Minnesota Health care News January 2015

January/February 2015 • Volume 13 Number 1

Autism spectrum disorder Elizabeth Reeve, MD

Peripheral artery disease Wobo Bekwelem, MD

Life insurance after cancer Lindy Yokanovich, Esq.

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January/February 2015 • Volume 13 Number 1

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News

People

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Calendar

Perspective Troy Zimmerman National Kidney Foundation

10 QUESTIONS Joseph P. Buhain, EdD, MBA, RRT, FAARC, EMT

Palliative care Why aren’t more Minnesotans using hospice care?

By B arry Baines, MD, and Janelle Shearer, RN, MA

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Winter air quality

By J ill Heins Nesvold, MS, and Cynthia Isaacson

Respiratory Care program at Saint Paul College

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MINNESOTA HEALTH CARE ROUNDTABLE

Environmental Health

Vascular Medicine

Peripheral artery disease

By W obo Bekwelem, MD; Niki Oldenburg, DrPH; and Alan T. Hirsch, MD

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The New Face of Health Care

Patient to Patient

Catch and release

Expanding medical professional relationships

By Charles Bransford, MD

Insurance

Thursday April 23, 2015, 1:00-4:00 PM

By Lindy Yokanovich, Esq.

Downtown Minneapolis Hilton and Towers

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Life insurance after cancer

Hospitals

Medical bills

From The Office of Minnesota Attorney General Lori Swanson

Behavioral Health

Autism spectrum disorder

By Elizabeth Reeve, MD

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Caregiving

Long-term care

By Deb Holtz, JD

Background and Focus: With dramatic population growth, and as baby boomers become senior citizens, the demand for health care is exceeding the supply. Addressing the shortage of medical doctors involves creating new relationships between medical professionals. Training and licensure for Physician Assistants, Advanced Nurse Practitioners, Chiropractors, Respiratory Therapists, Physical Therapists, Home Care Providers, Dentists, and many other health care professions have become increasingly rigorous and provide expanded support to our health-care delivery system. Greater integration of these professions allows medical doctors to work to the top of their license but requires new pathways for communication and care coordination.

Objectives: We will examine many of the new partnerships that are emerging between medical doctors and other medical professionals. We will look at the ways leveraging these new relationships can improve access to care while reducing costs and improving outcomes. We will consider points of resistance to forming these kinds of health care teams and what should be avoided in creating them. We will discuss what the proper oversight for these relationships should entail and how to maximize the coordination of care that they require.

Panelists Include: • Mehul Desai, MD, Minneapolis Advanced Pain Specialists • Derek Hustvet, LRT, Pediatric Home Service • John Gulon, DDS, President of Park Dental • Craig Johnson, PT, MBA, President MPPTA, Director of Clinical Integration Therapy Partners Sponsors Include: Minneapolis Advanced Pain Specialists, Park Dental, and Pediatric Home Service

Publisher Mike Starnes | mstarnes@mppub.com Senior Editor Janet Cass | jcass@mppub.com Editor Lisa McGowan | lmcgowan@mppub.com Art Director Alice Savitski | asavitski@mppub.com Office Administrator Amanda Marlow | amarlow@mppub.com Account Executive Stacey Bush | sbush@mppub.com Account Executive Jan Ehrlich | jehrlich@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.

Please send me tickets at $95.00 per ticket. Tickets may be ordered by phone at (612) 728-8600, by fax at (612) 728-8601, on our website (mppub.com), or by mail. Make checks payable to Minnesota Physician Publishing. Mail orders to MPP, 2812 East 26th Street, Mpls, MN 55406. Please note: tickets are non-refundable.

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News

MDH Announces Medical Cannabis Manufacturers The Minnesota Department of Health (MDH) has selected LeafLine Labs and Minnesota Medical Solutions as the registered manufacturers of medical cannabis for the new program launching in Minnesota.

The manufacturers were selected from 12 applicants after a lengthy review process that looked closely at each applicant’s operational track records, financial stability, business plans, and other factors. A panel of representatives from the agriculture, pharmacy, public safety, commerce, and finance industries conducted the review and Ed Ehlinger, MD, Minnesota commissioner of health, made the final decision after considering recommendations from the panel.

“We are pleased to have two strong partners for Minnesota’s medical cannabis program,” said Ehlinger. “Our goal is to safely

provide medical cannabis products to patients with qualifying conditions by the deadline of July 1, 2015, and our attention over the next few months will be working with these two manufacturers to implement the program and safely grow, process, and distribute the products.”

LeafLine Labs’ manufacturing facility will be in Cottage Grove. It plans to open its first distribution center in Eagan on July 1, 2015.

Additional distribution sites are planned for Hibbing, St. Cloud, and St. Paul by July 1, 2016.

“LeafLine Labs started with a committed search to find research-based treatments—including medical cannabis—that could bring comfort to people and, perhaps someday, even cure some medical conditions that Minnesotans live and die with,” said Andrew Bachman, MD, cofounder of LeafLine Labs. “We are focused on bringing safe, consistent, and high-quality medical cannabis to the people of Minnesota.”

Minnesota Medical Solutions

started its manufacturing facility in Otsego last July, which was functional as of the first week of December 2014. Four distribution centers are planned to open in July 2015: Rochester, Maple Grove, Minneapolis, and Moorhead.

a place and program that can support patients and families— where care and support is linked and coordinated across specialties and clinical services,” said Mary Brainerd, HealthPartners president and CEO.

“This program is ultimately all about getting ill people medicine that can help reduce their suffering,” said Ehlinger. “This is an important day for the rollout of the program, and an important day for those Minnesotans suffering from conditions that may be improved through the use of medical cannabis.”

The new four-story, 130,000-square-foot facility will offer programs for stroke, spine care, dementia, Parkinson’s disease, brain and spine tumors, and other neurological disorders.

HealthPartners Plans New Neuroscience Center HealthPartners has announced plans to build a neuroscience center between the HealthPartners Specialty Centers and Regions Hospital in St. Paul.

“Our vision is to create both

“It’ll help us really coordinate all of neurosciences under one roof,” said Bret Haake, MD, assistant medical director of neurosciences at HealthPartners. “[It] really will help give people a destination to know where to go to if they have numbness, weakness, or brain-, spine-, or nerve-related diseases.”

Construction is scheduled to start in the spring of 2015 with an estimated completion date in early 2017. According to HealthPartners, it will be the largest freestanding neuroscience center in the Upper Midwest.

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Minnesota Health care news January/February 2015

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Impotence Clinic Closed, Physician Suspended The Minneapolis Men’s Medical Clinic has been closed and the Minnesota Board of Medical Practice has suspended its employee Richard Beck, MD, from the practice of medicine, citing several allegations of misconduct. These include false advertising, engaging in unethical conduct, aiding an unlicensed person in the practice of medicine, improperly managing medical records, and prescribing a drug or device for something other than medically accepted therapeutic purposes.

The suspension was announced after several complaints were filed.

Physicians with Edina-based Urology Associates filed complaints with the Minnesota attorney general and the Minnesota Board of Medical Practice. Several patients filed complaints as well, after suffering from a condition called priapism, characterized by painful erections lasting four or more hours. Those episodes were a direct result of using powerful injectable medications prescribed at the Minneapolis Men’s Clinic. According to a Better Business Bureau website file, patients at Men’s Medical Clinic locations across the country claimed to have felt pressured to purchase thousands of dollars worth of those injectable medications, which now are considered a secondary line of treatment for men who don’t have success with oral medications like Viagra and Levitra. Priapism can result in long-term impotence and other complications.

According to Ruth Martinez, executive director of the Minnesota Board of Medical Practice, suspension during the board’s disciplinary review is “an action reserved for significant issues of concern,” such as when a physician presents imminent harm to patients.

Beck’s lawyer, Dave Bunde, claimed that Beck was suspended because he was the only licensed physician on staff at the clinic and therefore the only target the board could take action against. He said the misconduct allegations related more to the clinic itself than to Beck, who moved to Minnesota after retiring from a career as a

surgeon and plastic surgeon in Florida. Bunde claimed Beck only worked part time at the clinic and was not involved in advertising or responding to after-hours patient problems.

The Men’s Medical Clinic is based in Florida.

Regions Opens Renovated Cancer Care Center Regions Hospital has announced the completion of a $4.4 million expansion project that has doubled the size of its Cancer Care Center to 19,000 square feet.

“Tremendous planning went into creating this new center,” said Brock Nelson, Regions president and CEO. “We were deliberate in the design to incorporate feedback from patients, colleagues, and physicians. The end result is a fresh, new facility that provides compassionate and individualized care for each of our patients.”

With the additional space, the center increased the number of exam rooms from eight to 21, and the number of infusion therapy chairs from 15 to 26. Other new features include holistic treatments and services, a space for support groups and classes, and a “fast track” area for patients who come in for short visits.

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“Cancer treatment can be physically and emotionally exhausting for patients and family members,” said Randy Hurley, MD, HealthPartners oncologist and medical director of the Cancer Care Center at Regions. “It’s very different from other illnesses in that the road to recovery is often long and at times challenging. With our expansion, we wanted to create a space that focuses on health, healing, and hope.”

Diabetes Testing Needed for Adults with Hypertension About one in three, or 345,000, Minnesotans with hypertension (high blood pressure) reported that they have not been tested for diabeNews to page 6 January/February 2015 Minnesota Health care news

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News from page 5

tes in the last three years, according to an analysis from the Minnesota Department of Health (MDH).

The U.S. Preventive Services Task Force recommends that health care providers test blood glucose levels in patients with hypertension because research shows that there is a 50 percent reduction in cardiovascular events if people who are diagnosed with diabetes receive proper treatment.

About 1.1 million adults in Minnesota have hypertension. Researchers used data from the 2011 Minnesota Behavioral Risk Factor Surveillance System to determine how many of these patients also were being tested for diabetes. This is the first analysis of its kind from MDH. “We need health care providers to be aware of the need to screen people with hypertension for diabetes,” said Renee Kidney, PhD, lead author of the analysis and senior epidemiologist at MDH. “And, very importantly, we need

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people with hypertension to talk to their providers and ask for the screening.”

There were adults from all age groups, gender, and weight categories who reported not having a diabetes screening. Overall results showed that adults with hypertension who were less likely to have been tested for diabetes also were 18 to 44 years old; normal weight or overweight (not obese); not taking high blood pressure medication; had less than a college education; and had not been to a checkup in the last two years.

Kidney added that the results reveal both a lack of testing and a misunderstanding among respondents about tests they already may have been given by their doctors.

“It may be that one is needed, or it also may be an issue of people not recognizing the name of a test that their provider has given them already,” she said.

