MN Healthcare News Sep 2015

September 2015 • Volume 13 Number 9

Diabetes care

By Matthew Wicklund

Living with lupus

By Jennifer Monroe, MA, MPH, and Timothy Niewold, MD

Sports-related concussions

By Jessica L. Schara, OD

American Diabetes Association EXPO in Minneapolis!

Learn how to be healthy, active and live well with diabetes.

• • • •

Free health screenings Cooking demonstrations Product exhibits and presentations on diabetes prevention and management Information and activities geared towards kids, teens and parents

Minneapolis Convention Center 1301 Second Avenue S. Hall E Minneapolis, MN 55403 Saturday, October 10, 2015 9:00 AM - 3:00 PM Visit EXPO website to print a FREE Metro Transit pass for any bus/light rail to the event.

For more information, call 1 888 DIABETES EXT. 6652, or visit diabetes.org/expominneapolis.

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Minnesota Health care news September 2015

September 2015 • Volume 13 Number 9

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News

Optometry

Sports-related concussions

By Jessica L. Schara, OD

PEOPLE

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MINNESOTA HEALTH CARE ROUNDTABLE

Wound Care

Your feet and lower extremities

By N icole A. Bauerly, PERSPECTIVE DPM, FACFAS, and Sue Abderholden, Michael Hu, MD, FACS MPH

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NAMI Minnesota (National Alliance on Mental Illness)

10 QUESTIONS Scott Benson, MD Apple Valley Medical Center

Insurance

18 28 30

Diabetes care

By Matthew Wicklund

CALENDAR

FORTyFOURTH SESSION

Behavioral Health Integration New pathways to care

Thursday, November 12, 2015 • 1:00-4:00 PM Downtown Minneapolis Hilton and Towers

Urology

Overactive bladder

By Steven Siegel, MD

C hronic Conditions

Living with lupus

By J ennifer Monroe, MA, MPH, and Timothy Niewold, MD

Background and Focus: Increasing evidence supports the link between access to mental health care and reducing health care costs. Primary care physicians often lack the expertise to diagnose behavioral health correctly and are not always able to easily refer a patient to a mental health care provider. Many initiatives nationwide are addressing this issue. It is so important that the ACA stipulated the development of the Behavioral Health Home in 2015. Some states, including Minnesota, are also creating Behavioral Health Home programs.

Objectives: We will review numerous initiatives that support the development of new pathways to behavioral health care. We will introduce new ideas and discuss how to incorporate them into our health-care delivery system. We will examine the value they can bring and the challenges they will face. Our panel of industry experts will outline the steps that must be taken to increase the overall access to mental health care and the broad improvement in population health that this increased access will bring.

Panelists include: • Sarah Anderson, MSW, LICSW, CEO, Psych Recovery, Inc. • Lee Beecher, MD, President, Minnesota Physician-Patient Alliance • Timothy P. Gibbs, MD, FAPA, DFAACAP, Chief Medical Officer, Natalis Counseling and Psychology Solutions • Martha Lantz, MSW, LICSW, MBA, Executive Dir., Touchstone Mental Health • Judge Kerry W. Meyer, Hennepin County Criminal Mental Health Court • Jane Pederson, MD, Medical Affairs Director, Stratis Health

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• Jeff Schiff, MD, MBA, Medical Director, MN Dept. of Human Services

MINNESOTA HEALTH CARE ROUNDTABLE The new face of health care

By MPP Staff

• L. Read Sulik, MD, Chief Integration Officer, PrairieCare Sponsors include: • MN Community Healthcare Network • MN Dept. of Human Services • Natalis Outcomes • PrairieCare • Psych Recovery, Inc. • Stratis Health Please send me tickets at $95.00 per ticket. Tickets may be ordered by phone at (612) 728-8600, by fax at (612) 728-8601, on our website (mppub. com), or by mail. Make checks payable to Minnesota Physician Publishing.

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SEPTEMBER 2015 Minnesota Health care news

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News

Drug Companies Delay Reporting Serious Patient Harm to FDA

95 percent of which come from drug manufacturers. For each adverse event, they calculated the number of days between when doctors alerted the drug companies Drug manufacturers delay reporting to when documents were submitted adverse events to the U.S. Food and through the reporting system. Federal regulation requires that when Drug Administration (FDA) quite drug manufacturers receive reports often, according to a new study for serious and unexpected adverse from the University of Minnesota’s events, they must report them to the School of Public Health.

FDA within 15 calendar days.

Researchers analyzed 1.6 The results show that drug commillion reports submitted through panies did not follow this regulathe FDA’s Adverse Event Reporting tion for about 10 percent of serious System between 2000 and 2014,

adverse event cases. More than 160,000 events were not disclosed to the FDA within the 15-day time frame, and more than 40,000 of those reports involved patient deaths.

Internal Medicine. As part of the report, researchers proposed that the FDA create a regulation allowing patients to report side effects directly.

“Our findings are even more concerning because they are likely an underestimate of the overall underreporting or misreporting of serious or adverse events,” said Pinar Karaca-Mandic, PhD, associate professor of health policy at the University of Minnesota’s School of Public Health and coauthor of the study. “Our study analysis is limited to the events that are reported to the FDA and there could be cases in which drug manufacturers fail to report serious or unexpected events at all by downward classifying serious reports as non-serious.”

“Our study suggests that direct submission of reports to the FDA, in lieu of submitting to an intermediary such as the drug manufacturer, may help reduce reporting delays,” said Paul Ma, PhD, assistant professor of accounting in Carlson School of Management at the University of Minnesota and coauthor of the study. “While it is possible that drug manufacturers spend additional time in verifying reports with more serious patient outcomes, the delays are not just by a few days, but can be several months or years.

Future research is needed to help understand the mechanisms behind the drug manufacturer’s decision to delay which could help policymakers such as the FDA in determining the optimal reporting rule.”

Researchers also found that the delays were longer, on average, for the cases that involved deaths. “A larger fraction of these serious and unexpected events that involved a patient death were delayed—about 12 percent of events with patient death, compared to 9 percent of events without patient death,” said Karaca-Mandic.

Some of the cases were even reported months late. “What was also surprising was that typically these were not delays of just a few days,” said Karaca-Mandic.

“For example, among events that involved a patient death, about 6 percent were reported within 16 to 90 days, about 3 percent within 91 to 180 days, and about 3 percent were delayed more than 180 days.”

In defense of the findings, a spokesperson for the Pharmaceutical Research and Manufacturers of America (PhRMA), which represents biopharmaceutical researchers and biotechnology companies, said, “It is important to remember that prior to reporting any adverse event, including serious unexpected adverse events, companies must investigate the reports that they receive from patients and health care professionals. Companies typically verify the accuracy of patient and physician reports, and often contact adverse event reporters to supplement the information that they provide to the FDA.” The analysis was published online July 27 in the journal JAMA

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Minnesota Health care news September 2015

Dayton Names Members to New Health Care Program Task Force Gov. Mark Dayton has announced his appointments to the 11-member state task force that will evaluate the future of state health care programs, including MNsure and MinnesotaCare.

The Task Force on Health Care Financing will look at MNsure’s longterm financial viability, the possibility of moving to the federal health care exchange, and changes to other public health care programs.

“The launch of MNsure created serious problems for many consumers. Although we have seen significant improvements, there are still important unresolved issues,” Dayton wrote. “Looking ahead, we must make some major policy and programmatic decisions that will strengthen Minnesota’s position as the nation’s health care leader, while making the best use of our state’s financial resources.”

The 33-member task force will report to Dayton and the Legislature by Jan. 15, 2016.

North Memorial to Open Clinic on Nicollet Mall North Memorial Health Care has announced plans for an 8,000square-foot clinic on Nicollet Mall in the second-floor space formerly occupied by the Saks Off 5th department store. This will be the health care system’s 16th location in the metro area.

The primary care clinic will offer walk-in appointments, advanced imaging, mammography, podiatry, occupational medicine, and lab services. It will have direct access to Gaviidae Common and the IDS Center.

“With this new location we are bringing the North Memorial care that this community has come to trust and value close to where they live and work,” says Kelly Macken-Marble, president of population health and ambulatory services at North Memorial Health Care.

on public health for residents of the seven-county metro area in 2008.

They found that fine particles or ground-level ozone, the two most directly harmful air pollutants, made conditions worse for an estimated 6 to 13 percent of residents in the area who died and 2 to 5 percent of residents who visited the hospital or emergency room for heart or lung issues.

Air pollution in the Twin Cities metro area contributed to an estimated 2,000 deaths, 400 hospitalizations, and 600 visits to the emergency room in 2008, according to a new report from the Minnesota Department of Health (MDH) and Minnesota Pollution Control Agency (MPCA).

The report, called “Life and breath: How air pollution affects public health in the Twin Cities,” analyzed air quality data from MPCA and public health data from MDH. The agencies used mathematical modeling software to estimate the effects of air pollution

Hea perf Turn to p you find the get. d el let us h needs and bu r u meet yo

“This report helps us see much more clearly than we could before just who is affected by air pollution, how serious the effects are, and where we have health disparities that need to be addressed,” said Ed Ehlinger, MD, Minnesota commissioner of health.

“This report gives us a baseline by which we can measure the health impacts of future reductions in air pollution.”

Researchers analyzed data by ZIP codes, and while there were no significant differences in air pollution levels between them, the agencies did find that people residing in ZIP codes that had a United Properties and its joint higher percentage of people of venture capital partner Capital Real color and residents in poverty had Estate, Inc. purchased the first few more health effects from the air floors of the Nicollet Mall site in pollution. This is partially due to December 2014. North Memorial these areas having higher rates of signed a lease for the second-floor preexisting heart and lung condispace in May and the clinic will tions. In addition, “Places that have open in November. more elderly people with heart and lung conditions and children with uncontrollable asthma are places where air pollution has a greater impact,” according to Ehlinger.

Report Shows Effect of Air Pollution on Public Health

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“We can’t control Canadian wild fires or who is burning coal around the world,” said John Linc Stine, MPCA commissioner. “We can look at our own choices every day. We can choose the most fuel-efficient transportation we can afford or use mass transit. Small steps really do add up. Air pollution is a day-inday-out cumulative problem; we can all make a positive impact with the daily choices we make.”

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H2462_72596_01 Accepted 9/25/2013. HealthPartners is a Cost plan with a Medicare contract. Enrollment in HealthPartners depends on contract renewal. ©2013 HealthPartners

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Terry Thomas

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Minnesota Optometric Notes Association

Description

Doctors on the frontline of eye and vision care

[­­­­]

AS

Mark Jenson

[­­­­]

AM

Linda Gogolin

[­­­­]

PM

Krista Kraabel

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Tera Gilmore

Did you know?

According to Ehlinger and Stine, data from 2014 indicate that air quality has improved since 2008. However, it is not yet known whether health outcomes improved as well.

• Diabetic retinopathy can be controlled and diabetic patients need regular eye exams to maintain vision and good eye health.

• Diabetes Type ll can also cause vision changes.

• Glaucoma must be diagnosed in early stages in order to prevent vision loss.

• All children entering school need a comprehensive eye exam, because vision screenings do not detect a number of eye disorders.

• To maintain eye health, everybody from babies to boomers to older adults needs a regular eye exam by a family eye doctor.

To locate an optometrist near you and find comprehensive information about eye health visit

News to page 6

http://Minnesota.aoa.org September 2015 Minnesota Health care news

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News from page 5

HealthPartners to Study Improvements in Prediabetes Care HealthPartners Institute for Education and Research has launched a five-year study to determine if web-based clinical decision support can help in the identification and treatment of patients with prediabetes to help reduce their chances of developing type 2 diabetes.

“Clinical decision support in electronic medical records has improved care for diabetes and appropriate high-tech imaging and we hope to see if it can improve care for people at risk of developing diabetes,” said Jay Desai, PhD, MPH, research fellow at HealthPartners Institute for Education and Research and principal investigator of the study.

Researchers will study about 17,000 patient participants with

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prediabetes who receive care at 30 Essentia Health clinics in northern Minnesota, northwest Wisconsin, and eastern North Dakota. They will implement a clinical decision support system to identify people with prediabetes, give personalized care recommendations, and evaluate the effectiveness of the system.

“This study aims to impact our patients’ lives by reducing their cardiovascular risk and improving their quality of life,” said Daniel Saman, DrPH, MPH, CPH, associate research scientist at the Essentia Institute of Rural Health.

Hysterectomy Linked to Risks for Women Under Age 50 Researchers at Mayo Clinic have shown that hysterectomy may be a marker of early cardiovascular risk and disease, most notably for women less than 35 years of age.

Through the Rochester Epidemiology Project, the researchers analyzed 3,816 available records of women who had a hysterectomy with ovarian conservation in Olmsted County between 1965 and 2002. They then determined Almost one-third of adults a randomly selected control group in the U.S. have prediabetes, of another 3,816 women of the according to the U.S. Centers for same age who had not undergone a Disease Control and Prevention. hysterectomy and compared cardioAnd without intervention care, 15 vascular risk factors and diseases to 30 percent of them will develop for the women. They discovered type 2 diabetes within five years. that the women who had a hysterPatients with diabetes have health care costs that are 2.3 times higher ectomy had slightly higher odds of having hyperlipidemia, obesity, and than people who do not have diabetes, according to the American metabolic syndrome.

Diabetes Association.

Minnesota Health care news September 2015

“Cardiovascular disease is the leading cause of death among women, and women see primarily gynecologists between 18 years and 64 years—a time when early screening for cardiovascular disease would be important,” said Shannon Laughlin-Tommaso, MD, obstetrician/gynecologist at Mayo Clinic and lead author of the study. “We wanted to do this study to find a gynecologic screening method for cardiovascular disease.”

In addition, stroke was significantly more common among women who had a hysterectomy before the age of 35 compared to women of the same age who did not have a hysterectomy. Women ages 35 to 40 that had a hysterectomy were more likely to have hypertension. And women who had a hysterectomy at the age of 50 or older didn’t demonstrate any notable increases in risk factors and, contrastingly, were less likely to have had a stroke or congestive heart failure compared with women of the same age that did not have a hysterectomy.

People Zhi Halbach, DO, has joined Hutchinson Health as a family physician. Halbach earned her doctorate in osteopathic medicine from the Des Moines University College of Osteopathic Medicine. She is originally from Chaska, and has moved back to Minnesota after completing her residency at St. Luke’s University Hospital in Pennsylvania. HalZhi Halbach, DO bech’s special interests include women’s health, preventive care, and office procedures. In addition, Tiffany Trenda, DO, has joined Hutchinson Health as a pediatrician. Trenda earned her doctorate in osteopathic medicine from Lake Erie College of Osteopathic Medicine in Pennsylvania and is moving back to her home state of Minnesota after completing her pediatric residency through Palmetto Health/University of South Carolina. Trenda has spent time as a volunteer pediatrician in medically underserved Tiffany Trenda, DO communities in Nicaragua and El Salvador.

Kevin Lindgren, MD, and Jaclyn Bailey, MD, have joined St. Croix Orthopaedics as orthopedic surgeons. Lindgren earned his medical degree from the Medical College of Wisconsin and completed an orthopaedic surgery residency at the University of Nebraska Medical Center/Creighton University, where he received the Frank P. Stone, MD award Kevin Lindgren, for Outstanding Resident. Lindgren completed his MD fellowship training at the University of Utah where he specialized in hip and knee reconstruction and hip preservation surgery. Bailey earned her doctor of medicine degree at the University of Minnesota Medical School and completed an orthopaedic surgery residency at Grand Rapids Medical Education Partners/ Michigan State University. She completed her fellowship training in hand and upper extremity surgery at the University of California in San Francisco. Lindgren will begin seeing patients at the Maplewood and Woodbury clinics in early September and at the new St. Paul clinic when it opens later this fall. Bailey will begin seeing patients at the Maplewood and Wyoming clinics at the end of September, as well as at the new St. Paul clinic.

Samith Kochuparambil, MD, has joined Minne­sota Oncology with the practice of medical oncology and hematology at the Minneapolis clinic.

