Minnesota Health care News October 2014 by Minnesota Physician Publishing

October 2014 â&#x20AC;˘ Volume 12 Number 10

Migraine J. D. Bartleson, MD

Indoor tanning Sherri Long, MD

Colorectal cancer Irshad H. Jafri, MD

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October 2014 • Volume 12 Number 10

4 7 8

18 20

News

Calendar

People

10 12 14 16

Perspective Melanie Ferris, MPH Wilder Research

10 QUESTIONS Rhonda Degelau, JD Minnesota Association of Conmmunity Health Centers

Allergy

at allergy and other C indoor sensitivities By Gary D. Berman, MD

Digestive Health

Infectious disease

Antibiotics in food animals

MINNESOTA HEALTH CARE ROUNDTABLE

By Peter Davies, PhD

24 26

Legislation

42nd Session

If your health data is stolen ... By Morgan Vanderburg, JD

Insurance

MNsure report card By Scott Leitz

Policy

Indoor tanning By S herri Long, MD, and Anudeep Rahill, MD

Neurology

Migraine

By J. D. Bartleson, MD

Colorectal cancer By Irshad H. Jafri, MD

Rehabilitation

Cognitive changes and cancer treatment By Nancy A.Hutchison, MD

Background and focus: As tools and techniques for treating chronic illness have expanded, so have methods and mechanisms of provider reimbursement. More people now have access to care, and with this comes a heightened awareness of the impact of social determinants on health. The transition to rewarding physicians for maintaining a healthier population is slow but the promise is clear. Treating chronic illness remains an area of high-volume use and, improperly managed, quickly becomes an area of high cost. Objectives: We will evaluate changes that health care reform is bringing to chronic illness care. We will examine new community-based partnerships that are forming to address prevention, compliance, and better identification of risk. We will look at specific diseases and how workplace solutions, insurance companies, clinics, hospitals, long-term care facilities, and home care providers are working together to lower costs and improve outcomes.

Panelists include: • Kari Benson, MPA, Minnesota Board on Aging • Durand Burns, MD, Minneapolis Heart Institute Foundation • L. Read Sulik, MD, PrairieCare Please send me ____ tickets at $95.00 per ticket. Mail orders to Minnesota Physician Publishing, Inc., 2812 East 26th Street, Minneapolis, MN 55406. Tickets may also be ordered by phone 612.728.8600 or fax 612.728.8601. Publisher Mike Starnes | mstarnes@mppub.com Senior Editor Janet Cass | jcass@mppub.com Editor Lisa McGowan | lmcgowan@mppub.com Art Director Alice Savitski | asavitski@mppub.com

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Minnesota Heath Care News is published once a month by Minnesota Physician Publishing, Inc. Our address is 2812 East 26th Street, Minneapolis, MN 55406; phone 612.728.8600; fax 612.728.8601; email mpp@ mppub.com. We welcome the submission of manuscripts and letters for possible publication. All views and opinions expressed by authors of published articles are solely those of the authors and do not necessarily represent or express the views of Minnesota Physician Publishing, Inc., or this publication. The contents herein are believed accurate but are not intended to replace medical, legal, tax, business, or other professional advice and counsel. No part of this publication may be reprinted or reproduced without written permission of the publisher. Annual subscriptions (12 copies) are $36.00/ Individual copies are $4.00.

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Top MNsure Provider To Leave Health Exchange PreferredOne has announced that it will not sell health insurance plans on MNsure for 2015. “Our MNsure individual product membership is only a small percentage of the entire PreferredOne enrollment but is taking a significant amount of our resources to support administratively,” the health insurance company said in a statement. “We feel continuing on MNsure was not sustainable and believe this is an important step to best serve all PreferredOne members.” The insurer had the lowest premiums on the state health exchange. It also had more customers through MNsure last year than any other insurer; nearly six in 10 who purchased a plan through MNsure chose PreferredOne. In the statement, officials said that MNsure’s administrative glitches and higher than anticipated costs drove the

business decision. “A year ago, PreferredOne chose to offer its coverage at rates well below other plans on MNsure, and gained significant market share from doing so,” said Gov. Mark Dayton. “The question now is whether PreferredOne can afford to continue to offer such low rates. If not, its continued participation in MNsure would distort the exchange’s average rates, which last year were the lowest in the nation.” Customers who are enrolled in PreferredOne plans through MNsure will be able to continue their coverage in 2015, but PreferredOne will be able to increase premium prices. In addition, those who qualify for tax credits can only access them if they purchase a plan through MNsure. “Simply put, both organizations understand that MNsure is still an evolving partnership,” said a statement released by MNsure CEO Scott Leitz and PreferredOne CEO Marcus Merz. “MNsure and PreferredOne will work closely to

Minnesota Health care news October 2014

minimize impact to current enrollees in a PreferredOne Plan through MNsure.”

Melrose Center Opens New Location In St. Paul Park Nicollet opened a new Melrose Center outpatient eating disorder treatment facility in St. Paul on Sept. 15. This is the third Melrose Center location in the metro area. The other centers are located in St. Louis Park and Maple Grove. “We wanted to better serve the St. Paul and East Side community,” said Heather Gallivan, clinical director at Park Nicollet. “We do have a large patient population that we currently serve there, and it’s sometimes a challenge for them to get to St. Louis Park.” However, patients who need a more intensive level of care will be referred to the St. Louis Park location, which offers inpatient services.

“Eating disorders are a serious mental illness that affects more than 24 million Americans,” said Babette Apland, vice president of behavioral health sciences at Park Nicollet. “Expanding the care Melrose Center [offers] provides better access for our patients, so they can get the treatment they need to be healthy and thrive.”

Personal Care Provider Sentenced For Medicaid Fraud A jury has found Charles Kwadzo Sokpa-Anku, guilty on three counts of Medicaid fraud. Ramsey District County Court sentenced him to pay $20,791 in restitution, serve 30 days in the Ramsey County Workhouse, and forfeit any employment where he could have access to Medicaid funds. He also must pay $300 in fines and serve five years of probation after he is released from the county jail. Investigators completed an

on-site review of Sokpa-Anku’s agency, Carelinks Home Care, Inc., after receiving a fraud report from a third-party witness. They found that Carelinks had billed for more than 24 hours of services in a day by a qualified professional in more than one instance. Because Carelinks had one qualified professional on staff during those times, it was impossible for the agency to legitimately bill for more than 24 hours in one day. The investigation also showed that Carelinks regularly submitted bills for services that had no supporting documentation. DHS officials ultimately determined that Carelinks had overbilled the state a total of $23,729.67 for services it supposedly provided in 2009 and 2010. According to Jerry Kerber, DHS inspector general, this represents a heightened effort to crack down on cases of fraud against state programs that use public funding. DHS also has started investigating child care providers who commit fraud by falsely billing the state for child-care assistance funds. “When providers fail to perform the job they are paid to do, they not only fail the program participants, but they violate the public trust they promised to respect,” said Kerber. “The punishment imposed on Mr. Sokpa-Anku should put everyone on notice that DHS is serious about pursuing providers and recipients who commit fraud against our publicly funded programs.” According to state data, DHS’ financial fraud department conducted 356 investigations in 2013, 38 of which it referred for prosecution. Those numbers increased from 2012, when it conducted 254 investigations and referred 30 for prosecution.

Cardiac Life-Saving Devices Will Be Distributed Statewide Automated chest compression devices will be placed in ambulances and hospitals across Minnesota at no cost to providers, according to the Minnesota Department of Health. The initiative is being funded with a $4 million grant from the

Leona M. and Harry B. Helmsley Charitable Trust. The project will include training on how to use the device, called Physio-Control LUCAS 2 Chest Compression System. It was made available in the metro area about five years ago, but a need in Grea-ter Minnesota was identified, as 80 percent of ambulances and hospitals lack access to the device.

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“This is part of our effort to ensure quality health care for all Minnesotans,” said Minnesota Commissioner of Health Ed Ehlinger, MD. “Our goal is to improve cardiac arrest survival rates by installing these devices in every ambulance and hospital in the state.” The survival rate from cardiac arrest is 14 percent in Minnesota, while the national rate is less than 5 percent.

State Has Lowest Rate of Underage Tobacco Sales Minnesota reached a 99 percent compliance rate with state and federal laws that prohibit tobacco sales to people under 18 years of age throughout the 2013 federal fiscal year, according to the Minnesota Department of Health (MDH). Minnesota tied for the lowest retailer sale violation rate of all the states, at 1 percent; Nevada also had a rate of 1 percent. Maryland and Ohio had the highest rates of retailer sale violations, at 16.8 percent and 16.6 percent respectively.

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“Curtailing illegal sales of tobacco is a vital step to promoting healthier kids and healthier communities because the smoking habit often starts at an early age,” said Human Services Commissioner Lucinda Jesson. “Minnesota’s high compliance rate shows that retailers are recognizing their responsibility to help keep tobacco out of the hands of people who are underage.” According to MDH, this is the seventh straight year that Minnesota’s compliance rate has been at least 90 percent.

News to page 6 October 2014 Minnesota Health care news

News from page 5

Hospitalization Rates Increase in Midwest For Opioid Overdoses The rate of adult inpatient hospitalizations involving prescription opioid overuse in the U.S. increased more than 150 percent between 1993 and 2012, according to a new report from the Healthcare Cost and Utilization Project (HCUP). The report only included instances of prescription opioid overuse; those that involved illegal drug use were excluded. In 1993, the national rate of opioid-related hospital stays was 116.7 per 100,000. By 2012, that reached a rate of 295.6 per 100,000, with a total of 709,500 incidents of hospitalization from opioid overuse in the U.S. The largest rates of increase from 1993 to 2012 were found among people living in the Midwest, women, and people 85 years of age and older.

The Midwest had a total of 163,700 total hospitalizations from opioid overdoses in 2012. While that number is the second-lowest of the regional subgroups, the Midwest’s average increase rate is 9.1—a much higher rate than other regions. The Northeast region had a considerably higher rate than other regions in 1993, but its average increase rate has been much lower than other regions. There is no longer a blatant disparity between regions in 2012 rates. Rates for hospitalization from opioid overdoses were nearly equal for men and women in 2012, compared with 1993, when men had a staggeringly higher rate. Rates for age groups were far more similar in 2012 than they were in 1993, when the rate for people ages 25 to 44 was more than double that of any other age subgroup. From 1993 to 2012, that age group’s rate increased an average of 2.7 percent each year. Because the rate for adults aged 45 and older has increased an average of 9 percent each year, the age

groups are almost equally as likely to be hospitalized due to an opioid overdose.

Jeanette Schwartz, RN, clinical director of the Maternity Care Center at Woodwinds Health Campus.

