MN Health Care News Feb 2016 by Minnesota Physician Publishing

February 2016 â&#x20AC;˘ Volume 14 Number 2

Birth centers Michelle Smith, MSN, MBA, RNC, and Alice Chernich, RN, MSN

Living with epilepsy Coach Jerry Kill

Peptic ulcers Benjamin Mitlyng, MD

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CONTENTS

4 7 8

February 2016 • Volume 14 Number 2

News

PEOPLE

NOMINATION

DERMATOLOGY Acne Treating a common condition III, MD

PERSPECTIVE

Problem gambling The impact on health Nick Vega Puente

10 Questions

Living with epilepsy Coach Jerry Kill

Legislation

M L H OS T I ARS EA T I N LT H N F L U E A D E CARE LE

2016 Legislative preview Pending health care issues

By Kate Johansen, JD

18 30

cALENDAR

Gastroenterology

Peptic ulcer disease Common, but treatable

Head Coach, University of Minnesota Gophers Football (Ret.)

NNESOTA’S MI

By Charles E. Crutchfield

Minnesota Department of Human Services

ReQuesT FOR

By Benjamin Mitlyng, MD

Obstetrics

Birth centers New trends and approaches

By Michelle Smith, MSN, MBA, RNC, and Alice Chernich, RN, MSN

In our august 2016 edition, minnesota Physician will profile 100 of our state’s most influential health care leaders. In a format featuring photos, bios, and quotes, we will highlight the men and women most responsible for making minnesota a global model for health care delivery. These individuals will represent every aspect of the industry: physicians, business executives, political leaders, policy analysts, etc. We invite you, our readers, to participate in this recognition process. If you know anyone within your organization you feel should be considered, please fill out the form below and return it by mail, fax, or email prior to may 27, 2016. We welcome your input and participation in making this list as comprehensive and meaningful as possible.

100 Most Inﬂuential Health Care Leaders Nomination Form i would like to nominate the following individual(s): Name and location of nominee’s employer or practice:

Nominee’s contact info:

MINNESOTA HEALTH CARE ROUNDTABLE Behavioral health integration By MPP Staff

brief description of the nominee’s work and inﬂuence:

Publisher Mike Starnes | mstarnes@mppub.com Editor Lisa McGowan | lmcgowan@mppub.com Associate Editor Richard Ericson | rericson@mppub.com Art Director Joe Pfahl | joe@mppub.com Office Administrator Amanda Marlow | amarlow@mppub.com Advertising Stacey Bush | sbush@mppub.com Advertising Linda Nervick | linda@mppub.com 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.

Nomination submitted by: Name: address: City, State, Zip: Phone #: email:

February 2016 Minnesota Health care news

News

HealthPartners Announces Plans to Build New Como Clinic HealthPartners has reached an agreement with Luther Seminary to purchase land for a new clinic. The land is across the street from the current HealthPartners Como Clinic, which will move to the new location once it is complete. “Como Clinic represents the roots of our organization, and we are pleased to partner with Luther Seminary and Ecumen on an investment that will continue to serve the community for decades to come,” said Beth Averbeck, MD, senior medical director for primary care at HealthPartners. The land purchase is the first step in a process that HealthPartners expects to take years. Next they will begin a community engagement and design phase. Groundbreaking is expected to happen in three to four years and construction will take an estimated 18 months. The new clinic will be about the same size and offer the same services as the current facility,

which will remain open until the new location is completed.

Drug Diversions Large Part of Vulnerable Adult Abuse Claims The Minnesota Department of Health (MDH) has found that drugs stolen in health care facilities accounted for about 20 percent of the 141 substantiated allegations of abuse, neglect, or financial exploitation of vulnerable adults between July 2013 and June 2014. According to the Maltreatment of Vulnerable Adults Update, 14 health care workers diverted drugs from 27 vulnerable adults in the one-year period. “Drug diversion and prescription abuse is a growing area of concern nationally and in Minnesota,” said Ed Ehlinger, MD, Minnesota commissioner of health. “We want patients to be aware of the possibility of drug theft, we want workers to know it will not be tolerated, and we want providers to help prevent it by using best medicine management and tracking policies.”

Minnesota Health care news February 2016

The majority of the thefts, about 70 percent, took place in nursing homes. The others took place in assisted living facilities or in-home care arrangements. Some employees replaced the patient’s narcotics with over-the-counter medications, while others forged documents to steal the medications. MDH found the individual workers, and not the facilities at which they were employed, at fault for the diversions in all of the cases. Most facilities notified authorities and fired the employee who committed the theft, and some took steps to prevent future problems. Some strategies for this included daily narcotic counts, narcotic counts between shifts, training nurses to identify the signs of drug diversion, changing locks on medication storage boxes, and requiring two staff members to sign off on medication flow sheets. This is the first year MDH has tracked incidences of drug theft as part of the report on the maltreatment of vulnerable adults. Previously, it included drug diversion cases in the financial exploitation category but didn’t look at them separately.

Blue Cross Recognized for Commitment to Veterans Blue Cross and Blue Shield of Minnesota was designated as a Beyond the Yellow Ribbon company on Jan. 22 for its commitment to supporting military members and their families through employment and community outreach. The State of Minnesota Yellow Ribbon Action Plan Review Board unanimously voted in favor of the designation, making Blue Cross the first health insurance company in Minnesota to be recognized as a Beyond the Yellow Ribbon company. To earn the recognition, companies must build relationships with local military leaders, identify which employees have military connections, and commit to hiring and retaining veterans. Blue Cross established a steering committee in 2015 through its Veterans’ Employee Resource Group, a volunteer organization of company leaders and other employees with former military service that works with human resources staff and leadership

to enhance the company’s policies and programs.

rates are alarming given our current ability to safely and effectively save lives by preventing HPV infection and its associated cancers.”

Masonic Cancer Center Endorses Statement Tobacco Cessation Urging HPV Vaccination Services Now Free for Cancer Prevention Under State Health The University of Minnesota’s MaInsurance sonic Cancer Center has joined the other 68 National Cancer Institute (NCI)-designated comprehensive cancer centers in issuing a statement meant to emphasize the importance of human papillomavirus (HPV) vaccination for cancer prevention. According to the Centers for Disease Control and Prevention (CDC), HPV infections lead to about 27,000 new cancer diagnoses each year in the U.S, while vaccination rates remain low. Fewer than 40 percent of girls and about 21 percent of boys receive the recommended three doses of the HPV vaccine.

Minnesotans insured by Medical Assistance and MinnesotaCare will no longer have copays for tobacco cessation services beginning in 2016, under 2015 legislation that waives copays for preventive services rated “A” or B” by the U.S. Preventive Services Task Force. These services include tobacco treatment counseling and FDA-approved smoking cessation medications.

“Expanding access to tobacco treatment medication will further support our state’s efforts to reduce tobacco use,” said Emily Johnson Piper, Minnesota commissioner “Everyone wants a vaccination of human services. “By ensuring to prevent cancer,” said Douglas more Minnesotans can afford Yee, MD, director of the Masonic these medicines, we can work to Cancer Center at the University of increase the success rate for quitting Minnesota. “The HPV vaccination smoking in Minnesota.” is a safe, effective way to prevent illness and stop cancer before it starts. Overall, smoking rates in This simple three-course series can Minnesota have decreased, but save lives, and it is imperative we there are communities who conwork together to increase the vacci- tinue to smoke at disproportionate nation rates in the United States to rates, according to the Minnesota better protect our young people.” Department of Health (MDH). Minnesotans enrolled in Medicaid Experts from the NCI, CDC, American Cancer Society, and more smoke at about twice the rate of the general population, and health care than half of the NCI-designated costs for smokers are 34 percent cancer centers met in November to higher than they are for nonsmokdiscuss strategies for overcoming barriers to higher vaccination rates. ers. Smoking continues to be the leading cause of preventable health Part of the strategy that resulted and disease, with nearly 5,900 peofrom those conversations is the ple dying due to smoking each year. release of the statement about the importance of HPV vaccination for It accounts for almost $2.5 billion cancer prevention, which they hope annually in medical costs. will reach parents, adolescents, and health care providers.

The statement says, in part, “Together we, a group of the National Cancer Institute (NCI)-designated Cancer Centers, recognize these low rates of HPV vaccination as a serious public health threat. HPV vaccination represents a rare opportunity to prevent many cases of cancer that is tragically underused. As national leaders in cancer research and clinical care, we are compelled to jointly issue this call to action…The low vaccination

“Quitting smoking is one of the best things people can do to improve their health,” said Ed Ehlinger, MD, Minnesota commissioner of health. “To help all Minnesotans realize the benefit of being smoke-free, we need to remove barriers, especially financial barriers, to quitting. This is particularly important for people with low incomes who may not have the resources to pay for essential tobacco use cessation programs.” News to page 6

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News from page 5

Audit Shows Eligibility Errors Cost State Up to $271 Million Minnesota potentially overspent between $115 million and $271 million on people enrolled in public health care programs due to MNsure errors, according to a report from Legislative Auditor James Nobles. The legislative audit analyzed a sample of 103 Medicaid enrollees and 54 MinnesotaCare enrollees who enrolled through MNsure and qualified due to low income. Auditors used state employment data and tax returns to verify whether those people qualified for the programs they were enrolled in. They discovered that 59 of the enrollees, or 38 percent, did not meet the criteria and that those 59 people were overpaid about $93,000 in health care benefits. The audit estimates that if that number is extrapolated over the entire population of the 270,000 that they represent, between 57,000

and 108,000 Minnesotans received Medicaid or Medicare benefits who should not have because they did not actually qualify for the program. The report says the problems stem from MNsure software and human errors where correct procedures were not followed by staff.

Mayo Clinic Using Ultraviolet Light to Reduce HospitalAcquired Infections Mayo Clinic has implemented the use of ultraviolet light devices to help combat clostridium difficile (C-diff) bacteria in patient rooms. “C-diff is extremely distressing for our patients,” said Priya Sampathkumar, MD, chair of Mayo Clinic’s infection control committee. “It can be debilitating, decrease quality of life, and can even result in death.” Mayo Clinic participated in a pilot program from October 2014 through March 2015 as part of a quality improvement project with The Joint Commission Center

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Minnesota Health care news February 2016

for Transforming Healthcare, the Centers for Disease Control and Prevention (CDC), and five health care systems. They used the devices to supplement normal cleaning routines. Results from the pilot showed a 30 percent decrease in C-diff infections in the units cleaned by the ultraviolet light devices compared to those that were not. The results were enough to convince Mayo Clinic to purchase 10 of the ultraviolet light devices in fall 2015 for between $50,000 and $120,000 each. They began using them in early January after training Environmental Services staff to properly use the devices, which are used in rooms after patients have been discharged. Staff set up the devices in the room aimed at surfaces that could have C-diff bacteria, leave the room, and start the device remotely. The device goes through cycles of ultraviolet light bursts in three different parts of the room, adding about 25 minutes of cleaning time per unit. “It’s worth it, because the average increased length of stays for a person with C-diff is three days,”

said Sampathkumar. “If we can prevent C-diff infections, we gain that time back.” While cost could prevent Mayo Clinic from purchasing more of the devices in the short-term, there is an optimism about the future of ultraviolet light technology in hospitals. “I suspect as technology improves, prices will come down as it has for other things,” said Sampathkumar. “I do think that at some point in time, this or other similar types of technology will become commonplace.” C-diff is one of the most common hospital-acquired infections. About 500,000 people contract it each year in the U.S. and 15,000 die as a direct result of the infection, according to the Centers for Disease Control and Prevention. The bacteria spores are resistant to many routine hospital disinfectants and can survive in hospital rooms for months. While C-diff infections are on the rise nationally, Mayo Clinic has seen a decline in recent years and has had no deaths related to C-diff in at least two years, according to Sampathkumar.

People Kari Benson has been named the new executive director of the Minnesota Board on Aging and director of the Minnesota Department of Human Services (DHS) Aging and Adult Services Division where she will oversee planning for and providing sustainable financial, housing, and service options for older Minnesotans. Benson has more than 15 Kari Benson years of experience in aging services, including working at the federal Administration for Community Living and holding several positions within DHS. Most recently, she served as planning and policy coordinator in DHS’ Aging and Adult Services Division and as a senior services consultant for the Minnesota Board on Aging. Benson earned a master’s degree in public affairs from the Humphrey School of Public Affairs at the University of Minnesota. David Hardten, MD, ophthalmologist and director/founding partner of Minnesota Eye Consultants, PA, has been named a recipient of the Allina Health HOPE Award in recognition of excellence in service to patients as measured by the Press Ganey patient experience survey. Hardten earned his medical degree at the University of Kansas David Hardten, School of Medicine, completed a residency in the MD University of Minnesota Department of Ophthalmology, and completed his fellowship training in cornea and external disease at the University of Minnesota and Phillips Eye Institute. He also serves as an attending ophthalmologist at Phillips Eye Institute, an adjunct associate professor of ophthalmology at the University of Minnesota Department of Ophthalmology, and an adjunct professor for the Illinois College of Optometry. Terry Mahoney, LICSW, OSW-C, certified oncology social worker at Essentia Health Cancer Center in Duluth, has received the Lane W. Adams Quality of Life Award from the American Cancer Society. The award recognizes individuals who consistently exhibit excellence and compassion in providing care to cancer patients and who go Terry Mahoney, beyond their duties to make a difference in the lives LICSW, OSW-C of patients and their families. Mahoney was one of 10 recipients of the 2016 award. She has been with Essentia Health since 1997 and became the cancer center’s first social worker in 2007. She also has volunteered for the American Cancer Society for almost 20 years. Charles E. Crutchfield III, MD, clinical professor of dermatology at the University of Minnesota Medical School, has been recognized by the Twin Cities Medical Society with the 2015 First a Physician award for making a positive impact on organized medicine. Crutchfield was selected due to his extensive volunteer work and leadership in his Charles E. field, including writing a weekly medical column Crutchfield III, in the Minnesota Spokesman-Recorder newspaper MD and working with his foundation to support Camp Discovery, a summer camp for children with severe skin diseases. He is also an active member of the Minnesota Association of Black Physicians. Crutchfield earned his medical degree at the Mayo Clinic Medical School.

