Your Guide to Consumer Information March 2017
Vol. 15 No. 3
CMV and your baby By Taryn McEvoy, MD, and Kristin Smith, MPH
Varicose veins By Primepares G. Pal, MD, FACP, RPVI, and Jacqueline S. Pal, CNP, RPhS
Bariatric surgery By Guilford G. Hartley, MD
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Opportunity Partners: Empowering people with disabilities Armando Camacho, MEd
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Medical cannabis Tom Arneson, MD, MPH
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CMV and your baby: What moms-to-be need to know By Taryn McEvoy, MD, and Kristin Smith, MPH
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Diagnosing and treating brain tumors: The advancing role of neuro-oncology By Emil Lou, MD, PhD, and Elizabeth Neil, MD
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Bariatric surgery: Addressing the impact of overweight By Guilford G. Hartley, MD
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Value-Based Reimbursement: A new way to pay for health care
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Varicose veins: Advancements in treatment By Primepares G. Pal, MD, FACP, RPVI, and Jacqueline S. Pal, CNP, RPhS
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MARCH 2017 MINNESOTA HEALTH CARE NEWS
Return to Community Initiative Recognized Minnesota’s Return to Community program has been recognized by the Ash Center for Democratic Governance and Innovation at Harvard University’s John F. Kennedy School of Government as part of the 2017 Bright Ideas in Government Initiative. The initiative highlights and promotes creative government initiatives and partnerships with the idea that other government leaders, public servants, and individuals can learn about noteworthy ideas and potentially adopt those initiatives in their own communities.
30 days, while the remaining 30 percent end up staying and spending up to $180 per day for care. Reducing how long they stay in nursing homes saves money for both them and the public, as once residents deplete personal assets they become eligible for Medical Assistance, which is funded by the state. The program was developed in collaboration with the nursing home industry and policy staff. It begins by generating a list of candidates. Then assessments are made, discharge plans are completed, and services are arranged for patients, including a five-year follow-up period for each patient once they return home.
The Minnesota Board on Aging and the Department of Human Services (DHS) launched the Return to Community program in 2010. Since its inception, it has helped more than 4,000 older Minnesotans return to their homes after a stay in a nursing home.
“Return to Community honors the wish most older adults have to remain in their home for as long as possible,” said Emily Piper, DHS commissioner. “After injuries or illness, it can be challenging to make that happen but Senior LinkAge comAccording to DHS, 70 percent of munity living specialists throughout Minnesotans admitted to a nursing Minnesota help older adults and their home for rehabilitation leave within families get the resources they need
MINNESOTA HEALTH CARE NEWS MARCH 2017
to stay home. This not only helps a significant increase from the 85,000 families but is good for taxpayers.” enrollees last year. About 47 percent Return to Community is one of 70 programs that were recognized from more than 500 nominations. “These programs demonstrate that there are no prerequisites for doing the good work of governing,” said Stephen Goldsmith, director of the Innovations
of the private plan enrollees are new to the health exchange. An estimated 64 percent of all enrollees are receiving tax credits, which average about $621 per month or $7,457 per year. Minnesota also set a record for public program enrollments. A total of
in American Government Program 147,880 Minnesotans enrolled in public at the Ash Center. “Small towns and programs, with 33,369 newly enrolled
massive cities, huge federal agencies in MinnesotaCare and 114,511 newly and local school districts, large bud- enrolled in Medical Assistance. gets or no budgets at all—what makes
“We are enrolling people at his-
government work best is the drive to
torically high levels,” said Allison
do better, and this group proves that O’Toole, MNsure CEO. drive can be found anywhere.”
Despite MNsure’s significant enrollment increase, the overall individ-
MNsure Enrollment Up, Individual Health Plan Enrollment Down
ual health care market in Minnesota
A total of 117,654 Minnesotans enrolled in individual health insurance plans through MNsure during the 2017 open enrollment period and one-week special enrollment period,
A preliminary analysis released Feb.
has seen an overall decline of about 30 percent, according to data from the Minnesota Council of Health Plans. 9 shows that no more than 190,000 Minnesotans are buying individual market coverage for 2017, compared to about 270,000 last March.
“MNsure is getting a bigger share of a smaller pie,” said Jim Schowalter, president of the Minnesota Council of Health Plans, in a press release. “While it’s great that more people are getting help from the federal and state governments to pay their monthly premiums, the fact that so few people have signed up is alarming. The bad news is that fewer people will be helping to pay for really high medical bills. In the past about 5,300 people (1.6 percent of those who bought health insurance on their own) needed medical care totaling $630 million. I’m concerned that fewer people paying premiums will mean more problems in the future.”
Chemotherapy Increases Risk of Kidney Damage in Breast Cancer Patients A new study from the University of Minnesota School of Public Health shows that side effects from chemotherapy could cause kidney damage in elderly breast cancer patients. This is one of the first population-based studies to examine the relationship between acute kidney injury and chemotherapy. Shuling Li, PhD, who conducted the research as part of her dissertation, analyzed two groups of women ages 66 through 89 who were diagnosed with stages I-III breast cancer between 1992 and 2007. The first group included 14,000 chemotherapy patients and the second group included 14,000 non-chemotherapy patients. She found that 110 of the chemotherapy patients had been hospitalized with acute kidney injur y, compared to 30 in the non-chemotherapy patient group. Li says there are two possible explanations for the association between chemotherapy and acute kidney injury. The first is that people who are treated with chemotherapy have a higher risk for infections and febrile neutropenia, a white blood cell illness. Those infections can advance into the body’s tissues and
damage kidneys. The second is that patients treated with chemotherapy often suffer from nausea, vomiting, and diarrhea, which can eventually cause dehydration and damage the kidneys.
Smoking Causes 6,000 Deaths, Costs $3 Billion Each Year Blue Cross and Blue Shield of Minnesota has released a new report showing that smoking is responsible for 6,312 deaths and $3.19 billion in excess medical costs each year in Minnesota. The report, called “Health Care Costs and Smoking in Minnesota,” showed that while Minnesota’s smoking rate is at a historic low, there are populations that continue to smoke at disproportionately higher rates and that they are more frequently targeted by the tobacco industry’s marketing. Results show that low-income residents have significantly higher rates of smoking and smoking-related illnesses than the general population; people suffering from mental health issues smoke at nearly twice the rate of the general population; and 59 percent of American Indians in Minnesota smoke, along with 24 percent of Somalis, compared to 14 percent of all Minnesota adults. Minnesotans for a Smoke-Free Generation, a coalition of 50 organizations working to prevent youth smoking, responded to the report. “We all know the emotional and physical toll that smoking has on citizens of our state,” said Molly Moilanen, director of public affairs at ClearWay Minnesota and co-chair of the coalition. “Now we know the dollars and cents cost of tobacco use to Minnesota employers, taxpayers and citizens—billions of dollars spent combating diseases such as cancer and emphysema.”
News to page 6
MARCH 2017 MINNESOTA HEALTH CARE NEWS
News from page 5
St. Francis’ growth reflects growth within the community. Shakopee’s population has increased by 93 percent since 2000 and is expected to continue growing. Part of that growth is due to Amazon and Shutterfly locations that have brought more than 7,000 jobs to the community since 2012. The medical center has seen a 30 percent increase in patient volume between 2015 and 2016 and the number of surgeries it performs each year continues to rise.
collaboration between Children’s The new program will primarMinnesota and Allina Health, has ily focus on treating spina bifida in added open fetal surgery to its fetal fetuses. There is no cure for spina care program. bifida, however research has shown The procedure entails exposing that surgery while a baby is in-utero the fetus in the womb and partially can have significantly better results removing the fetus to allow for cor- than traditional postnatal repair, rerective surgeries. Once the procedure sulting in better cognition and motor is complete, the fetus is returned to development with improved rate of the womb to continue gestating until unassisted ambulation.
Renovations for the $1.5 million facility began early last year. It includes four large exam rooms, a St. Francis Regional Medical room for minor procedures, an X-ray Center has opened a new urgent care room, and a full lab so test results clinic location in Shakopee’s Southmay be completed onsite. bridge Crossings retail area. It will be staffed primarily with physicians who will have access to services at Midwest Fetal Care the main St. Francis hospital, which Center Launches Open is located about five miles away. They expect to serve between 10,000 Fetal Surgery Program and 12,000 patients in the clinic’s The Michael and Ann Ciresi first year. Midwest Fetal Care Center, a
“Open fetal surgery enables us minimally invasive techniques,” said to potentially save the life of the Brad Feltis, MD, PhD, surgery direcfetus or provide long-term health tor and pediatric surgeon at Midwest
“It’s more important than ever to take common sense steps to keep kids from smoking,” said Janelle Waldock, vice president of community health and health equity at Blue Cross. “Raising the tobacco age to 21 and restricting access to kid-friendly flavored tobacco products would reduce health care costs and mean a healthier future for our state.”
St. Francis Opens New Urgent Care Facility
MINNESOTA HEALTH CARE NEWS MARCH 2017
birth. Midwest Fetal Care Center is “We’re working to advance prenow one of fewer than a dozen cen- natal diagnosis and therapy so that in ters in the U.S. to perform open fetal the very near future we will routinely surgery. treat spina bifida in the womb using
benefits that couldn’t be achieved if we waited until after the baby was
Fetal Care Center.
A multi-disciplinary team at
born,” said Joseph Lillegard, MD, Midwest Fetal Care Center will dePhD, pediatric surgeon and research
termine if a patient is a candidate
director at the Midwest Fetal Care
for the surgery. If they are, and the
Center. “This capability allows our family chooses to proceed, a team of center to fulfill an unmet need for
specialists including fetal surgeons,
expecting families in the region and neurosurgeons, and maternal fetal keeps families close to home for care,
medicine specialists, work together
to perform the surgery.
PEOPLE SUSAN WINSLOW, MA, MSW, LICSW, a clinical social worker and therapist, has joined Choices Psychotherapy. Winslow has been in practice for over 25 years and provided leadership in nonprofit social service agencies for over 15 years. She received training in psychodynamic therapy, mindfulness, dialectical behavior therapy, motivational interviewing, and cognitive behavioral strategies. She has a special interest in mindfulness, chemical health problems, women’s issues, career coaching, and gay, lesbian, bisexual, and transgender concerns and has experience working with people to address depression, anxiety, trauma and abuse, spirituality, grief and loss, schizophrenia, work/career issues, major life transitions, and medical problems. Winslow sees patients at Choices Psychotherapy’s St. Louis Park location.
BENJAMIN MUELLER, MD, PHD, an orthopedic surgeon, has joined Twin Cities Spine Center. Mueller sees both adult and pediatric patients for cervical, thoracic, and lumbar spine conditions. His is fluent in English and German and has special interests in scoliosis, spondylolisthesis, stenosis, tumors, and disc replacement. He sees patients in clinic at St. Paul, Vadnais Heights, and Burnsville. Mueller earned his medical degree at the University of Minnesota, where he also completed his orthopedic surgery residency. He went on to complete a Spine Surgery Fellowship at the Leatherman Spine Center in Louisville, Ky., and has been actively practicing since 2012.
KEN KEPHART, MD, primary care physician/ geriatrician at Fairview Health Systems, has received the First a Physician Award from Twin Cities Medical Society. The award recognizes physicians for effective leadership, involvement in improving the public health, policy and/or legislative advocacy resulting in a positive impact on the practice of medicine or a healthier community. Kephart is a past president of the Twin Cities Medical Society and currently serves as medical director of Honoring Choices Minnesota. He earned his medical degree at the University of Minnesota.
KAYE MICKELSON, MD, has joined Clinic Sofia, an OBGYN clinic with offices in Edina and Maple Grove. Mickelson has more than 20 years of OBGYN experience, including training in advanced laparoscopic gynecologic surgery as well as medical and surgical treatment of menopausal symptoms. Her interests include treatment of endometriosis, diagnosis and treatment of abnormal uterine bleeding, menopause, and diagnosis and treatment of PCOS (polycystic ovary syndrome). She earned her medical degree at the University of Hawaii’s John A. Burns School of Medicine and completed her residency at the University of Minnesota.
MARCH 2017 MINNESOTA HEALTH CARE NEWS
Opportunity Partners Empowering people with disabilities
ym members smile at the attendant as they enter the fitness center. White towel in hand, Alyssa busily wipes down treadmills with determination, occasionally making small talk with visitors but never letting chitchat interfere with her work. She’s a go-getter whose manager at Williston Fitness Center in Minnetonka appreciates her hard work and friendly demeanor. Alyssa happens to have Down syndrome.
Boosting success Armando Camacho, MEd Opportunity Partners Mr. Camacho is president and CEO of Opportunity Partners, a nonprofit disability organization with annual revenues of $36 million and a staff of 600 that helps advance the quality of life for 2,000 people with disabilities each year. Prior to joining Opportunity Partners, Armando served as president of Neighborhood House, where he led a strategic redesign of programs and expanded core programming, as a district administrator for the St. Paul Public School District, and as a principal for the Minneapolis Public School District.
Opportunity Partners, a Twin Cities area nonprofit organization, each year helps more than 2,000 people with disabilities—like Alyssa—succeed on the job, live more independently, and lead lives filled with purpose and meaning. Founded in 1953 by parents of teenage children with disabilities, Opportunity Partners has always focused on the abilities of people. Back when many people with disabilities were institutionalized, it developed work programs enabling young adults with disabilities to be productive, become part of the community, and feel the pride of earning a paycheck. The organization serves about 1,000 people in its day services programs, 500 people through the State of Minnesota’s Vocational Rehabilitation program, 400 people in its residential programs, and 165 people in its brain injury programs. The types of disabilities vary widely and include Down syndrome, Autism Spectrum Disorder, cerebral palsy, visual and hearing impairments, brain injuries, and mental illness.
Employment services Opportunity Partners was founded under the premise that people with disabilities have much to offer as dedicated, hard working employees, and that communities benefit when people of all abilities are more fully integrated into society. Originally called Opportunity Workshop, the organization renamed itself Opportunity Partners to more accurately describe its partnerships with the community and with businesses. Today, the organization provides a wide range of employment skills training programs, job placement and ongoing job coaching, disability awareness training for businesses, and much more. To help match interests and skills with business needs, Opportunity Partners collaborates with Dunwoody Workforce Training & Continuing Education to provide Certified Learning Platforms in the areas of computer network support and professional cleaning. Working with Walgreens’ nationwide Retail Employees with Disabilities Initiative (REDI), Opportunity Partners guides in-store trainees as they master everything from stocking to operating a cash register. Opportunity Partners’ 2015 REDI graduates have outstanding success rates, with 71 percent going on to get retail jobs.
Partnerships with business
Opportunity Partners also provides business services and workforce solutions to its business partners, creating meaningful and community inclusive work opportunities for people with disabilities. The organization partners
MINNESOTA HEALTH CARE NEWS MARCH 2017
with companies to offer three broad types of employment opportunities for individuals with disabilities: • Production services at its centers, including packaging, assembly, and kitting. One of its oldest customers—dating back 50 years—is Coghlan’s, a Canadian-based outdoor accessories company. • On-site services at businesses, including mailroom, food service, document imaging, stocking, and custodial/ professional cleanings. Typically, a team of individuals with disabilities works at the business location alongside an Opportunity Partners instructor who provides training and support. • Direct hires at Twin Cities companies. Working oneon-one with individuals, Opportunity Partners placed 145 people with disabilities at competitive, community jobs in 2015, and that number is expected to climb. Opportunity Partners supports nationwide movements to more fully integrate people with disabilities into the community in all areas of their lives, including employment. The organization is enhancing its community job placement efforts while continuing to advocate for employment choices for individuals.