Minnesota Health care news January/February 2015

Medical Group Quality Data Show Improvements MN Community Measurement (MNCM) released medical group quality data late last year that evaluated what percentage of patients received appropriate medical care, immunizations, and screenings for 10 measures at medical groups in Minnesota and bordering communities.

The data showed that 82 percent of Minnesota women age 50 to 74 had a mammogram in the past two years, a 3 percent increase from the previous year. This rate reached a high of 77 percent in 2009, after which it fell to 73 percent in 2011 and 2013. MNCM notes that the increase in 2014 may have been due to expanding the age range for the measure because of mammogram guideline changes.

Before, it measured women age 50 to 69, which has been changed to women 50 to 74.

Medical groups that had the highest rates of female patients that

were screened for breast cancer were Sacred Heart Mercy Health Care Center in Jackson; Paul Larson Ob/Gyn Clinic in Edina; Minnesota Gynecology & Surgery in Edina; Clinic Sofia Ob/Gyn in Edina; and John A. Haugen Associates in Minneapolis.

Among the remaining nine measures, another notable result was that the average rate of adolescent immunizations rose from 62 percent to 66 percent. Specifically, this measure assesses whether adolescents have received the recommended vaccinations by the time they turn 13 years old. In addition, the average rate of appropriate care for bronchitis—meaning not prescribing antibiotics, because bronchitis is viral—rose 3 percent.

The remaining measures determined rates of chlamydia screenings, high blood pressure control, immunizations for children age 2, and appropriate care for COPD, sore throats, colds, and ADHD. All showed average changes of 1 percent or 2 percent, or no change at all.

People

Thomas Arneson, MD, MPH

Thomas Arneson, MD, MPH, board-certified in preventive medicine, has assumed the role of research manager at the Minnesota Department of Health Office of Medical Cannabis. He graduated from Mayo Medical School; served a preventive medicine residency at the University of Minnesota School of Public Health; and earned an MPH at the school. His role includes generating information about possible long-term health effects and the societal effects of cannabis use.

Love

Amy Chang, OD, FAAO (fellow of the American Academy of Optometry), has joined the physical medicine and rehabilitation clinic at Hennepin County Medical Center (HCMC), Minneapolis. She graduated from the State University of New York Amy Chang, OD, College of Optometry and completed a residency FAAO in acquired brain injury vision rehabilitation and primary care at the same institution. Previously, she was the neuro-optometrist at Womack Army Medical Center in Fort Bragg, N.C., where she developed the first vision rehabilitation clinic in the U.S. Army to offer treatment for wounded warriors who had visual deficits after traumatic brain injury.

Christopher Heck, MD, board-certified in cardiothoracic vascular surgery, has joined Essentia Health–Duluth Clinic in a fulltime position after working at the clinic part time since 2011. Heck graduated from Mayo Medical School, completed a general surgery residency at the University of California–San Francisco School of Medicine, and completed a cardiothoracic surgery fellowship at Stanford University School of Medicine in Stanford, Calif.

Michael T. Osterholm, PhD, MPH, a professor in the University of Minnesota School of Public Health, Division of Environmental Health Sciences, has been awarded a McKnight Presidential Chair in Public Health by the university. The award acknowledges the critical contributions of university faculty who have distinguished themselves and their schools in research, education, and public engagement.

Osterholm earned both of his graduate degrees from the university’s School of Public Health and began his public health career at the Minnesota Department of Health in 1975 as the state epidemiologist.

Stephen Ready, MD, board-certified in family medicine, has joined Ridgeview Chaska Clinic, part of Ridgeview Medical Center. Ready graduated from the University of Minnesota Medical School and served a residency in family practice at Fairview University Medical Center, Minneapolis.

Andrew Schmidt, MD, FAAOS, board-certified Stephen Ready, in orthopedic surgery, has assumed the position as MD chief of orthopedics at HCMC. He is also a professor of orthopedic surgery at the University of Minnesota. Schmidt completed medical school at the University of California, San Diego; an orthopedics and rehabilitation residency at Oregon Health Sciences University, Portland; and a fellowship in total joint replacement at HCMC. He researches traumatic and cause-complicated extremity injuries, improving treatment of military and civilian trauma.

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

Care Beyond Cost.

January/February 2015 Minnesota Health care news

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Perspective

Facilitating organ transplants Legislative initiatives to help people who need kidneys

Affordable medication Since 1972, individuals with kidney failure (also known as end-stage renal disease, or ESRD) have had all of their health expenses covered under Medicare. Kidney patients whose Medicare eligibility is due to ESRD rather than their age or Social Security disability are able to keep their Medicare coverage indefinitely if they remain on dialysis.

Troy Zimmerman National Kidney Foundation Troy Zimmerman is vice president for government relations at the National Kidney Foundation (NKF). NKF is the leading organization in the United States dedicated to the awareness, prevention, and treatment of kidney disease for hundreds of thousands of health care professionals, millions of patients and their families, and tens of millions of Americans at risk for kidney disease.

Since its founding in 1950, NKF has been the leading advocate for policies that enhance patient care, advance medical research, and increase the availability of all organs for transplantation. Learn more at www.kidney.org

However, if an ESRD patient receives a kidney transplant, his or her Medicare coverage ends 36 months later unless he or she is age 65 or disabled.

This is a problem, because kidney recipients must take immunosuppressive drugs daily to minimize the risk of rejecting the transplant they have received. Immunosuppressive medications can be financially burdensome for many transplant recipients. Because of this, some patients avoid transplantation altogether because they can’t afford these medications after their Medicare coverage ends. While many kidney recipients have access to group health insurance and others can obtain immunosuppressive coverage through the Affordable Care Act, a gap remains for many individuals.

Federal legislation to help kidney recipients H.R. 1428/S. 323 This is why the National Kidney Foundation (NKF) has spearheaded the introduction of federal legislation to eliminate the 36-month limit for Medicare coverage of immunosuppressive medication. H.R. 1428 and S. 323, introduced by Rep. Michael Burgess, MD (R–TX), and Sen. Richard Durbin (D–IL), respectively, would provide indefinite Medicare coverage for kidney transplant recipients, but only for immunosuppressive drugs; all other Medicare coverage would end three years after the transplant. We have worked closely with the bill sponsors to develop strategies to increase support and move the bill forward, resulting in more than 140 cosponsors to date.

Immunosuppressive drug coverage is cost-effective.

Medicare spends about $4,000 annually on immunosuppressives for each transplant patient under Medicare Part B. In contrast, it spends more than $86,000 annually for all health care for someone on dialysis because he or she is awaiting a kidney transplant. Furthermore, as noted in a 2013 Congressional Research Service report, since 2009 the average cost of the most commonly used immunosuppressive medications has

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Minnesota Health care news

January/February 2015

decreased by more than 50 percent due to increased use of generic medications.

Thanks to our advocates around the country who contacted their members of Congress, support for H.R. 1428 and S. 323 is significant. Unfortunately, despite broad Congressional support, this legislation was not passed before Congress adjourned for 2014. However, we will work with Sen. Durbin and Rep. Burgess to reintroduce the bill in 2015.

Protecting living organ donors H.R. 5263 NKF also is working to reduce disincentives for individuals who hesitate to donate because of insurance or job concerns.

Working closely with NKF, Rep. Jerrold Nadler (D– NY) and Rep. Michael Burgess, MD (R–TX) introduced H.R. 5263 in July 2014 to expand opportunities for increased living organ donation (a Senate companion bill was not introduced). This legislation would prohibit discrimination in the availability, benefits, and pricing of life insurance, disability insurance, and long-term care insurance for donors. It also would expand the Family and Medical Leave Act (FMLA) to include living organ donation under the law that mandates unpaid leave to protect an individual’s job during a time of specified family and medical need. Currently, the FMLA does not specify that living organ donors are covered and can take unpaid leave to recover from their donation and does not guarantee that donors will have a job waiting for them after they return from the surgery. NKF has long advocated for the removal of disincentives for living donors, including access to life, disability, and long-term care insurance, which are sometimes harder to obtain by someone who has donated a kidney. This, despite research showing that kidney donation does not shorten or disable the donor’s life nor, typically, lead to long-term medical problems. We also believe people should be able to donate an organ without fear of losing their jobs.

We are optimistic this legislation will make it possible for more individuals to consider being a living donor and could reduce the length of time someone in need of a kidney must wait for one. We expect it will be reintroduced in 2015. You can get involved with these and other advocacy efforts by visiting www.kidney.org/advocacy

Alcohol is more harmful to an unborn baby than cocaine, marijuana or heroin.

Drinking during pregnancy can cause Fetal Alcohol Spectrum Disorders (FASD) which permanently harm the way your baby learns and behaves.

- ZERO ALCOHOL FOR NINE MONTHS.

10 Questions

Respiratory therapy Joseph P. Buhain, EdD, MBA, RRT, FAARC, EMT Dr. Buhain is director of the Respiratory Care program at Saint Paul College.

How did the field of respiratory therapy get started? In 1943, a primitive inhalation therapy program was established at Michael Reese Hospital, Chicago.

In 1960, the American Registry of Inhalation Therapists was formed to oversee a new credentialing examination for the field.

Respiratory care practitioners were registered for the first time in Minnesota in 1991 and governed by the Minnesota Department of Health. In 1997 we became self-governing and in 2009, state law changed registration to licensure and changed our title from “respiratory care practitioner” to “respiratory therapist” (RT).

RTs work with a wide range of patients, medical conditions, and settings.

Would you please share some of these details? We treat everyone from premature infants with undeveloped lungs to aging adults, including the more than 15 million adults in the U.S. with chronic obstructive pulmonary disease (COPD), the name for conditions that limit airflow and cause breathing trouble. We also provide emergency breathing support for patients suffering from heart attacks, near drowning, or shock.

RTs work in clinics, rehab centers, nursing care facilities, and travel to patients’ homes, but most work in settings where they manage critical care, including hospital medical-surgical intensive care units and emergency departments. We do pulmonary function testing; sleep-lab therapy; asthma and COPD education; and pulmonary rehabilitation, which has been shown to reduce COPD patients’ hospital readmissions. RTs are expanding into hospital administration, neonatal and adult flight medicine transport, long-term care, discharge planning, and research.

We teach nonsmoking as part of cardi-

ac and pulmonary disease prevention in middle schools.

Conditions we frequently treat include four of the top 15 causes of death in 2011: heart disease, chronic lower respiratory disease, influenza and pneumonia, and pneumonitis due to solids and liquids.

That last condition refers to inflammation of the lungs caused by inhaling food, drink, or drugs.

Please help us understand how advances in technology have improved the lives of patients treated by RTs. Advances affect everything from how and what RTs administer during aerosol therapy, to improved mechanical ventilation and intubation. The list of disease processes that benefit from aerosolized medication therapy is expanding to include diabetes, osteoporosis, infertility, and more.

