Volume XXV, No. 4
July 2011
The Independent Medical Business Newspaper
Small steps, long journey Achieving “meaningful use” By Paul McGinnis, MD
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Equity W in health care
PAID
EQUITY to page 10
PRSRT STD U.S. POSTAGE
By Stephen Nelson, MD
MEANINGFUL USE to page 12
IN THIS ISSUE: Health Care Roundtable Page 20
Detriot Lakes, MN Permit No. 2655
Examining the impact of racial bias
e all strive to provide quality health care to our patients and families. But what exactly is quality health care? The Institute of Medicine defines it as care that is timely, efficient, effective, safe, patient-centered, and equitable. Here we examine equity in health care, specifically for black Americans. While many factors affect health care equity, disparities based on race that target communities of color are consistently reported in the management of many diseases. For example, blacks receive a lower standard of care than whites when being treated for breast cancer, orthopedic problems, cardiovascular disease, pain, and end-of-life care, among other conditions. According to the 2009 National Healthcare Disparities Report produced by the Agency for Healthcare Research and Quality, many of these discrepancies are not decreasing. Blacks receive worse
n April 18, 2011, the Centers for Medicare & Medicaid Services (CMS) opened its website for health care practitioners to attest to meeting electronic health record (EHR) meaningful use goals (see sidebar and EHR Incentive Programs information at www.cms. gov/ehrincentiveprograms/). Twelve physicians from Western Wisconsin Medical Associates (WWMA) were among the first 100 physicians to attest on that site. Our accomplishment resulted not from a spontaneous, Friday-afternoon decision, but rather from months of decisionmaking, planning, study, monitoring, and evaluation. Achieving meaningful use is best understood in the context of focusing on the quality of care we deliver to our patients. While initially there are financial incentives—and, later, financial disincentives—for achieving meaningful use goals, the incentives cannot be the only driving factor. If
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CONTENTS
JULY 2011 Volume XXV, No. 4
FEATURES Equity in health care Examining the impact of racial bias
1
MINNESOTA HEALTH CARE ROUNDTABLE
By Stephen Nelson, MD
Small steps, long journey Achieving “meaningful use”
1 T H I R T Y- S I X T H
SESSION
By Paul McGinnis, MD
Minnesota Health Care Roundtable The Wellness Revolution
20
DEPARTMENTS 4
CAPSULES MEDICUS
7
INTERVIEW
8
PEDIATRICS Fetal alcohol syndrome disorders
14
By Mary Meland, MD
Accountable Care Organizations Accountable to Whom? Thursday, October 13, 2011
Ron Latz State Senator
1:00 – 4:00 PM • Duluth Room Downtown Mpls. Hilton and Towers
SPECIAL FOCUS: ONCOLOGY Quantum leap
28
By Cally Vinz, RN, and Melissa Marshall, MBA
Proton beam therapy
Breast cancer care
32
By Madeline Gartner, MD
30
By Robert L. Foote, MD
The Independent Medical Business Newspaper
Background and focus: Created as part of national health care reform, accountable care organizations (ACOs) are now part of every health care policy discussion. As defined by the 111th Congress, ACOs are organizations that include physicians, hospitals, and other health care organizations with the legal structure to receive and distribute payments to participating physicians and hospitals to provide care coordination, invest in infrastructure and redesign care processes, and reward high-quality and efficient services.
Exactly what this means is unclear, and a confusing array of levels and qualifications for ACOs has been proposed. With 2012 as a start date for Medicare reimbursement through ACOs, Congress is developing firm definitions at this time. Some say ACOs turn physicians into insurance companies; others say they are a way for physicians to take a leadership role in fixing a broken system. As health care organizations race to join, create, or redefine themselves as ACOs, they all face more questions than answers. Objectives: We will review the history, goals, and rationale behind the ACO model. We will review the latest federal guidelines defining what an ACO can be. We will discuss how the ACO will affect health insurance companies, employers, and the pharmaceutical industry. We will illustrate what must not be allowed to happen if the model is expected to succeed. We will examine who decides if ACOs are successful and how those decisions will be made. We will explore why so many people, representing very different perspectives on health care, are opposed to the idea and what can be done for it to achieve its best potential.
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JULY 2011 MINNESOTA PHYSICIAN
3
CAPSULES
Mayo Re-brands Health System A new branding effort recently took place in health facilities in Minnesota, Wisconsin, and Iowa, as Mayo Health System becomes Mayo Clinic Health System. The Rochester-based health system first announced plans for the change last October, and the new name became official on May 20. The change may seem subtle at first glance, but it will be more noticeable in communities whose hospitals and clinics have operated under locally familiar names that in many cases have had the words “Mayo Health System� added on. With the new branding, for example, Franciscan Skemp Healthcare in LaCrosse, Wis., becomes Mayo Clinic Health System in La Crosse. St. Joseph’s Mayo Health System in Mankato will now be known as Mayo Clinic Health System in Mankato. Fairmont Medical Center becomes Mayo Clinic Health System in Fairmont.
Officials say all 70 communities that are served by Mayo Clinic Health System facilities will now see a common, uniform name for health care delivery. “Mayo Clinic Health System has evolved over time, and today our sites work together more closely with each other and Mayo Clinic than ever before,� says Rob Nesse, MD, chief executive officer, Mayo Clinic Health System. “We operate as one system and work together to provide our patients with the care they need, where they need it—whether that’s in their hometown, a neighboring community, or in Rochester. Our new name reflects that.�
Report Ranks Minnesota 2nd in Health Care Quality Minnesota ranks second in the nation in a state-by-state report on health care quality by the Agency for Healthcare Research and Quality (AHRQ). The federal agency, part of the U.S.
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MINNESOTA PHYSICIAN JULY 2011
Department of Health and Human Services, issues the annual report based on data drawn from more than 30 sources, including governmental and private surveys. New Hampshire ranked first in the report, followed by Minnesota, Maine, Massachusetts, and Rhode Island. The study found that Minnesota was one of the top states for showing overall improvement in health care quality. Nationally, AHRQ officials say, states are seeing improvements, but disparities in care for minority and lowincome residents persist. “Every American should have access to high-quality, appropriate, and safe health care, and we need to increase our efforts to achieve that goal because our slow progress is not acceptable,� says AHRQ Director Carolyn M. Clancy, MD. “These AHRQ 2010 State Snapshots not only provide states with a benchmark on how they are doing in these areas, but they also provide resources that states can use to
make improvements.� The AHRQ report called Minnesota’s overall care “strong� and ranked it high in a number of areas, including first in the nation for timely care for heart attacks, first for lowest number of deaths due to HIV, fourth for ambulatory care, fifth in nursing home care, and eighth for hospital care. The report says Minnesota’s weakest areas came in measurements of mobility and bathing with home health care, fecal occult blood tests, the number of anxious or depressed nursing home residents, and obstetric trauma in cesarean births.
Diabetes Wizard Application to Help Patients, Providers HealthPartners is providing a new “Diabetes Wizard� as part of its electronic health record (EHR). The new application will help diabetes patients and their providers customize a treatment plan for each individual patient, officials say.
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The Diabetes Wizard application was developed by the HealthPartners Research Foundation in collaboration with the HealthPartners Medical Group, and has been tested in a number of clinics throughout the health system. The app will be expanded for use in all HealthPartners clinics this summer, officials say. Officials say the application takes much more patient detail into account than previously available in “prompts” provided by EHR systems. The details include data on patient age, current medications, smoking status, kidney function, and history of heart disease or congestive heart failure. The system can also identify gaps in care, such as the need for a screening test for kidney disease The application will be helpful to primary care physicians, who provide much of the care for patients with diabetes, by providing additional resources through the EHR, officials say. “Because much diabetes care is provided in primary care settings, EHRs truly have the potential to meaningfully improve the health of patients with diabetes,” says Patrick O’Connor, MD, MPH, senior clinical research investigator of the HealthPartners Research Foundation. “The EHR can present personalized patient information in a single screen to the physician and patient in an instant. This allows physicians and patients to have complete information at the office visit when they are making choices about their care.”
MDH Says Growth In Health Spending Slowed in 2009 A new report by the Minnesota Department of Health (MDH) finds the lowest level of growth in health care spending in more than a decade. The report says total health care spending in the state rose to $36 billion in 2009, but the recession led many to put off elective and other types of care, resulting in a 3.8 percent rate of
growth in health care spending. That’s the slowest rate of growth since 1997, officials note. The Health Economics Program at MDH created the report using data from public programs, Medicare, private health plans, and out-of-pocket spending. The study found that Minnesota continues to spend less on health care per person than the country as a whole. In 2009, per-person spending in Minnesota was $6,913, compared to $7,590 nationally. In addition, health care spending in Minnesota accounts for a smaller share of the economy than nationally: 14.1 percent, compared to 16.5 percent. The recession hit Minnesota hard in 2009, resulting in changes in utilization of health care, MDH officials say. “There is evidence that during the recession Minnesotans reduced their use of elective and even routine care, a trend that mirrors national patterns in 2009,” says Stefan Gildemeister, assistant director of the Health Economics Program. “Several factors contribute to this change, such as the loss of private coverage, the expectation to pay more in premiums or out-of-pocket costs, and declines in income in 2009.” Even with the slow recovery, health care spending is projected to grow at a rate of 7.6 percent in Minnesota through 2019. MDH Commissioner Ed Ehlinger, MD, says the report shows the importance of sticking with the state’s health care reform law passed in 2008, which uses a range of tools to address rising health care costs. MDH officials note that among those tools are provisions such as provider peer grouping, health care homes, and investments in public health. “Health care spending makes up an ever-increasing share of our economic resources in Minnesota, and we have to find a way to restrain that cost growth,” Ehlinger says. “One important way to do that is to invest upstream, to make fundamental, long-lasting
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CAPSULES to page 6
JULY 2011
MINNESOTA PHYSICIAN
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CAPSULES
Capsules from page 5 changes that improve health and help prevent Minnesotans from being pulled into the health care system in the first place.” Without the state reforms, MDH officials say, health care spending would more than double over the next 10 years, to $78 billion.
Mayo, Allina Named as Top Health Systems Mayo Clinic in Rochester has been named one of the top 10 health systems in the country by Thomson Reuters. The annual report looks at a range of independent research and public data sources to identify high-quality health systems, officials say. The report says top health systems have better short- and long-term survival rates, have fewer complications, closely follow care protocols and patient safety standards, and garner
6
MINNESOTA PHYSICIAN
better patient satisfaction results than other hospitals. The report also lists Minneapolis’ Allina Hospitals and Clinics as being in the top 20 percent of the 285 U.S. health systems analyzed.
Klobuchar, Paulsen Launch Wellness Caucus Two Minnesota lawmakers recently helped launch a new Wellness Caucus in Congress to lobby for policies that promote healthy lifestyles and workplace wellness programs. Sen. Amy Klobuchar and Rep. Erik Paulsen say the new caucus will be a bipartisan group in both the House and Senate that will investigate and share best practices and resources to help businesses support employee health and wellness. The new caucus was announced on June 13 at Bloomington-based Apogee Enterprises, a window-making company that has promoted a
JULY 2011
wide range of wellness programs at its worksites. Several Minnesota health care leaders were at the event, including Commissioner of Health Edward Ehlinger, MD; Blue Cross and Blue Shield of Minnesota chief prevention officer Mark Manley, MD; and Tom Mason, president of Alliance for a Healthier Minnesota, which sponsored the event. Klobuchar and Paulsen praised the efforts of businesses like Apogee that are leading the way in wellness efforts, saying that employers are coming to understand the importance of addressing employees’ health in a proactive way. In her remarks, Klobuchar noted that congressional leaders from both parties see wellness as an issue where they can find agreement in the oftencontentious area of health care reform. “Staying healthy is not an issue of Democrats versus Republicans or business versus labor, it’s an issue where people can find common ground,” she says. “Fundamentally this is about empowering people, so
they can get better information, so that they can have access to workplace wellness programs, and so that they can have the tools and the resources to stay active and live healthy lives.” Paulsen also praised the bipartisan nature of the caucus and said he would work to bring more members of Congress into the effort and educate lawmakers by showcasing employer success stories. Paulsen added that working on prevention and wellness will be key to bringing down health care costs. “This is a win-win for everyone in the work place. Employers see lower health care costs. Employees see the benefits of better health, lower out-of-pocket costs for health care, better access to health care resources, and also working in that safer, healthier environment,” he says. “I think the days of eating clubs and going to happy hour are slowly diminishing, and now we’re going to see more fitness clubs and 5K runs.”
MEDICUS
Two physicians have joined Lakeview Health and will practice at Stillwater Medical Group’s Curve Crest Clinic in Stillwater. Jessica Macrie, DO, MPH, received her doctor of osteopathy degree from the University of New England College of Osteopathic Medicine and completed her residency at Cabarrus Family Medicine in North Carolina. She is board-certified in family medicine. Nicolas Krawczyk, MD, received his medical degree from the University of Minnesota Medical School and completed his residency in family medicine at the U of M/North Memorial Hospital. He is board-certified in family medicine. Suja Roberts, MD, has joined Clinic Sofia, an Edina-based ob-gyn clinic. She had practiced for the past four years at Fairview Health Services. Roberts completed medical school in India before completing her residency training Suja Roberts, MD at Loyola University in Chicago. She is boardcertified by the American College of Obstetrics and Gynecology. Essentia Health has hired several new physicians. Kunal Shah, MD, has joined Essentia Health’s Duluth Clinic in the pulmonary and critical care section as a critical care intensivist. Shah attended Maharaja Sayajirao University in Baroda, India. He completed his residency in internal medicine at Beth Israel Medical Center in New York and a fellowship in critical care at the University of Pittsburgh Medical Center. He is certified by the American Board of Medical Specialties in internal medicine. Steven Sutherland, MD, has joined Essentia Health’s Behavioral Health Department. He is certified in psychiatry and neurology as well as child and adolescent psychiatry by the American Board of Medical Specialties. Sutherland’s medical degree is from Mayo Medical School in Rochester, Minn. He completed his residency in psychiatry at the University of Wisconsin Hospital and Clinics in Madison, where he also completed a fellowship in child and adolescent psychiatry. He will be involved in the new Amberwing project, a $5 million mental health facility being developed by the Miller-Dwan Foundation. Jeffrey Rengel, MD, has joined the anesthesiology department at Essentia Health–St. Mary’s Medical Center. Rengel received his medical degree from Tulane University School of Medicine in New Orleans. He completed his residency in anesthesiology at the San Antonio Uniformed Services Health Education Consortium in Texas. Rengel is certified by the American Board of Medical Specialties in Anesthesiology. The American Society for Laser Medicine and Surgery (ASLMS) has named Brian Zelickson, MD, president of the professional organization. Zelickson, who is director of Zel Skin & Laser Specialists, Edina, received his medical degree from Mayo Medical School in Rochester, Minn., and completed postgraduate medical training at Hennepin County Medical Center and at the Mayo Clinic Graduate School of Medicine, and the University of North Carolina, Chapel Hill. He has published more than 30 medical journal articles on laser medicine and surgery and currently serves on the Government Liaison/Blue Ribbon Committee for the ASLMS. Didima Mon-Sprehe, MD, MPH, has joined Children’s Respiratory and Critical Care Specialists, PA. She had been a pediatric intensivist at Sanford Children’s Specialty Clinic in Sioux Falls, S.D., since 2006. She received her medical degree and master’s of public health at the Tufts University School of Medicine in Boston and completed a fellowship at Children’s Didima Mon-Sprehe, Hospital in San Diego, Calif. MD, MPH William C. Vincent, MD, has joined the medical staff of Fairview Mesaba Clinics, where he is practicing as a full-time general surgeon at Fairview University Medical Center– Mesabi and seeing patients in the Fairview Mesaba Clinic–Hibbing. He received his medical degree from the University of Minnesota and completed his residency in general surgery at the Iowa Methodist Medical Center in Des Moines.
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MINNESOTA PHYSICIAN
7
INTERVIEW
A controversial bill galvanizes legislative action ■ Tell us about the anti-cloning bill.
Ron Latz Minnesota Senate Senator Ron Latz was first elected to the Minnesota Senate in 2006. He represents District 44, which includes St. Louis Park, Hopkins, and two-thirds of Golden Valley. Prior to being elected to the Senate, Latz served for four years in the Minnesota House of Representatives and for nine years on the St. Louis Park City Council. This spring, Latz helped lead the opposition to anti-cloning legislation in the 2011 Session. The bills, which were passed by the Legislature as part two omnibus spending bills, were defeated when Gov. Mark Dayton vetoed all major spending bills in May. The governor singled out the anticloning provisions as being harmful to medical research and job creation in Minnesota.
8
try, you are committing a crime. If you receive it in the mail, you are committing a crime. In addition to affecting clinical treatment, this has a business impact. The Biobusiness Alliance came out opposing this bill, and for good reason. We have an enormous medical research business community in Minnesota. This kind of law could have a specific effect on some of their research. But more importantly, it sends a message to the rest of the county that we’re not open for this kind of business. That the political climate here is such, that if you were to invest in Minnesota businesses doing this, you might find that the Legislature will pass a law prohibiting you from doing it. That has a huge potential impact—not only for biobusiness, but also for the University of Minnesota and for Mayo Clinic’s efforts to recruit scientists who might do research and clinical work that has any relation to this. It’s a terrible message.
The bill was introduced under the guise of banning human cloning. The key to the bill was in the definition of human cloning. The definition that the bill’s authors used is far broader than what the scientific community or the average person understands human cloning to mean. The process here is that scientists take an unfertilized egg and replace its nucleus with a nucleus from a living individual’s skin cell. They put the egg in a Petri dish and allow it to grow for three or four days. So it divides 16 times, or 32 times, or 64 times. Technically, it’s an embryo at that point. And it has developed stem cells, and those stem cells are pluripotent: They can develop into any more specialized kind of cell. When they put these cells back into the donor’s body they will not be seen as a foreign body, and the immune system will not attack and destroy them. Essentially what you have is the ability ■ Is this really just a pro-life issue? to personalize the treatment for someone who I think it is, although I wouldn’t characterize it that is sick. And there have been some instances in way. Pro-life has two meanings which it’s been demonstrated to me. Yes, the movement that to be successful. is generally referred to as the What the bill’s supporters This bill goes further pro-life movement, sometimes are saying is, “You can’t do also known as the antiabortion than just prohibiting that.” Because when you’re movement, for them this is a removing the stem cells from a particular scientific significant issue. Minnesota the embryo, you’re destroying Citizens Concerned for Life technique. it and therefore destroying a (MCCL) for example, testified human life. That’s the theory at every hearing for this. They of those who would ban this were the principal movers behind this. Their execu[process]. And it is consistent with their definition tive director, Scott Fischbach, is the husband of of life, within the pro-life movement. Sen. Michelle Fischbach, the president of the However, from my perspective it’s not a human Senate and the author of the bill. life at that point. I’m not belittling the sincerity To me, pro-life has a much broader meaning. of their position or the religious views that also It seems to me that lives can be saved, diseases can inform that position. But they’re calling it human be cured or prevented, or potentially so, by using cloning because they know the public objects to this kind of scientific research and techniques, and human cloning. And almost all scientists object that is very much pro-life. on ethical and moral grounds to actual human cloning. But the way they’ve defined this now, it ■ How did this bill reach the point that it took has a much broader reach. a veto from the governor to stop it from becoming state law? ■ What are some of the implications this legislation could have for health care delivery? There are a lot of implications. This bill goes further than just prohibiting a particular scientific technique. It says you cannot “participate” in an attempt to perform this technique. Participation could include simply donating your own skin cell. Quoting from the bill, “you cannot ship, import, or receive for any purpose an embryo produced by this technique or any product derived from such an embryo.” So if you are a patient and you go to Wisconsin and receive a treatment with stem cells derived from using this technique, and you return to Minnesota, you are committing a crime. If you are a doctor and you import stem cells that have been created with this method in another state or coun-
MINNESOTA PHYSICIAN JULY 2011
A couple of ways. One is that the MCCL has tremendous influence in the Legislature. The new Republican majorities in the House and Senate are particularly susceptible to the influence of the MCCL. So they had the numbers this year that they hadn’t had in the past. And they had chairs of the committees that were willing to hear the bills and pursue them. Part of it, at least initially, was that it was introduced and scheduled for committee hearings very, very fast. It was introduced on a Friday, and already on the committee agenda on Tuesday. So the broader array of interest groups that might have mobilized to oppose it didn’t have the ability or the time to do that, certainly not quickly enough.
