Your Guide to Consumer Information January/February 2017 • Vol. 15 No. 1
Antibiotic resistance By Amanda Beaudoin, DVM, PhD
Home care By Leann Lindahl
Spinal surgery Christopher Alcala, MD
HELPING FAMILIES FOR 25 YEARS. Accra provides support to children, adolescents, adults and families that need help in their homes for a loved one with a disability. We'll help you navigate the different services available to you. PCA Choice services allows you to choose a family member or friend to be your paid caregiver.
Non-Profit Home Care Agency We accept major insurance plans; Medicaid and private pay.
Call and ask about the possibilities!
866-935-3515 • Metro 952-935-3515 SERVING PEOPLE STATEWIDE
www.accracare.org
January/February 2017
•
Volume 15
•
Number 1
NEWS .......................................................................4 PEOPLE .....................................................................7 PERSPECTIVE Carbon monoxide: A year-round threat.........................8 Becca Virden
10 QUESTIONS
Spinal surgery...................................................................... 10 Christopher Alcala, MD
PUBLIC HEALTH
Antibiotic resistance: A growing problem......................... 12 By Amanda Beaudoin, DVM, PhD
LEGISLATION
2017 Minnesota legislative preview: ................................ 14 Pending health care issues By Kate Johansen, JD
CAREGIVING
Home care: Understanding your choices.......................... 16 By Leann Lindahl
HEALTH POLICY
Understanding the “public option”: ................................. 20 It’s still just a concept By Kip Sullivan, JD
BEHAVIORAL HEALTH
Adverse childhood experiences: Surviving the impact... 22 By Anna Bohlinger, PhD, LMFT
LONG-TERM CARE
Navigating senior care options: Planning is key............. 26 By Anne Marie Bartlett, LSW
ONCOLOGY
Clinical trials: Patients contributing to cures..................... 28 By Toni Kay Mangskau
Publisher . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Mike Starnes, mstarnes@mppub.com Editor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Lisa McGowan, lmcgowan@mppub.com Associate Editor . . . . . . . . . . . . . . . . . . . . Richard Ericson, rericson@mppub.com Art Director . . . . . . . . . . . . . . . . . . . . . . . . . . . Sunshine Sevigny, sunny@mppub.com Office Administrator . . . . . . . . . . . Amanda Marlow, amarlow@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.
JANUARY/FEBRUARY 2017 MINNESOTA HEALTH CARE NEWS
3
NEWS
Minneapolis VA offers same-day appointments Veterans will now be able to receive same-day service when they need it at the Minneapolis VA Medical Center’s primary care and mental health clinics. The service, called MyVA Access, is part of a nationwide initiative by the U.S. Department of Veterans Affairs to improve veterans’ health care experiences. “When you contact us, we will either address your need that day or schedule appropriate follow-up care, depending on the urgency,” said Patrick Kelly, director of the Minneapolis VA Medical Center. “We may provide a face-to-face visit, return a phone call, arrange a telehealth or video care visit, respond by secure email, or schedule a future appointment.”
is in crisis, they will receive immediate attention from a Minneapolis VA Medical Center health care professional. If they are new to mental health and have a non-urgent care need, they will receive an initial screening evaluation by the next calendar day.
Fairview to study new treatment for hypertension Fairview Health Services is launching a one-year, 800-person prospective research study involving gene-specific treatment protocols for high blood pressure. The condition affects 1 in 3 adults in the U.S. and causes 1,000 deaths each year.
“We believe we can dramatically cut the time, cost, and side effects involved in managing high blood pressure through the use of gene-specific treatment protocols,” said Dang Tran, The medical center has added staff MD, vice president of medical pracand increased space in order to offer tice at Fairview Medical Group and veterans same-day service when they principal investigator of the study. require primary care assistance during Qualified patients at eight Fairregular business hours, and next-day service when they require care after view clinics may be able to enroll in regular business hours. If a veteran the randomized controlled clinical
4
MINNESOTA HEALTH CARE NEWS JANUARY/FEBRUARY 2017
“Every infant who is withdrawing has a mom who was exposed to opioids, and possibly, didn’t have access to the treatment she needed,” said Katy Kozhimannil, PhD, associate professor of health policy and management at the University of Minnesota’s School of Public Health and co-author of the study. “So many people are prescribed opioids for “The implications for the nation’s pain and become physically depenhealth are staggering,” said Bob dent on them. Some of these people Beacher, RPh, president of shared become pregnant, but they can’t just clinical services at Fairview. “Uncon- stop taking opioids—both because of trolled hypertension contributes to their dependence, but also because strokes, coronary heart disease, and without opioids, a baby could withcardiovascular disease. The findings draw in utero and possibly die.” from this research could transform The researchers investigated the the health of an entire population.” growth over time in opioid use during pregnancy and its effects on women Rates of infants born with and their babies. They discovered a seven-fold increase in the occurrence opioid withdrawal rising of Neonatal Abstinence Syndrome in A study from the University of rural areas and a four-fold increase Minnesota School of Public Health in urban areas between 2004 and has shown a significant increase in 2013. More than 21 percent of all cases of babies born with Neona- cases in the U.S. were in rural areas, tal Abstinence Syndrome, or opioid where fewer than 15 percent of all withdrawal, especially in rural areas. births take place. research trial. Fairview entered a clinical research agreement with Geneticure, a Minnetonka-based pharmacogenetics testing company, to conduct the study. Early research of Geneticure’s patented genetic test has shown that it can help clinicians personalize hypertension treatment for each patient for better, more effective results.
“These are huge increases and very concerning,” said Kozhimannil. “The trend is stronger in rural areas where the infrastructure for screening, treatment, and support services for maternal opioid dependence is much more limited compared to urban areas. Solutions need to be tailored to rural areas, because approaches designed for urban areas are less effective or work in different ways in rural communities.”
Ehlers Danlos Syndrome, and insomnia. MDH received 50 public comments, heard from a citizen’s review panel, and reviewed a set of research summaries for each condition that was prepared by MDH staff.
PTSD added as qualifying condition for medical cannabis
Smoke-free rule enacted for public housing
“This decision was made after careful deliberation of available evidence, consultation with experts in the field, and public input,” said Ed Ehlinger, MD, Minnesota commissioner of health. “While the process According to Kozhimannil, the of reviewing these potential addibest way to address the issue is a tions was difficult due to the relative public health approach focusing on lack of published scientific evidence, prevention. “In public health we PTSD presented the strongest case talk about going upstream—not just for potential benefits. PTSD also has saving people before they go over the few effective treatment alternatives waterfall—but stopping them from available for some patients with the falling into the river,” she said. “For condition.” women struggling with opioid abuse, Patients with PTSD will be elgetting them screened and treated igible to receive medical cannabis before they become pregnant—and beginning Aug. 1, 2017, with adthen providing them access to apvance certification from a Minnesota propriate health services once they health care provider. are—will minimize the chances Petitions were also submitted for the baby will be born experiencing new delivery methods for medical withdrawal.” cannabis, including topical, edible, Recommendations include imand vaporizing the whole plant. plementing policies and programs to MDH made the decision to begin alreverse the rising trend of opioid-aflowing manufacturers to develop and fected births in rural areas that focus provide topical formulations of medon both prevention and treatment; ical cannabis. According to Ehlinger, treatment that consists of in-comevidence suggests that patches, lomunity support; and developing or tions, creams, gels, and ointments enhancing rural health care infracould offer a safe, effective, and lowstructure to include mental health, risk method for providing medical substance abuse, chronic pain, and cannabis in known dosages to qualiobstetric services. fied patients.
Post-traumatic stress disorder (PTSD) has been added as a qualifying condition for Minnesota’s medical cannabis program. The Minnesota Department of Health (MDH) announced the decision on Dec. 1. Throughout June and July, Minnesotans were invited to submit petitions to add qualifying conditions to the state’s medical cannabis program. Nine conditions were put forward for consideration—PTSD, schizophrenia, acquired absence of limb (phantom limb syndrome), arthritis, autism, depression, diabetes,
All public housing agencies are required to implement a smoke-free policy within 18 months, according to a U.S. Department of Housing and Urban Development decision announced on Nov. 30. Many public housing agencies already have smoking restrictions in place for their buildings and grounds. For those that don’t, the Minnesota Department of Health (MDH) and local public health departments will work with community partners as their housing authorities implement the rule to expand smoke-free News to page 6
JANUARY/FEBRUARY 2017 MINNESOTA HEALTH CARE NEWS
5
News from page 5
environments to all residents. They offer one-on-one help, sample materials with policy language and resident notification letters, signage, and materials about quitting smoking for residents.
However, the provisions did not in- pressure, diabetes, cardiovascular clude smoking in individual or multi- disease, weight gain, and memory unit housing. issues—sleep disorders contribute to all of these.”
Lakeview Hospital opens new sleep health center
Lakeview Hospital’s new Sleep Health Center, located within the “This change will help protect former First Church of Christ Sciensome of the most vulnerable people tist in Stillwater, doubles the number in our state—children and older of rooms available for sleep studies adults—and will encourage more from two to four. The hospital prepeople to quit smoking,” said Ed viously used the former church buildEhlinger, Minnesota commissioner ing for office space. of health. MDH notes that young The expanded sleep center was children and older adults are most in response to increasing patient susceptible to the harmful effects demand, which has increased more of secondhand smoke, including inthan 200 percent over the past four creased risk of breathing problems years. However, space restrictions as well as more frequent and more at the former space meant that some severe asthma attacks. In addition, people in low- and fixed-income people who required special equipgroups have a greater risk of second- ment for their study could not be hand smoke exposure in their homes accommodated. than those in higher income groups. The Freedom to Breathe changes to the Minnesota Clean Indoor Air Act, enacted in 2007, banned smoking in nearly all indoor public spaces.
6
“More people are aware of how sleep affects their overall health,” said Jenny Kratochvil, manager of pulmonary services at Lakeview Health. “For example, high blood
MINNESOTA HEALTH CARE NEWS JANUARY/FEBRUARY 2017
Conference, Aligning for Innovation and Outcomes. The networks were recognized for their diligent work; authentic collaboration with paThe new off-site location across tients, clinicians, and partners; and from the hospital will be able to unprecedented national impact on treat an additional 145 patients per patient safety in all U.S. hospitals. year, Lakeview president Ted We- They received a total of $347 million gleitner said when the Stillwater from CMS to continue their efforts. City Council approved the project Improvement efforts have rein March. It will continue to treat sulted in saving more than 87,000 nearly any kind of adult sleep prob- lives, preventing 2.1 million inlem, including snoring/obstructive stances of patient harm, and yielding sleep apnea, insomnia, narcolepsy, $19.8 billion in cost savings nationrestless leg syndrome, REM sleep wide from 2010 to 2014, as well as behavior disorder, sleep problems substantial reductions in the 30-day related to shift workers, teeth grind- Medicare fee-for-service all-cause ing, sleepwalking, nightmares, and readmission rate. leg cramping. According to CMS, the focus of the Hospital Improvement Innovation Networks’ work going forward MHA accepts award for will be to sustain and accelerate reducing patient harm national progress and momentum The Minnesota Hospital Associ- toward continued harm reduction in ation (MHA) was one of 16 Hospital the Medicare program. In addition, Improvement Innovation Networks they commit to improving health across the U.S. to be recognized at equity, and giving specific attention the 2016 Centers for Medicare & to identifying and reducing health Medicaid Services (CMS) Quality care disparities.
PEOPLE JOEL BOYD, MD, orthopedic surgeon at TRIA Orthopaedic Center, has been selected by Gov. Mark Dayton to serve on the board of directors of the Minnesota State High School League (MSHSL). The goal of the MSHSL is to improve the health and safety for high school athletes in Minnesota. Boyd represents the public in his role on the board—other members represent a specific school or district. Boyd has more than 25 years of experience in orthopedics and sports medicine, including nine years as a team physician for the Minnesota Vikings. He currently serves as head team physician for the Minnesota Wild and the University of Minnesota Golden Gophers men’s football team. Boyd earned his medical degree at Temple University School of Medicine in Philadelphia, Penn.
PATRICIA
WALKER,
MD,
medical
director
of
HealthPartners Travel and Tropical Medicine Center and physician at HealthPartners Center for International Health, has received the Shotwell Award from the Twin Cities Medical Society Foundation for her work in refugee and immigrant health. Walker serves as professor in the division of infectious disease and international health at the University of Minnesota and an adjunct professor in the School of Public Health’s division of epidemiology and community health. Previously, she served for 23 years as medical director of HealthPartners Center for International Health, a refugee and immigrant health clinic. Walker earned her medical degree at Mayo Medical School and a diploma in tropical medicine and hygiene from the London School of Tropical Medicine and Hygiene.
SARAH KESLER, MD, critical care physician and assistant professor of medicine in the University of Minnesota’s Division of Pulmonary, Allergy, Critical Care and Sleep Medicine, has received the 2016 Community Service award from the American College of Physicians–Minnesota Chapter for her international health community service. Kesler worked regularly for Doctors Without Borders for nearly six years, serving in Sudan, South Sudan, Uganda, Chad, and the Philippines. She is now the course director of the Humanitarian Crisis Simulation, which trains prospective humanitarian aid workers. Kesler earned her medical degree at the University of Minnesota.
