tests

MEDICUS

By Jeffrey Rank, MD

INTERVIEW

PROFESSIONAL UPDATE: ORTHOPEDICS Shoulder replacement surgery 28

CAPSULES

Kim StutzmanEngwall, PhD

By Gregory N. Lervick, MD

Pfizer

ONCOLOGY Breast cancer RESEARCH Shingles vaccinations: worth a second look

By Noel Laudi, MD, MRCP (UK)

By Barbara P. Yawn, MD, MSc

WOMEN’S HEALTH “Double trouble”

By Anna R. Peters, PhD, LP

PRACTICE MANAGEMENT Genie in a bottle, or Pandora’s box? 16 By Michael Reiling, Anne Smith, RN, CPC, CCS-P, CPMA, CPC-I, CEMC, CPEDC, and Steven Beck, JD

The Independent Medical Business Newspaper

www.mppub.com PUBLISHER Mike Starnes mstarnes@mppub.com EDITOR Donna Ahrens dahrens@mppub.com

T H I R T Y- F I F T H

Background and focus: Until recently, when the word wellness came up in organized medicine it was regularly dismissed as pseudo-science. Our health care delivery system, or as many call it “sick care delivery system,” evolved in a way that doctors were not paid to keep patients well and thus wellness strangely fell outside the purview of medicine. Obviously it is better to stay healthy than try to fix complex and someA changing focus in health care times avoidable medical conditions. Selling servApril 28, 2011 ices supporting this 1:00 – 4:00 PM • Duluth Room approach was often Downtown Mpls. Hilton and Towers criticized for lack of randomized clinical trial research; inadequate licensing, credentialing, and oversight for practitioners; and many other concerns. Wellness as an industry, with its wide diversity of methods and approaches, was kept at arm’s length by the medical establishment. Economics have forced this to change and now everyone is engaged with using an old tool in new and more collaborative ways for the betterment of all.

The Wellness Revolution

Objectives: We will explore the definition of wellness, why today there is a wellness revolution, and why doctors now embrace the concept. Examining multiple collection methodologies and sets of data, we will discuss how and why employers are driving this new approach to health care. We will consider privacy issues and many other challenges to an already overburdened administrative process posed by collecting and storing individual health care data in places such as work sites and health clubs. We will discuss the breadth of wellness initiatives, their pros and cons, and how they can lower the cost of health care while improving individual health status.

Please send me tickets at $95.00 per ticket. Mail orders to Minnesota Physician Publishing, 2812 East 26th Street, Minneapolis, MN 55406. Tickets may also be ordered by phone (612) 728-8600 or fax (612) 728-8601. Name

ASSOCIATE EDITOR Martha Malan mmalan@mppub.com

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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; e-mail 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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JANUARY 2011 MINNESOTA PHYSICIAN

CAPSULES

St. Paul Heart Clinic Joins Larger Systems St. Paul Heart Clinic, the last large independent cardiology group in the Twin Cities, joined Allina Hospitals and Clinics and HealthEast Care System on Jan. 1. The clinic no longer exists as an independent organization, having folded its services into existing programs within the two large health systems, officials announced. “It is important to remember that while the St. Paul Heart Clinic name will go away, we will stay in our community and look forward to meeting our patients’ needs,” said Thomas Johnson, MD, president, St. Paul Heart Clinic. “We are confident that our decision to integrate with Allina and HealthEast is the beginning of an exciting new era of delivering care at the vanguard of cardiology. As physicians, we can focus our efforts toward innovative care models and superior clinical outcomes.” Clinic officials say there is a nationwide trend of mergers involving independent cardio-

logy practices, with 70 percent of such groups taking steps to join larger health systems. In a letter to its patients, the St. Paul clinic noted that cardiology practice is changing, including a shift from inpatient to outpatient care. It added that changes at the federal level, including health care reform, have played a role in these changes, along with increasing emphasis on chronic disease management, prevention, and quality.

Blue Cross/Shield Announces New Contracting Model Blue Cross and Blue Shield of Minnesota has announced a new approach to contracting with physicians that will replace yearly contracts with longerterm agreements that seek to reward quality, efficiency, and transparency, officials say. The new “shared incentive” program is seen as a more collaborative approach that fits better with a changing health care

landscape. With federal and state reforms emphasizing models such as medical homes, health plans say they are working with delivery systems to place the focus on outcomes, not volume of care. “It is such a different world today,” says Jim Eppel, senior vice president of health management and commercial markets at Blue Cross. “Chalk some of it up to health care reform, chalk some of it up to purchaser dissatisfaction with the increase in health care costs, and chalk some of it up to ever-increasing transparency. What we find is delivery systems that say, ‘We really want to demonstrate that we do a better job of managing cost and delivering outcomes.’ ” The new realities of the industry have allowed health plans and providers to negotiate longer contracts that not only provide increases in reimbursement over time but also incentives for quality built on a “total cost of care” approach, according to Eppel. Eppel says the move is in part an acknowledgment that

health plans’ “pay-for-performance” efforts were not as effective as health plans hoped they would be. “Pay-for-performance didn’t go deep enough; it wasn’t meaningful enough,” he says. “The basic concept was there but it wasn’t large enough to change behavior.”

MHA Counsel Fired After Video Criticizing PMAP Accounting David Feinwachs, general counsel of the Minnesota Hospital Association (MHA) for almost 30 years, was fired from the organization recently, not long after making a controversial video questioning the administration of state health plans by private insurance companies. Neither Feinwachs nor MHA will discuss the reason for the dismissal, but Feinwachs concedes his work in questioning the lack of transparency around payments for the state’s Prepaid Medical Assistance Program (PMAP) was “controversial” (Ed. note: see cover story).

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Feinwachs made two videos for the PMAP Reform Advocacy Group in spring and fall of 2010. In the second video, posted online in September, Feinwachs describes the PMAP system as a â&#x20AC;&#x153;black boxâ&#x20AC;? with no realistic accounting oversight for the billions of tax dollars that fund state health plans. Under the current system PMAP is administered by private health plans and funded by state and federal Medicaid dollars. Janice Hennings, MHA spokeswoman, declined to provide details on Feinwachsâ&#x20AC;&#x2122; dismissal, saying that MHA could not comment on personnel matters. She says the hospital group is committed to transparency on issues like PMAP. â&#x20AC;&#x153;We believe in transparency of information for all aspects of health care, and we are continuing to have a dialogue with Minnesota health plans to get to transparency,â&#x20AC;? Hennings says. Feinwachs says there was considerable interest in the PMAP issue in last yearâ&#x20AC;&#x2122;s Legislature, with two bills calling for changes to the system advancing, but ultimately stalling at the end of the session. He says he expects the issue will continue to be discussed in the next Legislature. In the meantime, Feinwachs says he is proud of his tenure at MHA. â&#x20AC;&#x153;I considered it an honor and a privilege to serve Minnesota hospitals for almost 30 years,â&#x20AC;? he says. â&#x20AC;&#x153;Iâ&#x20AC;&#x2122;m extremely proud of the things we accomplished during that 30-year period. Things like negotiating with the attorney generalâ&#x20AC;&#x2122;s office to put an end to egregious collection practices and to provide some level of discounted care to people with no insurance, things like standardization of billing processes and administrative simplification, things like the adverse event reporting law in Minnesota. I was delighted to play at least a small part in such important efforts.â&#x20AC;?

Lakeview Talks Merger with HealthPartners Lakeview Health System in Stillwater is discussing an affiliation with Bloomington-based HealthPartners, officials from the two groups announced recently. Lakeview provides medical services in the Stillwater area, including parts of the Twin Citiesâ&#x20AC;&#x2122; northeastern metro region and western Wisconsin. The system includes Stillwater Medical Group, Lakeview Hospital, and Lakeview Foundation. Officials say that under the terms of the affiliation, Lakeview Health will keep its own governing and foundation boards, while sharing resources with the larger HealthPartners system. â&#x20AC;&#x153;We are excited about the opportunities this partnership can provide for Lakeview Health and the population we serve,â&#x20AC;? says Tracey Galowitz, chair of the Lakeview Health System board of directors. â&#x20AC;&#x153;Our board looks forward to working with HealthPartners to expand the type and level of services offered in our community.â&#x20AC;? The move comes at a time when many small and midsized health facilities and systems are joining larger groups. Analysts say health care reform efforts and economic realities are forcing smaller organizations to join larger systems, which can coordinate resources and fund improvements in areas such as electronic medical records. In addition to moves by metro systems such as Allina Hospitals and Clinics and Fairview Health Services to acquire smaller practices, large regional systems such as Mayo Health System in Rochester and Sanford Health in Sioux Falls have moved to bring community hospitals and clinics into their collective brands. HealthPartners for its part has an established presence in eastern Minnesota and owns a hospital in Hudson, Wis.

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CAPSULES to page 6

JANUARY 2011

MINNESOTA PHYSICIAN

CAPSULES

Capsules from page 5 Officials say the two groups will finalize details of the affiliation over the next few months. A final agreement is expected in April.

Dayton Confirms He Will Proceed with Medicaid Expansion With the resolution of the race for governor, Minnesota health groups will see one of their major goals accomplished, as Gov.-elect Mark Dayton has confirmed he will participate in a Medicaid expansion plan to replace the state’s floundering General Assistance Medical Care (GAMC) program. Although some health care providers praised the revamped GAMC for its care management approach and two of the hospitals in the program recently announced they would begin accepting GAMC patients again, the program was seen by many as an underfunded stopgap measure. Only four metro-area hospitals participated in the new

GAMC system, and funding issues were an ongoing problem for the program, which serves an impoverished and often chronically ill population. The Medicaid expansion will allow the state to receive $1.1 billion in federal funds as part of the Affordable Care Act (ACA), to be matched with state Medicaid dollars. Approximately 35,000 Minnesotans now on GAMC and MinnesotaCare will be shifted to the Medicaid program under the expansion plan. Health groups such as the Minnesota Medical Association expressed relief at Dayton’s Dec. 8 announcement. However, questions still remain about how quickly the new expansion can take place. Dayton has criticized Pawlenty administration officials for saying the transition could take as long as nine months.

UCare Pays $2 Million In P4P Rewards Minneapolis-based UCare gave more than $2 million to clinics and care systems as part of its

Pay for Performance (P4P) program based on results in 2009. The program recognizes providers for meeting measurement standards or improving results from previous years in care delivered to members of public health care programs such as Prepaid Medical Assistance or Medicare Advantage plans. “We are pleased to recognize our providers for their performance,” says Russ Kuzel, MD, chief medical officer for UCare. “The improvement in the measures benefits our members through better preventive care and monitoring of their chronic conditions.” Officials note that the UCare P4P approach rewards providers of all sizes in measurement areas including immunizations, diabetes care, health screenings, and cardiovascular disease care. In all, 920 care systems and independent clinics split $2.16 million in P4P payments from UCare for 2009. For the first time in several years, UCare’s 2009 P4P payments were less than the payments from the previous year.

For 2008, UCare distributed $2.44 million in P4P payments, and the health plan set aside approximately the same amount for the program in 2009. However, the $2.16 million in payments for 2009 was well short of that. UCare officials say they are satisfied with the results of the program. “Every year UCare allocates funds based on the number of members who need the preventive care and chronic condition management services we measure in our program,” Kuzel says. “We measure the delivery and quality of these important services, which the participating clinics and care systems of all sizes are providing. The actual payout figure reflects the demand and provision of those services, which benefit the health of our members—and that’s our goal. We’re quite pleased with the program’s performance in 2009.”

Upcoming CME Courses www.cmecourses.umn.edu Office of Continuing Medical Education • 612-626-7600 or 1-800-776-8636 • email: cme@umn.edu

UP-COMING 2011 Bariatric Education2011 Day 2010 CME COURSES UP-COMING May 25-26, 2011 Internal Medicine Review and COURSES COURSES Update Symposium 2010 WORLD 2011 November – 12, 2010for “Organizing10Research

Lysosomal Diseases”in Emerging Infections February 16 – 18, 2011 Clinical Practice and Public (Las Vegas, Nevada)Infections Health: Emerging and Emerging Vectors

WORLD Symposium Workshops in Clinical 2011 “Organizing Research for Hypnosis Lysosomal Diseases” June 2-4, 2011 February 16 – 18, 2011

(Las Vegas, Nevada) in Topics and Advances Pediatrics Cardiac Arrhythmias: An InterJune 9-10, 2011

Cardiac Arrhythmias: An November 19, 2010 active Update for Primary Care Interactive Update for March 25, 2011 Primary Care Geriatric Orthopaedic Fracture Global Health Training August 1 – 26, 2011 Conference 2010 March 25, 2011 Bridging the Transition to December 2 – 3, 2010

Lillehei Cardiology 4th Annual Bakken Symposium Symposium 2010 – Heart Failure April 18-19, 2011 December 6 – 7, 2010

Life after Cancer Treatment Cancer Survivorship Conference April 29 – 30, 2011 Family Medicine Update May 16 – 18, 2011 Global Health Training August 1 – 26, 2011

MINNESOTA PHYSICIAN

JANUARY 2011

ON-LINECOURSES COURSES ON-LINE CME ON-LINE courses available ON-LINE Courses available for for CME Credit. VisitCME CMEwebsite website CME Credit. Visit atatwww.cme.umn.edu. www.cme.umn.edu. FetalAlcohol Alcohol spectrum Disorders ••Fetal spectrum Disorders (FASD) (FASD) • Reducing Recurrent Preterm Birth • Reducing Recurrent Preterm Birth • ECG of the Week • ECG of the Week • The Reality of: Pathways to • The Reality of: Pathways to Diagnosis, Therapy, and Quality Diagnosis, Therapy, and Quality of Life of Life • Adult Congenital Heart Disease • Adult Congenital Heart Disease Allcourses coursesare areheld heldininthe the Twin All Twin Cities Cities noted unless noted unless

MEDICUS

Aaron Friedman, MD, takes over this month as dean of the University of Minnesota Medical School. He replaces Frank Cerra, MD, who has been the medical school dean for more than 20 years and announced his retirement in 2010. Friedman has been the RubenBentson Chair and a professor of pediatrics in the medical school, where he has served since arriving at the university in 2008. Before coming to the U of M, he was chair of the departments of pediatrics at Brown Medical School in Providence, R.I., and at the University of Wisconsin–Madison. Friedman also is pediatrician-in-chief at the University of Minnesota Amplatz Children’s Hospital. Integrity Health Network in Duluth has announced the appointment of two new medical directors. David C. McKee, MD, will serve as medical director of specialty care, and David D. Luehr, MD, will serve as medical director of primary care. Luehr also will be IHN’s chief medical officer. A family practice David C. McKee, MD physician at Raiter Clinic in Cloquet for 32 years, Luehr also has been chairman of the Quality in Medicine committee for the Minnesota Medical Association and was David D. Luehr, MD that association’s president. He is a graduate of the University of Minnesota Medical School. McKee, a neurologist at Northland Neurology and Myology in Duluth, is in his 18th year of practice. He is a graduate of the University of Wisconsin–Madison School of Medicine. Radiologists Daniel Thompson, MD, and Mark Bechtel, MD, have joined Suburban Radiologic Consultants. Thompson received his medical degree from the University of Minnesota and specializes in interventional radiology. He will practice at Suburban Imaging North, the Daniel Thompson, MD Mercy Vascular Center at Mercy Hospital, Unity Hospital, and Rice Memorial Hospital. Bechtel received his medical degree from the University of Washington and completed a diagnostic radiology residency Mark Bechtel, MD at the University of Wisconsin Hospitals and Clinics at Madison. He has subspecialty fellowship training in musculoskeletal radiology at Penn State Milton Hershey Medical Center in Hershey, Pa. He will practice at Suburban Imaging South and Fairview Hospitals, primarily Fairview Northland. Kyle A. Menzel, MD, has joined the team of surgeons at Orthopaedic Associates of Duluth. Menzel graduated from the U.S. Naval Academy and the Medical College of Wisconsin, in Milwaukee. He completed his residency in orthopedic surgery at the Naval Medical Center in San Diego and served in the Navy as an orthopedic surgeon and naval flight surgeon. Menzel is a board-certified orthopedic surgeon and recently served as the head of Orthopaedics and Podiatry at the Naval Health Clinic in Great Lakes, Ill. His specialties include sports medicine; hip arthroscopy; arthroscopic surgery and reconstruction of the shoulder, knee and ankle; general orthopedics; joint replacement; and fracture care. April Grudell, MD, has joined Minnesota Gastroenterology. She completed her residency and GI research fellowship training at Mayo Clinic in Rochester. Subsequently, Grudell completed a clinical gastroenterology/hepatology fellowship at the University of Michigan in Ann Arbor. She has a special interest in functional bowel disease and in motility disorders, including gastroparesis, post-vagotomy dysmotility, and chronic constipation. She sees outpatients at the practice’s Coon Rapids office and is on staff at United Hospital.

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JANUARY 2011

MINNESOTA PHYSICIAN

INTERVIEW

Genome research speaks to medical mysteries ■ Tell us about the increasing role of molecular

genetics in developing new pharmaceutical products.

Kim Stutzman-Engwall, PhD Pfizer Kim Stutzman-Engwall, PhD, is an associate research fellow at Pfizer’s Neurosciences Research Unit in Groton, Conn. Stutzman-Engwall is a top researcher for Pfizer in the area of molecular biology. She is a graduate of Iowa State University with post-doctoral work at the University of Wisconsin–Madison. Stutzman-Engwall is also active in educational efforts, and represents Pfizer as a science ambassador. She recently spoke at the Girls in Science event at the Science Museum of Minnesota in St. Paul.

Molecular genetics is a very broad area. What I think is interesting is the recent sequencing of the human genome. There’s a lot of promise in what we are going to be able to learn from getting the complete human genome sequence. We have learned that it is much more complicated than we ever thought it was going to be. We are using genetics and molecular genetics right now to try to figure out what diseases and what pathways are involved in different disease states. There are a few diseases that are one gene/one gene mutation and we have a disease phenotype. But the majority of diseases are a series of multiple defects and in trying to tease those out we are using molecular techniques to study various steps in the pathway.