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February 2016 Minnesota Health care news

Perspective

Problem gambling The impact on health

ambling may be considered a recreational activity, but it can also lead to a downward spiral of addiction and problem behavior, often before the gambler realizes it. This fact is commonly understood—and witnessed all too often—by many Americans. What is less well known is the effect that gambling has on health, and its connections to substance abuse and other addictions.

Problem gambling

Nick Vega Puente Minnesota Department of Human Services Mr. Puente is supervisor of substance abuse prevention and problem gambling services with the Alcohol and Drug Abuse Division of the Minnesota Department of Human Services. He has been in the field of substance abuse prevention, treatment, and recovery for 37 years, and he was the first Hispanic in Minnesota to be appointed to the State Alcohol and Other Drug Abuse Advisory Council in 1983.

Gambling is more prevalent than ever before. Once limited to lotteries, racetracks, or casinos, it has expanded to include online gambling, sports betting, and fantasy drafts. Estimates vary, but a February 2014 article in The Week magazine pegged U.S. gambling losses at $119 billion in 2013—the highest in the world, according to the article. Among Americans ages 18 and older, 75 percent have gambled at least once, according to the Substance Abuse and Mental Health Services Administration (SAMHSA) Advisory Report. “Problem gambling” is a term often used to describe gambling-related issues spanning a continuum from mild to severe. The National Council on Problem Gambling (NCPG) describes problem gambling as behavior that causes disruptions in any major area of life: psychological, physical, social, or vocational.

A majority of people with problem gambling—70 to 76 percent—have a lifetime history of depression, according to research published in the American Journal of Psychiatry. SAMHSA reports that 40 to 60 percent of problem gamblers demonstrate some type of mental illness, including mood, anxiety, and personality disorders, while The Journal of Clinical Psychiatry says that problem gamblers are three times more likely to suffer from a major depressive episode. In addition to depressive episodes, people with problem gambling behaviors or gambling disorders may struggle with suicidal thoughts and tendencies. Data from the NCPG suggests that about 80 percent of those with a gambling addiction consider suicide, while one in five will attempt suicide. This is about twice the rate of suicide attempts compared to other addictions.

Gambling and physical health

Migraines, intestinal disorders, high blood pressure, loss of sleep, and other anxiety-related symptoms often affect those with problem gambling behaviors. Other physical symptoms include changes in the levels of the hormones cortisol and epinephrine, as well as changes in heart rate, metabolic functions, and blood pressure during periods spent gambling.

Eighty percent of those with a gambling addiction consider suicide.

For some, this may lead to a formal diagnosis of gambling disorder, characterized by increasing preoccupation with gambling, a need to bet more and more frequently, and difficulty in stopping despite mounting consequences. The Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) classifies these diagnosable conditions under the category “Substance-Related and Addictive Disorders.”

Even with conservative estimates, 6.2 million people experience problem gambling in the U.S., and approximately 3.4 million adults meet the criteria for gambling disorder diagnosis, according to the NCPG. It’s a tough road for those hoping to recover: studies show that the brain activity of people with gambling problems is similar to that of drug users, and that gamblers may develop a tolerance for the excitement, escalating the experience by chasing wins and betting increasing amounts of money.

Gambling and substance abuse

Problem gamblers are also likely to abuse substances. Psychiatrist and addiction expert Jon Grant, MD, JD, MPH, states that substance abuse rates are seven times greater in those who gamble. Leading that abuse are alcohol and nicotine. In one national survey, 73 percent of people diagnosed with a gambling disorder also had an alcohol use disorder, and 60 percent reported nicotine dependence. Other studies conclude that alcohol consumption influences the average bet amount and accelerates the rate at which gamblers play through their available funds.

Gambling and mental health

Minnesota Health care news February 2016

The stress associated with the consequences of gambling contributes to poor mental and physical health. Furthermore, worrying about a loved ones’ gambling problem may cause friends and family to experience these physical symptoms. Problem gamblers may also neglect their health, avoiding fresh air, exercise, and healthy eating habits. For this reason, Dr. Grant urges that yearly physical exams should routinely screen for predictors of problem gambling, although developing accurate screening methods may be difficult.

Help for problem gambling

Minnesota’s Problem Gambling Program, managed by the Department of Human Services (DHS), provides funding for both residential and outpatient treatment and family support services. Training and education for behavioral health and allied professionals is also offered through program funding. Public awareness campaigns are coordinated by DHS and the Northstar Problem Gambling Alliance (www.northstarproblemgambling.org). Minnesota’s program includes a statewide toll-free confidential helpline, available 24/7. For immediate support, call 1-800-333-HOPE or text “HOPE” to 61222 (a service of TXT4Life). Those concerned for themselves or a loved one can visit a DHS website (getgamblinghelp. com), www.facebook.com/NoJudgment, or www. treatmentworks.us. Other online resources include Gamblers Anonymous (www.gamblersanonymous.org/ga/), Minnesota Gamblers Anonymous (www.minnesotaga. org), and Gam-Anon (www.gam-anon.org).

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February 2016 Minnesota Health care news

10 Questions

Living with epilepsy Coach Jerry Kill Coach Kill retired as head coach of the University of Minnesota Gophers football team in October 2015. He has partnered with the Epilepsy Foundation of Minnesota and other community groups to share his story of living with epilepsy and to raise public awareness.

came out like that, I might not have a job. But then I went to their Rise Above Seizures Gala and they had young people talking about it, and we had some similarities, and so I said, “I’m all in.” I’m fortunate. There are kids who have 30, 40 seizures a day, there are people whose cognitive skills have slowed down so much that they can’t work, and then there are others, just like me, who they won’t hire. I’m a very blessed person and I owe that to a lot of good athletic directors in our profession who weren’t scared of my situation.

What is epilepsy? With epilepsy, you have seizures caused by electrical activity in the brain. Some people don’t want to use the word “epilepsy” and say “seizure disorder” instead, but if you have two or more seizures you are usually considered to have epilepsy. There are also epileptic seizures and non-epileptic seizures. The public knows a lot about cancer and other diseases, but with epilepsy, they don’t know as much. That’s one of the reasons we’re trying, with the Epilepsy Foundation of Minnesota, to bring awareness to epilepsy, because one out of 26 people will develop it in their lifetime.

What advice do you have for others who are diagnosed with epilepsy? The biggest thing is to find somebody that you feel comfortable with. My personal opinion is that you should see an epileptologist [a neurologist specializing in epilepsy]. You have to get your sleep, because your brain needs rest. You have to eat properly. And then you’ve got to be on the right type of medication. If the medication is not working, then you have to get on something else. In my case, I stayed on one medication a little too long, and then my epileptologist said, “We’re going to find out what works best for you,” and I was weaned off one drug slowly and onto another one. There’s a lot of side effects to epilepsy drugs, but for me, today, there haven’t been many side effects, and the seizures I’ve had have not been as bad.

What did you experience? I experienced grand mal seizures [characterized by loss of consciousness and muscle spasms], and some absence seizures [“petit mal” seizures, with brief lapses of awareness]. Some were more difficult than others. I’ve had them as long as 30 minutes, and I’ve had up to 16 seizures over a two-day period. I don’t really remember anything about them. I’m very slow and lethargic and tired after having them. What can you tell us about the medical management of your epilepsy? In my case, I’ve been using different medications to stop the seizures or to limit them. Some people are having surgery now, but I was not a candidate for surgery, because I have both non-epileptic and epileptic seizures. What led you to share your story with the public? When I came to Minnesota and met Vicki Kopplin [executive director of the Epilepsy Foundation of Minnesota], she said, “Coach, you have to come out and say that you have epilepsy, because that will help so many people.” I didn’t want to do that at first, because if I

Minnesota Health care news February 2016

Photo: Minnesota Athletic Communications

What were the most supportive things that you heard from others? I’ve had support from all over the country, and I’ve turned it into a positive, instead of a negative. I just got an email from a young woman with epilepsy who rides in equestrian contests. When I saw her in Philadelphia, she said, “Coach,

you’re my hero.” People in Minnesota have been great to me. As far as the University goes, President [Eric W.] Kaler was good to me during that time. The team was outstanding. Our players made me want to coach. The faculty was outstanding. What could people do to support others? After you get them to an epileptologist, learn what you should do. Don’t hold them down. Just let them go through the seizure and make sure their head doesn’t bang against something. Don’t stick anything into their mouth. But the big thing is to get them to a specialist immediately. What about encouraging them to continue with their lives, as you were fortunate enough to do? I can give you examples of people with epilepsy who are successful right now, who are handling it all of the time. So many people won’t say anything about it because they’re nervous about their job. I can tell you that there are CEOs in the state of Minnesota who have epilepsy, but they’ve never told people, because they don’t feel like they can, or they don’t want to. They hide it, which I understand. As a football coach, it was hard for me to hide anything. But there are many who do.

for kids with epilepsy and seizure disorders, and for some of those kids, it’s the happiest place they go. My wife and I are also a big part of the Coach Kill Chasing Dreams Epilepsy Fund. The money that we raise goes to Camp Oz. And we’re working with schools to help them understand how to deal with somebody who has a seizure disorder or epilepsy. I also have opportunities to speak all over the country, share my story, and talk to doctors and top researchers. What else do you want the general public to know about epilepsy? I’d ask them to jump in and help us with the Chasing Dreams Fund, which will help us to educate those who have epilepsy, educate the schools, and continue to keep Camp Oz going. I want people in Minnesota and across the country to know that it’s a problem and we need to do all the research and attack it as we would any other disease. In time we’ll be able to handle it, but we need financing in order to do that. Until then, our dream is to help kids chase their own dreams, whatever those may be.

People in Minnesota have been great to me.

What are your plans moving forward as you work with the Epilepsy Foundation of Minnesota and other community groups? We have a camp in Wisconsin called Camp Oz

To learn more about Coach Jerry Kill’s story and the programs mentioned in this interview, visit the Epilepsy Foundation of Minnesota’s website at www.epilepsyfoundationmn.org.

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February 2016 Minnesota Health care news

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Obstetrics

Birth centers New trends and approaches By Michelle Smith, MSN, MBA, RNC, and Alice Chernich, RN, MSN

oday’s birth centers offer a different experience than your mother probably remembers. Centers today look and feel more like high-end hotels than maternity wards, with many featuring large private rooms for mothers and babies and dedicated family spaces to welcome loved ones. But newborns enter the world the same way they always have, and the spa-like environments are engineered to accomplish that as safely as possible.

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The ambiance of a new birth center is much gentler than the maternity units of the past, and the health providers are more flexible in their thinking. Since you can choose where to have your baby, including at home, birth centers compete, and their goal is to help you have an exceptional experience. And because the birth experience is unique for you and your family, birth centers offer multiple options to be sensitive to your specific preferences. But not all birth centers are the same. Here are some ideas and considerations to look for when making a decision. Birth options to consider New parents can expect more than just fancy rooms. Today’s birth centers encourage mothers to work with physicians and health care providers to choose the type of birth that works best for them, based on individual preferences and medical considerations. Start your research early, and be prepared to discuss multiple options with your provider or family: • Traditional birth or vaginal childbirth, which begins with labor to coax the baby through the birth canal.

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Min n esota Health care n ews February 2016

• Cesarean birth (C-Section), a surgical approach that may be planned in advance (at your physician’s recommendation) or used as an emergency procedure if your health care provider determines that the health of you or your baby is at risk. • M idwife birth involving a certified nurse midwife, a registered nurse with advanced training in midwifery. A midwife can provide care throughout pregnancy, childbirth, and after childbirth. • Doula birth involving a doula, or birth assistant, that the mom or family has previously selected and coordinated to accompany them. A doula is specially trained to guide you through labor with relaxation and breathing exercises, massage, words of encouragement, and other comforting measures. A doula can also work with your husband or partner to encourage involvement and to create a warm and positive experience. A doula does not replace your health care provider, nurses, or other medical staff.

• Water birth is the process of giving birth while immersed in a tub of water. Water birth is available to women who meet certain criteria. During labor, the mother is in a cushioned tub of warm water that can help her relax and manage pain. At birth, the newborn is lifted out of the water.