Ko­chu­pa­rambil earned his medical degree from the Madras Medical College, Chennai, India. He completed a residency in internal medicine at the Medical College of Georgia, where he received a STAR resident award, and completed his fellowship in medical oncology and hematology at Mayo Clinic. Kochuparambil specializes in treating prostate cancer, kidney cancer, bladder cancer, multiple myeloma, and general oncology.

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September 2015 Minnesota Health care news

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Perspective

Mental Illness Reaching out to youth in crisis

Y

oung people experiencing their first psychotic episode wait an average of 72 weeks to seek treatment. Other studies report that people wait an average of 10 years before treatment.

Half of all people living with a serious mental illness began experiencing symptoms before the age of 14. Three-quarters will develop a mental illness by age 24. So, it is a “young person’s” illness during a prime time in their lives.

For any health care condition, early identification and treatment are critical. The more we wait to treat a mental illness, the more likely it is to become severe and for the individual to develop a substance use disorder as well. So why is this happening?

Building awareness Sue Abderholden, MPH NAMI Minnesota (National Alliance on Mental Illness) Ms. Abderholden is the executive director of NAMI Minnesota (National Alliance on Mental Illness), a nonprofit organization that works to improve the lives of children and adults with mental illnesses and their families through its programs of education, support, and advocacy. NAMI Minnesota offers more than 500 free classes and presentations and over 60 support groups each year.

One reason is that many people, including youth, are not aware of the symptoms of mental illness. Teachers don’t receive much initial education about mental illnesses.

Limited access to treatment, transportation, insurance coverage, and parent work schedules cause many to go without treatment.

Minnesota schools do not require mental health education, although there are mental health components in the National Health Education Standards.

However, there are recommended free and low-cost programs available to schools, including NAMI Minnesota’s free Ending the Silence program.

Ending the Silence fits into 50-minute high school or middle school class periods, and covers how common mental illnesses are, signs and symptoms, and the personal story of a young adult doing well in recovery. Students receive resources to get help for themselves or a friend, and information on how to fight the stigma of mental illnesses. NAMI Minnesota also developed a website for youth.

In 2007, the Legislature funded school-linked mental health grants. Grants are provided to mental health providers, who then co-locate in the schools, eliminating the barriers to treatment. Funds pay for activities not funded by insurance, such as collaboration with school support staff and teachers, and for treatment of children who are uninsured and Minnesota Health care news September 2015

Reducing stigma Another issue is that parents and other adults working with youth are not aware of the symptoms and frankly have stigmatizing attitudes. Some believe that mental illnesses cannot occur in children and others believe that it’s just a “phase.”

We use slang words such as “crazy” and “nuts” for people with mental illnesses, but we don’t have slang words for other illnesses. We never think to use the words “courageous” or “determined” to describe someone with schizophrenia or depression.

These are no “hot-dish” or get-well card illnesses. By harboring negative views we make it more difficult for people to seek treatment.

Half of all people living with a serious mental illness began experiencing symptoms before the age of 14.

In 2003, Minnesota became the first state to require continuing education for teachers on the key warning signs of early-onset mental illnesses in children and adolescents. In 2013, trauma and autism were added. These trainings help teachers understand the difference between willful behavior and symptoms—not to have teachers diagnose students, but to know when to talk to parents about a referral.

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underinsured. Data from the first four years show that nearly half of the children had never received treatment and half of those had a serious mental illness. While funding was doubled in 2013, only roughly 50 percent of schools have such a program.

Several strategies help to address this. Mental Health First Aid, an eighthour class geared toward youth or older adults, increases mental health literacy. It teaches people about the symptoms of mental illnesses and how to help when a person is in crisis or is suicidal. The nation-wide class educates people about the signs and symptoms of mental illnesses.

Another strategy is the Make It Ok campaign, a one-hour presentation on how we talk and think about how mental illnesses impact people’s lives.

Online videos of people with mental illnesses and their families present the impact of mental illnesses, as well as personal stories of recovery. The goal is to “make it ok” to talk about mental illnesses.

First Episode programs strive to identify psychosis early, provide intensive treatment, and help young people return to school or work, so that they do not become disabled by their illness. Early signs can include changing sleep patterns, beginning to feel paranoid or having odd thought patterns, having a hard time paying attention, avoiding bathing and grooming, and cognitive decline. Efforts are underway to identify young people at closer to four weeks instead of 72 weeks. But parents need to be watchful and not pass it off as a phase. Funding was provided by the Legislature in 2015. For details, visit the NAMI Minnesota website, www.namihelps.org.

Progress and hope We are making progress that will lead to earlier identification and treatment, but our work is not yet done. It’s important for everyone to learn about signs, symptoms, and what actions to take.

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10 Questions

Diabetes Scott Benson, MD Dr. Benson is a board-certified family medicine physician at the Apple Valley Medical Center.

What is diabetes? Diabetes, or diabetes mellitus, is a chronic metabolic disease involving high blood glucose. It occurs either when a body doesn’t produce enough insulin or when the body does not respond properly to the insulin it does produce. Insulin is a hormone the body needs to convert sugar, starches, and other food into energy. Diabetes is rapidly becoming a national epidemic.

The American Diabetes Association says diabetes affects 29 million people in the U.S. alone—but only three out of four individuals have been diagnosed. There are three types of diabetes: type 1, type 2, and gestational diabetes, which occurs in some women during pregnancy.

What is the difference between type 1 and type 2 diabetes?

Type 1 diabetes is sometimes called insulin-dependent or juvenile diabetes. It usually occurs in children or young adults when the body’s immune system destroys insulinmaking cells that control blood glucose. Patients with type 1 diabetes need to take insulin injections their entire lives.

Type 2, or adult-onset, diabetes is the most common form and accounts for more than 90 percent of all diabetes. With type 2 diabetes, either a person’s pancreas stops producing enough insulin for the body to function properly or the cells in the body become insulin resistant. Type 2 diabetes can often be treated with lifestyle changes or medications before insulin is needed.

What is prediabetes? Prediabetes is a condition in which blood glucose levels are higher than normal but not high enough to be classified as diabetes. At this stage, cells in the body are starting to become resistant to insulin. The majority of patients who develop type 2 diabetes start out with prediabetes. Some patients with prediabetes benefit from medication, including metformin. Others respond well to medications that control cholesterol, such as statins, or those that lower blood pressure. The best option for individuals with prediabetes, however, is to make lifestyle changes in diet and exercise before the condition becomes full-blown diabetes.

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Minnesota Health care news September 2015

What are the common symptoms of the onset of diabetes? The most common symptoms of diabetes include the following: • Increased thirst • Frequent urination • Extreme hunger • Unexplained weight loss (with type 1) • Ketones in the urine • Fatigue • Irritability • Blurred vision • Slow-healing sores • Frequent infections • Tingling, pain, or numbness in hands and feet (with type 2) Some people with type 2 diabetes have very mild symptoms that may not be noticed. Pregnant women with gestational diabetes may not have any symptoms. Physicians can determine if the symptoms are signs of diabetes with one of three tests: A1C, fasting plasma glucose, or oral glucose tolerance.

The initial diagnosis of diabetes can be overwhelming.

What advice do you have for people facing this news? Remember that most cases of diabetes can be well managed. Individuals who suspect they or someone they love has diabetes should seek help from a medical professional right away.

Together, they can begin to make lifestyle changes that will have a positive impact on the illness. This might include a healthier diet with more fruits, vegetables, lean meats, and low-fat dairy products. It also might include 30 to 60 minutes of physical activity or exercise at least five days a week. Individuals with diabetes should also have regular check-ups so their physician can manage important diabetes indicators.

What advice might you give parents of diabetic children? Parents of children with diabetes have special issues. Managing the disease affects the entire family, and special precautions must be made for those times when the child is away from his or her parents. School teachers, for example, must be made aware of dietary restrictions and signs of distress should your child’s blood glucose level get too low. In addition, the American Diabetes Association suggests that parents develop a written care plan, such as those developed under federal disability law (a Section 504 Plan or an Individualized Education Program) to ensure their child is given the same educational opportunities as others despite his or her diabetes.

What are common treatments and medications for both types of diabetes? Individuals with type 1 diabetes almost always need insulin injections to manage their blood glucose levels.

Some people with type 2 diabetes can manage their disease with lifestyle changes involving diet and exercise. Others may need medications to stimulate their pancreas, inhibit the production of glucose from their liver, or block enzymes that make the body more sensitive to insulin. Some may need insulin injections to control their diabetes. Today, there are exciting new products on the market to measure blood glucose and deliver insulin, including blood glucose meters and implantable insulin pumps. There also are effective insulin medications available that act faster and last longer than those used in the past. Metformin is a frequently prescribed medication for patients with type 2 diabetes.

What can happen to patients who do not manage their diabetes? Diabetes is serious and can lead to a number of complications, including cardiovascular problems such as ischemic heart disease, high blood pressure, stroke, and peripheral arterial disease. It also can cause kidney disease and diseases of the nervous system, such as neuropathy. People with diabetes are more likely to develop infections, slow-healing wounds, hearing loss, and gum disease. They also can develop eye problems, such as glaucoma, cataracts, and diabetic retinopathy. In extreme cases, diabetes can lead to kidney transplants, blindness, or amputation of feet and legs.

Most cases of diabetes can be well managed.

Please discuss recommended diet and exercise habits for diabetics. Patients with diabetes need to watch their diet and eat healthy foods, such as fruits, vegetables, lean meats, whole grains, and low-fat dairy products. They should eat more foods with fiber and fewer with fat and salt. A physician can help to create a meal plan that fits into a person’s lifestyle. Exercise is also important.

Patients with diabetes should get between 30 and 60 minutes of physical activity at least five days a week. Individuals with diabetes should also keep their blood pressure and cholesterol levels within a normal range and have them checked by a physician regularly.

What does the future of diabetes research hold? Recent scientific developments to address diabetes include a “smart insulin” patch that imitates the body’s beta cells by sensing blood glucose levels and releasing insulin. Research is being conducted to develop new medications, to learn about rare forms of diabetes caused by gene mutations, to study the link between obesity and diabetes, and to understand how to reduce cardiovascular complications in people with type 1 diabetes. Medical device companies are conducting clinical trials on a closed loop insulin delivery system, also known as an artificial pancreas. This device links a continuous glucose monitor to an insulin pump in order to deliver insulin automatically.

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8/28/15 3:55 PM September 2015 Minnesota Health care news 11

Insurance

Diabetes

care

Minimizing the costs

By Matthew Wicklund

O

pen enrollment is just around the corner for people buying health care insurance under the Affordable Care Act and for employees facing annual renewals under their company plans. Picking the best coverage and asking the right questions is always challenging, but for diabetics and those concerned about becoming diabetic, it can be even more daunting.

That’s because medical expenditures for people diagnosed as diabetic can run 2.3 times higher than for non-diabetics, according to the American Diabetes Association (ADA). Those costs make it even more important to pick the right plan. The following guidelines are important for diabetics and for all consumers of health care insurance.

Costs of diabetes The ADA reports that one in five U.S. health care dollars is spent caring for the 29 million Americans diagnosed with diabetes. In a study released in 2013, the ADA reported that people with diagnosed diabetes incurred average annual medical expenditures of $13,700, most of which ($7,900) was attributed to their diabetes.

Most of those expenditures (90 percent) went to: • Hospital inpatient care: 43 percent • Prescription medications to treat complications: 18 percent • Anti-diabetic agents and diabetes supplies: 12 percent • Physician office visits: 9 percent • Nursing/residential facility stays: 8 percent

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12

Minnesota Health care news September 2015

If you’re in the market for a new health care plan, you’ll need to consider all of these factors. The least expensive plan could end up costing you more, after you factor in costs for medications and testing supplies.

Tips for selecting insurance Health care consumers face a world of new options, including subsidies, tax credits, and new rules for MinnesotaCare and Medical Assistance. Traditionally, most consumers obtained insurance under group plans from their employer, limiting their choices and services.

Employees and private consumers may now find more options for doctors, hospitals, clinics, prescriptions, and price.

As a consumer, you should view health insurance as an investment in your health and financial future. Start by reading the fine print of both group plans and individual plans. How do they differ with regard to your medications? How do your yearly expenses for durable medical equipment, test strips, and other supplies affect your deductibles or maximum out-of-pocket expenses? Does your current plan offer discounts to health clubs? Are pre-diabetic screenings covered?

Do your homework Ready to start your research? One place you can go to is a private exchange, which is a marketplace that offers multiple plans, multiple carriers, and, possibly, other types of insurance such as dental, vision, and life insurance. This marketplace may offer more options than traditional group plans, but it can come with limitations. Not all insurance products are available in these exchanges, and the private exchange also does not allow consumers to use any public subsidies should they qualify for them.

Minnesota residents may visit the MNsure public exchange to see whether they qualify for Medicaid, MinnesotaCare, or Qualified Health Plans (QHP). Consumers who qualify for a QHP might be eligible for tax credits, cost sharing, or premium relief. Qualifications are based on a combination of income, access to employer-sponsored plans, and residence.

higher monthly premium of $590, a deductible of $3,000, no co-insurance, and a Max Out Of Pocket of $3,000 per year. By choosing the higher monthly premium plan, you could save $2,420 per year.

People with type 1 or type 2 diabetes should also look for plans offering a discount on health club memberships.

Most plans today offer up to $20 off your monthly bill if you use the membership 12 times per month. (Usage and reimbursement requirements vary by plan.)

The public exchange is similar to the private exchange, where there can be multiple insurance companies offering products and some choice in plan offerings. You may pick a deductible, co-insurance, and plan or network that is best for you. Unlike a private exchange, you can use premium or tax credits (should you qualify) on this site.

Like the private exchange, not all carriers and plans are offered on a public exchange.

Consumers may also go directly to the open market, visiting the websites of insurance companies to shop for plans available in their area.

It is also important to look at the drug formulary to see if your insulin or medication is covered. Drug formularies change from year to year, so check this regularly. You should also see if you could obtain discounts directly from the manufacturers of testing supplies.

Think beyond the monthly price tag.

Making sense of dollars and cents Regardless of your search strategy, think beyond the monthly price tag. You monthly premium is important, but consumers need to make sure that they get what they pay for. Look at your needs and future plans, and try to maximize the benefits, while weighing the cost of premiums with the costs of deductibles and co-pays.

I ask my clients several questions to help identify the best plan for them. For example, I ask how much money they could spend if something bad were to happen to them or to their family. The purpose is to find out how high of a deductible that client could afford.

If you pick a plan based on the lowest premium, you will likely have a very high deductible, which is the portion of health coverage for which you are responsible. If you have a $2,000 deductible, you will pay the first $2,000 in medical expenses before the insurance company pays anything. So if something bad happens to you or your family, can you write a check for $2,000?

The next question is about co-insurance, which means payments split between the insured and the insurance company. You might have a plan with a $2,000 deductible and 20 percent co-insurance.

What that means is once you have paid $2,000 towards your health care, the insurance company will cover 80 percent of expenses, while you pay the remaining 20 percent. Most people do not like unexpected bills, so it’s worth seeing whether raising the premium a bit—perhaps by $10 per month—might reduce the co-insurance and save you money in the long run.

Conclusion It is important to look at health insurance as an investment. Look at your wants and needs in insurance and maximize your premium, co-pay, and deductible. Allow your money as well as the insurance to work for you, and refer questions to a licensed health insurance broker or to your state exchange.

Matthew Wicklund is a health insurance broker with Contego Capital Insurance Group. MNsure and Medicare certified, he focuses on individual, family, and Medicare clients.

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Consumers also need to look at the Max out of Pocket (MOOP), which represents the most they will spend in one plan year. If your plan has a Max Out Of Pocket of $6,500, you will spend that amount in one plan year, after which the insurance company will pay for all covered medical expenses at 100 percent. There are plans that offer a deductible and a reduced price for services until you reach your MOOP. For diabetics, this can be very important. You might select a plan with a monthly premium of $500, a deductible of $1,000 dollars, co-insurance of 20 percent, and a Max Out Of Pocket of $6,500 per year. This plan might appear to be the best for the client, based solely on the monthly price. But compare this to a plan with a

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INFORMATION September

2015 Minnesota Health care news

Job Number

245-13124

Trim

Client

HealthPartners

Description

MN Health Care News

File Name

245-13124 Medicare [Carpenter][4x5.25]_3_

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Modification Date

October 22, 2014 2:33 PM

Bleed

Output Date

10/22/14

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1

4” x 5.25”

Optometry

Sportsrelated

concussions Your eye doctor may see the signs

By Jessica L. Schara, OD

“

What are we doing here? Was I competing in slalom or GS (giant slalom)?” Adam asked while getting into the car. Alarm bells were going off for Adam’s mom. “Was I competing in slalom or GS?” he asked again repeatedly en-route to Children’s Hospital.