MAURICIO CIFUENTES, PHD, LICSW, senior division director of health and well-being at CLUES (Spanish for: Comunidades Latinas Unidas en Servicio), has received the Professional of the Year award from NAMI Minnesota (National Alliance on Mental Illness) for his service, leadership, and commitment in the field of mental health. Cifuentes has been with CLUES, a nonprofit by Latinos for Latinos that connects people to programs and services, since 2013. He initially trained in Colombia as a lawyer before shifting his focus to pursue clinical social work. Mauricio moved to the U.S. and graduated from the Masters of Social Work Program at Loyola University Chicago, then designed and oversaw a mental health program for Latino immigrants in Chicago before returning to Loyola to earn his PhD in social work in 2010. He has taught at Loyola University, the Institute for Clinical Social Work in Chicago, and Augsburg College. JANUARY/FEBRUARY 2017 MINNESOTA HEALTH CARE NEWS
7
PERSPECTIVE
Carbon monoxide A year-round threat
W
e hear more about carbon monoxide (CO) as people dial up their thermostats during the cold winter months, but this deadly gas can be produced any time carbon-bearing fuels are burned. In fact, most deaths from CO are unrelated to furnaces; you can even be exposed on a hot July day in the middle of the lake.
Colorless and odorless
Becca Virden, CenterPoint Energy Together with CenterPoint Energy emergency responders and service technicians, Ms. Virden responds each year to multiple incidents of carbon monoxide exposure and poisoning. As public relations manager for the company, she helps develop and oversee CenterPoint Energy’s public awareness program, complying with all federal and state law regarding required gas safety.
CO is a colorless, odorless, and tasteless gas that, when inhaled, enters the blood stream, where it prevents proper absorption of oxygen and leads to illness and even death. The most common symptoms of carbon monoxide poisoning are often mistaken for food poisoning or the flu. Because there is no smell, you may not know that you are breathing this deadly gas until you experience symptoms such as: • M ild exposure: Slight headache, vomiting, nausea, fatigue, blurred vision, and flu-like symptoms that disappear when you breath fresh air • Medium exposure: Drowsiness, confusion, severe headache, and rapid heart rate • S evere exposure: Convulsions, unconsciousness, cardiac/respiratory arrest, and even death If you detect any of these symptoms, get to fresh air and call 911. Severe exposure requires prompt medical attention.
A burning issue When carbon-containing compounds are burned in a space with insufficient oxygen, carbon monoxide can accumulate. Properly maintained natural gas furnaces and fireplaces provide safe and efficient heating, but those that are poorly maintained or ventilated can burn fuel inadequately and produce dangerous, mounting levels of CO. There is an even greater risk of accumulation when a home is tightly sealed and improperly ventilated. The Minneapolis Fire Department reports a 10 percent increase in non-fire related CO incidents during the winter heating season. Household CO alarms provide early warnings, but should not be solely relied upon because they do expire and must be checked frequently.
Surprising sources Three in five deaths from carbon monoxide poisoning are caused by vehicles, according to the National Fire Protection Association (NFPA). If you choose to warm up your car before driving, do so in the driveway or on the street. CO accumulates quickly in a garage, even with the door open, and can seep from there into the house. CenterPoint Energy emergency responders and service technicians encountered one such case recently. After strapping her one- and five-year-old daughters into a running car with the garage door open, their mother stepped inside to retrieve something for school. When she returned a short time later, the mother
8
MINNESOTA HEALTH CARE NEWS JANUARY/FEBRUARY 2017
found her one-year-old passed out and her five-yearold ill. The girls were later released after treatment that included time breathing pure oxygen in a hyperbaric chamber at Hennepin County Medical Center (HCMC). Carbon monoxide accumulates outdoors as well, in and around idling cars or small engines. Heated winter ice fishing houses can present risks, as can boat engines. In fact, CO can even be dragged behind and inside a boat with a gas engine, in what is known as the “station wagon effect.” The Minnesota Poison Control Center ranks CO as the leading cause of death due to poisoning, while the National Fire Incident Reporting System reports that municipal fire departments across the country respond to more than 60,000 annual CO incidents.
Carbon monoxide poisoning [is] often mistaken for food poisoning or the flu. Safety and prevention Act now to protect yourself from carbon monoxide, both indoors and outdoors. State law requires carbon monoxide alarms in Minnesota homes to be installed within 10 feet of each lawfully used sleeping area. Purchase a CO detection device with an audible alarm and a digital display. Look for the Underwriters Laboratories (UL) Standard 2034 stamp on the box and follow the instructions for placement, operation, and maintenance. Replace the batteries and test frequently. Most CO alarms expire every 2–10 years, depending on the type of unit. Note the installation date and replace per the manufacturer’s recommendations. Make sure your fresh air intakes and vents are unobstructed, change your air filters often, and have fuel-burning equipment checked regularly by a qualified technician, preferably each year. Check your home frequently for high indoor humidity, or soot or water collecting near a burner or vent. Never attempt to heat a room with a range, oven, or clothes dryer, and never leave a fire smoldering in a fireplace. Never run your car, barbecue grill, or any combustible engine in your attached garage or any enclosed area, such as your home, tent, fish house, or place of business, even with the door open.
Conclusion Carbon monoxide poses a serious year-round health threat. To reduce your risks, maintain gas-burning appliances properly and exercise caution whenever you are near engines or devices that burn carbon fuels.
rehabilitate a body, we start T owith the mind and soul. If you or someone you know needs rehabilitation after an accident, surgery, illness or stroke, we have a simple premise for you to consider: To recover physically, you need support mentally and emotionally. How positive and how determined someone is can make all the difference. We believe the most effective therapy treats your body, mind and soul. That’s our approach. Post-acute rehabilitation services from the Good Samaritan Society are offered at multiple inpatient and outpatient locations throughout Minnesota and the Minneapolis/St. Paul area.
To make a referral or for more information, call us at (888) GSS-CARE or visit www.good-sam.com/minnesota.
The Evangelical Lutheran Good Samaritan Society provides housing and services to qualified individuals without regard to race, color, religion, gender, disability, familial status, national origin or other protected statuses according to applicable federal, state or local laws. Some services may be provided by a third party. All faiths or beliefs are welcome. Š 2015 The Evangelical Lutheran Good Samaritan Society. All rights reserved. 15-G1553
JANUARY/FEBRUARY 2017 MINNESOTA HEALTH CARE NEWS
9
10 QUESTIONS
Spinal surgery CHRISTOPHER ALCALA, MD, is a board-certified, fellowship-trained
orthopedic spine surgeon with Twin Cities Spine Center.
What are the most common low back (lumbar) issues that require surgery? The most common issues are degenerative conditions that affect the interlocking bones, or vertebrae, that make up the spine; the discs that separate those bones; and the spinal nerves. In the lower back, common issues include disc herniation, stenosis, and spondylolisthesis. Herniated or ruptured discs occur when part of the disc material moves outside of its intervertebral space. Stenosis is a narrowing of the space for the nerves. Spondylolisthesis is a slip of one vertebra over the other. These conditions may compress nerves, causing pain in the low back that may radiate down the leg(s). These are usually not dangerous conditions, and they are rarely associated with weakness. They do cause significant pain, though, and some patients may experience numbness and tingling. These common disorders do not typically represent an emergency situation unless the patient also experiences weakness or bowel and bladder incontinence.
What steps are taken to avoid surgery for patients with spinal issues? Unless the patient has weakness or other symptoms that would indicate the need for surgery, the first steps are usually conservative, and may include physical therapy and epidural steroid injections. Physical therapy can be very beneficial for patients, helping not just to reduce pain, but to avoid re-injury and “deconditioning”—a gradual loss of strength and mobility that may develop in patients who limit their activities for long periods. Epidural steroid injections are usually performed for two primary reasons: for pain management, and for diagnostic reasons that will guide treatment or surgical planning.
What can you tell us about how patients respond to surgery, and what percentage end up not requiring surgery? Most of the patients seeking spine specialty care will be treated conservatively and will not require surgery. But if their symptoms persist for more than three consecutive months despite conservative treatment options, there is a 70 percent chance that they will need surgery to achieve more permanent relief. Low
10
MINNESOTA HEALTH CARE NEWS JANUARY/FEBRUARY 2017
back pain that worsens when standing and walking and is relieved by sitting usually responds to surgery. This may change, however, depending on the cause or origin of the low back pain (infections in the back, for example, can produce constant back pain). While these are not usually emergency situations, they affect the quality of life, and it is the patient’s decision to undergo surgery. Your surgeon will work with you to determine which procedure best meets your needs.
Please tell us about some of the recent advances in spinal surgery. There have been recent advances in spinal surgery involving instrumentation and minimally invasive surgery, which employs small incisions rather than the larger incisions used in traditional “open” approaches. In some studies, minimally invasive surgery has been associated with shorter hospital stays and reduced pain. Nevertheless, it has not been shown to affect long-term quality of life or clinical outcomes in patients. It is my opinion that the primary goal of surgery would be to complete it in the safest way possible, so the patient can have the best outcome regardless of whether the surgery is accomplished through a minimally invasive or an open approach.
What are the most common neck (cervical spine) problems? Common neck conditions are associated with arthritis and nerve compression, including disc herniation, and usually produce neck and arm pain. Fortunately, the majority of these patients can improve with conservative treatment options involving physical therapy and injections. In the majority of the population, it subsides in the first 6–12 weeks. If it does not, the patient should be evaluated by a spine specialist.
What are the best things people can do to take care of their spines? Number one is to have an active lifestyle to avoid deconditioning of the musculature, which increases the strain in the bone and intervertebral discs and accelerates the degenerative process. Number two would be to avoid weight gain, which can place added strain to the back/spine and, therefore, increase the risk of acute low back pain. Number three would be not smoking (or quitting smoking). Smoking is an independent risk factor for acute and chronic low back/ neck pain. photo credit: Greg Christensen
What are the most common preventable things you end up treating patients for? The usual conditions that we treat with surgery are degenerative in nature. Nevertheless, occasionally patients may experience acute neck and arm pain due to disc herniation(s) in their cervical spine (neck). The same is true for the lower back. Generally, only 5 percent of cases can be associated with a traumatic event. Usually, it is associated with poor weightlifting mechanics or with deconditioning. That is why it is really important to educate patients about proper mechanics when lifting, twisting, or doing their usual daily activities.
Back pain is a major contributor to the opioid addiction epidemic. How do you help your patients with this issue? Education and prevention are the basis of medicine. We try to provide patients with as much information as we can, so they can understand the cause of their pain and know if it can be treated with surgery or if it cannot. I believe the best chances for appropriate treatment are through a multidisciplinary program that includes multimodal physical therapy, injections, and anti-inflammatory medications. Although opioids may be beneficial for some patients, they are rarely recommended as a longterm management for spine conditions.
Please tell us about cervical total disc replacement. Unlike cervical or lumbar fusion—which permanently joins two vertebrae together and immobilizes parts of the spine—total disc replacement inserts a new, artificial disc between the bones, allowing them to continue to move independently. The theory is that, by
preserving the motion of these segments, total disc replacement will decrease the chances of degeneration of the levels above and below the surgery. This is still to be validated with long-term studies. In the cervical spine, it has promising results compared to its counterpart in the lumbar spine. It is not indicated for everyone. The best candidates are young patients who are not going to be involved in high-risk activities or contact sports, and who do not have a cervical deformity or multiple segments with spinal cord compression.
Most of the patients seeking spine specialty care…will not require surgery. How can a patient know that it is time to schedule an appointment with you? Patients who have had an episode of neck and low back pain for more than 6–12 weeks, as well as arm or leg pain, should be evaluated by a spine specialist. If a patient is having weakness, progressive numbness, tingling, or bowel or bladder incontinence, he/she should be evaluated on an emergency basis by a spine specialist. Patients with spinal deformities (abnormal curves of the spine, including scoliosis), especially the adolescent population, typically do not experience pain, but they should be evaluated by a spine specialist to assess and monitor the curve and to direct treatment. We welcome any patient that would like our help in understanding their spine condition and their options for treatment.
JANUARY/FEBRUARY 2017 MINNESOTA HEALTH CARE NEWS
11
PUBLIC HEALTH
Antibiotic resistance A growing problem By Amanda Beaudoin, DVM, PhD
A
ntibiotics help us treat bacterial infections—and brought
Antibiotics are an important tool for treating bacterial
formerly rampant diseases such as tuberculosis and syphilis
infections in each of these patient populations. But antibiotics are
under control—but these powerful drugs are losing their
only effective in fighting bacteria; they don’t work on viruses that
effectiveness as growing numbers of bacteria develop a resistance to
cause colds, the “flu,” bronchitis, and many sore throats, sinus, and
them. An estimated 2 million U.S. citizens develop infections from
ear infections. When antibiotics are prescribed inappropriately for
antibiotic-resistant bacteria each year, and 23,000 die from associated
viral infections, they don’t do anything to make patients better,
causes, leading the Centers for Disease Control and Prevention
and they can even do harm, contributing to the development of
(CDC) to rank antibiotic resistance as one of our most serious health
antibiotic resistance and specific adverse effects in patients.
threats. As this resistance problem grows, we’re running out of effective antibiotics to treat certain bacterial infections. What are antimicrobials, antibiotics, and bacteria?