Baby Center, for instance, offers a mobile app that lets parents follow baby’s kicks and movements during pregnancy, time and track contractions during labor, and track feedings and diaper changes after baby is born. Lactation. Lactation consultants offer support to moms learning how to breastfeed. Moms may request to see them during their hospital stay and make appointments to see them after they leave. Lactation consultants are registered nurses who are certified by the International Board Certified Lactation Consultants.

Service and support New parents may also expect an expanded range of services before, during, and after delivery, including: Pain relief. Pain relief during labor includes both pharmacological and non-pharmacological options, depending on what makes sense for you and your family. Anesthesiologists and certified registered nurse anesthetists should be available 24-hours a day to help you through your childbirth experience.

Centers today look and feel more like high-end hotels than maternity wards.

Many families prefer alternative approaches to pain control. For example, Allina Health’s Penny George Institute for Health and Healing offers integrative therapies to many new moms before, during, and after delivery at The Mother Baby Center at Abbott Northwestern and Children’s Minnesota. Therapies include acupressure, acupuncture, massage, relaxation techniques, guided imagery, and more. Online support. Most birth centers offer online resources to support families before, during, and after childbirth. The Mother

Some babies, for medical reasons, require supplementing, and in the past this was done by giving formula. Some centers have donor breast milk that can be given when medically indicated to better support exclusive breast milk for infants.

Social workers. Childbirth can be an emotional roller coaster for some patients and families, and clinical social workers can provide services to help with physical, emotional, and social issues and concerns. Social workers assist in crises intervention, counseling, and bereavement. They can also connect you with financial, hospital, and community resources. Many health care facilities and birth centers can put you in touch with social workers on staff or in the community. Birth centers to page 29

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Director of the Master of Public Health Program, North Dakota State University; Senior Policy Advisor, Great Plains Tribal Chairmen’s Health Board

Learn more and register at

alz.org/mnnd #ALZminds February 2016 Min n esota Health care n ews

Dermatology

Acne Treating a common condition By Charles E. Crutchfield III, MD

cne—also known by the medical term acne vulgaris—is the most common skin disorder in the U.S., and the number one reason patients visit a dermatologist. Approximately 50 million Americans suffer from acne. While more than 80 percent of all teenagers battle acne, it is, unfortunately, not just a teenage disorder. In fact, acne can occur at any stage of life. Over 35 percent of women over the age of 30 struggle with acne. There are often significant physical and psychological side effects, such as scarring, low self-esteem, anxiety, and depression.

Internet postings and advice from friends and family can often lead those seeking legitimate acne information astray. Here we will discuss and explain the causes, complications, and treatment options from the knowledge base of a board-certified dermatologist and skin doctor. Causes of acne Six key players contribute to acne formation: 1) Excess oil (sebum) production 2) Clogged pores 3) Bacteria 4) Inflammation 5) Genetics/hormones 6) Trigger foods Many areas of our skin contain oil-producing glands, with large numbers concentrated in the face, neck, chest, and back. The oil produced by these glands, also known as sebum, provides many advantages, including protection of the skin and even mild immune protection. Sebum travels to the surface of the skin via tubes, commonly called pores, the insides of which contain skin cells. These skin cells sometimes become sticky, creating a clump that can plug the pore and produce a small bump. The medical term for a plugged pore is a “comedone.” If the contents become oxidized and turn dark, the lesion is termed an “open comedone,” commonly called “blackhead.” If no oxidation and darkening occurs, the lesion is called a “closed comedone” or “whitehead.” Comedones are the precursors to acne. When oil is produced behind the plugged pore, a nodule develops. This nodule attracts bacteria, which in turn release “free fatty acids” that cause extreme inflammation. Inflammation produces redness, bumps, and pustules, the clinical manifestation of what we call acne.

Minnesota Health care news February 2016

Hormones influence oil production and the ability of skin cells lining the inside of pores to stick together and plug the pores. That is why acne occurs in adolescence, as hormone levels start to change. It is also why situations that influence hormone levels—such as stress, medications, and menstruation—can make acne worse. Genetics and heredity determine the level of sensitivity to hormonal changes, which is why some people suffer more with acne than others.

Foods are not a significant contributor to acne, although some foods may be personal triggers for some people. These include greasy foods, chocolate, and a diet high in dairy, especially skim milk. If you find that your acne flares on a regular basis after eating these foods or any others, you should minimize them in your diet. You may also need to avoid some cosmetic products than can exacerbate acne. These may include makeup and hair care products. Use skin care products labeled “non-acnegenic” if possible. Sports equipment that applies pressure on the skin and clogs pores can also lead to acne. Acne treatment options The six key players causing acne also serve as targets to modify in its treatment. Contrary to popular TV commercials, there really are no overnight treatments for acne. It takes four to eight weeks to see a significant improvement with most acne treatments, and continued success requires ongoing treatment. While waiting for an acne treatment to work, it can be tempting to manipulate or squeeze acne lesions to make them go away faster. Dermatologists do not recommend squeezing acne lesions. Manipulating acne lesions can make the situation worse and cause permanent scarring.

• Steroids, taken in pill form on a short-term basis to prepare the skin for a big event like a wedding, prom, senior class picture, or any big event where the skin needs to look its best on short notice. This is a rescue treatment for very special situations and certainly not a long-term approach to acne control. Steroids can also be injected into painful acne lesions for pain relief and good short-term results, but steroids can also cause depressions at the injection site. • Retinoids, a class that includes isotretinoin. This medication, a variation of vitamin A, is the most effective acne treatment, and the only medication approved by the U.S. Food and Drug Administration (FDA) for severe nodulocystic acne. While it is the only medication that can cure acne, isotretinoin has many complications and must be used with strict oversight under the close watch of a dermatologist. If pregnancy occurs during the taking of isotretinoin, severe birth defects can occur. All patients taking isotretinoin must enroll in the FDA’s “I Pledge” safety program. There are regular monitoring visits and other risks and considerations with this medication that should be discussed in detail with your dermatologist.

There really are no overnight treatments for acne.

Acne to page 32

Acne treatment may utilize topical treatments, systemic treatments, or a combination of both. These treatments may include over-the-counter products or medications prescribed by a doctor/ dermatologist. Topical over-the-counter acne treatments (available under many brand names) may include benzoyl peroxide or salicylic acid, or may take the form of chemical acne peels designed to remove (exfoliate) the top layers of skin. Topical prescription products come in many forms, including gels, creams, lotions, and procedures. Your doctor will recommend the best form for you; possibilities include: • Antibiotic lotions/gels, used in part to reduce the bacterial population of the skin, but, most importantly, to serve as effective anti-inflammatory agents. • Retinoids, which prevent skin cells from clumping and plugging the pores. They may also break up pores and help to reduce oil production. Many dermatologists believe this is the fundamental treatment for acne. • Topical anti-inflammatory medications, a newer class of drugs that includes potent anti-inflammatories such as dapsone. • Laser and other light-based treatments that can reduce oil production and inflammation contributing to acne. Oral prescription products, prescribed by your doctor or dermatologist, may include: • Antibiotics, used for their potent anti-inflammatory properties. • Hormone modulators, including birth control pills and anti-androgen medications such as spironolactone.

February 2016 Minnesota Health care news

Legislation

Pending health care issues By Kate Johansen, JD

he start of a new year also brings the start of a new legislative session. The 2016 Minnesota Legislature officially convenes March 8, but the state’s work is already well underway. Health care leaders and advocates work both during and between sessions to advance issues that impact all Minnesotans, often turning to the public for input.

Get involved Private citizens can impact legislation by reaching out to legislators, attending committee meetings, or providing public comment at each step of the way. It might help to know a bit about the process. The Minnesota Legislature operates on a biennial schedule. That means the state passes legislation in two-year cycles, with each year considered one “session.” In odd-numbered years, the Legislature usually convenes from January to May, with a main goal of passing a state budget. In even-numbered years, the session begins in late winter and concludes in May, with a main objective of passing a bonding bill. Legislative schedules often determine which additional issues the Legislature addresses each year. Many expect 2016 priorities to include legislation to increase transportation funding, cut taxes, and approve bonding measures. But health care remains a perennially important topic. Past sessions, especially since the advent of the Affordable Care Act (ACA), have produced health care legislation of significant impact to the general public. Previewing the 2016 session Below are some of the recent, current, and forthcoming 2016 health care issues before the Minnesota Legislature. Budget matters. Health and Human Services (HHS) is the largest part of the state’s budget, representing more than $12 billion in spending for 2016–2017. In addition to paying for Minnesota’s existing health care programs, the current budget bill also included an extra $138 million to boost pay for nursing home workers, required that providers be paid equal reimbursements from commercial insurers for telemedicine services, and provided a significant investment in mental health services. It did not include significant changes to Medical Assistance (MA), MinnesotaCare, MNsure, or other state programs that support state health care. While Minnesota now forecasts a $1.8 billion budget surplus, it is unlikely that the Legislature will direct much of this surplus to

Minnesota Health care news February 2016

additional health care spending, since the existing budget had bipartisan support and adequately funds current state health care programs through the next biennium. Moreover, other issues, such as required state savings, transportation, and tax reform, will likely take priority. In other words, 2016 will be a quiet year for health care expenditures.

Prior authorization. Last session, the Minnesota Medical Association (MMA) advocated for state legislation to change prior authorization of certain prescription medications. Without such prior authorization, insurance providers and third-party carriers could deny coverage, forcing consumers to pay more for their prescription drugs. The bill, Senate File 934 (Franzen-DFL) and House File 1060 (Albright-R), offered 18 pages of reform to the current system and generated both strong support and opposition. The bill carried a

Private citizens can impact legislation.

One of the task force’s recommendations was to continue MNsure. The online health insurance exchange continues to recover from its rocky start, and information technology infrastructure, while much improved, remains a challenge. Some lawmakers had previously favored dropping MNsure altogether and moving the state to the federal HealthCare.gov exchange, while others pointed to the costs and complications of such a transition. The task force recommended to continue the program for now and to launch a comprehensive review of MNsure following the end of the current open enrollment period. To fund future MNsure operations, the task force also recommended expanding a user fee withheld from premiums paid on individual health care insurance plans. That fee—currently 3.5 percent—is currently levied only on plans sold through MNsure and then applied across the market. The new recommendation asks the Legislature to reduce that rate, but to apply the lower amount to individual plans sold outside of the MNsure exchange. Federal grant assistance for MNsure ends in 2017. The task force also examined the future of public health care programs, including MinnesotaCare, which offers low-cost plans for Minnesotans meeting income guidelines. When Minnesota implemented the ACA, it had to lower those eligibility guidelines from 275 percent of the Federal Poverty Level (FPL) to 200 percent. The task force recommended expanding eligibility back up to the former 275 percent of the FPL, and adding new benefits to align with Medical Assistance. These steps would require federal approval, so the issue will remain a discussion instead of a decision in 2016. A “provider tax,” imposed on payments health care providers receive for providing services to patients, currently funds Minnesota’s Health Care Access Fund, which finances health care programs such as MinnesotaCare. But the Legislature has raided that fund to pay for other projects not related to health care. The tax is currently slated to sunset at the end of 2019, leaving MinnesotaCare without a clear finance mechanism. The task force recommends continuing the provider tax through June 2021.

2016 Legislative preview to page 19

Telephone Equipment Distribution (TED) Program

Task force topics. The most recent budget also funded a Task Force on Health Care Finance, which submitted its final report on Jan. 15 with recommendations affecting both public programs and MNsure, the state’s online health insurance marketplace for consumers and small businesses. While the report is expected to shape 2016 legislative discussions, it could face opposition in the Republican-dominated House, because some of its recommendations are at odds with positions taken by that party last session.

The task force also addressed care coordination and payment reform. First, the group focused on how Minnesota laws hinder integrated care delivery. The task force recommended amending state law to allow providers to share patient information more effectively with each other and with relevant health groups. Privacy advocates will strongly oppose this measure if it emerges in 2016. Second, the group made recommendations regarding new payment structures, including the expansion of direct contracting projects. The Legislature will likely start discussing care delivery and payment reform as health care issues as a result of the task force’s work.