Twelve-year-old Adam, an avid downhill skier, had fallen and suffered a concussion. When his teammates found him, he wasn’t making any sense. Adam is one of the millions of adolescent athletes

who suffer concussions. Contact sports such as football, hockey, basketball, soccer, lacrosse, volleyball, and wrestling are among those posing the highest risk for concussion.

What is a concussion?

A concussion is a brain injury caused by a direct blow to the head or by any other force that can be transmitted to the head. Ultimately, this results in axonal (nerve) injury and lack of energy (glucose) to brain cells, resulting in neurological symptoms. Symptoms of a concussion are confusion, headaches, blurred or double vision, nausea, dizziness, fatigue, sensitivity to light and noise, dazed feelings, difficulty concentrating, memory loss, irritability, and sleep disturbances. Concussion symptoms may take days to be recognized, underscoring the importance for anyone suspected of having a concussion to be evaluated by a medical professional.

Diagnosis of concussion may be difficult and underreported, as can be seen from the wide range of reported cases. The Centers for Disease Control and Prevention (CDC) estimates between 1.7 million and 3.8 million sports-related concussions per year in the U.S. School-age athletes may or may not have access to a medical professional who can assess whether a concussion has occurred, and may rely on a trainer, coach, or even parents who may or may not be trained to identify concussions. Some athletes may report feeling “fine” and deny symptoms in order to remain in the game. Unfortunately, reliable, valid, cost-effective concussion testing methods that can be used by all athletes, coaches, and trainers have been difficult to find and standardize.

Psychiatric Care evolved.

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prairie-care.com

Minnesota Health care news September 2015

Vision as the key in sideline concussion screening It would seem that vision would almost always be affected by concussion, because vision is so embedded in the brain. Vision involves more than 30 areas of the brain, and is responsible for more than 70 percent of sensory processing. The King-Devick Test, used for years by eye care professionals, is now used on the sidelines to screen athletes for concussions. Administered to athletes in the preseason in less than two minutes by non-medical professionals, the test includes verbally reading numbers in columns and rows. Later, if a concussion is suspected, the test is administered in the same manner as the baseline testing. If the response time is slower, a concussion is highly

likely. The science behind this test is that saccades, or fine reading eye movements, take place in over nine areas of the brain.

After a concussion Visual symptoms that may occur after a concussion include light sensitivity, double vision, blurred vision (affecting nearby objects more than distant objects), focusing difficulty (such as reading and looking up to a blurred board and vice versa), headaches above the brow, tracking difficulty, skipping lines when reading, omitting words, illusions of movement, decreased speed of processing and comprehension, peripheral vision defects, and balance and gait disturbances due to visual processing distortions.

headaches, and visual fatigue. Over- or under-convergence can be affected after a concussion, which can cause double vision, eyestrain, covering of an eye while reading, and headaches. Prisms and/or vision therapy may be beneficial to patients with convergence issues.

Pupils may enlarge after concussion, causing increased light sensitivity, or photophobia. Tinted lenses may help.

Tracking issues, called pursuit dysfunction, may be impaired and may cause difficulty in tracking a moving object or reading. Saccades—fast fine-eye movements needed when reading from word to word—may be affected post-concussion, causing patients to lose place when reading, skip lines or words, and reread for comprehension. Peripheral vision can be affected after a concussion, which can cause part of peripheral vision to be “missing.” This can be difficult for patient activities such as driving, reading, and playing sports (people may not see a ball coming at them or another player from the side view of the field).

Vision is critical in concussion diagnosis and management.

Vision can be blurred due to changes in nearsightedness, farsightedness, or astigmatism after a concussion, which may be transient or may remain after healing.

Simple changes in spectacle prescription may be enough to improve the function of concussion patients, allowing them to return to school or work.

When we read, our eyes’ internal focusing system is stimulated, our eyes converge (both eyes turn inward as though looking towards our nose), and the pupil constricts. The focusing system, called accommodation, can be disrupted after concussion, and reading glasses are commonly prescribed to alleviate near vision blur, eyestrain,

How we move and navigate through space is determined in large part by visual processing. Eighty percent of fibers from the optic nerve go to the visual cortex; however, 20 percent will go to the superior colliculus part of the midbrain. Those 20 percent are considered ambient visual processing, which can affect balance, posture, Sports-related concussions to page 32

Call 1-800-333-HOPE Before you lose what really matters

Gambling problems can only be solved if you have the conversation. Reach out and ask for help before you lose what is really important.

GetGamblingHelp.com September 2015 Minnesota Health care news

15

Wound Care

Your feet

and lower extremities

Common risks and complications

By Nicole A. Bauerly, DPM, FACFAS, and Michael Hu, MD, FACS

C

uts and abrasions to the feet and lower extremities are common occurrences in everyday life. Usually these wounds heal quickly on their own with minimal intervention and basic wound care, including keeping the area clean and dry with perhaps a light bandage and some antibiotic ointment. However, wounds can sometimes turn into ulcers, defined as wounds with a full thickness depth through the skin and a tendency for slow healing. In order for these lower extremity ulcerations to heal, the underlying causative factors need to be addressed. Common causes of lower extremity ulcerations include venous insufficiency, arterial insufficiency, diabetes, trauma, or combinations of these factors.

We will attempt to address some of the basic characteristics of these types of wounds and some of the treatments that may be required for healing.

Venous insufficiency and ulceration These wounds sometimes occur due to problems with the veins that take the blood flow back up toward your heart. This is known as venous insufficiency or venous reflux disease, and may be related to weakened vein walls or damaged valves within the veins. Patients with venous ulceration—ulcers related to restricted venous blood flow—may have a history of venous blood clots, varicose veins, leg swelling, or obesity. Wounds themselves typically appear on their medial or lateral anklebones and can be very painful. The surrounding calf may be swollen and the skin may be stained red or brown and scaly in texture.

In addition to local wound care, treatment may include compression of the legs with either a medicated bandage or compression hose.

Your primary care provider may refer you to a vascular specialist, who may evaluate your venous blood flow with additional testing such as ultrasound. If the ultrasound shows significant venous insufficiency in the superficial veins, sometimes minimally invasive treatment of the bad superficial veins with some combination of laser or radiofrequency ablation, surgical removal, or injection may be in order.

Do You Suffer from 3 to 8 migraineS per month?

If so, consider joining Samurai–a clinical study to assess a potential new migraine medication for people like you.

We’re looking for people over 18 years of age to take part.

We’d especially like to hear from migraine sufferers with at least one of the following cardivascular risk factors (But aLL migraine sufferers are welcome to contact us): • High blood pressure • High cholesterol • A smoker • Overweight • Diabetes

• Family history of coronary artery disease • Female and post-menopause • Male and over 40 years of age

Contact the study team or ask your physician about SAMURAI to learn more.

radiant Clinical research

www.radiantresearch.com 16

Minnesota Health care news September 2015

In laser or radiofrequency ablation, a catheter is placed into the leg’s greater or small saphenous vein. The abnormal refluxing vein is then taken out of circulation by clotting if off with laser or radiofrequency energy. Surgical vein removal may entail making some small incisions over the squiggly dilated superficial varicose veins, which are often branches off the leg’s main superficial saphenous veins.

Smaller branch veins can sometimes be handled with injection of medication that clots, narrows, and scars the vein shut (sclerotherapy). Often these procedures can be done with local anesthesia and minimal sedation in an outpatient setting.

Arterial insufficiency and ulceration These wounds are due to poor blood flow down the legs. Those at risk include smokers or patients with diabetes, hypertension (high blood pressure), hyperlipidemia (high lipid levels), or kidney failure.

Patients with poor arterial circulation may have hairless skin that is very shiny, tight, and dry. Wounds may appear on the toes, between the toes, or on the feet, and may be very slow to heal. Typically, the

wounds may have a “punched out” appearance with a wound bed that may be pale or contain some dead tissue.

The wounds may initially be small, but if they are slow to heal or worsening and enlarging, you must see your primary care provider.

He or she may refer you to a vascular specialist, who will evaluate your blood flow down the legs and may order further testing to evaluate or improve blood flow, which is important for healing.

Interventions to improve the blood flow down the leg may include same-day minimally invasive techniques including: • Angioplasty: opening the artery with a balloon catheter placed through the skin (percutaneously) into the leg artery, usually from one of the groin arteries • Stenting: opening and holding the artery open with a cylindrical metal mesh tube also placed percutaneously if angioplasty is not enough or if the amount of narrowing is more extensive • Atherectomy: opening the artery with a percutaneously placed catheter that can cut and drill through narrowing in the arteries Or, in more severe cases: • Leg bypass surgery: making incisions in the leg and sewing leg veins or artificial grafts into the arteries above and below the blockages, allowing the blood flow to go around or to bypass more extensive blockages. This type of surgery requires a hospital stay.

Diabetic wounds Diabetic patients have up to a 25 percent lifetime risk of developing a foot ulcer. Diabetic foot ulcer complications are the most common cause of nontraumatic lower extremity amputations in the industrialized world. These types of foot ulcers can form due to a combination of factors that include: a lack of feeling in the foot (neuropathy), poor circulation, foot deformities, irritation (such as friction or pressure from shoes), and trauma. Patients who have had diabetes for many years can develop a reduced or complete lack of ability to feel pain in the feet due to nerve damage caused by elevated blood glucose levels over time. The nerve damage often can occur without pain, and you may not even be aware of the problem. Keys to preventing diabetic foot ulcers include checking your feet daily, avoiding going barefoot in or out of the home, achieving good control of your diabetes to prevent further nerve and circulation damage, and seeing a physician (primary and podiatric) on a regular basis. If you develop a diabetic foot ulcer, it is important to seek medical attention immediately. Initial treatment may include local wound care, offloading of the wound to decrease pressure, vascular studies to evaluate your blood flow, and other necessary tests depending on the severity of the wound.

Wounds to the feet are common occurrences.

Your feet and lower extremities to page 19

This device should be worn at night and is not intended to replace the need to properly test your blood sugar levels with a blood glucose meter.

September 2015 Minnesota Health care news

17

Calendar Sept.-Oct. 2015 SEP.9

Nutrition for Managing Lupus

The Lupus Foundation of Minnesota hosts this free class to teach people with lupus and other chronic conditions how better nutritional choices can help manage inflammation caused by these conditions. Call Sandy at (952) 746-5151 to register by September 8.

Wednesday, Sept. 9, 12–1 p.m., Maple Grove Library, 8001 Main St. N., Maple Grove

14

New Moms Support Group

Park Nicollet hosts this free support group for women who have recently had a baby and are experiencing stress, anxiety, sadness, or are feeling overwhelmed. Join other women experiencing similar feelings for support and healing. Registration is not required. Call (952) 993-3307 for more information or other meeting dates.

Monday, Sept. 14, 12–12:45 p.m., Park Nicollet Clinic, 7th Floor, 3800 Park Nicollet Blvd., St. Louis Park

16

Caregiver Support Group

North Memorial Medical Center hosts this free support group for care partners of stroke survivors. Come learn more about how to care for your loved one and feel support from others who understand. Registration is not required.

Call (763) 581-3650 for more information or other meeting dates.

Wednesday, Sept. 16, 2–3 p.m., North Memorial Medical Center, Plaza Level, 3300 Oakdale Ave. N., Robbinsdale

28

Diabetes Insulin Pump Support Group

HealthEast hosts this free support group for individuals who are interested in information about insulin pumps, or are already using one. Come learn more about how insulin pumps work and if one is right for you.

Call Diane at (651) 232-6322 to register.

Monday, Sept. 28, 6–7:30 p.m., Woodwinds Health Campus, 1925 Woodwinds Dr., Woodbury

Send us your news: We welcome your input. If you have an event you would like to submit for our calendar, please send your submission to MPP/Calendar, 2812 E. 26th St., Minneapolis, MN 55406.

Email submissions to amarlow@mppub.com or fax them to (612) 728-8601. Please note: We cannot guarantee that all submissions will be used. CME, CE, and symposium listings will not be published.

National Recovery Month Each September, the Substance Abuse and Mental Health Services Administration (SAMHSA) works to spread the word that behavioral health is essential to health, that prevention works and treatment is effective, and that people can and do recover from mental and/or substance use disorders.

In 2013, about 43.8 million adults, or 18.5 percent of the population, had experienced a mental illness in the past year, according to SAMHSA. And about 21.6 million people age 12 or older were classified with a substance dependence or misuse disorder. However, many of these people are not getting the treatment they need.

People facing mental and substance use disorders have the best chance of recovery when they realize they are not alone in how they feel. Meeting with others who have experienced recovery and being supported by their families, peers, and schools can bring hope and a sense of belonging to support long-term recovery.

SEP.29

Mental Health First Aid

The National Alliance on Mental Illness hosts this free class to teach the basic skills needed to help a person who is experiencing a mental health problem or crisis.

Come learn how to identify, understand, and respond to signs of a mental illness and substance abuse disorders. Registration required.

Call Kara at (651) 645-2948, ext. 114.

Tuesday, Sept. 29, 8:30 a.m.–5:30 p.m., Oak Grove Presbyterian Church, 2200 W. Old Shakopee Rd., Bloomington

Oct.6

Grief & Loss Support Group

The Aliveness Project hosts this free support group for people with HIV or their partners who have lost a loved one. Come gain support and learn new strategies on how to cope. Call Becca at (763) 253-2110 to sign up or learn about other meeting dates.

Tuesday, Oct. 6, 1–2 p.m., The Aliveness Project, Community Room, 3808 Nicollet Ave. S., Minneapolis

10

Food Allergy Resource Fair

The Food Allergy Support Group of Minnesota hosts this free resource fair, featuring allergy-friendly foods and products, allergy safety information, and doctors who will be available to answer questions. No registration required, but there is a $5 suggested donation per family. Visit www.foodallergysupportmn. org for more information.

Saturday, Oct. 10, 9 a.m–12 a.m., Eisenhower Community Center, 1001 Hwy. 7, Hopkins

14

Colorectal Cancer Support Group

Allina Health hosts this support group for those living with colorectal cancer and their caregivers. Come to meet others on a similar path for support and to learn methods for coping with the physical and emotional impact of living with these cancers. No registration required. Call (763) 236-6060 with questions or to learn about other meeting dates.

Wednesday, Oct. 14, 6–7:30 p.m., Virginia Piper Cancer Institute — Mercy Hospital, 11850 Blackfoot St. NW, Suite 130, Coon Rapids

17

Huntington’s Disease Support Group

The Minnesota Chapter of the Huntington’s Disease Society of America offers this free support group for those affected by Huntington’s Disease. Come make new connections in a safe, caring environment. Call Jessica at (612) 371-0904 or email jmarsolek@hdsa.org for more information.

Saturday, Oct. 17, 10:30 a.m.–12:30 p.m., Oak Grove Lutheran Church, 7045 Lyndale Ave. S., Richfield

America’s leading source of health information online 18

Minnesota Health care news September 2015

Your feet and lower extremities from page 17

Traumatic foot wounds Traumatic foot wounds are a common entity encountered by health care professionals. The severity of these can vary widely, and can include: minor abrasions, lacerations, foreign bodies in the foot leading to puncture wounds, open fractures, machinery injuries, and degloving injuries where the skin is completely removed from the underlying tissue. Given that the feet are a weight-bearing surface and in constant ground contact, preventing infection in open wounds of the feet is important to maintaining the ability to walk and bear weight.

Local wound care is important to prevent infection. Antibiotics—taken orally or applied topically—may be necessary to prevent infection. For puncture wounds and for more serious traumatic foot wounds in general, it is important to make sure that your tetanus status is up to date. Depending on wound severity, surgery may be necessary to remove any devitalized (dead) tissue and to thoroughly irrigate and clean the area. You should seek medical attention for deep puncture wounds or more serious traumatic foot wounds in general, but especially if there are any signs of the wound being infected. Those signs of infection might include increased redness, drainage, swelling, or pain.