I’m talking about the disease-oriented groups, the American Diabetes Association, the American Cancer Society, the Muscular Dystrophy Association—you can run through the long list, all these health-related organizations that raise money and fund research to cure particular diseases—they were practically absent from the legislative process. They, as organizations, just can’t move quickly enough to be responsive to this kind of fast-track legislative process. Mayo Clinic, by the way, sat on the sidelines for quite a while. I finally called Mayo directly and said, “We need a letter from you, a letter that says this is bad. We know that’s where you’re at, but we need you on record.” They came up with a letter that put them on record as opposing this legislation, and that just infuriated Sen. Fischbach, who was carrying the bill as the chief author. ■ Why was anti-cloning language included
in a number of bills, including two major budget bills? I can’t state for certain what their legislative strategy was. I would suggest that probably they figured they could get something through in one bill or another. If it gets buried in a big bill, a lot of times people will vote for it even if they don’t like certain provisions in it.
■ The University of Minnesota was very
vocal in mobilizing opposition to this bill. What can you tell us about their perspectives? They were caught flat-footed too, at first. Eventually the U of M galvanized a broader array of opponents and held a big press conference on the topic with a lot of families with kids who had been treated this way. Mayo, on the other hand, I’m not sure why it took them a while to get on board. At first they told the Senate leadership they were going to stay out of it. They eventually put a letter together. They don’t specifically do this technique, but they’re partners with the U of M on a lot of research. And certainly from the scientific standpoint, they objected to these kinds of statutory restrictions. I suspect earlier they made a political decision that they were not going to get involved, but eventually the heat got turned up. I know I leaned on them a bit. They probably heard from other places as well and eventually decided to put out a letter. ■ You mentioned that Sen. Fischbach is
married to the executive director of the MCCL. How common is this sort of situation? I think it’s pretty uncommon. They’re obviously a family involved in politics. It’s been mostly a non-issue over the years. But the
MCCL has been a very powerful lobbying organization at the Capitol for many years. It just happens they’ve now got a senator in a very high place who has a very unique connection to them. With her as Senate president, if there were any members of the majority who were inclined to vote against the bill for whatever reason, they would have that much added incentive to toe the party line and vote for the bill. I think it raises some questions. They didn’t shy away from it—the MCCL staff was sitting right up there next to the Senate president who was the author of the bill. ■ What can physicians do to help elevate
the public understanding of the nature of medical research as it applies to these issues? One thing they ought to do is embolden the Minnesota Medical Association to be active in these kinds of questions at the Capitol. Doctors can write letters to the editor or op-ed pieces, and they will be credible voices on this topic. I don’t know if it would have changed the outcome in this case, due to the policy positions of the legislators now in the majority. But in terms of public opinion, it’s important, and in the long run that does have an impact on positions that legislators take. It only takes a few votes on the floor to change the outcome of a bill.
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Blacks receive worse care than whites for half of the core measures studied.
Equity from cover care than whites for half of the core measures studied, and only about 20 percent of measures of disparities in quality of care improved over the study period of 2000–2007. Being uninsured was the single strongest predictor of quality of care. However, when correcting for uninsurance and socioeconomic status, blacks still receive worse care than whites. Locally, a recent Wilder Foundation study reported similar results. Blacks in the Twin Cities have significantly shorter life expectancy than whites, even after correcting for socioeconomic status. (“The unequal distribution of health in the Twin Cities: a study commissioned by the Blue Cross and Blue Shield of Minnesota Foundation,” October 2010) These discrepancies raise the question: In what ways does racism shape disparities in health care, especially for blacks? Background
For 18 years I have had the honor of caring for the majority
of children with sickle cell disease (SCD) in Minnesota. About 100,000 Americans, including approximately 600 Minnesotans, are living with SCD. I have only recently begun to consider how, as a white male physician, my race may affect the health care delivery to our patients of color. This consideration is long overdue. Barriers to racial health care equity include the health care system (insurance, funding, white domination in provision of care), the patient (poor health literacy, fear, mistrust), the community (awareness, advocacy), and we the providers (bias, attitudes, expectations). The vast majority of Americans with SCD are black. This might not be a concern if there were not significant gaps in private and public funding for clinical care and research between diseases affecting
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blacks and whites in our country. In 2004, the National Institutes of Health spent $90 million on SCD and $128 million dollars on cystic fibrosis (CF), a disease that predominantly affects whites—despite the fact that there are three times as many Americans with SCD. When philanthropic support from the CF Foundation and the Sickle Cell Disease Association of America is considered, the percapita support for patients with CF is $5,074, compared to $6 per person with SCD. These gaps are even more disconcerting when we consider that SCD is the most commonly detected disease in newborn screening programs in the U.S. Patient perspective
From early medical experimentation on slaves, starting in the 17th century, to the Tuskegee experiments (1932–1972), to coerced sterilization of young black women (which was legal until 1974 in areas of the South), to present-day attitudes about AIDS contraction, the history of racism in medicine (and health care overall) toward black Americans has undoubtedly shaped this community’s lack of trust in the health care system. This legacy of racism and the resultant mistrust may partially explain racial disparities, as it may decrease black patients’ willingness to follow evidence-based recommendations made by (predominantly white) physicians. Another patient-related issue reflecting this history and the race-class connection in the U.S. is decreased access to care based on socioeconomic status. For example, access issues such as health care literacy, time and physical availability to optimize the most rigorous treatment plan, and even transportation to and from a clinic can dramatically affect the patient’s perspective on and experience of care.
Provider perspective
Medical staffs’ perceptions and awareness levels also affect the care patients receive. Several studies have shown race and sex to influence physicians’ management decisions. With respect to provider bias, SCD patients are perceived as being opioiddependent at twice the rate of other patients with pain. In one study, both staff and families in a sickle cell center perceived whites getting better service than blacks. A larger study of more than 200 providers in a sickle cell center showed differing perceptions of the effect of race on the quality of health care delivery: Providers of color and women providers perceived race as an issue, whereas white male providers tended not to see race as a factor in health care delivery. In a recent study, white providers prescribed hydroxyurea (the only FDA-approved drug to treat SCD) less frequently than did black providers. Identifying perceptions of race and racism
According to the 2000 U.S. Census Bureau data, our nation’s population was 75.1 percent white and 12.3 percent black. However, Minnesota’s population was 89.4 percent white and only 3.5 percent black. In 2010, the Minnesota black population had increased to 5.2 percent. Given the overwhelming majority of white providers in the health care system, the effects of institutional racism may be significant. Lack of provider awareness of institutional racism and the resultant structural barriers that patients of color face are areas our center felt were important to examine. In 2009, we initiated research with the goal of identifying perceptions of race and racism among our staff and patients, with particular attention to provider attitudes as a potential contributor to racial health care disparities. Methods. An 11-item survey was adapted from the Centers for Disease Control’s 2008 Behavioral Risk Factor Surveillance System and the Sickle Cell Transfer Questionnaire, with specific questions regarding race, racism, and health care
delivery. The target population was staff, patients, and families from the Sickle Cell Center at Children's Hospitals & Clinics of Minnesota. Demographic data obtained included age, race, ethnicity, and gender. For staff, data were also collected about work position and work location (inpatient vs. outpatient). The survey was given to all patients with sickle cell disease >12 years of age and their families upon arrival to clinic. The survey was made available online to all staff in the hematology/oncology program. Results. We received completed surveys from 112 patients/families. Surveys were made available to 158 staff members and 135 were completed (85 percent return rate). This very high return rate speaks to the deep interest in this topic. Not surprisingly, 92.6 percent of patients/families identified as black, while 94.1 percent of staff identified as white (P<0.001). Among the significant findings were the following: â&#x20AC;˘ More patients/families than staff felt that race affects the
quality of health care for sickle cell patients (50 percent vs. 31.6 percent, P=0.003, OR 2.1). â&#x20AC;˘ More staff than patients/families perceived unequal treatment of patients at our institution, especially in the inpatient setting (20.9 percent vs. 10.9 percent, P=0.03, OR 0.46). â&#x20AC;˘ Patients/families showed a greater awareness of race than staff, as measured by selfreports of emotional responses because of race while at the hospital (56.6 percent vs. 27.5 percent, P<0.001, OR 3.43). â&#x20AC;˘ Patients/families perceived race affecting interpersonal relationships with caregivers more than did staff (47.5 percent vs. 29.2 percent, P=0.005, OR 2.13). â&#x20AC;˘ Though the majority of staff and patients/families agreed that racism is a problem in the U.S., most respondents felt this was not an issue at our institution. â&#x20AC;˘ More staff than patients/families perceived racism as a problem nationally (83.9 percent vs. 72 percent, P=0.02, OR 0.49).
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â&#x20AC;˘ Of respondents who felt there was racism at our hospital, more staff than patients/families perceived this to be an issue (23.7 percent vs. 9 percent, P=0.002, OR 0.31). Discussion of results
As expected, patients/families showed a greater awareness of race than did staff and felt that race affected the quality of care they received. This was less of an issue with our more recent West African immigrant families as compared to our African American families. More staff than patients/ families perceived racism as a problem in our institution. Staff also perceived unequal treatment of sickle cell patients based on race, especially in the inpatient setting. We were surprised to find perceptions of racial issues being more prevalent among staff. Perhaps the female-majority staff is more sensitive to discrimination of any kind because of personal experiences with sexism. Other factors that may have contributed to these findings:
â&#x20AC;˘ Our staff was significantly older than patients/families. â&#x20AC;˘ Health care workers may be more sensitive than those in other fields. â&#x20AC;˘ Our work in healing fellow humans may help make us more aware of inequities. â&#x20AC;˘ Perhaps because of the nature of their daily experiences with racism, patients and families perceive our institution as less racist when compared to other areas of their lives. It might have been better to ask how Childrenâ&#x20AC;&#x2122;s compares to their experiences with racism in other areas of their lives. The survey gave us insight into how provider attitudes may contribute to continued racial health care disparities. For example, one provider commented that â&#x20AC;&#x153;[sickle cell] patients are challenging because of their lack of support systems, not because of race.â&#x20AC;? This providerâ&#x20AC;&#x2122;s separation of systemic issues such as support structures from the realities of race and racism in the U.S. is a powerful indicator of the lack of knowledge and EQUITY to page 38
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MINNESOTA PHYSICIAN
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What Is â&#x20AC;&#x153;meaningful useâ&#x20AC;?? Meaningful use from cover the criteria established for meaningful use are viewed in the context of improving process, efficiency, and ultimately, quality for the patient, then meaningful use becomes a goal worth striving for. This is the most important lesson learned from our experience: Ultimately, what we do needs to focus on the patient by providing highquality, efficient care. Putting the process in motion
The planning process to achieve meaningful use started more than eight months before we were able to attest to reaching that goal. An organization-wide decision was made that meaningful use standards would be used to evaluate all providers, regardless of their ability to participate in the federal incentive program. [Participation is dependent on the percentage of the physicianâ&#x20AC;&#x2122;s patients in government programs or through professional titleâ&#x20AC;&#x201D;medical and osteopathic physicians qualify for the program, but physician assistants, nurse practitioners,
The American Recovery and Reinvestment Act of 2009 specifies three main components of meaningful use: 1. The use of a certified EHR in a meaningful manner, such as e-prescribing. 2. The use of certified EHR technology for electronic exchange of health information to improve quality of health care. 3. The use of certified EHR technology to submit clinical quality and other measures. Simply put, â&#x20AC;&#x153;meaningful useâ&#x20AC;? means providers need to show they're using certified EHR technology in ways that can be measured significantly in quality and in quantity. Source: Centers for Medicare & Medicaid Services website, www.cms.gov/ehrincentiveprograms/ and midwives do not.] In addition, it was understood early on that this needed to be a team effort. As such, it included our receptionists, patient care staff, clinical assistants, providers, medical records, information technology, and many other support staff. WWMA established an overall electronic health record committee and committees at each of our three sites. This was an important piece in achieving full adoption of an electronic health record, as these committees became the groups charged with achieving meaningful use. The committees spent extensive time
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MINNESOTA PHYSICIAN JULY 2011
studying each measure and understanding the elements that compose each numerator and denominator. Attention was then directed to the EHR and the capabilities it brought to achieving each of the 15 core and five of the 10 menu measures. Finally, the committees evaluated workflow in order to understand how to adapt to meet the standard for each measure. We took care to identify the level at which the task could be accomplished and who would be responsible for each task. For example, patient demographics are recorded by our front-desk personnel, and vital signs such as blood pressure, temperature, height, and weight are all entered by clinical assistants. We wanted to be careful not to add to a providerâ&#x20AC;&#x2122;s already growing workload. We then selected a number of measures that we felt were low-hanging fruit and worked to accomplish these first. In one case, a oneon-one discussion and demonstration by a colleague helped a physician begin to e-prescribe; the physician soon discovered how much faster it is than paper prescribing. At the same time, we identified significant barriers to achieving more difficult measures and determining how to overcome them. In some cases, it meant working closely with our EHR vendor, Cerner Corporation, and pushing them to adjust or improve their electronic health record to make it more efficient, enabling physicians to more easily meet the measure. Cernerâ&#x20AC;&#x2122;s assistance was critical as we captured the data needed to attest to meaningful use. In some situations we found ourselves working closely with our providers and staff individually
or as a group around individual responsibilities. Key areas we focused on with providers included e-prescribing, medical reconciliation, and providing visit summaries to patients. We came to understand that a consistent, regular presentation to the providers and to the staff, focused on tips and tools within Cernerâ&#x20AC;&#x2122;s Ambulatory EHR, would be quite beneficial. EHR committee members have presented tips twice monthly over the past six months. Often, tips came from what our colleagues were doing. Providers shared functionality and processes. We quickly learned many providers had not considered or realized what was within the EHRâ&#x20AC;&#x2122;s capabilities. For example, many providers struggled with maintaining medication lists, only to find that Medication Reconciliation was a tool that not only greatly reduces the number of steps involved, but also achieves a meaningful use goal. Early in the quest for meaningful use, we developed reports utilizing data from the EHR, sorting it by practitioner first and then presenting that information to the entire group so that we could see and monitor our own progress and the progress of our peers. WWMA has had a tradition of open, unblinded presentation of quality results, so this was not a difficult transition for providers and other staff members. We have consistently found this openness, rather than being punitive, has provided an opportunity for those not performing at a level they would like, to seek out and talk to those who demonstrate higher levels of performance. It also helped the meaningful use team to identify system and process problems on a consistent basis. For example, we discovered early on that we were not recording and charting changes in vital signs in ways that successfully met the attestation goal. We worked with the clinical assistants to reinforce the critical importance of recording all vital signs at every visit. Now, with everyone understanding the expectation, we consistently perform well above the 50 percent set target. In a
Sample task lists for achieving meaningful use goals couple of situations, this process enabled us to work with specific providers one-on-one to help them adapt their practice and workflows to achieve these goals. Significantly, there are a number of the EHR measures that are dependent upon the IT department and the practice’s specific electronic health record and less on the practitioner’s involvement. Several of those measures were very easy to accomplish; some required “addon” EHR modules; and a couple of measures required cooperation and assistance from outside organizations. Measures in this category are shown in the sidebar. They include: • Implementing drug interaction checks • Implementing decision support rules • Performing a security risk assessment • Exchanging electronic information with other providers • Implementing drug formulary checks • Incorporating laboratory results
Provider/clinical assistant team: • CPOE for medication orders • Maintain active medication allergy list • Maintain active medication list • Maintain up-to-date problem list • Perform medication reconciliation • Provide clinical summary • Provide patient education • Provide summary of care at transition • Record and chart changes in vital signs • Record smoking status • Transmit prescriptions electronically Care coordinators/quality team: • Generate patient lists • Report quality measures to CMS • Send appropriate patient reminders • Submitting electronic data to immunization registries • Providing timely electronic access to records • Providing patient education • Submitting electronic syndromic surveillance data to public health agencies
Front-desk staff: • Record patient demographics Medical records staff: • Provide electronic health information on patient request Information technology staff: • Exchange electronic information with other providers • Implement drug formulary checks • Implement drug interaction checks • Implement one decision-support rule • Incorporate laboratory results • Perform security risk assessment • Provide timely electronic access • Submit electronic data to immunization registries • Submit electronic syndromic surveillance data to public health agencies An exercise in quality
In short, achieving meaningful use becomes a classic exercise in quality, systems, and process improvement. It involves focusing on the big picture, beginning with sound, broad-based decisions that understand the challenge and opportunities of your internal workflows, having an
in-depth understanding of your electronic health record, a good working relationship with your electronic health record vendor, and working closely with your staff. Meaningful use is not just doing one thing well, but doing a lot of little things better to achieve a large impact overall. While today we cannot say that every single meaningful use requirement has contributed to increasing the quality of our patient care, engagement in this process has led to a more sophisticated understanding of our electronic health record and our own workflows. As a result, we are able to make changes that improve the quality and the efficiency of the care we deliver to our patients. It is said that every journey begins with a single step. In our experience, the journey to meaningful use is hundreds, if not thousands, of small steps leading to 21st-century medicine. Paul McGinnis, MD, practices family medicine with Hudson Physicians, a division of Western Wisconsin Medical Associates.
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MINNESOTA PHYSICIAN
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P E D I AT R I C S
W
hy are infants born in Minnesota still being damaged by prenatal alcohol exposure when the cause is well known and completely preventable? And why are children growing up with the effects of this exposure and struggling without recognition of their disability? There are many reasons, and some of them involve us as health care providers. Defining fetal alcohol syndrome disorder
Alcohol is the only known teratogen with the potential to cause death, malformation, growth deficiency, and functional deficits in the developing fetus. French researcher Paul Lemoine observed the teratogenic effects of alcohol on the developing fetus in 1968, and research in the following decade confirmed his findings. In 1973, the name fetal alcohol syndrome (FAS) was used by researchers at the University of Washington Medical School to describe the pattern of “craniofacial, limb, and cardiovascular defects associated with prenatal onset
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Fetal alcohol syndrome disorders Working toward full prevention By Mary Meland, MD growth deficiency and developmental delay” in children born to alcoholic mothers. Over time, the term fetal alcohol spectrum disorder (FASD) was developed to include FAS as well as other conditions resulting from prenatal alcohol exposure. FASD is an umbrella term describing the range of effects that can occur in an individual whose mother drank alcohol during pregnancy. In FAS, facial abnormalities are present along with growth failure and neurodevelopmental deficits. In FASD, milder effects of confirmed prenatal alcohol exposure may include only facial anomalies or developmental disabilities. FASD is one of the leading causes of intellectual impairment in the Western world. It is also one of the most
preventable causes. Nationally, Centers for Disease Control and Prevention (CDC) studies show the prevalence of FAS as one per 1,000 births and of the more inclusive FASD as one per 100 births. Based on the 2009 National Survey on Drug Use & Health conducted by the Substance Abuse and Mental Health Services Administration (SAMHSA), an estimated 8,500 babies are born each year in Minnesota showing some effects of intrauterine exposure to alcohol. These effects may include facial anomalies, cardiac defects, growth failure, limb deformity, or abnormalities of brain development. Statistics from the 2009 SAMHSA survey show that 12 percent of mothers in Minnesota consume five or more drinks per month in pregnancy and 5 percent binge drink, defined as consuming five or more drinks during a four-hour period of time.