Mechanical ventilators are becoming more intuitive, interactive, and easier for patients to manage themselves. Improvements in ventilators and electronic medical records allow RTs to respond faster to ventilated patients experiencing a breathing emergency. Improved intubation devices allow RTs to insert a breathing tube faster, which increases the chances that someone whose windpipe (trachea) has collapsed due to an accident, for example, will retain brain function by getting enough oxygen.

These advances help reduce the length and cost of hospital stays.

RTs are often part of a care team that includes other health care professionals. What can you tell us about these teams and how members interact? Teams contain different specialists depending on the need. In a critical care setting, the team might include specialists and technicians in pulmonary, critical care, surgery, and cardiology.

Some of the ways we collaborate with co-workers: We obtain information for physicians by performing diagnostic tests such as measuring lung capacity; supervise respiratory therapy technicians during tests and evaluate test results; consult with physicians to develop patient treatment plans; and monitor and record the progress of treatment for the physician to review.

People may not realize that an RT’s work can involve life-and-death decisions. What can you share with us about these situations? One Saturday morning, I was driving to military reserve duty and saw a car swerve off the road. I got the driver out of the car, started CPR, and told a bystander to call 911 and to get my airway support kit from my car. Once the fire department and EMS personnel arrived, I continued to provide airway support to the driver so that the person could breathe, while the other first responders inserted an intravenous tube to provide medication to stabilize the driver for the ride to the emergency room.

How are RTs involved with patients who have sleep disorders? We monitor patients whose breathing is interrupted during sleep in order to determine the cause of their problem, and provide therapeutic intervention such as a CPAP breathing mask once the cause of the interruption is determined. Monitoring is done overnight in a sleep lab using a machine called a polysomnograph. It measures certain bodily functions during sleep, including brain activity, heart rhythm, and airflow. This can diagnose or rule out sleep apnea and other sleep disorders.

We treat everyone from premature infants with undeveloped lungs to aging adults.

What kinds of patient communication and family education skills are required to be a successful RT? It is critical for RTs to establish rapport with patients’ families.

Good communication skills, the ability to work with others, and compassion are essential.

Please tell us about the training, qualifications, and licensure required of an RT. Training includes courses in anatomy, physiology, cardiopulmonary pathology, math, physics, disease process management, and equipment, plus a clinical internship.

Most entry-level RT jobs require a two-year associate’s degree in respiratory therapy. This qualifies someone to take a state exam to become licensed, which is required by all states except Alaska. Once licensed, an RT can become a CRT (certified respiratory therapist) through additional education, training, and examination by the National Board of Respiratory Care. A CRT with additional education and experience may take the exam for RRT certification (registered respiratory therapist), which allows specialization. Neonatal respiratory care is one specialty.

Looking to the future, what changes do you foresee in this field? Increased engagement with patients and their families in disease education and lifestyle changes. Technologically, we foresee using acoustics to measure components of respiration instead of needing patient blood samples. Ventilators are in development that will make it easier to wean patients off ventilators, which are currently a major source of infection. Medications for COPD are being refined.

We foresee increasing need for our skills because of the aging population. In 2012 there were about 119,300 RT jobs in the U.S., according to the Bureau of Labor Statistics (BLS). By 2020, baby boomers will be 55 or older and increasingly susceptible to respiratory conditions like COPD and pneumonia, so this field looks promising for job prospects.

The BLS predicts RT employment will grow 19 percent by 2022, faster than the average rate for all occupations. Eventually, I believe, RTs will be allowed to provide care independently under a physician’s directive.

What would you like people to know about respiratory therapy? We are a unique bunch of providers, rarely recognized but providing lifesaving intervention when needed.

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January/February 2015 Minnesota Health care news

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Pa l l i at i v e c a r e

Why aren’t more

Minnesotans

using hospice care?

T

he number of patients and families served by hospice nationally has increased recently. In 2008, more than 1.2 million Americans received this care. By 2012, more than 1.5 million had, according to the most recent data available.

Reasons and solutions

By Barry Baines, MD, and Janelle Shearer, RN, MA

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

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Minnesota Health care news January/February 2015

That’s good news because hospice care offers relief from pain, along with specialized services for emotional complications of dying, such as depression. Hospice caregivers ensure that terminally ill patients have medications, medical supplies, and special equipment so that patients and their families have peace of mind during the time that a patient has left. Hospice also saves money because hospice patients have lower rates of hospital and intensive care use, as well as fewer hospital readmissions. Interdisciplinary care

provided in hospice helps to anticipate and head off problems that can lead to hospitalization.

Low hospice use in Minnesota The not-so-good news? Minnesotans don’t use hospice services as much as residents of other states, even though they might qualify for it. And even those who do receive hospice care often delay unnecessarily; 35 percent to 40 percent die within seven days of starting it, despite the fact that Medicare will pay for six months of hospice for an eligible patient. (“Eligible” means being referred by a doctor who expects the patient to live six months or less.)

In 2012, the National Hospice and Palliative Care Organization reported that 73.5 percent of families rated hospice care as “excellent” for their loved ones. When the survey asked how well hospice services met the needs of survivors, families responded “very well” 75.8 percent of the time. Health care professionals often hear surviving family members say, “We wish we’d used hospice care sooner.”

Since this service is covered by Medicare and valued by families, why isn’t it used more often in Minnesota?

Boston-based Dana Farber Cancer Institute revealed that 69 percent of advanced lung cancer patients and 81 percent of advanced colon cancer patients believed the chemotherapy they were receiving would cure them (New England Journal of Medicine 2012). Congestive heart failure’s six-year survival rate is only 20 percent to 25 percent, yet one study reported that 60 percent of patients with heart failure did not understand their illness was life-limiting (Journal of the American Medical Association 2008).

Previous research and anecdotal conversations show that when physicians were asked if they were willing to talk to their patients about end-of-life topics such as hospice, the response was, “Yes, if the patient brings it up first.” As you might guess, when patients Why aren’t more Minnesotans using hospice care? to page 34

Understanding the reasons Stratis Health conducted a one-year project to increase the use of hospice services in the state. This project aimed to help eligible patients enter hospice care sooner, and to increase physicians’ hospice referrals in Minnesota, by identifying barriers to access. Called Targeting Resource Use Effectively (TRUE), the project was funded by the Centers for Medicare & Medicaid Services’ Quality Improvement Program.

Alexandria, Mora, and Waconia were chosen to participate in the project because they had lower hospice-use rates than other Minnesota cities, and appeared to have opportunities to optimize the use of hospice. Identifying hospice access barriers included conversations with laypeople and with patients and their families who were currently in hospice or had used hospice. Information also was gathered from area health care providers, hospital representatives, clinics, and senior care facilities.

Identifying barriers In all three communities, nearly all patients and their families agreed that if they knew they had a life-limiting illness, they’d want to know about hospice. Yet, when each community’s team interviewed physicians and other health care providers, interviewees said that the biggest barrier to receiving hospice care for patients was the fact that “patients are in denial about their illness” and that “they don’t accept that they have a serious illness.”

This brings up even more questions. Are patients in denial or is it possible that patients and families don’t fully understand the nature of their serious illnesses? Do people not know enough to ask about hospice as an option? Is this a missed opportunity to educate people about hospice?

Yes. There are opportunities to learn what hospice offers and how to access it, since 90 percent of the time, death is predictable.

That percent is based on the fact that approximately 10 percent of deaths arise from unpredictable causes such as accidents or massive heart attacks. Within the predictable 90 percent, we know, for instance, that advanced cancer can’t be cured. However, research at

January/February 2015Minnesota Health care news

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Va s c u l a r m e d i c i n e

Peripheral artery disease Underdiagnosed, undertreated, common threat

By Wobo Bekwelem, MD; Niki Oldenburg, DrPH; and Alan T. Hirsch, MD

P

eripheral artery disease (PAD) is one of the most common and dangerous of all cardiovascular diseases. Yet, it is also the most underdiagnosed and undertreated one. PAD affects 202 million people worldwide and more than 8 million in the U.S. It is seven-fold more common than HIV, more common than heart failure or atrial fibrillation, and causes more deaths than colorectal

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Minnesota Health care news

January/February 2015

cancer, breast cancer, or AIDS. In a typical primary care clinic, PAD is present in approximately one in three adult patients. Nevertheless, the public seems to be largely unaware of the disease or its symptoms; fewer than one in four adults is aware the disease exists. Of those who have heard of PAD, even fewer know of its increased risk of heart attack, stroke, amputation, and death. PAD places individuals at the same increased or greater risk for heart attack or stroke as a person who has already suffered a recent heart attack or stroke. It also causes more than 1,000 amputations per year in Minnesota.

What is it?

PAD can be understood as heart disease that “hits below the belt.”

It is characterized by blockages in arteries outside the heart. Arteries are blood vessels that carry oxygen-rich blood and nutrients to your heart and all other parts of your body. The term “PAD” is used to describe the disease and associated symptoms that occur when these blockages prevent blood from reaching the legs. The blockages are usually caused by atherosclerosis, the disease process in which plaque accumulates inside your arteries. Plaque is composed of fat, cholesterol, calcium, and other substances found in the blood.

Risk factors People who smoke, are exposed to secondhand smoke, or have diabetes have the greatest risk of developing PAD. Additional risk factors are high blood pressure, high blood cholesterol levels, increasing age (risk increases quickly in people over 50), and a family history of PAD (i.e., in a parent or sibling).

Symptoms The most easily recognized symptom is claudication. Claudication is defined as fatigue, discomfort, cramping, or pain in leg muscles that occurs during exercise and is always promptly relieved by rest.

In severe PAD, pain may occur in a foot even without exercise.

Some patients with severe PAD may experience poorly healing foot skin wounds (requiring more than one month to heal) or gangrene.

These symptoms should prompt an immediate medical examination, without delay.

More than half of all individuals with PAD will not have any recognizable leg symptoms, and thus may not be aware of their risk.

As many as one in three individuals with PAD will have leg symptoms that are difficult to recognize as being due to artery blockages, because more than one cause of leg pain is present in many adults.

This makes it difficult for individuals with PAD, and their doctors, to make an accurate diagnosis relying on symptoms alone. That’s why people in certain categories should seek diagnostic testing.

Who needs to be tested?

Individuals 65 years or older, or those over 50 years of age who have at least one risk factor (a history of smoking, diabetes, high blood cholesterol, or high blood pressure) should consider asking their physician for a PAD evaluation. People with unexplained leg muscle fatigue or discomfort when they use their legs (possible claudication) should be evaluated for PAD. Those with a poorly healing foot wound, unexplained foot pain, or gangrene should seek emergency medical care.

done not just at home, but also will be overseen by trained exercise physiologists, nurses, or physical therapists in an established outpatient program. A second method uses the prescription medication cilostazol, proven to improve pain-free walking in PAD patients.