In 1993, Medicaid had the largest proportion of stays involving opioid overuse. However, Medicare had the largest annual increase over time, and by 2012, Medicaid and Medicare were each billed for about one-third of all opioidrelated hospital stays.

The certification means that HealthEast utilizes skin-to-skin contact with mothers and babies after birth; offers patients breastfeeding support and education; and allows rooming-in, where babies stay in the mother’s room to learn feeding cues and to bond.

HealthEast Hospitals Certified “Baby-Friendly” HealthEast’s St. Joseph’s, St. John’s, and Woodwinds hospitals have been nationally certified as Baby-Friendly birth facilities. Only 7.6 percent of U.S. hospitals have earned this certification and HealthEast is the only health care system in Minnesota to receive it. “This special recognition ensures our patients along with their babies will experience the best maternity care practices at all of our HealthEast hospitals,” said

HealthEast spent two years earning the certification, which required 20 hours of education for all nurses as well as a minimum of three training hours for each of its 400 providers, according to Carol Busman, clinical nurse specialist for the HealthEast Maternity Care Center. The designation is given by the Baby-Friendly Hospital Initiative, a global program sponsored by the World Health Organization and the United Nations Children’s Fund. Correction: The example of a 1 percent reduction in HbA1c on page 23 of the September 2014 issue should have been 9.0 percent.

Choose well New choices in health care are here. Introducing UCare ChoicesSM, affordable new health plans from a leader in Minnesota health care, with coverage for young adults, families, empty nesters and everyone in between. Find out more at UCareChoices.org, and look for us on the MNsure health insurance marketplace and choose UCare Choices.

2 6 UC610_UCare_Choices_HCN_Ad_8.5x5.25.indd Minnesota Health care news

October 2014

9/23/14 4:46 PM

People

Christopher Alcala, MD

Christopher Alcala, MD, board-eligible in orthopedic surgery, has joined Twin Cities Spine Center (TCSC), Minneapolis. He completed medical school and a residency in orthopedic surgery at the University of Puerto Rico School of Medicine, San Juan, and a fellowship in spinal surgery at TCSC.

Qing-Min Chen, MD, board-eligible in orthopedic surgery, has joined Essentia Health St. Mary’s– Detroit Lakes Clinic. Chen graduated from Wayne State University School of Medicine, Detroit, and completed an orthopedic surgery residency at University of Colorado Hospital, Aurora. Joining Essentia Health–Duluth Clinic Qing-Min Chen, MD is Nahi Kiblawi, MD, board-certified in internal medicine. He earned a medical degree from the University of Toledo Medical Center, Ohio, and completed an internal medicine residency and a fellowship in endocrinology, diabetes, and metabolism at the University of Minnesota Medical School.

Love

Dionne Hart, MD, board-certified in psychiatry, has been named Psychiatrist of the Year for 2014 by the Minnesota Psychiatric Society. She received the award for her efforts in psychiatric education and ending health care disparities, and for excellence in patient care. She graduated from Rush Medical College, Chicago, Dionne Hart, MD and completed an adult psychiatry residency at Mayo Clinic. Hart provides advocacy services through Care From The Hart, Rochester. Ameer Khowaja, MD, board-certified in internal medicine, has joined the division of diabetes and endocrinology at Hennepin County Medical Center (HCMC), Minneapolis. He graduated from Aga Khan University in Karachi, Pakistan; completed an internal medicine Ameer Khowaja, MD residency at HCMC; and served a fellowship in diabetes, endocrinology, and metabolism at the University of Minnesota. Rachel Sandler, MD, MPH, Rachel Sandler, board-certified in internal medicine, has joined MD, MPH HCMC to provide primary care in several clinics. She earned a medical degree from the University of Iowa Carver College of Medicine, Iowa City, and served an internal medicine residency at Tulane University, New Orleans. Terri Peterson, MD, board-certified in physical medicine and rehabilitation, has joined Courage Kenny Rehabilitation Institute, Minneapolis. Peterson earned a medical degree from the University of Minnesota and served a physical medicine and rehabilitation residency at Mayo Clinic.

Pediatric Orthopaedics Appointments: 612.596.6105 www.facebook.com/ShrinersTWI

Care Beyond Cost.

Terri Peterson, MD October 2014 Minnesota Health care news

Perspective

Want to be healthier? Get to know your neighbors.

hat do you see when you take a walk find out about on our own (Journal of Epidein your neighborhood? Are there parks miology and Community Health 2006). where children can play, or are there • We have a support network when times are neglected, empty lots? Are there well-marked tough. Although we seek medical care when crosswalks, or busy streets we are sick, we rely on the where vehicles don’t give help and support of others Higher levels of trust pedestrians the right of to help us regain our health. way? Countless studies Family, friends, and neighbetween neighbors are have demonstrated that bors may become informal associated with lower the conditions of the caregivers by bringing us places where we live, meals, mowing our lawn, mortality work, age, learn, and taking us to doctor appointplay influence our health. ments, or helping us run It is easier to be active in neighborhoods that are errands when our health doesn’t allow us to safe and have well-maintained sidewalks and do so independently. paths, and to eat healthfully when fresh foods are • We encourage (or discourage) one another affordable and readily available. However, it isn’t to be healthy. Groups set informal rules, or just the physical features of our neighborhoods “social norms,” that influence behavior. Early that shape our health. It is also the relationships in life, these norms are set by parents and we have with our neighbors and how we work family members. As we get older, we create together to make our communities better places to new habits with groups of friends, neighbors, live. and colleagues that influence the choices we Benefits of social networks make. For example, it may be easier to eat Regardless of where we live, as individuals, we healthy foods when going out to eat by going benefit by having a strong social network of peowith friends who tend to order salads. ple who care about us, support us, and help us Working together to create healthy connect to resources. These connections to others neighborhoods can improve our health in several ways: Many of us use technology to build and maintain • We feel better. Studies show that individuals relationships with others. However, it is important who feel more connected to others have lower to also feel connected to the community where we blood pressure, better immune responses, and live. Many studies have shown that people who lower levels of stress hormones, all of which live in neighborhoods where residents know, trust, help prevent chronic disease (Psychological and help one an-other rate their overall health Bulletin 1996). In addition, by keeping stress at higher than those who live in neighborhoods bay, we may be more likely to get adequate where people feel disconnected from one anothsleep, follow a healthy diet, and avoid overuser and lack a sense of belonging. In fact, higher ing alcohol and tobacco. levels of trust between neighbors are associated • We learn about resources that support with lower mortality rates (Social Science and our health. Many of our conversations with Medicine 2003). friends, co-workers, and neighbors turn into Residents of close-knit communities also benconversations about health. By simply mention- efit when neighbors work together to discuss ing that you need to pick up glucose testing problems, identify solutions, and advocate for strips for your mother at the pharmacy after changes that improve the community conditions work, co-workers may tell you about a recent that influence the health of all residents. Together, newspaper article about diabetes, recommend neighbors can turn an empty lot into a thriving a health care provider, share a sugar-free community garden or work with city officials to dessert recipe, or tell you about a new exercise add marked crosswalks and signs at intersections group in the community. These informal conthat children are likely to use to walk to school. By versations help us learn about resources that building relationships with our neighbors, we not can help us improve or maintain our health. only reap the individual benefits that come with When we have a broad and diverse social having a strong social network, but we can also network, we are more likely to learn about work together to make our communities healthier information and resources that we may not places to live.

rates.

Melanie Ferris, MPH Wilder Research Melanie Ferris, MPH, is a research scientist at Wilder Research (www. wilderresearch.org). Much of her work focuses on evaluating efforts aimed to reduce health inequities and improve children’s mental health outcomes. Wilder Research is part of the Amherst H. Wilder Foundation, located in St. Paul. Working with organizations at the local, state, and national level, Wilder Research conducts research and evaluation to strengthen communities and the lives of families and children.

Minnesota Health care news October 2014

Alcohol is more harmful to an unborn baby than cocaine, marijuana or heroin. Drinking during pregnancy can cause Fetal Alcohol Spectrum Disorders (FASD) which permanently harm the way your baby learns and behaves.

- ZERO ALCOHOL FOR NINE MONTHS.

10 Questions

Community health centers Rhonda Degelau, JD Ms. Degelau has served as executive director of the Minnesota Association of Community Health Centers for the past 19 years.

What is a community health center (CHC)? It is a nonprofit primary care clinic serving a community designated “medically underserved” under federal law. It provides medical, dental, mental health, and supportive services, primarily to uninsured patients or those on Medical Assistance. The care model emphasizes care coordination, teambased care, and supportive services that work for the patient. A patient-majority board of directors oversees the health center’s operations, ensuring its responsiveness to the community’s health care needs. Today, 1,200 community health centers serve 22 million people in the U.S. Please tell us about the Minnesota Association of Community Health Centers (MNACHC). Formed in 1980, MNACHC has 17 community health centers, with 70 clinical sites serving a total of 183,000 patients. MNACHC serves health centers as a resource on federal regulatory and funding issues, assists communities interested in establishing a community health center, and does a great deal of health-care policy analysis and government relations work on behalf of the health centers. We also seek out partnerships and other resources aimed at increasing access to care and improving quality of care, and provide educational opportunities for health center staff. How is federal health care reform affecting the work you do? The Affordable Care Act provides a great

opportunity for many of our uninsured patients to get health insurance coverage, either through Medicaid expansion or through commercial plans offered under MNsure. Our health centers work hard to reach existing patients and others in their communities, to help them enroll in Medical Assistance or purchase private coverage. The movement toward “accountable care” provides community health centers with opportunities to demonstrate the value and quality of their services in new ways. We have always embraced the goals of the Triple Aim: improving the patient experience, improving population health, and reducing per capita cost of care. All of our health centers are either designated, or in the process of becoming, patient-centered medical homes through Minnesota’s “Health Care Home” initiative or NCQA. NCQA is the National Committee for Quality Assurance, a private nonprofit organization founded in 1990 and dedicated to improving health care quality. MNACHC also is moving into Medicaid delivery system and payment reform pilot projects. What can you tell us about your patients? More than 70 percent of our patients live below federal poverty guidelines (FPG); 25 percent live just over FPG. Thirty-seven percent are uninsured; 42 percent are on Medical Assistance or MinnesotaCare. Only 13 percent are privately insured; 8 percent are on Medicare. Our patients are ethnically diverse. Two-thirds are African Americans, Latinos, Asians, or Native Americans; one-third are Caucasians. How do patients access your services? Minnesota’s community health centers welcome all patients, whether insured or not. For those who are uninsured, health centers provide services on a sliding fee scale based on income and family size. MNACHC’s website, www.mnachc.org, includes maps with the locations of all of our facilities. What can you share about how your services are funded? Community health centers bill for and collect payments from Medicare, Medicaid, and private plans for patients who have coverage. They also receive annual federal grants to

help defray the costs of caring for the uninsured, although the grants cover less than 50 percent of those costs. Patients contribute on a sliding fee scale, as they are able. Health centers also pursue local public/private grants to fill funding gaps.