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The timing of maternal use of alcohol determines the type of damage seen, with facial and cardiac anomalies occurring during the first trimester and growth retardation later in gestation. Brain development can be impaired at any stage of the pregnancy. These are permanent changes. Each mother and each pregnancy is different, and many factors determine whether and how maternal use of alcohol will harm the fetus. A recent British study by Kelly et al., published in the October 2010 issue of the Journal of Epidemiology and Community Health, suggested that mothers can safely drink small amounts of alcohol during pregnancy without causing recognizable abnormalities in their children. Each of us can recall mothers we know who drank to
excess during several pregnancies and had healthy children. Clearly, there are poorly understood correlations between timing and amounts of alcohol use and protective features of pregnancies. Because the safe threshold for alcohol exposure in a given pregnancy is unknown, the only certain way to prevent damage to the fetus is to avoid all alcohol use during pregnancy. To that end, in 2005 the Office of the Surgeon General issued an advisory recommending no alcohol use during pregnancy. Prenatal care and counseling
Providers are often the first touch point for pregnant women and among the most influential sources for moms-tobe. It is important that providers give women consistent messages about alcohol use during pregnancy. The Minnesota Organization for Fetal Alcohol Syndrome (MOFAS) promotes “049”— meaning zero alcohol for the nine months of pregnancy—as the safest recommendation. The MOFAS website at www.mofas. org has further information on this recommendation. Obtaining a history of drug or alcohol use during pregnancy requires sensitive, nonjudgmental questioning. Often, asking a woman about her alcohol use prior to becoming pregnant is perceived as less threatening, as is finding out when the mother determined that she was pregnant. Asking about prior use and when the mother found out that she was pregnant may reveal alcohol exposure during the first trimester. Because 50 percent of pregnancies are unplanned, a woman may expose the fetus to alcohol unknowingly in early gestation. Inquiring about current use of alcohol during the pregnancy may help providers identify women who are alcohol dependent and will need referral for treatment. The MOFAS website has links to a variety of treatment centers under the heading “Women.” Other women can be counseled that the safest choice to protect their developing fetus is to abstain from alcohol during FASD to page 19
&OR YOUR PATIENTS WITH RELAPSING FORMS OF MULTIPLE SCLEROSIS
&GžDBDZ BU IBOE 1PUFOUJBM BU UIFJS žOHFSUJQT Primary end point1:
Primary end point1: RELATIVE REDUCTION IN ANNUALIZED RELAPSE RATE vs interferon beta-1a IM (0.16 vs 0.33; P<0.001)
RELATIVE REDUCTION IN ANNUALIZED RELAPSE rate vs placebo (0.18 vs 0.40; P<0.001) Key secondary end point: s REDUCTION in the risk of 3-month confirmed
Key secondary end points: s 3IGNIFICANT REDUCTION in mean number
disability progression as measured by the EDSS compared with placebo (hazard ratio of disability progression [95% CI]: 0.70 [0.52-0.96]; P=0.02)
of new or newly enlarged T2 lesions compared with interferon beta-1a IM (1.6 vs 2.6; P=0.002)
s .O SIGNIFICANT DIFFERENCE in the time to 3-month confirmed disability progression between GILENYA and interferon beta-1a IM at 1 year (hazard ratio [95% CI]: 0.71 [0.42-1.21]; P=0.21) TRANSFORMS: A 1-year, randomized, double-blind, double-dummy, active-controlled (interferon beta-1a IM) phase III study in 1292 people with RRMS. At baseline, patients had a diagnosis of RRMS with at least 1 documented relapse during the previous year or at least 2 documented relapses during the previous 2 years. They had a score of 0.0 to 5.5 on the EDSS with a median score at baseline of 2.0. Previous therapy with either any type of interferon beta or glatiramer acetate was not a criterion for exclusion.
FREEDOMS: A 2-year, randomized, double-blind, placebocontrolled phase III study in 1272 people with RRMS. At baseline, patients had a diagnosis of RRMS with at least 1 documented relapse during the previous year or at least 2 documented relapses during the previous 2 years. They had a score of 0.0 to 5.5 on the EDSS with a median score at baseline of 2.0. Patients did not receive any interferon beta or glatiramer acetate for at least the previous 3 months and had not received any natalizumab for at least the previous 6 months.
INDICATION
GILENYA is a sphingosine 1-phosphate receptor modulator indicated for the treatment of patients with relapsing forms of multiple sclerosis (MS) to reduce the frequency of clinical exacerbations and to delay the accumulation of physical disability.
EFFICACY ENCAPSULATED
IMPORTANT SAFETY INFORMATION
Initiation of GILENYA treatment results in a decrease in heart rate and has resulted in transient (AV) conduction delays. Obtain baseline electrocardiogram before first dose if not recently available in those at higher risk for bradyarrhythmia. Observe all patients for signs and symptoms of bradycardia for 6 hours after the first dose. Patients receiving Class Ia or Class III antiarrhythmics, beta-blockers, calcium channel blockers, those with low heart rate, history of syncope, sick sinus syndrome, second degree or higher conduction block, ischemic heart disease, or congestive heart failure are at increased risk of developing bradycardia or heart blocks. First and second degree AV blocks following first dose have occurred. These conduction abnormalities were usually transient, asymptomatic, and resolved within the first 24 hours, but occasionally required treatment with atropine or isoproterenol. If GILENYA is discontinued for >2 weeks, the effects on heart rate and AV conduction may recur on reintroduction of treatment and the same precautions for initial dosing should apply. GILENYA may increase the risk of infections. A recent complete blood count should be available before initiating GILENYA. Suspension of GILENYA should be considered if a patient develops a serious infection. Monitor for signs and symptoms of infection during treatment and up to 2 months after discontinuation. Do not start GILENYA in patients with active acute or chronic infections. Two patients receiving a higher dose of GILENYA (1.25 mg) in conjunction with high-dose corticosteroid therapy died of herpetic infections. Concomitant use with antineoplastic, immunosuppressive or immune modulating therapies would be expected to increase the risk of immunosuppression. Before initiating GILENYA, patients without a history of chickenpox or without vaccination against varicella zoster virus (VZV) should be tested for antibodies to VZV. VZV vaccination of antibody-negative patients should be considered prior to commencing GILENYA treatment, following which GILENYA initiation should be postponed for 1 month. Macular edema can occur, with or without visual symptoms. An ophthalmologic evaluation should be performed before starting GILENYA and at 3 to 4 months after initiation. Monitor visual acuity at baseline and during routine patient evaluations. Patients with diabetes mellitus or history of uveitis are at increased risk and should have regular ophthalmologic evaluations. Decreases in pulmonary function tests can occur. Dose-dependent reductions in forced expiratory volume over 1 second (FEV1) and diffusion lung capacity for GILENYA is a trademark of Novartis AG.
carbon monoxide (DLCO) were observed in GILENYA patients as early as 1 month after initiation. The changes in FEV1 appear to be reversible after discontinuing GILENYA; however, there is insufficient information to determine the reversibility of DLCO. Obtain spirometry and DLCO when clinically indicated. Liver transaminases may increase. Recent liver transaminase and bilirubin levels should be available before initiating GILENYA. Elevations 3- and 5-fold the upper limit of normal occurred with GILENYA. Recurrence of liver transaminase elevations occurred with rechallenge in some patients. The majority of elevations occurred within 3 to 4 months and returned to normal within 2 months after discontinuing GILENYA. Assess liver enzymes if symptoms suggestive of hepatic injury develop. Discontinue GILENYA if significant liver injury is confirmed. GILENYA may cause fetal harm. Women of childbearing potential should use effective contraception during and for 2 months after stopping GILENYA. A registry for women who become pregnant during GILENYA treatment is available. Blood pressure should be monitored during treatment with GILENYA. An average increase of 2 mm Hg in systolic and 1 mm Hg in diastolic blood pressure was observed. GILENYA remains in the blood, and has pharmacodynamic effects, including decreased lymphocyte counts, for up to 2 months following the last dose. Lymphocyte counts generally return to normal range within 1 to 2 months of stopping therapy. Initiating other drugs during this period warrants the same considerations needed for concomitant administration. Carefully monitor patients concomitantly receiving Class Ia or Class III antiarrhythmics, beta-blockers or systemic ketoconazole. The use of live attenuated vaccines should be avoided during and for 2 months after stopping GILENYA. The most common adverse reactions with GILENYA (incidence >10% and >placebo) compared with placebo were headache (25% vs 23%), influenza (13% vs 10%), diarrhea (12% vs 7%), back pain (12% vs 7%), liver transaminase elevations (14% vs 5%), and cough (10% vs 8%). EDSS=Expanded Disability Status Scale. FREEDOMS=FTY720 Research Evaluating Effects of Daily Oral Therapy in Multiple Sclerosis. IM=intramuscular. RRMS=relapsing-remitting MS. TRANSFORMS=Trial Assessing Injectable Interferon vs FTY720 Oral in Relapsing-Remitting Multiple Sclerosis.
Please see Brief Summary of Prescribing Information on adjacent pages. Reference: 1. GILENYA [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; 2010.
Novartis Pharmaceuticals Corporation East Hanover, New Jersey 07936-1080
Š2011 Novartis
Printed in the USA
01/11
JULY 2011
C-GYA-100006
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GILENYAâ&#x201E;˘
(fingolimod) capsules
Initial U.S. Approval: 2010 BRIEF SUMMARY: Please see package insert for full prescribing information. 1 INDICATIONS AND USAGE GILENYA is indicated for the treatment of patients with relapsing forms of multiple sclerosis (MS) to reduce the frequency of clinical exacerbations and to delay the accumulation of physical disability. 4 CONTRAINDICATIONS None 5 WARNINGS AND PRECAUTIONS 5.1 Bradyarrhythmia and Atrioventricular Blocks Reduction in heart rate Initiation of GILENYA treatment results in a decrease in heart rate [see Clinical Pharmacology (12.2) in the full prescribing information]. Observe all patients for a period of 6 hours for signs and symptoms of bradycardia. Should post-dose bradyarrhythmia-related symptoms occur, initiate appropriate management and continue observation until the symptoms have resolved. To identify underlying risk factors for bradycardia and atrioventricular (AV) block, if a recent electrocardiogram (i.e., within 6 months) is not available, obtain one in patients using anti-arrhythmics including beta-blockers and calcium channel blockers, those with cardiac risk factors, as described below, and those who on examination have a slow or irregular heart beat prior to starting GILENYA. Experience with GILENYA in patients receiving concurrent therapy with beta blockers or in those with a history of syncope is limited. GILENYA has not been studied in patients with sitting heart rate less than 55 bpm. GILENYA has not been studied in patients with second degree or higher AV block, sick sinus syndrome, prolonged QT interval, ischemic cardiac disease, or congestive heart failure. GILENYA has not been studied in patients with arrhythmias requiring treatment with Class Ia (e.g., quinidine, procainamide) or Class III (e.g., amiodarone, sotalol) antiarrhythmic drugs. Class Ia and Class III antiarrhythmic drugs have been associated with cases of torsades de pointes in patients with bradycardia. After the first dose of GILENYA, the heart rate decrease starts within an hour and the Day 1 decline is maximal at approximately 6 hours. Following the second dose a further decrease in heart rate may occur when compared to the heart rate prior to the second dose, but this change is of a smaller magnitude than that observed following the first dose. With continued dosing, the heart rate returns to baseline within one month of chronic treatment. The mean decrease in heart rate in patients on GILENYA 0.5 mg at 6 hours after the first dose was approximately 13 beats per minute (bpm). Heart rates below 40 bpm were rarely observed. Adverse reactions of bradycardia following the first dose were reported in 0.5% of patients receiving GILENYA 0.5 mg, but in no patient on placebo. Patients who experienced bradycardia were generally asymptomatic, but some patients experienced mild to moderate dizziness, fatigue, palpitations, and chest pain that resolved within the first 24 hours on treatment. Atrioventricular blocks Initiation of GILENYA treatment has resulted in transient AV conduction delays. In controlled clinical trials, adverse reactions of first degree AV block (prolonged PR interval on ECG) following the first dose were reported in 0.1% of patients receiving GILENYA 0.5 mg, but in no patient on placebo. Second degree AV blocks following the first dose were also identified in 0.1% of patients receiving GILENYA 0.5 mg, but in no patient on placebo. In a study of 698 patients with available 24-hour Holter monitoring data after their first dose (N=351 on GILENYA 0.5 mg and N=347 on placebo), second degree AV blocks, usually Mobitz type I (Wenckebach) were reported in 3.7% (N=13) of patients receiving GILENYA 0.5 mg and 2% (N=7) of patients on placebo. The conduction abnormalities were usually transient and asymptomatic, and resolved within the first 24 hours on treatment, but they occasionally required treatment with atropine or isoproterenol. One patient developed syncope and complete AV block following the first dose of fingolimod 1.25 mg (a dose higher than recommended) in an uncontrolled study. Re-initiation of therapy following discontinuation If GILENYA therapy is discontinued for more than two weeks the effects on heart rate and AV conduction may recur on reintroduction of GILENYA treatment and the same precautions as for initial dosing should apply. 5.2 Infections Risk of infections GILENYA causes a dose-dependent reduction in peripheral lymphocyte count to 20-30% of baseline values because of reversible sequestration of lymphocytes in lymphoid tissues. GILENYA may therefore increase the risk
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of infections, some serious in nature [see Clinical Pharmacology (12.2) in the full prescribing information]. Before initiating treatment with GILENYA, a recent CBC (i.e., within 6 months) should be available. Consider suspending treatment with GILENYA if a patient develops a serious infection, and reassess the benefits and risks prior to re-initiation of therapy. Because the elimination of fingolimod after discontinuation may take up to two months, continue monitoring for infections throughout this period. Instruct patients receiving GILENYA to report symptoms of infections to a physician. Patients with active acute or chronic infections should not start treatment until the infection(s) is resolved. Two patients died of herpetic infections during GILENYA controlled studies in the premarketing database (one disseminated primary herpes zoster and one herpes simplex encephalitis). In both cases, the patients were receiving a fingolimod dose (1.25 mg) higher than recommended for the treatment of MS (0.5 mg), and had received high dose corticosteroid therapy for suspected MS relapse. No deaths due to viral infections occurred in patients treated with GILENYA 0.5 mg in the premarketing database. In MS controlled studies, the overall rate of infections (72%) and serious infections (2%) with GILENYA 0.5 mg was similar to placebo. However, bronchitis and, to a lesser extent, pneumonia were more common in GILENYA-treated patients. Concomitant use with antineoplastic, immunosuppressive or immune modulating therapies GILENYA has not been administered concomitantly with antineoplastic, immunosuppressive or immune modulating therapies used for treatment of MS. Concomitant use of GILENYA with any of these therapies would be expected to increase the risk of immunosuppression [see Drug Interactions (7)]. Varicella zoster virus antibody testing/vaccination As for any immune modulating drug, before initiating GILENYA therapy, patients without a history of chickenpox or without vaccination against varicella zoster virus (VZV) should be tested for antibodies to VZV. VZV vaccination of antibody-negative patients should be considered prior to commencing treatment with GILENYA, following which initiation of treatment with GILENYA should be postponed for 1 month to allow the full effect of vaccination to occur. 5.3 Macular Edema In patients receiving GILENYA 0.5 mg, macular edema occurred in 0.4% of patients. An adequate ophthalmologic evaluation should be performed at baseline and 3-4 months after treatment initiation. If patients report visual disturbances at any time while on GILENYA therapy, additional ophthalmologic evaluation should be undertaken. In MS controlled studies involving 1204 patients treated with GILENYA 0.5 mg and 861 patients treated with placebo, macular edema with or without visual symptoms was reported in 0.4% of patients treated with GILENYA 0.5 mg and 0.1% of patients treated with placebo; it occurred predominantly in the first 3-4 months of therapy. Some patients presented with blurred vision or decreased visual acuity, but others were asymptomatic and diagnosed on routine ophthalmologic examination. Macular edema generally improved or resolved with or without treatment after drug discontinuation, but some patients had residual visual acuity loss even after resolution of macular edema. Continuation of GILENYA in patients who develop macular edema has not been evaluated. A decision on whether or not to discontinue GILENYA therapy should include an assessment of the potential benefits and risks for the individual patient. The risk of recurrence after rechallenge has not been evaluated. Macular edema in patients with history of uveitis or diabetes mellitus Patients with a history of uveitis and patients with diabetes mellitus are at increased risk of macular edema during GILENYA therapy. The incidence of macular edema is also increased in MS patients with a history of uveitis. The rate was approximately 20% in patients with a history of uveitis vs. 0.6% in those without a history of uveitis, in the combined experience with all doses of fingolimod. MS patients with diabetes mellitus or a history of uveitis should undergo an ophthalmologic evaluation prior to initiating GILENYA therapy and have regular follow-up ophthalmologic evaluations while receiving GILENYA therapy. GILENYA has not been tested in MS patients with diabetes mellitus. 5.4 Respiratory Effects Dose-dependent reductions in forced expiratory volume over 1 second (FEV1) and diffusion lung capacity for carbon monoxide (DLCO) were observed in patients treated with GILENYA as early as 1 month after treatment initiation. At Month 24, the reduction from baseline in the percent of predicted values for FEV1 was 3.1% for GILENYA 0.5 mg and 2% for placebo. For DLCO, the reductions from baseline in percent of predicted values at Month 24 were 3.8% for GILENYA 0.5 mg and 2.7% for placebo.