Less commonly, when claudication is caused by specific kinds of artery blockages and other treatments are ineffective, treatment may include improving blood flow through the artery by one of several procedures. These include leg artery angioplasty or stent insertion (inflating a balloon in the artery, sometimes with placement of a permanent metallic coil) or leg artery surgery. All patients benefit from regular follow-up with their primary care doctors and referral to a vascular specialist to create a lifelong care plan. With excellent care, leg function can be maintained; heart attack, stroke, and amputation avoided; and a productive life maintained.

More than half of all individuals with PAD may not be aware of their risk.

Treatment PAD is a lifelong disease that requires you to control risk factors in order to stay healthy. For example, if you smoke, it is critical to consider how you will successfully achieve complete, lifelong smoking cessation, because artery damage can be avoided by stopping smoking.

Most individuals with PAD benefit from using any one of three anti-clotting medications, such as a daily aspirin (81 mg). Check with your doctor before starting aspirin or any other anti-clotting product. Hypertension (high blood pressure), high cholesterol, and diabetes all should be treated according to goals you and your doctor agree upon. If you have claudication, your health care provider can offer you a range of possible treatments; you always should be offered information to make a carefully informed choice.

The most effective and safe method for improving claudication is a prescribed program of supervised exercise that strengthens leg muscles over a period of at least three months. Exercising will be

Wobo Bekwelem, MD; Niki Oldenburg, DrPH; and Alan T. Hirsch, MD, are members of The Vascular Medicine Program at the University of Minnesota Medical School and School of Public Health, Minneapolis.

Telephone Equipment Distribution (TED) Program

Diagnosis When you see your doctor, he or she will ask you about symptoms of PAD and will evaluate your risk factors for it and other heart diseases. You’ll have a physical examination that includes checking your blood pressure; checking for pulses in your neck, arms, and legs; and your doctor will listen with the stethoscope for sounds that may indicate blockages of the leg arteries. The most common test used to diagnose PAD is the “ankle-brachial index” (ABI). This simple, risk-free, inexpensive test compares the blood pressure readings in your ankles with that in your arms using a blood pressure cuff and electronic stethoscope or ultrasound machine. If you experience symptoms suggesting claudication, you may be asked to walk on a treadmill with the arm and ankle blood pressures measured at rest and again after exercise. Other tests can define the location of any potential artery blockages using ultrasound or a CT or MR scan, but these rarely are needed to establish a diagnosis and plan care.

Take PAD seriously In 2014, the danger of PAD is greater than that of most other forms of heart disease. PAD affects at least one member of nearly every family that has more than five adults over age 50. Fortunately, PAD is easily diagnosed and treated: Visit your primary care provider if you have any risk factors or symptoms.

Do you have trouble using the telephone due to hearing loss, speech or physical disability?

If so…the TED Program provides assistive telephone equipment at NO COST to those who qualify.

Please contact us, or have your patients call directly, for more information.

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

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

January/February 2015 Minnesota Health care news

15

E n v i r o n m e n ta l h e a lt h

Winter air quality Tips for breathing easier

By Jill Heins Nesvold, MS, and Cynthia Isaacson

B

GOUT–3clr 210 041 01.14.15

reathing healthy air is important year-round, but winter brings additional concerns. That’s because we spend more time inside, where air is dry, and because the weather itself can trap pollutants in outdoor air. Consequently, it can be harder to breathe easily at this time of year. This is especially true for individuals who have asthma, chronic obstructive pulmonary disease

Do you experience occasional flare-ups of

Gout?

Radiant Research is conducting a clinical research study of an investigational medication for Gout.

Qualified participants will receive all study-related care and investigational medication at no charge and may be compensated for time and travel. Call the number below to see if you may qualify.

Call Mon-Fri for more information

952.848.2065

7700 France Ave., Suite 100, Edina, MN www.radiantresearch.com

16

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(COPD), or lung cancer. Other populations also are affected disproportionately by unhealthy air during cold weather, including those whose neighborhoods near busy roads and factories expose them to large doses of dangerous outdoor pollutants. Read on to learn how to breathe more easily and healthfully this winter.

Indoors Indoor air quality is often much worse than outdoor air during the winter because keeping windows shut against the cold keeps fresh air from circulating and can unintentionally trap allergens and pollutants inside. Since people spend up to more than 90 percent of their time indoors during the winter months, poor air quality can have a major effect on health.

Indoor allergens and pollutants include mold, dust mites, pet dander, dust, smoke from wood-burning appliances, and tobacco smoke. The lack of adequate air filtration and ventilation and increased moisture in a crowded, well heated home can encourage mold growth, which can trigger allergic reactions and asthma. Children with asthma who have a parent who smokes in the home have much more severe symptoms and increased hospitalizations and emergency department visits. Fumes from household cleaning products, personal care products, paints, adhesives, building materials, and carpeting can get trapped inside a sealed winter home more easily. Improperly vented or malfunctioning combustion appliances that use gas, oil, kerosene, or coal can quickly increase the level of carbon monoxide.

Cold, dry winter air can cause asthma and COPD symptoms to flare.

Effects of exposure to indoor allergens and pollutants can appear after a single exposure and can include headaches, dizziness, fatigue, and itchy eyes, nose, and throat. Individuals with asthma, COPD, or other respiratory diseases may experience increased symptoms. These include shortness of breath, wheezing, increased

Minnesota Health care news January/February 2015

ed for newspapers, fliers, posters, mailings, public transportation, or outdoor advertising.

mucus production, and coughing, all of which can lead to emergency department visits and/or hospitalization.

Outdoors While indoor air pollution levels are often two to five times greater than outdoor levels all year long, we still should be concerned about outdoor air quality. Outdoor winter air pollution comes from a variety of sources, including traffic, industry, wood-burning stoves, and smoking. Primary causes of poor outdoor air quality at this time of year include the weather and increased particulate matter.

Indoor air quality is often much worse than outdoor air during the winter.

Particulate matter. On a typical day, roughly half of the particulate matter (i.e., small particles in the air) that contribute to pollution in urban air is emitted from combustion sources such as vehicle exhaust. The other half is formed by chemical reactions that occur in the air. Particulate matter from tailpipe emissions can increase during winter months due to increased idling in vehicles and slower commutes. Particulate matter from wood-burning appliances also can increase during the winter months when people regularly heat their homes.

Weather can make particulate matter stay around longer. This happens due to temperature inversion, which can occur during winter months when warmer weather sits on top of cold air, thereby trapping cold air closer to the ground. On cold, windless days and nights, the quality of the air we breathe can deteriorate quickly because smoke and vehicle exhaust collect in that layer of cold air.

Asthma and COPD Poor outdoor air quality makes asthma worse in both children and adults. One contributor to this is traffic exhaust. A map developed by the Minnesota Department of Health shows that the percentage of people with asthma is 21 percent to 43 percent in ZIP codes nearest interstates, compared with the Minnesota asthma average of 7 percent.

Cold, dry winter air also can cause asthma and COPD symptoms to flare.

What to do Fortunately, there are many ways to improve air quality, indoors and outdoors.

Inside • Ventilate, ventilate, ventilate.

• Change furnace filters at least every three months, using a pleated electrostatic filter that is designed to catch small particles. The higher the number on the filter, the better it is at capturing smaller particles.

• If you find mold in your home, clean it up and fix the source of moisture to avoid future mold growth.

• Use a HEPA (high efficiency particulate accumulator) vacuum, and dust with a wet cloth or mop to capture dust and dirt.

Carbon monoxide poisoning Carbon monoxide poisoning is caused by inhaling combustion fumes. If you notice any of these symptoms, immediately go outside: • Dull headache

• Shortness of breath

• Weakness

• Confusion

• Dizziness

• Blurred vision

• Nausea

• Loss of consciousness

• Vomiting Exposure to carbon monoxide affects fetuses and children more quickly than adults. Older adults are more likely than younger ones to have lasting problems, including brain damage.

• I ndividuals with lung disease should avoid smoke and wood-burning appliances. Ask anyone who smokes in your home to do so outside to avoid exposing inhabitants to secondhand smoke.

• Properly ventilate or adjust combustion appliances, such as furnaces, to lower exposure to indoor air pollutants, including carbon monoxide.

• Every home should have a carbon monoxide detector. Carbon Winter air quality to page 19

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A brief overview of benefits from using the BioMat: • Stress and anxiety relief

• Core body temperature support

• Improved mobility and flexibility

• Improved circulation

• Chronic and acute pain relief

• Lymphatic drainage

• Arthritis, neuropathy and fibromyalgia relief

• Relief from persistent infection

• Detoxification

Mini BioMat 33"x20" $650.00

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BioMat Professional 74"x28" $1,650.00

We are so sure the BioMat will improve your health that we accept returns for full refund if you are not satisfied for any reason. If you order through us, you will also receive a 30 year repair guarantee and lifetime trade-in policy.

866.689.7336 For more details please visit: www.crystalbiomat.com January/February 2015 Minnesota Health care news

17

Calendar Feb.11

Living with Lupus Lunch

Lupus Foundation of Minnesota is hosting this free lunch for those living with lupus to connect, hear research updates, and discuss living well with lupus. Family and friends are welcome. To register, call Sandy at (952) 746-5151 by Feb. 10.

Wednesday, Feb. 11, 12–1 p.m.

Lupus Foundation of Minnesota 2626 E. 82nd St., Bloomington

Feb.12

Memory Loss Discussion Group

Amherst H. Wilder Foundation hosts this free monthly discussion group for those caring for a person with memory loss. Join others to share your experiences, learn coping strategies, and connect in a supportive environment. On-site respite is available with pre-approval. Call (651) 280-2273 to RSVP. Thursday, Feb. 12, 10–11:30 a.m.

Amherst H. Wilder Foundation 650 Marshall Ave., St. Paul

Feb.16

Brain Tumor Support Group

HealthEast hosts this informal discussion group for brain tumor survivors and their loved ones. Come join others on the same journey to share your experiences, discuss educational topics, and connect in a supportive environment. Call Kathy at (651) 232-3987 to sign up.

Monday, Feb. 16, 7–8:30 p.m., St. Joseph’s Hospital, 3M Conference Center, Rms. A/B, 45 W. 10th St., St. Paul

Feb.17

If I Knew Then What I Know Now

PACER Center hosts this free event featuring a panel of parents of children with disabilities.

They will share insights they have gained through raising and educating their children and answer questions from the audience.