Complications The keys to successful wound healing include: prompt recognition of the wound, accurate diagnosis of the causative factors, appropriate wound care, and timely referral to a wound specialist or clinic while the wound is still small and easily treated. Cooperation and commitment to a wound plan are vitally important, especially in more difficult or extensive wounds. Despite all the resources available in most modern hospitals and wound clinics, late treatment of extensive leg wounds, especially in patients with multiple medical issues, still can lead to problems with infection, chronic pain and disability, extended hospital stays for multiple procedures or operations, and, in extreme cases, amputation or death.

Nerve damage often can occur without pain.

BILATERAL KNEE REPLACEMENT HELPS FARMER GET HIS

Conclusion Cuts, abrasions, and wounds to the feet are common occurrences and usually heal quickly. However, depending on the severity of the wound and your other underlying medical issues, these injuries can become more serious. Close observation and prompt evaluation of any slowly healing wounds by your medical providers is key to successful healing and prevention of more serious complications.

Nicole A. Bauerly, DPM, FACFAS, is chief of the Department of Podiatry Surgery and assistant program director of the Podiatric Surgery Residency Program at Hennepin County Medical Center (HCMC). She is board-certified in foot surgery and reconstructive rearfoot/ankle surgery. Michael Hu, MD, FACS, is a vascular surgeon at HCMC. His professional interests include aneurysm disease, peripheral arterial and venous disease, and carotid disease.

Tim Jackson has been a dairyman most of his life. As the years passed, his knees wore out. “Two years ago they were getting so bad that I could hardly navigate anymore,” said Tim. He began to get depressed because it was too painful to continue his work and enjoy an active lifestyle. Tim sought help from providers and had some treatment before finding St. Croix Orthopaedics (SCO). His treatment journey with SCO helped him find the solution he was looking for. “It was a positive experience from the beginning,” said Tim. “He (the surgeon) painted a whole other picture for my life.”

Watch Tim’s story online. Go to http://bit.ly/183Vlpc Appointments: Online or call 651-439-8807 | Multiple clinics in Minnesota and Wisconsin

www.stcroixortho.com

September 2015 Minnesota Health care news

19

Minnesota health care roundtable

Mr. Starnes: Today we will talk about expanding medical professional relationships, which can take many forms. In some—an oncologist working with a radiologist, for example—there is a well-defined protocol for communication and continuity of patient care. We want to focus more on medical doctors working with medical professionals who are not MDs. Let’s start with a definition. What is a medical professional?

Dr. Hu: It has to do with a degree of specific medical training in some specific field as well as professional interest. It has to involve some aspect of medicine, however broadly you want to define that.

About the Roundtable Minnesota Physician Publishing’s forty-third Minnesota Health Care Roundtable examined the topic of The New Face of Health Care: Expanding medical professional relationships. Seven panelists and our moderator met on April 23, 2015 to discuss this topic. The next roundtable, on Nov. 12, 2015, will address Behavioral health integration: New pathways to care

Dr. Sawyer: In our institution, we not only train chiropractic doctors but acupuncturists and massage therapists, and our definition of massage therapy is therapeutic massage. We very much consider them to be medical professionals.

Dr. Desai: When you define a medical professional, you get into a lot of political discussions, and some people get their hackles up. Folks who have gone through medical school or dental school or chiropractic school sometimes show an ingrained defensiveness based on the school they’ve attended and the education they’ve had. I’m part of a multidisciplinary practice, so I work very closely with behavioral health specialists, psychologists, licensed social workers, physical therapists, and others. Oftentimes I work with chiropractors or other medical professionals, as well as with acupuncturists. The value of that is undeniable.

Mr. Hustvet: I like the term “health care professional.” Our current discipline is really pushing to alleviate some of the problems of having a limited number of physicians.

Would I take it personally if I were called a “mid-level provider?” I would really look more at what I’m able to do for the patient.

Am I able to meet a need in a timely fashion? Am I able to assist and provide care where maybe there would have been a delay?

Mr. Starnes: As science and training expands, many health care professionals have the ability to make frontline diagnoses of conditions that could be shared with physicians. Any examples of the ways in which these individuals could work with physicians?

Dr. Gulon: Dental schools now include the team-based approach to care as part of the

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payment. When a patient walks in our door we manage that patient in a silo, and we aren’t thinking of other providers that might be able to have a better impact or an additional impact on that patient.

Mr. Wingrove: A lot of us are still getting to know each other, and I think that is one of the keys to having successful interdisciplinary approaches. We’re being forced now to look outside of our own box and collaborate with other people. In the long run, I think that’s going to serve the patients well.

It’s probably something we should have done a decade ago.

Dr. Desai: Patient ownership is an area that we tend to ignore. It’s the most uncomfortable of the areas to discuss. The cultural issues surrounding patient ownership are the ones that are the hardest conversations to have.

The new face of health care Expanding medical professional relationships curriculum. Dentists are trained to not only work on prevention, but disease treatment as well—and, like our physician colleagues, to deliver care over the lifetime of our patients. It’s obvious that everything that goes into the mouth pretty much enters all the pathways of all the basic systems of the body. Understanding that and applying disciplines and approaches to care that impact and/or prevent it are going to be useful in at least the teamwork process in health care.

Mr. Starnes: Let’s talk about expanding the relationships between health care professionals and the benefits this can bring. What are some of the existing barriers to this more collaborative approach?

Dr. Sawyer: The biggest barriers really have to do with payment and the incentives in

Minnesota Health care news September 2015

Dr. Gulon: I see this as an opportunity, not as a barrier. First of all, 40 percent of the population seeks dental care in any given year. Fifteen percent of those people don’t see a physician, and that’s a problem. If we’re presented with conditions in which we could be a source of referral to the physicians through appropriate screening, whether it’s hypertension, which we do routinely, oral cancer screening examinations, diabetes screening, or sleep apnea screening, there are windows and/or opportunities to collaborate at a higher level with our physician colleagues.

Mr. Starnes: Are we are going to foster better relations between provider types if the consumers themselves broaden their approach to health?

Mr. Hustvet: Changing a patient’s view on taking ownership of their health isn’t going to happen in a five-minute conversation at a physician’s office. It probably won’t happen even after three or four five-minute conversations at the physician’s office.

Dr. Hu: Say you need to get a CT scan and an MRI. Each costs different amounts at different places, whether it’s inpatient, outpatient, or in hospitals. There’s very little transparency, so even if they want to be involved in making those decisions in a cost-effective manner based on their insurance or deductible, they can’t do it.

Minnesota health care roundtable Mr. Johnson: We all need to provide education to our patients about preventive care and following up with preventive checkups, because it can’t be a burden for just one profession.

Dr. Hu: I’m a specialist, a vascular surgeon, so my view may be skewed towards specialty care. Again, we’ve been siloed for a long time. We have radiologists who do angiograms and surgeons who do surgery, but those barriers have changed, and everyone wants to protect their turf. I think the financial barriers are the first hurdle and probably the biggest hurdle in order to build a multidisciplinary team with a common goal.

Mr. Starnes: We need to better understand the levels of training of different kinds of providers. How early in one’s health care career should this learning begin?

Mr. Johnson: In the physical therapy program it happens early, and for good reason. Everybody is in learner mode.

I think it needs to be a little bit more robust, actually, so training would continue beyond those initial few years.

Mr. Starnes: What about health care professionals who are well into their careers and well removed from the academic or school environment?

Mr. Hustvet: Sometimes it’s directed by a physician above everyone who pulls teams together to promote exposure and greater comfort levels with the different fields. Being outside the facility, it’s really a challenge for us.

We spend a lot of effort trying to track

“ You want to do the best thing for the patient.”

Michael Hu, MD

people down and explain what kinds of services and offerings we have, asking questions about their needs, and where we can fill in the gaps.

Mr. Wingrove: I represent the profession that will literally decide for about 80 percent of you in the room today at least once whether you live or die.

That’s about 10 percent of what we do.

We have another 30 percent that deals with your urgent care needs, and about 60 percent that involves your social needs. Until recently, we weren’t training our professionals in how to deal with your social issues beyond some of the safety issues. That’s one of the real promises of the new generation of community paramedics. It’s taking a professional that is super-sharp in lifesaving skills and retraining them to do the majority of the work they actually perform each day, which involves more psychosocial skills.

Mr. Starnes: How can reimbursement mechanisms further collaboration?

Dr. Desai: There’ll be a shortage of 90,000 physicians within the next two to five years, and certain states are suffering from it more acutely than others. If we formed a care team with seven health care professionals and we all saw the patient together, only one of us could get reimbursed. We need to create incentives for people to want to be part of that team. If you come to see me as a patient, I will almost always refer you to a physical therapist, possibly a behavioral health specialist, an acupuncturist, or a surgeon.

Mehul Desai, MD, MPH, practices at the Maple Grove and Fridley offices of Medical Advanced Pain Specialists (MAPS). Board-certified in pain medicine and physical medicine and rehabilitation (PMR), he has served as an assistant professor in the Department of Anesthesiology and Critical Care Medicine and of neurosurgery at George Washington University (GWU) Medical Center, Washington, DC. John Gulon, DDS, has served at Eden Prairie-based Park Dental since 1987. In addition to seeing patients at the group practice’s Roseville clinic, he has served as the president and CEO of Park Dental and its 37 practice locations since 2005. He graduated from the University of Minnesota School of Dentistry.

Michael Hu, MD, practices at Hennepin County Medical Center. He completed his medical degree and general surgery training at the University of Minnesota and his vascular surgery fellowship at Washington University in St. Louis. His professional interests include aneurysm disease, peripheral arterial and venous disease, carotid disease, and dialysis access.

Derek Hustvet, RRT-NPS, LRT, is director of respiratory service at Pediatric Home Service (PHS). He earned a bachelor’s degree in respiratory therapy from North Dakota State University, Fargo, and is a licensed respiratory therapist and a neonatal/ pediatric respiratory care specialist.

Craig Johnson, PT, MBA, is president of the Minnesota Physical Therapy Association (MNPT), where he is active in government affairs and payer relations as well as strategic repositioning efforts, association payer forums, and payer relation meetings. He is also a partner and director of clinical integration at Therapy Partners.

Charles Sawyer, DC, is senior vice president at Northwestern Health Sciences University in Bloomington, Minnesota. During his 35-year career, he has been a leader in the chiropractic profession and a member of the faculty and administration at Northwestern Health Sciences University.

Gary Wingrove is director of government relations and strategic affairs for Gold Cross Ambulance/ Mayo Clinic Medical Transport in Minnesota and Western Wisconsin. He is a former Minnesota state EMS director who was awarded the Minnesota Department of Health’s Jim Parker Leadership Award for Community Health Services.

A bo ut th e Mo d e r ato r Mike Starnes has been the publisher at Minnesota Physician Publishing since 1986.

His duties include the production of MedFax, Minnesota Physician, Employee Benefits Planner, and Minnesota Health Care News; directing the Minnesota Health Care Consumer Association; and hosting the Minnesota Health Care Roundtable.

September 2015 Minnesota Health care news

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Minnesota health care roundtable Dr. Sawyer: Right now, with the fee-forservice reimbursement formula, we don’t have any incentive to talk about team-based care. If and when the payment shifts to focus on the value that the team provides, it will be more productive.

Dr. Desai: In 2018 it shifts, as Medicare makes the majority of payments based on value as opposed to fee-for-service.

Mr. Starnes: What could be gained by better relationships between health care professional relationships?

Dr. Desai: Low-back pain is the single most expensive medical condition, with costs approaching around $100 billion annually in the United States. It’s three times more expensive than cardiac care services, and it’s more expensive than diabetes and cardiac care combined. Eighty percent of Americans will have an episode of low-back pain. However, it turns out that 7 percent of those patients—around 15 to 25 million Americans—are using up 85 to 97 percent of that $100 billion. If the different health care professionals treating these patients operated more collaboratively, there could be huge cost savings.

Mr. Johnson: I think that many of our current outcome measurements are really process measurements. They’re not quality-

of-life measurements, like those used in Europe, and they’re not functionally based either. An outcome that’s worth measuring, in my mind, one that moves the health of the population higher, requires a functional measure and a quality-of-life measure. I think we do need to address that and not go with just process measures or measuring whether we get the person from point A to point B and they’re happy and out the door, but, rather, on their ability to function in society and their quality of life.

Dr. Hu: In the large medical groups I’ve worked in, patient satisfaction is different from measuring the real outcomes—for example, that they’re functioning better, they’re able to walk, and they’re pain free.

At the same time, you’re getting these little management metrics—for example, what would you as a physician do? Is the patient satisfied and happy? All of those are not necessarily the same as treating the problem. I think that trying to have patient satisfaction is a tremendous problem that a lot of physicians complain about in these large care systems, but it doesn’t necessarily correlate with better care.

Dr. Desai: I agree with you, because when you look at the HCAHPS (Hospital Consumer Assessment of Healthcare Providers and Systems) scores, patients who are more likely to be satisfied are more likely to die earlier. Patient satisfaction and outcomes are not correlated. You’re more likely to provide more tests, more medications, more interventions for someone because then they feel

“ We are trying to promote innovative clinical pathways.”

Craig Johnson, PT, MBA

as if something happened to them and they report being more satisfied—but that’s not the same as actually getting better.

Dr. Hu: At HCMC (Hennepin County Medical Center), we’re working on a so-called Limb Salvage Center, where we have people from different specialties—radiology, vascular surgery, hyperbaric oxygen, dietary—trying to save limbs. All of us bring different perspectives, and maybe we have different tools. The whole goal is not to have two different ideas about how to treat this, but to have one consensus idea of how to treat the patient.

Dr. Gulon: Certainly we’d see some advantages of interoperability between the medical record and the dental record.

That doesn’t exist today. Instead we do it the old-fashioned way, with a call or paper referral. One challenge is to follow up to ensure that the patient did follow through with the referral with the physician. The other challenge is getting the results of that referral and/or the tests or evaluation back to the dentist.

Mr. Starnes: Any other thoughts on how we could improve care by improving relationships between provider types?

Dr. Gulon: One, for example, is periodontal disease. It’s present in roughly half the population today, and there are certain clear associations between periodontal disease and its management and cardiovascular health. Today, roughly 80 million people have some form of hypertension and 14.5 million people go undiagnosed or are unaware of the associated risks.

Mr. Starnes: Are there examples from within your own organizations of how expanded relationships between different kinds of health care providers are producing good results?

Mr. Wingrove: Within paramedic service, we have some high-utilizer groups of patients.

The people that abuse our system tend to call on different days and at different times, so they’ll see nurse Judy on Monday and nurse Tammy on Wednesday and nurse Steve on Friday. North Memorial’s community paramedics now follow patients at home who have 10 or more medications, three or more comorbidities, and time-sensitive medications. The paramedics use the same electronic medical record, so they can see all the hospital visits, all the clinic visits, and can issue a request for a physical

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Minnesota health care roundtable therapy service or a secure message to the physician. It’s part of a Medicaid shared savings ACO (Accountable Care Organization), so the state gave them a significant portion of shared savings last fall. Of course, 80 percent of it should go to the paramedic and 20 percent be shared by the rest of you, but that model is a shining star in the country.

Dr. Sawyer: The Hennepin Health initiative is extremely novel. It combines the clinical services that we all think about, but then it adds social services, and throws a big net over the most complicated, vulnerable population of patients where the costs are high and the access is not good. They’re bringing mental health professionals and social workers in and dealing with poverty and homelessness.

Mr. Hustvet: We are trying to have more proactive team involvement. We are also trying to prevent emergency room visits and the expense of Medicare dollars. We do this not just with asthma and obesity but also with our general patient population. The bigger challenge is when we have to communicate with four different physicians from two different hospitals, with one to four involved parents, and three, four, or five different primary nurses. Care conferences are probably a great example as well. We get to sit with the physicians, with the family, with everybody involved and have a conversation. These meetings can sometimes raise really important, crucial questions. If the discharge is tomorrow, what happens, how do we fix this, do we rush through things?