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

1-800-657-3663 www.tedprogram.org Duluth • Mankato • Metro Moorhead • St. Cloud The Telephone Equipment Distribution Program is funded through the Department of Commerce Telecommunications Access Minnesota (TAM) and administered by the Minnesota Department of Human Services February 2016 Minnesota Health care news

Calendar Feb.-Mar. 2016 Feb.20

The National Ataxia Foundation offers this free support group for those affected by ataxia and their loved ones. Come gain insights, support, and new connections. Call (612) 924-4947 or email maryann. sween@gmail.com for more information. Saturday, Feb. 20, 10–11 a.m., Langton Place, 1910 W. Cty. Rd. D, Roseville

Cancer Support Group

Fairview Health Services offers this free support group for anyone affected by cancer and their friends and loved ones. Join the informal discussion and gain support in dealing with a cancer diagnosis. No registration required. Call (952) 9245000 for more information. Tuesday, Feb. 23, 10 –11 a.m., Fairview Southdale Hospital, Board Rm, 6401 France Ave. S, Edina

Brain Aneurysm Support Group

HealthEast invites people dealing with a brain aneurysm and their loved ones to join this free monthly support group. Registration not required. Call Tess at (651) 326-3415 for more information. Thursday, Feb. 25, 12:30 –2 p.m., St. Joseph’s Hospital, dePaul Tower 2nd Flr., 3M Conference Ctr., Conference Rm. C/D, 45 W. 10th St., St. Paul

Multiple Sclerosis Awareness Month

Ataxia Support Group

Talk With a Doc About Breast Health

Allina Health hosts this free education session for anyone wanting to learn about breast health. Bring your questions for an interactive discussion about breast cancer risk factors, screening guidelines, and more. Two times are available; no registration required. Call (651) 255-8108 for more information. Saturday, Feb. 27, 1–2 p.m. and 2–3 p.m., Whole Foods Market, 222 Hennepin Ave., Minneapolis

Send us your news: We welcome your input. If you have an event you would like to submit for our calendar, please send your submission to MPP/Calendar, 2812 E. 26th St., Minneapolis, MN 55406. Email submissions to amarlow@mppub.com or fax them to (612) 728-8601. Please note: We cannot guarantee that all submissions will be used. CME, CE, and symposium listings will not be published.

Multiple Sclerosis (MS) is a nervous system disease that affects the brain and spinal cord, disrupting communication between the brain and other parts of the body. It is not yet fully understood what causes MS, despite the fact that it is the most widespread neurological disease among young adults across the world. Most people diagnosed with MS experience their first symptoms between the ages of 20 and 40. Typical initial symptoms are blurred or double vision, red-green color distortion, or blindness in one eye. MS can also cause muscle weakness, trouble with coordination and balance, sensations of numbness or pins and needles, and thinking and memory problems. The disease tends to be mild in most people, however, some lose the ability to write, speak, or walk. There is no known cure for MS. Medications have been shown to help ease MS attacks and possibly slow down the disease, however many of these have serious side effects and some carry significant risks. Physical and occupational therapy can help manage symptoms and improve quality of life for people with MS.

Feb.24

Support Group for Recently Diagnosed

The Upper Midwest Chapter of the National Multiple Sclerosis Society offers this monthly support group for anyone diagnosed with MS in the last 10 years. Come learn more about the disease, gain knowledge on how to manage symptoms, and connect with others. To sign up, call Carol at (612) 212-1511. Wednesday, Feb. 24, 6:30–8 p.m., Houlihan’s Restaurant, 6601 Lyndale Ave. S., Richfield

March1

Newly Diagnosed with Epilepsy Event

The Epilepsy Foundation of Minnesota offers this free open house for individuals newly diagnosed with epilepsy and their families. Come learn about available services, meet others, and gather resources. Please call (651) 287-2310 or email rsvp@efmn.org to sign up. Tuesday, March 1, 6–8 p.m., Epilepsy Foundation of Minnesota, 1600 University Ave. W., #300, St. Paul

Understanding Medicare

Hennepin County Library hosts this free class to learn how to navigate Medicare. Come learn about how and when you should enroll, what changes resulted from the Affordable Care Act, and what services are available through the Senior LinkAge Line. For more information or to RSVP, call (612) 543-5825. Monday, March 7, 6:30–7:30 p.m., Plymouth Library, 15700 36th Ave. N., Plymouth

Multiple Myeloma Support Group

Park Nicollet hosts this free monthly support group for individuals with myeloma, their family members, and friends. Share your experiences with other patients with multiple myeloma from those just diagnosed to a survivor of more than 19 years. No registration required. For questions or more information, call Pat at (952) 649-1377. Saturday, March 12, 10 a.m.–12 p.m., Park Nicollet Frauenshuh Cancer Center, 1st Flr. Conference Rm., 3931 Louisiana Ave. S., St. Louis Park

ALS Family Caregiver Support Group

The Minnesota/North Dakota/South Dakota Chapter of the ALS Association offers this monthly support group for family members who are caring for loved ones living with ALS. Come connect, ask questions, and learn from other caregivers. Contact Jennifer at (612) 672- 0484 to register. Wednesday, March 16, 7–8 p.m., Union Plaza Building, 333 N. Washington Ave., Ste. 105, Minneapolis

America’s leading source of health information online 18

Minnesota Health care news February 2016

2016 Legislative preview from page 17

high cost and logistical challenges; it did not advance last session. Electronic prior authorization, required starting Jan. 1, 2016, will hopefully resolve many of the issues the legislation sought to address. Still, prior authorization will return as a legislative issue in 2016. Costs and prescription drugs. The Legislature may focus on a new issue in 2016: health care costs. Cost growth slowed for a few years but recently began accelerating again and continues to outpace inflation. One high-profile driver is prescription drug costs. Prescription spending jumped 13 percent, to over $374 billion, in 2014— the highest increase since 2001. Miracle drugs, such as Sovaldi, can cost more than $100,000 annually. Patients bear these costs through their premiums and out-ofpocket payments. And 75 percent of voters say prescription drug costs are too high. Given recent news stories about the issue, legislators may raise the topic in 2016 to see what Minnesota can do.

that impact the public never receive press coverage. Here are some tips to follow emerging legislation: To track a bill, visit the Legislature’s “Bill Search and Status” tool at www.leg.state.mn.us/leg/legis. Search for bills by their assigned numbers, authors, and topics, or search by key words. The site also shows the legislative history of a bill, including the committees in which it has been heard and links to audio and video discussions by legislators.

Many initiatives that impact the public never receive press coverage.

Follow the process Health care issues are wide-reaching and complex. The above are just a few of the topics that may emerge in 2016. Many initiatives

Don’t Suffer Alone

To track multiple bills, visit “MyBills” at www.leg.state.mn.us/mybills. Enter your preferences, and view bills and relevant information based on your entries; the service even sends you alerts and updates if anything changes.

To reach out to your legislator, visit www.leg.state.mn.us/leg/districtfinder. This Secretary of State site allows you to search for your elected officials, and provides contact information and links to their offices. To review current laws, visit the Office of the Revisor of Statutes site at www.revisor.leg.state.mn.us, which posts all state statutes and regulations. Kate Johansen, JD, is director of government relations at Medica.

Gambling Addiction Is Lonely

RecoveRy is Not

For most, gambling is a fun-filled adventure enjoyed in the company of others. But for a gambling addict it is often a lonely pursuit as they become more and more withdrawn and desperate.

Don’t suffer alone. Treatment is free and confidential. And it works.

Gambling addicts don’t need to suffer alone. A full life can be restored with treatment and support.

Call 1-800-333-HOPE • Or visit www.NorthstarProblemGambling.org February 2016 Minnesota Health care news

Minnesota health care roundtable

Mr. Starnes: Conservative estimates suggest that one in five people have some form of behavioral health concern. In Minnesota, that means that over 1 million people could use professional assistance. Every element of the health care delivery system finally recognizes the role that behavioral health care can play in improving the quality of life and lowering overall costs of health care. How can recognizing and treating behavioral health issues before they manifest in negative ways address these issues? Dr. Sulik: A recent report found that, on average, the cost of treating a medical condition will triple if the individual has a co-occurring behavioral health condition. Data also show that an adult with a serious mental illness will die 25 years sooner than an adult without a mental illness. This is an extraordinary statistic, but it has not triggered the level of alarm that it should. These individuals are not dying as a result of their behavioral health conditions, they are dying as a result of medical conditions that their mental illness impedes access in care for. Dr. Gibbs: I recently read about an individual in St. Cloud who had a serious mental illness that had not been fully diagnosed. While they were waiting to get a formal diagnosis and treatment plan in place, a police officer was killed, and the patient ultimately died as well. It was a very bad outcome, because of the lack of access to care and because they could not get the right assessment at the right time. Judge Meyer: I have yet to meet a person in my professional career that we have reached before things got out of control. By definition, people appear in front of me after they have been charged with a crime. I have seen how treatment and taking a holistic approach to their physical health, behavioral health, housing, medication, employment, and education can turn lives around so that people do not remain in crisis. That means fewer emergency room beds, fewer jail beds, and fewer crimes. Their whole quality of life improves. Ms. Lantz: For a lot of the population, particularly on the high end of the need spectrum, access to behavioral health care opens up access to primary care and physical health care. That population has a much

About the Roundtable Minnesota Physician Publishing’s forty-fourth Minnesota Health Care Roundtable examined the topic of Behavioral health integration: New pathways to care. Eight panelists and our moderator met on Nov. 12, 2015, to discuss this topic. The next roundtable, on April 21, 2016, will address Medical innovation vs. medical economics: When payment policies limit quality of life.

generalized anxiety. There is a shame associated with that, and so to make that bridge or to have that openness within primary care to say, “Yes, this is also my struggle,” is a barrier that we need to overcome. Dr. Schiff: We often face folks who have already hit the criminal justice system or are already seriously mentally ill, but people move up and down a continuum of mental well-being. Finding folks earlier—before their illness gets out of control and also earlier on in their lives—should be the focus for resources and effective treatment. Mr. Starnes: What obstacles or barriers to access do patients face in seeking care for behavioral health concerns? Dr. Gibbs: Beds are very limited. It is a huge problem, starting with the waiting list to get acute patients into the hospital. The other problem—getting patients out of those beds and into an appropriate aftercare setting—jams up the whole system. It has been a serious problem in Minnesota for the last five or six years, and it usually gets worse in the winter.

Behavioral health integration New pathways to care higher incidence of asthma, of cardiovascular disease, of pulmonary disease, and of preventable disease. So, as folks come in to the mental health system, we need to look at physical health indicators and figure out how to get people into primary care as well. Dr. Pederson: We sometimes forget that behavioral health and medical conditions are linked together, especially in the older population, where you may have some cognitive impairment that makes it harder to distinguish the two. We need to work together so that primary care is not just going down its path, or mental health is not just going down its path, with neither one seeing how they could link together better. Ms. Anderson: Another important perspective is the stigma for clients of even being offered resources, whether it is a serious and persistent mental illness or a

Minnesota Health care news February 2016

Ms. Anderson: Prior authorization also creates significant obstacles, especially with some third-party companies that are paid to scrutinize and make decisions without ever meeting the client or speaking to the treatment team. If a client does not fall within this box at this time or into an average length of stay or treatment, their coverage is denied and their access is limited. Dr. Beecher: I helped my patients deal with prior authorizations and reimbursement limitations as a solo practitioner. For five years, as a medical director for a PPO [preferred provider organization], I was on the other side of those issues. I left that position because my style was to call and find out what the assessment and the plan was, to speak with some professional who knew what was going on. I would usually approve it and I do not think that was thought of too highly by some of the people that were hiring me, so I finally decided to stay in my office practice. It is a real tension, and the thing that makes one angry about it is that there are human beings involved here. Ms. Lantz: I’d like to say a word about Medicaid reimbursement rates. I do not think there is a provider out there that thinks the

Minnesota health care roundtable Medicaid rates cover the cost of care or allow for uniqueness in innovation, and that is part of the issue. Medicaid might cover much of the cost of a specific service, but when you are dealing with people, the work that you do is much broader than that, and the payment does not allow flexibility to do innovation, to be unique. It does not allow for, say, a case manager to go to a doctor’s appointment to explain what is happening. There are a lot of limitations on what Medicaid rates will allow, and they are a pretty marginal rate to begin with. Dr. Pederson: One of the things that we will do next year is to work with clinics to help them examine their screening processes for getting folks in to see providers if they are in the hospital, and to make changes in that work flow. It is a very complicated piece, but unless we study those steps and processes, there is no amount of money that we can throw at it that will make it work. Dr. Sulik: Mental illnesses cause impediments in the ability to organize and follow through. For example, if a primary care physician or advanced practice provider identifies a patient who needs mental health treatment, they will initiate a referral, but 50 percent of those patients will not be able to follow through successfully to that first appointment. If it is for a substance abuse issue, we lose 75 percent of the people. As a system, we penalize those individuals for exhibiting the symptoms related to their illness and we create additional barriers, and if somebody misses two appointments or if they do not show up for that first appointment, they cannot reschedule.