What types of health concerns do you see the most? Like any primary care clinic, our health centers see patients of all ages. We manage a lot of chronic disease (mostly asthma, diabetes, and cardiovascular disease) and provide a lot of preventive services. There is also great demand for dental services. Because we see a high volume of immigrant populations, we may see more hepatitis and HIV than some providers. Many immigrant patients from war-affected countries also have a high level of post-traumatic stress disorder.

Minnesota’s community health centers welcome all patients, whether insured or not.

How would you say the term “safety net” applies to your work? Community health centers care for those who fall outside the mainstream, in terms of health insurance coverage and income level. We strive to make health care more accessible by providing interpreter services for non-English speaking patients, transportation support, and other services that help people reach us. Even if the Affordable Care Act makes significant inroads to reducing the numbers of uninsured, we still will need a safety net of health care providers whose stated mission is to care for low-income populations. Having an insurance card does not solve all problems. It certainly doesn’t change someone’s income status. The challenges of living in poverty still will exist and affect someone’s opportunities to achieve optimal health. Even with increased insurance coverage, people will fall through the cracks: the homeless, undocumented, and those who voluntarily remain uninsured. It is in our best interest, both from a public health standpoint and from a cost containment standpoint, to provide timely and necessary preventive and primary health care services to all who are in need. It’s simply the right thing to do.

How does mental health factor into your patients’ physical health concerns? Since our patients have a high poverty rate, the stress of that often shows up as anxiety and depression, which compound our efforts to help our patients manage their medical conditions. What would you like the public to know about community health centers? Community health centers are for everyone! They care for people from all walks of life. They focus on meeting the patient’s needs, whether it’s medical care, dental care, or mental health care. They strive to provide care that is sensitive to and respects the patient’s circumstances. The doctors, nurses, dentists, counselors, and other clinic staff truly care about the well-being of the communities they serve.

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October 2014 Minnesota Health care news

A l l e rgy

Cat allergy and other indoor sensitivities Management tips and potential new treatment By Gary D. Berman, MD

s cold weather approaches and people start spending more time indoors, those who are allergic to cat hair and other indoor allergens may notice an increase in the common allergy symptoms collectively called rhinoconjunctivitis: sneezing; runny, itchy nose; and red, itchy eyes.

Symptoms reduce a susceptible person’s quality of life, causing problems with social activities and interfering with performance at work and school. Thus, if spending more time indoors includes being in closer proximity to a cat, this poses a vexing problem for someone allergic to cats.

Center for Sexual Health Compassionate patient care in sexual health for individuals, couples and families of all backgrounds and ages. Patient assessment and treatment is available in the areas of relationship and sexual problems therapy, compulsive sexual behavior, sexual offending, transgender health services and sexual abuse. HIV counseling, as well as psychological treatment for people living with HIV/AIDS. Our physicians provide care for many medical conditions including (but not limited to) the following: • Compulsive sexual behavior

• Premature ejaculation

• Emotional pain or physical pain with sexual activity

• Sexual abuse

• Erectile dysfunction (ED)

• Sexual desire discrepancies

• Gender identity disorder

• Sexual harassment

• Gender exploration for children and adolescents

• Sexual offending

• Hepatitis

• Sexual orientation

• Mental health

• Sexual problems

• Orgasm problems

• Transgender health Treatments

Our professional staff members have received specialized training in human sexuality, psychology, psychiatry, and medicine and are credentialed through state and national organizations.

612-626-4702 | www.umphysicians.org 12

Minnesota Health care news October 2014

Allergy to cats affects 10 percent to 15 percent of the population, or about 26 million sufferers in the United States, according to 2011 data from the World Allergy Organization. Although the advice that people with pet allergies should not live with pets is obvious, many patients love their pets and are looking for alternatives to that advice. Before we explore them, here’s some background information. Cause The major cause of cat allergy is one member of a group of proteins found in cat saliva, urine, and dander (“dander” refers to flakes of dead skin). Exposure to this protein or related proteins initiates a series of reactions in susceptible people that results in rhinoconjunctivitis and can include hives, which are red, itchy welts on the skin. In cat-allergic patients, welts commonly occur around the neck and on the upper chest, although they typically occur elsewhere on the body in response to other allergens. Complications If allergies are untreated or poorly controlled, people can develop sinusitis, asthma, or both. Sinusitis, or sinus infection, can require treatment with antibiotics for as long as 12 weeks. If symptoms persist, it may be necessary to consult a surgeon that specializes in ear, nose, and throat problems to evaluate the possibility of surgically treating the infection.

sure to cats. If living with a cat is unavoidable, bathe the cat frequently, keep the cat out of the bedroom, and use HEPA filters in the bedroom. This has been demonstrated to reduce the amount of cat allergen in the living space where the person spends the most time. Filter units are sized to the square footage of a room, so be sure to use a filter that is the correct size. A HEPA filter also may help if someone with asthma is allergic to a different furry animal, such as a dog. And, there are HEPA filters that can be placed in a home’s heating and cooling system to reduce allergens throughout the home.

People with cat allergy should avoid exposure to cats.

It’s important to note that some indoor allergens, such as dust mites, are not reduced by the use of a HEPA filter. This is due to the fact that such particles are comparatively heavy and sticky compared with cat allergens, and hence are not sufficiently airborne to be removed by a HEPA filter. Some patients may choose to purchase certain breeds of cats in the hope that a given breed would cause fewer symptoms. Although certain cat breeders may use the term “hypo-allergenic” or “hairless” in marketing their cats, all breeds of cats produce the proteins that can cause allergies. However, female cats and neutered males produce fewer of these proteins. Medications may help. Those that can be purchased without Cat allergy and other indoor sensitivities to page 34

Asthma causes a person’s airways to narrow, making it difficult to breathe. This leads to a feeling of tightness in the chest, wheezing, shortness of breath, and coughing. As a result, the person may need inhalers to improve the ability to breathe. Two different kinds of inhalers may be needed if symptoms persist. One inhaler type, known as “controller medication,” is used daily to prevent symptoms. The other type is known as a “rescue” inhaler, used when the asthmatic person experiences an urgent need to stop symptoms. This type of inhaler typically stops symptoms as soon as it’s used. However, anyone having trouble breathing due to an unknown cause should seek immediate assistance in an emergency room. Diagnosis How does a patient know that he or she is allergic to cats? In most cases it is obvious. A self-test that some people undertake is to avoid their pet for one to two weeks by going on vacation to see if their allergy symptoms improve. If symptoms improve during vacation and worsen upon returning home, it’s likely that the cat is the cause. It is, however, always a good idea to consult an allergist for proper evaluation and skin testing to accurately identify the allergen culprit(s). There may, in fact, be several allergens to which someone reacts, and identifying all of them enables the affected person to know what to avoid, which can diminish symptoms dramatically. Current treatment Lifestyle modification. People with cat allergy should avoid expo-

Minnesota Optometric Association

Doctors on the frontline of eye and vision care Did you know? • 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 http://Minnesota.aoa.org October 2014 Minnesota Health care news

D i g e s t i v e h e a lt h

Colorectal cancer A preventable disease By Irshad H. Jafri, MD

olorectal cancer (cancer involving the intestines from the appendix to the rectum) is very common. Worldwide, about 850,000 people develop this disease and 500,000 die of it each year. In this country, colorectal cancer (CRC) is the thirdmost common cancer in men and women. There are approximately 150,000 people newly diagnosed with it every year in the U.S., and about 50,000 deaths caused by it annually. It’s estimated by the American College of Gastroenterology that the majority of these deaths could be avoided if people obtained screening tests. Autism Day Treatment (ages 2–6)

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Minnesota Health care news October 2014

Risk factors CRC does not discriminate by gender or ethnicity. It affects men and women and all ethnicities equally, although the incidence of it rises with increasing age. One risk factor for this disease is a high-fat diet that contains few fruits and vegetables. Risk also is increased by inactivity, obesity, smoking, and alcohol use. All of these factors relate to lifestyle, which makes CRC a very preventable condition. In fact, more than two-thirds of colorectal cancer is nonhereditary. In only about 20 percent of cases is there a clear-cut family history that predisposes someone to developing CRC. All instances of this cancer are thought to start as a polyp, which is a small, usually benign growth of tissue on the lining of the digestive tract. If a polyp is detected and removed in its early stage, the possibility of it becoming a cancer is entirely removed. This, in addition, to lifestyle risk, is another reason why colorectal cancer is an extremely preventable condition. Diagnosis If a diagnosis of CRC is made, the outcome depends entirely on how advanced the cancer is at the time it is detected. In other words, the earlier the cancer is found, the more curable it is. The ideal course of action is to detect colon polyps when they are still premalignant and remove them, thereby eliminating the risk of their developing into colorectal cancer—which brings us to colorectal cancer screening options. CRC screening is recommended for all individuals starting at age 50. For those who have a family history of colorectal cancer or who have had precancerous polyps themselves, there is an increased risk of developing cancer. Consequently, these individuals should start the screening process earlier, usually 10 years before the age at which they or a family member were diagnosed with this condition. In the African American population, screening is recommended starting at age 45 because of an earlier age of onset in this group. Screening options There are many options for CRC screening, and they all have their pros and cons. Choices range from a stool study (looking for blood

in a stool specimen or DNA analysis of tumor cells), to radiologic tests (X-rays used in conjunction with barium enema or virtual colonoscopy), to endoscopic evaluation (colonoscopy). Stool studies Testing for blood in stool, also called fecal occult blood testing, is one way to detect CRC, whose hallmark symptom is the presence of blood in the stool. This test involves an individual collecting a sample of stool and using a simple kit to detect the presence of blood in it. (Blood in stool may not be visible to the naked eye.) While stool studies have the advantage of being conducted by an individual in the privacy of his or her own home, these tests are not very sensitive or specific. They may falsely “detect” blood in someone’s stool when there is none, and may not detect blood that actually is in stool.

moved during the procedure and sent to the pathologist in order to determine whether they are cancerous. Other than some abdominal cramping that patients may experience for a short time after this procedure, most patients do not remember the exam. After a 20- to 30-minute recovery period after the procedure, they are allowed to go home. Patients are not allowed to drive at that point because they are still somewhat sedated, so they need to arrange for someone to drive them home. In the hands of an appropriately trained professional, a colonoscopy is typically a fairly painless procedure that not only detects abnormal tissue but can remove it at the same time.