If the team does save dollars, it’s hospital-based versus home care versus maybe an extended living facility, that determines where that benefit goes.

Mr. Johnson: What’s going well? Here are a few examples. One is a primary spine program in Mankato. The primary care clinic is a medical home, and they’re using a tool to risk-adjust patients in terms of the risk of accessing services and making referrals to physical therapy. Another therapy clinic in our network is working with a primary care clinic, and when a patient is identified with prediabetes based on blood work, they refer them to physical therapy for education.

They’ve shown very good results in reducing blood sugar levels over a six-month period.

Finally, Courage Kenny set up a pilot program a couple of years ago as a medical

home with about 200 patients. The patient population was essentially defined as dual eligible, which means they are eligible for Medicaid and Medicare. By being very preventivefocused and “ We are trying to helping manage have more proactive their health, I believe they team involvement.” saved the state Derek Hustvet, RRT-NPS, LRT about $2 million.

Mr. Starnes: Why are health plans so unwilling to offer fair compensation to non-physician health care professionals?

Dr. Sawyer: It’s all about coding and chasing the money. We’re starting to ditch the terms complementary and alternative because they don’t mean anything. If acupuncture is the best early treatment to use, along with reasonable medication management for a patient with acute or chronic pain, then that should be put into effect right from the start. Typically, to qualify for reimbursement for acupuncture the pain has to be four months of chronicity or longer.

This delays the use of a therapy that has no downside to it whatsoever. Then, once payment is approved, reimbursement is so low that it’s not feasible to provide the care in a pain clinic or large health system.

Mr. Johnson: In our current fee-for-service system it’s obvious that the current pathway for most disease processes is too costly.

We’ve done a fair amount of research into payer data of delivery partners and timing of care in relation to physical therapy and particularly musculoskeletal conditions, and there’s a huge amount of care that’s provided upstream. There have been a couple of very good research articles from Spine magazine and Health Affairs demonstrating that early access to physical therapy for low back pain—within 14 days of seeing a primary or a medical provider— has reduced the total episode cost for that back episode by 40 percent.

Mr. Starnes: Dental insurance reimbursement seems to differ from other reimbursement models. Why is this?

Dr. Gulon: I’m not sure that dental is doing it any better. In fact, in dental we get paid by procedures. In the dental world, we don’t operate with diagnostic codes, but that world is evolving. On the other hand, we’re working on a couple of novel projects with integrated physician networks, including some sleep studies right in our practice.

We’ve worked out some reimbursement mechanisms between the physician network and our group.

Mr. Starnes: One of the biggest challenges comes from corporate culture and senior leadership. In some systems individuals won’t change regardless of evidence that suggests they should, and in some systems senior leadership is very proactive about change but it somehow gets bogged down in mid-level management. Any comments on this?

Dr. Desai: We do have progressive-thinking leadership, and we’re doing some things that are progressive and innovative on the training level. People who have been trained already and have been out of school, for five, 10, or 15 years, is where the gap is.

What we really need is to identify and mentor and support great clinical leaders.

What I mean is that health care is not going to change until health care providers buy in. You can have a great administrator, you can force it down someone’s throat, but you need a foil to that with great health care

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Minnesota health care roundtable

“ Everybody ought to be right at the top of their license.”

Charles Sawyer, DC

leadership. Getting folks who are mid-career to change their practice patterns, as we’ve all been talking about, is a significantly greater challenge because they’re set in their ways. Those are the folks running the show, so to speak.

Dr. Gulon: I’m really optimistic that the ears are open from the medical administrators’ point of view. Many of us have been proud that in Minnesota, overall, we’re pretty progressive with regards to health care.

Unfortunately, when it comes to the pediatric dental benefit, Minnesota is dead last, 50th out of 50, in terms of reimbursement.

Switching gears for a moment, from the conversations we’ve had with chief medical officers, there’s a significant amount of waste in terms of the access for dental care through emergency departments, with roughly $50 million each year being spent on dental care in emergency rooms. Interestingly enough, we’ve been able to partner with a physician group to leverage some of the synergies so that we can actually have those patients access the care through the dental practice rather than through the emergency room.

Mr. Wingrove: When we encounter a patient who has congestive heart failure and has significant breathing difficulty, we have two choices. We can intubate them, or we can put them on CPAP (continuous positive airway pressure). If we intubate them, what do you suppose happens to the hospital-

acquired infection rate? It has nothing to do with the hospital, but it’s in an unsterile environment, and it’s an invasive procedure. On the other hand, if we use CPAP and maybe even get a better result than intubation, we can drive the hospital score into a better position. Those are some of the things that have value to patients as well as to the payers.

Mr. Starnes: Under the Accountable Care Act (ACA), reimbursement for health care services will migrate from a volume- to a value-based methodology. How does expanded collaboration between health care professionals respond to this migration?

Mr. Johnson: The whole notion of collaboration has been spurred on by the ACA. The Centers for Medicare & Medicaid Services (CMS) has announced that they’re moving towards 50 percent of their payment being value-based by 2018, and that will certainly foster innovation around collaboration. I am a firm believer that we should manage what we measure, so measuring outcome is going to be very critical in this collaboration. Financial incentives, when they are aligned, will also drive collaboration, and financial incentives really do drive our provider behavior.

Mr. Starnes: Part of the health care reform is going to deal with attempts to reduce rehospitalization. How can penalties for rehospitalization drive better collaboration?

Mr. Hustvet: From a home care perspective, we actually have some incentive right now to keep patients out of the hospital. We can’t bill for our equipment, and we can’t bill for the pieces or parts or supplies they use if they’re in the hospital. We have a clinical piece that often does not get reimbursed. If it does get reimbursed, it’s not a full reimbursement, but that piece of equipment is necessary to keep that patient out of the hospital. We’ve noticed, in the last three years, more focus from the hospital facility level at care management and discharge planning. There’s a lot more focus on providing 24-hour, 7-day-a-week support.

There used to be just a daily discharge plan, after which you didn’t have a lot of communication and cooperation. I think from our perspective, we’ve been trying to do this because it’s good for our business model and it’s good for our patients.

Mr. Starnes: Can an increased emphasis on prevention foster improved collaborations?

Dr. Desai: It’s very unlikely that prevention can be achieved with just one provider.

It’s unlikely that just one specialist or one primary care provider could achieve prevention. I think that in itself provides the foundation for greater collaboration. One of the things I tell patients all the time is, I don’t have to be the one to fix you, I don’t have to be the one to make you better, but if I can get you to the right person, it still makes me look good.

Dr. Sawyer: I’m not sure who is able, by virtue of their training and experience, to actually provide preventive services. I’m not talking about pap smears and mammograms, I’m talking about the discussions, the coaching, and visiting with the patient.

We’ve got a mixed bag, and I think it’s too early to know for sure how that’s going to work, but we certainly have to put that in place because it’s now mandated.

Mr. Starnes: Are there future legislative actions at the state or federal level that might drive collaboration?

Mr. Johnson: It can be demonstrated that silo management mentality is ineffective.

From our association’s standpoint, we are trying to promote innovative clinical pathways, and research has shown that early access to physical therapy is key to saving dollars throughout that whole episode. We have a very innovative national association.

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Minnesota health care roundtable I applied for a grant from them to run a pilot study around worker’s compensation patients directly accessing physical therapy.

We have had discussions with stakeholders at high levels including the Chamber of Commerce, the Department of Labor, brokers, and the worker’s compensation insurer for the state. I think this is definitely beginning to show up on their radar. I think that will obviously affect future legislation and the way that the worker’s compensation fee schedule works. Ultimately, we are hoping to change legislation.

Mr. Starnes: We recently had landmark approval from the House and Senate on new Medicare reform. Is Medicare reform going to help foster better relationships between health care professionals?

Mr. Hustvet: I think it’s a good start. I think anytime you’re getting physicians involved with alternative providers, there’s going to be more collaboration. There’s a push right now on both physicians and even physician assistants to see how much work they can get done. If we can spend 10 minutes, 20 minutes, or a half hour with the patient and then have a five-minute conversation with the physician—versus the physician only getting five minutes with the patient—​ I think that’s going to drive a little more collaboration, and offer a little more exposure.

The physician, I think, will end up ultimately being more of a coordinator and manager of the other therapies and services.

Mr. Starnes: In every legislative session, there are bills introduced that redefine the scope of practice for specific provider types, and there are always “turf-war” conflicts over their passage. How do we best address this?

Mr. Wingrove: Sometimes that’s healthy tension, and sometimes that’s not healthy tension. We’re in a time when change is here and it’s being made everywhere, and I think we just have to recognize there have been changes over time in all of our professions, and those are cyclic. This is a new time when the professions will change.

Technology also plays a role in how safely different providers can do different things.

The professional protection, I don’t think, will ever go away, but we’ll have to respond to it based on what the payment system forces on us.

Mr. Johnson: We don’t really like this licensure turf battle, but it does happen. There’s

a filter that describes scope and helps legislators make decisions. Legislators make decisions about scope for every profession in this state, and they’re not really the experts most of the time. They’ve actually appreciated that here’s something that you can measure when somebody comes to you and they want to expand in a certain area.

I think we need to get beyond that as well and be very proactive, because the time that it takes and the resources it takes to fight those battles are pretty wasted. I think we need to recognize that and try to maximize the training level of each provider on the care team and not have legislative turf battles about scope.

Dr. Sawyer: The real issue is that everybody ought to be right at the top of their license, and if these care models can change and the reimbursement can change, then the commercial payers will follow what Medicare is doing. Getting this shift to value would allow clinicians like Gary and me to sit down at the table and say, well, if we’re in the shop together, if we’re in the same practice together, what can we do to elevate the model of care and the delivery of it and the efficiency of it and go right to a payer, along with nurse practitioners, pain specialists, and acupuncturists and say, we’ve got a proposal from you and it’s too good to turn down.

point, I believe that fee-for-service can be a very powerful motivator sometimes just to do the work. Will people work as hard when you take away some of that financial incentive? I know that under different health care models and within different health care groups, when you incentivize doing a procedure and you’re a subspecialist, you do make your people work harder.

When you take that incentive away, they don’t work as hard.

Dr. Sawyer: I do worry a little bit about the fact that maybe we’re over-vilifying feefor-service reimbursement. If we shift into value-based reimbursement and shared savings and shared risk, I wonder if there’s going to be another perverse incentive. If I do less, the team that I’m on, the hospital that I practice in, and the system that I’m a health care provider in, is going to do better, and by extension I will do better if my contract shows some performance.

Mr. Hustvet: I think there’s also potential for cost savings. If I’m a respiratory therapist and I’m allowed to manage an asthma patient, more than likely I’m going to get reimbursed less than the pulmonologist would.

I could be working for a pulmonologist or a physician or a primary pediatrician through their office. I’m getting reimbursed less but they’re seeing three times as many asthma patients because I’m there as well.

I think there’s some potential to shift some

Dr. Gulon: Dentistry, as I mentioned earlier, has added mid-level practitioners in the form of dental therapists and advanced dental therapists with expanded functions.

Dentistry was not unlike other professions “ We’re in a time that were slow to when change recognize the shortagis here.” es that we are encountering. We have to be Gary Wingrove more creative, and I think that’s driving a lot of the behaviors out there.

Dr. Hu: If you can get the collaborations to work, is it going to be revenue neutral? If it’s revenue neutral, basically you’re redistributing income from one group to another group. From a practical stand-

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Minnesota health care roundtable of the work to me, or other folks that aren’t billing quite as much, and still see quality patients and allow the physician to see the higher-needs patients that maybe are getting delayed or pushed off or even going into the hospital.

Mr. Starnes: An emerging model involves community-based initiatives, many of which could be duplicated and expanded. Can you give some examples?

Mr. Wingrove: Our state got a grant from CMS to work on different sorts of models, and one of the ones they’ve chosen is to create opportunities to expand three emerging professions: community paramedics, community health workers, and dental therapists. They are contracting now for each of these to create tool kits for potential employers. The goal is to speed the adoption of the professions by employers. It will set the stage for the employer to learn about the training they come in with, the sorts of things you can expect them to do, and how reimbursement works—if it works at all.

They are also, at least in our case, subsidizing the employment of a handful of professionals so that employers can test it out and make sure it works and learn about the intricate details of actually putting the profession into practice.

Dr. Sawyer: I’m not sure that the innovations would have happened in either the state innovation model initiative or the Hennepin Health initiative if there hadn’t been legislation and direct involvement by state agencies with provider groups. In other words, I’m not sure that would have evolved or happened if the payers weren’t the ones responsible for it, and I don’t think they would’ve taken the initiative.

Mr. Johnson: Under one community-based program that, in its original form, our association worked on, we developed an education program that assessed seniors for their risk of falling. Reducing the number of falls has an impact on that individual’s health as well as on the health of those in the community. The program was first developed for assessment and then for intervention, and oftentimes the assessment revealed that a community-based strengthening program would help to reduce the risk of falls. This was a grant-funded initiative with a trainthe-trainer model, which trained community health nurses and others to assess and then to address the issue. Now the Department of Health is reviving this initiative, with about a dozen health care providers and community organizations working on reducing falls by seniors in the community.

“ I see this as an opportunity, not a barrier.”

John Gulon, DDS

Mr. Starnes: How could a value-based care model promote interprofessional relationships or address the turf or silo mentality?

Dr. Desai: The greatest advantage of a value-based reimbursement model is that, for the most part, the value of a person’s contribution to the care team gets equalized a little bit better. The traditional system is quite hierarchal, with certain people on the top and others along the way. By bundling care and by providing reimbursement in a value-based system, long-term management becomes more important than incident-based management, which also then shifts away from the silo effect.

Mr. Starnes: If we increased the focus on the patient experience, might we break down some of that silo mentality?

Dr. Hu: I think so. Like anything, you want to do the best thing for the patient, and it’s rare that you’re the only one who can do it. I think centering on the patients, giving them the best experience, requires you to seek out all the other things that they need.

I think, yes, that will help break down some of the silos.

Dr. Gulon: Patients who go through different levels of care—whether it’s with a dentist or a physician or a chiropractor or whomever—will benefit if there’s a high level of transparency, communication, and coordination within the care team. Certainly we recognize the challenges of achieving that, but also it’s pretty obvious how that might feel to the patient.

Mr. Starnes: Even though different types of providers have similar goals, they may not talk to each other. Why not?

Dr. Desai: Synergies are often unrealized because of time and malaligned financial incentives. Those are the two primary reasons. Right now there’s no incentive to learn what the other guys do. He might be the specialist in this, I might be the specialist in that. In order to get that 360-degree view or that spherical view of what the patient’s going through, you need to get all partners involved. If you do that, then the value of your partnership increases and your incentive to learn about what others do, at least to some extent, increases.

Dr. Sawyer: If we’re in the same practice business together, we sit down at the table and figure out how are we going to be

M i n n e s o t a h e a l t h c a r e r o u n d t a b l e sponsored by

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Minnesota Health care news September 2015

Minnesota health care roundtable successful, because we’d like to approach this particular payer, public or private, with a proposal to do X for a new model of care and delivery. We’ve got to get to know each other, on both a professional level and a personal level, so we have some trust and assurance that we’re watching each other’s backs. Being in business together is a big deal.

“ I tell patients all the time, ‘I don’t have to be the one to fix you.’”

Mehul Desai, MD, MPH

Mr. Hustvet: We lack easy communication and easy access tools. Just because I’m only free at noon and you’re only free at one doesn’t mean I couldn’t have gone into a shared system and put in a note or a comment for you. That’s better than a system in which one physician calls, one emails, and one faxes or leaves a note on the nurse’s desk. I can’t communicate with three or four of the hospitals that use different electronic records, and one physician who prefers to use a pager and calls me back when I’m already out on the road seeing somebody else.

Mr. Starnes: Do patients need to be educated not to fear being part of a collaborative process?

Dr. Desai: I think so. I think, increasingly, you have patients who have been exposed to advocacy groups. Also, patients are increasingly more educated about their disease states. Patients come to me all the time and say, well, PT (physical therapy) doesn’t work for me, or chiropractic doesn’t work for me, or acupuncture doesn’t work for me. That ties back into that initial conversation we had about training and understanding what your collaborators bring to the table. I say to the patient, well, it’s not that PT doesn’t work for you, but it’s that therapist.