■ How many people are on a team?

It can vary. Teams can be as small as four to five people. Once a compound is ready to start human clinical trials, the teams will be at 30–40 people. The teams are very dynamic; people come in as their expertise is needed, and then leave the team. In some ways it is a little frustrating because it takes so long to develop the medicine. We’re talking 11 to 15 years. We have a lot of patience. ■ I imagine there are cases

■ What are you personally

working on?

Think of a prescription pharmaceutical as a key and a gene defect as a lock.

Currently my laboratory is working on expressing proteins or targets that we are interested in studying. I like to think of it as a key and lock mechanism. Think of a prescription pharmaceutical as a key and a gene defect as a lock. One of the things we are trying to do is identify keys that fit into particular locks. In order to study those locks, a lot of times we have to express large quantities of them. That is one of the things my lab does: We figure out what the systematic sequence of the lock is and then express a lot of that lock. Then we can study different drugs to see how they interact with that particular lock. One of the problems is that if you think of a prescription or a pharmaceutical as a key, those keys can open a lot of different locks-—and that is what gives the secondary effects or side effects. In the neuroscience department we are studying diseases that have unmet medical need right now. One of those is Alzheimer’s disease. We also have a group that is working on autism, trying to figure out what some of the causes of autism are, and how we can develop pharmaceuticals to treat kids that develop autism symptoms. ■ Tell us about the working relationships between

physicians and researchers in the process of developing new drugs. Anytime we have a particular target or an unmet indication that we are working on, we have teams at Pfizer that work together on all aspects of the drug development. Those teams always have physicians and researchers who work together. The physicians are critical for helping decide how we are going to run the clinical studies.

What Pfizer is doing right now, and I think is a great idea, is we have started moving that interaction back even earlier in the discovery process. Now, once we identify a compound that we are going to start working on, we have physicians involved even earlier to make sure that we are looking at the right target and that we are approaching it in the best way as an unmet medical need.

MINNESOTA PHYSICIAN JANUARY 2011

where the drug does not work out as planned.

Yes, for every project we test millions of compounds. It is like a funnel, we start out with millions and it narrows down. Eventually we get down to one or two compounds that we will take into preclinical species for safety studying. We are always looking at efficacy to make sure it is working in the way that we hope and think it is working. We are also always looking at safety testing. We are trying to push the safety testing earlier and earlier in the development so that we can learn what issues the compound is going to have.

■ What are some of the most promising new

therapies you’re seeing today? We have done a pretty good job of treating heart disease. That used to be the major thing that people were dying from. That is decreasing significantly, and people are living longer. What we are seeing now is that other diseases like cancer, diabetes, and Alzheimer’s are going to play a more significant role. These are really unmet medical needs. The sequencing of the human genome taught us that in some ways we are not as complicated as we thought, and in other ways we are way more complicated than we thought. We originally thought there were probably going to be 100,000 genes that humans had. It turns out that we have 20,000-30,000 just like everyone else—just like mice, just like nematodes, just like a million other species. So those genes are regulated by something called RNAi. This is turning out to be what I think is a really, really interesting area of research. Once we have a better understanding of how RNAi is helping regulate gene expression, we will have a way forward into finding new kinds of medicines.

■ Often when a new drug comes into the

market it is accompanied by significant research proving its efficacy and yet it does not become widely adopted by prescribing physicians. What are some of the dynamics behind this? We do see that. A lot of times it has to do with physicians needing to prescribe within a certain formulary, not being able to go outside the formulary without having the patient incur significant cost. That is an issue. A lot of times there are different medications that will treat the same indications. In my own personal experience, I get migraine headaches, and I have found that some of the triptans work well for me, and some don’t work well. I think it is important that the individual patient in combination with their physician be able to figure out which particular medication works best for them, but it takes a little bit of trial and error to do that. ■ Has the health care reform law had any

effect on research? It is pretty early to tell that right now. We are still trying to figure out what all is in the bill and how this is going to impact us down the road. Personally, I don’t see any impact for my research. Again, it is so early in the process that it is not going to change the targets that we are focusing on. We are

focusing on Alzheimer’s, schizophrenia, and autism—these will be things we will continue to work on, because they are such unmet medical needs. There has been some more funding that has gone into basic research from the federal government. There are a number of grants that have become available for more basic research at universities. Pfizer is also part of a consortium with the Michael J. Fox Foundation for Parkinson’s Research, another unmet medical need. We are working very closely with this foundation to work on understanding what is happening with Parkinson’s and to come up with some medicines. It has gotten more funding from the government. ■ What can you tell us about the FDA

approval process and how it affects the ability to get new drugs into the market? The FDA approval process is evolving; it does not stay static. Pfizer tries to think like the FDA and to understand what the FDA is looking for when we submit a new drug application. The process is very long. As I said, it takes 11 to 15 years to take an idea to a marketed pharmaceutical. A lot of what we do during that time are safety studies. And we continue to study medicines once they are approved. There are always safety studies continuing once a compound is approved by the FDA. The FDA

has established a number of rules and regulations in how adverse effects are reported. We are very aware of what the rules are and we report those. ■ If you could wave a magic wand to

address the problem of why drugs cost so much, what would you do? I am going to take a different tack on that question. My personal feeling is that I don’t think drugs actually cost that much relative to total cost of medical treatment. We have some really interesting data that shows over the course of the past 45 years pharmaceuticals have been between 10 percent and 12 percent of the total health care dollars. The latest data from 2008 show that they are still in that 10 percent range. Now, everything has gone up; as a proportion, though, it is still the same. When I hear, “Why do drugs cost so much?”, I think we have not done a very good job of looking at what costs have been eliminated, because we have drugs like the statins that have taken LDL levels to pretty remarkable numbers and cut the number of heart attacks. So those patients are no longer being admitted for emergency room services, having bypass surgeries, having heart attacks. It is really difficult to figure out what those costs are that are not happening.

Supporting Our Patients. Supporting Our Partners. SupportingYou. In 2008, Tanzanian missionaries brought little Zawadi Rajabu to the U.S. to seek treatment for her two severely clubbed feet. A physician referred Zawadi to Dr. Mark T. Dahl of St. Croix Orthopaedics. Using the Ilizarov Method, Dr. Dahl surgically changed the course of Zawadi’s feet and her life. Dr. David Palmer and Russ McGill, OPA-C, recently traveled to Tanzania on another of their frequent medical missionary trips. They dedicated an entire day to checking in on their partner’s patient. To their delight, they were greeted by 6-year-old Zawadi her face aglow, her healed feet dancing toward them.

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MINNESOTA PHYSICIAN

Accountable from cover Establishing the Prepaid Medical Assistance Program

In 1992, with the creation of MinnesotaCare (MNCare, a publicly subsidized program for Minnesota residents who do not have access to affordable health care coverage), the state bundled together a number of statefunded health care programs, including Medical Assistance (Minnesota’s Medicaid program), MinnesotaCare, the now-defunct GAMC, worker’s compensation, and the health care program for state employees. With this bundling they created Rule 101, a requirement that to participate in any of these programs, providers would be required to participate in all of them. This was done to leverage the betterpaying programs (such as worker’s comp and state employees’ health care) against the poorly paid programs (such as MN Care and GMAC) so that, on average, both access to pro-viders and adequacy of provider reimbursement would be guaranteed. Although no data were available to justify the decision,

in 1995 the managed care Medicaid pilot became a permanent program, called the Prepaid Medical Assistance Program (PMAP). With the outsourcing of the program on a permanent basis, the state also outsourced the Rule 101 bundled contractual leverage to the HMOs to compel provider participation. This significant economic weapon has been in the hands of PMAP HMO vendors, unchecked for many years now, and there is no real way of knowing if it is being used solely for the benefit of the state or for the economic advantage of the HMOs themselves. The prepaid medical assistance program is an incredibly good deal for HMOs. They are compensated for any and all administrative expenses. There is no definition of what constitutes “reasonable” or “appropriate” administrative expense. The HMOs are guaranteed, by virtue of their contracts with the state, a minimum profit (approximately 2 percent), but there is no limit on maximum profitability or expense recovery.

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MINNESOTA PHYSICIAN JANUARY 2011

A common misconception regarding this program is that because HMOs receive capitated payments, they are assuming some sort of insurance or managed care risk in this scenario. In fact, the HMOs hold virtually no risk. The Minnesota Department of Human Services (DHS) creates rates based on the health plans’ total expenses and expenditures. Their actual experience for the prior year becomes the justification for certifying the so-called capitated rates in the subsequent year. Because there is no competition and all HMOs are permitted to participate as PMAP vendors, the only real risk to the HMOs is that the state of Minnesota will cease to exist before they can recover all their expenses and costs in the subsequent year—a risk that is remote at best. And each year the HMOs receive increases to the contractual price for reasons that are less than apparent. Just in case all of these arrangements aren’t adequately tilted in favor of the plans, if health plan spending is higher than projected, DHS will make retrospective payment adjustments. Apparently DHS certifies these rates for federal match after they have already been implemented. Let’s be clear: This is a very, very good deal for the HMOs. Lack of transparency, accountability

Part of the unspoken justification for this system is the notion that the state is able to draw down more federally matched Medicaid dollars because of this unintelligible rate-setting process. In fact, some would argue that this extra federal match helps prop up state programs that do not qualify for federal matching funds (e.g., MNCare and GMAC), thus accomplishing some sort of Robin Hood effect by taking from the rich feds and giving to the poor state. The fallacy here is twofold. First, Minnesota taxpayers—and in particular, providers, who pay extra taxes to the Health Care Access Fund (the tax levied on doctors, dentists, and other health care providers to help pay premiums to the state-

subsidized health care plan for low-income Minnesotans), have no way of knowing where the money actually goes. Second, at what cost to the integrity of the system and the sustainability of health care providers is this result being achieved? What if the state is getting an extra $5 by allowing the health plan brokers (HMOs) to charge us a 20 percent commission? Shouldn’t we know these things? The lack of transparency in our PMAP program causes other problems as well. It is impossible to determine who is being paid for what and whether or not there is any economic or quality justification for differential or disparate payments. How can the state meet any established medical loss ratio without this data? How would it ever be able to enforce MN Statute 62D.12 sub.9, which requires that health plans spend money in a logical and fair fashion? And finally, why on Earth would we allow vendors receiving public money to be exempt from all bookkeeping requirements? The HMOs argue that their conduct is a trade secret that must be maintained to protect their competitive advantage. However, the PMAP program requires no competition—any and all vendors may participate. Even if one were naive enough to believe the argument for protection of competitive advantage, it has no application in a system where any willing HMO is allowed to participate. Legislative action (and inaction)

During the 2010 Legislature, these issues were brought to the attention of legislators, resulting in the introduction of SF2986 and its House companion HF3663. The proposed legislation would have required HMOs to keep books using generally accepted principles of accounting and to make those books available for audit. The legislation also would have required the HMOs to meet a medical loss ratio (MLR) of 93.5 percent for public programs. (This would have required HMOs to pay the state a refund if they spent too much on administrative overhead or profited too

greatly from their administration of these public programs.) Though this MLR percentage may seem high, in fact it was selected because it is the percentage that the health insurers have said they are meeting in their publicly funded programs. The HMOs nevertheless protested the proposed MLR during legislative hearings. These legislative proposals were defeated, but only after significant debate and some unusual arguments and testimony from the Minnesota Department of Human Services. DHS put forth the notion that any failure to pay HMOs for any and all of their expenses would violate established principles of actuarial soundness. A DHS official stated: â&#x20AC;&#x153;â&#x20AC;Ś we already have rates that are certified. If we reduce the rates below an amount that would cover administrative and claims costs, the rates would not be actuarially sound.â&#x20AC;? â&#x20AC;&#x153;The requirement for us is that we cover administrative costs and claims costs and obligations under contract and that we permit plans to take necessary actions that they may need to insure that their costs are covered.â&#x20AC;? (Karen Peed, director, Managed Care and Payment Policy, Minnesota Department of Human Services, May 11, 2010) These arguments were so forcefully presented that the Legislature not only defeated the legislative proposals, but also passed an amendment to MN Statute 256b.69 adding language statutorily legitimizing rates paid to managed care plans. The amendment stated that in order to justify federal matching dollars, PMAP vendors would have to â&#x20AC;&#x153;â&#x20AC;Ś be certified as meeting the requirements of federal regulations by actuaries who follow the practice standards established by the American Academy of Actuaries and follow the practice standards established by the Actuarial Standards Board.â&#x20AC;? Legislators and other interested parties were assured that this statutory change would provide comfort and security, and

that all was well and being properly administered in our public programs. Despite these assurances, some health care providers expressed concern that the standards proposed for incorporation into MN Statute in fact did not exist. Their concerns went unanswered. On Aug. 4, 2010, the U.S. Government Accountability Office (GAO) issued a report to Congressional committees (GAO-10-810). The report, Medicaid Managed Care: CMSâ&#x20AC;&#x2122;s Oversight of Statesâ&#x20AC;&#x2122; Rate Setting Needs Improvement, was critical of CMSâ&#x20AC;&#x2122;s oversight of state ratesetting; but most notably, the report stated: â&#x20AC;&#x153;â&#x20AC;Ś There is no Actuarial Standard of Practice (ASOP) that applies to actuarial work performed to comply with CMSâ&#x20AC;&#x2122;s regulations.â&#x20AC;? In addition, the GAO report noted that in 2005 the American Academy of Actuaries had issued â&#x20AC;&#x153;nonbinding guidanceâ&#x20AC;? for setting standards. The report recommended that â&#x20AC;&#x153;â&#x20AC;Ś rates do not have to encompass all possible costs that any health plan might incur.â&#x20AC;? The view of the American Academy of Actuaries is contrary to Minnesota Department of Human Services and health plan practices. Thus we must face the reality that our convoluted, secretive, and dysfunctional PMAP payment systemâ&#x20AC;&#x201D; and, indeed, all of the publicly funded programsâ&#x20AC;&#x201D;are based on assertions that appear to be untrue and requirements that are nonexistent. What now?

This leaves us with several very important questions. First, some trade and professional groups have committed to continue working with HMOs and the Department of Human Services to find â&#x20AC;&#x153;common groundâ&#x20AC;? regarding transparency and accountability issues in Minnesotaâ&#x20AC;&#x2122;s publicly funded health care programs. What is the common ground between misrepresentation and honesty? Second, what needs to be done in the 2011 Legislature? The answer to the first question I leave to the reader. In regard to the second question, I recommend greater accountabil-

ity, transparency, and efficiency in PMAP, to be attained through the following solutions: â&#x20AC;˘ The state must have information. The Legislature should make it explicitly clear that Minnesotaâ&#x20AC;&#x2122;s Data Practices Act applies to PMAP vendors. With appropriate HIPAA protections, but without allowing trade-secret protection, the state must know where its Medicaid dollars are spent. â&#x20AC;˘ Minnesota should require PMAP vendors to maintain segregated accounts for public programs if HMOs believe their payment methodologies are trade secrets. â&#x20AC;˘ Minnesota should establish medical loss ratios for public programs. Current loss ratios apply only to commercial business. â&#x20AC;˘ There must be a meaningful audit mechanism available to the state and the public to guarantee accountability of PMAP vendors. â&#x20AC;˘ If the state wants to promote new alternatives in health care delivery, it must mandate the

assignment of insurance contract benefits. In other words, if a health insurance policy provides for out-of-network coverage, that benefit must be assignable. â&#x20AC;˘ Minnesota must change its anti-trust laws to prohibit conduct tantamount to bid manipulation among PMAP vendors. We must now confront a critically important issue: What if one of the largest cost drivers in our health care system is the HMOs? What if they are overpaid and largely unnecessary brokers connecting very willing sellers with desperate purchasers? Wouldnâ&#x20AC;&#x2122;t we want to know whether or not this was in fact true? If we fail to demand data regarding our tax-funded programs and neglect to answer these questions, then we deserve our current system and forfeit any right to complain. David Feinwachs, JD, PhD, served for 30 years as legal counsel to the Minnesota Hospital Association. He teaches courses in health law and policy at the University of Minnesota.