“ We need to make it okay for people to talk.” artha Lantz, MSW, M LICSW, MBA

Mr. Starnes: What changes do we need to make within the delivery system to address these issues? Dr. Schiff: Behavioral Health Homes should, with federal approval, get launched in July. The whole idea is to integrate physical health, behavioral health, and community partnerships. Basically, they are care coordination, family and patient support, education, and integrated transition. For those who are not already in a targeted case management situation, we will provide a continuity of care, with a core team delivering services. That team will involve either a nurse on the mental health side or a behavioral health provider on the physical health side, along with community health workers or peer support specialists or recovery coaches. All of those people will provide, for the first time, an integrated service. Dr. Pederson: In health care, we are not producing a product; we are producing a service. It is not the health care organization producing it and giving it to the person, it really needs to be the patient and the health care team working together. As I think more about Behavioral Health Homes and all of what we need to do regarding reimbursement, it is this joint production of health care services that we need to consider, not just a product that we are producing. Ms. Lantz: Behavioral health plans should not just be client centered, but also client driven. Consumers should

Sarah Anderson, MSW, LICSW, is CEO of Psych Recovery, Inc., where she currently practices clinically. She is the author and program director of Solveig IOP as well as the CEO of the outpatient clinic. She is also the CEO of The Professional Matrix Inc., a company that assists Minnesota social workers in receiving and providing supervision. Lee Beecher, MD, DLFAPA, FASAM, is president of the Minnesota Physician-Patient Alliance (MPPA), a nonprofit organization committed to improving health care. Now retired, Dr. Beecher maintained a solo practice in adult and addiction psychiatry in St. Louis Park for more than four decades. Timothy P. Gibbs, MD, FAPA, DFAACAP, is chief medical officer for Natalis Counseling and Psychology Solutions. A child and adolescent psychiatrist, he is a fellow in the American Psychiatrist Association and a distinguished fellow in the American Academy of Child and Adolescent Psychiatry. Martha Lantz, MSW, LICSW, MBA, is executive director of Touchstone Mental Health and treasurer of the Minnesota Community Healthcare Network. She is a licensed independent clinical social worker and holds a masters degree in business administration from the Carlson School of Management at the University of Minnesota. Judge Kerry W. Meyer is a judge in Minnesota’s 4th Judicial District, serving in the Hennepin County Criminal Mental Health Court. She has presided over cases involving adult criminal, juvenile delinquency and child protection, and civil litigation. Her current assignment, starting in 2013, is in Problem Solving Treatment Courts. Jane C. Pederson, MD, MS, is chief medical quality officer for Stratis Health, providing leadership and clinical guidance for health care quality and safety initiatives. Pederson is boardcertified in both internal medicine and geriatrics, and maintains a clinical practice providing primary care for residents in the assisted living setting. Jeff Schiff, MD, MBA, is medical director for Minnesota health care programs at the Minnesota Department of Human Services, where he focuses on the development and implementation of evidence-based benefit policy, the advancement of improved care delivery models, and the improvement of clinical quality. L. Read Sulik, MD, is chief integration officer and executive director at PrairieCare Institute. A pediatrician and child, adolescent, and adult psychiatrist, he has spent his career addressing the barriers that behavioral health needs create, as well as how these barriers contribute to negative and costly outcomes in chronic health conditions.

About the Moderator Mike Starnes has been the publisher at Minnesota Physician Publishing since 1986. His duties include the production of MedFax, Minnesota Physician, Employee Benefits Planner, and Minnesota Health Care News; directing the Minnesota Health Care Consumer Association; and hosting the Minnesota Health Care Roundtable.

February 2016 Minnesota Health care news

Minnesota health care roundtable be the creators of their plan and drive that plan. Regardless of their level of mental health condition, people still know what they want in their life. It might not be what anyone else wants for them, but they know what they want. If we can have an opportunity to be innovative or to help them meet their needs, there is that potential to open up the doors and let it be client driven, not just client centered. Dr. Beecher: There also has to be a demand on the part of the person for these services. When I was in my residency at the University of Chicago many years ago, a behavioral psychologist, Israel Goldiamond, took me down to Manteno State Hospital, and he told me he was going to take an unusual approach. During a group therapy session, he pulled the patient aside and asked, “How did you get to the hospital?” She said, “I’m a schizophrenic.” He said, “No, how did you get to the hospital?” She said, “Well, I threw a brick through a squad car window in Grant Park and the police picked me up and then I ended up here at the hospital.” So, in other words, there is a behavioral chain that needs to be identified and personalized for each client patient. Unless the team does that, we are not going to be able to motivate them.

Dr. Gibbs: We talked earlier about reimbursement being too low, but part of the issue is that reimbursement pays for the wrong things. It pays for procedures and things that are easy to put into codes, but it does not pay for things like establishing a relationship. It does not pay for sitting down and talking to the patient’s other care team. Behavioral Health Homes will pay for those things, and will allow care managers to establish a relationship with the patient and to coordinate the care. Dr. Pederson: The goal should not be following protocols, but designing protocols to help us do what we want to do for that patient. We are talking about patients who are at different places when they enter the health care system. Before we start developing the health care plan, we need protocols to help us determine where this person is. Are they at a point where we need to provide a lot of structure? Are they at a point where they can provide input into their plan? Our goal is to get them there. Ms. Lantz: There are all kinds of opportunities for technology as well, such as telemedicine in rural areas or for people who do not want to leave their homes. We also need systems that talk to each other. Primary care doctors and behavioral health providers should have access to each other’s electronic health records, with client consent. There may be not just one, but three, four, or five care plans out there, and everybody who is working with the patient may or may not know about the others. One of the greatest movements is creating those health information exchanges and figuring out a way that we can communicate between all the providers.

“ We now treat the electronic health record rather than the patient.” Lee Beecher, MD, DLFAPA, FASAM

Mr. Starnes: Another significant obstacle is the coordination of care between health care professionals who see the same patient, whether this is between a primary care physician and a mental health care professional or between different kinds of mental health care professionals. How can we incentivize this coordination? Dr. Sulik: All of our professional organizations are doing major work to set standards of communication and integration between behavioral health providers and medical providers. There has traditionally been somewhat of a black hole when a primary care physician sends a patient to a behavioral health clinician. They just automatically send the patient there and never hear much back. Even in integrated systems, there still could be barriers because of misconceptions that mental health records have to be kept completely separate. HIPAA does not prevent communication and coordination of care. The system has to incentivize providers to be able to communicate and collaborate effectively between themselves and individual patients and their families. Dr. Schiff: There was some commentary in professional journals recently about patients with mental health diagnoses having access to their own records. In the physical health world, we have made a lot of progress in this area. Some mental health patients are a little more reluctant to do that, but I think that that sort of transparency is necessary. Dr. Beecher: We also need to protect privacy. At the Minnesota Psychological Association convention last year, we had a good debate about electronic health records and whether there should be a mandate for psychologists to have access to the records. One woman working in a state system said that her clients would not come to the clinic if they had an electronic record and they knew that their information was going to be put into that record. Ms. Anderson: For people receiving mental health services, there is a lot of very personal information that they do not want shared with other professionals or to appear within their medical record. I give my patients reassurances of how I document and share information with primary care or other professionals. I tell them that I’m not going to share and document every single detail

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Minnesota health care roundtable that we talk about, but some information needs to be shared to best serve them. We are not jeopardizing their privacy by doing this, but a lot of clients get really nervous about electronic health records. Everybody has different opinions or fears about people hacking into mental health records. There could be details that some of their closest family members do not know about. We need to assure clients that data is safely protected, tell them what information we share, and the purpose behind it.

have some“ People move up and body who is down a continuum of in multiple mental well-being.” systems, to share Jeff Schiff, MD, MBA relevant information. Just having snippets of information is not the same as having a conversation about the client’s real concerns and fears, but it is still better than having no communication.

Judge Meyer: On this discussion about giving everyone access to their records, I believe that the tenor and detail of forensic evaluations would change if the professionals knew that the subject of the evaluation was going to see it. That is why, in my world, I would not want patients to see all the evaluations that are done, because I think I would not get as much detail, as a judge, to help me plan their services and the community bases I want them involved in. The psychologists are very open with me about information, but patients do not want to see their trauma written down anywhere. I need to see it in general information from the providers, but I do not think that the patients want to see it again.

Ms. Anderson: We already spend a significant amount of our time on documentation. We see clients for an hour, then we document later, on our time. Some of the documentation requirements, frankly, are ridiculous. Adding even more documentation is very concerning because there simply is not the time, and it is either going to result in lower actual reimbursement, because you do not have time to see as many clients, or you may get sloppy.

Dr. Beecher: I agree that there are special occasions where details of exams should not be shown to the patient, such as when a patient is in a court situation or forensic situation. However, why can’t we use the phone? One of the reasons I stayed in private practice and solo practice is because I could use the phone. I would call people, clinics, primary care. I was down the hall from a primary care clinic, and I would walk my patients down there. I would even do home visits occasionally if I felt that was necessary. That has vanished. We now treat the electronic health record rather than the patient, in my opinion. Mr. Starnes: Is there a way the electronic health record could be improved to allow better compatibility with behavioral health issues? Ms. Lantz: Yes, we are working on it, but it is not an easy task. There are competing thoughts about who wants what information, how that information can be shared, what information should be shared, and who has the authority to see different levels of detail. The electronic health record is not the only answer, but it is one way, when you

Dr. Sulik: One of the biggest mistakes is that people are still documenting in the exact same way they documented before the electronic health record, and it does not work that way. Also, the requirements for people providing therapeutic services do not exist in other areas of health care. There is no physician that needs to complete a 90-day treatment plan. Nobody in primary care has to do that. We treat behavioral health conditions and behavioral health providers as somehow different than the rest of health care, as if they need to be treated and regulated differently. This is health that we are talking about. Mr. Starnes: Substance abuse issues are a significant element of behavioral health. An enormous industry, disconnected in many ways from the rest of health care delivery, has grown up around substance abuse. How can this industry, which operates under very different levels of reporting and accountability, become better aligned with the rest of health care delivery? Dr. Schiff: The whole concept of a dual diagnosis for somebody who has a mental

health disorder and a chemical dependency

disorder seems almost ironic, because the two are so interrelated. People self-medicate their mental illness, for example. We need to figure out a much better way of integrating this care so people are not told, well, you can only get your behavioral health services once you have done CD [chemical dependency treatment], or vice versa. They need to be treated at the same time. Judge Meyer: Most of the people who come to me [in court] will start getting consistent mental health treatment through a substance use disorder clinic. I send almost all of them into a dual diagnosis MI/CD [mental illness/chemical dependency] program. It is incredible what we have available in our community in these areas, as well as for serious and persistent mental illness and in dealing with self-medication. It is amazing to watch the lights come on for people when I say to them, “You can’t use marijuana anymore,” and they ask, “What are you talking about?” I tell them that I know that drugs make them feel good, but that we are going to try legal drugs, so that I know exactly what they are getting every day, and have them check in with the doctor. That way we are going to get the right amount so you do not have to take this illegal substance anymore that is unpredictable. They are okay with that. They agree to try that. We start through the detox process

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Minnesota health care roundtable “ We have to keep hammering away at reducing stigma.” Timothy P. Gibbs, MD, FAPA, DFAACAP

in a CD treatment facility and they just do a great job of having mental health providers, psychiatrists for medication, and therapists to start talking about the underlying trauma that led to the substance use in the first place, and then they integrate the physical care as well. Mr. Starnes: Are patients with substance abuse disorder viewed as “less sick” than patients with other types of behavioral health care issues, and are there issues around pulling this type of data into the medical records? Dr. Gibbs: I believe that the issue of stigma has come up for some patients. Somehow substance abuse disorder is seen as something that is behavioral, rather than as an underlying illness. Patients may want their records kept separately, because they think that substance abuse diagnoses will affect their ability to get insurance or a job later on, and the mental health professionals are complacent with that and say that these records are somehow special, they need to be kept in a special place. I think it is a bad system and a bad split that has grown up and we just need to say that this is all part of health treatment, it should all be treated equally. Ms. Lantz: I believe that most mental health folks feel as if mental health has been siloed from the system, and some believe that chemical dependency has been siloed from the mental health community even further. Mental health funding has really shifted

over the last 15 to 20 years. It has become more of a Medicaid-reimbursable service, and been added to the state Medicaid plan. Chemical health did not follow that route. There is a state-funded consolidated treatment fund that covers most chemical dependency services and has not been embedded into categorical funding, and so it creates systems where you are not sure how much and what is going to be funded every year. You are creating a system that is more driven by the Legislature and how much money can be added to that consolidated treatment fund. Medicaid is not the be-all, end-all for everything, but at least there is a susceptibility model there and at least there is a predictability around that, so I think those funding models really have hampered some progress that chemical dependency could have had. Mr. Starnes: Let us talk about the negative social perception or stigma that is associated with mental illness. What impact does this have on individuals with mental illness and what can we do to change it? Ms. Anderson: A large part of that starts with the legislation and with our government. The Department of Human Services is given a budget by the Legislature and the governor. When have they heard your voice? It is amazing that a lot of times we get caught up in our professional world, and we do not follow through with macro-level advocacy. It is sad, because we could have quite an impact if they did hear our voice. If we shaped policies and law based on how to best treat people and what we want for our community, versus waiting for something terrible to happen and then reacting to it, it would be a great start. Dr. Pederson: Words are always important. We think about mental illness being

in this bucket and physical illness being in that bucket. We have to start putting them together into that holistic piece. Also, we need to quit thinking about health care as a product, and thinking that we always have to do something. It is much easier to do something about blood pressure, for example. It’s a little harder for me to get my head around what I am doing if you are suffering from anxiety. I can give you a pill, but that might work, or it might not. We have to change our thinking about how these all come together. Ms. Lantz: Some of the new approaches are putting behavioral health into a public health model. It could be funding more education programs, embedding language about emotional health in schools, and using a public health approach to educate a community. We need to make it okay for people to talk about feeling sad, having depression, being anxious, all those things. Dr. Schiff: Where you cross from being well to being ill is really a vague thing. There is no magic number at which my risk is incremental as I go further up the line. The other thing about stigma is that we are trying to determine where mental health issues can be addressed. If we could address a lot of them in primary care, there would be less suffering, because people would have access where they would not necessarily have it otherwise, because of culture or gender or generation. Not everyone wants to run off and talk to a psychiatrist or a therapist, so we need to find the right balance and create improved access across the board. Mr. Starnes: What are the best ways to measure outcomes in behavioral health? Dr. Gibbs: The ideal would be to interview the patient four years or six years after treatment and ask how things turned out and have the patient say, “Well, I still have this problem,” or “No, that problem is completely gone and everything is good in my life.” We do not have the time or the tools to do that now, but we can do other kinds of measurements that will show us how patients are doing in the short term. Sometimes those tools show us things that the patient cannot or will not tell us in our face-to-face interviews. At our clinic we are developing our own outcomes measure using a 50-question, patient-administered questionnaire on an iPad or other electronic device. It gives a color-coded visual result