Mr. Johnson: I think that’s exactly right.

We have a joke in physical therapy about a patient making a comment to the doctor: “I tried physical therapy, and it didn’t work.” The comeback is, “Have you tried doctoring?” It’s the individual. There is a provider in town that is absolutely selective about which therapist he sends his patients to because he’s taken the time to build a relationship. Understanding the person who’s delivering the care is really critical, and I think that’s a great point.

Dr. Desai: A lot of us who believe in multidisciplinary or interdisciplinary care have taken the time to create our own networks. I have already identified the folks I’m going to

send people to. I have preferred providers, and those are the only people I’m interested in sending patients to if I have a choice. I know at the end of the day, the patients are going to get better, and it’s going to make me look good, and everyone, so to speak, is happy at the end of that experience.

Mr. Starnes: What must be done to expand interprofessional relationships in health care delivery?

Mr. Wingrove: I think it centers on the people and the relationships between the professionals. It will go faster if we spend time on the front end managing that process well.

Mr. Hustvet: I think the most basic piece is just increased communication, whether that involves meetings, discussions, or electronic communications. That’s really going to be the main driver.

Dr. Desai: In my estimation, it’s financial misalignment. Until we align the financial incentives to collaborate, there’s going to be some resistance. I think that with the Accountable Care Act and with value-based reimbursement, we’re moving in the right direction, and I think there are some really creative ideas with regards to that, but finances need to be aligned.

Dr. Sawyer: I think it has to be initiative and motivation. In other words, when I’ve got a reason to reach out, I should make that phone call or send that email and ask if we can have lunch so we can start talking about some different ways of working together.

Dr. Gulon: From the consumer point of view, I would ask patients to continue to access the system and to understand how relationships and overall health are interconnected and to continue to demand from the medical care system that which seems obvious but which may be more difficult to achieve.

I think that with continued persistence, that will happen.

Dr. Hu: If I had to pick one, I would say good communication between the different specialties and the different providers.

Concurrent with that would be a good understanding of the capabilities of everyone on the team and what they can do for the patient.

Mr. Johnson: I would echo those. It’s a long list, but I believe that aligning the financial incentives and relationships and understanding what each provider does are most important.

M i n n e s o t a h e a l t h c a r e r o u n d t a b l e sponsored by

September 2015 Minnesota Health care news

27

Urology

Overactive bladder When going too often becomes a problem

By Steven Siegel, MD

O

veractive bladder (OAB) is not a disease, but a condition with symptoms of increased urinary frequency and urgency.

OAB may also include urinary leakage associated with a bothersome degree of urge to get to the bathroom. It is a common condition, afflicting more than 33 million Americans. It may occur among both sexes of all ages, but is more common in female adults.

Is it really a problem?

Yes, it is. The normal frequency of urination is around six to eight times per day, and up to two times per night. Urinary leakage due

In the next issue...

Your Guide to Consumer Information

• Eczema • Male osteoporosis • Neuropathy

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Minnesota Health care news September 2015

to urgency is also abnormal. While having an increase in frequency every once in awhile is not necessarily a problem, when the symptoms of OAB start to have a consistent negative effect on a patient’s quality of life, it becomes a medical condition. Patients with OAB suffer physical and emotional harm from the problem. They have been shown to have a significantly decreased quality of life, causing extreme embarrassment that limits their social interactions, employment opportunities, and trips outside the home. It also promotes social isolation and depression. It is not unusual for patients to dehydrate themselves in order to minimize the symptoms of OAB, which may have other unintended health consequences such as falls and hip fractures among the elderly. Patients often spend hundreds of dollars annually on pads and diapers in order to contain the leakage. As one of our 20-something patients once told us, “It’s not like you put a diaper on and then you are normal!”

How is it diagnosed?

The patient’s history is key. Amounts and type of fluid intake, other medical conditions, and current medications need to be understood.

We ask them to recount how many times per day they void, what is the degree of urgency, and whether or not there are accidents before reaching the bathroom. We need to know if the degree of leakage may require pad use, and if so, what type and how many pads per day are usually required. It is often hard for patients to answer these types of questions without giving them some forethought. A urinary diary, used by the patient to count these events, can be very helpful in zeroing in on the symptoms, and often can be a surprise to the patient, who may have been dealing with the problem by trying to ignore or minimize the symptoms.

We also need to know how much bother each individual patient experiences from these complaints. It does not always follow that a patient who leaks more is more troubled. Some patients can cope well with a lot of leakage, and some find small amounts extremely bothersome. We usually use surveys that include a score, based on a series of questions that have been validated to measure the impact on quality of life for OAB. Not only can these be helpful on initial assessment, but, along with voiding diaries, they can help us to assess the impact of treatments and the need for further measures should the problem remain.

It is not unusual for the problem of OAB to coexist with other conditions, such as leakage with cough or sneeze or other physical exertions (stress urinary incontinence); vaginal bulges due to pelvic prolapse, in which pelvic organs slip out of place; urinary tract infection; and slow stream or incomplete bladder emptying, which could be related to prostate problems in men. Bowel symptoms such as constipation or lack of control (fecal incontinence) can also be present, and need to be assessed. On physical exam, we need to check for vaginal support and visible leakage in females, prostate size in men, pelvic muscle tone and control, changes that may affect hip function, swelling in the lower extremities, and neurological signs that may be associated with urinary symptoms. We also check a urine sample to rule out blood or infection, and measure how much remains in the bladder after urination to understand the patient’s ability to empty. This type of workup is usually enough to get started for most patients. In some cases, cystoscopy testing (which uses a thin, lighted tube equipped with a lens to inspect the bladder) or a nerve test of bladder function (urodynamics exam) may be needed.

for advanced options for OAB. They include nerve stimulation therapies similar to acupuncture (Urgent PC), or implantable devices that work like a pacemaker (InterStim). Injection of the bladder with Botox can also be used to successfully treat OAB symptoms. Each option has pros and cons for an individual patient, and providers need to help the patient understand them in order to weigh them and decide what may work best in each case.

Summary OAB is a common problem of both men and women, and can have a significant impact on overall health. Specialists in OAB are dedicated to helping patients with this problem, and will continue to work to improve symptoms with the increasingly wide range of options that are currently available.

Since this is a problem of symptoms and quality of life, when our patients are happy, we are happy. If they are still being bothered by symptoms, we will continue to offer appropriate solutions. There is rarely a patient with this problem who cannot be helped.

Normal frequency of urination is around six to eight times per day.

What can be done about OAB? Lots! Most people are aware that there are medications for the woman who has “gotta go, gotta go, gotta go right now!” However, while many brands of medication have been available for decades, they mostly work about the same, and for most patients, particularly younger ones with few other health concerns, they may prove to be a limited and unsustainable solution, due to incomplete benefits and side effects, including dry mouth and constipation. Plus, medications don’t solve the problem; they simply attempt to minimize the symptoms. While medications are an option for all of our patients, other options are often more successful and desirable. We use a “roadmap” or pathway of conservative and advanced options to help the patient visualize where they stand with their problem, which treatments have been tried, and which additional options remain should they still be bothered by their OAB symptoms.

Conservative options: Many of our patients arrive ready to start with the first conservative steps that, in addition to drugs, include behavioral therapies, biofeedback, or physical therapy. As an example, types and patterns of fluid intake can be related to the problem.

Too much caffeine, pop, and even excessive water consumption may be contributing factors. Alternatively, severe restriction of fluid and lack of dietary fiber may contribute to constipation, which also could have a negative impact on symptoms. Dietary changes are a basic behavioral measure that carries little risk and can offer a big reward. Patients are often surprised at how well these conservative options can impact their condition, and we are always satisfied when something simple, inexpensive, safe, and reversible proves to be the right solution for a particular patient. Linking the patient to an appropriate resource such as physical therapy or a biofeedback therapist is critical in making the most out of these options.

Advanced options: Some of our patients will have already tried and failed conservative options, and this provides a starting point

Steven Siegel, MD, is the director of the Centers for Urinary Incontinence and Female Urology at Metro Urology. He is board-certified in urology and female pelvic medicine and reconstructive surgery. He practices in Woodbury, Minn.

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29

Chronic Conditions

Living with Managing an autoimmune disease

By Jennifer Monroe, MA, MPH, and Timothy Niewold, MD

L

upus is a chronic autoimmune disease where the immune system turns against parts of the body it’s designed to protect. This leads to inflammation and can affect many different body systems, including joints, blood cells, and organs.

Although one in 200 people is diagnosed with lupus—90 percent of whom are women—it remains one of the least well-known chronic illnesses.

Lupus can occur at any age and in either sex. Women are most often diagnosed during the childbearing years, between the ages of 15 and 45. African American, Latino, Asian, and Native American women have a significantly higher risk for lupus and tend to develop the disease earlier and have more complications than Caucasians.

Yet, statistics of individuals with lupus over the age of 50 show a significant increase in the number of males diagnosed.

There are four different types of lupus:

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Minnesota Health care news September 2015

• Systemic lupus erythematosus (SLE) is generally considered more serious than the other three forms. SLE can affect many parts of a person’s body, including kidneys, heart, lungs, brain, blood, and skin.

• Discoid is a form of lupus that only affects the skin and causes rashes typically found on the face, neck, and scalp, but can appear anywhere on the body. This type of lupus does not affect any of the internal body organs, although one in 10 people living with discoid lupus will develop systemic lupus.

• Drug-induced lupus occurs after a person takes certain types of medication. The symptoms are similar to SLE, but they usually disappear when a person stops taking the medicine.

• Neonatal lupus occurs rarely in newborns of mothers with lupus. This condition can cause skin rashes, anemia, or liver problems, and symptoms usually go away after a few months and don’t cause permanent damage.

Cause of lupus While the cause is unknown, scientists suspect that individuals are genetically predisposed to lupus, and that the disease remains quiet until a trigger sets the disease process in motion. Some outside environmental factor(s) create the right conditions for the disease to become active. The conditions that trigger lupus vary from person to person.

Only 10 percent of those with lupus will have a parent or sibling who already has or may develop lupus. The chance increases to 50 percent if one has an identical twin with lupus. About 5 percent of the children born to individuals with lupus will develop the illness.

Symptoms and diagnosis Each person with lupus has different symptoms that can range from mild to severe and may come and go over time. New symptoms may continue to appear years after the initial diagnosis, and different symptoms can occur at different times. In some, only one system of the body, such as the skin or joints, is affected. Other people experience symptoms in many parts of their body. Just how seriously a body system is affected varies from person to person.

Some of the most common symptoms include extreme fatigue, arthritis, unexplained fever, skin rashes, and kidney problems. Other symptoms include chest pain upon breathing, unusual loss of hair, pale or purple fingers or toes from cold or stress (also known as Raynaud’s phenomenon), sensitivity to the sun, swelling in legs or around the eyes, mouth ulcers, and swollen glands.

lupus require medication to minimize symptoms and maintain normal functions. The goals of an individual’s treatment plan are to prevent flares, control symptoms, and treat flares when they occur, and to reduce organ damage and other problems.

Common medications used to treat lupus include: Benlysta; aspirin and nonsteroidal anti-inflammatory drugs (NSAIDs); antimalarial drugs such as Avloclor or Malarivon (chloroquine phosphates) or Nivaquine (chloroquine sulfate); Atabrine or Mepacrine (Quinacrine Hydrocholorides); Plaquenil (hydroxychloroquine); or corticosteroids.

In serious cases, immunosuppressive drugs may also be prescribed.

People living with lupus can lead active, healthy lives.

Lupus can be difficult to diagnose, and it may take months or years because the symptoms are usually not present all the time. When the symptoms are present, they can mimic other diseases, resulting in misdiagnosis. Additionally, there is no single test to diagnose lupus. The process of diagnosis requires a patient’s entire medical history, details on the frequency and severity of symptoms, and an analysis of lab test results.

Flares and remissions Lupus is unpredictable and patients often suffer flares (active symptoms) followed by periods of remission (symptoms disappear).

For those who have not been diagnosed with lupus, this continued recurrence of symptoms might be the first clue that lupus is the cause.

Lupus flares can be classified as mild, moderate, or severe. An example of a milder flare might be the appearance of a rash, while an example of a very severe flare could cause fluid collection around the heart or even kidney failure.

What causes a flare is almost as unpredictable as when the flare will occur. There is no definitive way to predict when a flare will happen, how bad it will be, or how long it will last. When patients experience a lupus flare, they may have different symptoms than those they have had in the past.

The best way to manage lupus and avoid flares is to listen to the body, learn what the personal triggers and early warning signs are, and talk with a physician about them. Additionally, individuals and families whose lives are impacted by lupus can better educate themselves and learn about the different resources that exist, through organizations such as the Lupus Foundation of Minnesota, Mayo Clinic, and the University of Minnesota’s Lupus Clinic, to help them live well with the disease. However, if an individual with lupus thinks a flare is starting, it’s best to see a physician as soon as possible.

The treatment of lupus is still challeng­ ing, and because patients are not able to predict flares in advance, vigilance and communication between patient and physician are critical in managing lupus and controlling symptoms.

Rest, stress reduction, and a healthy diet and lifestyle are also important. In addition, the use of sunscreens is advocated in all patients, even in non-tropical regions, as ultraviolet light may exacerbate lupus.

Living with lupus to page 34

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Treatment and management Although there’s no cure for lupus yet, medications can control symptoms and prevent or slow organ damage. While some minor lupus cases can be handled without medication, most people with September 2015 Minnesota Health care news

31

Sports-related concussions from page 15

sleep, and visualization. For athletes this can be a critical component of returning to play at pre-concussion levels. After a concussion, if visual signals are disrupted, one may have a distorted sense of space called visual midline shift syndrome, leading to dizziness, gait disturbances, and falls or collisions with walls. Spectacle prescription with prisms and/or vision therapy may be appropriate.

suffered a concussion are at greater risk of suffering another concussion. Athletes are typically put on “brain rest,” which entails physical and cognitive rest—no time with computers or handheld devices, TV watching, or reading. Some may miss school or require frequent breaks. With their doctor’s approval, they may return to the classroom when they can tolerate 45 minutes of auditory/visual stimulation without symptoms, although they may still require adjustments in schedule, course load, tutoring, and other accommodations.

Secondary concussions Professional treatment for those suspected of concussion is vital to the prevention of secondary impact syndrome. If a person has not fully healed from a prior concussion and suffers another, possibly fatal brain swelling can result. Chronic traumatic encephalopathy is a progressive brain degeneration diagnosed in many football players and boxers, but it can also occur with anyone who suffers repetitive brain trauma. Most concussion symptoms can resolve within four weeks. If symptoms persist, the athlete may have post-concussion syndrome, which usually lasts about three months to one year.

Conclusion Vision is critical in concussion diagnosis and management. Adam underwent brain rest, and later physical therapy and vision therapy, to get him back to excellent reading speed and comprehension. He benefited from a mild spectacle prescription, which provided critical relief of headaches during the recovery process but was no longer necessary after one month. Vision therapy not only helped with Adam’s return to school but also enhanced his athletic ability. Just in time for baseball season, his mom reports he is hitting better than ever.

Athletes suspected of concussion should be removed from play and evaluated by a professional. Because children and adolescents have less developed neck muscles and thinner skulls, they may require more healing time than an adult. Also, those who have

Jessica L. Schara, OD, is an optometrist at Mead EyeCare & EyeWear in Woodbury. She currently serves on the board of the Minnesota Optometric Association and is a member of the Neuro-Optometric Rehabilitation Association (NORA).

Concussion symptoms can take days to be recognized.

Each month, members of the Minnesota Health Care Consumer Association are invited to participate in a survey that measures opinions around topics that affect our health-care delivery system. There is no charge to join the association, and everyone is invited.

1. I believe that, at some point in my life, I have suffered from a concussion.

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3. I am aware of the kinds of medical attention that should be provided in the event of a concussion.

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4. I believe that there should be stronger measures in place to protect student athletes from concussions.

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2. I am aware of the symptoms of a concussion.

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5. I am aware of the serious problems that can stem from multiple concussions.