The changes in FEV1 appear to be reversible after treatment discontinuation. There is insufficient information to determine the reversibility of the decrease of DLCO after drug discontinuation. In MS controlled trials, dyspnea was reported in 5% of patients receiving GILENYA 0.5 mg and 4% of patients receiving placebo. Several patients discontinued GILENYA because of unexplained dyspnea during the extension (uncontrolled) studies. GILENYA has not been tested in MS patients with compromised respiratory function. Spirometric evaluation of respiratory function and evaluation of DLCO should be performed during therapy with GILENYA if clinically indicated. 5.5 Hepatic Effects Elevations of liver enzymes may occur in patients receiving GILENYA. Recent (i.e., within last 6 months) transaminase and bilirubin levels should be available before initiation of GILENYA therapy. During clinical trials, 3-fold the upper limit of normal (ULN) or greater elevation in liver transaminases occurred in 8% of patients treated with GILENYA 0.5 mg, as compared to 2% of patients on placebo. Elevations 5-fold the ULN occurred in 2% of patients on GILENYA and 1% of patients on placebo. In clinical trials, GILENYA was discontinued if the elevation exceeded 5 times the ULN. Recurrence of liver transaminase elevations occurred with rechallenge in some patients, supporting a relationship to drug. The majority of elevations occurred within 3-4 months. Serum transaminase levels returned to normal within approximately 2 months after discontinuation of GILENYA. Liver enzymes should be monitored in patients who develop symptoms suggestive of hepatic dysfunction, such as unexplained nausea, vomiting, abdominal pain, fatigue, anorexia, or jaundice and/or dark urine. GILENYA should be discontinued if significant liver injury is confirmed. Patients with pre-existing liver disease may be at increased risk of developing elevated liver enzymes when taking GILENYA. Because GILENYA exposure is doubled in patients with severe hepatic impairment, these patients should be closely monitored, as the risk of adverse reactions is greater [see Use in Specific Populations (8.5) and Clinical Pharmacology (12.3) in the full prescribing information]. 5.6 Fetal Risk Based on animal studies, GILENYA may cause fetal harm. Because it takes approximately 2 months to eliminate GILENYA from the body, women of childbearing potential should use effective contraception to avoid pregnancy during and for 2 months after stopping GILENYA treatment. 5.7 Blood Pressure Effects In MS clinical trials, patients treated with GILENYA 0.5 mg had an average increase of approximately 2 mmHg in systolic pressure, and approximately 1 mmHg in diastolic pressure, first detected after approximately 2 months of treatment initiation, and persisting with continued treatment. In controlled studies involving 854 MS patients on GILENYA 0.5 mg and 511 MS patients on placebo, hypertension was reported as an adverse reaction in 5% of patients on GILENYA 0.5 mg and in 3% of patients on placebo. Blood pressure should be monitored during treatment with GILENYA. 5.8 Immune System Effects Following GILENYA Discontinuation Fingolimod remains in the blood and has pharmacodynamic effects, including decreased lymphocyte counts, for up to 2 months following the last dose of GILENYA. Lymphocyte counts generally return to the normal range within 1-2 months of stopping therapy [see Clinical Pharmacology (12.2) in the full prescribing information]. Because of the continuing pharmacodynamic effects of fingolimod, initiating other drugs during this period warrants the same considerations needed for concomitant administration (e.g., risk of additive immunosuppressant effects) [see Drug Interactions (7)]. 6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in labeling: • Bradyarrhythmia and atrioventricular blocks [see Warnings and Precautions (5.1)] • Infections [see Warnings and Precautions (5.2)] • Macular edema [see Warnings and Precautions (5.3)] • Respiratory effects [see Warnings and Precautions (5.4)] • Hepatic effects [see Warnings and Precautions (5.5)] The most frequent adverse reactions (incidence ≥10% and > placebo) for GILENYA 0.5 mg were headache, influenza, diarrhea, back pain, liver enzyme elevations, and cough. The only adverse event leading to treatment interruption reported at an incidence >1% for GILENYA 0.5 mg was serum transaminase elevations (3.8%). 6.1 Clinical Trials Experience A total of 1703 patients on GILENYA (0.5 or 1.25 mg once daily) constituted the safety population in the 2 controlled studies in patients with relapsing remitting MS (RRMS) [see Clinical Studies (14) in the full prescribing information].
Study 1 was a 2-year placebo-controlled clinical study in 1272 MS patients treated with GILENYA 0.5 mg (n=425), GILENYA 1.25 mg (n=429) or placebo (n=418). Table 1. Adverse Reactions in Study 1 (occurring in ≥1% of patients, and reported for GILENYA 0.5 mg at ≥1% higher rate than for placebo) Primary System Organ Class Preferred Term
GILENYA 0.5 mg N=425 %
Infections Influenza viral infections Herpes viral infections Bronchitis Sinusitis Gastroenteritis Tinea infections Cardiac disorders Bradycardia Nervous system disorders Headache Dizziness Paresthesia Migraine Gastrointestinal disorders Diarrhea General disorders and administration site conditions Asthenia Musculoskeletal and connective tissue disorders Back pain Skin and subcutaneous tissue disorders Alopecia Eczema Pruritus Investigations ALT/AST increased GGT increased Weight decreased Blood triglycerides increased Respiratory, thoracic and mediastinal disorders Cough Dyspnea Psychiatric disorders Depression Eye disorders Vision blurred Eye pain Vascular disorders Hypertension Blood and lymphatic system disorders Lymphopenia Leukopenia
Placebo N=418 %
13 9 8 7 5 4
10 8 4 5 3 1
4
1
25 7 5 5
23 6 4 1
12
7
3
1
12
7
4 3 3
2 2 1
14 5 5 3
5 1 3 1
10 8
8 5
8
7
4 3
1 1
6
4
4 3
1 <1
Adverse reactions in Study 2, a 1-year active-controlled (vs. interferon beta-1a, n=431) study including 849 patients with MS treated with fingolimod, were generally similar to those in Study 1. Vascular Events Vascular events, including ischemic and hemorrhagic strokes, peripheral arterial occlusive disease and posterior reversible encephalopathy syndrome were reported in premarketing clinical trials in patients who received GILENYA doses (1.25-5 mg) higher than recommended for use in MS. No vascular events were observed with GILENYA 0.5 mg in the premarketing database. Lymphomas Cases of lymphoma (cutaneous T-cell lymphoproliferative disorders or diffuse B-cell lymphoma) were reported in premarketing clinical trials in MS patients receiving GILENYA at, or above, the recommended dose of 0.5 mg. Based on the small number of cases and short duration of exposure, the relationship to GILENYA remains uncertain. 7 DRUG INTERACTIONS Class Ia or Class III antiarrhythmic drugs GILENYA has not been studied in patients with arrhythmias requiring treatment with Class Ia (e.g., quinidine, procainamide) or Class III (e.g., amiodarone, sotalol) antiarrhythmic drugs. Class Ia and Class III antiarrhythmic drugs have been associated with cases of torsades de pointes in patients with bradycardia. Since initiation of GILENYA treatment results in decreased heart rate, patients on Class Ia or Class III antiarrhythmic drugs should be closely monitored [see Warnings and Precautions (5.1)].
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Ketoconazole The blood levels of fingolimod and fingolimod-phosphate are increased by 1.7-fold when coadministered with ketoconazole. Patients who use GILENYA and systemic ketoconazole concomitantly should be closely monitored, as the risk of adverse reactions is greater. Vaccines Vaccination may be less effective during and for up to 2 months after discontinuation of treatment with GILENYA [see Clinical Pharmacology (12.2) in the full prescribing information]. The use of live attenuated vaccines should be avoided during and for 2 months after treatment with GILENYA because of the risk of infection. Antineoplastic, immunosuppressive or immunomodulating therapies Antineoplastic, immunosuppressive or immune modulating therapies are expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects such as natalizumab or mitoxantrone. Heart rate-lowering drugs (e.g., beta blockers or diltiazem) Experience with GILENYA in patients receiving concurrent therapy with beta blockers is limited. These patients should be carefully monitored during initiation of therapy. When GILENYA is used with atenolol, there is an additional 15% reduction of heart rate upon GILENYA initiation, an effect not seen with diltiazem [see Warnings and Precautions (5.1)]. Laboratory test interaction Because GILENYA reduces blood lymphocyte counts via redistribution in secondary lymphoid organs, peripheral blood lymphocyte counts cannot be utilized to evaluate the lymphocyte subset status of a patient treated with GILENYA. A recent CBC should be available before initiating treatment with GILENYA. 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Pregnancy Category C There are no adequate and well-controlled studies in pregnant women. In oral studies conducted in rats and rabbits, fingolimod demonstrated developmental toxicity, including teratogenicity (rats) and embryolethality, when given to pregnant animals. In rats, the highest no-effect dose was less than the recommended human dose (RHD) of 0.5 mg/day on a body surface area (mg/m2) basis. The most common fetal visceral malformations in rats included persistent truncus arteriosus and ventricular septal defect. The receptor affected by fingolimod (sphingosine 1-phosphate receptor) is known to be involved in vascular formation during embryogenesis. Because it takes approximately 2 months to eliminate fingolimod from the body, potential risks to the fetus may persist after treatment ends [see Warnings and Precautions (5.7, 5.8)]. GILENYA should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
8.2 Labor and Delivery The effects of GILENYA on labor and delivery are unknown. 8.3 Nursing Mothers Fingolimod is excreted in the milk of treated rats. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from GILENYA, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. 8.4 Pediatric Use The safety and effectiveness of GILENYA in pediatric patients with MS below the age of 18 have not been established. 8.5 Geriatric Use Clinical MS studies of GILENYA did not include sufficient numbers of patients aged 65 years and over to determine whether they respond differently than younger patients. GILENYA should be used with caution in patients aged 65 years and over, reflecting the greater frequency of decreased hepatic, or renal, function and of concomitant disease or other drug therapy. 8.6 Hepatic Impairment Because fingolimod, but not fingolimod-phosphate, exposure is doubled in patients with severe hepatic impairment, patients with severe hepatic impairment should be closely monitored, as the risk of adverse reactions may be greater [see Warnings and Precautions (5.5) and Clinical Pharmacology (12.3) in the full prescribing information]. No dose adjustment is needed in patients with mild or moderate hepatic impairment. 8.7 Renal Impairment The blood level of some GILENYA metabolites is increased (up to 13-fold) in patients with severe renal impairment [see Clinical Pharmacology (12.3) in the full prescribing information]. The toxicity of these metabolites has not been fully explored. The blood level of these metabolites has not been assessed in patients with mild or moderate renal impairment. 10 OVERDOSAGE No cases of overdosage have been reported. However, single doses up to 80-fold the recommended dose (0.5 mg) resulted in no clinically significant adverse reactions. At 40 mg, 5 of 6 subjects reported mild chest tightness or discomfort which was clinically consistent with small airway reactivity. Neither dialysis nor plasma exchange results in removal of fingolimod from the body. 16 STORAGE GILENYA capsules should be stored at 25°C (77°F); excursions permitted to 15-30°C (59-86°F). Protect from moisture.
Pregnancy Registry A pregnancy registry has been established to collect information about the effect of GILENYA use during pregnancy. Physicians are encouraged to enroll pregnant patients, or pregnant women may enroll themselves in the GILENYA pregnancy registry by calling 1-877-598-7237. Animal Data When fingolimod was orally administered to pregnant rats during the period of organogenesis (0, 0.03, 0.1, and 0.3 mg/kg/day or 0, 1, 3, and 10 mg/kg/day), increased incidences of fetal malformations and embryofetal deaths were observed at all but the lowest dose tested (0.03 mg/kg/day), which is less than the RHD on a mg/m2 basis. Oral administration to pregnant rabbits during organogenesis (0, 0.5, 1.5, and 5 mg/kg/day) resulted in increased incidences of embryo-fetal mortality and fetal growth retardation at the mid and high doses. The no-effect dose for these effects in rabbits (0.5 mg/kg/day) is approximately 20 times the RHD on a mg/m2 basis. When fingolimod was orally administered to female rats during pregnancy and lactation (0, 0.05, 0.15, and 0.5 mg/kg/day), pup survival was decreased at all doses and a neurobehavioral (learning) deficit was seen in offspring at the high dose. The low-effect dose of 0.05 mg/kg/day is similar to the RHD on a mg/m2 basis.
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Issued September 2010
Printed in the USA
Manufactured by: Novartis Pharma Stein AG Stein, Switzerland Distributed by: Novartis Pharmaceuticals Corporation East Hanover, New Jersey 07936 ©Novartis
T2010-81
FASD from page 14 the remainder of the pregnancy. Diagnosing fetal alcohol syndrome disorders. Signs that an infant or child has been affected by prenatal alcohol exposure can be subtle or quite obvious. Making an early diagnosis will enable the child to get specific intervention if needed. Physical effects of prenatal alcohol exposure may include growth deficiency with length, weight, or head circumference below the 10th percentile. A unique facial phenotype with a smooth philtrum, thin upper lip, and short palpebral fissures is characteristic of FASD. At-risk populations such as children in foster care can be screened by facial photographs using a software measurement program. Cardiac and forearm anomalies may also occur but are less specific to FASD. More significant but invisible are malformations in the brain, including the cerebral cortex, cerebellum, corpus callosum, and other areas. Although specific periods in gestation are associated with specific vulnera-
SEE 3 O OPERAS PERAS A FOR FO R AS LITTLE AS A
bilities, the central nervous system begins to develop in the third week and continues to develop throughout the pregnancy. Alcohol exposure at any time has the potential to cause injury to the immature nervous system. Research using MRI and fMRI is being done to assess focal and global central nervous system damage in children with FASD. A diagnosis of fetal alcohol syndrome (FAS) requires all three facial anomalies, along with growth deficits and central nervous system abnormality. Other diagnoses on the spectrum include alcohol-related neurodevelopmental disorder (ARND), alcohol-related birth defects (ARBD), and partial fetal alcohol syndrome (pFAS). Milder involvement is called fetal alcohol spectrum disorder (FASD). If any of these conditions is suspected, referral for a neurodevelopmental evaluation is warranted. As the child becomes a toddler and a preschooler, behavioral and learning problems may appear. Attention problems and hyperactivity are hallmarks,
$30 $3 0
though nonspecific ones, of prenatal alcohol exposure, and the response to stimulant medication is often poor. Memory and learning impairments are also commonly seen. Executive functions such as judgment, planning, and organizing are weak, making problem-solving difficult. Not surprisingly, secondary disabilities—including mental health issues, trouble with the law, inappropriate sexual behavior, and drug and alcohol problems—occur more frequently in young adults who were exposed to alcohol in utero. A goal of early diagnosis and intervention is to prevent these secondary disabilities. Support for families living with FASD is available at the MOFAS website. Prevention is the answer
Although early intervention can improve outcomes for children, those with the full fetal alcohol syndrome seldom achieve independent living as adults. Clearly, the answer lies in prevention. In addition to the frustration and heartache caused by disabilities in individuals with
fetal alcohol spectrum disorders, the costs for their health care in Minnesota total an estimated $131 million dollars per year, according to the L. Hurd Prevalence and Cost Calculator. Preventing a single case of fullblown fetal alcohol syndrome can save our community $1 million over the person's lifetime for services such as health care, disability services, occupational and physical therapy, juvenile justice. All of these costs are preventable if mothers abstain from alcohol throughout pregnancy. Minnesota health care providers must do their utmost to educate all women of childbearing age and their partners about the dangers of consuming alcohol during pregnancy. The toxic effects of alcohol on the developing fetus have been known for more than 40 years. It is time that all Minnesota infants are protected from this teratogen and allowed to lead healthy productive lives. Mary Meland, MD, is a pediatrician at South Lake Pediatrics and a board member of MOFAS.
EACH EACH
così fan tutte Sept. 24 – Oct. 2, 2011
silent night WORLD PREMIERE Nov. 12 – 20, 2011
werther Jan. 28 – Feb. 5, 2012
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madame butterfly Apr. 14 – 22, 2012
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612-333-6669 Photo by Steve McHugh.
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M I N N E S O T A
MR. CHRISTENSON: How do you define wellness? DR. LAWSON: Wellness is really about fully embodied health from a holistic standpoint. All the perspectives—mental, emotional, physical, environmental, relational—need to be involved. If you are just talking about wellness from a physical standpoint, you are missing three-fourths of the boat. The second part of it is that wellness does not exclude disease or disability or injuries. Many, many people who are suffering from some kind of diagnosis or injury can still pursue their highest level of wellness and well-being for themselves—that is important. The third thing is that it is not a set place that any of us are ever going to arrive at. It is a moving target, an ongoing evolution, and a commitment to a conscious participation in a welllived life. DR. RADCLIFFE: As someone who sees patients every day, I see wellness as a balance. It is a way to meet people where they are, with their experience, their heredity, their laboratory tests, and their resources, and then finding out what they are willing to do and how we can make a difference in their lives. MS. SARGENT: Health is about individuals truly understanding what is happening in their lives and developing a path and a plan to best achieve wellness at it relates to what they are experiencing. Expanded to the employer, it is the same thing. Every employer needs to have an understanding of where they are and where they want to be and customize that plan for wellness for their organization. MR. CHRISTENSON: Bill, how do you distinguish between wellness and preventive medicine? DR. LITCHY: Some people confuse preventive services and preventive medicine and wellness. Preventive services are those things we provide—at first-dollar coverage—to people to make sure they do not have or are not susceptible to certain diseases. Preventive care is about how you maintain health and sometimes even restore health. Wellness to me is a philosophy. All of those things go together. As allopathic physicians, we have been taught to cure disease. We should be thinking about how we restore health. MR. CHRISTENSON: Tom, what do you see as the generator of this wellness revolution? MR. HENKE: One big piece is that the finan-
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H E A L T H
C A R E
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About the Roundtable Minnesota Physician Publishing’s 35th Minnesota Health Care Roundtable examined wellness as the centerpiece of a changing focus in health care. Seven panelists and our moderator met on April 28 to discuss this topic. The next roundtable, on Oct. 13, will explore the role of accountable care organizations in health care reform.
The Wellness Revolution A changing focus in health care cials of health care have changed dramatically. The plan designs offered to consumers through employers have radically changed over the last five or six years. Now the majority of consumers have high-deductible plans—or if they do not have a high-deductible plan, they have much more personal accountability for the amount they spend in health care. With that, they have decided they spend too much. One of the drivers here is the consumer saying, “If this is going to cost me a lot, what could I do to avoid that?” The other part that put this in a supercharged position is that the government payment model changed to encourage accountable care organizations and to make rewards or payment to the care providers. It is much more beneficial for a care provider to get upstream and work on wellness to avoid the cost that will follow patients who are out of compliance or not at their optimal wellness state. Also, in the past, employers and health plans did not know what things had a good return on investment (ROI) in terms of wellness. We all knew that we should eat right, exercise, should not smoke or drink. But how do we best influence consumers to do that inexpensively, efficiently? The data is finally coming in.