Call (952) 838-9000 to register or for more information.

Tuesday, Feb. 17, 6:30–8:30 p.m., PACER Center, 8161 Normandale Blvd., Bloomington

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

18

National Eating Disorders Awareness Week The week of Feb. 22 is National Eating Disorders Awareness Week. Eating disorders, which include anorexia nervosa, bulimia nervosa, binge eating disorder, and others, can have devastating affects on a person’s physical health, relationships, and emotional well-being.

About 20 million women and 10 million men in the U.S. develop a clinically significant eating disorder at some point in their lives, according to a 2011 study.

In addition, many people live with body dissatisfaction, which is the best-known contributor to a person developing anorexia nervosa and bulimia nervosa.

This year, the National Eating Disorders Association (NEDA) is focusing on sharing the importance of early intervention. The earlier a person seeks professional treatment, the greater chance he or she has to make a full physical and emotional recovery. Signs and symptoms that can serve as early warning signs of eating disorders are often dismissed as inconsequential. Learning what to watch for can help you or a loved one get help before many of the more damaging physical and emotional effects of having an eating disorder develop. NEDA is offering a free online screening for eating disorders at www.mybodyscreening.org

Mar. 9

Family and Friends Support Group

The Emily Program offers this support group for those with a loved one affected by an eating disorder. Come learn how an eating disorder can affect people’s lives and relationships, as well as how to best support them through their recovery.

No registration required. Call (888) 3645977 for more information.

Monday, March 9, 6–7:30 p.m., The Emily Program, 2265 Como Ave., St. Paul

Minnesota Health care news january/february 2015

Feb.17

Pancreatic Cancer Support Group

Allina Health offers this support group for those with pancreatic cancer and their families.

Come share stories and information, and gain support from others who understand. Registration required. Call (612) 863-7553 for more information or to sign up.

Tuesday, Feb. 17, 4–6 p.m.

Abbott Northwestern Hospital, Piper Building, 6th Floor, 800 E. 28th St., Minneapolis

Feb.18

Heart and Vascular Lecture Series

Park Nicollet presents this free lecture series for people who have had heart attacks, open heart surgery, or other conditions affecting the heart or blood vessels. Family members and friends are welcome. No registration required. Call (952) 993-3454 with questions or to receive information on other dates of the lecture series.

Wednesday, Feb. 18, 6–8:30 p.m., Park Nicollet Heart and Vascular Center, Suite G-700, 6500 Excelsior Blvd., St. Louis Park

Feb.19

Youth AIDS Support Group

The University of Minnesota Youth & AIDS Projects offers this support meeting for anyone under the age of 25 who is HIV positive. Come learn how to improve quality of life, prevent premature illness/death, and prevent secondary transmission to partners and offspring. Call Val Smith at (612) 627-6829 to RSVP or for more information.

Thursday, Feb. 19, 5–7 p.m., The Aliveness Project, Community Room and Dining Room 3808 Nicollet Ave., Minneapolis

Feb.25

Honoring Choices

Fairview Health Services hosts this free class for anyone over the age of 18.

Trained facilitators will help attendees develop an advance care plan and a health care directive. Resources will be available to notarize the directive and scan it into your electronic medical record if it is finalized. No registration required; other dates are available. For more information, call (612) 672-7272.

Wednesday, Feb. 25, 2–3:30 p.m.

Fairview Clinics–Bloomington Lake–Xerxes 7901 Xerxes Ave. S., Bloomington

Winter air quality from page 17

monoxide is colorless, odorless, and can reach unsafe levels before someone experiences symptoms.

• Use nontoxic cleaners and unscented personal care products.

• Test your home for radon, a naturally occurring radioactive gas that can cause lung cancer. If high levels are detected, lower the amount entering your home through a variety of repairs, including sealing cracks in basement floors and walls. Learn how to test at www.lung.org/healthy-air/home/resources/radon.html Outside • Monitor the air quality index (AQI) for poor-quality outdoor air at www.pca.state.mn.us/index.php/air/air-quality-and-po llutants/general-air-quality/air-quality-index/current-air-quali ty-index.html • Before you go outside, lower the chance of an asthma flare-up by taking steps to breathe moist air: Cover your mouth and nose with a scarf, neck warmer, or winter face mask. Another strategy is to exercise indoors during the winter at a gym, in your home, or by walking laps inside a mall.

• If it is too cold to wait in your car without idling it, consider waiting indoors.

• Driving vehicles that use alternative fuels reduces pollution.

Use E85 fuel in a flex-fuel vehicle or biodiesel in diesel vehicles to

Resources

The American Lung Association’s (ALA) HelpLine, (800) 586-4872, is staffed with health care professionals that can answer questions about indoor and outdoor air quality. It’s open seven days a week, 7 a.m. to 11 p.m. CST. In addition, the ALA has tools to assess your home’s air quality (www.lung.org/healthy-air/); the EPA also has homeassessment tools (www.epa.gov/iaq/). help reduce particulate matter pollution. There are more than 250 E85 stations in Minnesota and biodiesel is blended into all diesel fuel by state law. Another clean air option is a plug-in vehicle powered partially or entirely by electricity. Details on all available alternatives are at www.CleanAirChoice.org Breathe safely, breathe easily Winter presents specific dangers for indoor and outdoor air, so improve air quality by taking the steps listed here to help yourself and your loved ones breathe better all year-round. For individuals with lung disease, following these steps can help prevent increased symptoms, emergency department visits, and hospitalization.

Jill Heins Nesvold, MS, is the director of respiratory health, and Cynthia Isaacson is the manager of respiratory health, at the American Lung Association in Minnesota.

Center for Sexual Health Compassionate patient care in sexual health for individuals, couples and families of all backgrounds and ages. Patient assessment and treatment is available in the areas of relationship and sexual problems therapy, compulsive sexual behavior, sexual offending, transgender health services and sexual abuse.

HIV counseling, as well as psychological treatment for people living with HIV/AIDS. Our physicians provide care for many medical conditions including (but not limited to) the following: • Compulsive sexual behavior

• Premature ejaculation

• Emotional pain or physical pain with sexual activity

• Sexual abuse

• Erectile dysfunction (ED)

• Sexual desire discrepancies

• Gender identity disorder

• Sexual harassment

• Gender exploration for children and adolescents

• Sexual offending

• Hepatitis

• Sexual orientation

• Mental health

• Sexual problems

• Orgasm problems

• Transgender health Treatments

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

612-626-4702 | www.umphysicians.org January/February 2015 Minnesota Health care news

19

Patient to Patient

Catch and release Undercurrents of healing

By Charles Bransford, MD

Editor’s note: In this essay on how nature enhanced the process of healing from cancer, the author shares his unique viewpoint as both a cancer survivor and a physician.

I

stand in the shallow water, comfortable in my trusty waders, fly rod in hand, looking patiently for clues. Rising haughtily out of the mist enshrouding the bulrushes to my left, a great blue heron flaps his wings and disappears, but not before he tips his head, winklike, toward the half-submerged tree near the water’s edge.

Now I know she is really there, the magical fish I’ve been seeking all my life. It’s the fish all anglers imagine every time they have a

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• Track your blood pressure and share with your doctor • Medicines can make a difference... if you take them • Eat healthy and be active • Avoid salt Minnesota Diabetes & Heart Health Collaborative

The Minnesota Diabetes and Heart Health Collaborative: Working together to keep you informed

www.mn-dc.org Adapted from the Minnesota Diabetes and Blood Pressure Performance Improvement Plan postcard

20

Today, the calls of red-winged blackbirds blend with the soft hum of cicadas and crickets. Bullfrogs provide percussion. However, it’s the silence between the sounds that calls to my soul and settles me into the magic of this place. I watch the water bugs jet back and forth, creating a kaleidoscope of ripples on the clear lake surface. I carefully choose the fly that mimics these bugs and tie it easily onto my line. I’ve tied so many of these I know the knot will hold.

Beginning my meditation, I lay out several feet of line in front of me, and then, with a smooth, even intake of breath, I draw the fly rod back until the line is fully extended behind me. Next, I slowly breathe out as I thrust the line forward. The reel sings as it releases the line.

This rod was handed down lovingly from my grandfather to my father, and then to me. Someday I hope to hand it down to my grandson, the one who spotted a heron—“Grandpa, look!”—outside his bedroom window at the cabin when he was little more than a year old.

PUT THE SQUEEZE ON HIGH BLOOD PRESSURE

• Do not smoke

big fish on the line, just before they actually see it. The fins appear, then shadows of the towering giant, and finally the real thing.

Minnesota Health care news January/February 2015

I begin to send my fly to imaginary points along the water, slapping the water, waking up the fish. Glistening drops of water cling to the line, reflecting the early morning sunlight. Eventually I launch a perfect cast to the base of the log my heron friend pointed to, and then: Wham! The fish takes the fly the moment it hits the surface.

She takes off with such power that I am temporarily stunned and it takes my breath away. The reel shrieks with the speed of its release, and I feel the wild power and instinctual drive toward freedom this fish possesses. She is not one bit afraid but rather is filled with the universal desire to wriggle free that all sentient beings carry deep within their souls. She transmits this intention through the fly line to my very soul. We are connected, this fish and I, as she zooms back and forth across the bay. Suddenly, she changes direction and dives for the bottom.

I think of her wrapping around a rock or a log, and gently pull up on my rod, but just as suddenly she turns and heads for the surface. She jumps completely out of the water, her body bent in an undulating S curve, flailing back and forth, using every muscle she has to dislodge the fly. I begin to feel her tiring. She has no less will, but simply is running out of energy. Just before reaching my hand

she makes one more gallant run for freedom, but I am lucky enough to raise my rod tip at just the right moment and this time, she comes in with her head bowed. I catch her, raise her gently out of the water, and remove the hook from the corner of her mouth. Then I can’t resist giving her one small loving caress from the tip of her mouth, across her back to her tail, and after offering a prayer for her safety and a thanksgiving for her appearance, I release her into the beautiful blue water. For a moment she sits stunned by this unexpected turn, and then, with a flick of her tail, she is gone.

The IV line clings tightly to my arm. No matter which way I pull or dive, I can’t get away. The chemotherapy invades my every thought and feeling. If only I could be as fearless as that fish, but I’m afraid. I have no instincts to fall back on. Senseless thoughts and continuous worry are my constant companions. I dive to the metaphorical bottom hoping to wrap the line around some rock or log in the form of a person, but they all treat me the same. They’re afraid they might say the wrong thing, or maybe that what I have is somehow catching. They push me away with their fear-filled platitudes.

I try to hide the line, but everyone knows. It’s written on my face, and the pity reflected in their faces doubles the pull of the cancer line. I leap out of the water, looking in every direction for help, but land back in the water with a helpless plop. I haven’t lost my will but I am getting tired, and I feel the pull of the line getting stronger.