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MINNESOTA PHYSICIAN

Sea change from cover health care delivery system, will play out during the 2011 legislative session. November elections bring massive change

Historically, midterm elections bring some new life to minority parties, but not even the boldest political pundit could have predicted the sizable sea change that November’s election brought to Minnesota. Former U.S. Sen. Mark Dayton enters a governor’s office that hasn’t been in DFL hands for more than 20 years. Republicans hold the majority in the state Senate for the first time in 40 years, and House Republicans have regained the majority they lost four years ago. In total, 60 new legislators will fill the halls of the Capitol—an unprecedented number in any election year. Without question, the new majorities will have a steep hill to climb as new legislators try to get up to speed on a vast number of issues. The Republican leadership teams

took shape shortly after the November elections. House Republicans elected Rep. Kurt Zellers (Maple Grove) speaker of the House and Rep. Matt Dean (Dellwood) as their majority leader. Dean brings with him a significant health care background, having served as the ranking minority member of the House Health and Human Services Budget Division and having played a key role in the General Assistance Medical Care discussions during the 2010 session. Senate Republicans elected Sen. Michelle Fischbach (Paynesville) president of the Senate and Sen. Amy Koch (Buffalo) as the new Senate majority leader. In addition to the leadership posts, the House and Senate have laid out their committee structures and appointed chairpersons. Rep. Jim Abeler (R-Anoka) and Rep. Steve Gottwalt (R-St. Cloud) will chair the Health and Human Services Finance Committee and Reform Committee, respectively, in the House, while Sen. David Hann (R-Eden Prairie)

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chairs the combined Health and Human Services Budget and Policy Committee in the Senate. Democrats also elected new leadership, with Rep. Paul Thissen (Richfield) serving as minority leader in the House and Sen. Thomas Bakk (Cook) taking on that role in the Senate. The sea change at the voting booth in November also brought a DFL governor back to the Capitol for the first time in two decades. Now that the recount dust has settled, Gov. Mark Dayton faces an uphill climb as he puts together his administration and prepares for the release of the February budget forecast. Dayton is charged with making the first move in the budget game when he puts together his budget recommendations to tackle the $6.2 billion deficit. Although the recommendations are unlikely to gain much traction among the Republican majorities, they will lay the groundwork for the governor’s positioning in what will probably be protracted budget negotiations. Dayton was often short on specific health care policies throughout his campaign, but he did lay out some specifics on his plans for balancing the state’s budget. Dayton’s boldest play likely will take the form of a proposed income tax increase on the state’s high wage earners. With many people viewing an income tax increase as a nonstarter at the Legislature, others, particularly those in the health care arena, have expressed a desire to put revenue on the table through an increase in the price of tobacco. Of potentially greater interest to many health care providers throughout the state is the future of the provider tax. An increase in the provider tax remains unlikely in the current session. The more likely scenario is a gradual reduction in the tax rate as the need for a consistent revenue stream in the Health Care Access Fund diminishes following implementation of the Accountable Care Act. This will be an interesting point of discussion even among Republican legislators, who have not hidden their disdain

for much of the federal health reform bill. Medical Assistance and the budget deficit

Eleven days into the new legislative session, the first major budget decision will be made as the new governor, not the Legislature, has the option to take more than $1 billion in federal monies for an expanded Medical Assistance (Medicaid) program, taking a significant chunk out of the budget deficit. This option for the incoming governor harks back to the end of the 2010 legislative session. As part of the final budget negotiation, the state share of the expanded MA program was paid for, but only the new governor had the option to accept the federal matching funds (which Gov. Tim Pawlenty had rejected). An expanded MA program not only affects the state’s budget but would come as a welcome alternative to the Coordinated Care Delivery System passed in the 2010 legislative session. Under that system, four Twin Cities metroarea hospitals are delivering care to Medicaid beneficiaries. Critics cite issues of payment for care delivery and difficult access to care for rural patients as major problems with the system. Following the decision to expand the Medical Assistance program, attention will shift to how significant a role the health care budget will play in proposed solutions to the $6.2 billion deficit. However, the new Republican-controlled Legislature generates a number of uncertainties, particularly as to potential cuts in the Health and Human Services (HHS) budget. Abeler, the new chair of the House Health and Human Services Finance Committee, gave some indication of where the HHS budget priorities may fall when he declared, “There will be a decided shift to more market-based systems and less emphasis on governor-run/centralized programming.” Abeler sees this as a welcome opportunity for providers and patients alike. If history is any predictor of future performance, expect both House and Senate

Republicans to focus on potential reforms or cuts to the MinnesotaCare program. In recent years, both House Republicans and Pawlenty had proposed a reduction in eligibility under MinnesotaCare for single adults as a means to generate savings in the health care budget. Proposals of this nature could surface during the upcoming legislative session as Republicans attempt to piece together a Health and Human Services budget based largely on cuts. The difficulty of accomplishing this is not lost on Abeler, who noted that “overlaying this is a record deficit that will challenge even the most resolute reformers.” Many physicians throughout the state are anxious to see whether the recent trend in cutting public program reimbursement will continue even under new leadership. Following a total cut of almost 15 percent to Medical Assistance reimbursement over the past two legislative sessions, physicians are beginning to question the sustainability of participating in

the state’s public health care programs. The recent cuts at the state level, in combination with the continuing crisis in Medicare reimbursement, have left Minnesota physicians, particularly those in outstate areas, wondering if they can continue to keep their doors open. An incoming class of new legislative leaders provides a great opportunity for physicians to turn the tide on reimbursement and educate new legislators about the effects of continuing down the current path. Other health care issues on the table

Although posturing on the budget will likely consume the last couple of months of the legislative session, expect to see increased attention to certain initiatives passed as part of the federal Accountable Care Act. Party politics could come to a head at the Capitol on this issue. According to Abeler, “There is a decided lack of enthusiasm for the federal health reforms on the part of the new leadership cadre.” This

lack of enthusiasm opposite a Dayton administration looking to leverage federal resources could result in considerable tension, particularly on the issues of reforming health care delivery and implementing health insurance exchanges. Other health care issues that could surface during the 2011 legislative session include possible reforms in the no-fault auto insurance system, efforts to reform the medical malpractice arena, and further efforts to reform the workers’ compensation system. Whether any of these efforts ultimately succeed likely will depend on the breadth of the potential changes and their projected fiscal im-pact. These are just some of the many initiatives that physicians and clinics need to watch in the upcoming legislative session as legislators struggle to govern in a deficit year.

best way to ensure that your practice’s or clinic’s opinion is heard is to reach out to your state senator or state representative. The state’s website at www.leg.state.mn.us lists contact information for all members of the Minnesota House and Senate and provides up-todate information on legislation, as well as descriptions of all bills introduced during the legislative session. You can call Senate Information at 651-296-0504 or House Information at 651-296-2146 for more information. Contact information for the governor’s office can be obtained through www.governor.state.mn.us. H. Theodore Grindal, JD, and Nate Mussell, JD, are with the Minneapolis law firm of Lockridge Grindal Nauen PLLP. They provide government relations services for health care providers.

What can my practice do?

The budget will dominate the landscape at the Capitol and significantly affect health care discussions and decisions. The

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RESEARCH

erpes zoster (HZ), or shingles, is a viral disease that has become potentially vaccine-preventable since the herpes zoster vaccine (Zostavax) for adults became available in 2006. The Food and Drug Administration recommends the vaccine for people age 60 and older who previously had chickenpox. Yet the use of the vaccine remains limited, due, at least in part, to several factors. • Vaccine shortages, which have now been solved, slowed marketing aimed at raising the public’s awareness for the vaccine and frustrated clinics that could not obtain any vaccine for their patients. • The vaccination is expensive; it costs more than $300 in most settings. For most adult and all children’s vaccinations, insurance companies usually pay first-dollar. While many insurance companies do pay for the Zostavax with little or no copay, beginning at age 65 most adults are currently covered by Medicare insurance, which does not assure firstdollar coverage for Zostavax.

Shingles vaccination: worth a second look Seeking a better understanding of HZ recurrence, complications By Barbara P. Yawn, MD, MSc

• Medicare rules cover Zostavax under part D rules. This means that to receive the vaccination in a doctor’s office, patients need to pay for it and be reimbursed by their insurance company, which can be very slow (and sometimes never occurs). Many seniors cannot afford to pay out of pocket and then wait for reimbursement. Pharmacies can determine insurance coverage immediately, but they may not be the appropriate site for this adult immunization. • The medical and patient communities often have an incomplete understanding of the burden of herpes zoster. Many people consider HZ to be a

Rugs of Distinction

once-in-a-lifetime experience, with recurrences limited to immune-compromised individuals, and therefore consider the varicella vaccine to be unnecessary. The plausibility, actual occurrence, and frequency of recurrent HZ have been debated for years, and most recurrence studies have been done in special populations with malignancies or exposure to chemotherapeutic or immunotoxic agents such as arsenic. In addition, most studies have used only administrative data, with community population-based studies dating back to the 1950s and 1970s. These 40- to 60-year-old studies needed to be updated

and accompanied by large studies of HZ recurrences. The best way to decide who should be vaccinated is by gaining a better understanding about the true impact of the virus. In 2007, our research group undertook a population-based study of HZ occurrences and recurrences over a 20-year period, using information from all health care facilities in Olmsted County, Minnesota. The goal of the study was to establish accurate, up-to-date data about the impact and incidence of shingles in the United States before the vaccine was introduced. Study results

A total of 1,669 confirmed incident cases of HZ were identified from Jan. 1, 1996, through Dec. 31, 2001, among Olmsted County residents 22 years of age or older. [Each case was confirmed by review of medical records and required a typical dermatomal rash and pain or dysesthesias.] Sixty percent (1005) of HZ cases were in women and 86 percent in known Caucasians.

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The mean age at HZ diagnosis was 59.4 years (range 22â&#x20AC;&#x201C;100 years), with 49 percent (817) of cases in individuals 60 or older, and 68 percent (1,131) in individuals 50 or older. Only 8 percent of the HZ cases (139/1,669) occurred in immune-compromised individuals, with little variation across the age span. The 1,669 HZ cases represented an incidence rate of 3.4 per 1,000 person-years in Olmsted County adults and 3.6 per 1,000 person-years (3.4 to 3.7 per 1,000 person-years, with 95 percent CI) when adjusted to the U.S. population. The ageadjusted, sex-specific rates extrapolated to the U.S. population are higher in men than in women (3.9 vs. 3.2 per 1,000 person-years, respectively, for women and men, p<0.0001) and increase with age. The largest percentage of HZ cases occurred in people 50 to 59 years of age. Pain was the most commonly documented symptom, resulting in more than 65 percent of the HZ patients receiving a prescription for a pain medication in the first week after HZ diag-

nosis and many others receiving documented advice to take overthe-counter pain medications. Pain for at least 30 days was identified in 18 percent of cases (n=302); pain for 60 days or greater in 13 percent of cases (n=213); and pain for 90 days or longer in 10 percent of cases (n=171). Complications other than pain for 30 or more days included 175 complications among 159 HZ cases (10 percent of HZ cases). The most common non-pain complications were ocular complications (4 percent), neurological complications (Ramsay Hunt syndrome, Bellâ&#x20AC;&#x2122;s-like palsy, and other motor nerve palsies) (3 percent), and skin superinfections (2 percent). The incidence rate showed a temporal increase, from 3.2 (2.9â&#x20AC;&#x201C;3.5) in 1996â&#x20AC;&#x201C;1997 to 4.1 (3.8â&#x20AC;&#x201C;4.4) in 2000â&#x20AC;&#x201C;2001 (adjusted rates per 1000 person-years, with 95 percent CI). Extrapolated to the entire 2005 U.S. population, the 2000â&#x20AC;&#x201C;2001 incidence rate from Olmsted County translates into nearly one million new HZ cases every year.

Following those 1,669 cases forward until 2008 revealed a total of 105 HZ recurrences from the medical records of 95 individuals, including six people with two recurrences and two people with three recurrences. This is a recurrence rate of 6.2 percent by eight years post-original HZ episode. Recurrences were more common among women than among men: 67 of 1005 women (6.7 percent) had at least one recurrence, compared to 28 of 664 (4.2 percent) men (p=0.03). The timing of the first HZ recurrences varied from 96 days to 10 years after the index episode. In 45 percent of the recurrences, the recurrence occurred in a different region of the body than the index episode. Only 15.8 percent of the people with recurrences (15/95) were among the 139 immunecompromised people in the initial incidence cohort (8 percent of the index cohort). Thus, more than 85 percent of recurrent cases occurred in individuals eligible to receive a live virus vaccine, such as the currently available zoster vaccine.

Analysis

Over an average of seven years of follow-up, HZ recurrences were as common as HZ incident occurrences in the studied population, when matching for age, sex, and immune status. Therefore, HZ is common, increasing in frequency of occurrences with high rates of recurrences in immune-competent adults. Zoster vaccine is recommended for prevention of incident cases of HZ and should be considered for people 50 to 59. Given the current high rate of HZ occurrence and high rates of complications, greater emphasis on effective and costeffective methods to immunize older patients against HZ seems appropriate. Our data also suggest that zoster vaccination may prevent HZ recurrences. Studies will be required to determine the value of vaccination in preventing HZ recurrence, but the number of recurrences appears to warrant such a strategy. Barbara P. Yawn, MD, MSc, is director of research at Olmsted Medical Center, Rochester, Minn.

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PRACTICE

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istorically, medical records have been in a paper format, but recent years have seen more and more clinicians moving to an electronic health record (EHR; sometimes referred to as electronic medical record, or EMR). Since there is no doubt that the EHR will be the standard going forward, it is crucial that physician practices use these great tools to their best advantage. An EHR can often solve many problems for a practice, but it can also bring with it a new set of problems. High on the list are unfortunate entries in the medical record, including this memorable one: “Patient is a 46-year-old woman with a soft and supple prostate.” Funny to read, maybe, but not so funny when one considers the importance of the medical record as part of quality health care. Attention to detail from the beginning stages of EHR implementation, as well as ongoing monitoring as physicians “go live” on the system, will go a long way toward alleviating some of the potential problems.

Genie in a bottle, or Pandora’s box? EHR lessons learned By Michael Reiling, Anne Smith, RN, CPC, CCS-P, CPMA, CPC-I, CEMC, CPEDC, and Steven Beck, JD First steps

Many physicians view the EHR as the proverbial “genie in the bottle” and think that all their coding and documentation problems will be solved once they have the new system in place. In fact, the EHR does not eliminate the need for good documentation. On the other hand, it can be very beneficial if used wisely. Involving the right staff from day one will help ensure that templates are built properly and formatting issues are dealt with before they become a bigger issue. Having a coder involved in the development of history templates might enable them to catch, for example, that no field for family history was included—before hundreds of

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claims are sent in with missing information that might be needed to support the code(s) billed. An initial decrease in the level of physician productivity is to be expected when implementing an EHR. This is often due in part to physicians having limited computer (or typing!) experience. The basics of using current technology can be a hurdle. Training—early and often— is the answer, along with available support when needed. Potential trouble spots

Not all EHRs are created equal, and ease of use varies—sometimes resulting in frustration for physicians. Here are a few common trouble spots. Data entry and screen views. Data entered may not always appear where the user thinks it will. We have seen notes where new data (e.g., a medication dosage adjustment made that day) is printed at the beginning of the note, but as part of the patient’s medication history—leaving the reviewer to wonder when the dosage adjustment was actually made. Other systems include a variety of different screen views, some of which may not include all of the documentation for the encounter. If a third-party payer is auditing and wants to check for adequate documentation for the billed services but does not select (or is not provided) the correct screen view, the results could be problematic. Having the right people involved during the design and implementation phase may help avoid these problems. Spot-checking to ensure EHR formats are appropriate is also recommended. Automatic populating of data fields. A potential issue with some EHRs is the automatic populating of various fields. While this feature can be a defi-

nite timesaver, it needs to be used wisely. For example, a common entry in the medical record is for the Review of Systems (ROS) portion of obtaining the patient’s history. If the physician has performed a complete ROS, it is acceptable for coding and billing purposes for the physician to specifically document pertinent positives and negatives along with a statement that the remainder of the complete ROS is negative. With the EHR, however, it is easy for the physician to click on “WNL” (within normal limits), resulting in the system automatically populating the ROS—even though a complete ROS may not have been done or may not have been appropriate based on the patient’s chief complaint. Another area of patient history where the EHR can streamline the process for the physician is Past, Family, and Social History (PFSH); but, again, users should exercise caution. Recently our firm conducted a review where several hospital admission notes included an entry that said, “Social history not on file.” That was likely a “default” field in the EHR. Since the admissions had been coded at higher levels, where social history is a required component, the services had to be downcoded. Sometimes the automatic populating of various fields results in “canned” statements that are not applicable to the patient’s age or gender—for example, “Patient does not smoke” (in the EHR for a 5-yearold) or “Psychiatric exam: patient shows good insight” (in the EHR for an infant). That type of documentation could result in an auditor questioning the integrity of the entire record. Focused training is necessary so that physicians understand how easily these types of issues can occur. It may not hurt to remind physicians that they “own” entries such as these, and it is in their best interest to be accurate. Contradictory, duplicative, or erroneous information. Contradictory information in the EHR is a common concern, often resulting from the physician not understanding how to

use the system correctly and allowing old information to be pulled forward that is no longer correct. For example: A patient presents with a chief complaint of shortness of breath, but the ROS documentation states, “Respiratory: negative”; or a patient presents for follow-up after having a head laceration sutured in the emergency room, but the exam documentation states, “Head normocephalic with no signs of trauma.” In both cases, the physician unintentionally “picked up” old information that appeared in the new entry. In addition to contradictory information, it is also common to find duplicative, erroneous, or just plain nonsensical entries in the EHR, often due to the physician not reviewing the note prior to signing. Excessive documentation. When reviewing EHR documentation, it is obvious that many notes are much more voluminous than was typically seen in paper records. This often occurs when a “carry forward” function is utilized, causing the patient’s entire history, or perhaps even a previous encounter’s documentation, to appear in a note. In such cases, it may be unclear what services were provided on which date. This also could be a potentially dangerous practice if the extensive documentation causes the visit to be coded at a higher level than is supported by medical necessity. In addition, physicians themselves often comment that they dislike having to weed through their colleagues’ excessive documentation to determine what is currently going on with the patient. This is often a training issue. Physicians should be alert to carrying forward only information that is “in sync” with the reason for the patient’s visit. If it is a common practice to carry information forward, vendors may be able to assist with tying correct dates to that information. More is not always better; sometimes it is just more. Legal issues. The law has not really adapted to the changes in medical recordkeeping that have emerged from

EHR technology over the last few years. Requirements for retention of records, provision of records to patients and payers, and the legal practices that have grown up around recordkeeping—physician signatures, how to make changes and modifications, and, more broadly, what the medical record means—all these are simply derived from the private law governing paper records. Many states have laws that restrict when a paper record may be stored electronically or on microfilm or fiche. These laws and rules are out of date, and it will be some time before the law adequately catches up. At the same time, HIPAA and related privacy and security laws have added another layer of legal complication to EHR management. In dealing with these rules in flux, practices should adopt some bedrock principles regarding their electronic health records systems: • The physician should think of medical documentation as being read by a number of different readers. Documentation should be done not just with a view to what other physicians or third-party payers will read, but what an outside regulator or jury might see in a note. • Medical record documentation should be as contemporaneous as possible with the actual work. Notes that are out of date, either preceding or succeeding the actual event, are less valuable. • In general, substantive changes in documentation should be done in a transparent manner, so that one can tell the time and date of the change, and find earlier documentation. • Security rules should be analogous to the rules for paper records. • Most importantly, the record needs to be functional. The worst legal risk is a record that confuses or misleads other physicians, potentially compromising the care rendered by subsequent caregivers.

tial to offer numerous benefits to physicians and patients alike. As with any new technology, however, there are lessons to be learned. In the case of EHRs, there are several fundamental rules that apply to the system implementation experience: • Ensure that every effort is made to set up the system properly. • Provide extensive training for all users. • Implement ongoing monitoring to ensure the EHR documentation is complete, accurate, and compliant.