Colorectal cancer is an extremely preventable condition.

DNA testing is not widely available yet, and is too expensive to propose as a screening tool. X-ray tests involve considerable radiation exposure, and do not detect small polyps or those that are flat. Barium enema is considered obsolete as a method of detecting CRC. It is much less likely to detect polyps or cancers than a colonoscopy and virtual colonoscopy, and does not include a method for removing polyps, as colonoscopy does. Therefore, patients whose barium enemas detect polyps often need to undergo subsequent colonoscopy to have them removed.

Small investment, big reward In the average-risk individual, a colonoscopy should be repeated every 10 years. In high-risk individuals (people who have a family history of CRC or polyps, or who have had polyps themselves) this procedure should be repeated every five years. Getting screened regularly is important because it usually takes 10 to 15 years for abnormal cells to grow into polyps and develop into colorectal cancer. So with regular screenings, you have the ability to avoid colorectal cancer altogether. Irshad H. Jafri, MD, heads the Department of of Gastroenterology and Hepatology at Regions Hospital (St. Paul) and HealthPartners Medical Group, and is an assistant professor in the Department of Medicine at the University of Minnesota School of Medicine.

Virtual colonoscopy takes a picture of the colon and rectum using a CAT scan machine. Although it is more accurate than barium enema, it has not been found to provide better detection than colonoscopy. As with barium enema, any polyps detected by this test would require the patient to have a subsequent colonoscopy to remove the suspicious growths.

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If someone’s stool or radiologic test suggests the presence of a polyp or cancer, the next step that the person’s physician likely will advise is to schedule a procedure called a colonoscopy. This is performed to rule out the presence of precancerous polyps and to detect and remove polyps that already are cancerous. A colonoscopy is the most sensitive, accurate, and thorough test for detecting precancerous colon polyps as well as colorectal cancer. It permits detection and removal of polyps during the same procedure and is considered the “gold standard” for colorectal cancer screening. Colonoscopy Because this procedure has the highest detection rate of any method currently available to screen for colorectal cancer, it is paid for by all insurers as a screening tool for this disease. This procedure should be thought of as a two-day investment of time, because it involves a thorough cleansing of the colon the day before the colonoscopy. At the time of the procedure, the person being screened will receive an intravenous sedative to keep him- or herself comfortable. The physician performing the examination will insert into the person’s digestive tract a narrow, flexible tube called an endoscope, which carries a tiny camera. Through this tube, instruments can be inserted to remove polyps. If any polyps are found, they are re-

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Rehabilitation

Cognitive changes and cancer treatment Chemo brain is real—and treatable By Nancy A. Hutchison, MD

roblems with thinking and memory that some cancer survivors experience during or after cancer treatment (especially chemotherapy) can be very distressing. Commonly called “chemo brain,” typical symptoms of these cognitive problems include forgetfulness, difficulty finding the right word to express a thought, trouble concentrating, difficulty multitasking, mental fatigue, inability to follow a conversation, and getting lost in previously familiar surroundings. It is not yet clear why some patients experience this and others do not. Cognitive difficulties during and after cancer treatment may

be due to anxiety, pain, insomnia, coexisting medical conditions, or side effects of medication. But these factors alone do not account for chemo brain’s pattern of cognitive changes reported by cancer patients who have no other medical reason for these problems. Research has concluded that chemo brain is real, and refers to it as “chemotherapy-induced cognitive dysfunction” (CICD). A review of the science behind these cancer-related cognitive changes reported that approximately 25 percent of cancer survivors have this condition and that interventions for treating it are beneficial (Journal of Clinical Oncology 2012).

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Minnesota Health care news October 2014

Be aware Cognitive decline is one of eight major areas that cancer survivors should be aware of so that they can pursue evaluation and treatment if problems arise in those areas. (See the sidebar on page X for a list of all eight areas.) If survivors experiencing new cognitive decline are unaware that CICD can be a side effect of cancer treatment, they may become anxious, depressed, or distractible, all of which can worsen the decline. And if their medical providers, family, and friends also are unaware of CICD, it may contribute to the survivor’s feelings of isolation, fear, loss of control, and hopelessness. A recent study showed that patients who developed cognitive problems related to cancer treatment had more distress than survivors who did not (Supportive Care in Cancer 2013). If rehabilitation therapy does not alleviate distress associated with cognitive changes, or if there is evidence of a more severe depression, a survivor typically will be referred to a mental health professional in addition to receiving cognitive rehabilitation. Diagnosis When a cancer survivor consults a health professional about cognitive changes during or after cancer treatment, the survivor should

be sure to ask the health professional if there is a treatable medical reason for the cognitive decline. Specific cognitive functions and the way they are affected by chemotherapy are attention (reduced), learning efficiency (reduced), organization (decreased), multitasking (difficulty), and retrieving memory, i.e., remembering (difficulty). It’s important to understand that intellect is not affected. And it’s also important to know that CICD is not dementia, nor does it lead to dementia.

approaches to her pre-chemotherapy way of doing things in order to decrease her sense of failure and distress, improve her everyday performance, and increase her sense of competence.

Cognition is improved by even light physical activity.

If there is no other medical reason for cognitive problems, CICD is likely the cause and the cancer survivor will be referred to a rehabilitation specialist for cognitive therapy. This professional is usually an occupational or speech-language therapist, but may be a psychologist. Treatment Medications offer little benefit for patients with CICD unless there is a coexisting medical or psychiatric condition. And medication cannot address the social, psychologic, and practical aspects of daily life with chemo brain that rehabilitation can improve. Additional reasons that it is less desirable to treat chemo brain with medication than with rehabilitation include the potential side effects of medication. An individualized plan to compensate for chemo brain takes a three-pronged approach. Learning new cognitive strategies can improve someone’s ability to perform daily activities. It may include such strategies as writing a to-do list on a daily planner and setting a smartphone timer as a reminder to act on the list.

The therapist recommended four weekly outpatient visits to prioritize Ms. G’s concerns and develop new strategies to help her effectively accomplish important activities. Each session focused on 1) understanding the reason behind the cognitive problem that was reducing her performance; 2) training in new cognitive strategies; and 3) figuring out how to integrate new strategies into her daily routine. Strategies

Pausing One of Ms. G’s main cognitive problems was poor encoding: Information was not being stored in her memory. To handle this, she learned to use a technique called “pausing.” This involved practicing awareness of when her mind was racing. When it was, she made a point to stop and take mental inventory of what she was doing, feeling, and thinking. She found that encoding was worse when she was fatigued. Ms. G also learned strategies for taking notes by using a notebook, planner, or smartphone app. In addition, she learned to follow routines that included always parking in the same location at the mall. Cognitive changes and cancer treatment to page 19

Physical exercise. Many research studies have shown that cognition is improved by even light physical activity. Physical activity that emphasizes relaxation or stress reduction, such as yoga, also can benefit cognition. Brain-training exercise. Online games that challenge memory, concentration, and the speed of processing new information have become popular but studies have shown they are less effective than rehabilitation strategies. This is due to the fact that these games may not translate to daily living without a rehabilitation professional’s skillful coaching to use the games in practical ways (Clinical Breast Cancer 2013; Life Sciences 2013; Breast Cancer Research and Treatment 2012). The process Ms. G is a 52-year-old woman who consulted her doctor because she was having problems with forgetfulness and distractibility that began during her chemotherapy for breast cancer. She started noticing that she repeatedly lost her car in the mall parking lot; made errors when preparing familiar recipes; couldn’t organize photographs for her daughter’s graduation party; and was increasingly stressed at work for fear of being unable to remember words or names, or to lead meetings. She also reported having insomnia and fatigue. Her doctor found no medical reason for Ms. G’s cognitive difficulty besides chemotherapy, and referred her to an occupational therapist. Therapy was designed to provide Ms. G with alternate

Catered Living for urban seniors is arriving Nov 2014 with the Green Line at your door! Imagine living with the Fairview Avenue Green Line Station (your passport to the best of both cities plus the airport) at your door! Inside, The Terrace at Iris Park will offer Catered Living, a concierge approach to meeting your needs as they change. In addition, you’ll be part of our campus community - a 5-Star Urban Village for Seniors that offers a continuum of care. Learn more about what The Terrace at Iris Park and the six other residences on our campus have to offer, and how they all set the stage for Lifelong Living! Call Deb Veit for the whole story. 651-632-8800. Or visit EpiscopalHomes.org October 2014 Minnesota Health care news

Calendar Bone and Joint Health National Awareness Week

Oct. 18

Understanding and Addressing Challenging Behaviors in Your Young Child

PACER Center offers this free workshop for parents of children ages birth through 5 years who have developmental delays or disabilities. Come learn about the stages of development and strategies to meet the needs of your child. Registration is required. Call (952) 8389000 or email PACER@PACER.org for more information. Saturday, Oct. 18, 9–11 a.m., PACER Center, 8161 Normandale Blvd., Minneapolis

Gluten-Free Trick or Treating

Celiac Center of Minnesota presents this free class for parents of children with celiac disease. Come get tips on how to navigate the challenge of a gluten-free Halloween. No registration required. For more information, email info@celiaccenterofminnesota.org. Monday, Oct. 27, 6:30–8:30 p.m., St. Stephen Lutheran Church, 8400 France Ave. S., Bloomington

Postpartum Depression Support Group

Allina Health hosts this support group for women who are experiencing or are at risk for postpartum depression. Come learn more about how to navigate this experience and meet other women who understand. Mothers are invited to bring their babies to the group. Call (612) 863-4770 for more information. Tuesday, Oct. 28, 1:30–3 p.m., Allina Mental Health—Abbott Northwestern Hospital, 800 East 28th St., Minneapolis

Bone and Joint Health National Awareness Week takes place Oct. 12–20 to promote better prevention and treatment for the millions of people with bone and joint disorders, or musculoskeletal conditions. These include arthritis, back pain, osteoporosis, and traumatic injuries. According to the United States Bone and Joint Initiative, almost half of people in the U.S. over the age of 18 are affected by musculoskeletal conditions. These conditions are the most common cause of severe long-term pain and physical disability worldwide, and their prevalence is expected to go up significantly as life expectancy increases. While some musculoskeletal conditions, like osteoporosis and arthritis, have genetic risk factors that cannot be prevented, there are steps you can take to help reduce the risks and help alleviate symptoms of other musculoskeletal conditions. Other conditions may develop from injuries and improper exercise habits. The most common sports injuries are sprains and strains of the muscles or tendons. Resting, compressing, and elevating the injured area and applying ice usually can treat these injuries. However, more severe injuries, such as rotator cuff or cartilage tears, may require surgery.