MR. CHRISTENSON: Not so long ago, health care insurance had no deductibles, no copays— it covered everything. Now—with copays, deductibles, et cetera—people are beginning to ask: Do I pay $20 or $30 to go to a physician when I can go to a wellness practitioner and pay the same amount for a whole-service visit? MR. HENKE: There has been a trend to covering less traditional or nontraditional practitioners over the last 15 years. One piece to this is that some employers are taking a very aggressive approach, using biometric screening—cholesterol levels, body mass index, weight measurement. It’s a first step in connecting to whether an individual is doing the work he or she needs to do. Employers are driving that because it comes back to cost. An overweight patient is much more likely to have additional health care costs, and employers just cannot afford it anymore. DR. LAWSON: Cost is by no means the only driver for consumer behavior. Twenty years ago, American consumers were spending significantly more out-of-pocket dollars to see complementary and alternative (CA) medicine providers. There were more visits to CA providers than to primary care providers in the United States at that time— and that was before those economic changes with payment policies and stuff with third parties. There has also been a growing grassroots hunger from the American population to the effect that “this is not enough, we want more.” DR. ZEIGLER: If you look at public policy on a national level as well as a local level, it is turning itself upside down—and with good reason. We are a country that per capita pays just about the most in dollars per person but has overall outcomes that are only moderate or worse. Looking at Third World countries in comparison to our own, we do not have much to brag about. We are a rich nation. We have generally a high standard of living. We have access to a lot of care, yet we tend not to change our health care behaviors. So how do we effect change in a society that is very much oriented to the here and now? It comes down to creating value-based systems that consumers are willing to purchase. We are seeing, as Karen said, consumers moving to other areas of health care because of its cost-effectiveness, because of their preferences, because of their outcomes. We need to take a step back and look at how we design
these systems and address those obvious shifts in what consumers are doing today. DR. RADCLIFFE: From the perspective of the consumer, there are a couple things that drive this strong interest in wellness. One is the change in our consciousness and awareness of how we see health and wellness. I see it as being driven by the availability of information from other traditions— Eastern philosophy and how other people are living their lives and how they are thinking about their health—and also from access to the Internet. Suddenly you are aware that there are all these other options. DR. LITCHY: With regard to ROI, there are issues that are very difficult to address. People struggle to find ROI in a variety of programs, whether it is health and wellness programs, disease management programs, whatever. But one issue that we always have to keep in mind is that it is not just the health care dollar that is being spent. It is—for employers— the absenteeism and presenteeism that is well beyond the dollars they spend for health care. DR. HALBERG: At General Mills, we have not been measuring absenteeism/presenteeism, but seeing the loyalty and the morale that lead to increased productivity. Our department of global health is about advocacy and helping employees understand their health and improve on it. We look at loyalty and morale —and thereby productivity. MR. CHRISTENSON: While new possibilities for cross-disciplinary partnerships are clear, much of the progress is stymied by the reimbursement system. What are the major causes of this problem? DR. RADCLIFFE: We have been stuck in the idea that we need to have a certain type and quantity of studies that prove efficacy. Though science is important, we need to be able to take a bigger-picture look. For instance, menopause. A patient has menopausal symptoms and can’t take hormones, so she wants a different solution. I have had really good luck having people do Chinese medicine and acupuncture. Knowing that there is a good response, I can refer her to get a treatment that may be beneficial for her. We need more data that shows that it is beneficial. I am looking for that as I try to find out where I can send people to do other alternatives. I also think that a lot of times
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when we send people for alternative treatments, we are also empowering them and they are making other changes that then impact other areas of their health. When we send people for Chinese medicine and acupuncture, they don’t need to stay on it for the rest of their lives. We create a change, and they are instructed in some health-changing lifestyle techniques that also play a role. There is a bigger picture to not having just science. DR. ZEIGLER: Our third-party payer system has historically reimbursed for disease management versus health promotion. Now there is a trend by third-party payers to look at how can we save dollars and move patient populations to providers who give care with the best evidence and the best cost-efficiency that improves patient satisfaction. Take lowback pain, for instance. I am aware of some third-party payers who are trying to move those patients to providers who they know are going to prevent low-back surgeries or more expensive procedures that are going to drive up the cost. Secondly, as you look at the movement toward medical homes and the encouragement to bundle payments, it does not matter when you have a collaboration of providers in the medical neighborhood, so to speak. It is about getting the patient as well as you possibly can in order to save the most dollars. It is a driver we are going to see being explored in Minnesota and across the country over the next two to three years. MR. CHRISTENSON: Why have health plans been hesitant to get into wellness? MR. HENKE: It is important to note that I don’t speak for a health plan at the moment, but have in the past. One piece of it is the way in which all systems are paid. Right now they are paid dominantly in this market by transactions. So every time something is done, a payment is made. That is starting to evolve with accountable care organizations (ACOs). In that world, we have coaching that is intangible—it’s very difficult to code exactly what conversation just occurred. That coaching time was pressed down as all the care delivery systems went to production models that required faster and faster visits. One statistic I find fascinating: There is a recent RAND study that showed that the 10 most common things done in the retail
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Julia Halberg, MD, MPH, MS, is vice president of global health services and chief medical officer of General Mills. Halberg earned her medical degree from the University of Connecticut. She received a master’s degree in biology/ecology and a master’s of public health degree in epidemiology from the University of Minnesota. She is board-certified in occupational medicine. Halberg has published extensively on several topics, including shift work and blood pressure. At the University of Minnesota, she is an adjunct assistant professor in the department of environmental and occupational health. Halberg serves on the Occupational Medical Residency and the Midwest Center for Occupational Health and Safety (MCOHS) advisory boards. Tom Henke, MBA, is president and CEO of QuickCheck Health. Henke’s 25 years in health insurance include 15 years of executive experience with Medica Health Plans as chief innovation officer, senior vice president and general manager of commercial markets, and vice president of sales and account management. In these roles, Henke had overall responsibility for Medica’s largest segment, representing 1 million members and more than $2 billion of revenue. He successfully launched many new products in many new markets and delivered market-leading growth. Henke has an MBA in finance from the University of St. Thomas. Karen Lawson, MD, is an assistant professor in the Department of Family Medicine and Community Health at the University of Minnesota Medical School and director of health coaching at the university’s Center for Spirituality and Healing. She is board-certified in both family medicine and integrative and holistic medicine, and was a founding diplomat of the American Board of Integrative Holistic Medicine. Lawson is the co-leader and initiator of the National Team for Standards, Certification, and Research for Professional Health and Wellness Coaches. At the university, Lawson is active in undergraduate and graduate medical education, and in the center’s graduate program. William Litchy, MD, is chief medical officer of MMSI, the Mayo Clinic health plan administrator. With graduate degrees from Saint Louis University (MS, Anatomy), the University of Minnesota Medical School, and the Mayo Graduate School of Medicine (Neurology), Litchy initially joined the Mayo Clinic staff in 1982 and currently is a consultant in neurology. He also is the chair of Mayo Health Plan Operations Committee, which is responsible for the oversight of Mayo Clinic employee health plans. With MMSI and the health plan, he has been involved in the development of wellness and care management programs for Mayo Clinic employees as well as other commercial and government-based companies. Noël Radcliffe, MD, is a family medicine physician at Edina Sports Health & Wellness, PA. Within her practice, she includes alternative, holistic, and spiritual care. A board-certified, active member of the American Holistic Medical Association, she began pursuing this area of interest when constraints of the managed-care system threatened the values of medicine she felt were important, namely caring and compassion. Radcliffe lectures locally and nationally on topics such as consciousness and healing, depression, and forgiveness. She received her MD from the University of Wisconsin Medical School, with specialty training in family medicine at Hennepin County Medical Center. Jennifer A. Sargent, MS, is vice president of corporate wellness for myHealthCheck. Prior to joining Life Time and myHealthCheck, Sargent was senior vice president of sales for U.S. Preventive Medicine. Her career also includes time at Matria Healthcare as vice president of sales and at Medica Health Plans as fitness program manager, as well as managing health enhancement programs for 3M and the University of North Dakota. A graduate of the University of Minnesota Duluth, Sargent has a master’s of science in kinesiology and is pursuing her MBA at the Carlson School of Management. Mark T. Zeigler, DC, a graduate of Northwestern College of Chiropractic, was named president of Northwestern Health Sciences University in 2006. Prior to that, he was in private practice for 26 years in Sturgis, S.D., and was the city’s mayor from 2001 to 2006. Under his leadership, Northwestern completed a major 2008 campus expansion; attained a 10-year re-accreditation; established clinical education partnerships with the University of Minnesota, the Mayo Clinic, and HealthPartners; and founded the Center for Health Care Policy and Innovation. Zeigler is vice president of the Association of Chiropractic Colleges and is on the board of the Minnesota Campus Compact and Foundation for Chiropractic Progress. Robert Christenson has 40 years of experience in health care policy and consulting. He helps solo and small-group practitioners build a full practice of ideal clients and improve their net revenue. JULY 2011
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M I N N E S O T A clinic—Minute Clinic or Target Clinic—represent 10 percent of its revenue. Those same 10 things also represent 18 percent of all primary care visits and 12 percent of all emergency room visits. In a world where we are spending enormous resources, $25 billion spent in clinics and emergency rooms for things that can be done in a Minute Clinic is not an efficient use of human capital. So you have a large, clogged-up health system. We have insurers that are paying the way they’ve always paid and, because of that, every portion is optimized in their piece. It does not allow for new thought processes. Since 1975 health plans, at least in Minnesota, all have covered preventive medicine and they have covered large numbers of wellness services, but they are not always well known. The nursing coach lines have been in place. We have also had chiropractic services that have been covered for many years in the local health plans. Acupuncture has been covered for quite a while. It is evolving, but to a great degree consumers did not know what they could use within the health plans. MR. CHRISTENSON: How well do thirdparty payers reimburse chiropractors? DR. ZEIGLER: The chiropractic profession, by and large, is covered by all third-party payers. It’s not the coverage, really—it’s how you drive patients to the right providers. In South Dakota they just had a legislative war on copays. The insurance industry, in particular Blue Shield, raised copays for a chiropractic visit to more than $50; for medical providers, it remained $15. So they introduced a bill in the Legislature saying that you cannot discriminate copays for the same services. It passed both the House and the Senate, but was vetoed by the governor. Both chambers overrode his veto. In the industry today it is all about eliminating barriers and getting the patient to the right provider. What we need to do in the future is watch the General Mills and the Life Times, as purchasers of health care design systems that will be value-based. They will look at leveraging and driving consumers and their employees to areas that ultimately save money. It will be business, not the public arena, that will change the way health care is going to go. MR. CHRISTENSON: What is the role of integrative health care and integrative medicine in helping to advance this wellness revolution? DR. LAWSON: The two big pieces of integrative health care are that it takes a holistic
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perspective to get us looking at all the components and all the perspectives of a person or a family or the system, and that it is open to and available to the best therapeutic interventions and resources that are available for that person’s situation and resources— whether those are things that may be perceived as conventional or things that have been outside the mainstream. Prior to the ’90s, we had alternative medicine—people were doing [either] that or this. Then we had complementary medicine. People were doing both things, but often they were not communicating between providers or telling one doc what the other was doing. With integrative health care, if you are, for example, an oncology patient, you may be receiving chemotherapy and seeing a naturopath for supplements and an acupuncturist for acupuncture. As you are doing that, everybody knows about everything. What that can bring to this movement has always been, to some extent, about wellness and wellbeing. It has always been about optimizing a way of living and the ability to live and do as one wants. A philosophy and focus that that movement has held for 25 to 30 years is now moving into the mainstream.
that exists for the condition, and the clinical experience. At our institution we have a chiropractic program, an acupuncture and oriental medicine program, and a massage therapy program. We concentrate on the whole person and try to deliver care with natural components and in a natural setting. We understand that there is a fit for all providers and a need for different delivery systems. That is why we seek out models of care that are integrated—whether it be with our Woodwinds Clinic in HealthEast, with our students at Abbott Northwestern, with our massage therapy students at Regions Hospital, with our chiropractor program at Methodist. We work with the Center for Spirituality and Healing. We put these young students together in an integrative setting and they go through diagnosis, the process of developing treatment plans, and then they allow patients to decide which route of care
There comes a point where personal accountability has to step in. Tom Henke, MBA
MR. CHRISTENSON: Much of integrative care is happening in a team environment. If we look at medical homes, who should be included on the team that is working with the patient? DR. HALBERG: You have to be open and inclusive. I use the integrative approach with our employees when I see someone who is not healing. They have been diagnosed, they have a condition and it is being medically treated, but their mind is not there. We are very fortunate to have high-quality integrative care in the Twin Cities. The holistic approach is what we need to look at with the medical home as well. Rather than saying who should be included, I think most people should be and you can pick from them all. DR. ZEIGLER: It depends on the condition and the situation. Certainly in a number of environments there are providers who excel because of their experiences and their training. The collaboration of providers takes into account patient preferences, the best evidence
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they would like to take. MR. CHRISTENSON: One of the most interesting innovations has been a new team member called a health coach. DR. LAWSON: For years we called it the missing provider. When you see an MD or a chiropractor or a naturopath, that provider says, “This is what you need to do.” Out in the parking lot, you ask yourself, “How am I going to do that in my life? What do I start on first? What are my barriers?” There was not a professional to help people navigate that. It’s the health coach or the health and wellness coach; the definition is still evolving. A national team is working on setting the standards for this. Team members have defined certified health and wellness coaches as “professionals from diverse backgrounds
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M I N N E S O T A in education that work with individuals and/or groups, in a client-centered process, to facilitate and empower a client to achieve self-determined goals related to health and wellness. Successful coaching occurs when coaches apply clearly defined knowledge and skills so that the clients mobilize their own internal strengths and external resources for sustainable life change.” The movement is coming from everywhere—fitness, recreation, wellness, mainstream medicine, psychology, behavior change, and everything in between. MR. CHRISTENSON: What type of training and oversight should be given to a health coach? DR. LAWSON: We are still working on that, but there is agreement that it is not a weekend class. This is not something that just anybody should be able to write on their
People come to the table with not just labs, but with their whole history and experiences. Noël Radcliffe, MD
business card. It will probably settle out between 130 and 150 hours of education in addition to a bachelor’s degree. There will need to be a requirement for four to six months of clinical supervision. There will be a national board-certification testing process that will identify knowledge in areas around lifestyle and lifestyle medicine. MR. CHRISTENSON: Should there be a process to certify wellness programs? DR. HALBERG: I am a little nervous about that. The more certifications you acquire, the more barriers you put up. Wellness programs need to be individualized; one size does not fit all. I think certification would take away innovation, as well as putting up barriers. DR. LITCHY: I am also concerned about certifi-
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cation of a program when we still are trying to define what everything really means. As it matures, there may be a time in the future, but I don't think the time is now. Program certification would more likely hinder progress at this time, because certification in general does that.
we prepare it. Look at tobacco use and how we continue to abuse alcohol in certain socioeconomic areas. Obesity still tends to be one of the largest problems within the United States. Look at cardiovascular disease and diabetes. The debate really is a public policy debate.
MR. CHRISTENSON: When did you begin your wellness programs at Mayo, Bill?
DR. HALBERG: I would take it one step further from a business standpoint, and say health and wellness have to be part of strategic vision for companies to be successful going forward. We have a senior leadership believing in that and that helps a lot to make a more open environment where we work.
DR. LITCHY: There has been a long history in the wellness programs we offer commercial clients, starting with health assessments and identifying how you can use them and then going into providing information through websites, books, and a variety of things. Mayo has a whole series of books, even one on complementary medicine. Now there is a strong move to approach all these things from multimodalities. Each person learns differently, each person will work differently. If you have only one tool to use with people, you will lose a lot of them. MR. HENKE: As Karen mentioned, consumers have been paying for things outside the health care insurance world all along, and we are not taking advantage of that. Winning models will win—period. Right now, even on the insurancecovered things, a typical deductible is between $1,000 and $3,000. That means something on the order of 50 percent or more of all patients will not reach their out-of-pocket maximum. So, in essence, they have zero coverage for the current system. That means that anything that is not covered by insurance is on an equal footing with covered things because it is 100 percent paid by consumers. The question is whether the world really is ready for this—and I would suggest it is. Then I would suggest we focus on adding value directly to the consumer. If it is there, employers will pay for it, insurers will pay for it. If it is not there, it won’t be paid for. It is about getting consumers what they need. DR. ZEIGLER: It goes deeper than just the health care system. Wellness needs to be part of our public policy. We have to take a stand on how we feed our children in school, how we promote good food, how we promote healthy living. It is changing perspectives of consumers and changing behaviors. Look at how we buy our food, how we cook it, how
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DR. LITCHY: Until senior leadership takes the role of wanting it and talking about it, it just does not happen. When we work with new companies, that is the biggest thing we emphasize. The stronger a company’s senior leadership, the more successful wellness programs are. That’s simply the way it is. MS. SARGENT: One of the biggest reasons we have seen employer wellness programs fail is because they don’t change their culture. They will put a wellness program in place, they may have a health risk assessment, do some biometric screening—but their cultural aspect does not change. They are still serving unhealthy foods and they do not have an environment that is conducive for people to exercise and manage stress. It does not become a part of what they do as an organization. It is more than just putting a program in place and hoping that it works. You have to have it be a part of your strategy and change your organization, your culture, and who you are. MR. CHRISTENSON: Many chronic conditions are linked to unhealthy lifestyle choices. What are some examples of how our society encourages people to make the wrong choices? MS. SARGENT: We have a society of convenience and a little bit of entitlement. We as a society have this “I want it and I want it now and I should have it now” kind of feeling— because we have such high-stress, busy lives and unhealthy things are convenient. Because healthy behaviors are much less convenient, it makes it easier to choose the unhealthy over the healthy. DR. RADCLIFFE: One thing that concerns me is advertising. How many ads [like this] do we see: “If you have the symptoms, see your doctor”? There is no empowerment, and very little public health information out there. DR. ZEIGLER: I read an article about a study at the University of North Carolina–Greens-
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boro. Two economists studied Walmart Supercenter openings in almost 1,600 locations nationwide. They demonstrated over 10 years, from 1996 to 2005, that when a Walmart Supercenter enters a county, on average the residents of that county gain about a pound and a half and the county’s obesity rate goes up by about two percentage points. So, fundamentally, our society is trying to make choices for us. It comes back to consumers making healthy decisions. It is the obligation of our educational institutions to talk to our future providers about changing behaviors, shifting consumer choices that consumers are making, and providing good, sound information that can change those behaviors.
DR. LAWSON: One of the most groundbreaking is Dean Ornish’s work with reversing heart disease. He put together a multidimensional team approach that was not using high-cost interventions. Many, many practitioners said, “You are never going to get people to eat that way, to exercise, to do group support.” And now it is reimbursed by Medicare because the cost of reversing heart disease by a lifestyle-change program at $5,000 per year versus a typical quadruple bypass, which starts and goes up from about $30,000 a year—with similar morbidity/ mortality outcomes—is pretty significant.
MR. HENKE: The alignment centers in health care are very, very difficult to put in place. Let me use this silly example. If I am not driving with my seatbelt on, I can get arrested. But my brother-in-law can get on his motorcycle without a helmet. That is a very simple example of an odd choice for society to make. Health plans struggle with not being able to say they won’t cover a statin if you haven’t stopped eating fats. We can’t do that. There comes a point where personal accountability has to step in. I would suggest that, rather than complain about the system and society, we just go after the targeted areas and win in those markets where there is interest. Rather than mandate that everyone has to eat right, let’s reward the people who are eating right. We are going to have to break down some of the insurance regulations to have that flow-through to the consumer. Right now consumers do not get rate cuts for following the right practices— even if they are following doctors’ orders.
MS. SARGENT: Partnering with employers succeeded when employers understood that you have to take the program past education to intervention. As an industry, we have done the education piece pretty well. But we have not had programs in place to intervene. The successful programs are where the employer took charge of the program and said, “We need to do more. We need to institute walking programs and we need to have a fitness center. We need to have fruits and vegetables available to our people,” and then incorporated the whole family. Kids are a big part in making a wellness program successful.
MR. CHRISTENSON: Jennifer, when you were with U.S. Preventive Medicine, what were some of their successful programs?
DR. HALBERG: With regard to responsibility, I vetoed a requirement that you had to fill out a health questionnaire before using our fitness center. I could not see instituting another barrier for liability purposes. People ask what small employers can do. There are so many things you can do, even at small companies: Join with the American Heart Association, American Cancer Society, American Diabetes Association. They have walks and runs all the time. You can buy T-shirts and get your people involved. To feel good about ourselves and to feel healthy, we need to engage. Volunteering is one way.