What is antibiotic resistance? Bacteria can develop a resistance to one specific antibiotic, or may develop into “multi-drug resistant” bacteria capable of withstanding
Antimicrobials are a group of drugs used to treat infections caused
many different types of antibiotics. Infections caused by these
by microbes, including bacteria, fungi, viruses, and parasites.
antibiotic-resistant bacteria, especially those that are multi-drug
Antibiotics are a group of antimicrobial drugs specifically used to treat infections caused by bacteria. Every antibiotic works in one of two ways: by killing bacteria or by preventing them from multiplying. Antibiotics are used in human and veterinary medicine, animal agriculture, aquaculture, and some plant agriculture. Common antibiotics include penicillin, amoxicillin, azithromycin, ciprofloxacin, and doxycycline. Countless types of bacteria live in our world and even in our bodies. Many serve a helpful function in keeping the environment,
resistant, are difficult, and sometimes impossible, to treat. When a person takes an antibiotic, bacteria that are sensitive (not resistant) to the antibiotic are killed or slowed down. This is a great outcome when the right antibiotic is used for the right type of infection. Unfortunately, if the bacteria causing the infection are resistant to the antibiotic, they survive, become more numerous, and continue to cause disease. This is why it’s important for doctors to make the right choice when deciding whether to prescribe an antibiotic to a patient.
animals, and people healthy and balanced. At this moment, helpful
Even when the right antibiotic is prescribed, some resistant
bacteria are thriving in your digestive system, elsewhere in your
bacteria are left to grow and multiply, and may cause a subsequent
body, and on your skin.
infection in that patient or in other people. Because of this, all
But there are also harmful bacteria that can cause infection and disease in people and animals. Bacteria can produce skin infection, pneumonia, blood infection (sepsis), gastrointestinal infection (e.g., diarrhea), heart infection, and many other conditions. Those at greatest risk of bacterial infection and disease include people who
antibiotic use, whether correct or unnecessary, contributes to the overall amount of resistant bacteria in our communities and health care facilities. Unfortunately, the CDC reports that 20–50 percent of antibiotics prescribed in U.S. hospitals and 30 percent in outpatient settings are either unnecessary or inappropriate.
have weak immune systems, suffer from chronic disease, or are very
Some types of resistance also spring from “resistance genes,” which
old or very young, but some strains of bacteria can cause disease
pass instructions on how to withstand antibiotics to other bacteria.
even in healthy people.
This process is of particular concern because it allows resistance to
12
MINNESOTA HEALTH CARE NEWS JANUARY/FEBRUARY 2017
spread even when antibiotics are not present. The best way to control this type of resistance is to use antibiotics wisely so “instructions” are not developed in the first place, and also to do laboratory-based surveillance in hospitals, states, and nationally, to track the location and number of bacteria with resistance that can be shared. Given these challenges, we can best limit antibiotic resistance by using antibiotics for the right reasons, in the right amounts, and for the right amount of time. “Antibiotic stewardship” is the process of improving the way we use antibiotics. What are the harms of antibiotic resistance? Infections that were once easily treatable are becoming more difficult or, in some cases, impossible to treat due to antibiotic resistance. This problem impacts every area of health care, from everyday community infections to patients undergoing advanced medical procedures such as organ and marrow transplants, surgeries, and cancer treatments.
Is antibiotic resistance a problem in Minnesota? Although Minnesota is considered one of the healthiest states, we aren’t immune to problems of antibiotic resistance or antibiotic misuse. In 2015, approximately 150 Minnesotans were identified with CRE infection. In addition, approximately 620 had severe MRSA (methicillin-resistant Staphylococcus aureus) infections, resulting in 150 deaths, and 230 Minnesotans were infected with quinolone-resistant Campylobacter. Antibiotic stewardship has been embraced by multiple health care providers. The Minnesota Department of Health’s Public Health Laboratory was identified by the CDC as one of seven Antibiotic resistance to page 34
Some bacteria, such as CR E (carbapenem-resistant Enterobacteriaceae), most commonly acquired in health care settings, are resistant to nearly all available antibiotics. The CDC estimates that 9,300 health care-associated CRE infections occur nationally each year, with over 600 deaths. Alarmingly, the production of new drugs to treat bacterial infections is being outpaced by resistance. The CDC lists the development of new drugs as one of four core actions needed to combat antibiotic resistance.
We’re running out of effective antibiotics to treat certain bacterial infections. What other adverse effects can antibiotics have on patients? Antibiotic stewardship can help ward off other problems, including “C-diff” (C. difficile) infections and drug-related toxicity. Antibiotics can kill or weaken normal, healthy gastrointestinal bacteria, sometimes for months, leaving patients at risk of serious intestinal infection with C. difficile bacteria. While present in the community, C. difficile is most commonly acquired in health care settings, where it may be spread on contaminated surfaces or medical equipment, or on the hands of health care providers. It is naturally resistant to many antibiotics. Like many other medications, some antibiotics also pose a risk of side effects, including toxicity that causes organ damage. Unfortunately, some of the only antibiotics left to treat serious infections cause the worst toxic effects. Thus, when we focus on decreasing antibiotic resistance by optimizing appropriate antibiotic use, we not only allow safe and commonly used antibiotics to remain effective, but we also ensure that we only have to use toxic antibiotics when absolutely necessary.
JANUARY/FEBRUARY 2017 MINNESOTA HEALTH CARE NEWS
13
LEGISL ATION
2017 Minnesota legislative preview Pending health care issues By Kate Johansen, JD
W
ith the start of the New Year, lawmakers are back in St. Paul for the 2017 Minnesota legislative session. Health care was a hot topic on last fall’s campaign trail, and it is certain to be a marquee issue at the Legislature this year. There is no better time for the general public to engage in policy discussions on the future of Minnesota’s health care system. Get involved State leaders often rely on public input to shape policy. Private citizens
can impact legislation by reaching out to their elected officials and attending committee hearings. To get involved most effectively, it helps to know the process. The Minnesota Legislature operates on a biennial schedule. That means the state passes legislation in two-year cycles, with each year considered one “session.” In odd-numbered years such as this one, the Legislature convenes in January and meets through May, with a main objective of passing a state budget. In even-numbered years, the session typically starts later and focuses on bonding. Beyond state budgets, health care is certain to be a top legislative priority in 2017. The cost of public programs, including Medical Assistance (MA) and MinnesotaCare, is on the rise, health care costs across the board are increasing, and developments in Washington create uncertainty for the Affordable Care Act (ACA, also known as “Obamacare”), Medicaid funding, and health care in general. All of these factors will face Minnesota lawmakers under new Republican majorities in both the Senate and the House of Representatives. On the Minnesota front Several developments will affect both the state budget and your personal pocketbook: Budget issues. Because this is an odd-numbered year, much of the legislative work in Health and Human Services (HHS) will focus on assembling a budget. HHS is the largest part of the state’s budget, representing more than $12 billion in spending for 2016–2017. In the past biennium, legislators boosted that figure with an additional $138 million in spending on nursing home workers. But legislators did not reach consensus on reforms to MA, MinnesotaCare, MNsure (the state-operated exchange under which Minnesotans may purchase private health care insurance), or other programs that support state health care. Those issues are likely to return in 2017. Republicans in the Legislature have previously asserted their desire to dissolve MNsure and transition the state to the federal health care insurance
14
MINNESOTA HEALTH CARE NEWS JANUARY/FEBRUARY 2017
marketplace, www.healthcare.gov. Those same legislative leaders have also expressed interest in converting parts of the state’s public health care programs to a voucher system and reforming benefit structures to rein in HHS spending. On the other side of the aisle, Democratic leaders have stated their interest in reforming MNsure and expanding public programs and benefits. The governor and legislative leaders remain far apart on these issues. Their ideological differences and the state’s divided government—under a Democratic governor and a Republican Legislature—could make budget negotiations difficult. Individual market. In addition to program spending, the Legislature is also likely to address instability in the individual health care insurance market. More than 250,000 Minnesotans—some 5 percent of the state’s total health care insurance market—purchase their own coverage. While premiums for most health care plans rose in 2017, most of the highest increases affected those in this individual market. Some families saw premium increases of 50
Leaders will also be interested in policy reforms to expand networks, provide continuity of care, offer greater product choice, and promote proper coverage. Other pocketbook issues. Health care delivery costs and prescription expenses underscore many of the issues the 2017 Legislature will face. While costs grew slowly in the first years of ACA implementation, they are now accelerating at about 6 percent, a rate that outpaces inflation. Many point to prescription drugs as a cost driver, and 75 percent of voters say that drug costs are too high. Others highlight the rising costs of a sicker, aging population. Many states are focusing on the cost implications of narrower networks. Minnesota’s lawmakers may also consider legislation around “surprise billing,” a practice in which patients believe they are receiving an in-network service that is, in fact, partially performed by an out-of-network provider, resulting in a higher bill. In addition, legislators may look at ways to improve cost transparency, so patients can shop for and compare services more easily.
to 67 percent over 2016 levels, creating an emergency strain on household resources.
State leaders often rely on public input to shape policy.
On the federal front Major changes in Washington will also impact Minnesota. The Trump administration and the Republican majorities in both houses of Congress have repeatedly expressed interest in repealing and
2017 Minnesota legislative preview to page 32
Individual market plans, in general, have always had higher premiums than employer- and other large-group plans, which can spread expenses across a wider pool. The ACA requires that all consumers be eligible to purchase private insurance, but the smaller pool of applicants, many of whom have costly preexisting conditions, is one of the key factors driving the current spike in premiums. Industry changes also impacted the individual market, with one insurer leaving the market and many others imposing enrollment caps. To manage their costs, some health care networks, particularly in greater Minnesota, are consolidating or contracting. Lawmakers will seek both immediate and long-term relief. Short-term ideas focus on rebates. Both the governor and legislators have suggested targeted relief to individuals who purchase insurance on the individual market but do not qualify for federal subsidies. Leaders had contemplated a special December 2016 session to deliver such relief, but could not reach consensus on how to structure the package. The issue will likely arise early in the 2017 session. One long-term solution might be to revive the state’s high-risk pool, which helped to ensure affordable coverage for the individual market before the ACA was fully implemented. By separating highcost individuals in the market and subsidizing their care, the state could stabilize the market and premiums. If lawmakers adopted this concept, they would need to do so in a way that aligns with the ACA’s requirement that people with preexisting conditions are not denied coverage or charged more. JANUARY/FEBRUARY 2017 MINNESOTA HEALTH CARE NEWS
15
CAREGIVING
Home care Understanding your choices By Leann Lindahl
C
oordinating home-based support for a family member who is aging or living with chronic illness or disability requires not just compassion, but knowing your choices. When determining how to keep a loved one at home, in the comfort of familiar surroundings and the people they love, it is important to research, understand, and navigate all of the available options. While many of us associate home care with elderly people, home care services benefit a much broader spectrum. It could be a
child with severe behaviors due to autism, a woman with a chronic illness or disability, an adolescent with mental illness, an individual that becomes disabled due to a motor vehicle accident, a family member that is coming out of a rehab facility after a traumatic brain injury or stroke, or an elderly family member with dementia. By learning about the different aspects of home care and where to start, we can help individuals and families take control of their lives and their futures, and provide the everyday assistance needed to keep people in their own homes. Learning under pressure Navigating systems and learning how to keep a loved one safely cared for at home can be very stressful. Concerns about quality care and attention, as well as the financial burden this places on a family, are common stressors, whether the in-home care involves a few hours a week or a full 24/7 plan customized to the family’s needs. Regardless of the specific plan, these services and supports can provide safety and well-being, allowing the individual to preserve independence and provide peace of mind for everyone involved. Home care is a general term used to describe a wide range of community-based services. This may include visits by registered nurses to provide skilled medical care; home physical therapy; and home health aides or personal care assistants (PCAs) to help with activities of daily living, ranging from daily routines to companionship to certain health-related tasks. Assess all of your loved one’s unique needs, and map out a customized plan that covers all of the bases. For individuals who require a skilled level of service, a physician must be involved to order the necessary services, which are then provided in the home setting by a licensed home health provider. The Minnesota Board on Aging’s Senior LinkAge Line (800-333-2433) or the Metropolitan Center for Independent Living’s Disability Linkage Line (866-333-2466), both available
16
MINNESOTA HEALTH CARE NEWS JANUARY/FEBRUARY 2017
at no charge to all Minnesotans, can help individuals or families locate a licensed provider. Help for all ages Home care is not just for older adults. Services—both medical and non-medical—are available for children, adolescents, adults, and families of all ages. Home health aides or PCAs can:
Determine who can provide these services and what they will cost. If the person needing home care has Medical Assistance (MA), they can contact their county or their health plan for an assessment and an authorization for services. Many home care services are funded through government health care programs to help individuals who are unable to fully care for themselves, providing support to stay in their homes and community.
• Ensure basic health and safety. • Assist with daily activities such as dressing, bathing, toileting, grooming, eating, transfers, mobility, and positioning. • Provide company and companionship. • Soothe anxieties or discourage inappropriate behaviors through “redirection”—encouraging the individual to switch focus to a different task or line of thinking. Some people seek continuing care for people with ongoing needs, but these same services can also provide short-term care for people moving from a hospital back to their home. The person seeking home care may be the individual in need of these services, the current caregiver of a handicapped spouse or child, an aging
Many people do not realize that they could become a paid caregiver for a family member.
For families who lack the personal financial resources or insurance coverage to pay for home care, one option is the Minnesota Department of Human Service’s (DHS) Personal Care
parent, or a family member with a physical or mental illness. In addition to enabling the individual needing support and services to remain at home in a safe environment, all care providers, regardless of skills or duties, can provide family caregivers with a chance to replenish their emotional and physical reserves. This respite support offers a break from caregiving responsibilities—a relaxing down time that can reduce stress.
Home care to page 19
For parents, this respite also provides relief from the overwhelming responsibilities of raising a child. Caring for a child with special needs—including chronic health conditions, behavioral health issues, or disability—can be challenging, and parents should seek help as needed. Some parents may qualify for financial assistance for home care services. When young adults with disabilities are preparing to make the transition from high school to work or post-secondary school, families should know that services and programs do not discontinue. The transitional planning process from high school to post-school activities helps to ensure that services support the youth’s goals and lead to successful outcomes while cultivating natural supports in the community. Planning and paying The navigation process includes two key steps: Define the tasks required by the individual needing services. This will help determine which home care services are most appropriate.