The harder I resist the deeper the hook sets into my tender skin. I give one more desperate lunge. After that I come in with my head bowed, utterly defeated.

I am completely pulled out of the water, but instead of being thrown into the frying pan I’m taken off my hook and placed gently back into the water. I could swear I’ve been lovingly caressed by some unknown being. I go into remission. I can feel the prayers that have been lifted up in my name, and all I can do is offer my unending thanks. I can’t believe it: I am free.

There are so many undercurrents of healing in this moment, including the waves of hard-won science and the water from the unending fountain of the human spirit. Healing is such a wondrous mystery. Cures are frequent, but healing is rare. Nature teaches that healing comes from accepting our place within the firmament. Life and death flow together within the natural order. Each is dependent on the other and has its own time and place: one moment the roaring lion; the next moment, the mourning dove.

I glide through the water of my life, slowly gaining strength. I swim joyously back and forth across the bay and dive to the bottom, then turn straight up and jump completely out of the water, my body undulating in a giant S curve using every muscle. The hook that was embedded in me was more than chemo. I feel the pull of hungry ghosts, desires, wants, fears, worries, the future, and the past all dissolving in this remarkable moment. I jump one more time, and this time I see the real sky.

Charles Bransford, MD, is director of hospice and palliative care services at Lakeview Health System, Stillwater.

Accidental Bowel Leakage (ABL) You no longer need to suffer in silence Nearly 18 million U.S. adults, or one in twelve, are affected by ABL. Men and women of all ages may be affected, although it is more common in older adults. Most people and many physicians are not aware of the reasons for ABL or that it can be easily treated. In addition, fear, shame and embarrassment are often impediments to seeking solutions to this problem.

We specialize in diagnosis and treatment of ABL. Modern medicine brings an array of simple, safe and effective procedures to treat ABL. At the Pelvic Floor Center we provide a multi-disciplinary approach for the treatment of ABL and other pelvic floor disorders including urinary incontinence and pelvic prolapse.

• Dietary modification • Biofeedback therapy • Office – based procedures We see patients on referral. If you are experiencing ABL your primary physician can refer you to the Pelvic Floor Center or you can see a provider at Colon and Rectal Surgery Associates for initial evaluation and referral.

651.225.7800 • www.pelvicfloorcenter.org For information about other services we provide please visit us at www.colonrectal.org January/February 2015 Minnesota Health care news

21

Insurance

Life insurance after cancer Navigating a changed landscape

By Lindy Yokanovich, Esq.

A

fter receiving a diagnosis of cancer and going through a cavalcade of treatments such as surgery, chemotherapy, and radiation, cancer survivors might think that the toughest part of surviving cancer is behind them. What people often are not prepared for is the impact a cancer diagnosis has on so many other, nonmedical parts of their lives, including the ability to secure insurance.

Medical insurance With the passage of the Affordable Care Act (ACA) and its full implementation effective Jan. 1, 2014, the biggest insurability fear of most cancer survivors—being denied medical insurance coverage for

having a preexisting condition of cancer—is largely a worry of the past. The law’s provision precluding medical insurance companies from denying coverage to applicants or to the already insured due to a preexisting medical condition has, and will, greatly change the landscape of survivorship for thousands of Minnesotans living with a history of cancer. While there are specific eligibility events and timelines for applying, the knowledge that regardless of job change or loss, a person’s ability to maintain insurance can no longer be denied solely for their past health conditions represents a tremendous improvement in the survivorship experience.

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Minnesota Health care news January/February 2015

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INFORMATION Job Number

245-13124

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Modification Date

October 22, 2014 2:33 PM

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HealthPartners

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Output Date

10/22/14

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MN Health Care News

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

4” x 5.25”

Life insurance Unfortunately, the same protections do not apply to securing life insurance after a cancer diagnosis. The protections and rights of the ACA apply only to health insurance, not other types of insurance such as life insurance or disability insurance. Consequently, getting an individual life insurance policy in the private market after a cancer diagnosis (as opposed to joining a group plan through your employer), while not impossible, does pose many more challenges.

Secure new coverage The easiest way for someone to secure life insurance after cancer likely will be under a group plan through his or her employer or through a professional association or organization to which she or he belongs. If neither of these alternatives to securing group coverage is available, there are still other options. While it is unlikely that cancer patients will be able to find life insurance coverage if they are currently in active treatment, the more time that has passed since the person completed treatment, coupled with the type of cancer for which he or she was treated, may make it easier for cancer survivors to find affordable coverage options.

Factors The ability to secure insurance after a cancer diagnosis depends largely on the type of cancer, its stage, and sometimes even on the treatment plan. Certain types of cancer, such as nonmelanoma skin cancer, are considered low risk and may not pose any obstacle to obtaining coverage. On the other hand, a person who has a cancer that

has metastasized likely will be denied. Between these two ends of the spectrum lies an area where there are no clear answers.

Sometimes, people who have a history of a highly treatable cancer such as breast, thyroid, prostate, and testicular cancer may be able to secure coverage at standard rates. People who have a history of a leukemia, lymphoma, or colon cancer may be able to secure coverage, but at a much more expensive rate. In all cases, an extensive review of the survivor’s diagnosis, medical records, and treatment plan will be performed by underwriters at the insurance company to which the survivor is applying for coverage.

Some life insurance companies have specific programs and policies for cancer survivors. These policies may include a progression of eligibility considerations as well as premium rates that depend entirely on the staging of the cancer, lymph node involvement, and amount of elapsed time since completing treatment. For example, insurance company MassMutual’s “Insurance for Breast Cancer Survivors” brochure states that breast cancer survivors with larger stage 1 tumors (greater than 1 cm in size) can be considered for life insurance coverage one year after they complete definitive treatment.

MassMutual also states that life insurance contract terms for these survivors may include a temporary additional premium of up to eight years.

In contrast, states the brochure, breast cancer survivors who have a history of more advanced tumors and who have had more than three lymph nodes involved cannot be considered for coverage Life insurance after cancer to page 27

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January/February 2015 Minnesota Health care news

23

H o s p i ta l s

Medical bills Pointers to help you understand From The Office of Minnesota Attorney Genral Lori Swanson

M

edical billing can be confusing. A hospital or clinic may bill you before your insurance company has been given a chance to pay, leading you to question whether you owe the bill. Or, you may have a high-deductible insurance plan and are struggling to keep up with large hospital bills. In either of these cases, the following medical billing pointers may be of help.

Ensuring that the bill and your portion of the bill are accurate Patients are sometimes billed incorrectly; are billed for services that have not been received; are billed for services that have already been paid, either by the patient or the patient’s insurance company; or are billed for services that should have been submitted to the patient’s insurance company. If you receive a bill from a hospital and clinic

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Minnesota Health care news January/February 2015

URGENT CARE

and dispute whether you owe the amount requested, or are unsure if you do, you may wish to:

a claim because the hospital negligently failed to bill the A hospital emergency room cannot deny you emergency care. patient’s insurance company EMTALA, a federal law, requires a hospital emergency room to on time. If a clinic or hospital • Request an itemized treat patients in emergency situations regardless of their ability asks you to pay a bill that you statement from the clinic to pay.

EMTALA also prohibits a hospital from asking for money believe should have been paid or hospital. An itemized before a patient has had a medical screening examination and by your insurance company, statement should contain before stabilizing treatment is provided. call both the clinic/hospital a full accounting of the and the insurance company to services provided to you. see if there is still time for the If the itemized statement claim to be processed. If not, question both the clinic/hospital and contains services you never received, call or write to the clinic the insurance company about your obligation to pay the bill if the or hospital to point out the discrepancy. Keep a copy of any clinic/hospital’s delay in filing a claim caused a claim denial. letters you send.

Emergency Medical Treatment & Labor Act (EMTALA)

• Ask the clinic or hospital for an itemization of all payments, whether made by you or your insurance company. By matching up the original charges with the payments made, you may be able to identify any discrepancies. In some cases, a clinic or hospital may have multiple accounts in your name (or that of your family). This can lead to confusion if the health care organization posts a payment for one account to another account. If you feel you’ve made a payment that is not showing up, ask if the health care organization might have posted the payment to another account in your name (or that of a family member).

• Ensure that your insurance company has paid what it should, if you have insurance coverage. In some cases, your clinic or hospital may send you a bill before your insurance company has been given a chance to pay. If you are uncertain whether you owe the bill, call your insurance company to find out whether it has received and acted on the bill and how much it will be paying. Ask your insurance company what its timetable is for paying the bill. Your insurance company will usually send you an “explanation of benefits” form showing what it has paid on a health care bill and how much you owe.

Payment and financial assistance plans Health care bills can be expensive, and some people may have difficulty paying them all at once. If this is your situation, you may wish to ask the clinic or hospital if it will work with you to reach an affordable payment plan. Under an agreement between the Minnesota Attorney General and most Minnesota hospitals, if a patient expresses an inability to pay an entire hospital bill at once, the hospital must work with the patient to see if a reasonable payment plan can be reached. This agreement also applies to some clinics that are part of hospital systems.

Minnesota nonprofit hospitals also offer financial assistance Medical bills to page 26

In the next issue...

• Find out if the clinic or hospital neglected to bill your insurance company.

Most HMOs and insurance companies require a clinic or hospital to bill them in a certain amount of time; if they do not, the insurer or HMO may then deny the claim. In some cases where a claim is denied because the clinic or hospital sent it to the insurer too late, the clinic or hospital may then turn to the patient for payment. Most provider agreements between doctors, clinics and hospitals, on the one hand, and HMOs and insurance companies, on the other hand, state that the clinic or hospital cannot turn to the patient for payment if the clinic/hospital bills the insurer too late. In addition, an agreement between the Minnesota Attorney General and most Minnesota hospitals prohibits most hospitals (and their associated clinics) from pursuing a patient for collections if an insurance company denied

Patients are sometimes billed incorrectly.

• Child abuse • Compounding pharmacists • Medication and memory loss

January/February 2015 Minnesota Health care news

25

Medical bills from page 25

programs to help people with limited income and assets pay their hospital bills. These programs vary from hospital to hospital and may have names like “charity care,” “community care,” or “financial assistance” program. If you have trouble affording a hospital bill, you may wish to ask the hospital whether you qualify for its financial assistance programs.

A hospital emergency room cannot deny you emergency care.

The Minnesota Attorney General Hospital Agreement The Minnesota Attorney General and most Minnesota hospitals have entered into an agreement relating to the hospitals’ billing and collection practices.