Communities benefit when people of all abilities are more fully integrated into society. Residential services Whether it’s at an individual’s home or in one of the organization’s 19 group homes, Opportunity Partners’ residential services help people build networks with friends, enhance their well-being, and become part of the community. Services range from a few hours of support each week in an individual’s home to 24-hour support in a residential group home. Opportunity Partners also offers a program under which individuals live in their own apartment with ongoing staff support as needed.
Advocacy efforts Legislative advocacy is important to all organizations serving people with disabilities. Five years ago, Opportunity Partners launched its Committee of Advocacy & Leadership (COAL) to ignite in everyone the power of advocacy. COAL currently has 50-plus members with disabilities, who meet regularly with staff allies to identify important issues and to get involved. COAL members have written letters to lawmakers and rallied at the Minnesota State Capitol about important disability issues. Through legislative advocacy, Opportunity Partners provides the tools and support for people with disabilities to build themselves up; this, in turn, can create positive change in our communities. In 2015, Opportunity Partners received top honors in the Advocacy category in the nonprofit Mission & Excellence awards from the Minnesota Council of Nonprofits and MAP for Nonprofits.
Learn more For more information about programs and services, or how to get involved as a business partner, donor, or volunteer, visit www.opportunities.org.
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. Thatâ€™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. ÂŠ 2015 The Evangelical Lutheran Good Samaritan Society. All rights reserved. 15-G1553
MARCH 2017 MINNESOTA HEALTH CARE NEWS
Medical cannabis TOM ARNESON, MD, MPH, research manager at the Minnesota
Department of Health’s Office of Medical Cannabis, provides a clinical and research perspective to implementation of the state’s medical cannabis program. Board-certified in public health and general preventive medicine, he also oversees research on the program’s impact.
What does your work as the research manager of the Office of Medical Cannabis (OMC) entail? A distinctive part of Minnesota’s program is tracking what happens with enrollees, including what they purchase and what they and their certifying provider report as benefits and harms. I helped design how information is collected during program participation and my staff and I are now organizing and analyzing data from the first year of the program. I also summarize existing research literature and spend significant time doing presentations and communicating with clinicians.
Only certain conditions qualify for use of medical cannabis. Please tell us about those conditions. The law that set up the program defined nine qualifying medical conditions and gave the health commissioner authority to add more. The nine original conditions were cancer, glaucoma, HIV/AIDS, Tourette syndrome, amyotrophic lateral sclerosis (Lou Gehrig’s disease), seizures, severe and persistent muscle spasms, Crohn’s disease, and terminal illness. In late 2015 the commissioner added intractable pain, effective August 2016, and on December 1, 2016, he announced addition of posttraumatic stress disorder, effective August 2017. Each June and July citizens can submit petitions to add additional conditions.
Please discuss the process by which a patient can obtain medical cannabis. Patients should first talk to their health care providers, because the first step in enrollment is being certified by a physician, advanced practice registered nurse, or physician assistant as having a qualifying medical condition. After getting certified, the Office of Medical Cannabis contacts the patient, letting them know how to complete their application and pay the enrollment fee needed prior to approval. The patient needs to be approved for the program by the Office of Medical Cannabis before they can purchase medical cannabis.
Please share some success stories that you have seen in the brief time that your office has been open. Both patients and their certifying health care practitioners describe a high level of benefit for many. Survey findings for
MINNESOTA HEALTH CARE NEWS MARCH 2017
patients enrolled during the first three months are in a report now on the OMC web site. Much more detailed descriptions of the patients and their experiences will become available over the next six months. The impact has been dramatic—even life changing for some. I have heard some of these stories directly from patients and some have been featured in the press. Though these are sometimes derided as “anecdotes,” it is important to remember that for the patient and their family, the life improvement can have profound significance.
What are some of the common consumer misperceptions you have heard about the medical cannabis program? We continue to hear from people who have the incorrect belief the program allows them to grow their own cannabis plants, smoke cannabis, and purchase cannabis at a retail pharmacy. The program does not allow any of these three things. Patients sometimes contact the Office of Medical Cannabis hoping or expecting to get a list of health care practitioners willing to certify patients for the program. The privacy policies under which the program operates do not allow the Office to share such a list.
A growing number of states have legalized recreational use of marijuana. How could this impact medical cannabis programs? The four states that first had medical cannabis programs and then legalized recreational marijuana prior to November 2016 are finding it challenging to regulate both programs simultaneously. Both of the cannabis programs in these four states focus on similar smokeable and edible whole plant materials, but with different levels of taxation and different rules. Minnesota’s medical cannabis products are oils and liquids, not whole plant, and there is no state sales tax or other state taxes charged when these products are purchased. If Minnesota were to legalize recreational marijuana, the impact on the medical cannabis program would depend on the details of recreational marijuana taxation and rules.
What advice can you give to people who might benefit from medical cannabis but, for whatever reason, are afraid to try it? Given the current state of knowledge, use of medical cannabis products is admittedly something of an experiment for any individual person. An important consideration is how well existing treatments are managing symptoms and how disturbing the side effects of current treatments are. The case for trying medical cannabis is stronger if patients are dissatisfied with their current symptom control and side effects. photo credit: Greg Christensen
The concerns I hear voiced most often by people considering the program are side effects, cost, and stigma. Side effects are overwhelmingly mild to moderate in intensity and can often be avoided by starting at a low dose and increasing the dosage slowly. THC is the cannabinoid (cannabis chemical) most responsible for making people feel “high.” Patients wanting to avoid this could try products that emphasize a different cannabinoid, CBD, which does not make people high. Out-of-pocket costs for the medical cannabis products can be quite high, but most patients get a pretty good idea of how helpful medical cannabis products are for them within a few weeks. So, if they aren’t very helpful, a different product can be tried or use of the products can be discontinued. Unfortunately, some participants in the program report judgmental attitudes from others about participation in the program. This seems to be due to a residual reputation of marijuana as “something only bad people use.”
What’s been the most surprising thing you have run into so far in your work as research manager of the program?
How do you respond to those who fear that medical cannabis is a gateway to addiction and more powerful drugs?
What can you tell patients about what lies in the future for medical cannabis?
There is some epidemiologic and animal-model data suggesting that use of marijuana in adolescence could influence multiple addictive behaviors in adulthood. But there is another potential explanation for the observed pattern of adolescents using marijuana (or alcohol or tobacco) first, and then additional drugs later. It could be that people more susceptible to drug-taking behavior are more likely to start with marijuana (or alcohol or tobacco) because of its accessibility and that the subsequent social interactions with other drug users increases their likelihood to try additional drugs. Both explanations could have some truth to them.
Within the next decade or two I am quite sure there will be a whole category of “ECS modulators” used routinely in medical care—some with FDA approval. A portion of these will be extracted from the cannabis plant and some will be synthetic. In parallel to this, some patients will continue to prefer use of whole-plant cannabis for medical purposes. Organizations are now developing to test and certify cannabinoid and terpene content in dried whole plant material, as well as freedom from contamination. These could allow more certainty about the content and safety of whole plant preparations.
When I was in medical school we weren’t taught about the endocannabinoid system (ECS) because it hadn’t been discovered yet. The ECS is a complex set of receptors spread throughout the body and chemicals—similar to those found in the cannabis plant—that activate those receptors. The ECS helps regulate appetite, sleep, alertness, and pain, among other things. Since taking this position I have been surprised by the large scope of research that has been done in laboratories to learn more about the ECS. Clinical research—research on humans—to find ways to manipulate the ECS for therapy is also developing rapidly.
Certifying health care practitioners describe a high level of benefit for many.
MARCH 2017 MINNESOTA HEALTH CARE NEWS
CMV and your baby What moms-to-be need to know By Taryn McEvoy, MD, and Kristin Smith, MPH
ecent headlines have left many women and mothers-to-be concerned about the health risks that a common virus—one they may never have heard of—could present to their babies. While CMV, or cytomegalovirus, can produce serious complications in developing fetuses and newborns, the transmission rates are low, and there are several steps that women can take to reduce the risks. What Is CMV? Cytomegalovirus (cyto-megAH-low-virus) is one of the most
common viral infections in the U.S. More than half of all adults have been infected with CMV by age 40, and one in three children have CMV by age 5, according to the Centers for Disease Control and Prevention (CDC). CMV is part of the family of herpes viruses, which also includes chickenpox, mononucleosis, and herpes 1 and 2. If you are CMV seropositive—meaning that you have contracted CMV—the virus will stay dormant in your body for the rest of your life, usually without symptoms, unless your immune system is run down or compromised. “Primary CMV” refers to the first time you contract the virus and develop CMV antibodies. “Reactivation” means a recurrence (return) of symptoms from an old CMV infection. “Reinfection” means you have contracted a new CMV strain. Most healthy women with CMV don’t know they have it, because this virus often produces no symptoms. Other patients report flu-like symptoms that can include fever, fatigue, muscle aches, swollen lymph glands in the neck, and a sore throat. Some may experience symptoms similar to mononucleosis or hepatitis. Pregnant women who experience these types of symptoms should follow up with their health care provider. Transmission and risk Like other viruses in the herpes family, CMV is spread through contact with someone who has CMV and who transmits (shares) it through bodily fluids. These fluids include but are not limited to saliva, blood, urine, genital secretions during sex, and breast milk. While healthy people who contract CMV generally have little to worry about, transmission rates and potential complications are higher for some individuals, including: • People with compromised immune systems, including those with significant health concerns ranging from HIV to an invasive surgery • Babies who have a low weight at birth, who are born early (premature), or who are born with other health concerns that make them more vulnerable to infection
MINNESOTA HEALTH CARE NEWS MARCH 2017
• Babies in the womb (in utero), whose immune systems aren’t fully developed • Child care workers and others who work closely with children, as well as parents with one or more children Babies and CMV The good news is that most healthy infants who contract CMV—in the womb or following birth—are at low risk for symptoms and complications. However, it’s important to understand how CMV can be shared with babies, and to recognize acute and chronic symptoms in newborns and children. While transmission rates are estimated to be fairly low, there are several ways a pregnant woman or new mom who is seropositive for CMV can unknowingly share the virus with her baby. Perinatal CMV means the baby contracted the virus at birth or shortly thereafter from a mother who is seropositive. The exposure may occur via maternal secretions when the baby passes through the birth canal or during breastfeeding. CMV can affect the health of these children, but the most significant risks involve those who contract the virus before birth. Congenital CMV occurs when the mom-to-be shares the virus with her baby through the placenta, following a primary infection or a re-activation of the virus. One in 150 babies is born with congenital CMV, but only one in five of those will display symptoms at birth or face long-term health problems.
In newborns, a number of tests can detect congenital CMV up to the age of three weeks. Tests later than this do not appear to distinguish between perinatal exposure during delivery and congenital CMV.
Most healthy women with CMV don’t know they have it. Treatment While there is no cure for CMV, preventive vaccine research is well underway. Outside of encouraging a healthy lifestyle and good sleep habits, no treatment is generally recommended for healthy women who are CMV seropositive, pregnant or not. Those with compromised immune systems are usually prescribed an antiviral medication to help fight the virus. Babies with CMV are often treated with antiviral medications, and there is some evidence that these medicines can improve longterm developmental outcomes. We collaborate with pediatricians and other providers who care for babies to ensure coordinated communications and care for mother and child.
CMV and your baby to page 34
Some babies with congenital CMV appear very sick at birth and may experience a low birth weight, a small head (microcephaly), yellow eyes and skin (jaundice), a skin rash, and problems with internal organs, including the lungs, liver, and spleen. Well-baby checks are critical to detection. A small percentage of babies with congenital CMV appear healthy at birth but develop symptoms over time that may include musculoskeletal concerns such as coordination or weakness, hearing and vision loss, cognitive disabilities, seizures, and more. Parents should stay alert, ask questions, and voice concerns about CMV symptoms at post-partum appointments and well-baby checks. Diagnosis and screening Routine prenatal screening for CMV is not currently recommended in the U.S., due in part to the lack of treatment options or preventive vaccines. Research at the University of Minnesota is exploring best practices in screening newborns for CMV, so this may change in the future. For women who are symptomatic, our office uses serologic (blood) tests to detect CMV. Primary CMV may be suspected in women who show signs of hepatitis or mononucleosis but test negative for the viruses associated with those diseases. Ultrasound can also show indications of CMV in fetuses. The most common ultrasound finding of CMV is calcification in the brain’s ventricles, a network of four cavities that are filled with cerebrospinal fluid. Unfortunately, there is no treatment for CMV that has been proven to prevent fetal disease. MARCH 2017 MINNESOTA HEALTH CARE NEWS
Diagnosing and treating brain tumors The advancing role of neuro-oncology By Emil Lou, MD, PhD, and Elizabeth Neil, MD
ore than 23,000 Americans are diagnosed each year with malignant primary tumors of the brain and spinal cord, and 200,000—nearly ten times as many—are diagnosed annually with malignant secondary brain tumors that originated from cancers elsewhere in the body. Treating these challenging cases requires a multidisciplinary, team-based approach that might include neuro-oncologists (physicians with expertise in treating multiple forms of cancer and related complications), medical oncologists, neurosurgeons, neurologists, neuropathologists, and
radiation oncologists, as well as psychologists, physical therapists, and other specialists. Neuro-oncology has advanced significantly in recent years, with research initiatives already holding promise for better and more individualized treatment options. Defining terms Tumors are abnormal growths derived from normal cells and organs. Tumors can arise anywhere in the body, and may be benign (slow growing, non-cancerous) or malignant (aggressive, cancerous). Types of cancer are named for the organs or tissues where the tumors originated, although the cancer may later spread (metastasize) to other parts of the body. “Primary” brain tumors originate in the brain itself, and may be benign or malignant. “Secondary” brain tumors are formed when cancers from other sites metastasize to the brain. To determine whether a brain tumor is benign or malignant, neurosurgeons will perform a biopsy, or, if possible, attempt to remove as much of the growth as safely possible (a procedure known as maximal safe resection). A neuropathologist will then process and examine the specimen to determine whether the tumor cells are dividing, whether they are capable of invading the surrounding brain, and whether they display other prominent cellular and molecular features that indicate malignancy. If the biopsy does not show these signs of malignancy, the benign tumor may be best treated with surgery alone. “Benign” tumors should not be confused with “low grade” tumors. In general, low grade glial tumors are slow growing and following surgery, may not require immediate radiation and chemotherapy, which is indicated for malignant glial tumors. However, recurrence is likely with low grade tumors and at some point will require additional treatment. The other biopsy finding—malignancy—is what most of us mean when we say “brain tumor.” Malignant primary tumors often form in the brain’s glial (supportive) tissue. The most common and aggressive of these gliomas are called glioblastomas (GBMs).