DR. HALBERG: We trademarked a real-time health risk assessment. Our Health Number gives people a snapshot in time of their health status. Then there are health coaches to educate, motivate, and help them choose one thing to move forward with. We use inkdated fingersticks to do fasting glucose and lipids. We record weight and blood pressure. And we ask six objective questions. We categorize scores on a scale of zero to 100. It’s all done anonymously. Everyone gets their own Health Number. Then we project what their peers are doing. It’s a healthy competition, totally confidential, but it motivates them to take the next step.
MR. CHRISTENSON: If a significant portion of wellness involves making healthy choices, what are some examples of successful programs?
MR. HENKE: The employer is an important centerpoint for a lot of change, but it is not the only place. People spend half their time
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at home, so reaching out just to the employer is not enough. Some successes I have seen are where the stakeholder—whether a government agency, employer, a vendor—takes a what’s-in-it-for-me approach and aligns it and meets with immediate response. If you are an employer who wants employees to behave differently, you have to have a carrot or a stick, and it will absolutely make a difference. If you put either rewards or penalties in, you will see dramatic change in participation. If you do it incorrectly, you can make people pretty unhappy as well. DR. LAWSON: While behaviors are critical and they are often the easiest thing to measure, belief change is a huge piece of this. Too
It will be business— not the public arena— that will change the way health care is going to go. Mark T. Zeigler, DC
often we minimize the impact and empowerment of learning to think of your life differently, working your life differently in everything from reducing pain to improving quality of life. A lot of people, when they ask about health coaching, really focus on behavior. We need to be thinking broader than that. MR. CHRISTENSON: What are some incentives that will make these programs successful? MS. SARGENT: There are a lot of ways you can do incentives—and you can take a stick and paint it orange and call it a carrot. More and more employers are moving away from the traditional carrot approach—I am going to pay my employee $300 because maybe they did a few things over the course of a year— to more of an outcome-based incentive program design. This is where you look at key indicators and tell people, “If you don’t reach certain goals, you are going to pay more.”
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M I N N E S O T A Maybe that’s a long-term strategy; it’s not that you have to get to these goals tomorrow. DR. ZEIGLER: Tom and Jennifer are right. Incentives can create tremendous shifts in behavior. They are taking nontraditional approaches to create those levers and using relationships as a driver in changing behavior. In other words, it is not just the fact that I am going to drop $100 into your HSA or I am going to reduce your annual health coverage by $200 if you meet these markers, but it is creating these communities of participants. You create obligations of one on another: If you don't meet your marker, you are letting down your friend, your coworker on the team. So I will get up at 6:30 a.m. be-
Kids are a big part in making a wellness program successful. Jennifer A. Sargent, MS
cause if I don't I am going to let down my team. Would I get up at 6:30 on my own? No. It is this obligation they are creating to incentivize behavior changes. DR. LITCHY: We spend a lot of time talking about how we are going to help the employee, but many of our employees are married and have children. Our cost for the dependents and children is more than the employee costs. We are challenged on how we can engage the other members of the family. DR. HALBERG: We have a healthy night out we sponsor for the community at the schools with parents, grandparents, and providers. We introduce fun ways of looking at nutrition, exercise—not just for our families but the whole community. Recently we joined with American Harvest: For employees who needed to lose weight, for every pound of weight they pledged to lose, we would give a
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pound of food to the local food bank. That tie to the community was a great motivation for our employees. MR. HENKE: One thing that is happening is a retailization of health care. Consumers are much more involved in their own decisions— good or bad—than ever before. One example we are working on now at QuickCheck Health is the question of how to monitor prediabetics. If someone is prediabetic, it is optimal to measure their A1c up to two times a year to see if it is progressing. In a perfect world, we would have a physician spending time with the patient twice a year doing that work. That is optimal. However, to have a prediabetic come in for an A1c check might mean two visits because the health system is not organized to do the test first and follow with the doctor immediately thereafter. It is organized to see the doctor, then go get your tests, and then you won’t have your score until you come back. That needs to be redesigned. A second piece is that it costs $200 to $300 for a typical office visit with some labs. So now we’re saying we are going to spend $400 a year on the 25 percent of all adults in America who are prediabetic. That is a huge increase in health care costs across the board. During a single year, only a portion of those will migrate upward towards diabetes. How do we address that? An example of what I would consider a disruptive innovation is a rapid test that could be sent to the home. The patient might have a $10 gift card for completing the rapid test. The patient cannot see the score until the doctor sees the score. If we could move to a world where that is the approach to health care rather than centralizing everything at the clinic, consumers win, doctors can spend less time on patients that don’t need to be there and more time with those who do, and the system can win. MR. CHRISTENSON: How have medical doctors begun to incorporate wellness more into their practice? DR. RADCLIFFE: It comes on many levels. The first is personal, how we chose to live our lives and model for patients. How do we as employers take care of our employees? But also wellness in the office: We take more time. We want to talk to patients, to look not just at their labs or their family history, but
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to understand the barriers to them living a healthier life. Are they caring for a sick mother? Are their kids having issues that take up a lot of their time? Is their workplace unsupportive? What are the issues and how can you help them so that they have the time and energy to focus some of their energy on themselves and their wellness? The patients I see fall into two groups. The first group feels helpless. How many people do we know who would save hundreds of dollars if they quit smoking and still they don't quit smoking? It isn’t about money. They do not feel like they can do it. Part of that holistic approach is understanding that people come to the table not just with labs, but with their whole history and experiences. In my clinic we spend a little extra time talking about those aspects versus just looking at their labs. DR. ZEIGLER: I was in private practice in Sturgis, S.D., for 26 years. When I entered practice in the late ’70s, I put an ad in the local newspaper talking about my approach to the whole person—body, mind, and spirit—and about eating healthy, having an active lifestyle, and taking care of ourselves. I remember getting chastised by my medical counterparts. In today’s environment, open up any magazine, any newspaper and look at how the ads are talking about health care. There is a remarkable generational shift. What excites us now in education is that we have an opportunity to build on that and break down the barriers to create better outcomes. MR. CHRISTENSON: Bill, is there a growing number of holistic practitioners at Mayo? DR. LITCHY: Yes. They have formed a section of interactive medicine. The philosophy at Mayo has always been that the patient comes first. Generally, the approach has been to treat the whole patient, although we as allopathic physicians have been constrained by our training. DR. HALBERG: I could not agree more that we are restrained by our training. I am old enough to say it was always about disease— we never did prevention. It was always what kind of technology or pharmacology you are going to use to get the person better. It is an awakening for those of us who are older to embrace these different treatments. MR. HENKE: But there always is this issue of compensation. Who is going to pay for it? DR. LAWSON: The restraints fascinate me. Yes, your payment plan covers acupuncture, but it has to come with a referral and the
ROUNDTABLE
sponsored by Minnesota Physician Publishing, Inc.
JULY 2011
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Let’s make this an evolution versus revolution. Julia Hallberg, MD, MPH, MS
port. We have talked about senior leadership, which is key, but we also found out that middle management has to kick in too or it will not be successful. MR. CHRISTENSON: Bill, how do you market your programs to employers?
referral specifically has to be from your primary care provider. Then I have to provide a pitch with research documents to my primary care provider to get them to write the referral. Or we will cover massage, but only if it is for a diagnosis. If I go preventively once a month, then I don’t get a diagnosis. DR. ZEIGLER: I practiced in an environment that was defined by patient preference. They could come to me for low-back pain or they could go across the street to the osteopath or MD. Now Optum Health— which has tens of thousands of chiropractors, physical therapists, and occupational therapists as part of their network— has developed a paradigm for low-back pain because of what they know through their data. They are going to shift many of their enrollees to chiropractors because they know the cost savings, the cost efficiency, and the patient satisfaction. Would they have done that 10 to 15 years ago? No. But because of the numbers they have, they know exactly the dollar amount they are going to save if they can get it to a certain provider before it goes to a specialist and on to probable surgery. Like it or not, that drives a lot of decisions—good most of the time. MR. CHRISTENSON: What are the most important things employers need to evaluate when they look at the myriad wellness programs available to them? DR. HALBERG: We always like to look at outcomes measurements, of course. Is the program going to engage people, sustain behaviors, and how is it going to go moving forward? There are a lot of good programs out there. There is no one-size-fits-all, whether it’s nutrition or getting moving. The programs also have to have management sup-
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DR. LITCHY: The brand opens a door, but does not close the deal. We are cognizant that some of the things we do simply will not work with some organizations. We want to make sure there is a match. Sometimes it does not match, not because we have a program that is not good or the company is not a good company. There can be different philosophies. You also have to be able to demonstrate that you can succeed at what you do. Outcomes are critical and that magic word “data” is essential. Sometimes it is hard to get the data you need. You may not be able to show the ROI, but you can show the engagement. MS. SARGENT: I will echo some things that have been said. Not every program is going to fit every employer. The program and company need to be flexible and nimble to meet the needs of the employer and build a strategy around it, not just put a program or a product in place. It also needs to offer a variety of modalities for people to engage. It cannot just be telephonic. There needs to be a physical way for people to engage, whether at the worksite or in other ways. One key is finding a wellness program that will integrate with other programs you provide. Employers may have disease management with a carrier and they may have an employee assistance program and they may have case management and then a wellness program. How does it all fit? How do we not confuse members with somebody calling from this company and somebody calling from another company for the same thing? We need partners that are willing to sit together on the client’s behalf to integrate the solutions for a seamless member experience.
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DR. HALBERG: One other point is to get a local champion. If you can get one or two employees to really engage people, that local champion will help determine success. MR. CHRISTENSON: What are some of the broader environmental and cultural aspects that affect the general health and wellness of employee populations? MS. SARGENT: There are a number of things —smoking policies, food served in the cafeteria, lots of little up to big things that culturally and environmentally can impact health. Are you willing to do the tough thing to change your culture and deal with the impact? MR. CHRISTENSON: What obstacles inhibit companies from investing in wellness programs? DR. LITCHY: Money—simply that and whether people are willing to realize that it is an investment in their organization. To be very frank, there are organizations where the investment really is not of value. If they have a turnover of 150 percent a year, I can see why they would choose not to invest in their population. If you have turnover of 2 percent a year—Mayo, for example—there is a big incentive to take care of the population. MR. HENKE: It is all about how the senior management culture sees health care. When they see a 10 percent renewal increase for health care and they are looking at cutting benefits, there is not an appetite for adding things that cost money unless they are absolutely proven to have a result. DR. ZEIGLER: We got a Blue Shield grant to apply for a wellness program. It was a god-
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Belief change is a huge piece of this. Karen Lawson, MD
sponsored by
M I N N E S O T A send because it gave us the green light to implement a change. It did change the work environment, and you have to have the support of senior management to do that. And you have to allow these things to evolve. The return on investment came quicker than we expected. Within two years we had premium drops in our overall insurance that we all collectively shared. MR. CHRISTENSON: What are some of the factors that inhibit wellness programs from being effective? DR. RADCLIFFE: Patients often do not feel supported in their workplace. Without that it is very hard for them to implement any change. Understanding how your workplace is stressful or unhealthy is critical to being able to help people commit to these programs. MR. HENKE: The data is really compelling on this. If there is one thing you can do, it is about the senior management engagement and the champions. If you do not have the local champion, it just won’t work. MS. SARGENT: There is a lot of research going on right now about intrinsic versus extrinsic motivation. The program has to have a component of working with the individual to find out what is going to intrinsically motivate them to make the change. That is the hard thing to do. DR. HALBERG: We combined health and safety; our safety managers were also our health managers. Often, people say, “I’m not sure I want my employer asking me about my health—that is very personal to me.” But from a safety perspective, it is all about behavior change. What do I have to do to be
The stronger a company’s senior leadership, the more successful wellness programs are. William Litchy, MD
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the safest I can be? Zero lost time, zero injury, win/win. Pair the health and safety duality and they can incorporate it easier into their everyday lives.
and are still challenged.
MR. CHRISTENSON: What role should health insurance companies play in keeping the wellness momentum going?
DR. RADCLIFFE: I would like us just to make some steps forward. One thing that stands out is the need to personalize any type of wellness plan. I love the idea that it starts from the top, but how do we do that? How do we actually get owners and senior managers involved in championing it? I think it will happen on its own because they themselves will be facing their own health issues. I think that will come.
DR. RADCLIFFE: I would like to see them offer incentives to employers to clean up their workplace. Maybe they would have to do some kind of analysis, but in the long run I think it would be a healthier workplace and healthier employees. MR. CHRISTENSON: There are lots of wellness programs where there are no medical practitioners involved at all. What issues are posed by how these establishments archive patient data? DR. RADCLIFFE: Having at one time practiced as a medical professional in an environment that was set up for what you are describing, there is not often educational expectation of things such as even basic rules of HIPAA. Certainly those wellness centers are very focused on client empowerment and the client being responsible for his or her own issues, challenges, and medical information. But there needs to be a certain level of safety triage awareness, because clients don't always understand what the level of knowledge is at the different places. I have seen those issues coming up more and more in the last five years as coaching has really taken off and we are getting a lot more partnerships among fitness facilities, community health places, and medical facilities. DR. LITCHY: On the other hand, it is critical to be able to integrate the data from all the different areas from which people are seeking wellness, so that we can do the evaluations that are essential to continued improvement. The struggle is how to obtain the data legally through HIPAA and how we can transfer that data among groups. Because, unfortunately, a field in one person’s data set is not the same field in another data set. We are working right now in a consortium of several major medical centers around the country and trying to figure out how we can put the identified data together in a single database. We are now at 18 months of very rigorous work
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MR. CHRISTENSON: We have come to our final question of the afternoon: How do we win the wellness revolution?
DR. LITCHY: Fifteen years ago we were worried about how we were going to take care of the high-dollar-cost people in the plan. Then we went on to say, “Let’s take care of everyone.” Now we’re talking about the high-cost people again. We talked about wellness a while ago and then forgot about it. We are now bringing it back again. MS. SARGENT: In order to win and not lose— or however you want to frame that—you need to have some common vision and collaboration among the key stakeholders: carriers, providers, employers all starting to move in the same direction with some sort of common vision. DR. ZEIGLER: We do know that the consumer is purchasing health care differently today than they did 10 years ago. They are spending their own dollars to purchase care the way they want to see it. I believe we need to listen to how consumers want to see their health care and use health care education to our advantage to shift those populations into different behaviors and different systems. MR. HENKE: If we focus exclusively on the consumer, focus exactly on what their problems are and what they need, and we don’t worry about the other stakeholders—who gets paid, who wins, who loses—that is how we are going to win. DR. LAWSON: As long as we have the mindset that there is a barrier, something to overcome—if there is a loser and a winner—we will continue to flail. MR. CHRISTENSON: The last word, Julia, is yours. DR. HALBERG: Slow and steady, let’s make an evolution versus revolution.
ROUNDTABLE
sponsored by Minnesota Physician Publishing, Inc.
JULY 2011
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SPECIAL
Society estimates that
cancer cases will be
ONCOLOGY
Quantum leap
The American Cancer
about 1,596,670 new
FOCUS:
Seeking to increase appropriate screening for colorectal cancer
diagnosed in 2011 in
By Cally Vinz, RN, and Melissa Marshall, MBA
the U.S., including 27,600 new cases in Minnesota. The articles in this month’s special focus address several ways in which the medical community is striving to reduce the burden of cancer— through screeening for colorectal cancer, research on breast cancer treatment, and technological advances in radiation therapy.
C
olorectal cancer (CRC) is the second leading cause of cancer death in the U.S., according to the American Cancer Society’s “Colorectal Cancer Facts & Figures 2011– 2013.” The report estimated that in 2010 in Minnesota, an estimated 2,410 new cases of colorectal cancer would be be diagnosed and 780 people would die from CRC. Many of these CRC cases and deaths could have been avoided if people had made the most of available screening tests and prevention strategies. The Minnesota Cancer Alliance, a coalition of more than 100 organizations, has been working over the past two years to improve CRC screening rates as an important way to reduce the burden of cancer in Minnesota.
Minneapolis VA Medical Center Director, Spinal Cord Injury/Disorder Center The Minneapolis Veterans Administration Health Care System (MVAHCS) is seeking a Director for its Spinal Cord Injury/Disorder (SCI/D) Center.The Center is the VA referral center for the upper Midwest and provides acute rehabilitation and lifelong care for 1200+ SCI/D Veterans. The SCI/D Center, a 68,000 square-foot-state-of-the art facility, has 30 inpatient beds and an extensive outpatient clinic with both a urodynamics/special procedure and telehealth room.The Center’s therapy department is equipped with a wall-to-wall ceiling lift, a full spectrum of robotic and FES training devices, and an assistive technology lab.A dedicated therapy pool with adjustable depth control and computer-controlled underwater treadmill includes underwater video monitoring capability. Affiliated with the University of Minnesota, the SCI/D Center has rotations for both medical students and PM&R residents. The Director is responsible for clinical care and administrative oversight of all aspects of the SCI/D Center, including leadership of Center functions such as continuous improvement activities, CARF and JCAHO compliance, oversight of satellite operations throughout the upper Midwest VA system, and direct supervision of medical staff and other clinical and administrative staff.The SCI/D Director will also be responsible for continued development of a SCI/D Home Care Program and SCI/D Fellowship Program.The Director reports to the Chief of Staff of the MVAHCS and participates in medical center and medical staff leadership activities. Candidates should be board-certified in Spinal Cord Medicine. Leadership experience preferred.