JANUARY/FEBRUARY 2017 MINNESOTA HEALTH CARE NEWS
17
CALENDAR NATIONAL BLOOD DONOR MONTH The American Red Cross has observed National Blood Donor Month in January since 1970, using it as an awareness campaign to increase blood and platelet donations during the winter, when donations typically drop due to the holidays, inclement weather, and illness. January is the most difficult month to collect blood donations in the U.S. About 36,000 units of red blood cells are needed every day in the U.S. Every two seconds, someone needs blood. Those who need it include individuals with sickle cell disease, who need frequent blood transfusions throughout their lives; people who have cancer, who often need blood transfusions during chemotherapy treatment; and people who have been injured in car accidents. An estimated 38 percent of U.S. adults are eligible to donate blood, however, less than 10 percent of that population actually donate each year. The process is sterile, safe, and the entire process of donating blood, from the time you arrive to the time you leave, takes about an hour and 15 minutes.
JAN 24
JANUARY-FEBRUARY 2017
Newly Diagnosed with Cancer Class
Park Nicollet hosts this free education program for individuals who have been recently diagnosed with cancer, their caregivers, family members, and friends. Come discuss changes, stress, and self-care and gain valuable resources to help cope. Other dates are available. Call (952) 993-5700 to register. Tuesday, Jan. 24, 3–4:30 p.m., Park Nicollet Frauenshuh Cancer Center, Curtis and Arlene Carlson Family Community Rm., 3931 Louisiana Ave. S., St. Louis Park
25
FEB 2
Stroke Support Group
Allina Health hosts this free monthly support group for anyone who has survived a stroke or head injury and their families and caregivers. Come gain information, support, and encouragement and share stories with others in a similar situation. No registration required. Call (763) 236-3068 for more information. Thursday, Feb. 2, 6:30–8 p.m., Unity Hospital, Classroom C, 550 Osborne Rd., Fridley
Honoring Choices
Fairview Health Services hosts this free class for anyone over the age of 18 who would like guidance planning for their future health care choices. Trained facilitators will help attendees develop an advance care plan and a health care directive. No registration required; other dates and locations available. For more information, call (612) 672-7272.
8
Lupus Wellness Class
Lupus Foundation of Minnesota offers this seminar for individuals living with lupus and other autoimmune diseases. Come learn how living with an autoimmune disease can impact a person’s emotional and social wellbeing and quality of life. To register, contact Sandy at (952) 746-5151 by Feb. 7.
Wednesday, Jan. 25, 10–11:30 a.m., Fairview Clinics—Fridley, 6341 University Ave. NE, Fridley
Wednesday, Feb. 8, 6:30–8 p.m., Maple Grove Library, 8001 Main St. N., Maple Grove
30
14
How Seniors Can Remain in Their Homes Longer
Hennepin County Library hosts this class for anyone wanting to learn about options for seniors or family members who still live at home but need support, socialization, health monitoring, and personal care service. Come learn about adult day services and what other options may be available to help them continue living at home. For more information, call (651) 543-5669.
Better Breathers Club
The American Lung Association in Minnesota hosts these free monthly meetings for anyone living with chronic lung disease. Come meet others facing similar issues and learn ways to cope with the challenges that come with chronic lung disease. No registration required. Call Cheryl at (651) 2239565 for more information.
Blood Donation Centers:
Monday, Jan. 30, 6–7 p.m., Walker Library, 2880 Hennepin Ave., Minneapolis
Tuesday, Feb. 14, 1–3 p.m., American Lung Association in Minnesota, 490 Concordia Ave., St. Paul
The American Red Cross Minnesota Region has several blood donation centers in the metro area.
30
28
Visit www.redcrossblood.org /northcentral Or call (612) 871-7676 to find a location near you.
Tai Chi for Parkinson’s and Wellness
Parent Leadership Training
HealthEast offers this tai chi class that is designed specifically for people living with Parkinson’s disease to help improve balance, coordination, concentration, strength, and mental well-being. This is a weekly class and there is a $5 per session cost, but the first session is free for beginners. Call Jill at (651) 232-2776 to register.
PACER Center is hosting this free class for parents who have children with mental health and behavioral health challenges. Come learn about improvements and progress within our systems of care and how to support these children. Live web streaming is available. Call (952) 838-9000 for more information.
Monday, Jan. 30, 10–11 a.m., Bethesda Hospital, 7th Flr. Conference Rm., 559 N. Capitol Blvd., St. Paul
Tuesday, Feb. 28, 6:30–8:30 p.m., PACER Center, 8161 Normandale Blvd., Minneapolis
America’s leading source of health information online 18
MINNESOTA HEALTH CARE NEWS JANUARY/FEBRUARY 2017
Home care from page 17
Assistance (PCA) Choice option. This program allows families or care recipients to independently recruit, hire, and train PCAs to provide care. It gives the person needing services or the family searching for home care a greater level of responsibility in managing
Learning how to keep a loved one safely cared for at home can be very stressful.
their own care or their loved one’s care. Having someone that the family or individual knows and trusts as the caregiver can provide consistency and familiarity. Many people do not realize that they could become a paid caregiver for a family member. For a person receiving PCA services,
their paid caregiver could be a trusted neighbor, friend, or family member. They can be employed as a PCA and get paid by an agency, such as Accra Care in Hopkins. The PCA who is caring for their loved one needs to pass a criminal background check from the DHS. Agencies such as Accra Care that provide PCA Choice services and supports can walk families step by step through this easy process. The PCA Choice agency employs the PCA, bills for the services, and collects the funds to pay the PCA. The agency also handles all taxes and other employment obligations, such as workers’ compensation and liability insurance coverage. Look to the future Access to home care can seem like a daunting task, but with the right information, resources, and tools, this can be done efficiently and easily. Knowing that there are choices and potential financial options as families consider what help is needed will allow for positive possibilities for the future.
Leann Lindahl is service development director at Accra Care, a nonprofit organization offering personalized home care to children, adolescents, adults, and families of all abilities and ages.
JANUARY/FEBRUARY 2017 MINNESOTA HEALTH CARE NEWS
19
HEALTH POLICY
Understanding the “public option” It’s still just a concept By Kip Sullivan, JD
A
mericans first heard about “the public option” in the summer of 2009 when congressional Democrats unveiled legislation that would eventually become the Affordable Care Act (ACA). The public option was not included in the final version of the ACA, but many Democrats continued to support it. The concept was revived last year when it was endorsed by several prominent Democrats, including Hillary Clinton. Since the unveiling of the public option in 2009, it has been so vaguely described it is impossible to define it. All we can say
about the concept at this date is that it would be run by some level of government (state or federal) and it would be subsidized to some degree by taxes. All the other vital details—who could buy insurance from the public option, who would receive subsidies, which clinics and hospitals the insured could see, how much the providers of medical goods and services would be paid, whether the public option’s premiums would be lower than those of existing insurers—all that is unknown at this point. The public option’s current status is a political Rorschach blot—a concept that can mean pretty much whatever you want it to mean if you’re in the mood to project hopes or fears onto it. The best way to understand the public option is to trace its history.
The best way to understand the public option is to trace its history. The original proposal The public option was first described by Jacob Hacker, PhD, in a paper published in 2001. The paper laid out a proposal to insure nearly all Americans. Six years later Hacker published a revised version. He called his revised version “Health Care for America Plan.” I will call it HCAP for short, although he did not. Hacker proposed that Congress create a “Medicare-like” program to sell health insurance to the non-elderly. Hacker and his followers repeatedly used the phrase “Medicare-like” to drive home their claim that HCAP would enjoy the advantages of Medicare’s traditional fee-for-service program: large size, low payment rates to doctors and hospitals, and low administrative expenses (just 2 percent of overhead, compared to an industry average of 20 percent). Because it had those advantages, Hacker predicted HCAP would be able to set its premiums far below those of the insurance companies and thereby induce at least half the non-elderly to enroll in HCAP. Hacker’s predictions were confirmed by two subsequent reports by the Lewin Group, a health care policy research and
20
MINNESOTA HEALTH CARE NEWS JANUARY/FEBRUARY 2017
management consulting firm. Lewin estimated the public option would insure somewhere between 113 and 129 million people. The Democrats’ version compared with Hacker’s But something happened to HCAP between 2007 when Hacker published his second paper and 2009 when House and Senate Democrats announced their versions. According to the Congressional Budget Office (CBO), the public option announced by House Democrats in June 2009 would insure 10 million people at most, and the public option unveiled by the Senate Health, Labor and Pension (HELP) Committee in July 2009 was unlikely to insure anyone. How was Hacker’s HCAP transformed from a program that would insure 115 to 130 million people into one that would insure zero to 10 million people? The answer: The Democrats stripped Hacker’s HCAP of every feature that would have given it the power to set its premiums below those of the insurance industry. Hacker had laid out these five criteria for HCAP: 1. It had to be pre-populated with tens of millions of people, that is, on the day it opened for business it had to represent a large pool of people. (Hacker proposed automatically enrolling the uninsured as well as enrollees of Medicaid and SCHIP into his public program.) 2. Only HCAP enrollees could get subsidies. 3. HCAP had to be available to all nonelderly Americans (not just the uninsured and employees of small employers).
by the Democrats. At this date, we can only assume that Hacker and his disciples thought the Democrats’ public option would succeed even though the CBO had doubts.
It simply is not true that any co-op program is better than no co-op program. The public option’s biggest obstacle We will never know how the weak public option proposed in 2009 would have performed had it found its way into the ACA. But we may predict with some confidence that any future public option that fails to meet Hacker’s original five criteria will probably fail, especially if it is restricted to selling only on the exchanges. The primary obstacle a public option will face is the high concentration of the health insurance industry and the spread of managed-care cost-control tactics. A brief review of Minnesota’s insurance market illustrates this statement. Minnesota’s health insurance industry began to consolidate in the 1980s as Health Maintenance Organizations (HMOs) and some traditional insurers adopted managed care tactics. These tactics gave insurance companies the power to shift large pools of patients from Understanding the “public option” to page 25
4. HCAP had to be given authority to use Medicare’s provider reimbursement rates. 5. The insurance industry had to be required to offer the same minimum level of benefits HCAP had to offer. In a 2008 report, the Lewin Group said that a public option meeting these criteria would have: • Enrolled 129 million enrollees (or 50 percent of the non-elderly) • Enjoyed overhead costs equal to 3 percent of expenditures • Paid hospitals 26 percent less and doctors 17 percent less than the insurance industry • Set its premiums 23 percent below those of the average insurance company The House and Senate bills met only one of Hacker’s five criteria, though: Both bills required the insurance industry to cover the same benefits the public option had to cover. None of the other four criteria were met. The public option was not pre-populated; subsidies to employers and to individuals would also be available to the insurance industry; employees of large employers could not buy insurance from the public option during its first few years and possibly never; and the public option was not authorized to use Medicare’s provider payment rates (the House bill authorized Medicare’s rates plus 5 percent). Neither Hacker nor any other prominent public option advocate ever publicly objected to the weakened version of HCAP proposed JANUARY/FEBRUARY 2017 MINNESOTA HEALTH CARE NEWS
21
BEHAVIOR AL HEALTH
Adverse childhood experiences Surviving the impact
By Anna Bohlinger, PhD, LMFT
B
eing sexually abused. Having a parent who is a problem drinker. A sibling with depression. These all qualify as adverse childhood experiences (ACEs), specific events or factors that raise the longterm risk of mental and physical health problems. The major categories of ACEs—experiencing abuse; violence against a mother; living with a family member who has substance abuse issues or mental health problems, including suicide; and/or living with a family member who has been incarcerated—can continue to affect people throughout their lives.
Numbers and impact About one-half of American adults report having had at least one ACE, according to the original 1998 study on adverse childhood experiences, conducted by the Centers for Disease Control and Prevention and Kaiser Permanente. According to that study’s ACE Pyramid, the lifetime impacts of these events include disrupted neurodevelopment; social, emotional, and cognitive impairment; adoption of high-risk behaviors; disease, disability, and social problems; and early death. Younger adults and women are more likely than older adults and men to have high ACE scores (which tally the total number of events). Ethnic minorities are more likely than Caucasians to have high ACE scores. Adults who moved frequently as children are at a higher risk of increased scores, as are those from families with lower incomes. Children and adults with high scores are more likely to have significant health problems. People who have experienced four or more ACEs—about 6.2 percent of the U.S. population—are at a 12-time higher risk than the general population to experience serious consequences, including depression, drug abuse, or suicide attempts. The more ACEs someone has, the more likely they are to also have significant physical disease, including heart disease and/ or cancer. High ACE scores also present challenges at school and at home. Common socioemotional problems include inappropriate behavior, academic and learning issues, difficulty relating to peers and family members, and mood and behavioral disorders. Children with high ACE scores are more likely than their peers to have troubles with basic emotional regulation skills, such as identifying emotions, using emotions to problem solve, and using emotions to relate to others. Functioning under stress Children with high ACE scores may be more accustomed than their
22
MINNESOTA HEALTH CARE NEWS JANUARY/FEBRUARY 2017
peers to functioning under very high levels of stress—although their reactions would not be considered optimal. Because of their history of ACEs, their bodies and brains are constantly responding to high levels of cortisol and other stress hormones. This makes it difficult for them to utilize their frontal lobe processing skills, which help with rationally responding to challenges in the moment. In effect, they are constantly responding as if they were in danger, even when there is no actual danger.