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Minnesota Health care news September 2015

Strongly agree

Agree

No Disagree Strongly opinion disagree

For more information, please visit www.mnhcca.org. We are pleased to present results of the most recent survey.

Minnesota

Health Care Consumer Association

Welcome to your opportunity to be heard in debates and discussions that shape the future of health care policy. There is no cost to join and all you need to become a member is access to the Internet.

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Members receive a free monthly electronic newsletter and the opportunity to participate in consumer opinion surveys.

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September 2015 Minnesota Health care news 33 NOVEMBER 2012 MINNESOTA HEALTH CARE NEWS 33

Living with lupus from page 31

All in all, treatment options for lupus have begun to improve, with more potential treatments in the pipeline than ever before, and people with the disease are living longer. Studies have shown that people who are informed and involved in their own care have less pain, make fewer visits to the doctor, feel better about themselves, and remain more active.

genetic architecture of the disease, as well as the immune system abnormalities that characterize lupus. This is leading to ideas for new therapeutic targets, and many of these are being worked on in academic research centers and pharmaceutical companies. Many other autoimmune diseases, such as rheumatoid arthritis and psoriasis, have seen a number of new effective immune system-based treatments, providing hope that lupus will enjoy the same type of progress in the coming years.

This is an exciting time for lupus research.

Advancements This is an exciting time for lupus research.

Scientists are at the threshold of a number of new treatment possibilities at various stages of clinical development. For instance, in Minnesota, studies are currently in process focusing on a myriad of critical areas, including: genetics; measuring and evaluating clinical disease development against normal biological processes using biological markers (or biomarkers); monitoring the lupus disease process; exploring treatment options; and overcoming barriers that tend to keep some populations from complying with prescribed treatment.

Although the cause of lupus remains unknown and a cure is yet to be discovered, people living with lupus can lead active, healthy lives. Support systems are in place, and public awareness is higher than it’s ever been. Significant progress also continues to be made year after year in the area of medical research. From new drugs to cutting-edge genetic research, the dynamic growth in clinical efforts to understand and treat lupus is encouraging.

Jennifer Monroe, MA, MPH, is president of the Lupus Foundation of Minnesota, an independent, nonprofit charitable organization based in Bloomington. Timothy Niewold, MD, is an associate professor of medicine at the Mayo Clinic in Rochester and a 2015 Lupus Foundation of Minnesota research grant recipient.

Great progress is being made in understanding the cause of lupus. Studies are mapping the

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Minnesota Health care news September 2015

S:9.75”

Victoza® (liraglutide [rDNA origin] injection) Rx Only BRIEF SUMMARY. Please consult package insert for full prescribing information.

WARNING: RISK OF THYROID C-CELL TUMORS: Liraglutide causes dose-dependent and treatmentduration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice. It is unknown whether Victoza® causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as human relevance could not be ruled out by clinical or nonclinical studies.

Victoza® is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Based on the findings in rodents, monitoring with serum calcitonin or thyroid ultrasound was performed during clinical trials, but this may have increased the number of unnecessary thyroid surgeries. It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate human risk of thyroid C-cell tumors. Patients should be counseled regarding the risk and symptoms of thyroid tumors [see Contraindications and Warnings and Precautions].

VICU3X1498_B_2_0_Journal_Ad_Tabloid_Resize_BS_r5.indd 1

for neutralizing effect against native GLP-1, and thus the potential for clinically significant neutralization of native GLP-1 was not assessed. Antibodies that had a neutralizing effect on liraglutide in an in vitro assay occurred in 2.3% of the Victoza®-treated patients in the double-blind 52-week monotherapy trial and in 1.0% of the Victoza®-treated patients in the double-blind 26-week add-on combination therapy trials.

Among Victoza®-treated patients who developed anti-liraglutide antibodies, the most common category of adverse events was that of infections, which occurred among 40% of these patients compared to 36%, 34% and 35% of antibody-negative Victoza®-treated, placebo-treated and active-control-treated patients, respectively. The specific infections which occurred with greater frequency among Victoza®-treated antibody-positive patients were primarily nonserious upper respiratory tract infections, which occurred among 11% of Victoza®-treated antibody-positive patients; and among 7%, 7% and 5% of antibody-negative Victoza®-treated, placebo-treated and active-control-treated patients, respectively. Among Victoza®-treated antibody-negative patients, the most common category of adverse events was that of gastrointestinal events, which occurred in 43%, 18% and 19% of antibody-negative Victoza®-treated, placebo-treated and active-control-treated patients, respectively. Antibody formation was not associated with reduced efficacy of Victoza® when comparing mean HbA1c of all antibody-positive and all antibody-negative patients. However, the 3 patients with the highest titers of anti-liraglutide antibodies had no reduction in HbA1c with Victoza® treatment. In the five double-blind clinical trials of Victoza®, events from a composite of adverse events potentially related to immunogenicity (e.g. urticaria, angioedema) occurred among 0.8% of Victoza®-treated patients and among 0.4% of comparator-treated patients. Urticaria accounted for approximately one-half of the events in this composite for Victoza®-treated patients. Patients who developed anti-liraglutide antibodies were not more likely to develop events from the immunogenicity events composite than were patients who did not develop anti-liraglutide antibodies. Injection site reactions: Injection site reactions (e.g., injection site rash, erythema) were reported in approximately 2% of Victoza®-treated patients in the five double-blind clinical trials of at least 26 weeks duration. Less than 0.2% of Victoza®-treated patients discontinued due to injection site reactions. Papillary thyroid carcinoma: In clinical trials of Victoza®, there were 7 reported cases of papillary thyroid carcinoma in patients treated with Victoza® and 1 case in a comparator-treated patient (1.5 vs. 0.5 cases per 1000 patient-years). Most of these papillary thyroid carcinomas were <1 cm in greatest diameter and were diagnosed in surgical pathology specimens after thyroidectomy prompted by findings on protocol-specified screening with serum calcitonin or thyroid ultrasound. Hypoglycemia :In the eight clinical trials of at least 26 weeks duration, hypoglycemia requiring the assistance of another person for treatment occurred in 11 Victoza®-treated patients (2.3 cases per 1000 patient-years) and in two exenatidetreated patients. Of these 11 Victoza®-treated patients, six patients were concomitantly using metformin and a sulfonylurea, one was concomitantly using a sulfonylurea, two were concomitantly using metformin (blood glucose values were 65 and 94 mg/dL) and two were using Victoza® as monotherapy (one of these patients was undergoing an intravenous glucose tolerance test and the other was receiving insulin as treatment during a hospital stay). For these two patients on Victoza® monotherapy, the insulin treatment was the likely explanation for the hypoglycemia. In the 26-week open-label trial comparing Victoza® to sitagliptin, the incidence of hypoglycemic events defined as symptoms accompanied by a fingerstick glucose <56 mg/ dL was comparable among the treatment groups (approximately 5%).

Table 5: Incidence (%) and Rate (episodes/patient year) of Hypoglycemia in the 52-Week Monotherapy Trial and in the 26-Week Combination Therapy Trials Victoza® Treatment Active Comparator Placebo Comparator None Monotherapy Victoza® (N = 497) Glimepiride (N = 248) Patient not able to self-treat 0 0 — Patient able to self-treat 9.7 (0.24) 25.0 (1.66) — Not classified 1.2 (0.03) 2.4 (0.04) — ® Add-on to Metformin Victoza + Metformin Glimepiride + Placebo + Metformin (N = 724) Metformin (N = 242) (N = 121) Patient not able to self-treat 0.1 (0.001) 0 0 Patient able to self-treat 3.6 (0.05) 22.3 (0.87) 2.5 (0.06) ®+ ® None Insulin detemir + Continued Victoza Add-on to Victoza Metformin Victoza® + Metformin + Metformin alone (N = 158*) (N = 163) Patient not able to self-treat 0 0 — Patient able to self-treat 9.2 (0.29) 1.3 (0.03) — Rosiglitazone + Placebo + Add-on to Glimepiride Victoza® + Glimepiride (N = 695) Glimepiride (N = 231) Glimepiride (N = 114) Patient not able to self-treat 0.1 (0.003) 0 0 Patient able to self-treat 7.5 (0.38) 4.3 (0.12) 2.6 (0.17) Not classified 0.9 (0.05) 0.9 (0.02) 0 Placebo + Metformin Add-on to Metformin + Victoza® + Metformin None + Rosiglitazone + Rosiglitazone Rosiglitazone (N = 175) (N = 355) Patient not able to self-treat 0 — 0 Patient able to self-treat 7.9 (0.49) — 4.6 (0.15) Not classified 0.6 (0.01) — 1.1 (0.03) Add-on to Metformin + Victoza® + Metformin Insulin glargine Placebo + Metformin + Glimepiride + Metformin + Glimepiride + Glimepiride (N = 114) Glimepiride (N = 232) (N = 230) Patient not able to self-treat 2.2 (0.06) 0 0 Patient able to self-treat 27.4 (1.16) 28.9 (1.29) 16.7 (0.95) Not classified 0 1.7 (0.04) 0 *One patient is an outlier and was excluded due to 25 hypoglycemic episodes that the patient was able to self-treat. This patient had a history of frequent hypoglycemia prior to the study.

In a pooled analysis of clinical trials, the incidence rate (per 1,000 patient-years) for malignant neoplasms (based on investigator-reported events, medical history, pathology reports, and surgical reports from both blinded and open-label study periods) was 10.9 for Victoza®, 6.3 for placebo, and 7.2 for active comparator.

After excluding papillary thyroid carcinoma events [see Adverse Reactions], no particular cancer cell type predominated. Seven malignant neoplasm events were reported beyond 1 year of exposure to study medication, six events among Victoza®-treated patients (4 colon, 1 prostate and 1 nasopharyngeal), no events with placebo and one event with active comparator (colon). Causality has not been established. Laboratory Tests: In the five clinical trials of at least 26 weeks duration, mildly elevated serum bilirubin concentrations (elevations to no more than twice the upper limit of the reference range) occurred in 4.0% of Victoza®-treated patients, 2.1% of placebo-treated patients and 3.5% of active-comparator-treated patients. This finding was not accompanied by abnormalities in other liver tests. The significance of this isolated finding is unknown.

Vital signs: Victoza® did not have adverse effects on blood pressure. Mean increases from baseline in heart rate of 2 to 3 beats per minute have been observed with Victoza® compared to placebo. The long-term clinical effects of the increase in pulse rate have not been established. Post-Marketing Experience: The following additional adverse reactions have been reported during post-approval use of Victoza®. Because these events are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to drug exposure: Dehydration resulting from nausea, vomiting and diarrhea; Increased serum creatinine, acute renal failure or worsening of chronic renal failure, sometimes requiring hemodialysis; Angioedema and anaphylactic reactions; Allergic reactions: rash and pruritus; Acute pancreatitis, hemorrhagic and necrotizing pancreatitis sometimes resulting in death.

OVERDOSAGE: Overdoses have been reported in clinical trials and post-marketing use of Victoza®. Effects have included severe nausea and severe vomiting. In the event of overdosage, appropriate supportive treatment should be initiated according to the patient’s clinical signs and symptoms.

More detailed information is available upon request.

For information about Victoza® contact: Novo Nordisk Inc., 800 Scudders Mill Road, Plainsboro, NJ 08536, 1−877-484-2869 Date of Issue: April 16, 2013 Version: 6 Manufactured by: Novo Nordisk A/S, DK-2880 Bagsvaerd, Denmark Victoza® is covered by US Patent Nos. 6,268,343, 6,458,924, 7,235,627, 8,114,833 and other patents pending.

Victoza® Pen is covered by US Patent Nos. 6,004,297, RE 43,834, RE 41,956 and other patents pending. © 2010-2013 Novo Nordisk 0513-00015682-1 5/2013

11/19/13 8:09 PM

S:12.25”

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

CONTRAINDICATIONS: Do not use in patients with a personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Do not use in patients with a prior serious hypersensitivity reaction to Victoza® or to any of the product components.

WARNINGS AND PRECAUTIONS: Risk of Thyroid C-cell Tumors: Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors (adenomas and/or carcinomas) at clinically relevant exposures in both genders of rats and mice. Malignant thyroid C-cell carcinomas were detected in rats and mice. A statistically significant increase in cancer was observed in rats receiving liraglutide at 8-times clinical exposure compared to controls. It is unknown whether Victoza® will cause thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as the human relevance of liraglutide-induced rodent thyroid C-cell tumors could not be determined by clinical or nonclinical studies. In the clinical trials, there have been 6 reported cases of thyroid C-cell hyperplasia among Victoza®-treated patients and 2 cases in comparator-treated patients (1.3 vs. 1.0 cases per 1000 patient-years). One comparator-treated patient with MTC had pre-treatment serum calcitonin concentrations >1000 ng/L suggesting pre-existing disease.

All of these cases were diagnosed after thyroidectomy, which was prompted by abnormal results on routine, protocol-specified measurements of serum calcitonin. Five of the six Victoza®-treated patients had elevated calcitonin concentrations at baseline and throughout the trial. One Victoza® and one non-Victoza®-treated patient developed elevated calcitonin concentrations while on treatment. Calcitonin, a biological marker of MTC, was measured throughout the clinical development program. The serum calcitonin assay used in the Victoza® clinical trials had a lower limit of quantification (LLOQ) of 0.7 ng/L and the upper limit of the reference range was 5.0 ng/L for women and 8.4 ng/L for men. At Weeks 26 and 52 in the clinical trials, adjusted mean serum calcitonin concentrations were higher in Victoza®-treated patients compared to placebo-treated patients but not compared to patients receiving active comparator. At these timepoints, the adjusted mean serum calcitonin values (~1.0 ng/L) were just above the LLOQ with between-group differences in adjusted mean serum calcitonin values of approximately 0.1 ng/L or less. Among patients with pre-treatment serum calcitonin below the upper limit of the reference range, shifts to above the upper limit of the reference range which persisted in subsequent measurements occurred most frequently among patients treated with Victoza® 1.8 mg/day. In trials with on-treatment serum calcitonin measurements out to 5-6 months, 1.9% of patients treated with Victoza® 1.8 mg/day developed new and persistent calcitonin elevations above the upper limit of the reference range compared to 0.8-1.1% of patients treated with control medication or the 0.6 and 1.2 mg doses of Victoza®. In trials with on-treatment serum calcitonin measurements out to 12 months, 1.3% of patients treated with Victoza® 1.8 mg/day had new and persistent elevations of calcitonin from below or within the reference range to above the upper limit of the reference range, compared to 0.6%, 0% and 1.0% of patients treated with Victoza® 1.2 mg, placebo and active control, respectively. Otherwise, Victoza® did not produce consistent dose-dependent or time-dependent increases in serum calcitonin.

Patients with MTC usually have calcitonin values >50 ng/L. In Victoza® clinical trials, among patients with pre-treatment serum calcitonin <50 ng/L, one Victoza®-treated patient and no comparator-treated patients developed serum calcitonin >50 ng/L. The Victoza®-treated patient who developed serum calcitonin >50 ng/L had an elevated pre-treatment serum calcitonin of 10.7 ng/L that increased to 30.7 ng/L at Week 12 and 53.5 ng/L at the end of the 6-month trial. Follow-up serum calcitonin was 22.3 ng/L more than 2.5 years after the last dose of Victoza®. The largest increase in serum calcitonin in a comparator-treated patient was seen with glimepiride in a patient whose serum calcitonin increased from 19.3 ng/L at baseline to 44.8 ng/L at Week 65 and 38.1 ng/L at Week 104. Among patients who began with serum calcitonin <20 ng/L, calcitonin elevations to >20 ng/L occurred in 0.7% of Victoza®-treated patients, 0.3% of placebo-treated patients, and 0.5% of active-comparator-treated patients, with an incidence of 1.1% among patients treated with 1.8 mg/ day of Victoza®. The clinical significance of these findings is unknown. Counsel patients regarding the risk for MTC and the symptoms of thyroid tumors (e.g. a mass in the neck, dysphagia, dyspnea or persistent hoarseness). It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate the potential risk of MTC, and such monitoring may increase the risk of unnecessary procedures, due to low test specificity for serum calcitonin and a high background incidence of thyroid disease. Patients with thyroid nodules noted on physical examination or neck imaging obtained for other reasons should be referred to an endocrinologist for further evaluation. Although routine monitoring of serum calcitonin is of uncertain value in patients treated with Victoza®, if serum calcitonin is measured and found to be elevated, the patient should be referred to an endocrinologist for further evaluation. Pancreatitis: Based on spontaneous postmarketing reports, acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, has been observed in patients treated with Victoza®. After initiation of Victoza®, observe patients carefully for signs and symptoms of pancreatitis (including persistent severe abdominal pain, sometimes radiating to the back and which may or may not be accompanied by vomiting). If pancreatitis is suspected, Victoza® should promptly be discontinued and appropriate management should be initiated. If pancreatitis is confirmed, Victoza® should not be restarted. Consider antidiabetic therapies other than Victoza® in patients with a history of pancreatitis. In clinical trials of Victoza®, there have been 13 cases of pancreatitis among Victoza®-treated patients and 1 case in a comparator (glimepiride) treated patient (2.7 vs. 0.5 cases per 1000 patient-years). Nine of the 13 cases with Victoza® were reported as acute pancreatitis and four were reported as chronic pancreatitis. In one case in a Victoza®-treated patient, pancreatitis, with necrosis, was observed and led to death; however clinical causality could not be established.