Send CV and application to: Human Resources Management Service MVAHCS, One Veterans Drive, Minneapolis, MN 55417 Attn: Ann Bolan, HRMS or, email to Ann.Bolan@va.gov EEO Employer
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In March 2009 the Minnesota Cancer Alliance and the American Cancer Society (ACS) co-sponsored a roundtable discussion entitled “Colon Cancer Prevention: The Next Quantum Leap.” Attendees included representatives of care delivery systems, health plans, the Institute for Clinical Systems Improvement (ICSI), MN Community Measurement (MNCM), the Minnesota Department of Health (MDH), and the ACS. The goal was to explore how care delivery systems could help achieve a population-wide appropriate screening rate of at least 80 percent in order to reduce deaths from CRC in Minnesota. According to MNCM, the screening rate in Minnesota in 2010 was 66 percent, up from 58 percent of appropriate patients screened in 2006. [Note: 2010 results are not directly comparable to those for earlier years, because the upper age limit was lowered to include patients only 75 years of age, vs. 80 years of age in 2006.] While the overall screening rate has climbed, there is significant variation in screening rates across the state. Screening rates for the 61 medical groups included in MNCM’s 2010 report ranged from a high of 92 percent to a low of 15 percent. Among the issues raised and discussed at the roundtable were how to systematically support patients and care teams to: 1) motivate average-risk people age 50–75 to opt for screening; 2) identify and initiate screening at the appropriate age and interval for individuals at higher risk; 3) address geographic and other disparities in CRC screening; and 4) ensure high-quality colonoscopy in Minnesota. Following the March 2009 roundtable, a Colorectal Cancer Advisory Council was formed. Subgroups of this council focused on: 1) clarifying the
screening message for averagerisk individuals to the public and providers; 2) revising ICSI’s CRC Screening Guideline to address screening for people at elevated risk; 3) addressing the complexities of billing and payment for CRC screening; and 4) working with MNCM to create standardized population measures of appropriate screening/surveillance and colonoscopy procedural quality. In October 2010, stakeholders reconvened to highlight work accomplished since the first roundtable and to determine how to further leverage Minnesota’s health systems to increase appropriate screenings. Highlights of work accomplished included: Revision of the ICSI CRC screening guideline and its use as a statewide evidence-based standard. Additions/changes to the guideline include new recommended routine screening options for individuals at average risk for CRC; quality indicators for colonoscopies; additional considerations for informed decision-making regarding valid and evidence-based screening options; and adding customizing screening for average-risk African American and American Indians to start at age 45. A change in how CRC screening measurement data will be collected and reported by MNCM to provide greater public accountability and transparency. New Colorectal Cancer Screening Direct Data Submission and Colonoscopy Quality & Surveillance measures were put in place in the summer of 2010. The data for these measures will be collected directly from medical groups in the fall of 2011, and will include additional information on patient’s race, ethnicity, and primary language. Clarification of billing and coding practices for screening procedures. Health plans and provider groups came together to review current billing practices and to understand barriers and challenges in the current system. A grid of colorectal cancer screening codes was developed as part of this work. Decisions by five health plans in Minnesota to work
Resources: colorectal cancer screening with their provider groups to improve colorectal cancer screening for their performance improvement project for the Minnesota Department of Human Services for 2011. Best practices
At the second roundtable, a panel with representatives of Stillwater Medical Group, CentraCare, and HealthEast Care System described the best practices they used to make significant improvements in their reported screening rates from 2008 to 2009. Panelists recommended the following practices: Plan ahead. • Standardize screening protocols to decrease confusion and support patients and providers with appropriate options. • Build a quality improvement and communications infrastructure to support patient/ physician/care team interaction with regard to CRC screening. Identify patients/engage providers. • Develop a process for targeted medical chart review to figure
• Revised ICSI CRC Screening Guideline: www.icsi.org/ guidelines_and_more/gl_os_prot/preventive_health_maintenance/ colorectal_cancer_screening/colorectal_cancer_screening_6.html • New MN Community Measurement screening measurement requirements: http://bit.ly/hvUC4S • Information and tools to increase the quantity and quality of screens provided to patients: www.mncanceralliance.org, www.icsi.org, and www.mncm.org • Additional resources: www.cancer.org/colonmd, www.nccrt.org and www.cdc.gov/screenforlife out which patients are most likely in need of a screen. • Effectively track, and transparently report, appropriate screening rates results within the organization; this adds “friendly competition” among colleagues. Send reminders to providers and patients. • Improve documentation and prompts—both electronic and paper. • Improve or initiate patient outreach—simple postcards and letters work. The panelists also noted the following common challenges they encountered: • Effectively tracking and documenting screening procedures not done within their own
organization. It is important to get this information back to the original clinic and documented in the medical record. • Tracking CRC screenings other than colonoscopies, as some information systems are not set up to do so. • Variation and confusion regarding insurance coverage for “screening” vs. “nonscreening” colonoscopy. • Difficulty with patient preparation for a colonoscopy procedure and the need to have patients’ questions regarding prep addressed in a timely manner prior to the procedure. Tactics to increase screening
Participants at both the 2009 and 2010 roundtable discussions
also generated the following ideas to increase CRC screening. Communication/information exchange tactics Within/between provider groups • Hard-wire one set of guidelines into the electronic health record with prompts for screening. • Clearly communicate appropriate CRC screening standards and options to both providers and patients. • Provide feedback to providers on their performance (measure and report). • Create methods to share patient data between systems. Physician/clinic to patient • Incorporate questions/provide information about CRC screening into other health care encounters (e.g., mammograms, flu shots). • Clearly communicate to patients their last preventive exams and what is recommended for their age/gender. • Develop a CRC pamphlet for use at appropriate appointments. QUANTUM LEAP to page 36
When Surgery is Necessary Medical management is key to the care of patients with Crohn's disease, but surgery is needed at times. When surgery is necessary, it is important to have a surgeon with experience and interest in surgical care of patients with inflammatory bowel disease, particularly Crohn's disease. Colon and Rectal Surgery Associates has specially trained surgeons with that expertise and experience. We provide comprehensive care you can trust! www.crsal.org
Coon Rapids/Plymouth 651-312-1717 • Edina/Burnsville 651-312-1700 • MInneapolis 651-225-7855 • St. Paul 651-312-1620 Pelvic Floor Center 651-225-7800 • Riverside Endoscopy Center 651-225-7999 JULY 2011
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M
ove over photons. Make room for protons. Photons, also known as x-rays, have been the mainstay of external beam radiotherapy for more than a century, but a new era of radiotherapy—using charged particles, such as protons—has begun, following pioneering efforts in the United States, Europe, and Asia. The beneficial effects of x-rays for treating cancer were noted soon after the discovery of x-rays over 100 years ago. Significant advances over the years have improved their safety and efficacy, including improved imaging of the cancer target using CT, MRI, and PET and more powerful computer hardware and software used for dose calculations and delivery. However, a problem with x-rays is that they pass completely through the body, administering harmful effects to normal organs and tissues as they enter and exit the body on their way to and from the cancer target. Protons, on the other hand, have a unique physical charac-
FOCUS:
ONCOLOGY
Proton beam therapy Putting radiation doses where they belong By Robert L. Foote, MD teristic called the Bragg Peak, in which there is very little entrance dose as the protons enter the body; then they slow down and deposit the majority of their energy in the cancerous tissues; and then they stop, eliminating the exit dose to normal organs and tissues. This more targeted form of radiotherapy allows exploration of dose escalation to improve tumor control and overall survival while simultaneously lowering the risk of acute and late side effects and complications of radiation on normal organs and tissues. The current generation of proton beam therapy uses passively scattered proton beams. This requires the use of costly devices to shape the radiotherapy beams for every patient treated, in order to reduce radiation exposure to normal tissue. These
devices are manually attached to the treatment machine and prolong treatment times. At present, all but one of the facilities offering proton radiotherapy in the U.S. employ this technology. The second generation of proton radiotherapy, pencilbeam scanning proton therapy, eliminates the need for these devices by using intensity-modulated proton therapy (IMPT) to conform the radiation dose to the cancer target—much as intensity-modulated radiation therapy (IMRT) improves precision of x-ray delivery. Pencil beam scanning proton therapy uses so-called spot scanning to embed dots of radiation throughout a tumor—“painting” dots of protons back and forth, similar to the pointillism painting style of French artist George Seurat. The protons fill the depth and contour of the tumor, allowing greater control over radiation doses, including application of higher doses to improve tumor control and survival, shorter and fewer treatment times, and fewer side effects compared with conventional photon and proton therapy. A third iteration of proton beam therapy is now undergoing final testing at the Paul Scherrer Institute in Switzerland, where proton pencil-beam scanning therapy was developed. Line scanning with IMPT will be 10 times faster than spot scanning—so fast that it can paint a tumor in between a patient’s breaths. That means this radiotherapy can be used in lung, liver, and other tumors that move due to respiration. In April, design began on two new advanced proton units at Mayo Clinic’s campuses in Minnesota and Arizona (see sidebar). The health system will install pencil beam scanning radiotherapy and hopes to use the third iteration as well. The case for charged particles
The U.S., in general, has been
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late to explore the use of charged particles to treat cancer. One reason is cost; researchers and physicians chose to examine whether less expensive advanced x-ray technology would offer similar benefits. Experts have spent a lot of time investigating whether IMRT technology could focus and concentrate x-rays on tumors better than conventional x-ray treatments could. Radiation oncologists know that the price paid for bathing the body with low doses of IMRT x-rays, which travel into the body, through the tumor, and then out of the body, is radiation damage to normal tissue and development of secondary late effects and cancers. The radiotherapy community remains concerned about the long-term effects of x-rays, especially when they are used in children and young adults. X-ray and proton radiotherapy has limited efficacy in treating some solid tumors that are deficient in oxygen, a condition that occurs when these tumors outgrow their blood supply. Tu-mor cells in such a hypoxic environment are often resistant to x-ray and proton radiotherapy. Comparatively, heavier charged-particle therapy using carbon ions offers an anti-tumor effect that does not depend on tumor oxygen content. In heavier charged-particle therapy, the large mass of the particle supplies directed energy that can break apart DNA, in a process referred to as high-linear energy transfer. Taking advantage of the same Bragg Peak physical characteristic of protons, the higher energy from heavier charged particles can be deposited directly within the tumor, with very little entrance or exit dose, thus reducing the impact on surrounding normal tissue and overcoming the resistance of the cancer cells to the killing effects of radiation. Recognizing these advantages, charged particle radiotherapy facilities have been built in Europe (Switzerland, Germany, England, France, Italy, and Sweden) and in Japan, China, and South Africa. Carbon ion units have been used since the mid-1990s, primarily in Japan, where more than 4,000
patients have been treated. There are also carbon ion facilities in Germany, Italy, and China. In the past few years, a number of commercial equipment vendors have begun to offer proton therapy, thus lowering the price of the equipment. Carbon ion therapy is considerably more costly than proton beam therapy, but it also offers a dose that is at least three times as powerful as protons or x-rays. There is much yet to be resolved regarding use of carbon ions in the U.S. The federal Food and Drug Administration has not approved the equipment for its use in this country; no one has applied for approval. And there is no mechanism yet for insurance reimbursement for this future therapy. The strategy Mayo Clinic has adopted is to build two units of the most advanced proton pencil-beam scanning therapy possible, at a cost of about $400 million, and to explore development of a â&#x20AC;&#x153;next-generationâ&#x20AC;? carbon ion facility in the future. Mayo radiation oncologists
While some first-generation proton treatment facilities are up and running in the United States, Mayo Clinic has announced plans to build two new advanced proton units at its campuses in Minnesota and Arizona, as part of Mayoâ&#x20AC;&#x2122;s three-site cancer center (the other campus is in Florida). With multi-site facilities, which are now in the design phase, Mayo Clinicâ&#x20AC;&#x2122;s commitment to proton beam radiotherapy is perhaps, at this point, among the strongest in the country. Eight rooms will be equipped with â&#x20AC;&#x153;pencil beam scanningâ&#x20AC;? proton beam therapy that will use spot scanning to â&#x20AC;&#x153;paintâ&#x20AC;? dots of protons back and forth through a tumor. Design of the proton beam facilities began in April, and construction is slated to begin in September in Rochester and in December in Arizona. The first patient will be treated in Rochester in mid-2015, and in early 2016 in Arizona. The proton beam therapy program will be fully integrated into Mayo Clinic's three-site cancer center in Minnesota, Arizona, and Florida. foresee a future in which a menu of charged particlesâ&#x20AC;&#x201D;protons, carbon ions, and other heavier charged particles such as helium, oxygen, neon, lithium, and beryllium ionsâ&#x20AC;&#x201D;will be offered to cancer patients. The choice of particles will depend on characteristics of the tumor (such as its anatomical location and genetic profile), in much the same way as biologically targeted chemotherapeutic agents for cancer, and antibiotics based on specific strains for bacteria. The need for research
Pencil beam scanning is very effective in treating tumors that
Minneapolis VA Medical Center Chief of Imaging Services The Minneapolis VA Health Care System (MVAHCS), affiliated with the University of Minnesota, is seeking a dynamic leader for the position of Chief of Imaging Services. MVAHCS provides comprehensive inpatient and outpatient care and serves as a tertiary referral center for VISN 23 and other medical centers across the country.The VA has state of the art equipment including all digital department with 3T and 1.5T MRI, 3 CT scanners, PET/CT and 2 angiographic suites. A full-time Chief is needed to assume clinical and academic leadership of the Imaging Service Line, and to serve as a member of the management team of the medical center. This position would include an academic appointment at the University of Minnesota and would oversee research and resident training at the VA.Applicants must be boardcertified in diagnostic radiology, have clinical, administrative, and teaching experience, and preferably experience working in a VA hospital. Competitive salary and benefits with recruitment incentive and performance pay possible.
Send CV and application to: Human Resources Management Service Attention: Ann Bolan MVAHCS One Veterans Drive, Minneapolis MN 55417 or, email Ann.Bolan@va.gov.
are deep-seated, close to critical, radiation-sensitive organs and body structures. These include some head and neck, breast, gastrointestinal, lung, spine, and prostate cancers, and tumors in or near the brain and eye. Even though it is known that patients benefit from putting radiation doses where they belong and nowhere else, the newness of proton therapy means that randomized, clinical proof that proton beam therapy in adults offers superior outcomes compared to advanced x-ray technology is still evolving. The benefit to children, however, is clear. The pediatric radiation
oncology community already has determined that proton beam therapy should be used whenever possible in preference to x-ray therapy. Researchers at the two Mayo Clinic proton beam facilities are planning on conducting joint prospective clinical studies as a unified program. Standardized treatment factors and clinical outcomes for all Mayo patients will be entered into one central database to improve care models and services for cancer patients. Mayo also plans to foster collaborative research with other centers worldwide. The goal is to minimize the harmful effects of the entrance and exit dose of radiation on normal organs and tissues and increase the beneficial effects on the cancer target by increasing the dose. This will give us a greater chance to cure more cancers and help people to live longer, free of the harmful acute and late effects of radiation. Robert L. Foote, MD, is chairman of the Radiation Oncology Department at the Mayo Clinic, Rochester.
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. Full- or part-time urban, suburban, and rural openings are available in the following specialties: t Allergy t Dermatology t %JTUSJDU .FEJDBM %JSFDUPS t &NFSHFODZ .FEJDJOF t &OEPDSJOPMPHZ t 'BNJMZ .FEJDJOF t (FOFSBM 4VSHFSZ t (FSJBUSJDT JODMVEJOH .FEJDBM %JSFDUPS
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t 1TZDIJBUSZ t 1TZDIPMPHZ t 1TZDI .PPOMJHIUFST t 6SHFOU $BSF
Allina offers a competitive benefits and salary package. For more information, please contact: Kaitlin Osborn, Allina Physician Recruitment Toll-free: 1-800-248-4921 | Fax: 612-262-4163 Email: Kaitlin.Osborn@allina.com Website: allina.com/jobs EOE EEO Employer
9533 0611 Š2011 ALLINA HEALTH SYSTEM. ŽA REGISTERED TRADEMARK OF ALLINA HEALTH SYSTEM
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New study highlights issues of surgical protocols, standard practice By Madeline Gartner, MD The SLN-alone group demonstrated a five-year survival rate of 92.5 percent; the ALND group, at 91.8 percent, showed no statistical difference from the SLN-alone group. The
cent—again, showing no comparative statistical difference. Further, the SLN-alone group demonstrated a five-year local recurrence rate of 1.6 percent, while the ALND group demon-
Although the study’s findings provide important guidance to surgeons, a number of questions remain about lymph node procedures and their interpretation for treatment. improved survival rate likely is the result of better radiation techniques and improved chemotherapy drugs. The SLN-alone group reached a disease-free survival rate of 83.9 percent, and the ALND group topped 82.2 per-
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.
• Pulmonologist • Orthopedic Surgeon • Emergency Department Physician
To be a part of our proud tradition, contact:
Human Resources Mgmt. Service P O Box 5046 Sioux Falls SD 57117 605-333-6852
www.siouxfalls.va.gov 32
ONCOLOGY
Breast cancer care
A
n article in the February 2011 issue of the Journal of the American Medical Association made national news in reporting the results of the American College of Surgeons Oncology Group Z0011 trial (JAMA 2011; 305(6):569–575). The study findings have implications for current surgical practice. Researchers compared sentinel lymph node (SLN) biopsy alone versus axillary lymph node dissection (ALND) for positive SLN. They carefully chose nearly 900 patients, selected for small, invasive breast cancers with no palpable adenopathy, who were undergoing lumpectomy and postlumpectomy radiation. Each patient’s physician determined whether she should receive chemotherapy. Approximately half of the women did. Based on the literature, the researchers hypothesized overall survival at about 80 percent at five years for optimally treated women with positive axillary lymph nodes. Surprisingly, after six years, survival for both groups was considerably higher.
FOCUS:
MINNESOTA PHYSICIAN JULY 2011
strated a 3.1 percent rate (P=0.11). Results point to a locoregional recurrence-free survival at five years of 96.7 percent in the SLN-alone group and 95.7 percent in the ALND group. Should we change standard practice?
Axillary lymph node dissection in the setting of breast cancer has long been controversial. Nodal sampling was at one time thought to be therapeutic, but more recently the consensus has been that it is diagnostic. Breast surgery, as a whole, has become much less radical, moving from the Halsted radical mastectomy, to various versions of the modified radical mastectomy, to lumpectomy. These changes in surgery have been accompanied by advances in adjuvant treatments including breast irradiation and chemotherapy/hormone therapy. Similarly, axillary lymph node surgery has become less invasive. The sentinel lymph node biopsy, associated with far less morbidity than axillary dissection, has become the standard. The accepted SLN biopsy procedure involves sending the sentinel node(s) to pathology during surgery for frozen section. If the SLN is positive, the surgeon performs an ALND and often places a drain. The risks of ALND include wound infection,
seroma, paresthesias, and lymphedema. No study has demonstrated a survival benefit associated with ALND when metastatic cancer is identified in an SLN. In light of the American College of Surgeons Oncology Group Z0011 trial results, should surgeons change their protocols and standard practice? The data are good and the number of patients is fairly large (420 and 436 in the respective groups). The follow-up period— six years, so far—is not that long, but the data appear valid as they are compared with fiveyear survival and recurrence numbers. If we apply this study to clinical practice, surgeons should adhere to the patient selection criteria as outlined (see sidebar). Also, because radiation treatment is important, a patient who will not need post-surgical radiation, such as a woman undergoing mastectomy, should have ALND if the SLN is positive. The surgeon should remove any palpably abnormal lymph nodes, regardless of procedure. Avoiding ALND in select patients will decrease the associated morbidity and post-operative discomfort, as well as save the time and money associated with performing a frozen section on the lymph node during surgery. The ACOSOG Z0011 study supports the idea that lymph node biopsy for breast cancer serves a diagnostic purpose, and that further dissection of lymph nodes does not improve survival as long as the patient receives radiation to include the inferior axilla. Questions remain
Although the study’s findings provide important guidance to surgeons, a number of questions remain about lymph node procedures and their interpretation for treatment. For example, does removing only one or two positive nodes affect the oncologist’s treatment selection? Typically, oncologists consider the number of affected lymph nodes when making decisions about chemotherapy. An oncologist may offer chemotherapy to a healthy woman in her BREAST CANCER to page 34
Minneapolis VA Medical Center Primary Care Provider The Minneapolis VA Health Care System (MVAHCS) is seeking a Primary Care Provider. Applicants must be board-certified in internal medicine. Clinical work involves taking care of Veterans in the outpatient setting with options to do inpatient attending, working with internal medicine residents.A faculty appointment in the Department of Medicine at the University of Minnesota is possible. Competitive salary and benefits with potential for a recruitment incentive.