Heart Safe

Hennepin County Library and the Rotary Club of Plymouth offer this free class for anyone who would like to learn the symptoms of cardiac arrest and receive training for CPR and the use of an automated external defibrillator (AED). Call (612) 543-5825 to sign up or for more information. Tuesday, Oct. 28, 7–8 p.m., Plymouth Library, 15700 36th Ave. N., Plymouth

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

Minnesota Health care news October 2014

Nov. 12 Joint Preservation Class St. Croix Orthopaedics offers this free class on improving health and wellness in relation to joint pain and its impact. Come learn how your joints function, ways to manage pain, exercises, diet tips, and available treatments. Registration required. Call (651) 275-2717 or email class@ stcroixortho.com. Wednesday, Nov. 12, 10–11 a.m., St. Croix Orthopaedics Corporate Office, 5803 Neal Ave. N., Oak Park Heights

Nov. 3

Alzheimer’s Caregiver Support Group

The Minnesota–North Dakota chapter of the Alzheimer’s Association hosts this support group for care partners, family members, and loved ones of those with Alzheimer’s disease or a related dementia. Meetings focus on emotional support, sharing experiences, and exchanging information. To learn more or RSVP, call Sandra at (763) 732-1479. Monday, Nov. 3, 7:15–9:15 p.m., Colonial Acres Health Center, 5825 St. Croix Ave. N., Golden Valley

Growth Through Grieving

HealthEast offers this group to anyone who is grieving the loss of a loved one. While grieving can be painful and lonely, sharing experiences and support with others going through similar losses can help. Contact Ted at (651) 232-7397 or thein@healtheast.org for more information. Monday, Nov. 3, 4–5:30 p.m., Maplewood Professional Building—St. John’s Hospital, Watson Education Center, Ste. 202, 1575 Beam Ave., Maplewood

Journey to Wellness

The Minnesota Brain Injury Alliance hosts this free conference for individuals with a brain injury, family members, and loved ones. Come participate in workshops and sessions focusing on innovations in the world of brain injury care, therapy, and rehabilitation. Registration required by Oct. 26. For more information or to RSVP, call (612) 378-2742. Saturday, Nov. 8, 1–4 p.m., North Como Presbyterian Church, 965 Larpenteur Ave. W., Roseville

Advanced-Care Planning Group

Park Nicollet presents this free class for those who are ready to start the advanced-care planning process. Come learn how to select a health care agent, begin a family conversation, and complete a health care directive. Registration required. Call (952) 993-3454 to sign up or for more information. Monday, Nov. 10, 2–3:30 p.m., Park Nicollet Clinic—Wayzata, Lower Level Conference Room #3, 250 Central Ave. N., Wayzata

Cognitive changes and cancer treatments from page 17

Supportive care of cancer survivors

Ms. G also started and maintained a daily walking routine and spent time each day on the computer playing games that challenged her memory and concentration. After she finished four therapy sessions, Ms. G felt more organized and less forgetful. She also reported being better able to conserve her energy, which allowed her to complete difficult tasks satisfactorily. She was using the new strategies at work and gaining greater confidence in her abilities. As a result, she felt less anxious

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Cancer survivors with concerns about any of these eight areas should contact their health care providers for evaluation and treatment. • Anxiety and depression

• Immunizations and infections

• Cognitive function

• Pain

• Exercise

• Sexual function

• Fatigue

• Sleep disorders

about her performance even though she did not feel completely back to her pre-cancer level of function. She felt that she could cope at her current level of function and had hope for more improvement as she continued using her strategies. Rehabilitation helps Chemo brain is real, and negatively affects cancer survivors in all domains of life: vocational, social, and emotional. Fortunately, rehabilitation strategies are available to help survivors improve their cognitive function and quality of life. Therapy typically involves only a few sessions but provides significant benefits to cancer survivors with this condition. Nancy A. Hutchison, MD, is medical director for cancer rehabilitation and survivorship, Courage Kenny Rehabilitation Institute and Virginia Piper Cancer Institute, divisions of Allina Health.

Telephone Equipment Distribution (TED) Program

Pacing Another strategy Ms. G learned is called “pacing,” which reduces the feeling of disorganization and lack of accomplishment by breaking complex tasks into simpler steps. By doing this and saving the simplified steps for times when she had more energy, Ms. G was better able to prioritize and plan. This helped her make progress on tasks. In addition, therapy showed her that complex tasks can be more enjoyable when planning is separated from doing. This is accomplished by making a list of steps, tackling each step individually, and crossing off each step once it is completed. She saved less complex cognitive tasks, such as folding laundry, for times when she had less mental energy.

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

1-800-657-3663 www.tedprogram.org Duluth • Mankato • Metro Moorhead • St. Cloud

The Telephone Equipment Distribution Program is funded through the Department of Commerce Telecommunications Access Minnesota (TAM) and administered by the Minnesota Department of Human Services

October 2014 Minnesota Health care news

Infectious disease

Antibiotics in food animals

se of antibiotics (also called antimicrobials) has led to certain disease-causing organisms becoming resistant to these drugs. Antimicrobial resistance is a pressing concern in human medicine, and calls for more prudent use of antibiotics are essentially unanimous. In addition to these drugsâ&#x20AC;&#x2122; crucial role in human medicine, antimicrobials are important for ensuring the health and well-being of animals, including those raised for food.

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.

Minnesota Health care news October 2014

What to expect in a changing landscape By Peter Davies, PhD

In the United States, the Food and Drug Administration (FDA) permits antimicrobial use in food animals for therapeutic purposes such as treatment and prevention of disease in individual animals and herd-wide disease control, and for nontherapeutic use (NTU). â&#x20AC;&#x153;Nontherapeuticâ&#x20AC;? use means adding antibiotics to livestock feed to help animals gain weight faster and more efficiently. In an effort to preserve the effectiveness of these valuable compounds, in December

2013 the FDA announced a three-year plan to phase out the use of antibiotics that are medically important in human health and also are used for nontherapeutic purposes in livestock and poultry.

Several countries have mandated systems to reduce antibiotic use in food animals.

History Given current concerns about overuse of antimicrobials, it is remarkable that in the 1950s antimicrobials became available for over-the-counter (OTC) sale for use in food animals in most countries, and NTU has been widespread since that time. Unrestricted OTC sale of antimicrobials remains the norm for both humans and animals in many developing countries. However, it has been difficult to establish that using antibiotics in food animals has significantly decreased antibiotics’ usefulness in humans. An extensive North American review in 2006 concluded that, “the extent to which antibiotic use in food animals produces clinically important antibiotic-resistant infections in humans is unknown.” This remains poorly understood and highly controversial. The argument that reducing antimicrobial use in any sector will lessen the development of antibiotic-resistant organisms is logical. However, reducing antibiotic use by humans likely will have more direct impact on human health than will reducing agricultural use. NTU in food animals was banned in Sweden in 1988, Denmark in 2000, and the entire European Union (EU) in 2006. The FDA’s phase-out of NTU in food animals by 2016 includes removing OTC availability of therapeutic products for use in feed and water of these animals. All feed and water administration of antibiotics for therapeutic reasons in food animals will come under the responsibility of veterinarians. While details of veterinary oversight are not yet finalized, this new landscape represents radical changes in livestock farmers’ accessibility to antimicrobials. This raises questions about what impact these changes will have in the short- and long term on patterns of antimicrobial use and resistant organisms, human health, animal health, and the farming community. To get some idea of what to expect, we can look to the European experiences, although some differences should be expected in the U.S.

tems to reduce antibiotic use in food animals without linking reduction to any measurable outcomes for public or animal health. Therefore, possible effects on human infections are not known.

Because the pig industry is the largest livestock sector in Minnesota, it’s instructive to consider antibiotic use as it relates to pigs. Contrary to expectations, total antibiotic use in growing pigs in Denmark, Holland, and Belgium increased in the years immediately after NTU was banned. In all three countries, this was related to increased therapeutic use to control disease in newly weaned pigs, the age group of pigs that is most vulnerable to disease. Subsequently, total use of antimicrobials in these countries decreased, although it’s hard to say why. In Holland, industry has been made directly responsible for reducing use and specific targets for reduction have been mandated. Since the NTU bans began in Europe, there are almost no data that indicate fewer antibiotic-resistant infections in humans, and resistance in some bacteria found in animals has increased markedly. Annual reports from Denmark have shown that antimicrobial resistance in the bacteria Salmonella from pigs has tended to increase rather than decrease since the ban on NTU in 2000. A EuropeAntibiotics in food animals to page 32

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The European experience Unfortunately, there is very little information with which to gauge the impact on human health of regulatory changes in Europe. A 2012 review of reduced antimicrobial use in food animals in Denmark included neither data nor claims of any measurable benefits to human health. This stems, in part, from the complexity identifying any potential effects, but also from a mindset that reducing antibiotic use in food animals is a sufficient goal in itself, and is assumed to be socially beneficial without regard to measuring expected benefits (human health) or costs (animal health and well-being; impacts on the farming community). This belief is common in northern Europe and among people in the U.S. who are lobbying for reduced use of antibiotics in animals. Several countries have mandated sysOctober 2014 Minnesota Health care news

Legislation

If your health data is stolen ... ... how you’re notified may change By Morgan Vanderburg, JD

uring the peak holiday shopping season in 2013, Target Corporation announced one of the largest retail data breaches in history. Criminals gained unauthorized access to Target’s data and obtained the credit and debit card information of an estimated 70 million individuals. The damaging effects of this breach were significant: Target shoppers closed financial accounts, banks issued new card account numbers, and Target profits plummeted while the company began a complete overhaul of its data security program.

Minnesota lawmakers also took action in response to this catastrophic data breach. During the 2014 legislative session, Rep. Dan Schoen (DFL–St. Paul Park) proposed a bill that would amend Minnesota’s current data breach notification law. It was not voted upon

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Minnesota Health care news October 2014

but may be reintroduced during the next legislative session, which starts in February 2015. Existing law requires Minnesota businesses to notify all affected individuals when a data breach incident occurs, while the proposed amendment provides stricter requirements and penalties for whoever is determined to have caused the breach. Unfortunately, personal data held by health care entities such as clinics and hospitals can be breached. Read on to learn who health care entities are required to notify in such cases, and how. Then, keep reading to find out how the proposed amendment may change notification and what that may mean for consumers of health care. How do data breach laws affect the health care industry? Breach notification requirements are familiar territory for health care entities. In 2009, the federal Department of Health and Human Services (HHS) issued regulations requiring health care providers and health plans to notify individuals when their health information is breached. This federal law, the Health Information Technology for Economic and Clinical Health (HITECH) Act, requires health care entities to notify affected individuals and HHS promptly when a breach occurs. In cases where the breach affects more than 500 individuals, the health care entity also must notify the local media. In addition to these federal requirements, health care entities also need to comply with breach notification requirements under state law. Although these state breach laws generally align with federal requirements, they sometimes differ from federal law in the following ways: • State laws often cover more than just health care entities. They may apply more broadly to any entity that conducts business in the state and holds personal information about customers. • Many state laws only apply when there is a breach to highrisk information, such as social security numbers, bank/ financial account numbers, driver license numbers, or genetic information. The federal breach notification law, however, applies to all identifiable health information, which may be as little information as an individual’s name and address. • State laws may impose stricter timelines than federal laws do for notifying affected individuals. States also may require entities that have been breached to report the breach incident to consumer reporting agencies.