Some patients had other risk factors for pancreatitis, such as a history of cholelithiasis or alcohol abuse. Use with Medications Known to Cause Hypoglycemia: Patients receiving Victoza® in combination with an insulin secretagogue (e.g., sulfonylurea) or insulin may have an increased risk of hypoglycemia. The risk of hypoglycemia may be lowered by a reduction in the dose of sulfonylurea (or other concomitantly administered insulin secretagogues) or insulin Renal Impairment: Victoza® has not been found to be directly nephrotoxic in animal studies or clinical trials. There have been postmarketing reports of acute renal failure and worsening of chronic renal failure, which may sometimes require hemodialysis in Victoza®-treated patients. Some of these events were reported in patients without known underlying renal disease. A majority of the reported events occurred in patients who had experienced nausea, vomiting, diarrhea, or dehydration.

Some of the reported events occurred in patients receiving one or more medications known to affect renal function or hydration status. Altered renal function has been reversed in many of the reported cases with supportive treatment and discontinuation of potentially causative agents, including Victoza®. Use caution when initiating or escalating doses of Victoza® in patients with renal impairment. Hypersensitivity Reactions: There have been postmarketing reports of serious hypersensitivity reactions (e.g., anaphylactic reactions and angioedema) in patients treated with Victoza®. If a hypersensitivity reaction occurs, the patient should discontinue Victoza® and other suspect medications and promptly seek medical advice. Angioedema has also been reported with other GLP-1 receptor agonists. Use caution in a patient with a history of angioedema with another GLP-1 receptor agonist because it is unknown whether such patients will be predisposed to angioedema with Victoza®. Macrovascular Outcomes: There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Victoza® or any other antidiabetic drug.

ADVERSE REACTIONS: Clinical Trials Experience: Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of Victoza® has been evaluated in 8 clinical trials: A double-blind 52-week monotherapy trial compared Victoza® 1.2 mg daily, Victoza® 1.8 mg daily, and glimepiride 8 mg daily; A double-blind 26 week add-on to metformin trial compared Victoza® 0.6 mg once-daily, Victoza® 1.2 mg once-daily, Victoza® 1.8

mg once-daily, placebo, and glimepiride 4 mg once-daily; A double-blind 26 week add-on to glimepiride trial compared Victoza® 0.6 mg daily, Victoza® 1.2 mg once-daily, Victoza® 1.8 mg once-daily, placebo, and rosiglitazone 4 mg once-daily; A 26 week add-on to metformin + glimepiride trial, compared double-blind Victoza® 1.8 mg once-daily, double-blind placebo, and open-label insulin glargine once-daily; A doubleblind 26-week add-on to metformin + rosiglitazone trial compared Victoza® 1.2 mg once-daily, Victoza® 1.8 mg once-daily and placebo; An open-label 26-week add-on to metformin and/or sulfonylurea trial compared Victoza® 1.8 mg once-daily and exenatide 10 mcg twice-daily; An open-label 26-week add-on to metformin trial compared Victoza® 1.2 mg once-daily, Victoza® 1.8 mg once-daily, and sitagliptin 100 mg once-daily; An open-label 26-week trial compared insulin detemir as add-on to Victoza® 1.8 mg + metformin to continued treatment with Victoza® + metformin alone. Withdrawals: The incidence of withdrawal due to adverse events was 7.8% for Victoza®-treated patients and 3.4% for comparator-treated patients in the five double-blind controlled trials of 26 weeks duration or longer. This difference was driven by withdrawals due to gastrointestinal adverse reactions, which occurred in 5.0% of Victoza®-treated patients and 0.5% of comparator-treated patients. In these five trials, the most common adverse reactions leading to withdrawal for Victoza®-treated patients were nausea (2.8% versus 0% for comparator) and vomiting (1.5% versus 0.1% for comparator). Withdrawal due to gastrointestinal adverse events mainly occurred during the first 2-3 months of the trials. Common adverse reactions: Tables 1, 2, 3 and 4 summarize common adverse reactions (hypoglycemia is discussed separately) reported in seven of the eight controlled trials of 26 weeks duration or longer. Most of these adverse reactions were gastrointestinal in nature. In the five double-blind clinical trials of 26 weeks duration or longer, gastrointestinal adverse reactions were reported in 41% of Victoza®-treated patients and were dose-related. Gastrointestinal adverse reactions occurred in 17% of comparator-treated patients. Common adverse reactions that occurred at a higher incidence among Victoza®-treated patients included nausea, vomiting, diarrhea, dyspepsia and constipation. In the five double-blind and three open-label clinical trials of 26 weeks duration or longer, the percentage of patients who reported nausea declined over time. In the five double-blind trials approximately 13% of Victoza®-treated patients and 2% of comparator-treated patients reported nausea during the first 2 weeks of treatment. In the 26-week open-label trial comparing Victoza® to exenatide, both in combination with metformin and/or sulfonylurea, gastrointestinal adverse reactions were reported at a similar incidence in the Victoza® and exenatide treatment groups (Table 3). In the 26-week open-label trial comparing Victoza® 1.2 mg, Victoza® 1.8 mg and sitagliptin 100 mg, all in combination with metformin, gastrointestinal adverse reactions were reported at a higher incidence with Victoza® than sitagliptin (Table 4). In the remaining 26-week trial, all patients received Victoza® 1.8 mg + metformin during a 12-week run-in period. During the run-in period, 167 patients (17% of enrolled total) withdrew from the trial: 76 (46% of withdrawals) of these patients doing so because of gastrointestinal adverse reactions and 15 (9% of withdrawals) doing so due to other adverse events. Only those patients who completed the run-in period with inadequate glycemic control were randomized to 26 weeks of add-on therapy with insulin detemir or continued, unchanged treatment with Victoza® 1.8 mg + metformin. During this randomized 26-week period, diarrhea was the only adverse reaction reported in ≥5% of patients treated with Victoza® 1.8 mg + metformin + insulin detemir (11.7%) and greater than in patients treated with Victoza® 1.8 mg and metformin alone (6.9%).

Table 1: Adverse reactions reported in ≥5% of Victoza®-treated patients in a 52-week monotherapy trial All Victoza® N = 497 Glimepiride N = 248 (%) (%) Adverse Reaction Nausea 28.4 8.5 Diarrhea 17.1 8.9 Vomiting 10.9 3.6 Constipation 9.9 4.8 Headache 9.1 9.3 Table 2: Adverse reactions reported in ≥5% of Victoza®-treated patients and occurring more frequently with Victoza® compared to placebo: 26-week combination therapy trials Add-on to Metformin Trial All Victoza® + Metformin Placebo + Metformin Glimepiride + Metformin N = 724 N = 121 N = 242 (%) (%) (%) Adverse Reaction Nausea 15.2 4.1 3.3 Diarrhea 10.9 4.1 3.7 Headache 9.0 6.6 9.5 Vomiting 6.5 0.8 0.4 Add-on to Glimepiride Trial ® Placebo + Glimepiride Rosiglitazone + All Victoza + Glimepiride N = 695 N = 114 Glimepiride N = 231 (%) (%) (%) Adverse Reaction Nausea 7.5 1.8 2.6 Diarrhea 7.2 1.8 2.2 Constipation 5.3 0.9 1.7 Dyspepsia 5.2 0.9 2.6 Add-on to Metformin + Glimepiride ® Victoza 1.8 + Metformin Placebo + Metformin + Glargine + Metformin + + Glimepiride N = 230 Glimepiride N = 114 Glimepiride N = 232 (%) (%) (%) Adverse Reaction Nausea 13.9 3.5 1.3 Diarrhea 10.0 5.3 1.3 Headache 9.6 7.9 5.6 Dyspepsia 6.5 0.9 1.7 Vomiting 6.5 3.5 0.4 Add-on to Metformin + Rosiglitazone ® Placebo + Metformin + Rosiglitazone All Victoza + Metformin + Rosiglitazone N = 355 N = 175 (%) (%) Adverse Reaction Nausea 34.6 8.6 Diarrhea 14.1 6.3 Vomiting 12.4 2.9 Headache 8.2 4.6 Constipation 5.1 1.1 Table 3: Adverse Reactions reported in ≥5% of Victoza®-treated patients in a 26-Week Open-Label Trial versus Exenatide Exenatide 10 mcg twice daily + Victoza® 1.8 mg once daily + metformin and/or sulfonylurea metformin and/or sulfonylurea N = 232 N = 235 (%) (%) Adverse Reaction Nausea 25.5 28.0 Diarrhea 12.3 12.1 Headache 8.9 10.3 Dyspepsia 8.9 4.7 Vomiting 6.0 9.9 Constipation 5.1 2.6 Table 4: Adverse Reactions in ≥5% of Victoza®-treated patients in a 26-Week Open-Label Trial versus Sitagliptin All Victoza® + metformin Sitagliptin 100 mg/day + N = 439 metformin N = 219 (%) (%) Adverse Reaction Nausea 23.9 4.6 Headache 10.3 10.0 Diarrhea 9.3 4.6 Vomiting 8.7 4.1 Immunogenicity: Consistent with the potentially immunogenic properties of protein and peptide pharmaceuticals, patients treated with Victoza® may develop anti-liraglutide antibodies. Approximately 50-70% of Victoza®-treated patients in the five double-blind clinical trials of 26 weeks duration or longer were tested for the presence of anti-liraglutide antibodies at the end of treatment. Low titers (concentrations not requiring dilution of serum) of anti-liraglutide antibodies were detected in 8.6% of these Victoza®-treated patients.

Sampling was not performed uniformly across all patients in the clinical trials, and this may have resulted in an underestimate of the actual percentage of patients who developed antibodies. Cross-reacting antiliraglutide antibodies to native glucagon-like peptide-1 (GLP-1) occurred in 6.9% of the Victoza®-treated patients in the double-blind 52-week monotherapy trial and in 4.8% of the Victoza®-treated patients in the double-blind 26-week add-on combination therapy trials. These cross-reacting antibodies were not tested

®

Victoza —a force for change in type 2 diabetes.

A change with powerful, long-lasting benefits

Reductions up to -1.1%a

Weight loss up to 5.5 lba,b

Low rate of hypoglycemiac

1.8 mg dose when used alone for 52 weeks.

Victoza® is not indicated for the management of obesity. Weight change was a secondary end point in clinical trials. c In the 8 clinical trials of at least 26 weeks’ duration, hypoglycemia requiring the assistance of another person for treatment occurred in 11 Victoza®-treated patients. a

b

A 52-week, double-blind, double-dummy, active-controlled, parallel-group, multicenter study. Patients with type 2 diabetes (N=745) were randomized to receive once-daily Victoza® 1.2 mg (n=251), Victoza® 1.8 mg (n=246), or glimepiride 8 mg (n=248). The primary outcome was change in A1C after 52 weeks.

The change begins at VictozaPro.com.

Indications and Usage

Victoza (liraglutide [rDNA origin] injection) is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Because of the uncertain relevance of the rodent thyroid C-cell tumor findings to humans, prescribe Victoza® only to patients for whom the potential benefits are considered to outweigh the potential risk. Victoza® is not recommended as firstline therapy for patients who have inadequate glycemic control on diet and exercise.

Based on spontaneous postmarketing reports, acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victoza®. Victoza® has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for pancreatitis while using Victoza®. Other antidiabetic therapies should be considered in patients with a history of pancreatitis.

Victoza® is not a substitute for insulin. Victoza® should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis, as it would not be effective in these settings.

Victoza® has not been studied in combination with prandial insulin. ®

Important Safety Information

Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice. It is unknown whether Victoza® causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as human relevance could not be ruled out by clinical or nonclinical studies.

Victoza® is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Based on the findings in rodents, monitoring with serum calcitonin or thyroid ultrasound was performed during clinical trials, but this may have increased the number of unnecessary thyroid surgeries. It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate human risk of thyroid C-cell tumors. Patients should be counseled regarding the risk and symptoms of thyroid tumors.

Do not use in patients with a prior serious hypersensitivity reaction to Victoza® or to any of the product components.

Postmarketing reports, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis. Discontinue promptly if pancreatitis is suspected. Do not restart if Victoza® is a registered trademark of Novo Nordisk A/S. © 2013 Novo Nordisk All rights reserved.

pancreatitis is confirmed. Consider other antidiabetic therapies in patients with a history of pancreatitis.

When Victoza® is used with an insulin secretagogue (e.g. a sulfonylurea) or insulin serious hypoglycemia can occur. Consider lowering the dose of the insulin secretagogue or insulin to reduce the risk of hypoglycemia.

Renal impairment has been reported postmarketing, usually in association with nausea, vomiting, diarrhea, or dehydration which may sometimes require hemodialysis. Use caution when initiating or escalating doses of Victoza® in patients with renal impairment.

Serious hypersensitivity reactions (e.g. anaphylaxis and angioedema) have been reported during postmarketing use of Victoza®. If symptoms of hypersensitivity reactions occur, patients must stop taking Victoza® and seek medical advice promptly.

There have been no studies establishing conclusive evidence of macrovascular risk reduction with Victoza® or any other antidiabetic drug.

The most common adverse reactions, reported in ≥5% of patients treated with Victoza® and more commonly than in patients treated with placebo, are headache, nausea, diarrhea, dyspepsia, constipation and anti-liraglutide antibody formation.

Immunogenicity-related events, including urticaria, were more common among Victoza®-treated patients (0.8%) than among comparator-treated patients (0.4%) in clinical trials.

Victoza® has not been studied in type 2 diabetes patients below 18 years of age and is not recommended for use in pediatric patients.

There is limited data in patients with renal or hepatic impairment.

In a 52-week monotherapy study (n=745) with a 52-week extension, the adverse reactions reported in ≥ 5% of patients treated with Victoza® 1.8 mg, Victoza® 1.2 mg, or glimepiride were constipation (11.8%, 8.4%, and 4.8%), diarrhea (19.5%, 17.5%, and 9.3%), flatulence (5.3%, 1.6%, and 2.0%), nausea (30.5%, 28.7%, and 8.5%), vomiting (10.2%, 13.1%, and 4.0%), fatigue (5.3%, 3.2%, and 3.6%), bronchitis (3.7%, 6.0%, and 4.4%), influenza (11.0%, 9.2%, and 8.5%), nasopharyngitis (6.5%, 9.2%, and 7.3%), sinusitis (7.3%, 8.4%, and 7.3%), upper respiratory tract infection (13.4%, 14.3%, and 8.9%), urinary tract infection (6.1%, 10.4%, and 5.2%), arthralgia (2.4%, 4.4%, and 6.0%), back pain (7.3%, 7.2%, and 6.9%), pain in extremity (6.1%, 3.6%, and 3.2%), dizziness (7.7%, 5.2%, and 5.2%), headache (7.3%, 11.2%, and 9.3%), depression (5.7%, 3.2%, and 2.0%), cough (5.7%, 2.0%, and 4.4%), and hypertension (4.5%, 5.6%, and 6.9%).

Please see brief summary of Prescribing Information on adjacent page.

1013-00018617-1

December 2013