MINNESOTA HEALTH CARE NEWS MARCH 2017
Gliomas almost never spread outside of the brain, but can move to different areas of the brain, the coverings of the brain, or even the spinal cord. As these brain tumors grow, they invade and displace normal brain tissue, often triggering persistent, severe headaches and other symptoms. Cancers from below the neck—most often, skin cancer (melanoma) and lung cancer—can spread through the bloodstream into the brain. These secondary brain tumors can cause symptoms similar to those of primary brain tumors, and can be just as concerning. Treatment recommendations for both primary and secondary brain tumors may include some combination of surgery, chemotherapy, and radiation. Neurologic symptoms Different areas of the brain control different functions. For example, one region of the brain is responsible for the movement of the left arm, another enables us to vocalize our thoughts, and still another gives us our unique personalities. Primary or secondary brain tumors can trigger symptoms related to these separate brain functions. For example, one patient may notice weakness in the left arm, another may have difficulty expressing words, and still another may start behaving out of character.
Treating these challenging cases requires a multidisciplinary, team-based approach.
recommended, including computerized tomography (CT) scans of the rest of the body, a lumbar puncture (spinal tap) to analyze cerebrospinal fluid, or surgery to remove more of the mass, if it is deemed safe to do so. Some benign forms of brain tumors may not require any of these tests, but rather can be monitored every few months with MRI scans. Treating brain tumors Treatment commonly involves three modalities: Surgery. While treatment plans typically start in the operating room, some tumors are not amenable to resection because they are located deep within or near parts of the brain and cannot be safely removed. For tumors that can be removed, there are still the risks associated with any surgery, as well as potential postoperative complications such as stroke or bleeding. After surgery, a combination of radiation and conventional chemotherapy is most commonly used, especially in primary or secondary brain tumors. Radiation therapy. Ongoing studies and clinical trials help us to determine the optimal form and means of delivering radiation therapy to treat brain tumors. For some patients, that may mean delivering a highly focused and intensive form of radiation using a “Gamma Knife” or other stereotactic radiosurgery approach. While not routinely used for initial treatment of GBMs, this approach Diagnosing and treating brain tumors to page 32
Tumors can also affect the brain’s nerve cells, which transmit the electrical impulses that allow us to voluntarily move, talk, feel, and think. As slow growing or aggressive brain tumors grow, the normal circuitry of these neurons can be disrupted, resulting in inadvertent firing of electric impulses—the very definition of a seizure. Advances in diagnosis Magnetic resonance imaging (MRI) is the first step in diagnosing a brain tumor. Advances in MRI and other technologies have made brain imaging more routine, and not just for patients suspected of having brain tumors. For example, it is not uncommon for a soccer player struck in the head during a game to have an MRI of the brain, even if she has no symptoms of brain injury. This increased imaging has helped us to diagnose a growing number of tumors in patients who displayed no apparent symptoms. If a tumor is suspected, a neurosurgeon will operate to confirm the diagnosis and determine whether the growth is benign or malignant. The patient should be evaluated by a neuro-oncologist or medical oncologist with expertise in treating brain tumors, as well as by a multidisciplinary team that will review the patient’s tumor pathology, brain imaging results, medical history, and neurological examination results, before determining the most appropriate next steps. Depending on the type of cancer (primary or secondary brain tumor, lymphoma, or others), additional work-up may be MARCH 2017 MINNESOTA HEALTH CARE NEWS
Bariatric surgery Addressing the impact of overweight By Guilford G. Hartley, MD
ore than half of all American adults have a significant problem with overweight, and are placing themselves at heightened risk of medical complications. For one in ten individuals, overweight is severe and has triggered enough medical problems to justify thinking about weight loss surgery. Problems and treatments Serious overweight often causes dangerous medical problems,
including diabetes mellitus, high cholesterol, high blood pressure, arthritis in the legs and back, and snoring with sleep apnea. While many people are aware of these problems, they may not know that severe overweight also increases the risk of certain kinds of cancer, such as cancer of the breasts, ovaries, and uterus. Some patients address overweight through combinations of diet, exercise, and medications, but these measures usually don’t work for the long term. A diet and exercise regimen helps some people to lose weight initially, but it almost never helps them keep it off. About 95 percent of those who lose weight on a diet and exercise program are back to their initial weight five years later. The U.S. Food and Drug Administration (FDA) has approved a number of medications to treat obesity, but they are not very effective, and it is not clear whether they are safe for long-term use. In addition, few insurance companies cover these medications, which can be very expensive. Significant overweight is almost always a long-term problem that requires more effective long-term treatments. Weight loss surgery is the safest and most effective treatment for severe obesity. Weight loss surgery can produce improvement in obesity-associated medical problems and, in some cases, can produce a complete remission of the problem. This is particularly important for people with diabetes mellitus type 2 (adult type diabetes), but is important for people with other problems as well. Weight loss surgery can also reduce the risk of developing cancer of the breasts, ovaries, and uterus, and can reduce the risk of death from these cancers. Most insurance covers weight loss surgery. The best candidates In our offices, we use body mass index (BMI)—a number reflecting the relationship between height and weight—to determine whether a person is overweight enough to justify surgery. Roughly speaking, men who are more than 100 pounds overweight or women who are more than 80 pounds overweight are likely candidates for weight loss surgery, but BMI is the more definitive guide. People with a BMI higher than 40 are candidates for weight loss surgery, even
MINNESOTA HEALTH CARE NEWS MARCH 2017
if they have none of the weight-related problems discussed above. People who do have weight-related problems would be considered candidates for surgery if they have a BMI of 35 or higher. (Assess your own BMI by consulting the chart at http://tinyurl.com/HCNBMI-Chart, or calculate it using an online tool such as the one at http://tinyurl.com/HCN-BMI-Calc). About 30 million Americans are overweight enough to consider weight loss surgery. Despite this, relatively few people (around 200,000) have weight loss surgery each year. Types of weight loss surgery There are four surgical procedures commonly performed in the U.S. to treat severe obesity. Most of these utilize laparoscopy, a minimally invasive approach that involves 4–5 separate halfinch incisions in the abdomen rather than a single long incision. Specialized surgical instruments are passed via tubes through these incisions, including a wand with a light and television camera at the end to guide the operation. Laparoscopy results in much quicker recovery after surgery and much less trouble with wound complications such as infection or hernia.
the diagnosis, about 75 percent of patients will have a complete remission of their diabetes and be diabetes-free 15 years later. It is not advisable for smokers to have Roux-en-Y gastric bypass because of the risk that smokers will develop ulcers at the new connection between the stomach and intestine. Vertical sleeve gastrectomy. This procedure has been done commonly in the U.S. for the last 5–10 years. Because of this shorter history, we have less experience with which to predict short- and long-term benefits and frequency of complications. Using laporascopy, surgeons make a long, curved cut along the length of the stomach, then disconnect and remove 80 percent of the organ. As with Roux-en-Y gastric bypass surgery, this limits the amount of food that can be eaten, making patients feel full on smaller portions. Bariatric surgery to page 19
The four procedures are: Roux-en-Y gastric bypass. Considered the gold standard by many bariatric surgeons, this procedure has been performed for some 50 years, a timeline that allows us to accurately assess shortand long-term benefits as well as the potential complications that it, like any other major surgery, can cause. The surgeon separates the stomach into two parts, one of which is formed into a small pouch holding just one ounce of food at a time. This pouch will be used as your “stomach” after the surgery. The rest of the stomach is sealed off but left in your body, never to receive food again. The surgeon also cuts the small intestine, below the stomach, and re-routes it into the shape of a Y.
Weight loss surgery is the safest and most effective treatment for severe obesity. In addition to limiting food intake, the procedure changes hormonal signals passing back and forth between the stomach, intestines, liver, pancreas, and brain, all of which regulate appetite and feelings of fullness. People going into surgery 100 pounds overweight can expect to lose about 60 pounds and keep this weight off for the long term, although some people lose more and some lose less. Some patients lose weight initially and then regain some or all of it. It is not clear why this happens to a small minority of people, but it is a reason for concern. Ordinarily, people spend just one night in the hospital after surgery. Roux-en-Y gastric bypass surgery is particularly effective for people with diabetes mellitus. If performed within one year after MARCH 2017 MINNESOTA HEALTH CARE NEWS
CALENDAR MULTIPLE SCLEROSIS AWARENESS MONTH Multiple Sclerosis (MS) is a disease of the central nervous system. More than 400,000 Americans are living with MS and an estimated 10,000 new cases are diagnosed in the U.S. each year, according to the Multiple Sclerosis Association of America. Most people diagnosed with MS are between the ages of 15 and 50. Women are more likely to be affected, as are people who are Caucasian, have a parent or sibling with MS, live in countries with temperate climates such as the U.S. and Canada, and have certain autoimmune diseases such as thyroid disease or type 1 diabetes. Symptoms vary widely from person to person and over the course of the disease, but may include visual problems such as prolonged double vision; numbness or weakness in limbs that occurs on one side of the body at a time; overwhelming fatigue; slurred speech; difficulty with balance and coordination; issues with bladder and bowel function; and various levels of impaired mobility. There is no known cause or cure for the disease, and researchers continue to search for answers. However, with the right treatment and wellness strategies, most people with MS live full and productive lives.
Multiple Sclerosis Support Group
The National Multiple Sclerosis Society hosts this free monthly support group for individuals living with the disease. Come connect with others, learn more about multiple sclerosis, and share ways to cope with the challenges you face. Additional dates and locations are available. Call Beth at (612) 790-0811 for more information. Saturday, March 18, 10:00–11:00 a.m., Kingsley Commons, 4550 Humboldt Ave. N., Minneapolis
Cancer Nutrition Education
Park Nicollet hosts this free class for individuals living with cancer and their friends and family. Come learn about nutrition and dietary recommendations, both during and after cancer treatment. Call (952) 993-5700 to register. Monday, March 20, 4:30–5:30 p.m., Park Nicollet Frauenshuh Cancer Center, Carlson Community Room, 3931 Louisiana Ave. S., St. Louis Park
Infertility Support Group
Monday, March 27, 7–9 p.m., Ridgedale Library, Room 172, 12601 Ridgedale Dr., Minnetonka
Dementia Caregiver Support
Monday, March 27, 6–8 p.m., Bethesda Hospital, 559 N. Capitol Blvd., St. Paul
Balancing Female Hormones
Fairview Health Services hosts this free communication group for stroke survivors, hosted by a speech-language pathologist. Come learn strategies and creative conversation in an accepting group. For more information, call (952) 924-5000.
Diabetes Support Group
HealthPartners hosts this free monthly support group for anyone affected by diabetes. Meetings are led by a certified diabetes educator who leads a talk on a specific topic and answers questions. Registration not required. Other dates and locations are available. For more information, call (651) 430-8715. Tuesday, April 4, 6–7 p.m., Stillwater Medical Group, Conference Room, 1500 Curve Crest Blvd., Stillwater
HealthEast hosts this twice-monthly support group for family and friends of a person with frontotemporal dementia to connect, ask questions, share concerns, and learn strategies for coping and caregiving. There is no cost and no registration is necessary. For more information, call Lynn at (651) 232-2202.
Stroke Survivor Communication Group
Monday, April 3, 12–1:30 p.m., Fairview Southdale Hospital, 6401 France Ave. S., Edina
RESOLVE: The National Infertility Association offers peer-led support groups for couples experiencing infertility to connect with one another, share their stories, and receive support from others going through similar experiences. Contact the group host, Teri, at teri. email@example.com before your first meeting.
Hearing Loss Support Group
Allina Health and the Hearing Loss Chapter of America host this free monthly support group for anyone who is hard of hearing. Come meet others in similar situations and gain insights from their experiences. For more information or to sign up, call Bob at (763) 537-7558. Saturday, April 15, 9:30 a.m.–12:00 p.m., Courage Kenny Rehabilitation Institute, 3915 Golden Valley Rd., Minneapolis
O’Keefe Matz Functional Health Clinic hosts this free class for women. Come learn how the symptoms from hormonal imbalance can affect you, how to alleviate symptoms such as depression, fatigue, weight gain, and insomnia, and what you can do to get back on track. For more information or to sign up, call (651) 292-8072.
Tuesday, March 28, 6:30–8:30 p.m., Carondelet Center, Room 102, 1890 Randolph Ave., St. Paul
Monday, April 17, 6–7:30 p.m., Brooklyn Park Library, 8500 W. Broadway Ave., Brooklyn Park
Finding Services for Seniors & Caregivers
Hennepin County Library and the Metropolitan Area Agency on Aging offer this free class for seniors and their caregivers and families. Come learn about resources in Minnesota to help you live and age well in the community. Call (612) 543-5669 to register.
America’s leading source of health information online 18
MINNESOTA HEALTH CARE NEWS MARCH 2017
Bariatric surgery from page 17
Using laporascopy, the surgeon wraps an inflatable band around the upper part of the stomach, connecting the device via a
Generally speaking, patients who have had vertical sleeve gastrectomy lose about 50 percent of their pre-surgery excess weight. People usually keep the weight off, but, as with gastric bypass, some patients regain weight. Ordinarily, people spend two nights in the hospital after this procedure. This procedure is particularly appropriate for smokers, since it does not present the risk of ulcers posed by Roux-en-Y gastric bypass surgery.
thin tube to a newly formed access port in the skin. After the patient
Biliopancreatic diversion with duodenal switch. This procedure is rarely done in the U.S. Because it produces more serious bad side effects, including problems with maintaining good nutrition, it is usually reserved for people who are most severely obeseâ€”for example, those who are more than 200 pounds overweight and have not been able to lose weight by any other means.
enough to cause death. Death from weight loss surgery occurs in
The procedure limits food intake by removing part of the stomach. In addition, it redirects food to bypass part of the small intestine, resulting in a lower absorption of calories. Adjustable gastric band placement. While very popular about 10 years ago, this procedure is not done very often now, for two principal reasons. Weight loss rates post-surgery have often been disappointing, and the artificial medical band device implanted in the body may malfunction at any time, from months to years after the surgery.
recovers from surgery, saline is injected into the inflatable gastric band, effectively reducing the size of the stomach and limiting food intake. All of these procedures are safe when weighed against the danger of severe obesity. As with any major abdominal surgery, complications may occur. It is rare, but complications can be severe fewer than 1 out of 200 patients. The bottom line Weight loss surgery is the safest, most effective treatment for severe obesity. It is recommended by primary care providers, endocrinologists, surgeons, and other specialists. It results in lower mortality (longer survival) and better quality of life than any other treatment for obesity, and it produces resolution or improvement in many obesity-related medical conditions.
Guilford G. Hartley, MD, an internist with the Hennepin Bariatric Center at Hennepin County Medical Center, is a member of the American College of Physicians, the American Society for Metabolic and Bariatric Surgery, and the Obesity Society.