How will the proposed Minnesota amendment change current notification requirements for health care entities? The proposed amendment to Minnesota’s data breach notification law would change breach notification requirements for health care entities conducting business in Minnesota in the following ways: 1. Breach notification timeline. The amendment requires Minnesota health care entities to provide a breach notification to all affected individuals within 48 hours of discovering the breach. This would be a drastic change for health care entities, which are currently required under federal law to report breaches of health information “without unreasonable delay but no later than 60 days.” This proposed 48-hour timeline is likely worrisome for health care entities because it takes time to thoroughly investigate and respond to a breach incident. The health care entity needs to determine the root cause of the breach and the scope of affected individuals, focus on mitigating the harm to affected individuals, and effectively prepare the notification communications. A rushed investigation of the incident may result in erroneous, unnecessary breach notifications to countless individuals, resulting in confusion and undue concern among notification recipients. Conversely, time is a critical factor in minimizing harm to individuals affected by a breach, especially when identity theft is a likely possibility. The sooner affected individuals are made aware of the breach, the sooner they may take actions to protect themselves, such as signing up for credit monitoring services or closing compromised financial accounts. It is likely that the Minnesota legislature will seriously consider both sets of concerns if the amendment is reintroduced. 2. Free credit monitoring services. The amendment also requires Minnesota health care entities to provide one year of credit-monitoring services to affected individuals. These services must be offered at no cost to the individuals and must be made available within 30 days of the breach. Although providing credit-monitoring services after a breach incident is a common best practice in the industry, Minnesota would be one of the first states to make this an actual legal requirement. 3. Reimbursement and gift cards. Health care entities have new compensation requirements under this amendment. They must reimburse affected individuals for any charges or fees that result from the breach. If the entity is a retailer or wholesaler of consumer goods or services, it must also provide the affected individuals a $100 gift card for future use. The extent to which this requirement would apply to health care providers and pharmacies is still up for debate. Health care providers and pharmacies will have to assess whether they fall into the definition of a “retailer” based on the clinical services they offer to patients or the goods they sell in their general merchandise or gift shops. This gift card requirement is arguably the most controversial part of the bill. When the bill was introduced it faced opposition by members of the Minnesota House commerce committee, who stated that Target would have been required to pay $11 billion in gift cards

to affected individuals if this requirement had been in place at the time of the breach. What you can do Individuals who are interested in providing feedback regarding this amendment should contact their elected representatives. Also, those who are concerned about the privacy of their health information may take the following actions: 1. R eview your health care provider’s Notice of Privacy Practices to learn more about how the provider uses information about patients and shares it with others. The notice describes patients’ rights related to health information and, more importantly, how patients may exercise these rights. It also provides contact information for the privacy official within the health care organization, who can answer your questions or concerns related to patient privacy. This notice is available on the health care provider’s website or in writing by request. 2. O btain a free credit report to monitor recent credit transactions and identify potential identity theft. Federal law allows individuals to receive a free copy of their credit report every 12 months from each credit monitoring company. To request your reports, visit www.annualcreditreport.com Morgan Vanderburg, JD, works as a senior privacy analyst for the Mayo Clinic in Rochester. The information in this article does not necessarily reflect the views of Mayo Clinic.

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Visit our showroom! 15155 Technology Dr, Eden Prairie, MN 55344 October 2014 Minnesota Health care news

Insurance

MNSure

Report Card The first year By Scott Leitz

So far

s of Sept. 16, 2014, Minnesota’s state-run online marketplace for health insurance, MNsure, had enrolled more than 330,211 individuals in quality, comprehensive health insurance since the marketplace opened for business on Oct. 1, 2013. Since it launched, more than 172,000 people have enrolled in Medical Assistance; more than 63,000 have enrolled in MinnesotaCare; and more than 53,000 have enrolled in a Qualified Health Plan. A study by the University of Minnesota School of Public Health found that between Oct. 1, 2013, and May 1, 2014, the

number of uninsured Minnesotans fell by 40.6 percent, from 8.2 percent to 4.9 percent. This is the lowest percentage of Minnesotans without health insurance on record since the state started tracking such information. Background Minnesota has a legacy of embracing health care reform. In fact, key policy portions of the federal Affordable Care Act (ACA) were based on long-standing reforms that Minnesota already had adopted. Consistent with that tradition, Minnesota took full advantage of the opportunity to establish its own health insurance marketplace. Had Minnesota not established its own marketplace, we would have had to accept the federal alternative, HealthCare.gov. During MNsure’s first year, its average rates were the lowest in the nation, according to a Minnesota Department of Commerce analysis. The ACA also made some significant changes to coverages and how consumers access insurance. For example, consumers no longer can be denied insurance based on their medical history, and dollar limits on coverage are no longer allowed. All plans sold on MNsure carry coverage for preventive care at no cost. This includes hospitalization, prescription drugs, and mental health benefits, among others. How it works MNsure is a website that offers consumers a one-stop shop where they can shop for health insurance. The website allows people to compare private health insurance plans offered by the insurers offering policies on the site or to enroll in Minnesota’s public health care programs such as Medical Assistance and MinnesotaCare. MNsure’s online application process determines if an individual is eligible for Medical Assistance or for MinnesotaCare, with eligibility for either program based on an individual’s income or on a family’s size and income. The lower an individual’s income, the less he or she is expected to contribute to the cost of health insurance and the greater the subsidy available via MNsure. If a person doesn’t qualify for either Medical Assistance or MinnesotaCare, the online process then determines whether he or she is eligible for tax credits to offset the cost of a private health insurance policy.

Growing pains As has been the case with the first year for online insurance exchanges in other states, the MNsure rollout was rocky. A number Minnesota Health care news October 2014

of steps have been taken since last December to chart a course toward improving the IT system and the consumer experience. MNsure sought a review and recommendations from an outside consultant, Optum Health, and followed many of Optum’s recommendations. These included hiring Deloitte Consulting, Inc., in early 2014 to further improve the system. Improvements currently being implemented represent both a sprint (to accomplish corrections in time for the start of open enrollment on Nov. 15) and a marathon (to ensure MNsure’s long-term success and viability).

If you are currently insured by PreferredOne PreferredOne will not offer insurance policies through MNsure during the upcoming open enrollment period. Here’s what you need to know if you’re insured through a PreferredOne policy you bought on MNsure. • People currently enrolled in PreferredOne will have continued coverage through their existing plan for the rest of 2014. Under state law, consumers have the right to have their insurance renewed for 2015. However, this mandate does NOT require insurance to be renewed at the same price. • MNsure is contacting PreferredOne customers. PreferredOne customers who purchased health insurance through MNsure last year will receive information from MNsure in October detailing next steps and providing more information. • Visit MNsure to shop and compare health insurance plans during the upcoming

open enrollment period, which begins November 15. Growing stronger In addition to establishing a new, competitive marketplace for • Find free, in-person help from a network of more than 3,000 assisters statewide. Access the online directory of assisters at MNsure.org or by calling, toll-free, private insurance, Minnesota also took advantage of the oppor(855) 366-7873. tunity to update the outdated computer systems for its public health insurance programs through the MNsure IT system. Modernizing these 30-year-old computer systems was long overdue the ACA. We will continue to seek input from the public through and will lead to more efficiency within state government. public board meetings and our contact center in order to continue to improve MNsure’s ease of use. Early cost savings The fact that there are now fewer uninsured individuals in the state Improvement continues should start to reduce the costly burden of uncompensated care. It’s With respect to its top priority—reducing the uninsured in Minnebeen well documented that uninsured individuals are least likely to sota—MNsure has been a success. The following three principles have access to preventive services and, as a result, to visit emerguide our efforts as we continue to improve it: transparency and gency departments more often than those with insurance. This is accountability, an improved consumer experience, and continuing to one driver of increased health care costs. A 2013 Minnesota Depart- reduce the number of uninsured people in Minnesota. ment of Health study estimated that the cost savings for Minnesota Scott Leitz is CEO of MNsure. health care providers could be as high as $168 million by 2016 due to implementation of the ACA (including MNsure) in Minnesota.

Moving forward The first year of the state’s online health insurance exchange has been a valuable learning experience. One of the main lessons we learned was that individuals want and need one-on-one assistance due to the inherently complicated nature of purchasing insurance. There are now more than 2,200 certified insurance agents and almost 1,000 certified navigators who provide one-on-one assistance for consumers. While many people are familiar with insurance agents, navigators represent a new class of support personnel. Navigators, as their name implies, help people move from one step to the next in MNsure’s enrollment process. They have been trained specifically to do so, and include individuals from houses of worship, community organizations, and nonprofit organizations. We’ve also revamped the navigator and broker look-up tool on our website to make it easier for consumers to obtain help in or close to their neighborhoods. To find free, in-person help from a network of more than 3,000 assisters statewide, visit the online directory of assisters at MNsure.org or call us, toll-free, at (855) 366-7873. We’ve also taken steps to bolster our contact center’s help line capacity in anticipation of the next open enrollment period. First, we’re in the process of hiring a vendor to assist us in managing what we anticipate to be significant call volume. Consumers can talk with a MNsure representative in the MNsure contact center toll-free at (855) 366-7873. Second, we’re working with our technology vendors to improve the website ahead of the upcoming open enrollment period. Third, we continue to educate the public about MNsure and

Read us online Wherever you are!

www.mppub.com October 2014 Minnesota Health care news

Policy

Indoor tanning There’s no such thing as a safe tan By Sherri Long, MD, and Anudeep Rahil, MD

s there really such a thing as a safe tan? Many people flock to tanning booths in search of a “sun-kissed glow.” Some do it as summer draws to a close, to hang on to their summer tan. Some do it to acquire a base tan in preparation for an upcoming sunny vacation because they mistakenly believe it will protect their skin from future sunburns. Some do it to look thinner, younger, or healthier. Some even do it to boost their levels of vitamin D. These are many of the reasons people give for visiting tanning booths, but are they justified?