About one-half of American adults report having had at least one ACE. For example, imagine a child who, after being sexually abused, is placed in foster care. That new home includes a foster parent struggling with alcohol abuse and a foster brother with a depression diagnosis and an attempted suicide. At school, this child would be more likely to struggle with paying attention to the teacher’s instructions. He or she would also seem to get irrationally angry at small things, and have trouble making friends. Unlike a classmate whose body and brain is less stressed, this child would respond to ordinary challenges—classroom learning, peer squabbles, and making friends—with extra-ordinary responsiveness. He or she would be hypervigilant to aspects of the classroom that would not be relevant to learning, perceiving personal attacks where there were none, and mistrusting peers without reasonable explanation.
poor health behaviors to help them cope with the emotional stress that accompany ACEs. Overeating, for example, is a common maladaptive health behavior, and may be amplified in adults with high ACE scores. Just as a child with multiple adverse childhood experiences may constantly respond to a high level of stress, whether or not the situation warrants it, adults with high ACE scores are also likely to respond to high levels of personal stress. For these individuals, developing calming strategies and habits is more than just a practice for good mental health; it’s a way to decrease their risk of serious physical consequences. The next generation Parenting poses another substantial challenge for adults with high ACE scores, above and beyond the physical and mental health problems they face personally. All too often, parents may perpetuate a cycle of adverse childhood experiences with their own children. Decreasing this risk is an important and, at times, daunting goal for parents who have had difficult childhoods. Developing and retaining outside resources, social relationships, and professional support to ultimately support both parent and child health can be essential for parents with high ACE scores.
Adverse childhood experiences to page 24
Health concerns over time Physical health consequences are common for children with high ACE scores. Children with high ACE scores are more likely than their peers to have problems with obesity, adolescent pregnancy, smoking, and physical inactivity. In one study, children with five or more ACEs reported substantially higher odds of smoking before age 14. A separate study found that recent adverse childhood events seemed to have a very strong impact on child health, especially with regard to physical problems with unknown causes (such as headaches, dizziness, and stomach problems). The physical consequences of high ACE scores begin even in childhood. The socioemotional and health consequences may persist throughout life. Adults with high ACE scores, especially those with four or more events, remain at risk for poor behavioral practices and physical health problems. Adults are more likely to smoke tobacco, have poor self-rated health, and/or have 50 or more sexual partners. Multiple studies also report an increased risk of other mental health consequences for adults in this group, including an increased risk of mood and anxiety disorders. Why are adults with high ACE scores at a higher risk of poor health behaviors and their related problems? While any mental health problem has multiple causes, including genetics, biology, and personal and environmental factors, these individuals may follow
JANUARY/FEBRUARY 2017 MINNESOTA HEALTH CARE NEWS
23
Adverse childhood experiences from page 23
Coping and surviving If you are an adult who has a high ACE score, there are ways to cope and decrease your overall risk of illness. Follow established practices to decrease overall stress. Consider exercise, spiritual wellness practices such as yoga or prayer, and/or mental health counseling to decrease your overall level of stress and to process your childhood experiences. While your level of stress may feel “normal,” your standard of normal could be much higher than that of the general population, and so regular, even daily, calming strategies may be extra important to your overall health. Community resources and public policy guidelines also play a role in decreasing the frequency, severity, and overall impact of ACEs. For example, universal home visiting programs after the birth of a new baby have been recommended by the U.S. Advisory Board on Child Abuse and Neglect. These and other social interventions strive to assist families during predictable, high-stress transitions, to decrease the likelihood of abuse, and to offer support to parents and caregivers who may be struggling with their own behavioral health problems. Stopping the cycle of adverse childhood events and then inadvertently re-enacting them in our own children is an important
24
MINNESOTA HEALTH CARE NEWS JANUARY/FEBRUARY 2017
challenge. Adults and parents who have had difficult childhood experiences may at times feel inadequate, damaged, or flawed. At the same time, adults and parents who have had difficult childhood experiences can also empathize deeply with their children and coach them in a deeply authentic resilience.
Parents may perpetuate a cycle of adverse childhood experiences with their own children. Brene Brown’s “Wholehearted Parenting Manifesto” reads in part, “We will practice courage in our family by showing up…We will share our stories of struggle and strength. There will always be room in our home for both.” High ACE scores do not need to be prophetic. With support from friends and professionals, adverse childhood experiences can become the soil of resilience. Anna Bohlinger, PhD, LMFT, is a marriage and family therapist, educator, and scientist who provides mental health services to children and adolescents. In addition to her clinical work as a therapist with PrairieCare, she is also a faculty member at Saint Mary’s University of Minnesota in the graduate marriage and family therapy program.
Understanding the “public option” from page 21
one clinic or hospital to another and to force providers to give them steep discounts that non-managed insurers could not extract. Those discounts allowed the managed care plans to lower their premiums, enroll more participants, and negotiate more discounts. This dynamic drove some insurance companies out of business, and caused others to merge. Several well-established insurance companies responded to this new market by leaving it or shutting down. It is now extremely difficult for any entity, be it a public option program or an insurance company, to crack the Minnesota market. We may predict that a public option that does not have the advantages that Hacker conferred upon his proposed HCAP, including pre-population and subsidies available only to the public option, will enroll few people and will fail. Failure of the ACA co-ops does not bode well Under the ACA, nonprofit, member-controlled co-ops (Consumer Operated and Oriented Plans) were authorized to sell insurance plans on the ACA exchanges. The initial 23 co-ops closely resembled the Democrats’ weak version of HCAP. They were not pre-populated with enrollees, and the subsidies they received were also made available to insurance companies, two disadvantages that led many observers to predict their underperformance or failure.
Sixteen of these co-ops have in fact gone under. We don’t fully understand why, but it is likely that they, like nearly all insurers that sold on the exchanges, underestimated how costly their enrollees would be. Other likely factors included their small size and inability to extract large discounts from providers, as well as naiveté regarding risk-adjustment mechanisms that can determine which insurers get the largest shares of healthy enrollees. Lessons The failure of the co-op program should provide public option proponents with a lesson in how not to write legislation. If you entertain the fantasy that a brand-new insurance company can crack today’s insurance market, you better write clear criteria into the enabling legislation that guarantees large size and an adequate supply of capital. And you better resolve, at the opening of each session of Congress, that you will pull the plug and oppose the bill if any of those criteria are stripped out of the authorizing legislation. It simply is not true that any co-op program is better than no co-op program. Similarly, it is not true that any public option program is better than no public option program.
Kip Sullivan, JD, writes frequently about health policy. His articles have appeared in peer-reviewed journals such as the New England Journal of Medicine and Health Affairs. His formal training is in law and economics.
JANUARY/FEBRUARY 2017 MINNESOTA HEALTH CARE NEWS
25
LONG-TERM CARE
Navigating senior care options Planning is key By Anne Marie Bartlett, LSW
M
any people never consider the need for senior care—and many avoid thinking about it. But that may change as our population ages and the need for senior or longterm care swells. The Minnesota State Demographic Center (SDC) estimates that 285,000 Minnesotans will turn 65 by the end of this decade, more than the past four decades combined. Around the year 2020, the SDC expects Minnesota’s 65-and-older population to eclipse that of children aged 5–17 for the first time in state
history. These numbers underscore the need for education and advance planning to ease worries and to help individuals and their families make the best decisions possible. The first signs Out-of-town friends or family members are often the first to notice changes in their loved one, particularly after a holiday or family gathering. At times this manifests in a sense of worry or panic, and at times it gets shrugged off as unnecessary fear and unfounded concern. When these challenging questions come into play, family dynamics can change. Calls coming in to the Saint Therese senior care and housing care coordinator illustrate some of these concerns. A daughter wonders if her mom has early signs of dementia, and is concerned for her safety. A son notices that his dad does not always take his medications and now spends a lot of time sleeping. A couple wants to be proactive about making decisions so they do not have to worry their children. A family’s loved one experiences a sudden change in health, prompting an immediate search for 24-hour care. Families and individuals are often overwhelmed by such concerns and the questions they raise: What type of care is needed? Can I provide the care my loved one needs at home? Do we have enough resources to cover the cost of care, and what happens when funds run out? Will I lose my independence? Should I move mom or dad closer to me or to their friends, and do they really even need to move? Seeking answers to these questions and making changes present challenges. In addition to the anxiety and fear of losing independence, the range of options, and the financial obligations, family members may disagree on the type of care that is needed, or they may experience feelings of guilt. The process is even more difficult when a sudden or unexpected health episode occurs and family or friends must make quick decisions, or when the individual does not have family or friends to consult and must navigate challenges alone.
26
MINNESOTA HEALTH CARE NEWS JANUARY/FEBRUARY 2017
Planning ahead and researching options will help make unexpected health episodes easier to handle and planned transitions easier. A sound plan can also make everyone involved more confident in the decision. Where to start It may help to break the process down into steps: Talk to your loved one’s doctor. The doctor can help determine what level of basic and specialty care is needed or may be needed in the future. A doctor’s orders are needed to move into a long-term care facility. Research communities online. Make a list of all factors that are most important to you and your loved ones so you can get an idea of what each community has to offer. Which location will work best— near family, or near the individual’s previous home and friends? What type of amenities does the campus offer—theater, bistro, library, art studio, gift shop, or outdoor areas? What levels of care are provided? If specialty care is needed, does the facility provide it? What spiritual care options are available, such as a chapel and pastoral care? Are there any health and wellness offerings, such as regular fitness classes or a swimming pool? What opportunities for socialization are provided, such as onsite coffees, bingo, or art classes, or offsite trips to the theater, restaurants, or grocery stores? Start with these items, add other features that are important to you, and compile lists comparing different communities.
Different services, different care Senior care communities may provide different levels of services, so pick a campus that meets the criteria you developed in your initial research. You may encounter variations on these sample types of community offerings: • One level of care, such as senior living, assisted living, or long-term care • A partial continuum of care comprising two or more of these levels of care • A full continuum of care that includes senior living, assisted living, memory care, and long-term care Learn all you can about the levels of care offered by your top campus picks, and determine what is most important to you or your loved one. Your needs may change, so consider whether you would prefer to move or to remain in the same community. Find out whether the community offers the specialty cares you may need, and whether services can be provided in your apartment. Finally, run some cost projections to determine whether it is more affordable to receive care in your home or in long-term care.
Navigating senior care options to page 31
A doctor’s orders are needed to move into a long-term care facility.
Tour two to four organizations. The best way to determine if you will feel comfortable at a campus is to spend time there. You can make an appointment, or you can drop in. If you did not get answers to your questions online, now is the time to ask. Look at the features that were promised on the website. Meet some of the staff and residents. Bring along any friends or family members who are involved in the decision-making. Ask for help. Look for resources in your local area or at your church. Some organizations, such as Saint Therese, offer care coordination support, with staff members available to help you navigate through your options. Churches may have a parish nurse or member of the congregation who can provide guidance. Senior centers are another place to connect with resources and gain insight from other seniors. Research a few of your favored communities and arrange formal tours if possible. Try to do this even in emergency situations, to ensure that you get all of your questions answered. If necessary, do so by phone. Any steps you are able to take will make the transition easier. JANUARY/FEBRUARY 2017 MINNESOTA HEALTH CARE NEWS
27
ONCOLOGY
Clinical trials Patients contributing to cures By Toni Kay Mangskau
M
ore than 29,000 Minnesotans will receive a new diagnosis of cancer this year. The disease is the state’s leading cause of death; nationwide, cancer strikes 1 in 2 men and 1 in 3 women in the course of their lifetimes. Patients who are struggling with a new diagnosis of cancer, living with the disease, or at high risk of developing it may take comfort in knowing that they can contribute to our efforts to combat cancer by participating in clinical trials and research.
In addition to helping us develop and test treatments for current patients, clinical trials provide lasting value for future generations. One patient undergoing cancer treatment told our Mayo Clinic’s Cancer Education Center that her ovarian cancer was the same form her mother had battled 10 years earlier. Back then, her mother participated in a Phase 1 clinical study that led to the standard treatment the daughter was now receiving. She told the staff, “Participating in the study was the last gift my mother gave to the family.” Long roads to hope It is estimated to take 12 to 14 years for a drug or treatment to be approved by the U.S. Food and Drug Administration (FDA). Most medications or treatments are studied for about six years in the laboratory before spending an additional 6–8 years in clinical trials. Even with so many resources being allocated to research, 20 percent of publicly funded studies fail because they are unable to attract enough patient participants—an issue that researchers define as a lack of accrual. At other times, slow accrual means that studies have to remain open for longer periods of time.
Clinical trials provide lasting value for future generations. The majority of Americans—70 percent, according to an article in the Journal of Clinical Oncology—are inclined or very willing to participate in clinical trials. That same article, though, notes that more than 95 percent of adult patients with cancer do not participate in clinical trials. Enrolling in clinical trials involves both patients and physicians communicating about possible study options. Based on the patient’s specific diagnosis, physicians can help determine whether a trial is available and whether the patient is eligible. If a specific trial is discussed and offered, the patient can decide whether to participate or to decline. This interactive communication between doctors and patients has the potential to produce more trial participants. In a 2013 poll
28
MINNESOTA HEALTH CARE NEWS JANUARY/FEBRUARY 2017
conducted by Research!America, a not-for-profit public education and advocacy alliance, 72 percent of respondents said they would be very likely or somewhat likely to participate in research if their doctor found a clinical trial and recommended that they join.