MARCH 2017 MINNESOTA HEALTH CARE NEWS
MINNESOTA HEALTH CARE ROUNDTABLE
Value - Based Reimbursement
A new way to pay for health care Value-based reimbursement (VBR) is not a new idea, but solving the problems it poses, most significantly measuring quality in health care, has been very elusive. Addressing this problem, to date, has involved fine-tuning best practice guidelines, improving electronic health records, developing better data analytics, addressing diversification of care teams, adjusting for health care disparities, and many other related considerations. We are now at a significant crossroads in health care delivery— moving from paying for volume to paying for value—that will be tied to better outcomes and prevention. Today we will look at the steps that must be taken to make VBR deliver on its potential. Let’s start by defining what is meant by value-based reimbursement. MS. LAVALLEY: Value-based reimbursement is intended to incentivize physicians and care teams to deliver higher quality care at lower cost. It’s essentially a different way of contracting. Instead of a set fee schedule, physicians will be reimbursed for the care they deliver, based on both the quality and the cost of that care. Fee-for-service payments will start to decline, and other forms of payment—such as per-member, per-month [PMPM] payments; bonus payments; incentive
payments; and shared saving payments—will start to make up a larger contribution of the revenue for both physicians and health systems. MR. FLOTT: This new value-based reimbursement
environment challenges providers to examine everything they are doing. It has different meanings depending on the lens you look through. The patient is saying, “I want wellness if I get sick, I want you to make me better, I want that done in a respectful manner, and I want it to be affordable.” The employer providing a group plan is saying, “I want to have a relevant company, I want to retain the best employees possible, and I want to do it affordably.” Payers also have their own perspectives. MR. MELLOH: Value-based reimbursement is one example of a larger trend that is putting providers at financial risk for the delivery of care, the cost of care, and the quality of care. It is one example of a larger industry trend that is influencing activity in the marketplace.
because the patients have one perspective of what “value-based” means, while providers and insurers have another. If we can reimburse providers for keeping their patients healthy and for doing a good job, as opposed to just reimbursing for the numbers of tests and procedures they do, then we are taking the right direction. MR. D’EMANUELE: It is a process; it is not an event. We are not going to be in a value-based purchasing world tomorrow. At this point, reimbursement from most payers, and certainly from Medicare, is around the margins of the current basic reimbursement system. In the physician world, there is a fee schedule, and value-based elements— cost, outcomes, population health, or use of EHRs [electronic health records]—will impact that by a few percentage points, rising to 9 percent in a few years. Where it goes after that, whether it gets to 25 or 30 percent, we will have to see. MS. SIMM: We are at the infancy in even defining
changing us from counting the number of widgets we put through the system to actually taking care of patients and doing so in a quality fashion. It really does matter whose perspective you take,
what “value” is in health care. I encourage both patients and physicians to be at the table to help us define this, because the devil is in the details. In Minnesota, there has been work done with some coalitions at the state level to define value. Hopefully this will push us even further.
LISA SIMM, MBA
ROSS D’EMANUELE, JD
Don focuses on the value of laboratory diagnostics and its impact on a patient’s total cost of care. Together with pathologists, scientists, and clinicians, he has developed data-driven methodologies for producing validated diagnostic clinical evidence that can drive out waste. He examines how laboratory diagnostic data will contribute to high-quality, effective personalized medical care with lower costs.
Lisa has served as a “Pathways to Excellence Committee” member with the Maine Health Management Coalition, a purchaser-led, multi-stakeholder partnership. Her risk management experience includes work in hospitals, outpatient settings, physician office practices, and long-term care settings. She manages a staff of risk management consultants in Coverys’ Boston office.
Ross is committed to translating a complex health care regulatory environment into practical and concrete advice for his clients in the health care provider, payer, and drug and medical device segments of the health care industry. His areas of expertise include health care fraud and abuse, Stark and anti-kickback laws, HIPAA, accountable care organizations, and valuebased reimbursement.
Mayo Medical Laboratories
DR. KLEEBERG: It is turning a battleship. It is
MINNESOTA HEALTH CARE NEWS MARCH 2017
Dorsey & Whitney, LLP
Value-based reimbursement, as driven by Medicare, includes three important acronyms, beginning with MACRA [Medicare Access and CHIP Reauthorization Act of 2015]. Let’s define MACRA’s two tracks: MIPS [Merit-Based Incentive Payment System] and APMs [Advanced Alternative Payment Models].
MIPS program track next year. There are a limited number of alternative payment models that are eligible under this program in 2017, but CMS has said it will expand models to encourage more physicians and groups to transition to alternative payment models. DR. KLEEBERG: At first we thought we were going
Medicare & Medicaid Services] payment program will encourage physicians to transition away from fee-for-service and into alternative payment models like ACOs [Accountable Care Organizations] or bundled payments. CMS responded to concerns that multiple quality programs were confusing and burdensome, so they introduced a new program. Unfortunately, it essentially just took three existing programs—meaningful use, physician quality reporting system, and valuebased payment modifier—then added another component. The new program still follows a feefor-service payment structure, but physicians or their groups are at risk for a penalty or eligible for a bonus based on a score of their use of EHR technology, submission of quality data, and practice improvement activities. CMS forecasts that a majority of physicians will go through the
to have to go into it full force as of January 1, but there are a couple of tracks that allow you to adapt more slowly. You can go into an alternative payment model and avoid the MIPS process if there is a dual-sided risk. The dual-sided risk had been prohibitive for independent practitioners and small practices that wanted to do an advanced alternative payment model, but with one new proposed rule, they are only going to be at risk for their portion of their Medicare payments. In 2018, under a proposed new ACO Track 1+ model, there is a possibility that some primary or smaller practices will want to be on dual risk. Right now most of them are still on Track 1, which means they also need to be in MIPS. Hopefully this will bring all of these programs together and make it coherent, and not squash independent practitioners that want to participate in alternative payment models.
PAUL KLEEBERG, MD
ALLISON LAVALLEY, MBA
DAVID MELLOH, JD
Paul is a regional medical director with Aledade, Inc., focused on enabling primary care providers to succeed in value-based payment systems and accountable care. Board-certified in family medicine, he has played key roles in EHR implementations in integrated delivery systems in small hospitals and clinics, and has represented the information technology needs of rural providers.
Allison is responsible for quality performance and value-based care delivered by athenahealth, setting the vision and priorities for future product development and for high quality, patient-centered care. She has also launched patient outreach programs focused on evidence-based chronic and preventive care, clinical data imports from other EHRs, and efficiency gains.
David advises hospitals and integrated delivery systems, physician group practices, surgery centers, and dental group practices. His background includes hospital-physician integrations and health system acquisitions, ACOs, clinically integrated networks, and other provider organizations designed to share economic risk and furnish high-quality health care services.
MS. LAVALLEY: The new CMS [Centers for
ABOUT THE ROUNDTABLE Minnesota Physician Publishing’s 46th Minnesota Health Care Roundtable focused on the topic of Value-Based Reimbursement: A new way to pay for health care. Six panelists and our moderator, Minnestoa Physician Publisher Mike Starnes, met on November 3, 2016 to discuss this topic. The next roundtable on April 20, 2017 will address Precision Medicine: A new approach to care.
Lindquist & Vennum, LLP
MARCH 2017 MINNESOTA HEALTH CARE NEWS
MINNESOTA HEALTH CARE ROUNDTABLE
MS. SIMM: One of the resources I use is CMS’s
Practice Transformation Networks. Their main purpose is to help individual physician office groups survive in this new payment model and to transform care in order to meet their new obligations. I use that and other resources on a weekly basis to touch base and learn solutions. We also partner with a company that helps organizations with bundled payments. MR. D’EMANUELE: This is a new Medicare payment
system, and it will have a big impact on physician reimbursement. There could be a reimbursement swing of up to 9 percent, depending on whether you perform well or poorly. Most physicians will be judged based on their data and reporting around four different categories—quality, clinical process improvement, use of EHRs, and resource use. The data will go into CMS in early 2018, and then they will tell you in 2019 what the impact is on your reimbursement. Your scoring in the quality category will be, I believe, 60 percent in the first year, and resource use that first year is 0 percent, but that will shift later to 30 percent of your total score. What that means is you are going to be judged with your peers on the cost and the resource use of treating patients. It will be an assessment based on claims data, not anything you report. CMS will come up with a score of how you treated a patient with a certain condition and what it cost the Medicare program, versus an analogous physician of an analogous specialty.
at the table to develop and to vet some good risk adjustment systems that take into account social determinates and genetic predispositions, which can be part of what predicts your medical outcome. What are the positive elements of value-based reimbursement? MR. FLOTT: Even in a closed practice like Mayo
that is 152 years old, we are seeing new clinician work groups develop. Along with other things such as bundled payments and accepting shared risk, this will ultimately benefit the patient.
This new value-based reimbursement environment challenges providers to examine everything they are doing. —Don Flott
MR. FLOTT: We now have access to big data sets that
MS. SIMM: Some risk adjustment systems have been around almost 30 years. They were developed by some of the best research institutions in the country, but they do not begin to encompass what we capture today in EHRs or on paper. Physicians need to be
so. When I started practicing health law, the distinction between payers and providers was very clear. Now payers are getting into the provider world, and some providers are taking risk. More and more payers are also providing care themselves. In a literal sense, the walls are breaking down. It is still to be answered whether value-based purchasing will actually work and the incentives will take hold and drive physician and other clinician behavior in the way it is intended. One of the challenges is that the different payers aren’t doing things that align with the same incentives. In some markets, you may only have Medicare moving in that direction, and in some markets it may be Medicare and a couple of the other payers. For some physician groups, a lower percentage of revenue is driven by value-based elements. Is it worth it for them to go to all the expense of doing this for any extra reimbursement they may get for just 20 or 30 percent of their business? MS. SIMM: Collaboration and communication
DR. KLEEBERG: That’s true even in the smaller
practice. If I am being reimbursed for value, I don’t have to do everything in my office. I can do some things remotely, and I can create more team-based care. So I’m not just paid to “treat and street,” but to keep patients healthy and to do prevention measures. Some of it is costly and harder up front, but because we can be focused more on health, we can be more efficient. Value-based care has the potential to move things in a positive direction, away from just building widgets or treating people that are crashing to actually keeping them healthy.
is aligned with protecting professional liability risk. When we look at claims throughout the nation, the major cause of poor outcomes in the diagnostic arena is miscommunication. Many are convinced that electronic solutions will get us there, but having seen what happened when all of the primary care physicians left the walls of the hospital, I remember thinking, “We’ve got to get them in here to talk to the specialist and the hospitalist,” because all of a sudden the communication was just a void. Collaboration improves the lines of communication.
MR. MELLOH: You mentioned the development
MS. LAVALLEY: I see an opportunity for improved
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Can value-based reimbursement break down barriers between providers and payers? MR. D’EMANUELE: It has the potential to do
How can we differentiate between expensive care being high quality or a waste of resources?
allow us to test our hypotheses of how we work up a patient, using diagnostics to determine whether it is best practice, and, potentially, driving out waste. Consider the explosion in genetic and genomic testing—an average increase of 20–25 percent per year when you include all the niche labs, with a single panel costing as much as $60,000. That may not be reimbursed, or there may be enormous deductibles or copays. Diagnostic medicine is evolving to play a significant role in this value-based journey.
of care teams, leveraging the time and expertise of providers in a way that is most efficient and is likely to drive lower resource use. What are the other implications? For example, we know that 5 percent of the patients drive 50 percent of the cost in the health system, but of those 5 percent of patients, 50 percent have some behavioral health issues. Does that mean that providers need to have an integrated model in which behavioral health providers, social workers, and psychologists are equipped to deliver care in tandem with other providers?
MINNESOTA HEALTH CARE NEWS MARCH 2017
collaboration between providers and payers. Payers are eager to get their hands on clinical data, and some payers are actually starting to mandate that physicians or groups submit clinical data along with claims data just to get reimbursed under feefor-service. Other payers are taking a slightly more passive route, saying, “We’ll give you a bonus payment if you submit some clinical data.” Right now, some payers are so anxious to get the data that they are sending patient assessment forms via fax, or they are asking you to log in and submit data via a portal or other means. That creates a vast amount of additional administrative work.
MR. FLOTT: Over the last five years, mergers
and acquisitions between health systems have become huge. The investments required to implement population health systems and other transformations is really expensive. It’s one thing to come together and put on a new name. Integration is a lot harder to do. It’s difficult for both organizations and physicians. I’ve got to keep one foot on the dock. I’ve got to keep an eye on the fee-for-service activity that allows us to conduct our mission. But I also have to stretch the leg over on the other side of the boat and find ways to innovate and find things to change.
What are some of the challenges that value-based reimbursement faces in becoming adapted? DR. KLEEBERG: Value-based care and value-based
payment, in the long run, are going to support the reason we went to medical school: to keep our patients healthy and happy. Under fee-for-service, especially when you’re working in a large integrated delivery system, your pressure is to move people through rapidly, and that takes a lot of the pleasure out of care. With value-based care, we will all have skin in the game, so I think the oversight will be easier. There is no intrinsic challenge in value-based care itself. The challenge is in the rules, the regulations, and all the steps you need to follow to demonstrate that what you’re doing is value-based. In the grand scheme, value-based care is going to work extremely well. It’s just going to be a painful transition process. MR. MELLOH: My impression is that the adoption
of value-based reimbursement is less difficult for primary care physicians than for a lot of specialists, whose practice has been oriented toward much more high-end fee-for-service work. I don’t mean to sound cynical about it, but they may be less inclined to gravitate toward a model in which they’re looking at the overall health of the patient as the outcome. MS. SIMM: We need more patient input. That
might mean a paper survey, right there in the office, to collect meaningful data up front. If I’m having my hip replaced, I may not expect to run any 5Ks or do any couch-to-5Ks. My sole hope may be to walk down the aisle, and if you do that for me, I will think you succeeded. We should have those conversations about shared outcomes up front, and then measure against that.
What challenges do fraud and abuse regulations based on the fee-for-service model and now switching to this value-based model present? MR. D’EMANUELE: Evolving reimbursement rules
present incentives for all the different providers to work together more carefully, to coordinate care, and to do things more efficiently. The problem is that the fraud and abuse rules are the same rules we’ve had for 25–30 years. Say I’m a post-acute care provider, and I want to give data to physicians about referral patients, or I want to give them access to an application or give them a license to an application that I bought so we can coordinate care better and prevent patients from being readmitted to the hospital. Is that data of value to a referral source—do I have to worry about paying a kickback to physicians? Is that license that I’ve given them to a paid application a problem under the kickback statutes? It isn’t always, but the fact that we have to ask those questions is emblematic of the problem. My approach is always that if we can justify and document that we’re doing this to take care of patients and to get to the right results in terms of reducing readmission or any other metric, then we should feel confident in proceeding. MR. MELLOH: Those barriers are much less significant
and prevalent in an integrated health system model where you have employed physicians. One of the implications of moving toward a value-based reimbursement model could be further consolidation of the industry so as to facilitate greater integration and sharing of data within a system.
A big part of success in value-based care is ensuring that patients actually participate in their own care. —David Melloh, JD
What are the most common misperceptions about value-based reimbursement? MR. D’EMANUELE: Reporting is difficult under the
new MIPS. From what I can tell, there are some 200 choices you can make. You have to report six or nine quality measures in order of magnitude, and you get to pick them from a wide array of quality measures. You have to pick some that are outcome oriented, and there are categories that limit your choices, but there are choices. It was meant to give flexibility to physicians so that they could make choices that are meaningful to their practice and, hopefully, are measures that they can do well on. And that’s just Medicare. Other commercial payers might ask for different things.