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Minnesota health care roundtable that you can view immediately in the medical record, and we share it with the patient. We also share it with the other providers to enhance coordination of care. Dr. Sulik: You need standardizations in what is measured and how it is measured. More than anything, we need a standard to measure how patients envision their ideal state and how treatment is improving their pursuit and achievement of that ideal state. We also need to be more efficient in providing behavioral health care and in making it less costly than it is today. If we do that well, we can also impact that individual’s total cost of medical care. Outcome measurements must be value-added, and they must be clinically relevant. I should not be measuring anything if I am not engaging the patient in that measurement, and I should not be reporting anything about an outcome if the patient has not already been engaged in that measurement. Dr. Pederson: We have outcome measures for accountability and outcome measures for quality, and we try to use them in the same way. We have a lot of measures created for accountability, but they really are not useful when we look at quality. We need to examine those measures to determine whether that provider/patient team could actually make an improvement in this measure, if they work together, if they use best practices. Mr. Starnes: Are you talking about the difference between measures of process versus measures of function? Dr. Pederson: No, not necessarily. Measures of process help us determine whether we are following the process in the way that we intend to follow it. Sometimes we can improve outcomes without ever changing the process, just because we are paying closer attention. The outcomes, then, are the actual output of that process that we can review over time. If it is not where we want it to be, we need to go back and look at how we changed that process of care. Those measures can be really helpful to the providers, as opposed to chasing down all these various measures that they are not necessarily linked to.

that we finally voted that sexual orientation was no longer a pathology. Can you imagine arranging process and outcome measures based on homosexuality and treatment? Well, there were people who were doing things like that even though we did not have it all systematized and did not have computers going at the time. We have got to be very careful about defining what a mental disorder or a mental illness is, and about what these things are called. Mr. Starnes: What issues do we need to address to better integrate families into the care team for individuals with behavioral health issues? Dr. Schiff: We need to ensure that we are using tax dollars wisely, but without prescribing too much detail to providers. And we must engage families. We have spent some time talking about privacy issues, but people do not get better in isolation or in isolation with their mental health providers. They get better in their communities and with their families. Behavioral Health Homes can support that reintegration into families and communities. Dr. Sulik: That is a great example of something that is not treatment but that supports the healing process. We have to change our way of thinking and our way of reimbursing to support individuals and their healing processes. Community and family support is critical, but there is no current mechanism of reimbursement. The idea that a Behavioral Health Home can reimburse for patient and family support is an innovation.

on building a supportive network around somebody. Different studies have shown that if people have two authentic relationships that are supportive of their well-being, then their odds of improving their life are far more significant. Having this supportive environment of people is the correct focus. There are a lot of clients who do not have family or who have families that do not want to be involved. Dr. Beecher: Dr. Marc Galanter [New York University School of Medicine] has a book on network therapy in which he goes through the steps of sitting with patients and identifying their significant others and supportive people. He asks patients who their friends are, who they can trust, stuff like that. Then he sets up contracts with the patient so that he can get hold of somebody to help if neccesary, or somebody could call him if the patient slips. Judge Meyer: For many of the people I talk with and work with, their families are the source of their trauma. It may not be the cause of their mental illness, but it is certainly an underlying trauma that has kept them from dealing with it appropriately. Their families, frankly, are clueless about mental illness and symptoms. They either say, “Oh you might be doing fine right now, but I know you are going to slip later,”

Ms. Anderson: We make a lot of assumptions when we use the word “families” with regard to our clients. A lot of times, those assumptions are not going to be helpful. Instead, I would focus

“ Behavioral health and medical conditions are linked together.” J ane C. Pederson, MD, MS

Dr. Beecher: I want to talk about diagnoses in this context. Until 1973, homosexuality was a disease, according to the American Psychiatric Association. I was on the assembly of district branches at the time

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Minnesota health care roundtable or they say, “There is nothing wrong with you, you have a learning disability, that is all. We do not have mental illness in this family.” There’s so much denial and it really counteracts what we are trying to do. So if there is a supportive family, awesome, right, they really care. But in the case of other family members, we just cannot possibly pull them along far enough to be helpful to the recovery process.

their understanding that we can create an ability within them to undergo that change. We have really failed to invest our time and efforts to make certain that our patients fully understand what we are thinking and what we believe may be impacting them, and helping to make sure, before they leave us, that they have achieved an improvement in their thinking and understanding about themselves.

Mr. Starnes: Ultimately, success with therapy comes down to choices that need to be made by the individual patient. How can this individual be best educated and engaged and empowered to make the choices that will be most beneficial?

Ms. Lantz: Even after they understand what they need to do, figuring out where to go for that particular help is very difficult. Even for people who have been in the field for a long time, understanding the mental health system and the chemical dependency system, how to access it, what kind of funding is needed, what criteria you have to meet— it really takes some kind of navigator within the system to understand it all.

Dr. Sulik: In all of health care, we have probably done an okay job of telling people what might be wrong and what they need to do to fix it. We do not do a good job at all, in behavioral health as a whole, but also more broadly in health care, in really developing that individual’s insight into what is truly going on and why. We don’t explain the full impact on them, how they can prepare to undergo the change they need to make, and how to find the right type of structure and support to undergo that change. It is really through education and improving

Ms. Anderson: If I ever told somebody that I knew what was best for them, I would lose them. The better path to success is to start where the client is at, offer them choices, and have them make the decision. Dr. Pederson: We have a son who is a French horn player and when he was going through his auditions we realized he had pretty significant performance anxiety. Me being the physician, I told him, “I have diagnosed your performance anxiety, and you need to see a mental health professional.” He did that, but said it did not help, and I thought, this system just does not work at all. Really, what he needed to do most was to talk to his friends. They said, “Hey, we all have performance anxiety.”

“ We need to assure clients that data is safely protected.” arah Anderson, MSW, S LICSW

The answer is to figure out how you can get people the tools, the techniques, to deal with some of these things. I was coming at it from the wrong perspective. I was coming at it by saying, “I diagnosed this, I am giving you the treatment, why aren’t you taking this from me?” We need to change our perspectives. Dr. Schiff: This is an interesting point: when is it a diagnosis, and when are you somewhere else on the continuum? I have a similar story with my son, who was sad at one point. I chose not to take him in because I knew he would have a diagnosis. I thought, okay, we are going to deal with this, and we dealt with him in a number of different ways, and actually he did go in for a while and then he left. He said, “All I need is my dogs, my friends, and my music.” He has recovered with support. One of the challenges is that we are all in this business. Diagnosis does not mean something bad for us, because we are past the stigma, but sometimes we have to figure out what are we going to do for mental well-being that is not diagnosis-related. Dr. Beecher: It has got to be a mutual thing between patients and providers. I might ask, “Why did you come today and what would you like to take away?” If I am a psychiatrist and I am supposed to do the meds or whatever, I will try to tell you what I think my role is in the system and then I will say, “Well, you know, I am supposed to help with the meds today, what do you think about that and where are we at?” And then I can say, “I am frustrated, too, with this crazy quilt system. Let’s see if I can help you and we get through this thing together.” Dr. Gibbs: I have a group of patients who have complete insight into their problem and still cannot change. So education is not the only thing. But if we use these outcome tools to share with the patient, helping the patient to see if they are getting better or not, that could be very helpful for patients to improve over time. Ms. Lantz: We have not spoken much about how we promote wellness—not just diagnosing and managing disease, but actually promoting wellness. Part of the conversation could be about what makes you happy, what motivates you, what made you get out of the car and come into the office today. We could promote talking about whether

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Minnesota health care roundtable it feels good to walk for 10 minutes when you are really mad at your dad or whatever. Those are the things that are lost in the system right now. Dr. Schiff: I’d like to ask my mental health colleagues about the relationship of stigma to the ability to recover. I believe that some people acquire that stigma regarding mental illness, and they believe that once you have it, you have it forever. Dr. Sulik: I have had many opportunities to watch patients tell stories of recovery. That’s never done often enough. People will stand up and celebrate that they are a breast cancer survivor, but you do not see enough people having the forums and the platforms and the opportunities to openly share their stories of recovering from trauma, depression, or living with bipolar disorder and being able to make it day to day and still hold a job or live independently. Dr. Beecher: I think we have to be sensitive to that personal story. Some patients will be traumatized by something and others will not be. It is not a clear thing as to what causes what. We have to start from the standpoint of how this factor has influenced this individual. Dr. Pederson: We tend to say, “They have depression,” as if they are just going to have depression forever and that is going to be how they are defined. Patients hear that as well. But if you have an infection, we say, “We are going to treat your infection, it will get better.” I do not know if they necessarily hear, from those of us in primary care, that you can recover from depression, that it is not necessarily something that will define you for the rest of your life. Judge Meyer: I have people who come back to court over and over again, and everyone around them has similar diagnoses. They see other people with that label who have succeeded and who may want to talk about what they are doing correctly. I understand that group work does not work very well in general for mental illness, but in some situations it really can, especially when you can be around people and talk openly about it. Talking about stigma, how about getting somebody to volunteer to come into a place called “Mental Health Court”? They ask me, “What is wrong with you, lady?” So I make them watch it and we do not talk so much about what it is called, but they have to watch before they say yes or no. Almost

everybody says yes because “ The system has they get to see other people to incentivize succeed. I do not know providers.“ how that plays out in real life or in a psychiatrist’s L. Read Sulik, MD office, but it has been really powerful for people to be able to brag about their successes, and, when they graduate the program, to talk about some of their life history and how far they have come in recovery. They are going to have that diagnosis and label forever, but they really get to see how their circumstances could change. Ms. Anderson: I agree with what people are saying, but I would like to point out personality disorder. If you are a client who does not have a lot of experience within mental health and you are told that you have a personality disorder, that sends a far different message than, “You have depression,” or “You have bipolar disorder.” “Personality disorder” insinuates something is wrong with them and with who they are. So I do think there are a lot of terms that actually contribute to the stigma. Mr. Starnes: What have we seen that has worked in terms of coordinated care teams and behavioral health? Judge Meyer: We have a psychiatrist available who can do a diagnosis, because we need people who can also write emergency prescriptions. We have a therapist who is excellent with people who have never been to therapy before. They may be scared of it, they have probably missed a bunch of appointments, but she is right there in court. We have a nurse who dispenses the medication for them, keeping it safe in her office. She can do the eyeball check and see if they look as if they took their medication yesterday, the day we took off, and watch them take their medication today. We have social workers who can hook up our individuals with the community providers we work with. We also address housing, education, employment, and doctor appointments. We teach them that you do not have to use the

emergency room for everything that ails you, and that is a cost savings for everyone. We surround them with a team. Now of course, you all know that I have a big hammer over their head, but all we are looking for is to get them set up in the community and into recovery mode. So that is what works for us. My hammer. Dr. Gibbs: Even for experienced clinicians, studies show over and over again that having some kind of objective measure works better than just clinical judgment. Outcomes measurements or other kinds of measurements definitely help people. Ms. Lantz: A team is really about who has the relationship and understanding of the consumer. We have teams in our agency that include occupational therapists, pharmacists, long-term care workers, peer specialists, and health coaches. But it still comes down to who holds the relationship with the consumer. The information should be funneled through that go-to person. You could have a team that revolves around one person, regardless of what facility they are in, whether they are in their home, whether they are in their school, who can intervene at times when needed. Dr. Beecher: Developing the holding relationship is critical. The patient must trust you. The patient will appreciate the fact