• Genetic studies look at what you inherit from your family, and
Academic centers and community clinics need to work together as well, to ensure that patients can learn about clinical research opportunities. Building awareness among all parties could boost the numbers of participants in clinical trials and help to accelerate medical advancements.
• Chart review studies review information from large groups of people to better understand, detect, control, and treat health-related conditions.
Understanding the options As you work with your physician, you may encounter two terms: clinical research and clinical trials. A quick summary: Clinical research involves people who volunteer to participate in studies that lead to better ways to prevent, diagnose, treat, and understand health conditions. Here are the types of clinical research: • Prevention studies look at ways to stop diseases from occurring. Options may include medicines, vaccines, or lifestyle changes. • Screening studies test for better ways to detect certain diseases or health conditions. • Diagnostic studies look for better tests or procedures for diagnosing a disease or condition. • Treatment studies test new therapies, combinations of drugs, new approaches to surgeries, or use of integrative medicine.
may be independent or part of other types of research. • Quality of life studies explore ways to improve people’s comfort and manage symptoms of chronic illness or treatment side effects.
The easiest way for you to participate in research is to grant permission for your medical records to be used in chart review studies. A large chart review study at Mayo involving over 10,000 patients with chronic lymphocytic leukemia (CLL) showed that CLL patients with low levels of Vitamin D had a significant difference in cancer progression and death than patients with a normal Vitamin D level. We are building on this earlier research, and currently have a Vitamin D treatment study enrolling participants with a variety of blood cancers. Ask if your clinic or health system conducts these types of chart review studies, and consider participating. Clinical trials are research studies created to answer specific questions about new therapies or new ways of using known treatments. Clinical trials are used to determine whether new drugs or treatments are both safe and effective.
Clinical trials to page 30
JANUARY/FEBRUARY 2017 MINNESOTA HEALTH CARE NEWS
29
Clinical trials from page 29
Clinical trials take place in phases. For a treatment to become standard, it must first go through two or three clinical trial phases: • Phase 1 studies are sometimes referred to as “dosing” studies. The goal is to find the best dose and figure out the best way to administer the treatment.
randomly and anonymously to control groups receiving different treatments. If you have had prior standard treatment, you could wind up being assigned to the group receiving your former standard treatment, so that study may not be an option. Throughout this period, from initial diagnosis until anytime you have exhausted standard treatments, keep seeking clinical trial opportunities that may be available to you.
• Phase 2 studies assess if the treatment is effective. • Phase 3 studies typically compare the standard treatment to the new treatment. When should I enroll in a study? The best time to consider participating in a clinical trial is when you are newly diagnosed and discussing treatment options with your doctor. Since you have not yet undergone treatments, you would have a “clean slate,” and more Phase 2 or 3 treatment studies may possibly be open to you; those studies may be further along in the FDA’s approval process. If you start standard treatments before investigating clinical trial options, you could be excluded from participating in specific Phase 2 or 3 trials that compare new treatments to standard treatments. Patients in these types of trials typically are assigned
Grant permission for your medical records to be used in chart review studies. Getting started Your physician and health care team will do all they can to take care of you, but consider seeking clinical trials along with other treatment options. It’s never too soon to start. In addition to determining whether a treatment or trial is appropriate for your circumstances, you may have to arrange travel and lodging. Clinical trials, as with any medical procedure, will pose questions regarding insurance and cost. Mayo Clinic’s public clinical trials website (www.mayo.edu/ research/clinical-trials) includes additional information and links, as well as search tools to help identify ongoing trials. Mayo’s cancer center has implemented a universal phone number and web form for clinical trial inquiries. Your health care provider may be able to provide additional resources. Take advantage of these and other resources that may be available online or at your library. When you are ready to talk with your doctor and prioritize possible studies to participate in, it is helpful to pose these three questions: 1. What phase is the clinical trial? 2. How familiar is the medical community with the medications or treatments? 3. What has earlier research shown? Leave a legacy In my role as clinical trials referral coordinator, I speak with thousands of patients and their family members from around the world who contact us for the latest clinical trial information. Many of the callers want to participate in research studies so they can have more time for themselves, but also so that their children or grandchildren never have to hear the words, “You have cancer.” They want to be part of a legacy that helps other cancer patients. Toni Kay Mangskau is clinical trials referral coordinator for the Mayo Clinic Cancer Center and oversees the clinical trials referral office for sites in Arizona, Florida, and Minnesota. Nationally, she has served as a steering committee member for the Summit Series on Cancer Clinical Trials, and was co-chair of the infrastructure/funding subcommittee to develop a nation-wide training program for research staff and to communicate with patients about clinical trials.
30
MINNESOTA HEALTH CARE NEWS JANUARY/FEBRUARY 2017
Navigating senior care options from page 27
rooms), area of the facility (e.g., memory care), financial assistance, and required care services. Making the move can be an anxious time for everyone involved.
Paying for care
Take advantage of support resources from the community, your
Monthly costs for senior living or long-term care vary. For senior
local area, and church. It can be a positive change. The individual is
living, the number of bedrooms and bathrooms, square footage,
moving into a new home; with it comes new amenities, new friends,
and amenities drive the monthly rent. Many communities offer
and new experiences.
services such as homemaking or health care for additional fees. Long-term care costs differ based on an individual’s health care needs. A medical evaluation is required to determine rates. Several types of government financial assistance may be available in either situation. Also, long-term care insurance can help cover the cost of
Several types of government financial assistance may be available.
care; review your policy carefully to determine what is covered and what is not covered. The information you gathered can help you feel confident
Making a decision
in your decision. Choosing a community that provides the best
After doing your research and discussing the options with your
available care for you or your loved one will allow you to continue
doctor, friends, and family, determine which type of community
making memories.
and location is best for you. It is important to have more than one top choice, since apartment openings are based on availability and open spots for those requiring financial assistance. Consider adding yourself to a wait list. Long-term care openings also depend on availability and other items such as gender (in the case of shared
Anne Marie Bartlett, LSW, a licensed Minnesota social worker and certified spiritual director, is director of care management at Saint Therese. She recently became certified as a dementia capable care instructor.
JANUARY/FEBRUARY 2017 MINNESOTA HEALTH CARE NEWS
31
2017 Minnesota legislative preview from page 15
replacing the ACA. Many speculate that the administration will defund the federal health law by reenacting a budget bill vetoed by President Obama in 2015. Others focus on multiple regulations that the incoming administration might decline to enforce or might repeal by issuing its own new executive actions. While the president-elect has stated he will try to preserve popular ACA provisions, such as requiring coverage to be issued for those with preexisting conditions, the market is unlikely to withstand a patchwork approach. If the administration steps back ACA provisions, states will likely pursue waivers to implement their own reforms. The Minnesota Legislature will probably begin to consider systemwide reforms that might be favorable under new federal control, including proposals to restore many aspects of the pre-ACA market. Republications in Washington have also signaled interest in revising Medicaid funding, with some urging that it be transformed into a system of state block grants. Federal action on this front would have a clear impact on the state’s Medical Assistance program and on overall HHS budgets. Follow the process Many legislative initiatives that impact the public never receive press coverage. Here are some tips to follow emerging legislation:
32
MINNESOTA HEALTH CARE NEWS JANUARY/FEBRUARY 2017
To track a bill, visit the Legislature’s “Bill Search and Status” tool at www.leg.state.mn.us/leg/legis. Search for bills by their assigned numbers, authors, and topics, or search by key words. The site also shows the legislative history of a bill, including the committees in which it has been heard and links to audio and video discussions by legislators.
Seventy-five percent of voters say that drug costs are too high. To track multiple bills, visit “MyBills” at www.leg.state. mn.us/mybills. Enter your preferences, and view bills and relevant information based on your entries; the service even sends you alerts and updates if anything changes. To reach out to your legislator, visit www.leg.state.mn.us/leg/ districtfinder. This Secretary of State site allows you to search for your elected officials, and provides contact information and links to their offices. To review current laws, visit the Office of the Revisor of Statutes site at www.revisor.leg.state.mn.us, which posts all state statutes and regulations. Kate Johansen, JD, is director of government relations at Medica.
JOIN US.
Be heard in debates and discussions that shape the future of health care policy. There is no cost to join this informed and informative online community. Members receive a free monthly electronic newsletter and the opportunity to participate in consumer opinion surveys.
www.mnhcca.org JANUARY/FEBRUARY 2017 MINNESOTA HEALTH CARE NEWS
33
Antibiotic resistance from page 13
Antibiotic Resistance Regional Laboratories, and will be a regional and national resource to better understand the threat. Because antibiotics can also cause resistance in animals and the environment, Minnesota’s leaders in human and veterinary medicine, agriculture, and environmental sciences have joined together in a “one health” cooperative effort to address resistance and improve antibiotic practices. Learn more at www.health.state.mn.us/onehealthabx/.
When antibiotics are prescribed inappropriately for viral infections, they don’t do anything.
What’s the big picture of the resistance problem? There’s never been more interest and scrutiny placed on antibiotic resistance and use. Resistant bacteria can be acquired in health care facilities and the community, as well as from animals, contaminated food, and contaminated environments. State and
34
MINNESOTA HEALTH CARE NEWS JANUARY/FEBRUARY 2017
federal public health and agriculture departments track and report resistant infections and help health care facilities, animal producers, and the public to identify best practices for prevention and response. Because global travel is simple and rapid, antibioticresistant bacteria know no borders. CDC works with the World Health Organization and foreign governments to understand and combat this worldwide threat. What can I do to prevent the development of resistance and be a good steward of antibiotics? You can do your part by understanding when antibiotics are needed, using antibiotics exactly as prescribed, disposing of them responsibly, and using non-antibiotic measures to feel better (e.g., if you have a viral infection, focus on rest, fluids, and over-the-counter medications). Of course, preventing illness is important, too, so wash your hands, stay up-to-date on vaccines, and make sure to follow safe meat cooking and handling practices. The CDC offers additional tips and background at http://tinyurl.com/AntibioticsTips.
Amanda Beaudoin, DVM, PhD, a Diplomate of the American College of Veterinary Preventive Medicine, is director of One Health Antibiotic Stewardship at the Minnesota Department of Health, working with partners across the state to prevent antibiotic resistance and improve antibiotic use in human, animal, and environmental health.
S:9.75”
Victoza® (liraglutide [rDNA origin] injection) Rx Only BRIEF SUMMARY. Please consult package insert for full prescribing information. WARNING: RISK OF THYROID C-CELL TUMORS: Liraglutide causes dose-dependent and treatmentduration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice. It is unknown whether Victoza® causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as human relevance could not be ruled out by clinical or nonclinical studies. Victoza® is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Based on the findings in rodents, monitoring with serum calcitonin or thyroid ultrasound was performed during clinical trials, but this may have increased the number of unnecessary thyroid surgeries. It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate human risk of thyroid C-cell tumors. Patients should be counseled regarding the risk and symptoms of thyroid tumors [see Contraindications and Warnings and Precautions].