Starting with those key strategies can help medical practices have a “benevolent genie in a bottle” experience—rather than opening a Pandora’s box of computer woes. Michael Reiling is a principal and CEO and Anne Smith, RN, CPC, CCS-P, CPMA, CPC-I, CEMC, CPEDC, is a principal with Fredrikson Healthcare Consulting, Ltd., Minneapolis. Steven Beck, JD, is chair of the health law group with Fredrikson & Byron, PA, Minneapolis.

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Key strategies

Electronic health records are here to stay and have the potenJANUARY 2011

MINNESOTA PHYSICIAN

GASTROENTEROLOGY

bnormal liver enzymes may be detected in the blood, indicating a variety of liver conditions. Elevated liver enzymes are common (up to 8.9 percent AST or ALT) when screening asymptomatic patients in a clinical setting or for insurance purposes. Evaluating elevated liver tests can be confusing, given that “normal” limits are too high, as they are derived from an asymptomatic population, many of whom have underlying liver disease. This difficulty is exacerbated by the fact that significant liver disease can be present in asymptomatic patients with minimal enzyme elevations. Patients with an elevation of liver enzymes greater than 2.5 times the upper limit of normal should undergo an evaluation directed by history and the pattern of elevation. A systematic approach to patients with mildly elevated values should lead to more cost-effective and better clinical outcomes. A good history and physical exam are critical in evaluating these patients and can often decrease the need

Elevated liver tests A systematic approach can cut costs, improve outcomes By Jeffrey Rank, MD for costly diagnostic tests, including liver biopsy. The term liver function tests usually refers to liver enzymes, bilirubin, and albumin. It is best to consider liver enzymes as an indicator of potential liver disease, but not of liver function. Bilirubin elevation may represent a disorder in liver function or an overload from hemolysis. An elevated, indirect-fasting bilirubin of less than 3 mg/dl commonly represents Gilbert’s, a benign disorder of bilirubin clearance. Low albumin can be seen in significant liver disease, malnutrition, and nephrotic syndrome. In addition, prothrombin time can be an indicator of liver function, if other causes of elevations have been ruled out. Like albumin, many clotting proteins are synthesized

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MINNESOTA PHYSICIAN JANUARY 2011

in the liver. These function tests (bilirubin, albumin, and prothrombin time) can be helpful in assessing the cause and severity of liver disease. Liver enzyme abnormalities can be divided into two categories: hepatocellular and cholestatic/infiltrative injury. AST (SGOT) and ALT (SGPT) are the most common indicators of hepatocelluar damage, while alkaline phosphatase (ALP) and gamma-glutamyltransferase (GGT) indicate cholestatic/infiltrative damage. Though these distinctions are helpful clinically, it must be remembered that there is overlap, as many liver diseases may present with more than one pattern. Elevated transaminases

Special considerations for the most common causes of liver enzyme elevations (Table 1) are discussed below. Alcoholic liver disease. An appropriate history of use can yield clues to the diagnosis of alcoholic liver disease. Elevation of AST two to three times greater than ALT is suggestive of alcoholic liver disease, as is radiologic evidence of fatty liver without other risk factors for the metabolic syndrome. The range of disease can vary from uncomplicated fatty liver to alcoholic hepatitis with or without cirrhosis. Cirrhosis develops in 20 to 30 percent of chronic abusers, defined as greater than a decade of 60–80 g/day of alcohol per day in males and 20 g/day in females (12 oz beer, 1.5 oz distilled beverages, and 5 oz wine are equivalent to 12 gm alcohol). The likelihood of developing cirrhosis is increased with females, obesity, hemochromatosis, chronic viral hepatitis, and use of hepatotoxic drugs. Fatty liver disease. This runs the gamut from benign steatosis to non-alcoholic steatohepatitis (NASH). Though gener-

ally a disease of obesity, it can be seen in the mildly overweight. The numbers in the U.S. have risen in step with the obesity epidemic. NASH is generally seen in the setting of metabolic syndrome (fatty liver, central obesity, high triglycerides, type 2 diabetes, and vascular disease). Insulin resistance appears central to the syndrome. A simple method of multiplying fasting glucose and insulin levels can indicate insulin resistance if greater than 700. Longstanding NASH is associated with cirrhosis. Treatment is weight loss; a 10 percent weight reduction is a reasonable goal in most cases. Exercise and calorie restriction, especially of carbohydrate calories, are encouraged. Viral hepatitis. Approximately 1.8 percent of the U.S. population has chronic hepatitis C infection. Hepatitis B is less common (0.2–0.9 percent), but in immigrants from areas endemic for this virus, estimates are as high as 20 percent. Most patients with these viruses are asymptomatic until end-stage liver disease is present. Because effective treatment options are available, it is important to make the diagnosis prior to overt symptoms of liver disease. A history obtained during the initial patient interview can be crucial in making the diagnosis. Any history of IV drug use, intranasal cocaine use, tattoos or body piercing, blood transfusions (especially prior to 1989), and men having sex with men puts the patient at risk for these viruses. A history of military service has been linked with an increased risk of hepatitis C. Screening with hepatitis C antibody and hepatitis B surface antigen should be the next step. If hepatic C antibody is positive, it should be confirmed by pCR. A referral to a hepatologist is appropriate if the pCR is positive. If the patient tests positive for hepatitis B surface antigen, referral is appropriate. It is helpful to draw viral DNA level and E antibody and antigen serologies at the time of referral. Other viral infections can cause elevated enzymes, including CMV and HSV, and should be considered in patients with acute febrile illness or immuno-

compromised patients. Hereditary hemochromatosis. This relatively common autosomal recessive disorder leads to excessive accumulation of iron in several organs, resulting in multisystem disease. Prior to manifestation of liver disease symptoms, the patient may present with vague complaints of fatigue and arthralgias. Check iron studies in patients with transaminase elevations in the initial evaluation. Also check iron and transferrin levels; an elevation of tranferrin saturation greater than 50 percent in women and 60 percent in males is highly suggestive of hemochromatosis. Because of menstrual iron loss, women often present later than men. Testing for genetic mutations in the HFE gene is helpful in confirming the diagnosis and counseling relatives. A known mutation may not be present in patients with hemochromatosis, as not all mutations have been identified. Excessive iron accumulation can also be seen in alcoholic liver disease. If a homozygous mutation is not present, it is appropriate to refer the patient to a hepatologist for consideration of phlebotomy or liver biopsy. Autoimmune liver disease. Seen most often but not exclusively in women, autoimmune hepatitis should be excluded in the workup of chronic transaminase elevations. Gamma globulins are usually elevated but are not specific. Anti-smooth muscle antibody or anti-liver-kidney microsomal antibody elevation is more specific, but the degree of elevation is important, as lowlevel elevations can be seen in other liver diseases, especially viral hepatitis and alcoholic liver disease. Other autoimmune diseases are often present in these patients, and the presence of arthritis, thyroid disease, or other immune-mediated disorders are clues to the diagnosis. Treatment with immune modulators is usually effective, making early diagnosis important; without treatment, cirrhosis is common. Wilson disease. This is a rare but potentially life-threatening genetic disorder of copper

accumulation in multiple organs. Patients are nearly always younger than 40, and a new diagnosis after the age of 50 is extremely rare. Clues to the diagnosis are a family history of neurologic or liver disease, neurologic disease in the patient, and presence of hemolysis. Ceruloplasm levels should be evaluated in patients under the age of 40 with persistent elevations of transaminases. Chelating agents and zinc supplementation are effective in treating this disorder. Alpha-1-antitrypsin deficiency. This genetic disease is a common cause of liver disease in the pediatric population. Patients may have emphysema or may have predominant liver manifestations of this disorder without overt emphysema, or a younger sibling may have liver disease. In this setting, liver disease may develop into end-stage liver disease in adulthood, for which transplantation is the only effective treatment. Elevated alkaline phosphatase

This enzyme can be derived from organs other than the liver, most notably from bone. Confirmation of a liver source can be done by fractionating this protein or testing for other cholestatic markers. GGT is an inexpensive and rapid test that, when elevated in the setting of ALP elevation, strongly suggests liver origin. However, GGT is a poor screening test, as it is extremely sensitive and can be elevated in patients without significant liver disease. Special considerations for common causes of elevated ALP (Table 2) are discussed below. Infiltrative disease. Any infiltrative process in the liver can lead to ALP elevations. This includes malignant and granulomatous disease (sarcoid, tuberculosis, etc). Imaging of the liver is helpful in evaluating an isolated elevation of ALP to rule out an infiltrating process and in evaluating for biliary obstruction. If a granulomatous process is suspected and cannot be confirmed by other testing, a liver biopsy is required to make the diagnosis. Primary biliary cirrhosis.

This rare, immune-mediated disorder of the biliary system predominantly affects women. Elevations of ALP are common. Elevation of cholesterol secondary to poor clearance may lead to xanthomas. PBC is often associated with other autoimmune diseases. Pruritus can be a vexing feature of this disorder. Antimitochondrial antibody (AMA) is elevated in 95 percent of patients with this disease. If there is strong suspicion and a negative AMA, liver biopsy may be needed to make the diagnosis. Primary sclerosing cholangitis. The majority of patients with this disease (70â&#x20AC;&#x201C;90 percent) have associated inflammatory bowel disease. It is more common in males and most often is diagnosed between the ages of 30 and 40. The diagnosis is made by visualization of the biliary tree by ERCP, EUS, or liver biopsy. The disease may lead to cirrhosis and cholangiocarcinoma; transplantation is frequently required. Stenting of dominant strictures may alleviate secondary infections and relieve jaundice but often is ineffective, as

this is a disease of both intrahepatic and extrahepatic ducts. Biliary obstruction. This can result from multiple causes, including gallstones, pancreatic cancer or cholangiocarcinoma, metastatic disease, or chronic pancreatitis. Appropriate imaging is essential. Ultrasound is a good first modality, but further studies, including EUS, may be required to better define the biliary system and allow for biopsy or converting the procedure to an ERCP if appropriate. Drug hepatoxicity. The pattern of enzyme elevations in drug-induced liver disease is variable. Cholestasis can be caused by several drugs and can persist for months following the withdrawal of the drug. Some drugs (including neuroleptics) are associated with a predictable and often benign elevation of ALP. Statins often are associated with a mild and often reversible rise in ALT. There can be confusion in patients with fatty liver disease because elevated lipids are common in this group. LIVER to page 38

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About the Roundtable MR. CHRISTENSON: How would you define comparative effectiveness research (CER)? DR. BOTTLES: The U.S. Department of Health and Human Services (HHS) definition reads: “Comparative effectiveness is conducting and synthesizing of research comparing the benefits and harms of different interventions and strategies to prevent, diagnose, treat, and monitor health conditions in real-world settings.” Basically, we need to have research that tells us what works and what does not work in terms of treatments, surgeries, pills, and tests. What gets controversial about CER is how you use it: Do you use it to determine what Centers for Medicare & Medicaid Services (CMS) and, ultimately, other insurance companies will cover?

Minnesota Physician Publishing’s 34th Minnesota Health Care Roundtable examined comparative effectiveness research as set forth in the Affordable Care Act. Five panelists and our moderator met on Oct. 21 to discuss this topic. The next roundtable, on April 28, 2011, will examine the wellness revolution and its capacity to change the focus of health care.

role this is going to play in the health system and the choices of individual patients.

Comparative effectiveness

MR. CHRISTENSON: What are the worst things about comparative effectiveness research?

DR. HANSEN: To my mind, CER is being wielded as a means by which to make budgets work. MR. CHRISTENSON: What are the best things CER offers us? MR. GOODNO: Ideally, CER would offer us better results for patients. If you have the best treatments at the right time, you should lower the cost of the health care system in the long run. You should have more general satisfaction and better outcomes for the patient—not only the health outcome but also the lifestyle outcomes. That should be the focus of CER. DR. DANIELS: The opportunity to find out what works and what doesn’t, irrespective of the politics behind CER, could help us improve care. DR. BOTTLES: I would link CER with the budget deficit even more strongly. Health care expenditures are making America uncompetitive in a global marketplace. If we don’t get the expenditures of health care under control, it means we don’t have money to spend on things like defense or energy policy or education. Linking CER to controlling the budget deficit is really, really important. DR. DANIELS: I would add that spending 18 percent of the GDP for health care might not be bad if our outcomes were the best in the world. But they are not. They are barely better than some Third World countries. MR. CHRISTENSON: Do you believe CER will improve outcomes? DR. DANIELS: It is one tool in the toolbox. It alone will not accomplish what we need, and

MINNESOTA PHYSICIAN JANUARY 2011

Common sense or nonsense? the $1.1 billion that the stimulus bill designated to be spent for CER—although that sounds like an enormous amount of money—is not a lot of money to solve these kinds of problems. MR. MONROE: None of us in the United States today should be proud of the outcomes we have versus the cost. The CER work is one step moving us forward. But we cannot pat ourselves on the back in this country and say that because we spend billions of dollars, we are automatically the best when our outcomes don’t stand up—our life expectancy doesn’t stand up. Survival rates at birth don’t meet other countries’. We have to figure out how to do it right. DR. HANSEN: I disagree just a little. We have to look at how some of those metrics are designed. It’s also important to look at what we think comparative effectiveness research will or won’t do for us. One thing to keep in mind is that populations are not individual patients. How are we going to reconcile effectiveness research with treating individuals? The other truism is that not all outcomes are changeable, no matter what we do to intervene. We are going to have to decide what

MR. GOODNO: I differ a bit on the Third World comparison. Dealing with my daughter’s epilepsy and her seizure disorder, I want her to be here. When it comes to providing services and treatment for epilepsy, this is one of the best places to be in the world. We have to be careful about talking in generalities about health outcomes and the money spent. I agree that we are spending too much money on health care. We are spending money ineffectively. We could do a whole lot better job of how we spend it. Perhaps CER will help us do that. But it is a tool, and the effective use of tools will depend upon the people using them, if they know how to use those tools, and if they are using them in appropriate circumstances at the appropriate time. Put the tools in the wrong hands, and you are going to have terrible outcomes.

DR. HANSEN: From the provider’s perspective, I will go back to my first caveat: Some outcomes are not changeable no matter what you do. We cannot ignore the large body of research on the social and economic determinants of health. Medicine is quite a ways down the chain of things that affect population health. I wonder sometimes if we are not holding medicine to too stringent a standard on what the outcomes are for populations. The other issue here is metrics. What exactly are we measuring? Are we measuring length of life, are we measuring freedom from disease, are we measuring activities of daily living, or “health,” whatever that is defined to be? One of our biggest challenges is to decide exactly what we are trying to measure in individual patients as we move along in so-called effectiveness research. DR. BOTTLES: The only negative thing I see about comparative effectiveness research is that it plays right into our partisanship and our polarization. We have to be able to understand what works and what doesn’t work. We have to have a frank discussion among professionals, medical device companies, pharma, the general public—that the status quo is unsustainable. Health plans, doctors, patients, everybody has a piece of the guilt for why we have bad outcomes. MR. GOODNO: The question is whether those negative outcomes are related to the health

care system or the environment or the consumerism that is going on out there and how people react and take care of themselves. We are looking at the outcomes and blaming it on one segment. We need to look at the whole picture and how that relates. Comparative effectiveness research itself is a good thing. It is always good to have data on what works and what doesn’t. The biggest danger is that people will take that research and misapply it to individual situations. One thing that became clear when I was dealing with my daughter’s situation: There is the science of medicine, and there is the art of medicine. When you get into those areas, especially dealing with the brain, there is a whole lot of art that goes on in treating folks. We need to make sure we don’t use tools like CER to take the art out of it. MR. CHRISTENSON: But do you believe that the best treatments are the most cost-effective treatments? MR. GOODNO: Not necessarily. We have a disconnect between expectations in our society for how we take care of individuals at or near death or in life-threatening situations. And our expectations regarding people with disabilities don’t match up with the resources we are willing to spend. Those things have to come together, but we have to have an open discussion. Politicians are not going to tackle this issue unless the public is willing to talk about it. MR. CHRISTENSON: Jim, do you have any concerns about the people who are writing these CER regulations and their experience? MR. MONROE: We do. Physicians need to be more involved. My concern is that we have a lot of people with PhDs behind their names who have not practiced. We need the practitioners, we need the data, we need the population base. My biggest concern with CER is that we are operating as Luddites on data collection. We do not have the ability to pool the data; we look at small groups instead of large groups. Our group is a self-insured group of 124,000 lives. We need to look at groups like that. We need to take that data and look at what works, what does not work, not from a cost-effective basis, not from a cost-dollar expense basis, but what the outcomes are and what the true value of the delivery of services are. We aren’t doing that. We are only concerned with how quickly we can process claims

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and how many procedures the docs are performing in order to get their billings in. We need to step back from that. DR. DANIELS: I want to go back to the issue of cost effectiveness. My understanding is that the Affordable Care Act (ACA) does not even allow cost as a metric. Kevin’s point is a good one: We have to understand what cost effectiveness means. Are we talking about the cost of refilling a prescription, are we talking about the cost of keeping a child out of the ER, are we talking about the cost of having that child be able to live a normal life free from the side effects of the drugs that may be required to treat epilepsy? Too often in health care we focus on the short-term goals and the easier ones to measure. One of the things that comparative effectiveness research will need to do is come up with the right outcomes. The most expensive knee replacement on the market might be worth it if it allows people to lead a more normal life. DR. BOTTLES: I share the concerns about how ACA is going to be implemented. I came from a conference in West Virginia where they talked about the Patient-Centered Outcomes Research Institute, a publicprivate partnership that is going to run CER. Some at the conference were concerned that there was not enough of a patient voice on the board of governors. MR. CHRISTENSON: Is using CER to develop physician compensation policies a good idea? DR. HANSEN: I certainly am sympático with the thought of trying to have more providers’ input into the structure of public policy. I use my days off to show up at these so-called policy meetings at the Legislature to try to give my input. I find that when I show up to Minnesota Community Measurement or to whatever legislator’s office, they are maybe or maybe not interested in what I have to say about what it is like to take care of a patient. This committee in Washington is a perfect poster child for business as usual. Where the heck are the patients? Sometimes I think some of these things by design are meant to keep providers and patients from providing input because, quite frankly, it does not serve the agendas of the people with the purse strings. MR. CHRISTENSON: Bobbi, how does the University of Minnesota Physicians group look at this?