Minnesota Health care news October 2014

What’s involved It’s long been known that ultraviolet (UV) light from the sun can cause premature aging, wrinkles, age spots, and skin cancers. The tanning industry proposes that tanning beds are a safer way to tan. They’re not. What the tanning industry won’t tell you is that tanning booths are more risky than sun exposure. Studies have shown that tanning beds can emit up to 15 times more UV radiation than the sun. While the sun emits both UVA and

UVB radiation, the type of radiation tanning beds emit is mostly UVA, which penetrates further into the skin than UVB rays and damages the skin cells’ DNA. This is precisely what causes most melanomas, which are the most common form of skin cancer. UVA also can cause immune suppression, cataracts, and ocular melanoma, which is a type of eye cancer. The base tan that many try to achieve in a tanning booth provides protection that is equivalent to a Sun Protection Factor (SPF) of 4 or less. Thus a base tan provides hardly any extra protection against the sun, and only allows for a small amount of extra time in the sun before one burns. And because tanning beds also emit UVB radiation, which damages the skin’s surface, people can easily get burned in a tanning booth.

Selecting sunscreen Due to a recent change in sunscreen labeling, you now can determine whether a certain sunscreen can help prevent sunburns, premature aging, and skin cancers. To select a sunscreen that can protect you best, look for: 1. “ Broad spectrum.” This means it can protect you from both types of harmful rays, UVA and UVB. 2. An SPF of 30 or higher. 3. “ Water-resistant.” This means that the sunscreen has the ability to stay on your skin even if your skin gets wet from swimming or sweating. You will see either “40 minutes” or “80 minutes” after the words “water-resistant.” This tells you how soon after you apply the sunscreen you should reapply it to stay fully protected. Not all sunscreens are water-resistant and there are no truly waterproof sunscreens available at this time. Most importantly, find a sunscreen that you really like. Smell it, touch it, apply a small sample if available, to see if you like the way it feels on your skin. Sunscreens can be white, clear, or tinted, and in the form of a lotion, cream, or spray. For people with more sensitive skin, choose one that contains titanium dioxide and/or zinc oxide. These components are considered “physical blockers” that don’t rely on chemicals to absorb UV rays. Whether you use sunscreen that contains physical blockers or chemicals that block UV rays, your skin will look younger longer, if you use sunscreen. Sunscreens will not work if you don’t use them.

Vitamin D Those who tan indoors in an attempt to increase their vitamin D levels need to understand that it is an inefficient way to do so. Since UVB is responsible for vitamin D production in the skin, and since tanning beds emit mostly UVA, it is difficult to predict how much UVB exposure one receives from a tanning bed. Therefore, it is difficult to calculate how much time in a tanning booth is necessary to truly boost vitamin D levels. The safe, sensible, and reliable way to increase vitamin D levels is not by using a tanning booth. The best way is to follow the American Academy of Dermatology’s (AAD) recommendation to obtain vitamin D from a healthy diet. This includes foods and beverages that are naturally rich in or fortified with vitamin D, and/or from dietary supplements approved by your personal doctor. The AAD reminds the public that vitamin D should not be obtained from unprotected exposure to UV radiation from the sun or indoor tanning devices, because UV radiation is a known risk factor for the development of skin cancer. Increased risk In fact, studies have shown that the use of tanning beds, even just once a month before age 30, increases the risk of developing melanoma by 75 percent. Melanoma is the most deadly type of skin cancer, killing one person in the U.S. every 50 minutes. It is the second-most common cancer of young adults 15 to 29 years old. The number of people diagnosed with melanoma is increasing faster among women age 15 to 29 than among young men in the same age group. The major difference between these age groups? Women diagnosed with this cancer are more likely to have used tanning beds. In fact, 70 percent of tanning salon customers are Caucasian girls and women between the ages of 16 and 29.

Tanning supplements What about supplements that claim to improve a person’s ability to tan? Indoor tanning to page 31

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October 2014 Minnesota Health care news

N eu ro lo gy

Diagnosis and treatment By J. D. Bartleson, MD

igraine affects 43 percent of women and 18 percent of men over a lifetime, with attacks that can be disabling for up to several days at a time. It’s unfortunate that this condition is often undiagnosed and hence undertreated, because effective therapy exists. This article summarizes the basics of migraine diagnosis and therapy.

In the next issue...

Symptoms Symptoms can begin at any age, but most often appear first during childhood, adolescence, or early adulthood. The three main forms of this condition have different characteristics: 1. M igraine headache with aura. Auras usually consist of visual disturbances that include sparkling lights or geometric patterns, and/or partial loss of vision that is typically on only one side. They also can include numbness or tingling of the face and hand, and/or speech difficulty, such as trouble finding the right word. Auras typically last 10 to 30 minutes but can last an hour.

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Minnesota Health care news October 2014

2. Migraine headache without aura. Headache tends to be worse in this type of migraine. 3. Migraine aura without headache.

People can have more than one type of migraine. When they do, they usually experience migraine with and without aura. The frequency, duration, and severity of migraine attacks can vary from person to person and from episode to episode for the same person. Typically, the pain is severe enough to interfere with work and non-work activities, reducing productivity and quality of life. Diagnosis The probability that someone’s headache is a migraine increases if pain is: worse on one side; throbbing; moderate to severe in intensity and accompanied by nausea or sensitivity to light and noise; or is associated with characteristic aura symptoms. A family history of

migraine also increases the likelihood that the person has migraine. While migraine is the most common cause of intermittent, severe headaches, other conditions can cause headache and mimic migraine. The first steps in evaluation are review of the headache and other medical history, and physical and neurological examinations. Diagnostic testing is usually unnecessary in the patient with established migraine headaches. If there is concern about an underlying secondary cause for the patient’s headaches, brain imaging is recommended. Usually, brain magnetic resonance imaging (MRI) is obtained unless there is concern about acute bleeding. In that case, brain computerized tomography (CT) is obtained. Headache diaries It can be helpful for people with migraine to keep a diary that records when headaches occur, the intensity and duration of pain and associated symptoms, and the effect of acute and preventive treatment. This can help identify migraine triggers. Treatment approaches 1. Avoid triggers Common triggers include both internal physiologic factors and external factors (see sidebar on page 30). Potential migraine triggers include fasting; consuming alcohol or certain foods; hormonal influences such as birth control pills and menstrual periods; stress and release from stress, such as weekends and vacations; too much or too little sleep; strong smells or bright lights; and changes in barometric pressure. Migraine patients only need to avoid triggers that are specific to them. It can take up to 24 hours for a trigger to provoke a migraine attack. Unfortunately, the majority of migraine attacks are not triggered and many recognized triggers are unavoidable, such as a change in the weather. Plus, triggers can be variable; sometimes drinking red wine triggers an attack and sometimes it doesn’t. This makes it harder to recognize triggers and can reduce someone’s willpower to avoid a trigger that does not always cause a headache. In addition, migraine triggers for a given person can change over time. 2. Acute treatment of the individual attack The mainstay for most people with migraine is to use an effective, acute medication as soon as possible during the course of the individual attack. The need to treat the individual attack early cannot be overemphasized. People with migraine frequently wait too long because they do not like to take medications, and they often think that this time will be different and they do not need to use a medication.

Advantages of this class of medication are that they are not habit-forming and leave the user clear-headed. Side effects include tingling, flushing, warmth, and sensations of heaviness, pressure, or tightness in the chest and/or neck. Contraindications. Triptans can, rarely, cause problems with coronary artery blood flow, so they should not be used by people who have coronary artery disease, uncontrolled high blood pressure, stroke, or peripheral vascular disease. Nor are they appropriate for people who have rare types of migraine associated with weakness on one side of the body or symptoms such as incoordination, vertigo (dizziness), double vision, or impaired consciousness.

Effective therapy exists.

While triptans are compatible with most other drugs, there is the potential for adverse drug interaction in patients who use a triptan and one of the newer antidepressants such as Prozac (fluoxetine) or Effexor (venlafaxine). Patients using either drug combination should be alert for symptoms of an adverse drug interaction called serotonin syndrome. Symptoms include agitation, confusion, rapid heart rate, incoordination, muscle rigidity, or twitching. Self-care With or without medication, many patients find that resting and sleeping in a dark, quiet room can reduce the severity and duration Migraine to page 30

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• Over-the-counter (OTC) medications Some patients find OTC medication such as acetaminophen, aspirin, ibuprofen, or naproxen effective, especially if they take a large enough dose soon enough after symptoms begin. Caffeine alone or with an OTC pain reliever can be helpful.

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• Prescription medications Triptans are the most effective drugs to alleviate symptoms of a migraine attack. In use for more than 20 years, they reverse nausea and pain in about 75 percent of patients. Sumatriptan (Imitrex) and rizatriptan (Maxalt) are two of the seven available triptans.

October 2014 Minnesota Health care news

cular drugs, specific antidepressants, and some anticonvulsants. Botulinum toxin A (“Botox”) injections into scalp muscles are approved only for chronic migraine headaches at this time.

Migraine from page 29

of attacks. Applying a cold pack to the head may also help. If symptoms worsen Intermittent acute migraine headaches can become chronic. Chronic migraine is defined as headaches that occur at least 15 days per month for at least three months, and which have features of migraine on at least eight days per month. Progression from occasional to chronic migraine is sometimes associated with frequent use of any acute medication and/or caffeine. Prevention If the frequency, duration, and severity of migraine attacks are severe enough, despite avoiding triggers and using acute medications, talk with your doctor about preventive therapy. Guidelines for it include: if someone has more than four to six headache days per month; when acute medications are contraindicated or ineffective; when acute medication is required more than twice per week; and for individuals whose migraine attacks could affect their safety or livelihood, such as pilots or professional athletes. Preventive options include certain cardiovas-

None of these drugs is 100 percent effective in migraine prevention. A 50 percent reduction in the frequency, severity, and duration of headaches is considered a good result and is often achieved. A given preventive agent is chosen because of its potential benefit on another condition that the person has. Alternatively, a preventive agent is avoided because of its possible adverse effect on another problem the person has. It can take two to three months before a benefit is obtained from a preventive agent. Summary Emerging evidence suggests that migraine headaches arise from a disturbance in pain pathways that affect the head, face, and neck. Ultimately, this knowledge will lead to even better treatment. For now, how-ever, effective migraine therapy consists of looking for and avoiding headache triggers, taking an acute medication as soon as possible after symptoms start, and using preventive anti-migraine medications if needed.