VICU3X1498_B_2_0_Journal_Ad_Tabloid_Resize_BS_r5.indd 1
for neutralizing effect against native GLP-1, and thus the potential for clinically significant neutralization of native GLP-1 was not assessed. Antibodies that had a neutralizing effect on liraglutide in an in vitro assay occurred in 2.3% of the Victoza®-treated patients in the double-blind 52-week monotherapy trial and in 1.0% of the Victoza®-treated patients in the double-blind 26-week add-on combination therapy trials. Among Victoza®-treated patients who developed anti-liraglutide antibodies, the most common category of adverse events was that of infections, which occurred among 40% of these patients compared to 36%, 34% and 35% of antibody-negative Victoza®-treated, placebo-treated and active-control-treated patients, respectively. The specific infections which occurred with greater frequency among Victoza®-treated antibody-positive patients were primarily nonserious upper respiratory tract infections, which occurred among 11% of Victoza®-treated antibody-positive patients; and among 7%, 7% and 5% of antibody-negative Victoza®-treated, placebo-treated and active-control-treated patients, respectively. Among Victoza®-treated antibody-negative patients, the most common category of adverse events was that of gastrointestinal events, which occurred in 43%, 18% and 19% of antibody-negative Victoza®-treated, placebo-treated and active-control-treated patients, respectively. Antibody formation was not associated with reduced efficacy of Victoza® when comparing mean HbA1c of all antibody-positive and all antibody-negative patients. However, the 3 patients with the highest titers of anti-liraglutide antibodies had no reduction in HbA1c with Victoza® treatment. In the five double-blind clinical trials of Victoza®, events from a composite of adverse events potentially related to immunogenicity (e.g. urticaria, angioedema) occurred among 0.8% of Victoza®-treated patients and among 0.4% of comparator-treated patients. Urticaria accounted for approximately one-half of the events in this composite for Victoza®-treated patients. Patients who developed anti-liraglutide antibodies were not more likely to develop events from the immunogenicity events composite than were patients who did not develop anti-liraglutide antibodies. Injection site reactions: Injection site reactions (e.g., injection site rash, erythema) were reported in approximately 2% of Victoza®-treated patients in the five double-blind clinical trials of at least 26 weeks duration. Less than 0.2% of Victoza®-treated patients discontinued due to injection site reactions. Papillary thyroid carcinoma: In clinical trials of Victoza®, there were 7 reported cases of papillary thyroid carcinoma in patients treated with Victoza® and 1 case in a comparator-treated patient (1.5 vs. 0.5 cases per 1000 patient-years). Most of these papillary thyroid carcinomas were <1 cm in greatest diameter and were diagnosed in surgical pathology specimens after thyroidectomy prompted by findings on protocol-specified screening with serum calcitonin or thyroid ultrasound. Hypoglycemia :In the eight clinical trials of at least 26 weeks duration, hypoglycemia requiring the assistance of another person for treatment occurred in 11 Victoza®-treated patients (2.3 cases per 1000 patient-years) and in two exenatidetreated patients. Of these 11 Victoza®-treated patients, six patients were concomitantly using metformin and a sulfonylurea, one was concomitantly using a sulfonylurea, two were concomitantly using metformin (blood glucose values were 65 and 94 mg/dL) and two were using Victoza® as monotherapy (one of these patients was undergoing an intravenous glucose tolerance test and the other was receiving insulin as treatment during a hospital stay). For these two patients on Victoza® monotherapy, the insulin treatment was the likely explanation for the hypoglycemia. In the 26-week open-label trial comparing Victoza® to sitagliptin, the incidence of hypoglycemic events defined as symptoms accompanied by a fingerstick glucose <56 mg/ dL was comparable among the treatment groups (approximately 5%). Table 5: Incidence (%) and Rate (episodes/patient year) of Hypoglycemia in the 52-Week Monotherapy Trial and in the 26-Week Combination Therapy Trials Victoza® Treatment Active Comparator Placebo Comparator None Monotherapy Victoza® (N = 497) Glimepiride (N = 248) Patient not able to self-treat 0 0 — Patient able to self-treat 9.7 (0.24) 25.0 (1.66) — Not classified 1.2 (0.03) 2.4 (0.04) — ® Add-on to Metformin Victoza + Metformin Glimepiride + Placebo + Metformin (N = 724) Metformin (N = 242) (N = 121) Patient not able to self-treat 0.1 (0.001) 0 0 Patient able to self-treat 3.6 (0.05) 22.3 (0.87) 2.5 (0.06) ®+ ® None Insulin detemir + Continued Victoza Add-on to Victoza Metformin Victoza® + Metformin + Metformin alone (N = 158*) (N = 163) Patient not able to self-treat 0 0 — Patient able to self-treat 9.2 (0.29) 1.3 (0.03) — Rosiglitazone + Placebo + Add-on to Glimepiride Victoza® + Glimepiride (N = 695) Glimepiride (N = 231) Glimepiride (N = 114) Patient not able to self-treat 0.1 (0.003) 0 0 Patient able to self-treat 7.5 (0.38) 4.3 (0.12) 2.6 (0.17) Not classified 0.9 (0.05) 0.9 (0.02) 0 Placebo + Metformin Add-on to Metformin + Victoza® + Metformin None + Rosiglitazone + Rosiglitazone Rosiglitazone (N = 175) (N = 355) Patient not able to self-treat 0 — 0 Patient able to self-treat 7.9 (0.49) — 4.6 (0.15) Not classified 0.6 (0.01) — 1.1 (0.03) Add-on to Metformin + Victoza® + Metformin Insulin glargine Placebo + Metformin + Glimepiride + Metformin + Glimepiride + Glimepiride (N = 114) Glimepiride (N = 232) (N = 230) Patient not able to self-treat 2.2 (0.06) 0 0 Patient able to self-treat 27.4 (1.16) 28.9 (1.29) 16.7 (0.95) Not classified 0 1.7 (0.04) 0 *One patient is an outlier and was excluded due to 25 hypoglycemic episodes that the patient was able to self-treat. This patient had a history of frequent hypoglycemia prior to the study. In a pooled analysis of clinical trials, the incidence rate (per 1,000 patient-years) for malignant neoplasms (based on investigator-reported events, medical history, pathology reports, and surgical reports from both blinded and open-label study periods) was 10.9 for Victoza®, 6.3 for placebo, and 7.2 for active comparator. After excluding papillary thyroid carcinoma events [see Adverse Reactions], no particular cancer cell type predominated. Seven malignant neoplasm events were reported beyond 1 year of exposure to study medication, six events among Victoza®-treated patients (4 colon, 1 prostate and 1 nasopharyngeal), no events with placebo and one event with active comparator (colon). Causality has not been established. Laboratory Tests: In the five clinical trials of at least 26 weeks duration, mildly elevated serum bilirubin concentrations (elevations to no more than twice the upper limit of the reference range) occurred in 4.0% of Victoza®-treated patients, 2.1% of placebo-treated patients and 3.5% of active-comparator-treated patients. This finding was not accompanied by abnormalities in other liver tests. The significance of this isolated finding is unknown. Vital signs: Victoza® did not have adverse effects on blood pressure. Mean increases from baseline in heart rate of 2 to 3 beats per minute have been observed with Victoza® compared to placebo. The long-term clinical effects of the increase in pulse rate have not been established. Post-Marketing Experience: The following additional adverse reactions have been reported during post-approval use of Victoza®. Because these events are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to drug exposure: Dehydration resulting from nausea, vomiting and diarrhea; Increased serum creatinine, acute renal failure or worsening of chronic renal failure, sometimes requiring hemodialysis; Angioedema and anaphylactic reactions; Allergic reactions: rash and pruritus; Acute pancreatitis, hemorrhagic and necrotizing pancreatitis sometimes resulting in death. OVERDOSAGE: Overdoses have been reported in clinical trials and post-marketing use of Victoza®. Effects have included severe nausea and severe vomiting. In the event of overdosage, appropriate supportive treatment should be initiated according to the patient’s clinical signs and symptoms. More detailed information is available upon request. For information about Victoza® contact: Novo Nordisk Inc., 800 Scudders Mill Road, Plainsboro, NJ 08536, 1−877-484-2869 Date of Issue: April 16, 2013 Version: 6 Manufactured by: Novo Nordisk A/S, DK-2880 Bagsvaerd, Denmark Victoza® is covered by US Patent Nos. 6,268,343, 6,458,924, 7,235,627, 8,114,833 and other patents pending. Victoza® Pen is covered by US Patent Nos. 6,004,297, RE 43,834, RE 41,956 and other patents pending. © 2010-2013 Novo Nordisk 0513-00015682-1 5/2013
11/19/13 8:09 PM
S:12.25”
INDICATIONS AND USAGE: Victoza® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Important Limitations of Use: Because of the uncertain relevance of the rodent thyroid C-cell tumor findings to humans, prescribe Victoza® only to patients for whom the potential benefits are considered to outweigh the potential risk. Victoza® is not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exercise. Based on spontaneous postmarketing reports, acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victoza®. Victoza® has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for pancreatitis while using Victoza®. Other antidiabetic therapies should be considered in patients with a history of pancreatitis. Victoza® is not a substitute for insulin. Victoza® should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis, as it would not be effective in these settings. The concurrent use of Victoza® and prandial insulin has not been studied. CONTRAINDICATIONS: Do not use in patients with a personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Do not use in patients with a prior serious hypersensitivity reaction to Victoza® or to any of the product components. WARNINGS AND PRECAUTIONS: Risk of Thyroid C-cell Tumors: Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors (adenomas and/or carcinomas) at clinically relevant exposures in both genders of rats and mice. Malignant thyroid C-cell carcinomas were detected in rats and mice. A statistically significant increase in cancer was observed in rats receiving liraglutide at 8-times clinical exposure compared to controls. It is unknown whether Victoza® will cause thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as the human relevance of liraglutide-induced rodent thyroid C-cell tumors could not be determined by clinical or nonclinical studies. In the clinical trials, there have been 6 reported cases of thyroid C-cell hyperplasia among Victoza®-treated patients and 2 cases in comparator-treated patients (1.3 vs. 1.0 cases per 1000 patient-years). One comparator-treated patient with MTC had pre-treatment serum calcitonin concentrations >1000 ng/L suggesting pre-existing disease. All of these cases were diagnosed after thyroidectomy, which was prompted by abnormal results on routine, protocol-specified measurements of serum calcitonin. Five of the six Victoza®-treated patients had elevated calcitonin concentrations at baseline and throughout the trial. One Victoza® and one non-Victoza®-treated patient developed elevated calcitonin concentrations while on treatment. Calcitonin, a biological marker of MTC, was measured throughout the clinical development program. The serum calcitonin assay used in the Victoza® clinical trials had a lower limit of quantification (LLOQ) of 0.7 ng/L and the upper limit of the reference range was 5.0 ng/L for women and 8.4 ng/L for men. At Weeks 26 and 52 in the clinical trials, adjusted mean serum calcitonin concentrations were higher in Victoza®-treated patients compared to placebo-treated patients but not compared to patients receiving active comparator. At these timepoints, the adjusted mean serum calcitonin values (~1.0 ng/L) were just above the LLOQ with between-group differences in adjusted mean serum calcitonin values of approximately 0.1 ng/L or less. Among patients with pre-treatment serum calcitonin below the upper limit of the reference range, shifts to above the upper limit of the reference range which persisted in subsequent measurements occurred most frequently among patients treated with Victoza® 1.8 mg/day. In trials with on-treatment serum calcitonin measurements out to 5-6 months, 1.9% of patients treated with Victoza® 1.8 mg/day developed new and persistent calcitonin elevations above the upper limit of the reference range compared to 0.8-1.1% of patients treated with control medication or the 0.6 and 1.2 mg doses of Victoza®. In trials with on-treatment serum calcitonin measurements out to 12 months, 1.3% of patients treated with Victoza® 1.8 mg/day had new and persistent elevations of calcitonin from below or within the reference range to above the upper limit of the reference range, compared to 0.6%, 0% and 1.0% of patients treated with Victoza® 1.2 mg, placebo and active control, respectively. Otherwise, Victoza® did not produce consistent dose-dependent or time-dependent increases in serum calcitonin. Patients with MTC usually have calcitonin values >50 ng/L. In Victoza® clinical trials, among patients with pre-treatment serum calcitonin <50 ng/L, one Victoza®-treated patient and no comparator-treated patients developed serum calcitonin >50 ng/L. The Victoza®-treated patient who developed serum calcitonin >50 ng/L had an elevated pre-treatment serum calcitonin of 10.7 ng/L that increased to 30.7 ng/L at Week 12 and 53.5 ng/L at the end of the 6-month trial. Follow-up serum calcitonin was 22.3 ng/L more than 2.5 years after the last dose of Victoza®. The largest increase in serum calcitonin in a comparator-treated patient was seen with glimepiride in a patient whose serum calcitonin increased from 19.3 ng/L at baseline to 44.8 ng/L at Week 65 and 38.1 ng/L at Week 104. Among patients who began with serum calcitonin <20 ng/L, calcitonin elevations to >20 ng/L occurred in 0.7% of Victoza®-treated patients, 0.3% of placebo-treated patients, and 0.5% of active-comparator-treated patients, with an incidence of 1.1% among patients treated with 1.8 mg/ day of Victoza®. The clinical significance of these findings is unknown. Counsel patients regarding the risk for MTC and the symptoms of thyroid tumors (e.g. a mass in the neck, dysphagia, dyspnea or persistent hoarseness). It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate the potential risk of MTC, and such monitoring may increase the risk of unnecessary procedures, due to low test specificity for serum calcitonin and a high background incidence of thyroid disease. Patients with thyroid nodules noted on physical examination or neck imaging obtained for other reasons should be referred to an endocrinologist for further evaluation. Although routine monitoring of serum calcitonin is of uncertain value in patients treated with Victoza®, if serum calcitonin is measured and found to be elevated, the patient should be referred to an endocrinologist for further evaluation. Pancreatitis: Based on spontaneous postmarketing reports, acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, has been observed in patients treated with Victoza®. After initiation of Victoza®, observe patients carefully for signs and symptoms of pancreatitis (including persistent severe abdominal pain, sometimes radiating to the back and which may or may not be accompanied by vomiting). If pancreatitis is suspected, Victoza® should promptly be discontinued and appropriate management should be initiated. If pancreatitis is confirmed, Victoza® should not