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Minnesota health care roundtable that you are a person trying to help. You are bringing the patient in and I think this holding relationship idea is really a very wonderful concept. Dr. Sulik: I had an opportunity to visit the Southcentral Foundation of the Alaska Native Medical Center. Their Nuka System of Care integrates primary health care, behavioral health care, and traditional healing practices for Alaskan natives. They do not have “patients,” they have “customer owners,” and their entire philosophy centers on serving those customer owners. Their health system is owned by the people they serve. That got me thinking about the silliness of how we continue to separate services. Imagine going into a restaurant and ordering your food and then having to find your own beverages at some other restaurant that serves only beverages, with no coordination between the two. Separating mental health care and primary care is just as silly. We need to integrate these two

separate worlds, because they are all part of health and well-being. Mr. Starnes: Final question. What is the most important thing that needs to be done to better integrate behavioral health access with the rest of health care delivery? Dr. Pederson: It is truly just communication. We have different modes of communication. We talked earlier about the electronic health records and how we need to improve them. Minnesota is creating an ehealth road map to better utilize our electronic services. I think we have to also bring in some of the things that were talked about on the panel today. We cannot totally rely on electronic communication for a lot of these complex issues. We have to figure out how to integrate and how to allow providers to actually talk to each other. Dr. Gibbs: We have to keep hammering away at reducing stigma and thinking about mental health as part of health. The more we can integrate the whole system into one system that takes care of people’s overall health, the better off we are. Ms. Anderson: The client-centered vote. The most important variable is to give clients options, communicate with them, and make them the decision-makers. Dr. Schiff: The one thing we have not talked about as much is social risk factors. We need to think about access, not just in terms of integrating

“ They are going to have that diagnosis and label forever.” Judge Kerry W. Meyer

behavioral health and physical health, but in terms of identifying and thinking about the entire new year in which people are living, and what that new year and those stresses might do to their physical and mental health. Ms. Lantz: I would love to see us refocus our health care system on talking about quality of life and wellness. How do we really just start talking about wellness, and what is wellness to you? What does that mean? How do we talk about quality of life? So then you do not get into this paradigm split about what is mental health, what is chemical health, and what is physical health. It is really about your highest quality of life that you want to attain, and how this system could help you achieve it. Dr. Sulik: That requires change in our current thinking and in our current way of being, and I think what is most needed is intentional change management across that process of change. We have to prepare ourselves for this change and structure ourselves to undergo this change successfully so that it is sustained. Judge Meyer: You are going to be able to tell that I am the outsider. I need services available to send people to. It is hard enough to figure out where to go, but when you call and they say it will be three months before they have an opening, it’s even harder. Right now it’s a three to four month wait for every psychiatrist in the metro area. We have a work-force crisis and so I need more trained professionals. If people can get services, then we can integrate the rest of it. But if services are not available, it does no good for me to order someone to go to a psychiatrist who does not exist. Dr. Beecher: A corollary question would be, who owns health? My answer would be that it is the client/patient/person who owns it. So then why don’t we empower that client/person to shape a care delivery system that would serve his or her needs? There may be questions about poverty and welfare and medical assistance, but I think we have not looked enough at giving people choices and power to actually put together these teams that we are talking about. The Alaska Native Medical Center talks about the customer owner. I think the customer owner is the patient.

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Minnesota Health care news February 2016

Birth centers from page 13

Home health care. Home is the best place for a healthy mom and baby, so birth centers should make every effort to streamline the discharge process. Check to see if you qualify for a home health visit at no additional cost when you leave the hospital within 48 hours after a vaginal birth and 96 hours after a cesarean birth. The goal is to check the health status of you and your baby, answer questions about health concerns or infant care, and provide education and support. Special circumstances Minnesotans may choose from several birth centers and health care providers offering these new and emerging services. As you research your options, you may also wish to learn more about special circumstances. The authors are associated with two leading providers:

Childbirth can be an emotional roller coaster.

Midwest Fetal Care Center. The Midwest Fetal Care Center in Minneapolis is the first and largest advanced fetal care program in the Upper Midwest and a national leader in providing care to expecting moms when an abnormality or condition is identified in a baby before birth. From comprehensive evaluation and diagnostics, to surgery while your child is still in the womb, the Midwest Fetal Care Center addresses conditions with the highest level of expertise and technology.

Neonatology program. Babies who arrive early or with unique needs often require the clinical expertise and compassionate care of neonatologists. Children’s neonatology program is the largest highrisk neonatal referral center in the Upper Midwest. Whether it’s septuplets, preemies, babies with heart failure, or those needing a little extra care, Children’s has some of the highest survival rates and lowest complication rates in the world. Share your plan After exploring all of the options available, talking with your health care providers, and choosing a birth center, we encourage you to state your preferences in a written birth plan. This will help you, your health care providers, and the birth center staff understand your needs and preferences. Then you will be well supported on your journey to an exceptional birth experience. Michelle Smith, MSN, MBA, RNC, and Alice Chernich, RN, MSN, are with the Mother Baby clinical service line, a partnership of Allina Health and Children’s Hospitals and Clinics of Minnesota.

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February 2016 Minnesota Health care news

Gastroenterology

Peptic ulcer disease Common, but treatable By Benjamin Mitlyng, MD

lcers are injuries to the lining of the digestive tract—similar to an abrasion of the skin—that can cause pain, nausea, upset stomach, or lead to bleeding. Peptic ulcers typically refer to injuries to the upper digestive tract, such as gastric ulcers of the stomach or ulcers of the duodenum (the first part of the small intestine). Peptic ulcer diseases in the U.S. are predominantly related to environmental factors such as a bacterial infection or medications, although smoking and potentially stress can contribute as well.

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Symptoms and complications Peptic ulcer disease may display no symptoms until patients experience bleeding, which may be visible in vomit, sometimes resembling dark coffee grounds, or as bloody or black, tarry stools. Ulcers can also cause more intense symptoms of upper abdominal pain, early fullness, nausea, or heartburn. Symptoms can be more vague as well, such as dyspepsia (indigestion), a non-specific feeling of fullness, or a burning or ache in the upper abdomen, although these could also be related to several other conditions. Overall, upper abdominal pain is the most common symptom, with over 80 percent of peptic ulcer patients reporting mid- to upper-abdominal pain. However, a significant proportion of patients with peptic ulcer disease will have silent ulcers, which are only diagnosed due to signs of bleeding. Silent ulcers are more common in older individuals and those on nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or naproxen. These symptoms can be difficult to distinguish at times from gastroesophageal reflux disease (GERD), which typically causes burning in the chest or reflux of liquid into the chest. One can also develop ulcers of the swallowing tube or esophagus, but these will typically involve painful swallowing or chest pain and are generally unrelated to peptic ulcer disease. Symptomatic ulcers—those that produce active symptoms such as those described above—are relatively uncommon compared to the early 20th century, and even in the last 20 years the incidence in developed countries has continued to fall. However, the risk does increase with age, and the risk of bleeding from peptic ulcers is 13 times higher in patients over 70 compared to those under the age of 40. Also, individuals infected with the bacteria Helicobacter pylori (H. pylori) have at least twice the lifetime risk of peptic ulcer disease than those who are not infected. There likely is a genetic component to peptic ulcer disease as well, with data suggesting people with a family history of ulcers are more likely to develop ulcers themselves. There also is some evidence that emotional stressors can increase the likelihood of developing ulcers, although this research is relatively limited and conflicting. Smoking, but not alcohol, can also increase the risk of peptic ulcer disease. Finally, although spicy or acidic foods

and beverages can increase symptoms associated with peptic ulcer disease, they do not cause ulcers on their own or delay ulcer healing. Peptic ulcer disease can have significant complications and can even be associated with death, although improvements in therapy and medications make this less frequent today. The most common complication for ulcers is bleeding. This can be subtle, such as black tarry stools, or dramatic, with profound weakness, fainting, and unstable vital signs. If gastric ulcers occur in the channel where the stomach empties into the small intestine, then gastric outlet obstruction can occur, causing significant fullness, bloating, nausea, vomiting, and occasionally dehydration. Ulcers can progress to the point where they penetrate deep through the bowel wall or cause leakage of bowel contents into the abdomen, but this is rare, occurring in a very small percentage of patients.

clip the ulcer to prevent further bleeding or complications. Tissue samples can also be taken to look for infection such as H. pylori or other factors. All patients with peptic ulcer disease should undergo testing for H. pylori bacteria, which are specially suited to live in the highly acidic environment of the stomach, potentially leading to inflammation, gastric ulcers, or gastric cancer. Testing for H. pylori can be done with biopsies as well as with tests of blood, stool, or breath, depending upon the individual patient’s case. If H. pylori is diagnosed, it should be treated with a combination of three to four medications, generally for seven to 14 days. There should be follow-up testing done as well to ensure that the ulcer does not recur, as some H. pylori bacteria are resistant to antibiotics.

Peptic ulcer disease can have significant complications.

Diagnosis Peptic ulcer diseases are generally diagnosed by direct visualization of the upper gastrointestinal tract. This is accomplished with upper endoscopy, also known as an esophagogastroduodenoscopy (EGD). With the patient sedated, a flexible scope with a light and a camera is inserted through the mouth and passed through into the upper digestive tract. This procedure can help to make the diagnosis, as well as to exclude other causes of disease such as cancer. Also, if the ulcer is bleeding or has features that present high risks for recurrent bleeding, the gastroenterologist may inject medication, cauterize, or

Discover

A thorough history should also be obtained to evaluate aspirin or NSAID use. H. pylori and NSAIDs account for nearly all clinically significant peptic ulcer disease in the U.S. Individuals diagnosed with peptic ulcer disease should be advised to avoid NSAIDs and to quit smoking. Limiting alcohol intake to no more than one alcoholic beverage per day can promote healing, too. In addition, patients should be started on a proton pump inhibitor (PPI). PPIs are medications that reduce acid levels in the stomach and will improve symptoms, reduce the risk of bleeding, and cure Peptic ulcer disease to page 34

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Acne from page 15

Skin care tips You may reduce your risk of acne by following some simple common-sense habits. Keep your skin clean, and always shower after heavy exercise. Gently clean your skin with a cotton washcloth and gentle non-detergent cleanser. There’s no need to scrub your face or use abrasives that exfoliate. If you use makeup, select brands that are non-comedogenic. Use acne medications on a regular basis for best effect. Most medicines work to prevent acne, not to clear it up during an outbreak. If acne is not better after eight weeks of using an over-the-counter product(s), consult your dermatologist.

There are many options to treat acne scars. These include laser treatments, injections of fillers such as platelet-rich plasma, and saline injections that cause the skin cells (fibroblasts) to produce collagen to fill in the scars. We also use light chemical peels to treat acne scars. For best results, we often recommend a combination of these treatments. Summing up It is important to realize that the vast majority of the medicines we use, both over-the-counter and prescription, are designed to make acne better. They’re absolutely not designed to make acne totally clear. The key is to find a product or combination of products that work best with an individual’s skin physiology to improve acne to a point where patients are happy.

Most medicines work to prevent acne, not to clear it up during an outbreak.

Treatment of acne scars The best treatment of acne scars is to prevent them in the first place. This can be accomplished by using effective acne treatments and by not manipulating or squeezing acne lesions. If scarring does occur it can be treated. When it comes to treating acne scars, I tell patients that I don’t want perfection to be the enemy of very good. In fact, it is impossible to change an acne scar back into normal skin. The goal is to make scars look more like the surrounding skin so the contrast is not as great; then the scars themselves will look better.

Today, there are many effective treatments to improve acne, but no single treatment is perfect for everyone. If you have acne that bothers you and over-the-counter medicines are not helping, be sure to see your dermatologist. Charles E. Crutchfield III, MD, is a board-certified dermatologist and clinical professor of dermatology at the University of Minnesota Medical School. He also has a private practice in Eagan, Minnesota.

January 2016 Survey

M I N N E S OTA H E A LT H C A R E

CO N S U M E R A S S O C I AT I O N

Each month, members of the Minnesota Health Care Consumer Association are invited to participate in a survey that measures opinions around topics that affect our health-care delivery system. There is no charge to join the association, and everyone is invited. 1. I or a member of my family has a problem with gambling addiction.

2. I or a member of my family has experienced health care-related problems as a result of gambling addiction.

70 70

60 60

3. I am aware of the warning signs of gambling addiction. 40 40

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Strongly agree

Agree

No opinion

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4. I know how to get help for a gambling addiction problem. 60 60

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Agree

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5. I feel any outlet that provides public gambling options should provide warnings similar to those related to tobacco and alcohol sales. 35 35

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Minnesota Health care news February 2016

Strongly agree

Agree

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No opinion

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

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Be heard in debates and discussions that shape the future of health care policy. There is no cost to join this informed and informative online community. Members receive a free monthly electronic newsletter and the opportunity to participate in consumer opinion surveys.

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Peptic ulcer disease from page 31

ulcers. Patients typically will be treated with a PPI for eight weeks to promote ulcer healing and prevent ulcer complication or recurrence. When treated with a high-dose PPI for eight weeks, ulcers are more than 90 percent cured. When large gastric ulcers are present, an upper endoscopy is often repeated in eight weeks to document ulcer healing and to exclude complications. This is usually not necessary with duodenal ulcers, which tend to heal more rapidly and present low risk for cancer. Medications such as histamine-2 receptor antagonists (H2RAs) can have some benefit, but are much less effective than PPIs and generally are not recommended on their own. Occasionally, patients will need to resume NSAIDs or aspirin on a regular basis due to other chronic medical conditions. In this setting, after the ulcer has healed, a maintenance-dose PPI should be considered to decrease the risk of ulcer recurrence.