Send CV and application to: Human Resources Management Service Attention: Brittany Buck MVAHCS One Veterans Drive Minneapolis MN 55417 or, email Brittany.Buck@va.gov. EEO Employer
The perfect match of career and lifestyle. Affiliated Community Medical Centers is a physician owned multi-specialty group with 11 affiliate sites located in western and southwestern Minnesota. ACMC is the perfect match for healthcare providers who are looking for an exceptional practice opportunity and a high quality of life. Current opportunities available for BE/BC physicians in the following specialties: • Family Medicine • General Surgery • Geriatrician/ Outpatient Internal Medicine • Hospitalist • Infectious Disease
• Internal Medicine • Oncology • Orthopedic Surgery • Pain Management • Psychiatry
• Pediatrics • Pulmonary/ Critical Care • Radiation Oncology • Rheumatology
For additional information, please contact: Kari Bredberg, Physician Recruitment karib@acmc.com, 320-231-6366 Julayne Mayer, Physician Recruitment mayerj@acmc.com, 320-231-5052 www.acmc.com
URGENT CARE Mankato Clinic is looking for BC/BE physicians for our Urgent Care Department. Urgent Care is three rotations of 3–12-hour shifts in a week, and one rotation of 2–12-hour weekday shifts plus a Saturday 8 a.m. — 5 p.m. and Sunday 11 a.m. — 5 p.m. There are no Call or hospital privileges required for Urgent Care. Service lines that support our group include our own lab, sleep center, nuclear medicine, Medicare Certified endoscopic center and radiology department with a 128 slice CT and co-ownership in an ambulatory surgery center. Opportunity highlights: • Market competitive compensation guarantee to start, followed by RVU based production income thereafter • Fully integrated Allscripts electronic medical record • 35 PTO / CME Days + paid holidays; generous CME allowance • Practice connects to a regional, 270 bed, not-for-profit Mayo-affiliated hospital, Level 3 Trauma Center • State university with 14k students; 150 undergraduate / 100 graduate / 4 PhD programs; 1800 Faculty / Staff • Named one of America’s Promise “100 of the Best Places for Youth” • Essential retail in the community; Target, Best Buy, Lowe’s, Sears, Old Navy • Affordable housing: 4-bed, 4.5 bath, 3,572 Sq/Ft. home - $264,900 • 50 miles of local, paved trails / hundreds of acres of community parks 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
We iinvite We nvite you you to to eexplore xplore our opportunities opport rtunities iin: n: our In the heart of the Cuyuna una Lakes region of Minnesota, the medical cal campus in Crosby includes Central Lakes kes Medical Clinic, a 30-physician multispecialty cialty group and Cuyuna Regional Medical Center, a critical access hospital offering superb s new ffacilities acilities with with the the llatest atest medical medical ttechnologies. echnologies. Outdoor activities abound, andd with the T i Cities metropolitan Twin t litan area just justt a short h t drive away, you can experience the perfect bbalance alance of of rrecreational ecreational and and ccultural ultural activities. activities. EEnhance nhance your your pprofessional rofessional life life in in an an eenvironment nvironment that that pprovides rovides exciting exciting practice practice Northwood’s oopportunities pportunities iinn a beautiful beautiful N orthwood’s ssetting. etting. welcomes TThe he Cuyuna Cuyuna Lakes Lakes rregion egion w elcomes you. you.
s &AMILY -EDICINE s )NTERNAL -EDICINE
CENTRAL C ENTRAL LAKES L AKES MEDICAL M EDICAL CLINIC CLINIC P.A. P .A .A.
Contact: Todd Bymark, mark, tbymark@cuyunamed.org (866) 270-0043 / (218) 546-4322 | www.cuyunamed.org org
www.mankato-clinic.com
JULY 2011
MINNESOTA PHYSICIAN
33
Lymph node study: criteria for breast cancer Breast cancer from page 32 60s or 70s who has one or two positive lymph nodes and an ER-positive breast cancer, but may not push for it, since estrogen blockade alone may be comparable treatment. However, the oncologist would be more likely to encourage a patient to accept chemotherapy if there were three or more positive nodes. Additionally, the stage of the cancer is based, in part, on the number of positive lymph nodes. Ten or more positive lymph nodes place the patient in stage IIIc. Furthermore, the Oncotype DX test—a diagnostic test that analyzes the expression of 21 genes within a tumor to determine a recurrence score that indicates the likelihood of distant (i.e., lungs, bones, liver, etc.) breast cancer recurrence within 10 years of the initial diagnosis if the patient was treated with Tamoxifen alone—is approved for use in patients with one to three positive nodes. If we remove only one or two nodes and they are positive, how do we know that the patient has three or fewer positive nodes? Can we
American College of Surgeons Oncology Group Z0011 trial compared sentinel lymph node (SLN) biopsy alone, versus axillary node dissection (ALND), for positive SLN.* The results showed that ALND was unnecessary for some patients who met the following criteria: • Tumors were at an early clinical stage, T1 or T2 (<5 cm in greatest dimension). • Sentinel node biopsies (i.e., 1–4 axillary lymph nodes are removed that are identified by pooling of radioactivity that was injected into the breast preoperatively) found cancer, but the positive nodes were not enlarged enough to be palpated during an exam. • The cancer had not metastasized to distant organs. • The patient would be undergoing post-lumpectomy radiation. *The study was published in the Journal of the American Medical Association (JAMA 2011; 305(6):569–575). still use the Oncotype DX test in a case where we remove one SLN and it is positive, but we remove no further lymph nodes? I have cared for patients in whom one of two sentinel lymph nodes is positive and another two or three nodes are found to be positive in the subsequent axillary dissection. The oncologist would not be aware of the additional positive nodes if the ALND were not performed. Not too long ago, I cared for a patient in her 60s with multiple comorbidities (diabetes, obesity, hypertension) who had a positive SLN and one additional positive node in the ALND. The
oncologist was not eager to give this patient chemotherapy, and because he knew that the total number of positive nodes was two, he was able to order the Oncotype DX test. The Oncotype DX recurrence score was very low for this patient, which gave the oncologist confidence that estrogen blockade alone was a reasonable treatment in this case. An oncologist would not order an Oncotype DX test for a patient who had four positive lymph nodes, but might order the test if there was one positive node. If we stopped doing ALND with a positive SLN, would the
oncologists assume that there are more positive nodes and be more likely to bypass the Oncotype DX test in favor of giving chemotherapy? Or would they assume that there is one, or no, further positive lymph node and order the Oncotype DX test to help with decision-making regarding chemotherapy? The study showed that surgeons found additional positive nodes on ALND only 27 percent of the time. The authors argue that the additional information gained from ALND is unlikely to change systemic therapy decisions, while the cost is significantly increased morbidity. Clearly, we need further discussion among physicians treating breast cancer before the medical community can accept a new standard of SLN alone in node-positive patients undergoing lumpectomy and subsequent radiation. Madeline Gartner, MD, is a solo practitioner specializing in breast surgery, with offices in Plymouth and Edina. She completed her general surgery training at Brown University/Rhode Island Hospital and the University of Minnesota.
Opportunities available in the following specialty:
Current Opportunities in: OB/GYN Occupational Medicine Family Medicine Internal Medicine Pediatrics & Adolescent Medicine Hospitalist Program
Olmsted Medical Center, a 150-clinician multi-specialty clinic with 10 outlying branch clinics and a 61 bed hospital, continues to experience significant growth. Olmsted Medical Center provides an excellent opportunity to practice quality medicine in a family oriented atmosphere. The Rochester community provides numerous cultural, educational, and recreational opportunities.
Family Medicine Rochester Northwest Clinic Rochester Southeast Clinic St.Charles Clinic Internal Medicine Southeast Clinic Occupational Medicine Southeast Clinic Dermatology Southeast Clinic
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
34
MINNESOTA PHYSICIAN JULY 2011
Come home.
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.
Where organizational strength lies in the diversity of people who call SANFORD HEALTH – home. Sanford Health – Fargo Region is redefining health care. Serving northwestern Minnesota and eastern North Dakota, we offer innovative technology, support of a multi-specialty organization, and dependable colleagues. Excellent practice opportunities exist in family-oriented communities that offer year-round outdoor activities, cultural events, and superior education districts that will allow you to balance your work & life. Our employment model features competitive salaries, a comprehensive benefits package, paid malpractice insurance, and a generous relocation allowance. Contact: Jean Keller Physician Recruiter Phone: (701) 280-4853 Jean.Keller@sanfordhealth.org
Contact: Gail Anderson (218) 999-1447 gail.anderson@granditasca.org.
Practice Well. Live Well.
Cardiology Dermatology ENT Emergency Medicine Family Medicine Gastroenterology Hospitalists Internal Medicine Neurology Occupational Medicine Oncology Orthopedic Surgery Pediatric Specialties Psychiatry Pulmonology (Sleep) Rheumatology Urology
Urgent Care Minneapolis/St. Paul
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
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.
• Family Medicine • Urology • Family Medicine • General Surgery • Psychiatrist • General Surgery
For more information contact
Barb Miller, Physician Recruiter bjmiller@lrhc.org • (218) 736-8227
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
712 Cascade St. S. Fergus Falls, MN 736-8000 | (800) 439-6424
Lake Region Healthcare is an Equal Opportunity Employer. EOE
healthpartners.com ©
JULY 2011
MINNESOTA PHYSICIAN
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Quantum leap from page 29 • Provide all screening choices to patients: colonoscopy, CT colonography, flexible sigmoidoscopy, fecal occult blood test (FOBT), and fecal immunochemical test (FIT). Population-wide communications • Develop a marketing campaign aimed at high-risk individuals. • Develop an interactive website/videos to engage public. • Provide all screening choices— not just colonoscopy—to patients. • Increase use of free screens (FOBT, FIT). System improvement tactics • Standardize screening questions to effectively identify high-risk patients and initiate screening at appropriate age and interval. • Schedule screening before patient leaves office. • Provide incentives to high-risk patients to get screening. • Emphasize team approach at the provider level. • Make CRC screening a strategic quality improvement goal
The Minnesota Cancer Alliance, a coalition of more than 100 organizations, has been working over the past two years to improve CRC screening rates as an important way to reduce the burden of cancer in Minnesota. at the board/senior leadership level for providers, systems, and plans. • Achieve consistent preparations to avoid variation in outcomes. • Reduce complexity of coverage, waive copay, and determine cost to patients before they have the test. Public policy and regulatory tactics • Expand educational and outreach efforts to the broader community (faith community, social service agencies, etc.). • Develop a statewide screening (and cancer) registry to optimize tracking of data for information exchange.
NEW POSITIONS:
Family Practice Urgent Care Dynamic, independent 3 location, single-specialty practice in northwest Minneapolis suburbs is seeking additional associates for its Rogers site and has Full Time/ Part Time shifts in the Crystal and Rogers Urgent Care. • • • • •
Partnership opportunity after 2 years Competitive salary with incentives Excellent benefits, 401k/employer paid pension Practice at one site/one hospital Physician-owned
Please contact or fax CV to: Joel Sagedahl, M.D. 1495 Highway 101 North, Plymouth, MN 55447 763-504-6600 • Fax 763-504-6622
• Create consistent benefit coverage/reimbursement and simplify coding options and requirements. • Develop measurement and reporting systems to encourage transparency in reporting rates. More discussion needed
Participants at the 2010 roundtable indicated that more discussion is needed to address two areas. First, since insurance coverage and cost sharing for colonoscopy vary depending on whether a colonoscopy is coded as “screening” or as “diagnostic,” steps should be taken in advance of the procedure to clarify the
indication and inform patients ahead of time. Higher than expected out-of-pocket costs can be a disincentive for colonoscopy screening. Second, if the ultimate goal of screening is to reduce deaths from colorectal cancer, attention must be paid to the quality and effectiveness of current screening procedures with an eye toward screening innovations that may be more cost-effective, less invasive, and more useful in detecting early cases of colorectal cancer. What providers can do
Medical groups are encouraged to help support this effort to increase screenings and reduce deaths from colorectal cancer in Minnesota. See the sidebar on page 29 for website resources related to CRC screening. Cally Vinz, RN, is vice president for clinical products and strategic initiatives, and Melissa Marshall, MBA, is a clinical systems improvement facilitator at the Institute for Clinical Systems Improvement.
St. Cloud VA Medical Center is accepting applications for the following full or part-time positions:
• Internal Medicine
• Geriatrician
(Nursing Home—Alexandria, Brainerd, St. Cloud)
• Family Practice
• Neurology (St. Cloud)
• Psychiatrist (Brainerd, • ENT
(St. Cloud)
• Hematology/Oncology (St. Cloud)
(Alexandria, Brainerd, St. Cloud)
St. Cloud)
(Nursing Home—St. Cloud)
• Dermatology (St. Cloud) • Disability Examiner (IM or FP) (St. Cloud)
US Citizenship required or candidates must have proper authorization to work in the US. J-1 candidates are now being accepted for the Hematology/Oncology positions. Physician applicants should be BC/BE. Applicant(s) selected for a position may be eligible for an award up to the maximum limitation under the provision of the Education Debt Reduction Program. Possible relocation bonus. EEO Employer.
Excellent benefit package including: Favorable lifestyle Competitive salary 26 days vacation 13 days sick leave CME days Liability insurance Interested applicants can mail or email your CV to VAMC
Visit our website at www.NWFPC.com
36
MINNESOTA PHYSICIAN JULY 2011
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
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Caring for mind, body and spirit. Mille Lacs Health System is seeking a Family Physician to join their rural practice on the southern tip of Lake Mille Lacs in Onamia, Minnesota. Our 7 Family Physicians, 8 PAs, and a Gen Surgeon provide a unique rural health opportunity with 4 outreach clinics, a 25-bed Critical Access Hospital, and attached Geriatric Psych Unit and LTC facility. We also provide services to the Mille Lacs Band of Ojibwe. Minimum qualifications: Must have an MD/DO in medicine from an accredited school and be licensed to practice in the state of Minnesota.
• ER is staffed 24/7 by skilled PAs • OB is required; C-section training is a bonus • Guaranteed competitive salary Mille Lacs Health System is an integrated healthcare organization that tends to the lifelong healthcare needs of all its patients. Come live where there is excellent hunting, fishing, and cross-country skiing. Practice medicine where your skills and experience can be fully utilized, and where you can make a difference.
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Please send inquiries to; Rob Stiles; 320-532-2606 rstiles@mlhealth.org or Dr. Tom Bracken; tbracken@mlhealth.org ONAMIA • ISLE • HILLMAN • GARRISON • MILACA
Tri-County Tri-Coun Tr unty ty Health H ealaltlth th C Care arree ar
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EEOE OE An A n eequal qual opportunity opportunity employer employer and and provider provider
Orthopaedic Surgery Opportunity Live in Beautiful Minnesota Resort Community
Two BC/BE Orthopaedic Surgeons wanted to join four orthopaedic surgeons at Sanford Bemidji Orthopaedics Clinic in Bemidji, Minnesota. Part of an 85-physician, multi-specialty group practice and 118 bed acute care hospital. 1:6 call anticipated. Competitive compensation/benefits package, paid malpractice, relocation assistance and more. Sanford Health of Northern Minnesota has 1,450+employees and is part of Sanford Health system based in Fargo, ND and Sioux Falls, SD. Bemidji, Minnesota, located in northwestern Minnesota, is a beautiful resort community offering exceptional schools, a state university, and yearround cultural activity as well as great access to the outdoors for year-round recreation activity. To learn more about this excellent practice opportunity contact:
Come to the Alexandria Lakes Area... • Dermatology • Emergency Medicine • Family Medicine • Internal Medicine • Pediatrics Broadway Medical Center is a rapidly growing, independent, physician-owned multi-specialty group practice with over 35 caregivers in 10 different medical specialties. We are located in Alexandria, MN; a beautiful and growing community with tremendous recreational opportunities. Welcome! Contact Daniel J. Jones, MHA at Broadway Medical Center 1527 Broadway Street, Alexandria, MN 56308 (320) 762-6841 or e-mail djjones@broadwaymedicalcenter.com
1527 Broadway Street, Alexandria, MN 56308
Kathie Lee, Director Physician Placement Phone: 701-280-4887 Fax: 701-280-4136 Email: Kathie.Lee@sanfordhealth.org AA/EOE
To learn more about our practice, please visit our website at www.broadwaymedicalcenter.com
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Equity from page 11 awareness of how racism operates in our country. Given that typically there is no intentional or direct training regarding racism in nursing or medical schools, and given that there has been no direct training at our institution about these issues to mitigate the presence of societal racism, it is not surprising that providers have very little understanding of the complexities of racism and its manifestations in provision of health care or in society as a whole. A recent survey of physicians at Children’s revealed that they had received an average of 5.3 hours of “racism training” during 1,200 person-years of practice. Further questioning revealed that this training actually represented diversity and cultural competency training, and not training specific to issues of race, racism, and whiteness. Next steps
Clearly, health care provider attitudes must change in order to reduce health care disparities associated with race. In 2009,
the U.S. Department of Health and Human Services recommended that in order to accelerate the pace of improvement, we must train providers. Diversity and cultural competency trainings are already in place at many institutions, including our own. While they have been shown to be successful in fostering an appreciation and awareness of difference, as well as developing tools for cross-cultural communication, they have not addressed the core of racism and, therefore, fall short of being able to truly effect change in racial disparity in patient care. After analyzing the results of our survey, we recommended social justice/anti-racist trainings in addition to the diversity and cultural competency trainings. To that end, we have developed a training module for staff to help providers address individual racial bias, the role of racism in evidence-based medical protocols, and the realities of systemic racism and its impact on patients. The ultimate goal is to improve provider atti-
tudes and provider confidence in caring for patients and families of color. We hope to take the training module hospital-wide following our initial pilot study, and then offer it to other institutions. We have developed a half-day and a full-day workshop, depending upon the needs of the organization. The training module will: • Address the definition of race/racism and history of the social construction of race • Differentiate among diversity, cultural competency, and social justice • Explore our current health care system (racial make-up of providers, how insurance became tied to employment, what we’re taught/not taught in school, evidence-based medicine, racial disparities) • Examine racism/whiteness in our society, including examples of racism/whiteness in medicine • Examine how race affects each of the Institute of Medicine's six measures of quality care, and provide trainees tools for understanding these effects
• Introduce critical thinking tools for improving medical providers’ comfort and skills in caring for patients of color We are currently developing a longer training experience (six half-day sessions over four to six months) for those who desire more in-depth exploration. Although our study focused on white providers and black patients, the findings and future directions can be applied across all aspects of health care delivery. Dismantling racism and provider bias will remove at least one of the barriers to racial equity in health care. We physicians have the greatest ability to affect change in this area. Until racial issues are addressed honestly by members of the health care team, it is unlikely that we will see significant improvements in racial health-care disparities for Americans. Stephen Nelson, MD, practices pediatric oncology/hematology and pediatrics and directs the Hemoglobinopathy Program at Children’s Hospitals and Clinics of Minnesota. He is also an adviser to the Minnesota Department of Health Newborn Screening Program.
continuing medical education 29th Annual Strategies in Primary Care Medicine • Joint Injections Skills Course • Basic Life Support (BLS) for Health Care Providers – Recertification • Hospital Medicine, 2011 Update
September 22 - 23, 2011
Pediatric Trauma Summit
September 22 - 23, 2011
Fundamental Critical Care Support Pediatric Conferences • Best Practices – Managing the Pediatric Patient in the Urgent Care Setting • Pediatric Update: Beyond the Basics
October 28, 2011 October 29, 2011
11th Annual Women’s Health Conference
November 4, 2011
Emergency Medicine and Trauma Update: Beyond the Golden Hour
November 17, 2011
Otolaryngology for Primary Care
November 18, 2011
33rd Annual Cardiovascular Conference
education that measurably improves patient care 38
October 13 - 14, 2011
MINNESOTA PHYSICIAN JULY 2011
December 1- 2, 2011
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