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Kent Bottles, MD, was president of the Institute for Clinical Systems Improvement (ICSI) from 2008 to 2010. Prior to that, he was chief medical officer of the Iowa Health System and held a number of leadership positions in academia, biotechnology, and community health systems. He currently serves on a National Quality Forum committee on quality and has been active in lecturing and writing about leadership topics. A board-certified pathologist, Bottles earned his medical degree from Case Western Reserve University in Ohio. Bobbi S. Daniels, MD, is chief executive officer of University of Minnesota Physicians. Prior to her appointment as CEO in 2009, she was chief medical officer for the group. She has served on the UMPhysicians board of directors since 1996 and chairs the clinical practice committee. After earning her medical degree from the University of Washington School of Medicine in Seattle, Daniels came to the University of Minnesota in 1981. On completion of an internal medicine residency and a nephrology fellowship, she joined the medical school faculty, where she is currently professor of medicine. Kevin Goodno, JD, LLM, is president of the board of directors of the Epilepsy Foundation of Minnesota and chair of the government relations practice at Fredrikson & Byron PA, in Minneapolis, where he focuses on health care and tax policy. As commissioner of the Minnesota Department of Human Services (DHS) from 2003 to 2006, he served on the Governor’s Health Cabinet to develop ways to inform, partner, and create efficiency in the health care industry. Prior to joining DHS, he represented the Moorhead area in the Minnesota House of Representatives for 12 years. Ronnell A. Hansen, MD, is immediate past president of the Twin Cities Medical Society (TCMS), licensed to practice medicine in 27 states, and president of Hansen Imaging Diagnostics. A University of Minnesota Medical School graduate, he completed residency in diagnostic radiology at the University of Michigan with fellowships in body imaging and information technology. Hansen served on the Minnesota Legislative Committee on Pooled Insurance in 2007–08, and is currently on the TCMS board of directors, co-chair of the TCMS public policy committee, on the executive committee of the Minnesota Radiological Society, and a member of the Minnesota Medical Association work group to advance health care reform. Jim Monroe is executive director of the Minnesota Association of Professional Employees. He holds a bachelor of arts degree from Ohio University. Prior to being appointed to his present position in 1999, he was chief operating officer of a life and health insurance company and, before that, executive director of independent publicsector labor unions in Washington, Maine, and Ohio. As a provider and consumer/employee representative for the past 37 years, Monroe has been actively involved in health-care provider, access, and quality issues at the state and national level. Robert Christenson has been involved in health care policy since 1965 and has been a health care consultant since 1978. His specialties are governance training and integrative medicine.

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M I N N E S O T A and another 1,500 employees, there is a diversity of views. In terms of physician comp, right now the method by which physicians are compensated is irrational. Primary care physicians at the front line are making tough decisions, but not a lot of money compared to their counterparts. On the other end of the spectrum, you might have a physician who rarely sees a patient, is associated with very high-level technology, making three, four, or five times the level of compensation as a primary care physician. The whole physician comp issue needs to be considered completely separate from comparative effectiveness. Physicians should be incented to provide the right care to the right patient at the right time to accomplish the right outcome. The problem, a lot of the time, is that we do not know the data to allow us to determine when we have done that. To the extent that comparative effectiveness research allows us to do that, we can improve the delivery of health care and better align the incentives. DR. BOTTLES: Here is a problem. In one of the few areas where we have comparative effectiveness research that has been published in a peer-reviewed journal and everybody accepts as good science, here is what happens: The COURAGE trial studied 200,287 patients for five years. The conclusion— that no one has challenged—is that patients with chronic chest pain usually receive no benefit from stents when used with a cocktail of generic drugs. We know that for this disease here is what we ought to do, and yet we continue to use stents in areas where they are not medically needed. We would save $5 billion a year in the United States if we just followed the scientific evidence of the COURAGE study. Yet we do not. MR. CHRISTENSON: Does it have anything to do with the incentives that physicians have for treating their patients? DR. BOTTLES: Well, cardiologists get $900 every time they do a stent procedure. What they are supposed to do is a cardiac stress test, which is not as expensive. I would have to conclude that, yes, reimbursement has something to do with it. MR. MONROE: Having preferred networks for those who comply with comparative effectiveness research is the way to try to move. We are discussing it; we have not been able to negotiate it. It forces some discussion between the provider and the individual patient. If we are able to use documented

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results as a basis to compensate people for outcome-based decisions, as opposed to the number of procedures, you are going to open doors. Doors will open where there are true discussions held with the patient rather than saying, well, you have X, Y, or Z, and therefore we are going to do this. DR. HANSEN: That is a key point. I agree with Kent that certainly Econ 101 does not go away when you are in the business of medicine. Even if we create a system of metrics, how do we avoid getting a bunch of providers treating to checklists? MR. CHRISTENSON: When the regulation gets developed for comparative effectiveness research, how do you incorporate the role of the patient in assessing results? DR. HANSEN: That, for many physicians, is the million-dollar question. We see how health care reform is evolving. To me the problem with a lot of it is that it does not seem to save a whole lot of money. The second thing: Where is the patient accountability in this? The social determinants of health have more impact on popula-

money and give patients what they want. The Cochrane Review, an evidence-based medicine review that is well respected, recently published a study about shared decisionmaking in cases of benign prostatic hypertrophy. There were videos to explain the tradeoffs and patients could talk to people who had chosen one treatment or the other. The review found that if you do shared decision-making and sit down with patients and spend the time to talk to them, there is a 24 percent decline in demand for elective surgery or for tests. That 24 percent decline would be about $4 billion in savings for Medicare. The idea is you can give patients what they want and what they need—if they understand it. The other thing I would comment on: With the new bill everyone thinks we are going to have a transition from feefor-service, where we pay piecemeal, to some sort of global payment. When you pay people globally, you take out the incentive to do more. That transition is going to be huge, complicated, and difficult. DR. DANIELS: Patient engagement flips accountability around and begins to put the patient in the driver’s seat. Kent has mentioned saving $5 billion with one simple

None of us in the United States today should be proud of the outcomes we have versus the cost. Jim Monroe

tion health than anything I will ever do in medicine. MR. GOODNO: Patients play a key role in the outcome of the disease or affliction they have. You can do all the research you want, but you can’t ignore the fact that you have to communicate with the patient. That communication aspect is key, yet it is quickly lost in this discussion. When you measure outcomes, you need to make sure you are measuring the right outcomes. It is not a checklist of inputs, it’s the actual outcomes and the benefits to the patients themselves. DR. BOTTLES: If we sat down with patients and talked to them about the tradeoffs—and there are tradeoffs in everything, nothing is perfect in terms of treatment—there are studies that show that you can both save

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intervention and another $4 billion with an additional simple intervention. The amount of money proposed to be spent on CER is $1.1 billion. This is a relatively small amount of money to solve a huge number of issues. When you think about what is out there to potentially be saved, the things we are doing that just do not make sense, we do not have to find many things before that $1.1 billion can be paid back. But, again, a lot of those are also political more than they are real. MR. GOODNO: Isn’t it ironic that one of the key elements of the new ideas is that we’ll have better outcomes if we communicate with patients and engage them in their own decisions with regard to their health care? Everything goes back to that basic.

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M I N N E S O T A MR. CHRISTENSON: Minnesota Physician Publishing recently conducted a physician opinion survey on the topic of CER. The leading response to every question, by an overwhelming margin, was “no opinion.” What might be inferred by these results? DR. HANSEN: What it says is that physicians are physicians. They are not actuaries, bureaucrats, or statisticians. Many of the physicians in this particular market are employed. They worry day to day about filling their patient lists. Many of them are employed because of the incredible bureaucratic hassles that went with private practice. In this particular subset of physicians, you have a bunch of folks that in some sense hope that it is just going to be taken care of. For those in private practice, many see this as a potential disaster in many ways. MR. MONROE: If we could teleport ourselves back to 1965, the discussions and concerns on Medicare were the same. Medicare, in my way of thinking, came on faster than this transition. I think one of the reasons that “no opinions” were high is that we are talking about an act that’s got four more years for different pieces to come in. I do not think it is nonresponsiveness or people washing

Linking CER to controlling the budget deficit is really, really important.

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tive effectiveness research, you can take a deep breath and wait 17 years. DR. BOTTLES: We have to have a frank discussion and say that the more expensive new thing is not always better. Direct-to-consumer advertising by pharmaceutical companies isn’t always better. We should have a frank conversation about what tradeoffs are involved in some of these things. An example: I am 58 years old, and I will never get a PSA test, the screening test that most people get for prostate cancer. Why? Because, for my values, I don’t want one. Because I understand that almost everybody who gets old and is male gets prostate cancer. I have done a lot of autopsies and it is always there. It turns out that I have a 97 percent chance in my life of dying of something other than prostate cancer. If you take a thousand men and screen them for 10 years, you will pick up one prostate cancer and maybe save a life. You will also over-treat 50 men, and the treatment for prostate cancer includes things like incontinence and inability to have sex. I am not saying that everybody should do what I am doing. But for me, as an informed individual with shared

MR. CHRISTENSON: Explain the differences among utilization review, best practices, and now comparative effectiveness research. DR. HANSEN: I feel that the evolving definition of utilization review is going to be: Who is using too much of X resource? I wish I could think of it in a benign sense. But once again, you get back to how are we going to balance the budget and pay for all this. I don’t know how we are going to do it, but I see upcoming utilization review as physicians using too much of X, Y, or Z— biologic drugs, imaging, etc.—for the care of their patients. To me, the very loaded concept of this is: Who, then, are physicians serving? The health care system? The at-risk capitation model of the accountable care organization? Or are they serving their patient? MR. CHRISTENSON: Jim, how do you, as an employer and representing employees, look at utilization review?

Kent Bottles, MD

their hands of it, it is just the magnitude of what we are dealing with. People put things off—until it happens. MR. CHRISTENSON: What are the biggest challenges in conveying to physicians the potential of CER to help identify the most effective and appropriate treatments? DR. DANIELS: Jim made a great point about how hard it is to get the information out. Go back to one of the first trials that showed the effectiveness of tight glycemic control for people with diabetes, or look at the things that have been demonstrated to be effective in treating heart failure. From when those studies were published to when the practices became commonly implemented—17 years. For those who are worried about compara-

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measurement folks: You have to be very, very careful about how you apply some of these things that may or may not be true. Kent has decided that it is not worth it for him to get this certain test. Bundled in that statement is the question of trying to figure out, if we decide as a system what we will pay for, what are we going to pay for in individual patients? Are we still allowing individuals to go outside the system and do whatever they deem is appropriate for themselves? We have to have a very frank discussion with the public, which I don’t believe political people are willing to have, on what we can and cannot afford to deliver to people.

decision-making, I don’t want to have that test, because I don’t want to be one of the 50 people who are going to be over-treated. I may die of invasive terrible prostate cancer and then you can say, “He was stupid and made a bad mistake.” There is no gold standard for this stuff, no guarantee. DR. HANSEN: Sometimes the truth is always moving. We think vitamin E is a great thing to add to cardiac patients—up until we figure out 30 years later that it kills people. We are very, very certain that very tight glycemic control is the best metric. So we impose that, and then people do worse. We are going to penalize docs if they don’t do best practice of vitamin E—and, oh yeah, the patients die. Sorry, we’ve been doing that for 30 years. I always try to bring this up to the community

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MR. MONROE: I think the group as a whole tends to give us some good data. But many times utilization review tends to be used to justify holding care delivery down; it puts pressures on the providers that aren’t justified. Utilization review when I was running an insurance company was, “How do we cut the cost for the services being provided?” DR. DANIELS: The insurance company retrospective utilization review as we currently know it is fraught with all of those difficulties. Take a step back, though, and think more broadly about how we use resources. Look at the Dartmouth Atlas where Medicare data has been put together and analyzed on a geographical basis. Look at care in the last six months of someone’s life. The variability across the country is two- to three-fold and highly correlated with the number of specialists or the number of hospitals involved. Is that type of variability what we really want to

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M I N N E S O T A use our health care dollars for? It is fine to think about a patient perhaps being harmed by utilization review, and sometimes that might indeed happen. But how about the other side of the coin, when the patient is struggling with being able to pay for food or rent—because they have to make a choice between those life essentials and their medications or their health care? That is a part of the patient cost we really haven’t taken into account. But that variability across the nation needs to be understood. Maybe it is justifiable. But I would submit that some of that variability is probably not appropriate. MR. GOODNO: I take what Bobbi said and flip it a little bit. If you look at prescribing practices with regard to controlling seizures in this state, you will get a different prescribing practice from the specialist than you will from the general practitioner. I would argue that the prescribing practice of the specialist is probably more cost-effective, with better outcomes, because they know exactly what they are dealing with and how to use those tools they are given. We have to be careful when we are using statistics to automatically assume that the specialists are providing inappropriate care or excessive care. I think utilization review is a tool that can be used effectively, not necessarily in controlling costs but in training doctors and helping them address and follow through on best practices. DR. BOTTLES: It is important to recognize the amount of variation. In 2005 the per-capita Medicare expenditures for CMS ranged from $5,281 in Rapid City, South Dakota, to $14,259 in Miami, Florida. Look at the last two years of life: If you live in Newark, New Jersey, you are going to spend 35 days in the hospital. If you live in Portland, Oregon, or Salt Lake City, Utah, 12 days in the hospital—35 versus 12 over two years. And the outcomes are the same. If we could get the people in Newark to treat people the way they do it in Portland and Salt Lake City, our problems of salvaging Medicare are gone— we have solved them. There is a 19 times difference in America on prostatectomy rates—19 times. This is a huge variation. MR. MONROE: I did live in Portland. There is a different care delivery, a different environment, a different quality of life than there is in Newark. When we look solely at the dollar delivery without the other variables, we are starting to look at rationing care. That I will oppose from day one.

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DR. BOTTLES: We ration care right now—talk to any doctor. MR. CHRISTENSON: Let’s address a criticism that comes up whenever health reform is attempted. What is the best response to those who characterize comparative effectiveness research as too much government involvement in health care? DR. BOTTLES: The best response is that government pays for more than half of health care, so they ought to have some say in it. MR. GOODNO: Is it appropriate for government to help fund and help encourage CER—the actual research? Yes. Again, I would caution on how government or other payers will use those tools in trying to control the cost of health care. MR. CHRISTENSON: Is it—to use another term—socialized medicine? MR. MONROE: When you hear people talking about socialized medicine or death panels, it’s nothing but a political spin on what we are trying to do, based on who is trying to get in office. In 1990 the Republican Party nationally and locally was in favor of CER. In 1997 and 1998 they came out in opposition. The average American is looking for higher quality of participation in care delivery and understanding of what the process is rather than being treated as a widget going down an assembly line. The reality is that CER, once we figure how to quantify the data, is going to provide a leap forward. MR. GOODNO: You can have socialized medicine without CER, and you can have socialized medicine with it. In and of itself, it is not socialized medicine. It is a tool. MR. CHRISTENSON: How can CER be designed to adjust to the significant variation among patients with similar conditions who require different treatments to achieve the best outcome? DR. HANSEN: Eric Nussbaum, who is a neurologic surgeon at HealthEast in St. Paul, wrote an op-ed piece in 2009 regarding the art of medicine. He said, “Where science stops, the art of medicine begins.” He deals with very difficult cases—stroke, tumor, brain injury—that there aren’t any guidelines

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for. He and his team at HealthEast have extremely good results. Who knows why? Sometimes long-term experience with patients and taking time with patients can reap benefits you can’t easily calculate or quantify. DR. DANIELS: Shouldn’t we have a culture of inquiry to understand why they are better? Then everyone else could learn from that kind of evidence. Maybe there’s something there—let’s find it out, instead of saying, “Everybody should be able to do whatever they want, because maybe they are right.” Because maybe Eric is right, but the next Eric may be wrong. That is the challenge we have to confront in medicine. MR. CHRISTENSON: Kent, is there a computer simulation program that would help with this? DR. BOTTLES: There is a company called Archimedes in San Francisco that may represent the next generation of evidence-based medicine guidelines. They are trying to take into account everything we know about a patient and translate that into very sophis-

We can’t intuit what we don’t understand. Bobbi Daniels, MD

ticated mathematical equations, to come up with health status scores for individuals. Guidelines by definition have a very sharp cutoff. If your blood pressure is over 140, you get treated; if it’s under 140, you don’t get treated. But some people who are under 140 probably should be treated because of other things—smoking history, exercise history, or others. Computer simulations are probably going to replace guidelines, and they can be personalized to each individual. That gets us to this personalized medicine that has been over-hyped and under-delivered. MR. GOODNO: Medicine is a combination of art and science. You don’t want somebody to practice just the art of medicine without using the scientific background and studies that have been out there. If that computer model works, that’s great. More than likely, you will find it a guideline to set the base standard and beyond that you have to leave

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M I N N E S O T A it up to the flexibility of the physician. When the guidelines become the mandate, that becomes a problem. DR. HANSEN: Unfortunately, patients are not Chevys. They do not all react in the same way to physical stresses or interventions. Reactions to medications can be idiosyncratic. Each patient will tend to respond somewhat differently than the next patient. I can take five different antihistamines—one works for me. How much is that one and is it on formulary? I don’t care what’s on the formulary; I need the one that works so I can work. Marrying the facts with the art or what the patient responds to appropriately is going to be a critical piece of this. MR. CHRISTENSON: What can be done to keep CER from becoming another tool to justify large administrative fees, unfair provider reimbursement policies, and increased costs of care? MR. MONROE: We are kidding ourselves if we assume that the Blue Crosses and HealthPartners of the world are somehow better because they are nonprofit than the

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MR. GOODNO: If your primary pressure is on the payment side and making sure you keep your rates down so your customers won’t yell at you or keeping your cost down so the legislatures that are managing it are approving your budget and are not yelling so much, your focus is more on the payment side and you use quality outcomes as an excuse to do that. If you are really looking at better outcomes for the patients, there’s less concern but you still have the pressure of cost. It depends on where you stand. DR. HANSEN: Or perhaps who you are. The question is not frequently about the money— it is all about the money. If we follow the dollars, we will find where the conflicts of interest are. I would like to believe that, at least in this country, the physicians are still the patients’ best advocate. Some of these so-called tools are going to be used to intervene between the physician/patient relationship and what is best for the patient.