be restarted. Consider antidiabetic therapies other than Victoza® in patients with a history of pancreatitis. In clinical trials of Victoza®, there have been 13 cases of pancreatitis among Victoza®-treated patients and 1 case in a comparator (glimepiride) treated patient (2.7 vs. 0.5 cases per 1000 patient-years). Nine of the 13 cases with Victoza® were reported as acute pancreatitis and four were reported as chronic pancreatitis. In one case in a Victoza®-treated patient, pancreatitis, with necrosis, was observed and led to death; however clinical causality could not be established. Some patients had other risk factors for pancreatitis, such as a history of cholelithiasis or alcohol abuse. Use with Medications Known to Cause Hypoglycemia: Patients receiving Victoza® in combination with an insulin secretagogue (e.g., sulfonylurea) or insulin may have an increased risk of hypoglycemia. The risk of hypoglycemia may be lowered by a reduction in the dose of sulfonylurea (or other concomitantly administered insulin secretagogues) or insulin Renal Impairment: Victoza® has not been found to be directly nephrotoxic in animal studies or clinical trials. There have been postmarketing reports of acute renal failure and worsening of chronic renal failure, which may sometimes require hemodialysis in Victoza®-treated patients. Some of these events were reported in patients without known underlying renal disease. A majority of the reported events occurred in patients who had experienced nausea, vomiting, diarrhea, or dehydration. Some of the reported events occurred in patients receiving one or more medications known to affect renal function or hydration status. Altered renal function has been reversed in many of the reported cases with supportive treatment and discontinuation of potentially causative agents, including Victoza®. Use caution when initiating or escalating doses of Victoza® in patients with renal impairment. Hypersensitivity Reactions: There have been postmarketing reports of serious hypersensitivity reactions (e.g., anaphylactic reactions and angioedema) in patients treated with Victoza®. If a hypersensitivity reaction occurs, the patient should discontinue Victoza® and other suspect medications and promptly seek medical advice. Angioedema has also been reported with other GLP-1 receptor agonists. Use caution in a patient with a history of angioedema with another GLP-1 receptor agonist because it is unknown whether such patients will be predisposed to angioedema with Victoza®. Macrovascular Outcomes: There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Victoza® or any other antidiabetic drug. ADVERSE REACTIONS: Clinical Trials Experience: Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of Victoza® has been evaluated in 8 clinical trials: A double-blind 52-week monotherapy trial compared Victoza® 1.2 mg daily, Victoza® 1.8 mg daily, and glimepiride 8 mg daily; A double-blind 26 week add-on to metformin trial compared Victoza® 0.6 mg once-daily, Victoza® 1.2 mg once-daily, Victoza® 1.8
mg once-daily, placebo, and glimepiride 4 mg once-daily; A double-blind 26 week add-on to glimepiride trial compared Victoza® 0.6 mg daily, Victoza® 1.2 mg once-daily, Victoza® 1.8 mg once-daily, placebo, and rosiglitazone 4 mg once-daily; A 26 week add-on to metformin + glimepiride trial, compared double-blind Victoza® 1.8 mg once-daily, double-blind placebo, and open-label insulin glargine once-daily; A doubleblind 26-week add-on to metformin + rosiglitazone trial compared Victoza® 1.2 mg once-daily, Victoza® 1.8 mg once-daily and placebo; An open-label 26-week add-on to metformin and/or sulfonylurea trial compared Victoza® 1.8 mg once-daily and exenatide 10 mcg twice-daily; An open-label 26-week add-on to metformin trial compared Victoza® 1.2 mg once-daily, Victoza® 1.8 mg once-daily, and sitagliptin 100 mg once-daily; An open-label 26-week trial compared insulin detemir as add-on to Victoza® 1.8 mg + metformin to continued treatment with Victoza® + metformin alone. Withdrawals: The incidence of withdrawal due to adverse events was 7.8% for Victoza®-treated patients and 3.4% for comparator-treated patients in the five double-blind controlled trials of 26 weeks duration or longer. This difference was driven by withdrawals due to gastrointestinal adverse reactions, which occurred in 5.0% of Victoza®-treated patients and 0.5% of comparator-treated patients. In these five trials, the most common adverse reactions leading to withdrawal for Victoza®-treated patients were nausea (2.8% versus 0% for comparator) and vomiting (1.5% versus 0.1% for comparator). Withdrawal due to gastrointestinal adverse events mainly occurred during the first 2-3 months of the trials. Common adverse reactions: Tables 1, 2, 3 and 4 summarize common adverse reactions (hypoglycemia is discussed separately) reported in seven of the eight controlled trials of 26 weeks duration or longer. Most of these adverse reactions were gastrointestinal in nature. In the five double-blind clinical trials of 26 weeks duration or longer, gastrointestinal adverse reactions were reported in 41% of Victoza®-treated patients and were dose-related. Gastrointestinal adverse reactions occurred in 17% of comparator-treated patients. Common adverse reactions that occurred at a higher incidence among Victoza®-treated patients included nausea, vomiting, diarrhea, dyspepsia and constipation. In the five double-blind and three open-label clinical trials of 26 weeks duration or longer, the percentage of patients who reported nausea declined over time. In the five double-blind trials approximately 13% of Victoza®-treated patients and 2% of comparator-treated patients reported nausea during the first 2 weeks of treatment. In the 26-week open-label trial comparing Victoza® to exenatide, both in combination with metformin and/or sulfonylurea, gastrointestinal adverse reactions were reported at a similar incidence in the Victoza® and exenatide treatment groups (Table 3). In the 26-week open-label trial comparing Victoza® 1.2 mg, Victoza® 1.8 mg and sitagliptin 100 mg, all in combination with metformin, gastrointestinal adverse reactions were reported at a higher incidence with Victoza® than sitagliptin (Table 4). In the remaining 26-week trial, all patients received Victoza® 1.8 mg + metformin during a 12-week run-in period. During the run-in period, 167 patients (17% of enrolled total) withdrew from the trial: 76 (46% of withdrawals) of these patients doing so because of gastrointestinal adverse reactions and 15 (9% of withdrawals) doing so due to other adverse events. Only those patients who completed the run-in period with inadequate glycemic control were randomized to 26 weeks of add-on therapy with insulin detemir or continued, unchanged treatment with Victoza® 1.8 mg + metformin. During this randomized 26-week period, diarrhea was the only adverse reaction reported in ≥5% of patients treated with Victoza® 1.8 mg + metformin + insulin detemir (11.7%) and greater than in patients treated with Victoza® 1.8 mg and metformin alone (6.9%). Table 1: Adverse reactions reported in ≥5% of Victoza®-treated patients in a 52-week monotherapy trial All Victoza® N = 497 Glimepiride N = 248 (%) (%) Adverse Reaction Nausea 28.4 8.5 Diarrhea 17.1 8.9 Vomiting 10.9 3.6 Constipation 9.9 4.8 Headache 9.1 9.3 Table 2: Adverse reactions reported in ≥5% of Victoza®-treated patients and occurring more frequently with Victoza® compared to placebo: 26-week combination therapy trials Add-on to Metformin Trial All Victoza® + Metformin Placebo + Metformin Glimepiride + Metformin N = 724 N = 121 N = 242 (%) (%) (%) Adverse Reaction Nausea 15.2 4.1 3.3 Diarrhea 10.9 4.1 3.7 Headache 9.0 6.6 9.5 Vomiting 6.5 0.8 0.4 Add-on to Glimepiride Trial ® Placebo + Glimepiride Rosiglitazone + All Victoza + Glimepiride N = 695 N = 114 Glimepiride N = 231 (%) (%) (%) Adverse Reaction Nausea 7.5 1.8 2.6 Diarrhea 7.2 1.8 2.2 Constipation 5.3 0.9 1.7 Dyspepsia 5.2 0.9 2.6 Add-on to Metformin + Glimepiride ® Victoza 1.8 + Metformin Placebo + Metformin + Glargine + Metformin + + Glimepiride N = 230 Glimepiride N = 114 Glimepiride N = 232 (%) (%) (%) Adverse Reaction Nausea 13.9 3.5 1.3 Diarrhea 10.0 5.3 1.3 Headache 9.6 7.9 5.6 Dyspepsia 6.5 0.9 1.7 Vomiting 6.5 3.5 0.4 Add-on to Metformin + Rosiglitazone ® Placebo + Metformin + Rosiglitazone All Victoza + Metformin + Rosiglitazone N = 355 N = 175 (%) (%) Adverse Reaction Nausea 34.6 8.6 Diarrhea 14.1 6.3 Vomiting 12.4 2.9 Headache 8.2 4.6 Constipation 5.1 1.1 Table 3: Adverse Reactions reported in ≥5% of Victoza®-treated patients in a 26-Week Open-Label Trial versus Exenatide Exenatide 10 mcg twice daily + Victoza® 1.8 mg once daily + metformin and/or sulfonylurea metformin and/or sulfonylurea N = 232 N = 235 (%) (%) Adverse Reaction Nausea 25.5 28.0 Diarrhea 12.3 12.1 Headache 8.9 10.3 Dyspepsia 8.9 4.7 Vomiting 6.0 9.9 Constipation 5.1 2.6 Table 4: Adverse Reactions in ≥5% of Victoza®-treated patients in a 26-Week Open-Label Trial versus Sitagliptin All Victoza® + metformin Sitagliptin 100 mg/day + N = 439 metformin N = 219 (%) (%) Adverse Reaction Nausea 23.9 4.6 Headache 10.3 10.0 Diarrhea 9.3 4.6 Vomiting 8.7 4.1 Immunogenicity: Consistent with the potentially immunogenic properties of protein and peptide pharmaceuticals, patients treated with Victoza® may develop anti-liraglutide antibodies. Approximately 50-70% of Victoza®-treated patients in the five double-blind clinical trials of 26 weeks duration or longer were tested for the presence of anti-liraglutide antibodies at the end of treatment. Low titers (concentrations not requiring dilution of serum) of anti-liraglutide antibodies were detected in 8.6% of these Victoza®-treated patients. Sampling was not performed uniformly across all patients in the clinical trials, and this may have resulted in an underestimate of the actual percentage of patients who developed antibodies. Cross-reacting antiliraglutide antibodies to native glucagon-like peptide-1 (GLP-1) occurred in 6.9% of the Victoza®-treated patients in the double-blind 52-week monotherapy trial and in 4.8% of the Victoza®-treated patients in the double-blind 26-week add-on combination therapy trials. These cross-reacting antibodies were not tested
®
Victoza —a force for change in type 2 diabetes. A change with powerful, long-lasting benefits
Reductions up to -1.1%a
Weight loss up to 5.5 lba,b
Low rate of hypoglycemiac
1.8 mg dose when used alone for 52 weeks. Victoza® is not indicated for the management of obesity. Weight change was a secondary end point in clinical trials. c In the 8 clinical trials of at least 26 weeks’ duration, hypoglycemia requiring the assistance of another person for treatment occurred in 11 Victoza®-treated patients. a
b
A 52-week, double-blind, double-dummy, active-controlled, parallel-group, multicenter study. Patients with type 2 diabetes (N=745) were randomized to receive once-daily Victoza® 1.2 mg (n=251), Victoza® 1.8 mg (n=246), or glimepiride 8 mg (n=248). The primary outcome was change in A1C after 52 weeks.
The change begins at VictozaPro.com. Indications and Usage
Victoza (liraglutide [rDNA origin] injection) is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Because of the uncertain relevance of the rodent thyroid C-cell tumor findings to humans, prescribe Victoza® only to patients for whom the potential benefits are considered to outweigh the potential risk. Victoza® is not recommended as firstline therapy for patients who have inadequate glycemic control on diet and exercise. Based on spontaneous postmarketing reports, acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victoza®. Victoza® has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for pancreatitis while using Victoza®. Other antidiabetic therapies should be considered in patients with a history of pancreatitis. Victoza® is not a substitute for insulin. Victoza® should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis, as it would not be effective in these settings. Victoza® has not been studied in combination with prandial insulin. ®
Important Safety Information
Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice. It is unknown whether Victoza® causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as human relevance could not be ruled out by clinical or nonclinical studies. Victoza® is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Based on the findings in rodents, monitoring with serum calcitonin or thyroid ultrasound was performed during clinical trials, but this may have increased the number of unnecessary thyroid surgeries. It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate human risk of thyroid C-cell tumors. Patients should be counseled regarding the risk and symptoms of thyroid tumors. Do not use in patients with a prior serious hypersensitivity reaction to Victoza® or to any of the product components. Postmarketing reports, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis. Discontinue promptly if pancreatitis is suspected. Do not restart if Victoza® is a registered trademark of Novo Nordisk A/S. © 2013 Novo Nordisk All rights reserved.
pancreatitis is confirmed. Consider other antidiabetic therapies in patients with a history of pancreatitis. When Victoza® is used with an insulin secretagogue (e.g. a sulfonylurea) or insulin serious hypoglycemia can occur. Consider lowering the dose of the insulin secretagogue or insulin to reduce the risk of hypoglycemia. Renal impairment has been reported postmarketing, usually in association with nausea, vomiting, diarrhea, or dehydration which may sometimes require hemodialysis. Use caution when initiating or escalating doses of Victoza® in patients with renal impairment. Serious hypersensitivity reactions (e.g. anaphylaxis and angioedema) have been reported during postmarketing use of Victoza®. If symptoms of hypersensitivity reactions occur, patients must stop taking Victoza® and seek medical advice promptly. There have been no studies establishing conclusive evidence of macrovascular risk reduction with Victoza® or any other antidiabetic drug. The most common adverse reactions, reported in ≥5% of patients treated with Victoza® and more commonly than in patients treated with placebo, are headache, nausea, diarrhea, dyspepsia, constipation and anti-liraglutide antibody formation. Immunogenicity-related events, including urticaria, were more common among Victoza®-treated patients (0.8%) than among comparator-treated patients (0.4%) in clinical trials. Victoza® has not been studied in type 2 diabetes patients below 18 years of age and is not recommended for use in pediatric patients. There is limited data in patients with renal or hepatic impairment. In a 52-week monotherapy study (n=745) with a 52-week extension, the adverse reactions reported in ≥ 5% of patients treated with Victoza® 1.8 mg, Victoza® 1.2 mg, or glimepiride were constipation (11.8%, 8.4%, and 4.8%), diarrhea (19.5%, 17.5%, and 9.3%), flatulence (5.3%, 1.6%, and 2.0%), nausea (30.5%, 28.7%, and 8.5%), vomiting (10.2%, 13.1%, and 4.0%), fatigue (5.3%, 3.2%, and 3.6%), bronchitis (3.7%, 6.0%, and 4.4%), influenza (11.0%, 9.2%, and 8.5%), nasopharyngitis (6.5%, 9.2%, and 7.3%), sinusitis (7.3%, 8.4%, and 7.3%), upper respiratory tract infection (13.4%, 14.3%, and 8.9%), urinary tract infection (6.1%, 10.4%, and 5.2%), arthralgia (2.4%, 4.4%, and 6.0%), back pain (7.3%, 7.2%, and 6.9%), pain in extremity (6.1%, 3.6%, and 3.2%), dizziness (7.7%, 5.2%, and 5.2%), headache (7.3%, 11.2%, and 9.3%), depression (5.7%, 3.2%, and 2.0%), cough (5.7%, 2.0%, and 4.4%), and hypertension (4.5%, 5.6%, and 6.9%). Please see brief summary of Prescribing Information on adjacent page. 1013-00018617-1
December 2013