MS. LAVALLEY: When you hear “value-based
reimbursement,” you think that just the payment is changing, but there are two sides to the coin. First, how do you achieve better patient outcomes, higher quality, and lower cost? Second, how is the payer going to reimburse you, what are the actual mechanisms of payment types, and when are they going to come in? Do you get a payment and then have to pay something back at a later date? Sometimes we don’t talk enough about both sides. MR. FLOTT: I think the perception of value-based health care is in the eyes of the beholder. Many physicians, admittedly, may not understand what’s happening. I also think patients need to
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MINNESOTA HEALTH CARE ROUNDTABLE
be educated, because they’re going to be treated a little bit differently. I had a conversation with my 80-year-old mom last week. She went to the doctor and he did “nothing,” according to her. She complained about that. Her expectation was that something more would happen. Patients will need more education, as will health care systems. MS. SIMM: When I talk to the public about it,
they think it makes sense, that we should be paid for the value we bring. They may not know that it probably won’t work unless all patients are treated this way. If you’re paid based on patient outcomes, then you might not take care of patients who don’t stand much chance of having a good outcome. We have to face that fact, or else we’re never going to move beyond where we are. I don’t know whether the public understands that, in order to be effective, we need to take care of everybody. Otherwise it won’t work.
occurring or not. You have some who believe that it is occurring, and all of a sudden all of their reimbursement is going to be based on value. And that’s not true. The metaphor was made of one foot on the dock and one on the boat. To use another metaphor, we’re on the roller coaster, but we’ve just started up the hill. On the other hand, there are some folks who say that 90 percent of reimbursement will still be fee-for-service—that’s never going to change. I don’t think that’s true, either. It is going to happen, but we are still in the beginning stages of it.
DR. KLEEBERG: I’ve heard out in the field that this
is managed care all over again, and some of the doctors still have a bad taste about managed care. I also hear doctors saying, “The government is just trying to control what I do. They won’t let me practice medicine the way I want.” We should look at the desired outcomes from the patient perspective. Maybe that patient doesn’t have high expectations to do wonderful things, or maybe they know they have a significant illness and the outcome from their surgery is not going to be optimal, but it’s still what that patient wants. On the other hand, some patients have unrealistic expectations, and they expect that when they have their hip replaced they’re going to walk again when it’s never going to happen. MS. LAVALLEY: We struggle with staying current on CMS policy regarding what physicians and practices must do, versus implementing our work flows to adhere to the policy. We often underestimate how much change is actually needed. In addition to technology solutions, how will the people and the processes need to change? How do you balance all of those changes at once? How do you sequence them? How do you make sure that you’re staffed appropriately? How do you make sure that you’re investing in the right pieces of technology to make your staff more efficient? It can feel overwhelming. MR. D’EMANUELE: One misconception I hear
is about whether value-based purchasing is
Value-based care is going to work extremely well. It’s just going to be a painful transition process. —Paul Kleeberg, MD
How will we know that value-based reimbursement is actually working? DR. KLEEBERG: It’s not the immediate cost that we
should look at, it’s the long-term outcome. The care and the preventive things that we do won’t have an immediate benefit, but they will prevent costs down the line. The way ACOs were designed meant that you always had to save costs from one year to the next, and then when you redid your contract after three years, you were competing against yourself. I used to think that was almost like a Ponzi scheme. There’s a point where you’re not going to win. We have the opportunity to say, okay, we have patients with certain risk factors, but they’re winding up doing better than other
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MINNESOTA HEALTH CARE NEWS MARCH 2017
patients in the community, because we’re doing a better job. You have to believe in it, and the proof will occur later on. We’ve already discovered within our ACOs that if they do transitional care management, for every seven or eight patients, they avoid one rehospitalization. MR. FLOTT: With access to big data, we’re able to illustrate downstream costs using objective data. Say you’re a male, and the advertisements during football games convince you that you have low testosterone. There are two tests for testosterone, total and free. Often only the total is ordered, because the free yields a false-positive rate of about 25 percent. You get put on drug therapy for a problem you don’t have, and then you go back for more blood draws to determine if your drug levels are appropriate. That’s just one area. A lot of insurance companies and providers use what are called episode treatment groups to identify areas of reducing cost, and we are trying to develop laboratory tests that could validate the use of certain drugs for individual patients to improve care and lower the total cost.
Rewarding prevention and better outcomes requires a big up-front investment before health care costs become lower. How can this be communicated to those who condemn valuebased reimbursement? DR. KLEEBERG: We didn’t go into medicine to be
rich. We went into medicine because we believed it had value, and because we were altruistic. In the long run, value-based reimbursement will add value, because you will see what’s going on with your patients and be able to exchange information. This transition is very difficult, but you have to have faith that by doing these preventive measures, by taking good care of your patients as opposed to just treating them when they are sick or doing disaster intervention, you are going to have happier patients. MR. FLOTT: By late 2020, it is estimated that the cost for premiums and care could overcome many people’s income. That’s hitting some people already. The Best Buy Geek Squad came to my house to hook some stuff up recently, and the man, I think he was about 50, started talking to me about health care, saying, “My health care premium now is the same amount as my house payment, about $480 a month, with $6,500 outof-pocket.” So I asked him, “Well, what do you do
then?” He said, “I just don’t go to the doctor.” If we don’t find a way to reduce costs and provide access, health plans become just catastrophic insurance. People coming in for wellness and diabetes checks may head off some train wrecks, but if they can’t afford the follow-up, it doesn’t do much good.
Patients are not sure how to interpret bills, and they can easily move into debt. Their bill goes to a collection agency, and the next thing that happens—not at Mayo, but I know it happens—is you’re labeled as a patient to avoid.
MR. D’EMANUELE: This is a transition period,
measure not just individual patients, but also the population. If we took advantage of some of our public health information, we might be able to develop severity adjustment. I spent a number of years in a rural setting in Maine where there is incredible poverty—85 percent of our inpatient
and there are also challenges with risk adjustment and measurement. You might judge that it’s successful if, at some point, most of the clinicians come to the conclusion that the way this has been implemented is fairly reasonable, and that what they’re required to report and measure as part of their reimbursement is reasonable as well. Then you might be able to say it was successful.
MS. SIMM: Sometimes I think we should
What needs to be done to engage the physician in efforts to maximize the potential benefits of value-based reimbursement?
MR. MELLOH: If we can eliminate cost barriers to
the patient, can we also incentivize the patient to seek care, so we can intervene at an earlier stage and avoid the train wrecks? Dentistry has done a far better job than medicine in engaging patients and instilling in them the idea that they should be seeking care on a periodic basis so as to avoid outcomes that are far more expensive. A big part of success in value-based care is ensuring that patients actually participate in their own care. How can we measure social determinants of health and account for them in a value-based reimbursement equation? DR. KLEEBERG: Social determinants have a
issues or other needs that wouldn’t typically be addressed in the health care system. That company developed an analytics platform to assist with early interventions, providing tools to the patients to help them monitor their own health conditions. Each patient got an iPad to monitor certain vital signs and to transmit them back to the provider. The care team could then deal more effectively with the patient’s issues, providing care on an as-needed basis and sometimes treating patients in their own residence. The goal was to keep the patient out of the ER, deliver better care, and intervene at an earlier stage to avoid catastrophic outcomes.
MR. FLOTT: One of the challenges is the spectrum of patient age groups. My mother is on one end of the spectrum, and my son, at 26, is on the other end. They are going to engage and access care in very, very different ways. Traditionally, we have been slow to build those types of access points through eHealth, Mobile Health, and all of these types of things. We need to find ways to engage patients in the way they want to be engaged, where they want to be engaged, and under what circumstances they want to be engaged.
Clinicians have to be excited by the opportunity and the prospects, but sober and patient in facing the challenges.
MS. LAVALLEY: We need to engage physicians, too,
significant impact on health, but how do we measure them? We have practices in Mississippi, Maryland, and Delaware, but they’re very different environments and the patients have very different knowledge about health care and even perceptions about their own ability to manage their health. There are big differences when patients don’t have a job or an education. They could have the same disease as someone else, but their outcome is going to be very different. The FQHCs [Federally Qualified Health Centers] have a very different population. They are held to the same quality measures as a suburban practice, yet their outcomes are poorer, which means they get lower reimbursement, and that’s unfair.
book of business and 75 percent of the outpatient business was Medicare, Medicaid, or people who weren’t paying at all. If you don’t find a way to provide access to care for those patients, they’ll be in your ER, and everybody will be paying for it. We used to see an uptick during the holidays. You might think, “Oh, it’s because they’re eating poorly.” No, their young relatives came home and said, “Mom, you look horrible, you really need to be checked. We’re here and we’ll take you to the hospital.” That ER visit was a $7,000 check-up.
MR. FLOTT: Some of our databases are able to help us, on a county-level neighborhood basis, to very precisely identify the propensities of diseases and the socioeconomic issues, and to begin to design programs. I’d also like to mention bad debt.
MR. MELLOH: Some of my own recent experience is with a California-based entity that is attempting to crack the tough nuts—the 5 percent of the population that generates such a large part of the health care spend. A lot of these people have behavioral health
— Ross D’Emanuele, JD
and to provide help during the transition. The first thing is to help physicians understand the “why” behind some of these changes. Often there is just a lot of activity, a lot of change management. People are just told to do certain things, and the context gets lost along the way. DR. KLEEBERG: Maybe I’m an idealist, but I think
where their hearts are, their hands and minds will follow. Once they understand how this will help them practice medicine, then the work becomes easier. If you can convince the clinical leaders, other doctors will begin to follow. From the patient’s perspective, the value is to learn that they can take care of their own health. Some patients are accustomed to going into the emergency room to get their needs met immediately. They don’t recognize that there may be preventive reasons to see a physician. We need to change that. MS. SIMM: Physicians like to see data, and they want to see their own data benchmarked against other
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people’s data. If we want to engage them, we need to provide that data frequently. Also, I don’t think there are many professions left on Earth where you don’t work in a team. More physicians should have a voice at the table. I know that means taking time away from the practice, but if physicians can find a way to utilize the rest of the team at the top of their scope so that they can make decisions about what we will measure and make decisions about their own practice of medicine, I think they will be engaged. Can shared decision-making help engage the patient with value-based reimbursement, and how could that work?
MR. FLOTT: It starts at the top. Leadership has to be
committed and serious about making the necessary changes. Our CEO at Mayo, Dr. Noseworthy, stresses ongoing communication to staff and to employees. There are also changes regarding what you’re going to invest in, and which infrastructures you need to be successful. It’s more than just equipment and processes. Talent is also part of the changing infrastructure. MR. D’EMANUELE: The challenge is to demystify
this MIPS program and value-based reimbursement in general. If you focus on the CMS program and you have administrators and physician leadership
DR. KLEEBERG: If I, as a patient, have my heart
MS. LAVALLEY: It is going to be costly at first,
I see an opportunity for improved collaboration between providers and payers.
Is it possible that a financial incentive like lower premiums might get the patients more engaged?
—Allison LaValley, MBA
who can sift through the reporting and the types of quality measures that fit with the particular organization, you can help physicians understand how it is going to apply to them. Right now everyone thinks it’s an abstract, and it seems overwhelming. I think it is incumbent upon all organizations to break through that, make it more concrete, and set out an initial strategy. Part of that might be financial incentives to physicians who do certain things. None of us knows the perfect formula for motivating individuals. That is more art than science. MR. MELLOH: It will be incumbent on providers
to rethink the way in which care is delivered and to redesign that. We talked earlier about the team-
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especially if most of your contracts are still in a feefor-service world. It is tough to maintain a positive revenue stream, but CMS and some other payers are starting to offer fee-for-service reimbursements for things like chronic care management or transitional care management, and those are definitely the types of care delivery that you are going to need to be successful in an alternative payment mode. Another aspect of that is looking at the physicians in your practice and in your network and looking at your patient panels to determine, as you transition into an ACO or join an ACO, whether you have the right mix of staffing to take care of your patients and remain profitable. MR. FLOTT: Many payers measure a PMPM basis,
MS. SIMM: There is much more we can do to engage
What should health care organizations be doing right now to prepare for value-based reimbursement?
DR. KLEEBERG: The message really has to come from the top, but it also has to be very clear. For the whole system to turn to value-based care, even when it’s not 100 percent of your bottom line, you need to be dedicated to it, because it’s going to be costly in the beginning, just as it always is to do something new. Strong leadership can help people understand it and keep their eye on the prize.
What should health care leadership be doing to implement value-based reimbursement?
in my goal, I’m much more likely to achieve that goal. With shared decision-making, I’m treated as a person, I’m given the pros and cons, and I’m given the information to make my own decision, even if it’s not the decision that the doctor thinks I should make. A good example of shared decision-making would be women who have had breast cancer. All the doctors assumed that the women would want radical mastectomy, as opposed to just taking out the nodule, and most of the women actually did want radical mastectomy when they were given the choice. As providers, we need to not just give orders, but to be a teammate with our patient to develop goals. Shared decision-making puts the patient in the driver’s seat.
people. Employee health plans often incentivize employees to take advantage of access to care, to become more in command of their own health. There really is no other form of insurance out there where the person covered doesn’t have some skin in the game. If you have homeowners insurance, you can lower your premiums with smoke detectors and chimney inspections. It may sound radical, but part of me believes the insurer needs to have a little skin in the game, too, but I don’t know how you’d do that with populations of people that might struggle in any event.
based models of care, and I think that in order to effectively manage against the resource use and other aspects of value-based reimbursement, there will have to be a lot of effort put into rethinking and reshaping the way in which patients are seen and care is delivered.
MINNESOTA HEALTH CARE NEWS MARCH 2017
which I believe is $300 per patient. How do we use services to lower that overall PMPM? In many organizations, including Mayo, that’s a new type of vernacular and a new type of thinking. Every step of the way, we need to ask how we deal with these patients, and how we hand off in order to bring that value back on the commercial side. MS. LAVALLEY: A number of our practices go through
patient-centered medical home transformation and want to get recognized by a group like NCQA [National Committee for Quality Assurance]. There are creative solutions or lower cost ways to implement things. A great example is one of our clients, a small practice single physician, with a total staff of about five employees. They wanted to be able to provide after-hour patient access to
care, but doing so would be very costly. So they found three other physicians in their community who were interested in doing the same thing, and developed an after-hour triage. Health care is increasingly utilizing teams of medical professionals with different levels of training, often working in different locations for unrelated organizations, so how is value-based reimbursement going to be adjusted to compensate the right caregivers for providing the right care? DR. KLEEBERG: When primary care practices get
the savings, they divide it up among the small practices, based on a formula that they all agree to in their board meeting. Each practice gets a certain amount for the number of patients they see, the quality of their service, and their participation in ACO activities. But how it’s divvied up within the practice is totally up to the practice itself. In a multispecialty clinic, there could be issues with how it gets divvied up between the specialist and the primary care providers. That was also an issue when we figured out the fee-for-service payment scale, because there had been only one or two primary care providers on the fee scale board, and specialists wound up getting more money, but we now recognize that primary care really has more value when it comes to keeping people healthy. I don’t have a magic answer regarding how much a nurse practitioner or how much the front desk should get, either, but it should be equitable across the group, and the decisions have to come in advance, not when the check arrives. MS. SIMM: Every specialty has at least a couple of agenda items in the Choosing Wisely campaigns that patients need to be more educated about. Even in radiology, patients feel that there are some unnecessary tests. When we pulled together our specialists in a large provider group, they were serious about it, long before Choosing Wisely. Employees at health care institutions are some of the heaviest utilizers of medical services in the country. Some of their premiums can be astronomical. It’s hard for physicians to say “no” for an MRI to that group, because they work hand in hand with them. MR. MELLOH: The likelihood is that specialist’s
incomes will decline over time. Diagnostic testing has been a large contributor to a specialist’s income, and diagnostic testing, generally speaking, declines in a value-based model. It’s inevitable that the glory
days for radiology, cardiology, even orthopedics have likely come and gone. We’ll see a drop in income immediately and for the foreseeable future. MR. D’EMANUELE: I think that’s true, not only
for value-based purchasing, but for CMS. Payers are going after that and will continue to go after that, even if we didn’t have value-based purchasing on a number of different levels. A corollary is that some specialty groups are most eager to get into ACOs and to share the savings with hospitals. They replace the income, or at least part of the income, that they are losing on the ancillaries.
in its entirety immediately, but we must develop foundations to successfully execute it. There is time, 3–5 years, probably, before it becomes applicable in a meaningful, material, and financial way. MS. LAVALLEY: It’s really about whether we are able
to achieve better outcomes at a lower cost, and, if so, whether we are able to demonstrate that this transformation of care is possible. As we start to see more proof points, we will continue to demonstrate that there is potential, and that will help to create more momentum to change the rest of the industry. DR. KLEEBERG: It is critically important for us to
exchange data across different EHRs and to notify primary care providers when patients have been discharged from the hospital. We have large systems that are very good at communicating within themselves, and also pretty good at communicating with other providers that have the same EHR product, but we need true interoperability, where data can flow from one place to another and patient data goes where they go. Minnesota is so far ahead in many aspects of care, but we’re behind in terms of health information exchange, primarily because we’ve got larger systems. MR. D’EMANUELE: There are a lot of challenges,
and they are all important to success. To be successful, clinicians have to be excited by the opportunity and the prospects, but sober and patient in facing the challenges. In my law firm, if we have a new document or management system, my first instinct is, “I hate this.” You have to hit the desk twice before you understand the reason for the new, more efficient system, and then you get on with it.