Politicians are not going to tackle this issue unless the public is willing to talk about it. Kevin Goodno, JD, LLM

for-profit Anthems of the world. They are not; they operate on the same business models. We are heading for some form of universal care. Even in a universal health care system, you still have a payer and if you have 100 payers or one payer, you still have the pressure on that payer or those payers to reduce the health care costs, and they will look for tools to try to reduce those costs. That is the danger of allowing this tool to be used by the wrong people for the wrong reasons. If it is used as a tool by the health care professionals who are trained in using the tools and in diagnosing the patients and working with the patients, it is an appropriate use. But if it is used by payers, one or 100, I don’t think you can keep them from using it inappropriately to reduce cost. MR. CHRISTENSON: In using CER, how much of it is directed by the money and how much is directed by quality outcomes?

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Rather than engaging the public in what we can and cannot afford, this is being levered onto physicians to figure out how, in a sense, to ration resources. It’s an unfair move, but it is brilliant politically, because it does not throw me out of office when I have to tell people they can’t have everything they want. I am leaving that to the docs. MR. CHRISTENSON: Bobbi, what role should employers play in this? DR. DANIELS: For an employer, the cost of health care comes in a lot of different ways. We just renewed our health insurance and made significant changes in the plan, because it was the way that we could afford to provide the best health care for our employees, but it certainly is a different plan than we have had in the past. If we are making those choices as a health care provider, I can only imagine what other employers are forced to do. The people who really come out

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on the short end are those employers who can no longer afford to buy health care. About 20 percent of employers, even in this area, are not able to afford health care. MR. MONROE: We have had five consecutive years as a self-insured group with no premium or out-of-pocket expense increases to the employees. The plan covers 124,000 lives. The doctors providing services under this plan are not making any less than they would if they were contracted with Blue Cross, because they are effectively contracted with Blue Cross, HealthPartners or PreferredOne—in reality, all three of them. There is not a decrease in the services being provided. The reason is that we are self-insured and we only contract out the administration, for a very limited amount of money. DR. HANSEN: I was on the Legislature’s Pooled Insurance Committee, which looked at all forms of insurance to try to come up with a solution for small businesses in Minnesota. After nine months of grueling meetings, the only model that seemed to make sense was Jim’s state employee plan. There are a couple of big truisms about it: One was transparency on cost, the other was appropriate remuneration for people running the program and lack of incentive for those people to withhold profits. When all of the money is appropriately put into insurance programs for the people who are paying the premiums, such systems can work. As we think about reforms going forward, we have to ask: What was insurance intended to do, and what is insurance doing today? How much are people paid to run those corporations? Where do profits go? As Jim points out, when stuff is laid out very clearly and honestly, the books are transparent, you treat your enrollees correctly, and they participate in some measure of preventive programs in caring for their own health—these things work. I can’t necessarily give a billion dollars to shareholders on that, but I can provide health care. MR. CHRISTENSON: If we use CER to determine what Medicare will cover, how do we avoid setting dangerous precedents that other insurers will use to take the patient out of the equation in making medical decisions? MR. GOODNO: You can’t use CER to determine what is being paid for. If Medicare starts using it, then it is going to be used as a model by other payers and that is a danger. You have to be very careful about misusing the tool at the very beginning. Because if it is

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being misused, especially by Medicare, it certainly sets the tone for everybody else.

MR. CHRISTENSON: What are the most important things for CER to compare?

DR. BOTTLES: It is important to recognize what’s actually in the law. The Affordable Care Act clearly says findings of CER may not be construed as mandates regarding payment or treatment or to deny or ration care. That is written into the bill. Having said that, I will take the exact opposite position: It should be used. There is nothing wrong with using what works: Pay for what works, don’t pay for what doesn’t work.

MR. MONROE: What is the outcome of a procedure, what’s the overall cost, and how effective is it? That is what we have to look at.

DR. HANSEN: Works for what? We have to have the dialogue with folks to decide exactly what they want to get out of their health care. Do they want health? Ability to perform activities of daily living? I have to have some idea of what my patients want from their “outcomes.” DR. BOTTLES: We can’t afford to have a carte blanche that everything will be covered by Medicare the way we do today. There ought to be some rationale for what we cover and what we don’t cover. Having scientific evidence of what works and what doesn’t makes sense to me. MR. GOODNO: I agree with having a rational reason for what we cover and what we don’t cover. What I am concerned about is using one tool to be the end-all that tells us exactly what we are going to do. Use it as a guideline. Don’t use it as “This is the only thing we are going to pay for, and if you happen to be an outlier, tough luck.” MR. MONROE: Effective CER data—if it is made available so that people know the outcomes of decision A, B, or C—will lead to a high majority of people making the right choice on future care delivery. We underestimate the individual willingness to do what is right for themselves, and that ultimately helps hold the cost down. DR. DANIELS: The problem I see with spending $1.1 billion on CER over the next few years is that it is not going to come anywhere close to providing the necessary breadth of knowledge. It would take a huge investment to get us to the point where, for the majority of the patients, we would know what was the most effective treatment. MR. MONROE: But having that data available and people being aware that they have a right to ask questions of their physicians will start opening doors regardless of how far we get down the line. I am hoping my grandchildren have it available.

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MR. CHRISTENSON: Is the source of data a major issue? Health plans consider so much of the data they hold to be intellectual property that they are not going to share. Where are we going to get good data to compare? DR. BOTTLES: That is why there are billions of dollars now from the office of the national coordinator for health information technology to try to get every hospital and every doctor’s practice on a computerized system. You have to have data that is readily available. You would no longer depend on health plan data. What matters is the outcome of the patient, not the surrogate endpoints of process measures. Even your hemoglobin A1c is not really what matters. What matters is whether you have complications from your diabetes.

measuring. I will go back to epilepsy. Say the outcome for a certain treatment is to stop the seizure. There are drugs out there right now that can stop any seizure, but you will probably stop most of the brain activity that is going on as well. The second issue is, OK, you can measure that outcome, stopping the seizure, but there are other issues that come along with that: lethargy, impact on development, weight gain—all those things are side effects. We are not even collecting that information right now. In our health care system right now, do we truly know what outcomes you are getting with your patients, where that is recorded, and how it is being shared? Even if we make all the records interact with each other, how are we collecting that data? Is it even out there? I would argue that, in most cases, it is not. DR. HANSEN: Kevin brings up a great point here. The overhead for some of this stuff can be dramatic. Even for things like preauthorization, for example. Some private practices and probably some health systems had to hire new staff just to get

How are we going to reconcile effectiveness research with treating individuals? Ronell Hansen, MD

MR. MONROE: The technology has evolved to gather the data, to aggregate it, to cleanse the database so I can’t tell who the patient is. Once the data is gathered, our biggest problem is going to be how to make any sense out of it—because it is huge. The first step is getting all providers on an electronic system that can communicate. We are going to be gathering so much data, it’s going to be lightspeed intellectual growth on what we can do with that data. I’m not sure we have the technology once we get it aggregated. MR. GOODNO: What we are talking about here feels like an exercise in futility. We’re saying, “Wouldn’t it be great if we had a perfect system? And if we had a perfect system, we would be able to do things like this and that is where CER comes in.” The key to all this comes down to what outcomes you are

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around these things. Some things that we believe are well intentioned in reality seem to be more along the lines of cost containment. They don’t necessarily relate practically to a medical condition or logic in terms of treating the patient. Rather, they are a device to stem the hemorrhage of dollars. I don’t know how we get away from the duality of profit motive from some elements of the health care systems and the desire of physicians, who are service folks, trying to do the best for their patients. It seems like I am frequently at odds trying to deliver good care with somebody else trying to hold down my costs, largely because it affects the budget of the entity supporting the patient. DR. DANIELS: Thinking about how we use the data, an important concept is that we can’t intuit what we don’t understand. That doc on

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M I N N E S O T A the front line can’t know what to do with any individual patient if she doesn’t have the knowledge that allows her to use her intuition to make the wise decision. At some point, we have to be formatting some body of knowledge that allows the physician, the nurse practitioner, the pharmacist, whoever, to be able to make those wise decisions. If we don’t have things like comparative effectiveness research, if we don’t have NIH trials, if we don’t have a great medical school and a great school of nursing, we are just not going to be able to do it. It isn’t that someone steps out of their residency and suddenly knows what the right answer is. One way to begin to make it easier for everyone to provide the care they need to provide, if they might not have the most outstanding intuition, is through some of the tools that we are talking about. If we don’t have the solid foundations to know what to understand, we are not going to intuit anything and provide that art of medicine. Because the art of medicine is intuition. It is not hocus-pocus that comes down from a bolt of lightning. MR. CHRISTENSON: Let’s assume really good metrics come out of this. How can these important metrics for determining what treatment is most effective for a patient be communicated to individuals with limited ability to understand complex medical analysis? DR. BOTTLES: We have a lot of tools that allow us to explain to people and yet we just haven’t had the ability to get that to the doctor/patient relationship at the point of service. There was a famous RAND study of people with insurance: Only 55 percent of Americans get platinum-level care for stuff we totally agree on. This drive to computerization can help us by embedded decision support. When I am seeing a patient, if I have a computer that can help me with drug interactions, that can help me improve on that 55 percent. Supposedly in my field there are 6,000 articles published every day that I should keep up with. No person can keep all of that in their mind. If we can get embedded clinical decision support at the point of service, it would help us. DR. DANIELS: It gets worse, even if the doc remembers to do every possible thing. Let’s say the patient gets a prescription for a wonder drug to take care of some problem. They take the medication on average only 50 percent of the time. That is a problem. Dick Migliori, chief medical officer for OptumHealth, did an interesting study. He was looking at this incredibly expensive drug to treat chronic myelogenous leukemia. It cost something

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like $50,000 a month. He wanted to figure out how they could decrease the cost of using this expensive drug. The surprising thing they found is that when the patients took the really expensive drug their health care cost less than when they didn’t take the really expensive drug. Sometimes the way we think about cost is not right. We have to help docs do the right thing, we have to help patients do the right thing, but then we have to understand what is behind the right thing. We don’t always know until we do something like comparative effectiveness research. MR. CHRISTENSON: What must be done to create a standard in CER that everyone will accept? DR. HANSEN: That is a tough question, because we can talk about it as a tool, but we have gone all around the circle of whose interest we are serving, whose dollars we are protecting, and what we are trying to get out of it. No matter which way we try to spin this, there is going to be some stakeholder that is going to spin it to their advantage. That is not necessarily going to be in the best interest of patients or their providers. Who will get the upper hand? Is it going to be the government? Is it going to be the moneyed stakeholders that we have already mentioned—big pharma, large health care corporations, hospitals? Is it going to be physicians? I view myself, as a private physician, on the bottom of the influence pile. MR. GOODNO: It will depend on how the results of the CER come out and how widely accepted that is. To have it accepted, you have to have people buying into the process, how it is being tested, and what outcomes are being measured. The best way to do that is to have more people involved from the front end and all the way through the process. In some cases, you may never be able to get all the right people at the table. The challenge is to be as inclusive as possible. You need to do an analysis of what the upfront costs are, but you also need to pull the cost part out of the system to focus on the patient outcomes. Then you can make another analysis: This is a better outcome, but how much does it cost versus this, and what are the alternatives? MR. CHRISTENSON: Let’s assume it is going to be pretty much impossible to create a standard everybody is going to accept. Given that, then what can be done to make CER work? DR. BOTTLES: We are trying to take better care of patients; that would be the trumping thing. Then you have to have a fair process, and you have to be totally transparent. You

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have to be very candid about what your biases are and what they aren’t, and then we have to think about what is truly in the best interest of the patient. If we do all those things, then comparative effectiveness research may well be an important tool for us to give patients what they really want and help control health care costs. MR. GOODNO: I don’t know if anybody would disagree with doing the research to see what is the most effective treatment and to get the right outcomes that we are expecting. I do think that once they determine that, there may be some people concerned about the pocketbook impact and whether we should have any limitations on what kind of treatments are out there. Getting the information is important. The challenge is how we use that tool and that information. DR. DANIELS: In the absence of the information, the prospects are even more bleak. MR. MONROE: We all are coming down on the same point: There is no viable alternative for care delivery in this country. We have to use CER. I urge everyone to look at the recent Kaiser Health Tracking Poll on the Web. At the top, it points out the strong number of people who are opposed to health care reform. But as you go down through the points, everybody is in favor of a majority of the points. We have to be accountable to the people who are being served. It doesn’t do anything to try to tie it up because of this or that or the other thing. As long as it stays patient-centered, we are going to get to the right end result. MR. CHRISTENSON: One final question: Is there anything that can be done now to influence how CER regulations are going to be written to get the result that you are all talking about? DR. BOTTLES: If you go to Washington as a representative of a group, you can get input. It does not mean they always listen to you. But physicians should take the time, through their professional societies, to make their voice heard. I would say the same thing for patients, health plans, government, and everyone else. MR. GOODNO: The health care bill, although very lengthy, was silent in some areas. The silence was intentional, to get the bill passed. It is very important for folks to be diligent about what is going on. You can’t have as much impact with the rule-making process as with the legislative process, but you still have to be engaged and be involved.

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JANUARY 2011

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PROFESSIONAL

or centuries, people suffering with shoulder arthritis, serious shoulder injuries, and other conditions affecting this critical joint simply lived with their pain. With limited use of their arms, many had to rely on others to help them perform even the most routine tasks. The first shoulder replacement was performed in 1893 by French surgeon Jules-Émile Péan to treat a joint that had been destroyed by tuberculosis. Since this first implant, which was made of platinum and rubber, many significant advances have been made. Total shoulder arthroplasty (TSA) has become the standard of care in surgical treatment of degenerative arthritis (osteoarthritis) of the shoulder, and can reduce pain and restore use of the joint in patients with other shoulder conditions. Over 26,000 shoulder arthroplasties were performed in the United States in 2009, making the shoulder the third most commonly replaced major joint in the body, after the hip and knee. Two shoulder arthroplasty

U P D AT E :

ORTHOPEDICS

Shoulder replacement surgery Advances in diagnosis and design improve patient outcomes By Gregory N. Lervick, MD design categories are currently in use: unconstrained or conventional TSA and semi-constrained or reverse total shoulder arthroplasty (RTSA).

arthritis, as well as for those who have suffered trauma or injury to their shoulders, such as a fracture, dislocation, or rotator cuff tear.

The shoulder is the third most commonly replaced major joint in the body, after the hip and knee. Indications

Surgery is an option for patients who have severe pain that affects their daily activities and that cannot be controlled with medication, activity modification, or joint injection(s). This is often the case for patients with

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Proper patient selection typically requires appropriate clinical history, physical examination, and plain radiographic evaluation. While age is always considered in determining the need for shoulder replacement, it is not the only factor. Even more important is the patient’s general health. In other words, physiologic age is more important than chronologic age. Surgeries have been performed successfully on spry people even in their early 90s. The status of the rotator cuff—the muscle and tendon group that stabilizes the shoulder—must be carefully evaluated when considering shoulder replacement surgery. Supplemental imaging with either magnetic resonance (MRI) or computed tomography (CT) scanning often helps determine the most appropriate implant type for an individual patient.

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Unconstrained total shoulder arthroplasty (TSA)

A patient whose rotator cuff is relatively healthy will most likely undergo conventional TSA. This surgery is done through an incision in the front of the shoulder, and the arthritic joint is typically replaced by a metal ball and plastic socket (Fig. 1). Management of the glenoid, or socket, side of the joint has been a major area of interest and debate. Typically, the glen-

oid component is made of polyethylene and secured with bone cement. Long-term follow-up of the earliest generation of TSAs has demonstrated good component durability, with 87 percent of implanted devices still in place at 15 years following surgery, according to the Journal of Shoulder and Elbow Surgery (1997). However, these early designs frequently had radiographic evidence of glenoid component loosening. As a result, some surgeons have advocated performing hemiarthroplasty (HHA), where the humeral head is replaced but the native glenoid is left intact. This technique eliminates the risk of glenoid component loosening over time, and is quicker and easier to perform from a technical standpoint. Despite these attractive attributes, numerous comparative studies have shown HHA to be less effective than TSA in terms of pain relief and the need for revision surgery. The main reason for failure is the persistence or progression of arthritis on the glenoid side of the joint, according to the Journal of the American Academy of Orthopaedic Surgeons (2009). Improving implant durability and survivorship of the glenoid component continues to be a major clinical and biomechanical research focus. New metalbacked glenoid components have been developed, but have yet to be proven successful or clearly superior. Further clinical research will help determine the effectiveness and benefit of these designs in terms of safety, cost, and implant longevity. Follow-up studies demonstrate that TSA is effective in reducing pain and restoring function, while infrequently requiring subsequent operations or treatment. Patients who have undergone the procedure generally report significant positive impact on physical and emotional well-being and on overall quality of life. Semi-constrained (reverse) total shoulder arthroplasty (RTSA)

A subgroup of patients—roughly 20–30 percent of people with shoulder arthritis—has poor rotator cuff function. When dis-

ruption or dysfunction of the patient’s rotator cuff limits the stability or function achievable with unconstrained components, a reverse shoulder replacement (RTSA) is required. In this surgery, the joint is typically replaced by a metal ball and plastic socket, but the position of the ball and socket are reversed (Fig. 2). Reversing the joint allows the patient to lift his or her arm using the shoulder’s deltoid muscle, compensating for the loss of strength and stability caused by damage to the rotator cuff. The U.S. Food and Drug Administration approved RTSA in November 2004, although doctors in Europe have been performing this surgery since the 1980s. Initially, RTSA surgery was advised mostly for patients with rotator-cuff-tear arthritis or severely limited function due to an irreparable rotator cuff tear. Today, the indications for its use have expanded to include some complex proximal humerus fractures, proximal humerus mal- or nonunions, tumor reconstructions, and treatment of chronic shoulder dislocations in elderly patients. RTSA may also be used in salvage situations, such as revision of previously failed partial or complete shoulder replacements. The major concern with RTSA is implant longevity. The longest-term follow-up suggests this is reasonable up to 10 years after implantation. However, most specialists suggest that this type of implant should be limited to patients of advanced age, physiologically or chronologically (e.g., patients over the age of 65–70). Follow-up studies have demonstrated good clinical outcomes and a high level of patient satisfaction, similar to that achievable with conventional TSA. Careful patient selection and a discussion of the potential concerns of implant loosening are important before considering this option. Future long-term clinical follow-up, as well as biomechanical research and design, will likely improve implant durability and patient outcomes.