NSAID use, or non-adherence to PPI therapy. Surgical management of peptic ulcers is exceedingly rare in the era of PPIs, and is generally reserved for ulcers that persist for more than 24 weeks despite highdose PPIs, when all other reversible factors have been addressed. The good news Peptic ulcer disease is a relatively common condition, one that may affect one in 10 Americans at some point, according to some estimates. Fortunately, severe complications requiring admission to the hospital for close monitoring or surgery are relatively rare. Ulcers are typically diagnosed with an upper endoscopy, at which time testing for infection can take place with a biopsy, and endoscopic therapy can take place if ulcers are bleeding. Most ulcers are due to reversible causes such as medications like NSAIDs, or stomach infections with H.pylori, which is treatable with antibiotics. Finally, ulcers have a high rate of cure if the trigger is addressed and proton pump inhibitors are taken as prescribed by health care providers.

Ulcers are typically diagnosed with an upper endoscopy.

Most ulcers will heal with antibiotic treatment of H.Pylori, stopping use of NSAIDs, and initiating a proton pump inhibitor. Occasionally one can develop a refractory ulcer, which persists for more than eight to 12 weeks after treatment has been initiated. This is most commonly due to H.Pylori antibiotic resistance, ongoing

Benjamin Mitlyng, MD, practices at Minnesota Gastroenterology, P.A.’s Plymouth Endoscopy Center and Clinic. He is board-certified in gastroenterology and internal medicine.

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Minnesota Health care news February 2016

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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].

VICU3X1498_B_2_0_Journal_Ad_Tabloid_Resize_BS_r5.indd 1

for neutralizing effect against native GLP-1, and thus the potential for clinically significant neutralization of native GLP-1 was not assessed. Antibodies that had a neutralizing effect on liraglutide in an in vitro assay occurred in 2.3% of the Victoza®-treated patients in the double-blind 52-week monotherapy trial and in 1.0% of the Victoza®-treated patients in the double-blind 26-week add-on combination therapy trials. Among Victoza®-treated patients who developed anti-liraglutide antibodies, the most common category of adverse events was that of infections, which occurred among 40% of these patients compared to 36%, 34% and 35% of antibody-negative Victoza®-treated, placebo-treated and active-control-treated patients, respectively. The specific infections which occurred with greater frequency among Victoza®-treated antibody-positive patients were primarily nonserious upper respiratory tract infections, which occurred among 11% of Victoza®-treated antibody-positive patients; and among 7%, 7% and 5% of antibody-negative Victoza®-treated, placebo-treated and active-control-treated patients, respectively. Among Victoza®-treated antibody-negative patients, the most common category of adverse events was that of gastrointestinal events, which occurred in 43%, 18% and 19% of antibody-negative Victoza®-treated, placebo-treated and active-control-treated patients, respectively. Antibody formation was not associated with reduced efficacy of Victoza® when comparing mean HbA1c of all antibody-positive and all antibody-negative patients. However, the 3 patients with the highest titers of anti-liraglutide antibodies had no reduction in HbA1c with Victoza® treatment. In the five double-blind clinical trials of Victoza®, events from a composite of adverse events potentially related to immunogenicity (e.g. urticaria, angioedema) occurred among 0.8% of Victoza®-treated patients and among 0.4% of comparator-treated patients. Urticaria accounted for approximately one-half of the events in this composite for Victoza®-treated patients. Patients who developed anti-liraglutide antibodies were not more likely to develop events from the immunogenicity events composite than were patients who did not develop anti-liraglutide antibodies. Injection site reactions: Injection site reactions (e.g., injection site rash, erythema) were reported in approximately 2% of Victoza®-treated patients in the five double-blind clinical trials of at least 26 weeks duration. Less than 0.2% of Victoza®-treated patients discontinued due to injection site reactions. Papillary thyroid carcinoma: In clinical trials of Victoza®, there were 7 reported cases of papillary thyroid carcinoma in patients treated with Victoza® and 1 case in a comparator-treated patient (1.5 vs. 0.5 cases per 1000 patient-years). Most of these papillary thyroid carcinomas were <1 cm in greatest diameter and were diagnosed in surgical pathology specimens after thyroidectomy prompted by findings on protocol-specified screening with serum calcitonin or thyroid ultrasound. Hypoglycemia :In the eight clinical trials of at least 26 weeks duration, hypoglycemia requiring the assistance of another person for treatment occurred in 11 Victoza®-treated patients (2.3 cases per 1000 patient-years) and in two exenatidetreated patients. Of these 11 Victoza®-treated patients, six patients were concomitantly using metformin and a sulfonylurea, one was concomitantly using a sulfonylurea, two were concomitantly using metformin (blood glucose values were 65 and 94 mg/dL) and two were using Victoza® as monotherapy (one of these patients was undergoing an intravenous glucose tolerance test and the other was receiving insulin as treatment during a hospital stay). For these two patients on Victoza® monotherapy, the insulin treatment was the likely explanation for the hypoglycemia. In the 26-week open-label trial comparing Victoza® to sitagliptin, the incidence of hypoglycemic events defined as symptoms accompanied by a fingerstick glucose <56 mg/ dL was comparable among the treatment groups (approximately 5%). Table 5: Incidence (%) and Rate (episodes/patient year) of Hypoglycemia in the 52-Week Monotherapy Trial and in the 26-Week Combination Therapy Trials Victoza® Treatment Active Comparator Placebo Comparator None Monotherapy Victoza® (N = 497) Glimepiride (N = 248) Patient not able to self-treat 0 0 — Patient able to self-treat 9.7 (0.24) 25.0 (1.66) — Not classified 1.2 (0.03) 2.4 (0.04) — ® Add-on to Metformin Victoza + Metformin Glimepiride + Placebo + Metformin (N = 724) Metformin (N = 242) (N = 121) Patient not able to self-treat 0.1 (0.001) 0 0 Patient able to self-treat 3.6 (0.05) 22.3 (0.87) 2.5 (0.06) ®+ ® None Insulin detemir + Continued Victoza Add-on to Victoza Metformin Victoza® + Metformin + Metformin alone (N = 158*) (N = 163) Patient not able to self-treat 0 0 — Patient able to self-treat 9.2 (0.29) 1.3 (0.03) — Rosiglitazone + Placebo + Add-on to Glimepiride Victoza® + Glimepiride (N = 695) Glimepiride (N = 231) Glimepiride (N = 114) Patient not able to self-treat 0.1 (0.003) 0 0 Patient able to self-treat 7.5 (0.38) 4.3 (0.12) 2.6 (0.17) Not classified 0.9 (0.05) 0.9 (0.02) 0 Placebo + Metformin Add-on to Metformin + Victoza® + Metformin None + Rosiglitazone + Rosiglitazone Rosiglitazone (N = 175) (N = 355) Patient not able to self-treat 0 — 0 Patient able to self-treat 7.9 (0.49) — 4.6 (0.15) Not classified 0.6 (0.01) — 1.1 (0.03) Add-on to Metformin + Victoza® + Metformin Insulin glargine Placebo + Metformin + Glimepiride + Metformin + Glimepiride + Glimepiride (N = 114) Glimepiride (N = 232) (N = 230) Patient not able to self-treat 2.2 (0.06) 0 0 Patient able to self-treat 27.4 (1.16) 28.9 (1.29) 16.7 (0.95) Not classified 0 1.7 (0.04) 0 *One patient is an outlier and was excluded due to 25 hypoglycemic episodes that the patient was able to self-treat. This patient had a history of frequent hypoglycemia prior to the study. In a pooled analysis of clinical trials, the incidence rate (per 1,000 patient-years) for malignant neoplasms (based on investigator-reported events, medical history, pathology reports, and surgical reports from both blinded and open-label study periods) was 10.9 for Victoza®, 6.3 for placebo, and 7.2 for active comparator. After excluding papillary thyroid carcinoma events [see Adverse Reactions], no particular cancer cell type predominated. Seven malignant neoplasm events were reported beyond 1 year of exposure to study medication, six events among Victoza®-treated patients (4 colon, 1 prostate and 1 nasopharyngeal), no events with placebo and one event with active comparator (colon). Causality has not been established. Laboratory Tests: In the five clinical trials of at least 26 weeks duration, mildly elevated serum bilirubin concentrations (elevations to no more than twice the upper limit of the reference range) occurred in 4.0% of Victoza®-treated patients, 2.1% of placebo-treated patients and 3.5% of active-comparator-treated patients. This finding was not accompanied by abnormalities in other liver tests. The significance of this isolated finding is unknown. Vital signs: Victoza® did not have adverse effects on blood pressure. Mean increases from baseline in heart rate of 2 to 3 beats per minute have been observed with Victoza® compared to placebo. The long-term clinical effects of the increase in pulse rate have not been established. Post-Marketing Experience: The following additional adverse reactions have been reported during post-approval use of Victoza®. Because these events are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to drug exposure: Dehydration resulting from nausea, vomiting and diarrhea; Increased serum creatinine, acute renal failure or worsening of chronic renal failure, sometimes requiring hemodialysis; Angioedema and anaphylactic reactions; Allergic reactions: rash and pruritus; Acute pancreatitis, hemorrhagic and necrotizing pancreatitis sometimes resulting in death. OVERDOSAGE: Overdoses have been reported in clinical trials and post-marketing use of Victoza®. Effects have included severe nausea and severe vomiting. In the event of overdosage, appropriate supportive treatment should be initiated according to the patient’s clinical signs and symptoms. More detailed information is available upon request. For information about Victoza® contact: Novo Nordisk Inc., 800 Scudders Mill Road, Plainsboro, NJ 08536, 1−877-484-2869 Date of Issue: April 16, 2013 Version: 6 Manufactured by: Novo Nordisk A/S, DK-2880 Bagsvaerd, Denmark Victoza® is covered by US Patent Nos. 6,268,343, 6,458,924, 7,235,627, 8,114,833 and other patents pending. Victoza® Pen is covered by US Patent Nos. 6,004,297, RE 43,834, RE 41,956 and other patents pending. © 2010-2013 Novo Nordisk 0513-00015682-1 5/2013

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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 ® Victoza 1.8 + Metformin Placebo + Metformin + Glargine + Metformin + + Glimepiride N = 230 Glimepiride N = 114 Glimepiride N = 232 (%) (%) (%) Adverse Reaction Nausea 13.9 3.5 1.3 Diarrhea 10.0 5.3 1.3 Headache 9.6 7.9 5.6 Dyspepsia 6.5 0.9 1.7 Vomiting 6.5 3.5 0.4 Add-on to Metformin + Rosiglitazone ® Placebo + Metformin + Rosiglitazone All Victoza + Metformin + Rosiglitazone N = 355 N = 175 (%) (%) Adverse Reaction Nausea 34.6 8.6 Diarrhea 14.1 6.3 Vomiting 12.4 2.9 Headache 8.2 4.6 Constipation 5.1 1.1 Table 3: Adverse Reactions reported in ≥5% of Victoza®-treated patients in a 26-Week Open-Label Trial versus Exenatide Exenatide 10 mcg twice daily + Victoza® 1.8 mg once daily + metformin and/or sulfonylurea metformin and/or sulfonylurea N = 232 N = 235 (%) (%) Adverse Reaction Nausea 25.5 28.0 Diarrhea 12.3 12.1 Headache 8.9 10.3 Dyspepsia 8.9 4.7 Vomiting 6.0 9.9 Constipation 5.1 2.6 Table 4: Adverse Reactions in ≥5% of Victoza®-treated patients in a 26-Week Open-Label Trial versus Sitagliptin All Victoza® + metformin Sitagliptin 100 mg/day + N = 439 metformin N = 219 (%) (%) Adverse Reaction Nausea 23.9 4.6 Headache 10.3 10.0 Diarrhea 9.3 4.6 Vomiting 8.7 4.1 Immunogenicity: Consistent with the potentially immunogenic properties of protein and peptide pharmaceuticals, patients treated with Victoza® may develop anti-liraglutide antibodies. Approximately 50-70% of Victoza®-treated patients in the five double-blind clinical trials of 26 weeks duration or longer were tested for the presence of anti-liraglutide antibodies at the end of treatment. Low titers (concentrations not requiring dilution of serum) of anti-liraglutide antibodies were detected in 8.6% of these Victoza®-treated patients. Sampling was not performed uniformly across all patients in the clinical trials, and this may have resulted in an underestimate of the actual percentage of patients who developed antibodies. Cross-reacting antiliraglutide antibodies to native glucagon-like peptide-1 (GLP-1) occurred in 6.9% of the Victoza®-treated patients in the double-blind 52-week monotherapy trial and in 4.8% of the Victoza®-treated patients in the double-blind 26-week add-on combination therapy trials. These cross-reacting antibodies were not tested

Victoza —a force for change in type 2 diabetes. A change with powerful, long-lasting benefits

Reductions up to -1.1%a

Weight loss up to 5.5 lba,b

Low rate of hypoglycemiac

1.8 mg dose when used alone for 52 weeks. Victoza® is not indicated for the management of obesity. Weight change was a secondary end point in clinical trials. c In the 8 clinical trials of at least 26 weeks’ duration, hypoglycemia requiring the assistance of another person for treatment occurred in 11 Victoza®-treated patients. a

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