More physicians should have a voice at the table [even though] that means taking time away from the practice. —Lisa Simm, MBA, CPHQ, CPPS, CPHRM
Let’s say that CMS can prove that value-based reimbursement saves money and improves care. How can we transpose the success onto health insurance plans in a way that is transparent and translates into lower premiums and higher provider reimbursements? MR. MELLOH: We need a foundation to deliver care that is both efficacious and cost effective. That means having appropriate data analytics, appropriate models of care delivery, and appropriate teams of providers. I don’t suggest that this is an easy process, but we do, of course, have time. We’ve acknowledged that MACRA is around the margins, and, by and large, we’re still in a fee-for-service world. This isn’t something that has to be tackled
MS. SIMM: The interoperability and the ability to
look at patients across the continuum is hugely important for this, and I think that physician leadership is hugely important. MR. FLOTT: We must keep the patient at the center. I’ve essentially grown up in an integrated system, and I’ve watched how integration works with family members, including myself. I couldn’t imagine any other way of delivering care where all the caregivers are working together on your behalf, and the information is available at your fingertips. There are systems around the country that are truly integrated beyond Mayo, and I think others are working very hard for that, but I think that is going to be one of the absolute keys.
Mayo Medical Laboratories MARCH 2017 MINNESOTA HEALTH CARE NEWS
VASCUL AR MEDICINE
Varicose veins Advancements in treatment By Primepares G. Pal, MD, FACP, RPVI, and Jacqueline S. Pal, CNP, RPhS
n estimated 30 percent of Americans will develop varicose veins at some point in their lives. The condition is often harmless, but may cause physical discomfort and symptoms
such as leg fatigue or heaviness, aching pain and throbbing, burning sensations, leg swelling, night cramping, and “restless legs.” Some patients develop more severe side effects, including skin discoloration, bleeding, and leg ulcers. Past treatments involved surgical removal, or “stripping,” of the affected veins. New advances allow less invasive and safer treatments in the office setting.
What are varicose veins? Blood flows from your legs back to your heart through a system of deep and superficial veins. These veins are divided into segments, each with a one-way valve that opens as blood flows toward the heart, then closes to prevent leakage and backflow. The leg’s deep veins carry 80 to 90 percent of the blood returning to the heart, and their valves are less likely to fail than those in the superficial veins. If the superficial veins require treatment, blood flow will be diverted to the healthy deep system. When the valves within your veins become damaged or weakened, the resulting backward flow creates increased pressure, or venous hypertension. Under this increased pressure, many veins—including those in the rectum, pelvis, and vagina—can expand and become “varicose,” a term that simply means enlarged. In most cases, varicose veins develop in your legs. Two of your leg’s superficial veins lie close to the skin and are the source of most visible varicose veins: the great saphenous vein, which runs on the
The condition is often harmless, but may cause physical discomfort. inside of the thigh and lower leg, and the small saphenous vein, which runs behind the calf. Other sources include perforator veins, which connect the deep veins with the superficial veins. Varicose veins are dilated and abnormal-looking, usually bluish in color, and frequently appear ropey or worm-like. By contrast, “spider veins,” also known as telangiectasias, are tiny red, blue, or purple blood vessels visible beneath the skin. Spider veins are frequently a mild cosmetic concern, but they can precede development of the more unsightly varicose veins. In addition to varicose veins, venous hypertension can also lead to ankle swelling and aching, skin discoloration, and leg ulcerations.
MINNESOTA HEALTH CARE NEWS MARCH 2017
Other associated conditions include lipodermatosclerosis, in which the fat under the skin just above the ankle becomes hard (sclerotic), resulting in an inverted “Coke bottle” look. About 10 percent of patients with venous hypertension also experience symptoms consistent with “restless legs” and nighttime cramping. These conditions are referred to as chronic venous insufficiency, and the valves are referred to as incompetent. Venous insufficiency or valve incompetence is usually related to genetics, and often runs in families. Women are affected more than men. Age, multiple pregnancies, blood clots in the veins, and occupations that require long periods of standing may all exacerbate vein wall and valve problems. Diagnosis Your physician may start with a visual examination, checking for swollen ankles, achy legs, persistent itching, and leg fatigue or heaviness, particularly after prolonged standing. In more advanced cases, visual signs may include leg ulcers, skin deformities, and discoloration of the skin. Inflammation and clots may develop in the surface varicose veins, resulting in pain, tenderness, and redness, a condition known as superficial phlebitis or thrombophlebitis. Diagnosing problems in the saphenous or deeper veins requires ultrasound evaluation. Before any treatment recommendations are made, varicose vein patients with leg swelling, skin changes, or other symptoms should undergo an ultrasound to determine which
veins are affected. In some cases, a vascular specialist may order additional testing, such as a CT-venogram or an MR-venogram, to further assess the deep venous system. Treatments Conservative measures include regular exercise, intermittent leg elevation, and weight loss. If worn properly, compression stockings may relieve symptoms, although they are not a cure.
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Varicose veins from page 29
More aggressive corrective treatment focuses on eliminating the leaky valves. Surgical stripping accomplishes this, but the procedure has been associated with complications such as hematoma (clotted blood within the tissues), nerve damage, and recurrent varicosities,
Advantages over traditional surgery include reduced pain, shorter convalescence, and fewer complications such as nerve damage, hematoma, wound infections, and deep vein thrombosis (DVT). Minimal adverse events include failure to close the vein, transient numbness and tingling, and a mild “pulling” sensation in the thigh.
and is no longer commonly performed in the United States. Instead of surgically removing them, modern therapies close off (ablate) varicose veins, addressing the underlying cause without
New advances allow less invasive and safer treatments in the office setting.
creating disfigurement. These minimally invasive ablation treatments are performed in the office, do not require hospitalization, and, in some cases, do not require local anesthesia around the target vein. Patients generally resume normal activities within days, and experience symptom relief within weeks. Endovenous catheters—thin tubes guided through the veins to problem areas identified by ultrasound—allow physicians to seal off the saphenous veins using thermal or non-thermal means: Thermal endovenous ablation. A catheter capable of generating heat—in the form of radio frequencies (RFA) or laser energy (EVLA)—is inserted into the saphenous vein or its tributaries. With local anesthesia applied around the target vein, the tip of the catheter is heated up and pulled back at a constant rate. Heat energy ablates the vein and prevents reverse blood flow.
MINNESOTA HEALTH CARE NEWS MARCH 2017
Non-thermal endovenous ablation. These procedures seal off the saphenous vein without the need for local anesthesia or heat energy. The elimination of heat results in less short-term pain and fewer adverse effects to the surrounding soft tissue and nerves. Physicians close off the veins using chemical sclerosants, which create inflammation; intentional scarring of the vein wall; medical adhesives; or a combination of approaches. Your physician may recommend one of these options: Ultrasound-guided foam sclerotherapy injects a chemical sclerosant into deeper leaky veins. While larger veins can be treated with this procedure, there may be higher failure rates, a slightly higher rate of inflammation, and a temporary darkening of the skin (hyperpigmentation).
Polidocanol endovenous microfoam treatments employ Varithena, a patented drug delivery device, to inject sclerosants into the saphenous veins and varicosities, thereby closing them off. ClariVein utilizes both a liquid sclerosant and a rotating wire to damage and close off the vein, with local anesthesia applied at the insertion site. The effectiveness of this Mechanochemical Endovenous Ablation (MOCA) is comparable to thermal endovenous ablation techniques. The VenaSeal Closure System uses a custom device to deliver a specially formulated medical tissue adhesive to the target saphenous vein, producing fibrosis (a form of scarring). Discomfort throughout the procedure is minimal. Additional treatments include sclerotherapy, an injection procedure commonly used to treat spider veins or smaller tributary veins, and ambulatory phlebectomy (AP), the removal of surface varicose veins under local anesthesia through very small incisions using specialized hooks. These may be performed as a single procedure or in conjunction with an endovenous ablation. Combining these technologies with accurate ultrasound imaging ensures a more complete treatment plan and a better outcome. Vein specialists Your primary care provider can recommend a vein specialist proficient with all available tools. This might include physicians
with backgrounds in general or vascular surgery, interventional radiology, anesthesiology, and internal medicine. You might inquire whether they are board-certified by the American Board of Venous & Lymphatic Medicine (ABVLM.org). Youâ€™ll find additional information from the American College of Phlebology (phlebology. org) and the American Venous Forum (veinforum.org). If you have ultrasound documentation of valve incompetence, most health insurance carriers will cover part or all of the cost for varicose vein treatment. Check your policy regarding vein treatments that are covered, what your potential share of the cost might be, and whether your health care professional needs prior authorization to perform the procedure. Summary Varicose veins are vessels expanded by pressure produced by damaged or weakened valves. Most frequently appearing in the legs, varicose veins are usually harmless, but may cause physical discomfort and other symptoms. Unlike prior treatments that required surgery, modern procedures can be performed in the office setting and do not produce permanent disfigurement.
Primepares G. Pal, MD, FACP, RPVI, and Jacqueline S. Pal, CNP, RPhS, are the founders and owners of Minnesota Vein Center, P.A., one the first dedicated vein clinics in the Twin Cities area. The center is located in North Oaks, MN.
MARCH 2017 MINNESOTA HEALTH CARE NEWS
Diagnosing and treating brain tumors from page 15
scalp patches that deliver a steady stream of alternating pulses to disrupt the growth and spread of cancer cells.
may be considered for treating more advanced forms, as well as for metastatic brain tumors that are relatively few in size and number. Cancer-directed drugs. Conventional chemotherapy drugs target proliferating (dividing) cancer cells, but can also harm healthy cells. Because of this, they often produce side effects such as fatigue, nausea, and bone marrow suppression resulting in decreased blood cell counts. All of these symptoms require close monitoring by treating physicians and teams. Clinical trials are underway on newer drugs that can identify markers on the surface of tumor cells and specifically “target” and kill these cells, sparing normal brain cells and organs in the body. New frontiers Immunotherapy—a new drug class being investigated in clinical trials, and already FDA-approved to treat advanced lung cancers and melanomas—also holds promise to treat brain tumors. Tumor cells evade the body’s natural immune responses. Immunotherapy drugs prevent this, causing a powerful inflammatory response in which immune cells seek and kill tumor cells. Other, non-drug based treatments are also being explored, including a recently approved medical device designed to treat newly diagnosed GBMs with electric field therapy. Patients wear
Summing up A multidisciplinary team works with each patient to define a therapy strategy based on personal goals and wishes. The team strives to address and manage treatment side effects, treat pain and seizures, and make appropriate referrals to rehabilitation practitioners.
Advances in cancer research and in clinical trials provide cause for optimism. Advances in cancer research and in clinical trials provide cause for optimism that new treatments will help patients lead longer lives while also improving quality of life for those living with cancer. Emil Lou, MD, PhD, an assistant professor at the University of Minnesota and physician with University of Minnesota Health Cancer Care, is board-certified in neuro-oncology through the United Council for Neurologic Subspecialties, and in medical oncology and internal medicine through the American Board of Internal Medicine. Elizabeth Neil, MD, an assistant professor at the University of Minnesota and physician with University of Minnesota Health Cancer Care, is board-certified in neuro-oncology through the United Council for Neurologic Subspecialties,
JANUARY 2017 SURVEY MINNESOTA HEALTH CARE CONSUMER ASSOCIATION Each month, members of the Minnesota Health Care Consumer Association are invited to participate in a survey that measures opinions around topics that affect our healthcare delivery system. There is no charge to join the association, and everyone is invited. 2. We should continue to allow children up to the age of 26 to be covered under their parents’ health insurance plans.
60 50 40 30 20 10 Strongly Agree
4. Health care insurance rate increases should be subject to increased legislative regulation.
40 30 20 10 Strongly Agree
Percentage of respondents
Percentage of respondents
5. Prescription medication costs should be subject to increased legislative regulation.
20 15 10 5 0
Percentage of respondents
3. No one should be forced to purchase health insurance.
80 Percentage of respondents
Percentage of respondents
1. It is important that we continue to guarantee that health insurance will not be denied based on pre-existing conditions.
MINNESOTA HEALTH CARE NEWS MARCH 2017
40 30 20 10 0
25 20 15 10 5 0
For more information, please visit www.mnhcca.org. We are pleased to present results of the most recent survey.
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 MARCH 2017 MINNESOTA HEALTH CARE NEWS
CMV and your baby from page 13
• Avoid eating off the same plates and utensils, or drinking out of the same cup as young children.
Breastfeeding Pregnant women who are seropositive for CMV are often concerned about sharing the virus with their newborn by breast milk. Depending on the health of the baby, I generally discuss the benefits and risks of breastfeeding with my patients and do my best to answer questions based on our knowledge of this virus.
• Clean toys and surfaces frequently used by children or exposed to urine and saliva.
Currently there are no breastfeeding recommendations for women who test positive for CMV. Research shows that healthy term infants rarely acquire CMV via breast milk and that the benefits of breastfeeding outweigh the small risk of transmitting CMV. While freezing and pasteurization appear to reduce or eliminate the virus from breast milk, these methods generally are not recommended because they affect the quality of the milk. Prevention: What you can do Pregnant women, parents, and others who work frequently with children, including teachers and child care workers, can follow simple steps to prevent CMV transmission. Prevention will help keep babies and children healthy before and after birth, so remember to: • Wash your hands with soap and water regularly after contact with young children. This includes contact with drool, tears, diapers, toys, and eating and drinking utensils.