The following are some of the provisions in the Minnesota Attorney General Hospital Agreement: • T he hospital cannot collect debt from the patient unless the applicable insurance company has been billed and given the opportunity to pay the claim and there is a reasonable basis to believe the patient owes the bill.

• T he hospital must offer a reasonable payment plan to patients who are unable to pay the full amount in one payment. The hospital may not refer a debt to a collection agency if the

patient makes payments in accordance with the terms of a payment plan agreed to by the hospital.

• A patient must be given a reasonable opportunity to submit an application for financial assistance from the hospital.

• A hospital collection agency must forward all patients who object to the collection activity to the hospital. In other words, you have the right to speak with the hospital directly.

• The collection agency must cease collection activity pending further review if the patient states that: (1) he or she doesn’t owe the bill; (2) the insurance company is obligated to pay the bill; or (3) the patient needs further documentation of the bill.

• For patients without insurance coverage, a hospital may not charge an uninsured patient more than the hospital would be reimbursed by its largest insurer for those with health insurance. In other words, an uninsured patient cannot be charged more than an insured patient.

If you have questions If you have any questions, or need help, you may contact the Minnesota Attorney General’s Office at: Office of Minnesota Attorney General Lori Swanson 1400 Bremer Tower, 445 Minnesota Street, St. Paul, MN 55101 (651) 296-3353 • (800) 657-3787 TTY: (651) 297-7206 • TTY: (800) 366-4812 www.ag.state.mn.us

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

• Diabetes Type ll can also cause vision changes.

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

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

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

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Life insurance after cancer from page 23

until 10 years after they have completed definitive treatment. In addition, their contract terms may include a temporary additional premium of up to seven years or a permanent additional premium.

Maura Steblay, MAEd, CLU, ChSNC, of Minneapolis Financial Group, has helped cancer survivors secure life insurance coverage and offers these tips to increase the chance of being approved for coverage.

• Adhere to treatment protocol.

• Be prepared to disclose all related medical records.

• Fully disclose your own health history and that of your family.

Retain existing coverage Unlike medical benefits, which may be continued after employment ends under the federal law known as COBRA, group life insurance benefits enjoy no such protection under this federal law. However, a Minnesota state law provides for the continuation of coverage for life insurance in certain circumstances when employment ends or a reduction of hours is in place such that the employee is no longer eligible for coverage under the policy.

Moreover, the Minnesota law allows for the group policy to be converted to an individual policy after a certain period of time.

In order to continue life insurance coverage under Minnesota law, a former employee (or current employee whose hours have been reduced) must pay the employer, on a monthly basis, the cost of the

continued coverage not to exceed 102 percent of the cost of the plan.

The employee is eligible to continue this coverage as long as she or he continues to pay premiums in full until she or he obtains coverage under another group plan, or for up to 18 months, whichever is shorter. If, after the end of 18 months, the employee is not covered under another group plan, Minnesota law requires that the insurer providing the group plan must offer the employee an individual policy providing the same or substantially similar benefits without further evidence of insurability and without interruption of coverage.

Find an agent to help Any insurance agent/broker who sells life insurance products may be able to help you identify options for coverage. But, like any other professional service provider, it helps to work with someone who has experience with these types of issues. One such professional is an insurance agent/broker who is a so-called “impaired risk” specialist.

These specialists are usually former insurance underwriters, so they understand how insurance companies assess applicants. Another way to find an experienced agent often can be by asking other cancer survivors for references.

The ideal time to obtain life insurance is while you are still healthy, before being diagnosed with a serious illness. Obtaining life insurance after a diagnosis of cancer may not be easy, but it isn’t necessarily impossible.

Lindy Yokanovich, Esq., is the founder and executive director of Cancer Legal Line, St. Paul.

January/February 2015 Minnesota Health care news

27

B e h av i o r a l h e a lt h

Autism spectrum disorder Improving quality of life for adolescents and young adults

By Elizabeth Reeve, MD

A

s a clinical psychiatrist, I often encounter roadblocks for my patients who need services outside traditional medical care.

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Minnesota Health care news January/February 2015

the need to improve the quality of life for people his age who are approaching adulthood.

A range of abilities My son is relatively self-sufficient day to day, and graduated from a technical school. He does not drive but can take public transportation, and enjoys many independent activities such as biking. He has a wonderful sense of humor, works hard, perseveres at everything he does, and enjoys being with others.

However, there is much he cannot do. Currently, he is unable to live on his own. As he and other high-functioning adolescents and young adults with autism move into the early stages of adult life, their difficulties do not go away. Here are issues people with autism may face as they become adults.

Challenges of approaching adulthood Finding meaningful employment is a serious challenge for young adults on the autism spectrum. Statistics suggest that this group is at a very high risk for not completing school and for failing to find success in secondary education or employment. While there are an increasing number of agencies that specifically target job placement for people with autism, the unique job needs of these young adults make job placement difficult. Often, a young adult with autism may have sensory needs that impair the ability to work in certain environments. Decision-making skills may be slowed and, therefore, fast-paced jobs may cause increased stress or anxiety.

Housing is another area of need, and our current social service model of working toward independent living may not always be best for someone with autism. Typical young adults may find the thrill of a first apartment exciting and motivating. They may explore the neighborhood and join the local gym in order to meet new people.

People with autism may be overwhelmed by all of the changes and isolate themselves. They may turn on the computer and get so lost in the Internet that they forget to buy groceries or shower. The per-

ceived benefits of integrating a person with autism into the community may quickly disappear.

Many agencies now are working on a variety of living options.

These include apartment buildings that have individual units and full-time staff who assist and check in on autistic residents. Shared space with part-time staff is another option. Or, families could collaborate and purchase a separate home for several young adults.

Creativity is the key to housing success, and individual needs must always be the priority.

Learning to drive may be a challenge if you have autism. Many adults with autism can drive, but many cannot. Although the physical aspects of driving may not be difficult, the multitasking required to drive safely may be. Not driving may limit job seeking and socialization, and people with autism in rural areas of the state have a greater risk for being isolated if they can’t drive. Parents wondering if their young-adult children with autism can manage driving can contact a rehabilitation organization that conducts independent driving assessments (www.couragecenter.org/ContentPages/drivers.aspx).

Social vulnerability Consideration needs to be given to the social vulnerability of this unique group. Young adulthood is a time when there are many complex new experiences such as signing contracts, buying a car, obtaining a credit card, and learning to manage money. People with autism may be vulnerable to being taken advantage of.

Someone without autism likely would recognize a voicemail message guaranteeing a “free” vacation in the Bahamas as a possible scam. Less sophisticated young adults with autism may fall prey to such schemes and quickly find themselves in over their heads without knowing what happened.

I know a young man with autism working as a cashier, who was convinced by acquaintances to give them a 10 percent discount every time they came through his checkout line. His line became popular and he perceived this to mean that he was making more friends, when actually, he was being taken advantage of. Because of these social vulnerabilities, families may want to consider pursuing legal guardianship for their young adult.

The physician’s role Your physician can contribute a great deal to helping your young adult with autism successfully transition to adulthood. Initiate a discussion with your doctor about transition issues and plans when your child is around 14 or 15. This may seem early, but it may take a family several years to process the complexities of the system and to grieve about the losses they may experience related to raising their child. Physicians likely will encourage you to contact your local autism society, which maintains a list of service organizations.

Societies often hold educational sessions that explain topics such as guardianship, future financial arrangements, medical insurance, and housing options.

Caregiver self-care Caregivers need to take care of themselves. Often, families deal with great stress when living with an older adolescent or an adult

who has a disability. Self-care, exercise, and time away is imperative for the long-term well-being of the caregiver. Long-term cumulative stress is emotionally exhausting and may exacerbate medical conditions. This is shown by the fact that caregivers have increased rates of chronic medical problems such as hypertension, obesity, and cardiovascular disease as well as increased mental health concerns.

Learn to talk about the possible financial stresses your family may be having because of your child’s disability. Often, parents accumulate debt supplying services and treatments for their child.

Retirement plans may be disrupted due to the need for parents to stay nearby the disabled adult. Adults with autism may earn enough income to decrease their dependence on social services, but not enough to live comfortably. Their families may help support them, causing further financial strain.

Recognition, growth, change Finally, recognize that autism is a permanent disability. Growth and change will occur over time, but the range of development between people with autism is huge and their outcomes depend on many factors. Take the time to talk to your physician and to other families who have children with autism about work, school, housing, and finances. My son is doing well now but I will not always be here to care for him. It is my greatest fear in life that he will not be able to manage his future. I need all the help I can get!

Elizabeth Reeve, MD, is a board-certified child and adolescent psychiatrist practicing with HealthPartners Medical Group.

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January/February 2015 Minnesota Health care news

29

Caregiving

Long-term Plan now to avoid obstacles later

By Deb Holtz, JD

M

any people don’t think much about long-term care—help with activities of daily living, such as eating and bathing—until they or a loved one need it.

Although most people require some kind of long-term care as they age, the fact is that almost everyone needs long-term care

sooner than they think they will. And it’s not just for seniors; about 40 percent of people receiving this care in Minnesota are 64 and younger. The need for this care can arise at any age, due to accident, illness, or a number of conditions that might be present from birth and require accommodations and supports.

Accessing long-term care can be challenging, confusing, and expensive. However, it does not need to be if you plan. Here are some common obstacles to accessing this care, and how to plan to avoid them.

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Personal planning Consider who you can count on for support and help if you become ill or acquire a disability as you age. Support from family and friends can supplement care from both paid and community volunteer service providers. Some people prefer to receive care from people close to them, while others don’t want to burden their loved ones with the responsibilities of caregiving. Think about how you feel about relying on family or friends for care.

Begin by having honest conversations with those close to you to ask if they are able to commit to caring for you. Otherwise, you risk having important decisions made for you during a crisis situation when emotions are high, choices are confusing, and little time is available to consider all factors.

Find out what long-term care options are available in your community. Knowing whether there are local volunteer-based, in-home programs may help you decide if you want to remain in your current home or move to another type of housing that provides services, such as an assisted living center.

Financial planning You may need to turn to paid caregivers or a care facility if you have no one to help you or if your helpers cannot provide for all your needs. Hiring long-term care can be expensive. In Minnesota, the average annual cost of two to three home health care visits per week is about $20,000; about $40,000 for one year in an assisted living

30

Minnesota Health care news January/February 2015

facility; and more than $70,000 for a year’s stay in a nursing home.

Some people have mistaken assumptions about how they’ll pay for long-term care. It’s important to know which insurance programs do not pay for this care: • Private health insurance does not pay for most long-term care.

• Disability insurance, even long-term disability insurance, does not pay for long-term care.

It partially replaces your income from wages while you are unable to work because of a disability.

• Medicare only covers very shortterm care (20 days) in a nursing home after a qualifying hospital stay.