FIGURE 1 (left). In unconstrained total shoulder arthroplasty, the arthritic joint is typically replaced by a metal ball and plastic socket.

Surgeon selection

Because shoulder arthritis is less common than arthritis of the hip or knee, surgeons generally have fewer opportunities to gain experience with these shoulder procedures. Familiarity with the technical aspects of the procedure, as well as its indications, is critical to ensuring safety and effectiveness for the patient. It is recommended that the procedures be performed by a surgeon who has advanced training in treating shoulder conditions or devotes a significant portion of his or her practice to treatment of shoulder conditions. Several studies have clearly shown that surgeons and hospitals performing large numbers of shoulder replacements have the highest success rates. A 2003 study by researchers at Johns Hopkins University found that shoulder arthroplasties performed by high-volume shoulder surgeons resulted in about half the risk of complications as those performed by low-volume surgeons. Complications

As with any major orthopedic intervention, TSA or RTSA can result in complications. Those can include implant failure or loosening, fractures around the components, neurovascular injury, infection, thromboembolism, and progressive rotator cuff disease. Major complication rates generally range from 5 percent to 10 percent, and seem to have improved with refinement of the technique and better implant design. It is expected that ongoing clinical and biomechanical research will continue to lower these adverse outcomes and increase the longevity of implanted components.

for arthritis reported pain relief and a high degree of satisfaction in their treatment. Many people return to the athletic activities FIGURE 2 (right). In semithey used to do, such as constrained (reverse) total hunting, fishing, golfing, shoulder arthroplasty, the tennis, and skiing. joint is typically replaced Shoulder replacement by a metal ball and plastic surgery has provided socket, but the position of remarkable results for the ball and socket is patients who previously reversed. were unable to sleep, fix their hair, or raise their Recovery and rehabilitation arm to a certain height due to After surgery, a patient will shoulder pain. With advancelikely stay in the hospital for ments in technology and techone to three days before going nique, as well as increased home. During the first week or access to qualified surgeons, two, it is typical for patients to patients no longer have to live feel some muscle soreness with shoulder pain. and/or fatigue. After the second week, muscle soreness decreases Gregory N. Lervick, MD, specializes in shoulder and elbow injuries and conditions steadily. At three months, most at Twin Cities Orthopedics. He is also on of the recovery is completed, the faculty at the Minnesota Orthopedic though patients will continue to Sports Medicine Institute and the Fairview make gains in their recovery and Orthopedic Sports Medicine Fellowship strength. Program. In 2007, a research team at Johns Hopkins Hospital’s Division of Adult Orthopedics found that 99 percent of the patients who had a shoulder replacement

Join Our Prestigious Upper Midwest Group Practice Sanford Health is currently seeking BC/BE Family Medicine physicians to join staff at several of its primary care clinics. Good call arrangements and modern well-established community hospitals. OB is desired but not required. Sanford offers competitive salary and comprehensive benefits, paid malpractice and a generous relocation allowance. Excellent practice opportunities exist in communities located in the “Heart of Minnesota” lake country including Sanford Clinics in: • Bemidji • Cass Lake • Detroit Lakes

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ONCOLOGY

Breast cancer

reast cancer will affect about one in eight women in the United States, and about 12 percent of women will develop invasive breast cancer over the course of their lifetime. For women in the U.S., breast cancer death rates are higher than those for any cancer other than lung cancer. This article addresses the role of primary care physicians in diagnosis and prevention of breast cancer and management of patients with breast cancer. Mammogram screening recommendations

Early breast cancer is often found on screening mammography, but about 10 percent of breast cancers are found on routine physical examination by the patient or the primary doctor. It is common practice for women over the age of 50 to undergo an annual mammography and breast exam by their physician. The debate over whether to pursue routine screening mammography in women 40–49 years of age remains unresolved. At this

An update on diagnosis, prevention, and management By Noel Laudi, MD, MRCP (UK)

time, it is still recommended that screening mammograms be initiated at the age of 40 years in women without a significant family history. A study from Sweden published in the September issue of the journal Cancer suggests that breast cancer screening can lower the risk of dying of the disease by 26 percent or more in women 40–49 years of age. If this study were to hold true, screening all 22 million American women 40–49 years of age this year would translate to 2,000–2,200 lives saved. The role of MRI in breast cancer screening

Women whose mammograms show a larger area of dense tissue than the mammograms of

With more than 200 providers, Prevea Health offers expertise in nearly every specialty, with advanced specialties that are not found anywhere else in Northeast Wisconsin. Our patients have their choice of care at 18 locations, as well as their choice of three hospitals: St. Mary's and St. Vincent Hospitals in Green Bay and St. Nicholas Hospital in Sheboygan. At Prevea Health we believe that we're all part of one family, and that the best health care starts with a trusted relationship—someone who is there for the patient, whatever their health care needs. If that sounds right for you, we invite you to join our family. Prevea offers a very competitive salary and benefit program including: • 4 weeks vacation/CME • Malpractice, health, life, (6 weeks as shareholder) dental and disability insurance • And much more! • Relocation assistance • 401(k) and retirement plan Opportunities are currently available in: *note if no site listed – opportunity is for Green Bay (J-1 Visa Waiver not available) Cardiology (Sheboygan) Geriatrics Pediatrics Family Medicine Gyn Oncology Pediatric (Green Bay, Sheboygan) Ophthalmology Hospitalist Dermatology Psychiatry Internal Medicine Emergency Medicine Pulmonology/ Neurology Sleep Medicine Endocrinology Orthopedic Hand Rheumatology Gastroenterology Orthopedic Spine Contact Information

Dolly Willems, Physician Recruitment Green Bay, WI

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women of the same age are at increased risk of breast cancer. In addition, the denser the breast tissue, the more likely a diagnosis of breast cancer will be missed. The American Cancer Society recommends annual breast MRI in women with a 20–25 percent lifetime risk of developing breast cancer, based on breast cancer risk-assessment tools, such as the Gail model (www.cancer.gov/bcrisktool), which estimate a woman’s risk of developing invasive breast cancer over specific periods of time. Patients with documented BRCA gene mutations or patients who themselves are untested but have a first-degree relative who is BRCA-positive are candidates for annual breast MRI, in addition to their annual mammography, based on the available data and evidence. Patients with a history of radiation therapy to the chest (including the breasts) before age 30 are also at an increased risk of breast cancer. This includes women treated with radiation for Hodgkin’s lymphoma. Studies show that the younger a woman was when she received radiation treatment, the higher her risk of breast cancer later in life. These patients are advised to have annual breast MRI, starting 15 years after the radiation therapy. Referral for genetic testing

Inherited mutations in BRCA1 and BRCA2 are relatively uncommon in the general population. The estimated carrier frequency ranges from 1 in 300 to 1 in 800. Certain ethnic groups have been shown to have a higher carrier frequency (i.e., individuals of Ashkenazi Jewish descent). Five percent to 10 percent of all breast cancer cases and up to 14 percent of all ovarian cancer

cases are thought to be caused by BRCA1 and BRCA2 mutations. Based on current guidelines, we recommend referring patients for genetic testing if there is: • A personal history of breast cancer at an age younger than 50 or ovarian cancer at any age • Bilateral breast cancer or two or more primary tumors of the breast • Breast and ovarian cancer (in the same individual) • Breast cancer in a male In addition, patients with a history of two or more family members with breast and/or ovarian cancer, one or more close male relatives with breast cancer, or early-onset breast or ovarian cancer (before age 50) in a close relative should be referred for genetic testing. It is important to identify patients and families with the mutation, since testing may clarify risk of specific cancers and lead to earlier/increased screening, chemoprevention, and/or surgical options. For families with a known mutation, a negative test result reduces the patient’s risk of breast and ovarian cancer to that of the general population. Studies have shown that women with a BRCA1 or BRCA2 mutation have a lifetime risk of breast cancer ranging from 50 percent to 87 percent. The lifetime risk of ovarian cancer has been noted to range from 15 percent to 44 percent, depending on the specific mutation. Men with a BRCA mutation have a 5–10 percent lifetime risk of developing breast cancer. Hormonal therapy to reduce risk

The initial National Surgical Adjuvant Breast and Bowel Project (NSABP) P-1 trial demonstrated that tamoxifen could reduce the risk of invasive breast cancer by 49 percent and established proof of principle that chemoprevention of breast cancer is possible. Tamoxifen has been FDA-approved since 1998 for breast cancer risk reduction. Despite the significant reduction in breast cancer risk conferred by tamoxifen, it has

not been widely accepted in the primary care community and utilization has been limited. This is likely due to myriad factors, including the risks of tamoxifen therapy as well as primary care practitioners’ relative unfamiliarity with the drug. Primary care clinicians have generally been unenthusiastic about tamoxifen for chemoprevention, given its original use by oncologists in breast cancer treatment, combined with concerns about serious adverse events. As a result, many women who are at increased risk of developing breast cancer are not offered risk-reduction therapy. The recent addition of raloxifene as another FDA-approved breast cancer risk-reduction agent has expanded the use of breast cancer chemoprevention in general medical practice, as raloxifene is already familiar to primary care clinicians in treating osteoporosis. While tamoxifen is the only agent approved to reduce breast cancer risk in premenopausal women at increased risk of breast cancer, postmenopausal women now

have two options: tamoxifen or raloxifene. The STAR (Study of Tamoxifen and Raloxifene) trial found raloxifene and tamoxifen to be equivalent in efficacy for lowering the risk of invasive breast cancer in postmenopausal women. Of note, however, compared with placebo, raloxifene did not increase endometrial cancer risk. Raloxifene also was associated with significantly less risk of thromboembolic events and cataracts. These results demonstrate that raloxifene is an alternative for lowering risk of invasive breast cancer in postmenopausal women with higher Gail risk scores and in those with lobular carcinoma in situ (LCIS), for whom the Gail model does not apply. In contrast to tamoxifen, raloxifene does not reduce the risk of noninvasive breast cancer in postmenopausal women. After five years of therapy, tamoxifen should be discontinued; there are no data indicating additional benefit with continued therapy. Follow-up data from the International Breast

INTERVENTIONAL RADIOLOGIST

Consulting Radiologists, LTD. (CRL) is a well-established radiology practice in Minnesota. CRL is thriving in the progressive Midwest healthcare community by providing services in large tertiary care centers, other regional healthcare facilities, and teleradiology services to over 80 facilities. We are seeking an Interventional Radiologist, board eligible or certified for our practice in Duluth, MN. The candidate must be capable of performing interventional and general radiology procedures/ interpretations. The position will be supported by our extensive teleradiology network and subspecialty radiologists. This is an excellent and unique opportunity for a fellowship trained or experienced Interventional Radiologist that is eligible for MN licensure. This position offers partnership track, competitive compensation and a benefits program including flexible vacation time.

Contact Information: Tim Kratzke Director of Physician Recruitment Consulting Radiologists, LTD. (612) 573-2261 • (612) 573-2240 fax Tim.kratzke@crlmed.com

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Cancer Intervention Study have shown that the benefit of breast cancer risk reduction appears to persist even after cessation of tamoxifen. At this time, use of raloxifene beyond five years of therapy would be based on osteoporosis treatment factors, as no data yet exist to suggest further breast cancer risk reduction with continued use, although this possibility cannot be excluded.

profile for AIs appears relatively favorable compared with tamoxifen. The principal toxicity of AIs is accelerated bone resorption. AIs are generally well tolerated, with the primary side effects being musculoskeletal and joint discomfort. Prospective studies are under way to investigate the role of AIs as potential breast cancer chemoprevention agents. At this time, AIs are not FDA-approved for breast cancer prevention.

Aromatase inhibitors Surgical therapy to reduce risk

Aromatase inhibitors (AIs) lower circulating estrogen levels by blocking the conversion of androgens to estrogens catalyzed by the enzyme aromatase. AIs have proven effective in breast cancer treatment among postmenopausal women with hormone-sensitive tumors. In the adjuvant setting, studies have found third-generation AIs (anastrozole, letrozole, and exemestane) to be superior to tamoxifen. Clinical trial data from three studies show that AIs decrease the incidence of contralateral breast cancers by 37 percent to 55 percent. The safety

Among women at moderate and high risk of breast cancer, bilateral risk-reduction mastectomy can reduce breast cancer risk by 89.5–100 percent. In women with BRCA1/2 mutations, elective bilateral salpingooophorectomy reduced their risk of breast cancer by 53 percent and their risk of ovarian cancer by 96 percent. However, this surgery may negatively affect quality of life by inducing menopausal symptoms and increasing the risk of osteoporosis. Presurgical evaluation at a BREAST CANCER to page 36

Physician/PA-C/CNP and Physical Therapist opportunities Culturally sensitive medical care Rehabilitation Consultants, P.A. Private medical clinic affiliated with the University of Minnesota is looking for an experienced physician/ PA-C/CNP and physical therapist with a special interest in culturally sensitive medical care and pain management. 100% outpatient work, no nights, occasional Saturday coverage. Knowledge of foreign language is a plus. J-1/H-1B visa acceptable. Equal opportunity employer. Send resume to elena@elenarehabilitation.com, and alextolstov@hotmail.com or Phone: 651-206-5258 Fax: 651-797-3592

www.elenarehabilitation.com JANUARY 2011

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WOMEN’S

female patient comes into the emergency department (ED) twice in one week reporting chest pain, nausea, and breathing difficulties. An adolescent female reports worsening episodes of self-injury. An older woman identifies acute cognitive symptoms and psychomotor retardation. It may not be immediately apparent, but all of these women could be chemically dependent with a co-occurring mental health disorder. Women in this situation face significant barriers to entering addiction treatment. They are also more likely than men with similar problems to experience serious medical issues within a relatively short time. Women with co-occurring disorders have unique biopsychosocial needs that can complicate recovery if not addressed in a timely fashion. For these reasons, the need is profound to identify co-occurring disorders in women early. Prevalence of dual diagnosis

Also called dual diagnosis or “double trouble,” co-occurring

“Double trouble” Identifying addiction and mental health problems co-occurring in women By Anna R. Peters, PhD, LP disorders involve the simultaneous presence of one or more mental health problems and an addiction. According to the Substance Abuse and Mental Health Services Administration (SAMHSA), 50–75 percent of clients in substance abuse programs have at least one co-occurring mental health diagnosis, and 20–50 percent of patients in mental health settings have a co-occurring substance use disorder. The 2004 SAMHSA publication “Substance Abuse Treatment for Persons With CoOccurring Disorders” provides valuable information on the characteristics and needs of individuals with co-occurring disorders, as well as the causal pathways. For example, common genetic predisposition may

Physician-owned, multi-specialty group practice with 100+ providers, has an exceptional opportunity for a BC/BE Neurologist to join two others. You will see patients with a full spectrum of disease states and have an opportunity to participate in clinical trials. We provide staff and support for EMG, Lumbar Punctures, Polysomnograpy, Botox, Occipital Block and a full-time, plus a registered EEG technologist. We offer a first year income guarantee with a production incentive income thereafter; service area 300,000; great payer mix; $6,600 annual CME business allowance; potential shareholder status after one year; 401(k); profit sharing. Our picturesque community, population 50,000+ provides a great setting to practice medicine and raise a family plus year-round indoor/outdoor recreational at nearby lakes and resorts; excellent public and private schools with award winning academics and sports teams; state university, two colleges, community college, business school with combined enrollment of over 18,000; shopping mall with four anchor stores and new retail construction. Just over an hour from Minneapolis/St. Paul southern metro; easy access to international airport. No J-1 openings. Contact Dennis Davito, Director of Physician Placement, Mankato Clinic, 1230 East Main Street, P.O. Box 8674, Mankato, MN, 56002-8674; phone: 507-389-8654; fax: 507-625-4353; email: ddavito@mankato-clinic.com.