Common triggers • Fasting • Alcoholic beverages • Hormonal therapy • Caffeine withdrawal • Stress or release from stress • Too much or too little sleep • Menstruation • Fatigue • Bright lights, loud noises, smoke, and strong scents • Change in barometric pressure • Acute head injury • Chocolate • Aged cheeses • Processed meats • Fermented foods • Aspartame • Monosodium glutamate • Citrus fruits • Nuts J. D. Bartleson, MD, is a board-certified neurologist, associate professor of neurology at Mayo Clinic, subspecialty-certified in headache medicine and pain medicine, and a Fellow of the American Academy of Neurology.

Accidental Bowel Leakage (ABL) You no longer need to suffer in silence Nearly 18 million U.S. adults, or one in twelve, are affected by ABL. Men and women of all ages may be affected, although it is more common in older adults. Most people and many physicians are not aware of the reasons for ABL or that it can be easily treated. In addition, fear, shame and embarrassment are often impediments to seeking solutions to this problem. We specialize in diagnosis and treatment of ABL. Modern medicine brings an array of simple, safe and effective procedures to treat ABL. At the Pelvic Floor Center we provide a multi-disciplinary approach for the treatment of ABL and other pelvic floor disorders including urinary incontinence and pelvic prolapse. • Dietary modification • Biofeedback therapy • Office – based procedures We see patients on referral. If you are experiencing ABL your primary physician can refer you to the Pelvic Floor Center or you can see a provider at Colon and Rectal Surgery Associates for initial evaluation and referral.

651.225.7800 • www.pelvicfloorcenter.org For information about other services we provide please visit us at www.colonrectal.org 30

Minnesota Health care news October 2014

Indoor tanning from page 27

Applying sunscreen

They don’t.

• Apply sunblock at least 20 to 30 minutes before going out in the sun, so it can fully penetrate the skin before sun exposure. Don’t wait until you get to the beach to apply it.

What makes someone tan is the naturally occurring compound melanin, which the body manufactures by using the amino acid tyrosine. The body produces all the tyrosine it needs from dietary protein and excretes any excess. So consuming tanning supplements that contain tyrosine merely gives the body excess tyrosine that is excreted.

•R eapply according to directions, at least every couple of hours. Most people do not reapply as often as they should. Even if you use sunscreen with a high SPF, such as 85 or 100, one application will not protect you for the entire day. •R emember to apply sunscreen to the rims of your ears. They can burn, too.

Some tanning supplements contain canthaxanthin, a substance found in food coloring. The FDA allows small amounts of this substance in foods such as ketchup, but the amount in tanning pills greatly exceeds the FDA-approved dosage that is considered safe. When taken orally, this substance can color skin brown, orange, or an intermediate shade, but the color is not from an increase in melanin.

burn protection via base tanning are false. The so-called benefits of tanning supplements are also false, as these supplements are not only ineffective but potentially dangerous.

Not only are all tanning supplements a waste of money, a variety of side affects have been reported by some people who use them. These include nausea, cramping, diarrhea, hives, and visual disturbances. To date, there are no FDA-approved tanning supplements.

The U.S. Department of Health and Human Services and the World Health Organization have declared UV radiation from the sun and from tanning beds to be a known carcinogen (something that causes cancer). Tan skin is damaged skin.

Many dangers, no benefits In summary, the dangers of indoor tanning are many and potentially lethal. In addition to the obvious risk of skin cancer, other negative side effects of tanning include accelerated aging of the skin and the associated development of wrinkles and age spots. Indoor tanning’s so-called benefits of providing increased vitamin D levels and sun-

•D on’t forget your lips. Unprotected lips can develop skin cancer that can be quite aggressive. Look for a sunscreen lip balm labeled “Broad Spectrum SPF 30” and use it daily.

Tanning, whether outside or indoors, is not safe. Sherri Long, MD, and Anudeep Rahil, MD, are board-certified dermatologists who practice with North Metro Dermatology, North Oaks. Editor’s note: Gov. Dayton signed legislation in May that prohibits Minnesotans under 18 years of age from tanning indoors, effective Aug. 1, 2014.

WHO’S A BIGGER BASEBALL FAN, YOU OR ME? You’ll find that people with Down syndrome have a passion for knowledge and learning that can rival anyone you’ve met before. To learn more about the rewards of knowing or raising someone with Down syndrome, contact your local Down syndrome organization. Or visit www.dsamn.org today. It is the mission of the Down Syndrome Association of Minnesota to provide information, resources and support to individuals with Down syndrome, their families and their communities. We offer a wide range of services, programs and materials at no charge. If you are interested in receiving one of our information packets for new or expectant parents, please email Kathleen@dsamn.org or For more information please call:

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October 2014 Minnesota Health care news

The future As we enter the “no NTU” era in the U.S., it is likely that effects on animal health and the livelihoods of smaller farmers will be more severe in this country than in the EU.

Antibiotics in food animals from page 21

an-wide report in 2010 showed that Salmonella, Campylobacter, and other common gut bacteria that do not usually cause disease were as resistant to antibiotics two years after the 2006 EU ban on NTU as they were during the four years preceding the ban.

Changes that consumers may encounter in the grocery store already exist. At least one major meat producer offers antibiotic-free pork and announced this past summer that this fall it would offer turkeys raised without growth-promoting antibiotics.

People can ingest antibiotic-resistant bacteria through handling or consuming raw or undercooked meat. This suggests that immediate, measurable reductions in antibiotic resistance in bacteria that are in animals should not be expected in the U.S. The continued growth of the pig industry in Denmark illustrates that, despite short-term setbacks in animal health after reducing NTU, the industry continued to thrive and be internationally competitive. However, part of the adaptation in Denmark was greater consolidation of farms and the corresponding loss of smaller farms.

It’s important to note that animals raised without antibiotics can still harbor antibioticresistant bacteria. Resistant bacteria can enter the food-processing environment via employees, equipment, or other means. People can ingest antibiotic-resistant bacteria through handling or consuming raw or undercooked meat.

Consumers electing to buy meat produced on “antibiotic-free” farms should understand that their choice is justified by a philosophical belief that reducing antibiotic use in all spheres is a worthwhile goal. Purchasing decisions should not be based on the belief that “antibiotic-free” meat products are safer from foodborne pathogens or antibiotic-resistant bacteria. Peter Davies, PhD, is a professor of swine health and production in the Department of Veterinary Population Medicine at the University of Minnesota, St. Paul.

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

70 60 50 40 30 20 10 0

Yes

35 30 25 20 15 10 5 Agree

30 20 10 0

Very satisfied

Satisfied Does not Dissatisfied Very apply dissatisfied

50 40 30 20 10 0

5. I would utilize other methods of screening tests for colorectal cancer before I scheduled another colonoscopy. Percentage of total responses

Percentage of total responses

Strongly agree

4. I would recommend getting a colonoscopy to anyone over 50 who has not had one.

3. I plan to schedule another colonoscopy within the time period recommend by my physician. Percentage of total responses

2. How satisfied were you with the procedure? Percentage of total responses

Percentage of total responses

1. Have you ever had a colonoscopy?

35 30 25 20 15 10

No Disagree Strongly opinion disagree

Minnesota Health care news October 2014

5 0

Strongly agree

Agree

No Disagree Strongly opinion disagree

Strongly agree

Agree

No Disagree Strongly opinion disagree

Minnesota

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â&#x20AC;&#x153;A way for you to make a differenceâ&#x20AC;? October 2014 Minnesota Health care news SEPTEMBER 2013 MINNESOTA HEALTH CARE NEWS

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Cat allergy and other indoor sensitivities from page 13

a prescription include antihistamines (Zyrtec, Allegra, Claritin), topical corticosteroids, nasal sprays, antihistamine eye drops, and cromoglycate nasal spray (Cromolyn). Some over-the-counter antihistamines, nasal sprays, and eye drops are covered by insurance if written as a prescription, so it’s worth asking your allergist if he or she can provide a prescription for them. Research New treatments currently are being studied to evaluate their effectiveness in treating cat allergy-induced rhinoconjunctivitis. Immunotherapy desensitizes people to an allergen. This process works like weight training, in that the allergic person starts by receiving a low-dose injection of an allergen, comparable to exercising with light weights. Every week, the person receives an increased dose of the allergen to build tolerance to it, just as an athlete gradually acquires the ability to tolerate increasingly heavier weights. This approach has been shown to build a person’s tolerance of an allergen, thereby diminishing his or her allergic response. Once someone’s allergic response has been reduced to an acceptable degree by this therapy, that person may need to receive periodic maintenance injections of the largest dose he or she received while building up tolerance. Historically, immunotherapy for cat allergy has involved injecting an extract of the entire major protein that causes this allergy.

The success of this method has been variable. A refinement of this method uses a small portion of the cat protein as the allergen and is currently being studied by Clinical Research Institute (CRI). Results of this research cannot be published yet because they are still being collected and have not gone through final analysis. However, the benefit that is anticipated from this refined method is that patients will experience relief of cat allergy symptoms with fewer injections over a shorter period of time. SLIT is another treatment undergoing evaluation at CRI, and stands for “sublingual immunotherapy.” This approach to desensitizing patients delivers allergen in the form of orally consumed drops or pills instead of by injection. Although it is too soon to know if this method will work for cat allergy, SLIT has been shown to alleviate certain other allergies, including those to ragweed and grass. Keep in mind To minimize your allergic reactions to cats as well as to other indoor allergens, use a correctly sized HEPA filter and keep your home clean to prevent allergens from accumulating. Currently, the best treatment for cat-induced rhinoconjunctivitis is cat avoidance, but if this is not possible, lifestyle adjustment, medicine, and immunotherapy may help reduce or avoid symptoms. Gary D. Berman, MD, is board-certified in allergy and immunology and in headache management. He is also an adjunct assistant professor of medicine in the University of Minnesota Division of Pulmonary, Allergy, and Critical Care, and practices with Allergy & Asthma Specialists, PA, and Clinical Research Institute, Inc., Minneapolis.

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Minnesota Health care news October 2014

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Victoza® (liraglutide [rDNA origin] injection) Rx Only BRIEF SUMMARY. Please consult package insert for full prescribing information. WARNING: RISK OF THYROID C-CELL TUMORS: Liraglutide causes dose-dependent and treatmentduration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice. It is unknown whether Victoza® causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as human relevance could not be ruled out by clinical or nonclinical studies. Victoza® is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Based on the findings in rodents, monitoring with serum calcitonin or thyroid ultrasound was performed during clinical trials, but this may have increased the number of unnecessary thyroid surgeries. It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate human risk of thyroid C-cell tumors. Patients should be counseled regarding the risk and symptoms of thyroid tumors [see Contraindications and Warnings and Precautions].

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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

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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 ® 1.8 + Metformin Placebo + Metformin + Glargine + Metformin + Victoza + 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 pharma® ceuticals, 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

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