MINNESOTA HEALTH CARE NEWS MARCH 2017
• Consider kissing children on the forehead instead of the lips. • Practice safe sex. • Use CMV-negative blood products if you require a blood transfusion. Conclusion CMV is the most common congenital viral infection. It is transmitted by close contact with multiple bodily fluids, including urine, saliva, and nasal secretions. The American College of Obstetrics and Gynecology recommends against routine screening for CMV, mainly because there is no vaccine available, there is no treatment to prevent the effects of CMV infection on newborns, and there is no way to predict whether the baby will develop significant negative outcomes from the virus. Since we have no treatment, prevention is extremely important. Just as pregnant women should avoid travel to areas afflicted with the mosquito-borne Zika virus, they should practice good hygiene to prevent transmission of CMV. This includes not sharing water bottles or food with young children. Taryn McEvoy, MD, is a practicing obstetrician and gynecologist at Oakdale ObGyn. Kristin Smith, MPH, is an outreach and education specialist at Oakdale ObGyn.
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].
for neutralizing effect against native GLP-1, and thus the potential for clinically significant neutralization of native GLP-1 was not assessed. Antibodies that had a neutralizing effect on liraglutide in an in vitro assay occurred in 2.3% of the Victoza®-treated patients in the double-blind 52-week monotherapy trial and in 1.0% of the Victoza®-treated patients in the double-blind 26-week add-on combination therapy trials. Among Victoza®-treated patients who developed anti-liraglutide antibodies, the most common category of adverse events was that of infections, which occurred among 40% of these patients compared to 36%, 34% and 35% of antibody-negative Victoza®-treated, placebo-treated and active-control-treated patients, respectively. The specific infections which occurred with greater frequency among Victoza®-treated antibody-positive patients were primarily nonserious upper respiratory tract infections, which occurred among 11% of Victoza®-treated antibody-positive patients; and among 7%, 7% and 5% of antibody-negative Victoza®-treated, placebo-treated and active-control-treated patients, respectively. Among Victoza®-treated antibody-negative patients, the most common category of adverse events was that of gastrointestinal events, which occurred in 43%, 18% and 19% of antibody-negative Victoza®-treated, placebo-treated and active-control-treated patients, respectively. Antibody formation was not associated with reduced efficacy of Victoza® when comparing mean HbA1c of all antibody-positive and all antibody-negative patients. However, the 3 patients with the highest titers of anti-liraglutide antibodies had no reduction in HbA1c with Victoza® treatment. In the five double-blind clinical trials of Victoza®, events from a composite of adverse events potentially related to immunogenicity (e.g. urticaria, angioedema) occurred among 0.8% of Victoza®-treated patients and among 0.4% of comparator-treated patients. Urticaria accounted for approximately one-half of the events in this composite for Victoza®-treated patients. Patients who developed anti-liraglutide antibodies were not more likely to develop events from the immunogenicity events composite than were patients who did not develop anti-liraglutide antibodies. Injection site reactions: Injection site reactions (e.g., injection site rash, erythema) were reported in approximately 2% of Victoza®-treated patients in the five double-blind clinical trials of at least 26 weeks duration. Less than 0.2% of Victoza®-treated patients discontinued due to injection site reactions. Papillary thyroid carcinoma: In clinical trials of Victoza®, there were 7 reported cases of papillary thyroid carcinoma in patients treated with Victoza® and 1 case in a comparator-treated patient (1.5 vs. 0.5 cases per 1000 patient-years). Most of these papillary thyroid carcinomas were <1 cm in greatest diameter and were diagnosed in surgical pathology specimens after thyroidectomy prompted by findings on protocol-specified screening with serum calcitonin or thyroid ultrasound. Hypoglycemia :In the eight clinical trials of at least 26 weeks duration, hypoglycemia requiring the assistance of another person for treatment occurred in 11 Victoza®-treated patients (2.3 cases per 1000 patient-years) and in two exenatidetreated patients. Of these 11 Victoza®-treated patients, six patients were concomitantly using metformin and a sulfonylurea, one was concomitantly using a sulfonylurea, two were concomitantly using metformin (blood glucose values were 65 and 94 mg/dL) and two were using Victoza® as monotherapy (one of these patients was undergoing an intravenous glucose tolerance test and the other was receiving insulin as treatment during a hospital stay). For these two patients on Victoza® monotherapy, the insulin treatment was the likely explanation for the hypoglycemia. In the 26-week open-label trial comparing Victoza® to sitagliptin, the incidence of hypoglycemic events defined as symptoms accompanied by a fingerstick glucose <56 mg/ dL was comparable among the treatment groups (approximately 5%). Table 5: Incidence (%) and Rate (episodes/patient year) of Hypoglycemia in the 52-Week Monotherapy Trial and in the 26-Week Combination Therapy Trials Victoza® Treatment Active Comparator Placebo Comparator None Monotherapy Victoza® (N = 497) Glimepiride (N = 248) Patient not able to self-treat 0 0 — Patient able to self-treat 9.7 (0.24) 25.0 (1.66) — Not classified 1.2 (0.03) 2.4 (0.04) — ® Add-on to Metformin Victoza + Metformin Glimepiride + Placebo + Metformin (N = 724) Metformin (N = 242) (N = 121) Patient not able to self-treat 0.1 (0.001) 0 0 Patient able to self-treat 3.6 (0.05) 22.3 (0.87) 2.5 (0.06) ®+ ® None Insulin detemir + Continued Victoza Add-on to Victoza Metformin Victoza® + Metformin + Metformin alone (N = 158*) (N = 163) Patient not able to self-treat 0 0 — Patient able to self-treat 9.2 (0.29) 1.3 (0.03) — Rosiglitazone + Placebo + Add-on to Glimepiride Victoza® + Glimepiride (N = 695) Glimepiride (N = 231) Glimepiride (N = 114) Patient not able to self-treat 0.1 (0.003) 0 0 Patient able to self-treat 7.5 (0.38) 4.3 (0.12) 2.6 (0.17) Not classified 0.9 (0.05) 0.9 (0.02) 0 Placebo + Metformin Add-on to Metformin + Victoza® + Metformin None + Rosiglitazone + Rosiglitazone Rosiglitazone (N = 175) (N = 355) Patient not able to self-treat 0 — 0 Patient able to self-treat 7.9 (0.49) — 4.6 (0.15) Not classified 0.6 (0.01) — 1.1 (0.03) Add-on to Metformin + Victoza® + Metformin Insulin glargine Placebo + Metformin + Glimepiride + Metformin + Glimepiride + Glimepiride (N = 114) Glimepiride (N = 232) (N = 230) Patient not able to self-treat 2.2 (0.06) 0 0 Patient able to self-treat 27.4 (1.16) 28.9 (1.29) 16.7 (0.95) Not classified 0 1.7 (0.04) 0 *One patient is an outlier and was excluded due to 25 hypoglycemic episodes that the patient was able to self-treat. This patient had a history of frequent hypoglycemia prior to the study. In a pooled analysis of clinical trials, the incidence rate (per 1,000 patient-years) for malignant neoplasms (based on investigator-reported events, medical history, pathology reports, and surgical reports from both blinded and open-label study periods) was 10.9 for Victoza®, 6.3 for placebo, and 7.2 for active comparator. After excluding papillary thyroid carcinoma events [see Adverse Reactions], no particular cancer cell type predominated. Seven malignant neoplasm events were reported beyond 1 year of exposure to study medication, six events among Victoza®-treated patients (4 colon, 1 prostate and 1 nasopharyngeal), no events with placebo and one event with active comparator (colon). Causality has not been established. Laboratory Tests: In the five clinical trials of at least 26 weeks duration, mildly elevated serum bilirubin concentrations (elevations to no more than twice the upper limit of the reference range) occurred in 4.0% of Victoza®-treated patients, 2.1% of placebo-treated patients and 3.5% of active-comparator-treated patients. This finding was not accompanied by abnormalities in other liver tests. The significance of this isolated finding is unknown. Vital signs: Victoza® did not have adverse effects on blood pressure. Mean increases from baseline in heart rate of 2 to 3 beats per minute have been observed with Victoza® compared to placebo. The long-term clinical effects of the increase in pulse rate have not been established. Post-Marketing Experience: The following additional adverse reactions have been reported during post-approval use of Victoza®. Because these events are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to drug exposure: Dehydration resulting from nausea, vomiting and diarrhea; Increased serum creatinine, acute renal failure or worsening of chronic renal failure, sometimes requiring hemodialysis; Angioedema and anaphylactic reactions; Allergic reactions: rash and pruritus; Acute pancreatitis, hemorrhagic and necrotizing pancreatitis sometimes resulting in death. OVERDOSAGE: Overdoses have been reported in clinical trials and post-marketing use of Victoza®. Effects have included severe nausea and severe vomiting. In the event of overdosage, appropriate supportive treatment should be initiated according to the patient’s clinical signs and symptoms. More detailed information is available upon request. For information about Victoza® contact: Novo Nordisk Inc., 800 Scudders Mill Road, Plainsboro, NJ 08536, 1−877-484-2869 Date of Issue: April 16, 2013 Version: 6 Manufactured by: Novo Nordisk A/S, DK-2880 Bagsvaerd, Denmark Victoza® is covered by US Patent Nos. 6,268,343, 6,458,924, 7,235,627, 8,114,833 and other patents pending. Victoza® Pen is covered by US Patent Nos. 6,004,297, RE 43,834, RE 41,956 and other patents pending. © 2010-2013 Novo Nordisk 0513-00015682-1 5/2013
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INDICATIONS AND USAGE: Victoza® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Important Limitations of Use: Because of the uncertain relevance of the rodent thyroid C-cell tumor findings to humans, prescribe Victoza® only to patients for whom the potential benefits are considered to outweigh the potential risk. Victoza® is not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exercise. Based on spontaneous postmarketing reports, acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victoza®. Victoza® has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for pancreatitis while using Victoza®. Other antidiabetic therapies should be considered in patients with a history of pancreatitis. Victoza® is not a substitute for insulin. Victoza® should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis, as it would not be effective in these settings. The concurrent use of Victoza® and prandial insulin has not been studied. CONTRAINDICATIONS: Do not use in patients with a personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Do not use in patients with a prior serious hypersensitivity reaction to Victoza® or to any of the product components. WARNINGS AND PRECAUTIONS: Risk of Thyroid C-cell Tumors: Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors (adenomas and/or carcinomas) at clinically relevant exposures in both genders of rats and mice. Malignant thyroid C-cell carcinomas were detected in rats and mice. A statistically significant increase in cancer was observed in rats receiving liraglutide at 8-times clinical exposure compared to controls. It is unknown whether Victoza® will cause thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as the human relevance of liraglutide-induced rodent thyroid C-cell tumors could not be determined by clinical or nonclinical studies. In the clinical trials, there have been 6 reported cases of thyroid C-cell hyperplasia among Victoza®-treated patients and 2 cases in comparator-treated patients (1.3 vs. 1.0 cases per 1000 patient-years). One comparator-treated patient with MTC had pre-treatment serum calcitonin concentrations >1000 ng/L suggesting pre-existing disease. All of these cases were diagnosed after thyroidectomy, which was prompted by abnormal results on routine, protocol-specified measurements of serum calcitonin. Five of the six Victoza®-treated patients had elevated calcitonin concentrations at baseline and throughout the trial. One Victoza® and one non-Victoza®-treated patient developed elevated calcitonin concentrations while on treatment. Calcitonin, a biological marker of MTC, was measured throughout the clinical development program. The serum calcitonin assay used in the Victoza® clinical trials had a lower limit of quantification (LLOQ) of 0.7 ng/L and the upper limit of the reference range was 5.0 ng/L for women and 8.4 ng/L for men. At Weeks 26 and 52 in the clinical trials, adjusted mean serum calcitonin concentrations were higher in Victoza®-treated patients compared to placebo-treated patients but not compared to patients receiving active comparator. At these timepoints, the adjusted mean serum calcitonin values (~1.0 ng/L) were just above the LLOQ with between-group differences in adjusted mean serum calcitonin values of approximately 0.1 ng/L or less. Among patients with pre-treatment serum calcitonin below the upper limit of the reference range, shifts to above the upper limit of the reference range which persisted in subsequent measurements occurred most frequently among patients treated with Victoza® 1.8 mg/day. In trials with on-treatment serum calcitonin measurements out to 5-6 months, 1.9% of patients treated with Victoza® 1.8 mg/day developed new and persistent calcitonin elevations above the upper limit of the reference range compared to 0.8-1.1% of patients treated with control medication or the 0.6 and 1.2 mg doses of Victoza®. In trials with on-treatment serum calcitonin measurements out to 12 months, 1.3% of patients treated with Victoza® 1.8 mg/day had new and persistent elevations of calcitonin from below or within the reference range to above the upper limit of the reference range, compared to 0.6%, 0% and 1.0% of patients treated with Victoza® 1.2 mg, placebo and active control, respectively. Otherwise, Victoza® did not produce consistent dose-dependent or time-dependent increases in serum calcitonin. Patients with MTC usually have calcitonin values >50 ng/L. In Victoza® clinical trials, among patients with pre-treatment serum calcitonin <50 ng/L, one Victoza®-treated patient and no comparator-treated patients developed serum calcitonin >50 ng/L. The Victoza®-treated patient who developed serum calcitonin >50 ng/L had an elevated pre-treatment serum calcitonin of 10.7 ng/L that increased to 30.7 ng/L at Week 12 and 53.5 ng/L at the end of the 6-month trial. Follow-up serum calcitonin was 22.3 ng/L more than 2.5 years after the last dose of Victoza®. The largest increase in serum calcitonin in a comparator-treated patient was seen with glimepiride in a patient whose serum calcitonin increased from 19.3 ng/L at baseline to 44.8 ng/L at Week 65 and 38.1 ng/L at Week 104. Among patients who began with serum calcitonin <20 ng/L, calcitonin elevations to >20 ng/L occurred in 0.7% of Victoza®-treated patients, 0.3% of placebo-treated patients, and 0.5% of active-comparator-treated patients, with an incidence of 1.1% among patients treated with 1.8 mg/ day of Victoza®. The clinical significance of these findings is unknown. Counsel patients regarding the risk for MTC and the symptoms of thyroid tumors (e.g. a mass in the neck, dysphagia, dyspnea or persistent hoarseness). It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate the potential risk of MTC, and such monitoring may increase the risk of unnecessary procedures, due to low test specificity for serum calcitonin and a high background incidence of thyroid disease. Patients with thyroid nodules noted on physical examination or neck imaging obtained for other reasons should be referred to an endocrinologist for further evaluation. Although routine monitoring of serum calcitonin is of uncertain value in patients treated with Victoza®, if serum calcitonin is measured and found to be elevated, the patient should be referred to an endocrinologist for further