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H E A LT H

MINNESOTA PHYSICIAN JANUARY 2011

increase risk for both mental health and addictive disorders. An individual may develop mental health symptoms and “selfmedicate” with chemicals until a full-blown addiction is formed. Alternatively, a chemical-abusing individual may also later develop substance-induced disorders involving mood dysregulation, anxiety, sleep disturbance, or psychosis. The mental health disorders that most commonly co-occur with addiction include depressive, bipolar, anxiety, personality, eating, and psychotic disorders. An impediment to proper diagnosis in primary care settings is that mental health symptoms and addiction symptoms can mask or mimic one another. For example, the woman described above with chest pains and nausea may be in benzodiazepine withdrawal; she may have full blown panic disorder, or she could have both problems. Individuals presenting with intense mood cycling may be bipolar, chemically dependent, or both. Comprehensive initial screening is crucial in determining appropriate care plans for all of these difficulties. Many mental health disorders—including most mood, anxiety, and eating disorders— are more commonly diagnosed in women than in men. Although addiction has historically been more common in men, the gender gap is closing, particularly with respect to prescription medications. Women face greater social stigma regarding addiction, unique interpersonal stressors due to gender role expectations, and socioeconomic limitations that can complicate co-occurring disorders and act as barriers to entering a treatment program. According to SAMHSA and the Center for Substance Abuse Treatment (CSAT), women with co-occurring disorders tend to develop a mental health problem

first and then fall into addiction through self-medication of emotional symptoms. (CSAT, Treatment Improvement Protocol 51: Substance Abuse Treatment: Addressing the Specific Needs of Women, 2009). However, women may also develop substance-induced mental health problems, such as depression, anxiety, cognitive dysfunction, or psychosis, after a period of abusing chemicals. Of the 2,577 women discharged between 2007 and 2009 from Hazelden inpatient treatment center in Minnesota, 81 percent had a co-occurring disorder, according to Hazelden’s Butler Center for Research. Thirtythree percent had an anxiety disorder and 40 percent had a depressive disorder. Twenty-six percent reported that prior to entering treatment at Hazelden, they had been hospitalized or treated in a residential setting for a mental health disorder. Unique characteristics and needs

Women with co-occurring disorders have unique characteristics and needs: • Mood disorders, anxiety disorders, and eating disorders are more likely to occur in women with substance-use disorders than in men with substanceuse disorders. • Between 55 percent and 99 percent of women in substance-abuse treatment have experienced trauma, particularly childhood physical or sexual abuse, relationship violence, and sexual assault, making them more susceptible to depression, PTSD, and other trauma-related conditions. • Women with eating disorders are more likely to develop chemical dependency later in life. The link between bulimia nervosa and substance abuse is particularly strong. • Women in recovery from addiction can develop compulsive overeating, spending, or gambling. These cross-addictions can contribute to relapse on the drug of choice and can complicate mental health functioning. • Cross-addiction can also manDOUBLE TROUBLE to page 34

St. Cloud VA Medical Center is accepting applications for the following full or part-time positions:

• Internal Medicine

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(St. Cloud, Brainerd)

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(St. Cloud)

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Great Partners, Great Staff, Great Patients, Excellent Income & Lifestyle

• Dermatology (St. Cloud)

(St. Cloud)

Position available in Internal Medicine or Family Practice for one-time disability assessments (compensation and pension exams) 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 relocation bonus. EEO Employer.

Excellent benefit package including: Favorable lifestyle–no call 26 days vacation CME days

Competitive salary 13 days sick leave Liability insurance

Interested applicants can mail or email your CV to VAMC Sharon Schmitz (Sharon.schmitz@va.gov) 4801 Veterans Drive, St. Cloud, MN 56303 Or fax: 320-255-6436 or Telephone: 320-252-1670, extension 6618

Family HealthServices Minnesota, P.A. is looking for several Board Certified/ Eligible Family Physicians to fill full-time, part-time or shared positions. Join our Independent Group of 64 physicians serving 13 clinic sites. Neighborhood Based – Physician Owned- Family Medicine

For more information, please contact: Paul Berrisford, 2025 Sloan Place, Suite 35, St. Paul, MN, 55117 651-772-1572 email: pberrisford@fhsm.com

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Family Medicine w/ OB Opportunities in 2 Wonderful Rural Locations Altru Health System is seeking Family Practitioners to join our existing and thriving practices in Crookston, MN and Roseau, MN. Crookston, MN, a strong community of 8,000, is located along the Red Lake River in the heart of the fertile Red River Valley. Altru Clinic—Crookston is a well-established, collegial medical group with 5 Family Practice Physicians, 4 Internists and 3 Mid-Level Providers. We have an ongoing partnership with RiverView Hospital in Crookston that is a 25-bed, critical-access hospital connected to our clinic. Call is 1:7.

Altru is a physician-led, not-for-profit integrated health system that serves a referral population of more than 225,000. More than 180 physicians representing 44 specialties serve this population base. Altru Health System provides competitive compensation, reviewed annually with specialty-specific industry data, along with an extensive benefits package including generous pension and profit-sharing plans.

Roseau, MN, which is just 20 minutes from beautiful Lake of the Woods, is a Family Practice clinic consisting of 6 Family Practice Physicians, 3 Mid-Level Providers and 1 Internist. The town of Roseau has over 2,500 residents. LifeCare Medical Center is a 25bed, critical-access hospital just adjacent to our clinic. Our friendly community is safe and welcoming. Call is 1:7.

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

www.altru.org JANUARY 2011

MINNESOTA PHYSICIAN

For additional information on co-occurring disorders

Double trouble from page 32 ifest in the opposite direction. For example, women who have struggled with compulsive overeating and have had gastric bypass surgery frequently begin abusing alcohol. • Risk of suicide attempts and self-injurious behavior is particularly high in women with co-occurring disorders. • Women are often not screened in health care settings for trauma history, domestic violence, addiction, or eating disorders. Treating co-occurring disorders in women

Hospital EDs and obstetric or primary care settings are often the initial point of contact between women and the treatment system and, therefore, ideal for early screening of cooccurring disorders. CSAT provides the following recommendations for initial screening of women with addiction and/or co-occurring disorders: • Always screen for substance

• Substance Abuse and Mental Health Services Administration, National Center for Trauma-Informed Care, Co-Occurring Center for Excellence: www.samhsa.gov/, www.samhsa.gov/nctic/, www.coce.samhsa.gov/ • Treatment Improvement Protocol 51: Substance Abuse Treatment: Addressing the Specific Needs of Women: www.ncbi.nlm.nih.gov/books/NBK26013 • Hazelden, Behavior Health Evolution: www.hazelden.org, www.bhevolution.org • Preventing Alcohol, Tobacco, and Other Substance-Exposed Pregnancies: www.niaaa.nih.gov/AboutNIAAA/Interagency/Reports/Documents/NIAAA Report122309.doc • Quick Guide for Clinicians Based on TIP 42: Substance Abuse Treatment for Persons With Co-Occurring Disorders: http://kap.samhsa.gov/products/tools/ cl-guides/qgc-41-60.htm • Women, Co-Occurring Disorders, and Violence Study: www.wcdvs.com/

use. An empathic, nonjudgmental approach asking about chemicals used, amounts, and frequency of use can elicit valuable information or, at the least, build a trusting relationship that can encourage future openness to disclosure. • Keep in mind that, if a woman is abusing substances, there is a strong likelihood for mental health symptoms as well. • Screen for current and past mental health disorders, including PTSD and other anxiety disorders, mood disorders, and eating disorders. • Screen for current and past trauma.

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

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www.siouxfalls.va.gov 34

MINNESOTA PHYSICIAN JANUARY 2011

• Always screen for any imminent risk for self-injury, suicide, and violence. • Screen for HIV/AIDS, hepatitis, and STDs, as the risk for these is much higher in individuals with co-occurring disorders. • Keep in mind that mental and physical health symptoms can mask and mimic each other. If co-occurring disorders are identified, the first step should be any necessary detoxification followed by a comprehensive assessment of mental health and addiction. Outcomes are best when both disorders are identified early, addressed as two primary disorders, and treated simultaneously. Treatment for women with co-occurring disorders should ideally address: • Unique health concerns of women • Pregnancy, parenting, and childcare issues • History of trauma • Nutrition and eating patterns • Women’s roles as caregivers • Significance of relationships for women • Women’s gender roles and expectations • Safety, housing, financial issues • Lifespan transitional issues, such as aging and menopause • Self-esteem • The stigma of being a woman with both an addiction and mental health concerns The manner in which physicians ask questions may be more important than the questions themselves. Women with addiction and co-occurring disorders generally respond best to a sensitive, nonjudgmental approach. In the context of such an alli-

ance, women may be more likely to follow recommendations. For example, in the case of the female patient with chest pains, nausea, and breathing difficulties, step one should be ruling out medical causes for the symptoms. A likely conclusion is that this woman is experiencing panic attacks. Such symptoms can suggest chemical use as well as mental health issues. Here’s an example script for speaking with this patient: “Sometimes symptoms like these can be related to using alcohol, drugs like Xanax or Ativan, or prescription pain medications. Have you been using any of those? Any other drugs or medications?” A brief acknowledgement that you understand this may be a difficult subject to talk about, as well as a comment on confidentiality, might help elicit honest answers. Further questions on recent feelings of anxiety or depression, as well as recent experiences of “any traumatic events, such as violence in a relationship, a physical or sexual assault, harassment by someone,” can be used to identify mental health symptoms and traumatic experiences. For the other two patients described above, who reported recurrent self-injury and cognitive/psychomotor symptoms, a similar approach to questioning might elicit important information for appropriate treatment and sensitive patient care. Sensitivity, care collaboration are essential

Due to the scope of the problem of co-occurring disorders in women, treatment must be accessible from a variety of care settings. Collaboration among medical, behavioral health, and case management professionals is essential in order to address the unique needs of this population. Sensitivity of primary care clinicians to the unique social stressors, stigma, and self-concept of women with co-occurring disorders helps to create the initial incentive for these women to seek treatment. Anna R. Peters, PhD, LP, is an assistant professor at the Hazelden Graduate School of Addiction Studies, on Hazelden’s Center City, Minn., campus.

Allina Hospitals & Clinics in Minnesota/Western Wisconsin Allina Hospitals & Clinics is known for its clinical quality, and an award-winning EMR. At Allina, physician leadership and involvement drive our success. The Clinic and Community Division features the Allina Medical Clinic, Aspen Medical Group, and Quello Clinics, as well as Home and Community Services. Our clinics, as well as our 11 hospitals, are located in the Twin Cities metro area, throughout Minnesota, and in western Wisconsin.

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• Allergy • Dermatology • Emergency Medicine • Endocrinology • Family Medicine • General Surgery • Geriatrics (including Medical Director) • Hospitalist • Internal Medicine • Internal Medicine/Pediatrics • Neurology • Obstetrics & Gynecology • Orthopedic Surgery • Pain Management • Perinatology • Physical Medicine & Rehab (Cancer Rehab & SCI) • Psychiatry • Psychology • Urgent Care • Urology

Allina offers a competitive benefits and salary package. For more information, please contact: Kaitlin Osborn Allina Physician Recruitment Toll-free: 1-800-248-4921 Email: Kaitlin.Osborn@allina.com Fax: 612-262-4163 Website: allina.com/physiciancareers EOE

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

Family Medicine Rochester Northwest Clinic

Family Medicine St. Charles Clinic

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.

Send CV to: Olmsted Medical Center Administration/Clinician Recruitment 1650 4th Street SE Rochester, MN 55904

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

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

www.olmstedmedicalcenter.org

JANUARY 2011

MINNESOTA PHYSICIAN

Breast cancer from page 31 comprehensive cancer center is recommended for any woman who is considering risk-reduction surgery. Postmenopausal hormone replacement

A meta-analysis of 51 studies examining the relationship between breast cancer risk and use of postmenopausal hormone replacement therapy (HRT) reported an increased risk among women who ever used HRT (RR 1.35), and risk increased with duration of use. Participants in the Women’s Health Initiative (WHI) aged 50–79 years at time of enrollment were randomized to either estrogen (conjugated equine estrogen, 0.625 mg daily) and progesterone (medroxyprogesterone acetate, 2.5 mg daily) or a placebo for a mean of 5.6 years and then were observed for a mean of 2.4 years. While breast cancer risk was not elevated over the 2.4 years of observation, there was a 27 percent increase in breast cancer risk

among those in the active-hormone-intervention arm. The current evidence suggests that combination postmenopausal hormone use (with estrogen + progesterone) increases breast cancer risk, even within five years of use. Estrogen alone increases breast cancer risk more modestly, with no increase seen until 10 to 15 years of use. For estrogen alone, excess risk declines rapidly after stopping; however, further follow-up of the WHI cohort is needed to understand whether this is similar for use of estrogen-plus-progesterone therapy. Postmenopausal symptoms in breast cancer survivors

Breast cancer is often hormonesensitive (ER-positive and PR-positive). Patients on antiestrogen therapy often have symptoms of estrogen deprivation such as hot flushes, vaginal dryness, and depression. It can be quite challenging to control symptoms in these patients without using products contain-

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: • Internal Medicine • Internal Medicine • Pediatrics • Pediatrics

• Family Medicine • Urology • Family Medicine • General Surgery • Psychiatrist • General Surgery

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Lake Region Healthcare is an Equal Opportunity Employer. EOE

MINNESOTA PHYSICIAN JANUARY 2011

ing estrogen. Vaginal dryness can be a particular challenge, especially in patients on AIs. Estrogenbased local therapies are contraindicated in patients with hormone-positive breast cancer due to potential systemic absorption of estrogen. We recommend local lubricant applications such as Replens. Hot flushes often respond to gabapentin and serotonin reuptake inhibitors. Venlafaxine (Effexor) is not known to disrupt tamoxifen metabolism and hence is a useful drug to control menopausal symptoms. CYP2D6 inhibitors in patients taking tamoxifen

Tamoxifen metabolism is complex, but it is known that CYP2D6 is necessary to form its active metabolite endoxifen. This hepatic enzyme can be inhibited by many drugs, of which antidepressants are the most important. Fluoxetine (Prozac), paroxetine (Paxil), bupropion (Wellbutrin), and duloxetine

(Cymbalta) can substantially inhibit CYP2D6 and may reduce tamoxifen efficacy. Weaker inhibitors of CYP2D6 include other antidepressants such as citalopram (Celexa), escitalopram (Lexapro), desvenlafaxine (Pristiq), and sertraline (Zoloft). Although they are probably preferable to the more potent CYP2D6 inhibitors, theoretically they could inhibit tamoxifen in some patients. Venlafaxine (Effexor) seems to have little or no effect on CYP2D6. Some over-the-counter antihistamines such as diphenhydramine (Benadryl) also inhibit CYP2D6. Patients receiving tamoxifen should be advised not to start any new medication (prescription or OTC) without someone checking to make sure it is not a significant CYP2D6 inhibitor. Noel Laudi, MD, MRCP (UK), practices hematology and medical oncology with Minnesota Oncology, at its Coon Rapids location.

Growing multi-specialty group practice in Northern Minnesota is looking for a BC/BE Family Practice Physician, Internal Medicine Physician, Emergency Room Physician, OB/GYN Physician, Urologist as well as an Orthopaedic Surgeon. Join an existing group practice and take over existing practices from departing physicians. Grand Itasca Clinic & Hospital in Grand Rapids, Minnesota has recently opened a new state of the art clinic & hospital. Excellent salary guarantee with outstanding income potential, full benefits and sign-on bonus. Community located in the beautiful northern Minnesota lakes area.

Contact: Gail Anderson (218) 999-1447 gail.anderson@granditasca.org.

Urgent Care Minneapolis/St. Paul

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

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

• Internal Medicine • OB/GYN • Oncology • Orthopedic Surgery • Pain Management • Pediatrics

• Psychiatry • 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

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JANUARY 2011

MINNESOTA PHYSICIAN

Table 1. Hepatic causes of mild AST/ALT elevations

Liver from page 19 Nonsteroidal anti-inflammatory agents (NSAIs) and penicillin derivatives are the most common causes of liver enzyme elevations and should be discontinued if possible. Acetaminophen can cause acute and chronic elevations that are dosedependent and exacerbated by chronic alcohol use. In general, if other causes of liver disease are ruled out and enzyme elevations persist, any medication not absolutely required should be eliminated. Clearly, if there is a temporal relationship between beginning a new medication and a rise in liver enzyme elevation, that medication should be stopped if possible. General approaches

If enzymes are elevated greater than 2.5 times normal, a workup is warranted. Lesser elevations require a more nuanced approach. Hepatitis serologies should be obtained when any elevations in patients with risk factors for viral hepatitis are seen. Transaminase elevations in a patient with chronic alcohol

Viral hepatitis (A-E, acute and chronic B and C, cytomegalovirus, Epstein-Barr virus) Non-alcoholic fatty liver disease (NAFLD) Non-alcoholic steatohepatitis (NASH) Alcoholic liver disease Hemochromotosis Medications/toxins Autoimmune hepatitis Alpha-1-antitrypsin deficiency Wilsonâ&#x20AC;&#x2122;s disease Table 2. Hepatic causes of mild ALP elevations Infiltrative disease (malignancy or granulomatous disease) Biliary obstruction Primary biliary cirrhosis Primary schlerosing cholangitis Drug toxicity use should be rechecked after several weeks of abstinence, especially if AST is greater than two times ALT. Medications for common hepatotoxins, especially NSAIs and penicillin derivatives, should be reviewed and potential offending medications eliminated. Iron studies should be obtained if there is a family history of liver disease. If the patient is younger than 40 and there is a family history of neurologic or liver disease, cerulo-

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plasm levels should be checked. In a patient with a significantly increased BMI or with other manifestation of metabolic syndrome, counseling to lose weight is important. Fatty liver is the most common cause of persistent low-level transaminase elevations. If fatty liver is suspected, imaging of the liver can be confirmatory. If enzyme elevations persist, liver biopsy to assess severity of damage may be required. Patients with autoim-

mune diseases warrant a check of anti-smooth-muscle and antimitochondrial antibodies. Generally, a single elevation of liver enzymes less than three times normal can be monitored (exceptions are noted above). If these remain elevated over several months, further workup is warranted. There is no absolute rule about how long to monitor, but a recheck at sixmonth intervals is reasonable. An acceptable approach would be to further investigate if the elevations are present on three occasions. If, however, there are signs of end-stage liver disease on physical exam (ascites, edema, spider angioma, jaundice) or laboratory indicators of liver dysfunction (low albumin, elevated INR, low platelets), referral for any liver enzyme elevation is warranted. Jeffrey Rank, MD, is a member of Minnesota Gastroenterology, PA. In addition to his regular practice, he sees outpatients at the groupâ&#x20AC;&#x2122;s Hepatology Clinic in St. Paul.

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