• Medicaid, called Medical Assistance in Minnesota, is a major payer of long-term care services.

However, people become eligible for Medical Assistance only after they spend down most of their resources or if they already have very limited income and assets.

port if you become unconscious or are unable to speak for yourself.

Learn how to find and fill out a health care directive on the Minnesota Board on Aging’s website (www.mnaging.net/en/Advisor/ HealthCareDirective.aspx).

Additional resources If you or a loved one is considering a nursing home, an excellent resource is the Minnesota Nursing Home Report Card (nhreportcard. dhs.mn.gov), which includes information about most state nursing homes regarding these quality measures: resident satisfaction and quality of life; clinical quality; hours of direct care; staff retention; use of temporary nursing staff; proportion of beds in single bedrooms; and state inspection results.

There are several steps you can take to help you stay out of a nursing home and safely in your own home, even if you need care.

The Own Your Future website (see resources on page X) includes information on a variety of financing options available to pay for long-term care costs. Long-term care insurance is one way to pay, but life insurance, long-term care annuities, health savings accounts, and home equity are among many other options.

Housing planning There are several steps you can take to help you stay out of a nursing home and safely in your own home, even if you need care.

Some steps are inexpensive, such as removing scatter rugs, which are tripping hazards. Other steps that can make a big difference include making sure smoke detectors are working or installing doorknobs that are easy to use. Additional steps may include adding a railing to outside steps or replacing floor coverings with slip-resistant carpet. Other home modifications to consider include installing grab bars and improved lighting in the bathroom, handrails and wider doorways for wheelchair access, and relocating a bedroom to the first floor of a two-story home for someone no longer able to climb stairs.

Almost everyone needs long-term care sooner than they think they will.

Advance care planning Advance care planning identifies your wishes for medical care in case you are unable to make decisions or communicate them yourself. It is important to plan while you still are able to state those wishes. For example, filling out a document called a health care directive allows you to specify whether you want artificial life sup-

Finally, when you or a loved one begin receiving long-term care and have questions, concerns, or complaints, Minnesota’s Office of Ombudsman for Long-Term Care provides free information and advocacy. Call (800) 657-3591 or (651) 431-2555 or visit (www.mnaging.org/en/Advocate/OLTC. aspx)

This office, a service of the Minnesota Board on Aging, works to enhance the quality of life and quality of Long-term care to page 32

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Long-term care from page 31

For more information Minnesota Nursing Home Report Card (nhreportcard.dhs.mn.gov) Minnesota Area Agencies on Aging. Find an agency near you at www.mnaging.net Minnesota Office of Ombudsman for Long-Term Care (www.mnaging.org/en/Advocate/OLTC.aspx) Own Your Future (mn.gov/ownyourfuture) helps Minnesotans create a plan for their long-term care, including how to pay for it. It includes to-do checklists for people in their 40s, 40 to 60, over 60 and not retired, and over 60 and retired. The website guides you through four key areas of planning for your future: personal planning, financial planning, housing planning, and advance care planning.

Senior LinkAge Line. Call (800) 333-2433 or visit www.mnaging.org for free information about long-term care and many other topics. services for consumers of long-term care through advocacy, education, and empowerment.

The Office of Ombudsman works to resolve individual complaints relating to: • Quality of care or services

• Hospital access or discharge for Medicare beneficiaries.

This office also works at the state and national level to identify systemic problems and advocate for change, including promoting culture change to emphasize a person-centered approach to care.

Start planning now Minnesota has a wealth of long-term care information and resources for individuals and family. The keys to successfully planning for future needs are to start planning earlier than you think you should; educate yourself about your care, financing, and housing options; and share your written plans with those you love.

• Quality of life • Rights violations • Access to services • Service termination • Discharge or eviction

Deb Holtz, JD, has more than 30 years of experience in the fields of disabilities and aging and is the Minnesota State Ombudsman for Long-Term Care.

• Public benefit programs

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

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

30 25 20 15 10 5 0

Strong

Good

Limited

Very limited

None

32

50 40 30 20 10 0

Hypertension

High cholesterol

Diabetes I’m very Smoking overweight

None

35 30 25 20 15 10 5 0

Daily

Regularly Sometimes

Rarely

Never

5. When I visit my primary care physician, we discuss PAD. Percentage of total responses

Percentage of total responses

4. I have one or more of the following PAD risk factors (check all that apply).

40

100 80 60 40 20 0

3. I experience numbness or coldness in my feet.

Percentage of total responses

35

2. I experience cramping and pain in my leg muscles.

Percentage of total responses

Percentage of total responses

1. My understanding of Peripheral Artery Disease (PAD) is:

Every Regularly Sometime times

Minnesota Health care news January/February 2015

Rarely

Never

40 35 30 25 20 15 10 5 0

Daily

Regularly Sometimes

Rarely

Never

Minnesota

Health Care Consumer Association

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

SM

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

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Join now.

“A way for you to make a difference�

January/February 2015 Minnesota Health care news 33 NOVEMBER 2012 MINNESOTA HEALTH CARE NEWS 33

Why aren’t more Minnesotans using hospice care? from page 13

were asked if they were willing to talk about end-of-life care, they said, “Yes, if my physician brings it up first.”

Starting the discussion If the physician doesn’t bring up the topic of end-of-life care, the patient or his or her family should bring it up sooner rather than later. That’s because physicians tend to overestimate how much time someone has left, according to published studies. It’s hard for physicians to predict when a patient will die; a patient they believe will live for five months may actually die in one month.

Since 50 percent of patients enrolled in hospice die in less than 19 days, it’s obvious that patients don’t receive hospice care early enough.

• Will you be the one to tell me when to contact hospice?

• Will you stay involved with my care even when I am no longer looking for treatment for my disease?

Even those who do receive hospice care often delay unnecessarily.

Patients should ask their physicians: • Do I have a serious or life-limiting illness?

• Can my illness be cured?

• If my illness can’t be cured, are there treatments that can slow it?

• W hat kind of care is available that focuses on making me comfortable?

• If my illness keeps getting worse, when is a good time to think about getting comfort-focused care?

Hospice is worthwhile Patient comfort and quality of life are as important as curing a disease or prolonging life. When curative treatments no longer have the desired effect, and when a disease continues to worsen in spite of treatments to slow it down, hospice care is a good option. Hospice offers patients the opportunity to stay at home and to make personal decisions about how to spend the time that remains.

According to a Duke University study, hospice use has been shown to reduce Medicare program expenditures during the last year of life by an average of $2,309 per patient (Social Science & Medicine, 2007). If Minnesota physicians increased appropriate hospice referrals to be comparable to other states and recommended hospice for an additional 7,000 patients each year, we estimate that our state could save more than $16 million annually.

The savings to patients and their families? Priceless.

Barry Baines, MD, is medical director at Sholom Johnson Hospice and a consultant for Stratis Health. Janelle Shearer, RN, MA, is program manager at Stratis Health.

Now accepting new patients

A unique perspective on cardiac care Preventive Cardiology Consultants is founded on the fundamental belief that much of heart disease can be avoided in the vast majority of patients, and significantly delayed in the rest, by prudent modification of risk factors and attainable lifestyle measures.

Elizabeth Klodas, M.D., F.A.S.C.C is a preventive cardiologist. She is the founding Editor in Chief of CardioSmart for the American College of Cardiology www.cardiosmart.org, a published author and medical editor for webMD. She is a member of several national committees on improving cardiac health and a frequent lecturer on the topic.

We are dedicated to creating a true partnership between doctor and patient working together to maximize heart health. We spend time getting to know each patient individually, learning about their lives and lifestyles before customizing treatment programs to maximize their health.

Whether you have experienced any type of cardiac event, are at risk for one, or

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Among the services we provide • One-on-one consultations with cardiologists • In-depth evaluation of nutrition and lifestyle factors • Advanced and routine blood analysis • Cardiac imaging including (as required) stress testing, stress echocardiography, stress nuclear imaging, coronary calcium screening, CT coronary angiography • Vascular screening • Dietary counseling/Exercise prescriptions

To schedule an appointment or to learn more about becoming a patient, please contact: Preventive Cardiology Consultants 6545 France Avenue, Suite 125, Edina, MN 55435 phone. 952.929.5600 fax. 952.929.5610 www.pccmn.com

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Minnesota Health care news January/February 2015

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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) — Add-on to Glimepiride Victoza® + Rosiglitazone + Placebo + 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 All Victoza® + Placebo + Glimepiride Rosiglitazone + 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 All Victoza® + Metformin + Placebo + Metformin + Rosiglitazone Rosiglitazone N = 355 N = 175 (%) (%) Adverse Reaction Nausea 34.6 8.6 Diarrhea 14.1 6.3 Vomiting 12.4 2.9 Headache 8.2 4.6 Constipation 5.1 1.1 Table 3: Adverse Reactions reported in ≥5% of Victoza®-treated patients in a 26-Week Open-Label Trial versus Exenatide Exenatide 10 mcg twice daily + Victoza® 1.8 mg once daily + metformin and/or sulfonylurea metformin and/or sulfonylurea N = 232 N = 235 (%) (%) Adverse Reaction Nausea 25.5 28.0 Diarrhea 12.3 12.1 Headache 8.9 10.3 Dyspepsia 8.9 4.7 Vomiting 6.0 9.9 Constipation 5.1 2.6 Table 4: Adverse Reactions in ≥5% of Victoza®-treated patients in a 26-Week Open-Label Trial versus Sitagliptin All Victoza® + metformin Sitagliptin 100 mg/day + N = 439 metformin N = 219 (%) (%) Adverse Reaction Nausea 23.9 4.6 Headache 10.3 10.0 Diarrhea 9.3 4.6 Vomiting 8.7 4.1 Immunogenicity: Consistent with the potentially immunogenic properties of protein and peptide pharma® ceuticals, patients treated with Victoza may develop anti-liraglutide antibodies. Approximately 50-70% of Victoza®-treated patients in the five double-blind clinical trials of 26 weeks duration or longer were tested for the presence of anti-liraglutide antibodies at the end of treatment. Low titers (concentrations not requiring dilution of serum) of anti-liraglutide antibodies were detected in 8.6% of these Victoza®-treated patients.

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

®

Victoza —a force for change in type 2 diabetes.

A change with powerful, long-lasting benefits

Reductions up to -1.1%a

Weight loss up to 5.5 lba,b

Low rate of hypoglycemiac

1.8 mg dose when used alone for 52 weeks.

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

b

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

The change begins at VictozaPro.com.

Indications and Usage

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

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

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

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

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

Important Safety Information

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Please see brief summary of Prescribing Information on adjacent page.

1013-00018617-1

December 2013