evaluation. Pancreatitis: Based on spontaneous postmarketing reports, acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, has been observed in patients treated with Victoza®. After initiation of Victoza®, observe patients carefully for signs and symptoms of pancreatitis (including persistent severe abdominal pain, sometimes radiating to the back and which may or may not be accompanied by vomiting). If pancreatitis is suspected, Victoza® should promptly be discontinued and appropriate management should be initiated. If pancreatitis is confirmed, Victoza® should not be restarted. Consider antidiabetic therapies other than Victoza® in patients with a history of pancreatitis. In clinical trials of Victoza®, there have been 13 cases of pancreatitis among Victoza®-treated patients and 1 case in a comparator (glimepiride) treated patient (2.7 vs. 0.5 cases per 1000 patient-years). Nine of the 13 cases with Victoza® were reported as acute pancreatitis and four were reported as chronic pancreatitis. In one case in a Victoza®-treated patient, pancreatitis, with necrosis, was observed and led to death; however clinical causality could not be established. Some patients had other risk factors for pancreatitis, such as a history of cholelithiasis or alcohol abuse. Use with Medications Known to Cause Hypoglycemia: Patients receiving Victoza® in combination with an insulin secretagogue (e.g., sulfonylurea) or insulin may have an increased risk of hypoglycemia. The risk of hypoglycemia may be lowered by a reduction in the dose of sulfonylurea (or other concomitantly administered insulin secretagogues) or insulin Renal Impairment: Victoza® has not been found to be directly nephrotoxic in animal studies or clinical trials. There have been postmarketing reports of acute renal failure and worsening of chronic renal failure, which may sometimes require hemodialysis in Victoza®-treated patients. Some of these events were reported in patients without known underlying renal disease. A majority of the reported events occurred in patients who had experienced nausea, vomiting, diarrhea, or dehydration. Some of the reported events occurred in patients receiving one or more medications known to affect renal function or hydration status. Altered renal function has been reversed in many of the reported cases with supportive treatment and discontinuation of potentially causative agents, including Victoza®. Use caution when initiating or escalating doses of Victoza® in patients with renal impairment. Hypersensitivity Reactions: There have been postmarketing reports of serious hypersensitivity reactions (e.g., anaphylactic reactions and angioedema) in patients treated with Victoza®. If a hypersensitivity reaction occurs, the patient should discontinue Victoza® and other suspect medications and promptly seek medical advice. Angioedema has also been reported with other GLP-1 receptor agonists. Use caution in a patient with a history of angioedema with another GLP-1 receptor agonist because it is unknown whether such patients will be predisposed to angioedema with Victoza®. Macrovascular Outcomes: There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Victoza® or any other antidiabetic drug. ADVERSE REACTIONS: Clinical Trials Experience: Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of Victoza® has been evaluated in 8 clinical trials: A double-blind 52-week monotherapy trial compared Victoza® 1.2 mg daily, Victoza® 1.8 mg daily, and glimepiride 8 mg daily; A double-blind 26 week add-on to metformin trial compared Victoza® 0.6 mg once-daily, Victoza® 1.2 mg once-daily, Victoza® 1.8
mg once-daily, placebo, and glimepiride 4 mg once-daily; A double-blind 26 week add-on to glimepiride trial compared Victoza® 0.6 mg daily, Victoza® 1.2 mg once-daily, Victoza® 1.8 mg once-daily, placebo, and rosiglitazone 4 mg once-daily; A 26 week add-on to metformin + glimepiride trial, compared double-blind Victoza® 1.8 mg once-daily, double-blind placebo, and open-label insulin glargine once-daily; A doubleblind 26-week add-on to metformin + rosiglitazone trial compared Victoza® 1.2 mg once-daily, Victoza® 1.8 mg once-daily and placebo; An open-label 26-week add-on to metformin and/or sulfonylurea trial compared Victoza® 1.8 mg once-daily and exenatide 10 mcg twice-daily; An open-label 26-week add-on to metformin trial compared Victoza® 1.2 mg once-daily, Victoza® 1.8 mg once-daily, and sitagliptin 100 mg once-daily; An open-label 26-week trial compared insulin detemir as add-on to Victoza® 1.8 mg + metformin to continued treatment with Victoza® + metformin alone. Withdrawals: The incidence of withdrawal due to adverse events was 7.8% for Victoza®-treated patients and 3.4% for comparator-treated patients in the five double-blind controlled trials of 26 weeks duration or longer. This difference was driven by withdrawals due to gastrointestinal adverse reactions, which occurred in 5.0% of Victoza®-treated patients and 0.5% of comparator-treated patients. In these five trials, the most common adverse reactions leading to withdrawal for Victoza®-treated patients were nausea (2.8% versus 0% for comparator) and vomiting (1.5% versus 0.1% for comparator). Withdrawal due to gastrointestinal adverse events mainly occurred during the first 2-3 months of the trials. Common adverse reactions: Tables 1, 2, 3 and 4 summarize common adverse reactions (hypoglycemia is discussed separately) reported in seven of the eight controlled trials of 26 weeks duration or longer. Most of these adverse reactions were gastrointestinal in nature. In the five double-blind clinical trials of 26 weeks duration or longer, gastrointestinal adverse reactions were reported in 41% of Victoza®-treated patients and were dose-related. Gastrointestinal adverse reactions occurred in 17% of comparator-treated patients. Common adverse reactions that occurred at a higher incidence among Victoza®-treated patients included nausea, vomiting, diarrhea, dyspepsia and constipation. In the five double-blind and three open-label clinical trials of 26 weeks duration or longer, the percentage of patients who reported nausea declined over time. In the five double-blind trials approximately 13% of Victoza®-treated patients and 2% of comparator-treated patients reported nausea during the first 2 weeks of treatment. In the 26-week open-label trial comparing Victoza® to exenatide, both in combination with metformin and/or sulfonylurea, gastrointestinal adverse reactions were reported at a similar incidence in the Victoza® and exenatide treatment groups (Table 3). In the 26-week open-label trial comparing Victoza® 1.2 mg, Victoza® 1.8 mg and sitagliptin 100 mg, all in combination with metformin, gastrointestinal adverse reactions were reported at a higher incidence with Victoza® than sitagliptin (Table 4). In the remaining 26-week trial, all patients received Victoza® 1.8 mg + metformin during a 12-week run-in period. During the run-in period, 167 patients (17% of enrolled total) withdrew from the trial: 76 (46% of withdrawals) of these patients doing so because of gastrointestinal adverse reactions and 15 (9% of withdrawals) doing so due to other adverse events. Only those patients who completed the run-in period with inadequate glycemic control were randomized to 26 weeks of add-on therapy with insulin detemir or continued, unchanged treatment with Victoza® 1.8 mg + metformin. During this randomized 26-week period, diarrhea was the only adverse reaction reported in ≥5% of patients treated with Victoza® 1.8 mg + metformin + insulin detemir (11.7%) and greater than in patients treated with Victoza® 1.8 mg and metformin alone (6.9%). Table 1: Adverse reactions reported in ≥5% of Victoza®-treated patients in a 52-week monotherapy trial All Victoza® N = 497 Glimepiride N = 248 (%) (%) Adverse Reaction Nausea 28.4 8.5 Diarrhea 17.1 8.9 Vomiting 10.9 3.6 Constipation 9.9 4.8 Headache 9.1 9.3 Table 2: Adverse reactions reported in ≥5% of Victoza®-treated patients and occurring more frequently with Victoza® compared to placebo: 26-week combination therapy trials Add-on to Metformin Trial All Victoza® + Metformin Placebo + Metformin Glimepiride + Metformin N = 724 N = 121 N = 242 (%) (%) (%) Adverse Reaction Nausea 15.2 4.1 3.3 Diarrhea 10.9 4.1 3.7 Headache 9.0 6.6 9.5 Vomiting 6.5 0.8 0.4 Add-on to Glimepiride Trial ® Placebo + Glimepiride Rosiglitazone + All Victoza + Glimepiride N = 695 N = 114 Glimepiride N = 231 (%) (%) (%) Adverse Reaction Nausea 7.5 1.8 2.6 Diarrhea 7.2 1.8 2.2 Constipation 5.3 0.9 1.7 Dyspepsia 5.2 0.9 2.6 Add-on to Metformin + Glimepiride ® Victoza 1.8 + Metformin Placebo + Metformin + Glargine + Metformin + + Glimepiride N = 230 Glimepiride N = 114 Glimepiride N = 232 (%) (%) (%) Adverse Reaction Nausea 13.9 3.5 1.3 Diarrhea 10.0 5.3 1.3 Headache 9.6 7.9 5.6 Dyspepsia 6.5 0.9 1.7 Vomiting 6.5 3.5 0.4 Add-on to Metformin + Rosiglitazone ® Placebo + Metformin + Rosiglitazone All Victoza + Metformin + Rosiglitazone N = 355 N = 175 (%) (%) Adverse Reaction Nausea 34.6 8.6 Diarrhea 14.1 6.3 Vomiting 12.4 2.9 Headache 8.2 4.6 Constipation 5.1 1.1 Table 3: Adverse Reactions reported in ≥5% of Victoza®-treated patients in a 26-Week Open-Label Trial versus Exenatide Exenatide 10 mcg twice daily + Victoza® 1.8 mg once daily + metformin and/or sulfonylurea metformin and/or sulfonylurea N = 232 N = 235 (%) (%) Adverse Reaction Nausea 25.5 28.0 Diarrhea 12.3 12.1 Headache 8.9 10.3 Dyspepsia 8.9 4.7 Vomiting 6.0 9.9 Constipation 5.1 2.6 Table 4: Adverse Reactions in ≥5% of Victoza®-treated patients in a 26-Week Open-Label Trial versus Sitagliptin All Victoza® + metformin Sitagliptin 100 mg/day + N = 439 metformin N = 219 (%) (%) Adverse Reaction Nausea 23.9 4.6 Headache 10.3 10.0 Diarrhea 9.3 4.6 Vomiting 8.7 4.1 Immunogenicity: Consistent with the potentially immunogenic properties of protein and peptide pharmaceuticals, patients treated with Victoza® may develop anti-liraglutide antibodies. Approximately 50-70% of Victoza®-treated patients in the five double-blind clinical trials of 26 weeks duration or longer were tested for the presence of anti-liraglutide antibodies at the end of treatment. Low titers (concentrations not requiring dilution of serum) of anti-liraglutide antibodies were detected in 8.6% of these Victoza®-treated patients. Sampling was not performed uniformly across all patients in the clinical trials, and this may have resulted in an underestimate of the actual percentage of patients who developed antibodies. Cross-reacting antiliraglutide antibodies to native glucagon-like peptide-1 (GLP-1) occurred in 6.9% of the Victoza®-treated patients in the double-blind 52-week monotherapy trial and in 4.8% of the Victoza®-treated patients in the double-blind 26-week add-on combination therapy trials. These cross-reacting antibodies were not tested
Victoza —a force for change in type 2 diabetes. A change with powerful, long-lasting benefits
Reductions up to -1.1%a
Weight loss up to 5.5 lba,b
Low rate of hypoglycemiac
1.8 mg dose when used alone for 52 weeks. Victoza® is not indicated for the management of obesity. Weight change was a secondary end point in clinical trials. c In the 8 clinical trials of at least 26 weeks’ duration, hypoglycemia requiring the assistance of another person for treatment occurred in 11 Victoza®-treated patients. a
A 52-week, double-blind, double-dummy, active-controlled, parallel-group, multicenter study. Patients with type 2 diabetes (N=745) were randomized to receive once-daily Victoza® 1.2 mg (n=251), Victoza® 1.8 mg (n=246), or glimepiride 8 mg (n=248). The primary outcome was change in A1C after 52 weeks.
The change begins at VictozaPro.com. Indications and Usage
Victoza (liraglutide [rDNA origin] injection) is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Because of the uncertain relevance of the rodent thyroid C-cell tumor findings to humans, prescribe Victoza® only to patients for whom the potential benefits are considered to outweigh the potential risk. Victoza® is not recommended as firstline therapy for patients who have inadequate glycemic control on diet and exercise. Based on spontaneous postmarketing reports, acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victoza®. Victoza® has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for pancreatitis while using Victoza®. Other antidiabetic therapies should be considered in patients with a history of pancreatitis. Victoza® is not a substitute for insulin. Victoza® should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis, as it would not be effective in these settings. Victoza® has not been studied in combination with prandial insulin. ®
Important Safety Information
Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice. It is unknown whether Victoza® causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as human relevance could not be ruled out by clinical or nonclinical studies. Victoza® is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Based on the findings in rodents, monitoring with serum calcitonin or thyroid ultrasound was performed during clinical trials, but this may have increased the number of unnecessary thyroid surgeries. It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate human risk of thyroid C-cell tumors. Patients should be counseled regarding the risk and symptoms of thyroid tumors. Do not use in patients with a prior serious hypersensitivity reaction to Victoza® or to any of the product components. Postmarketing reports, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis. Discontinue promptly if pancreatitis is suspected. Do not restart if Victoza® is a registered trademark of Novo Nordisk A/S. © 2013 Novo Nordisk All rights reserved.
pancreatitis is confirmed. Consider other antidiabetic therapies in patients with a history of pancreatitis. When Victoza® is used with an insulin secretagogue (e.g. a sulfonylurea) or insulin serious hypoglycemia can occur. Consider lowering the dose of the insulin secretagogue or insulin to reduce the risk of hypoglycemia. Renal impairment has been reported postmarketing, usually in association with nausea, vomiting, diarrhea, or dehydration which may sometimes require hemodialysis. Use caution when initiating or escalating doses of Victoza® in patients with renal impairment. Serious hypersensitivity reactions (e.g. anaphylaxis and angioedema) have been reported during postmarketing use of Victoza®. If symptoms of hypersensitivity reactions occur, patients must stop taking Victoza® and seek medical advice promptly. There have been no studies establishing conclusive evidence of macrovascular risk reduction with Victoza® or any other antidiabetic drug. The most common adverse reactions, reported in ≥5% of patients treated with Victoza® and more commonly than in patients treated with placebo, are headache, nausea, diarrhea, dyspepsia, constipation and anti-liraglutide antibody formation. Immunogenicity-related events, including urticaria, were more common among Victoza®-treated patients (0.8%) than among comparator-treated patients (0.4%) in clinical trials. Victoza® has not been studied in type 2 diabetes patients below 18 years of age and is not recommended for use in pediatric patients. There is limited data in patients with renal or hepatic impairment. In a 52-week monotherapy study (n=745) with a 52-week extension, the adverse reactions reported in ≥ 5% of patients treated with Victoza® 1.8 mg, Victoza® 1.2 mg, or glimepiride were constipation (11.8%, 8.4%, and 4.8%), diarrhea (19.5%, 17.5%, and 9.3%), flatulence (5.3%, 1.6%, and 2.0%), nausea (30.5%, 28.7%, and 8.5%), vomiting (10.2%, 13.1%, and 4.0%), fatigue (5.3%, 3.2%, and 3.6%), bronchitis (3.7%, 6.0%, and 4.4%), influenza (11.0%, 9.2%, and 8.5%), nasopharyngitis (6.5%, 9.2%, and 7.3%), sinusitis (7.3%, 8.4%, and 7.3%), upper respiratory tract infection (13.4%, 14.3%, and 8.9%), urinary tract infection (6.1%, 10.4%, and 5.2%), arthralgia (2.4%, 4.4%, and 6.0%), back pain (7.3%, 7.2%, and 6.9%), pain in extremity (6.1%, 3.6%, and 3.2%), dizziness (7.7%, 5.2%, and 5.2%), headache (7.3%, 11.2%, and 9.3%), depression (5.7%, 3.2%, and 2.0%), cough (5.7%, 2.0%, and 4.4%), and hypertension (4.5%, 5.6%, and 6.9%). Please see brief summary of Prescribing Information on adjacent page. 1013-00018617-1
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