MN Healthcare News November/December 2016

Your Guide to Consumer Information November/December 2016 • Vol 14 No 12

Stress tests

By Elizabeth Klodas, MD, FACC

Hearing aids

By Jason R. Leyendecker, AuD

Breast cancer

By Dana Carlson, MD

ACCRA SELF-DIRECTED CARE SERVICES FOR ALL AGES. In your home and community.

WE PROVIDE SERVICES FOR CHILDREN, ADOLESCENTS, ADULTS AND FAMILIES OF ALL ABILITIES AND AGE. Each person has unique needs and with our 25 years of experience providing support to people with disabilities – we'll help you navigate the different services and possibilities available to you.

With PCA Choice – you have the option of choosing your own caregiver, including your friends and family members.

More Choice. More Flexibility.

Toll Free 866-935-3515 • Metro 952-935-3515 SERVING PEOPLE STATEWIDE www.accracare.org

CONTENTS

4 8

NOVEMBER/DECEMBER 2016 • VOL 14 • NO. 12

NEWS

PERSPECTIVE Preventing HPV-related cancers Immunization is key

7 10

12

Stress tests What they can— and can’t—tell us

14

16

Breast cancer A look at new screening guidelines

By Dana Carlson, MD

20

By Tom von Sternberg, MD

26

18 22

HEALTH INSURANCE Demystifying Medicare Maximize your coverage

OPHTHALMOLOGY Glaucoma Preventing vision loss

By Elena Bitrian, MD

Dermatology An interview with Dr. Phillip Keith

PEDIATRICS Respiratory care Helping kids live at home

By Chad Muesing, RRT-NPS, LRT

By Elizabeth Klodas, MD, FACC

ONCOLOGY

10 QUESTIONS

Phillip Keith, MD

Sheldon Berkowitz, MD, FAAP

CARDIOLOGY

PEOPLE

CALENDAR

AUDIOLOGY Hearing aids Advances change lives

By Jason R. Leyendecker, AuD

28

RADIOLOGY Addiction and relapse Brain imaging suggests new hope

By Jazmin Camchong, PhD, Kelvin Lim, MD, and Kathryn Cullen, MD

PUBLISHER Mike Starnes | mstarnes@mppub.com EDITOR Lisa McGowan | lmcgowan@mppub.com ASSOCIATE EDITOR Richard Ericson | rericson@mppub.com ART DIRECTOR Sunshine Sevigny | sunny@mppub.com OFFICE ADMINISTRATOR Amanda Marlow | amarlow@mppub.com ADVERTISING DIRECTOR Dale Decker | ddecker@mppub.com Minnesota Heath Care News is published once a month by Minnesota Physician Publishing, Inc.

Our address is 2812 East 26th Street, Minneapolis, MN 55406; phone 612.728.8600; fax 612.728.8601; email mpp@mppub.com. We welcome the submission of manuscripts and letters for possible publication.

All views and opinions expressed by authors of published articles are solely those of the authors and do not necessarily represent or express the views of Minnesota Physician Publishing, Inc., or this publication. The contents herein are believed accurate but are not intended to replace medical, legal, tax, business, or other professional advice and counsel. No part of this publication may be reprinted or reproduced without written permission of the publisher. Annual subscriptions (12 copies) are $36.00/ Individual copies are $4.00.

NOVEMBER/DECEMBER 2016 MINNESOTA HEALTH CARE NEWS

3

NEWS

St. Francis Opens New Entrance and Lobby St. Francis Regional Medical Center, owned by Allina Health, Park Nicollet, and Essentia Health, has completed a $7 million, 15,500-squarefoot renovation that expanded its entrance and increased its footprint by more than a quarter acre.

The expanded entrance area includes a new pharmacy operated by Allina Health, an eye care department operated by Park Nicollet (relocated from the current locations inside the clinic), a health care retail store operated by Park Nicollet, and a coffee shop.

hospital treatment are moved to a The program will be brought to new program with a less intensive full operating capacity gradually as level of care. new staff are recruited, hired, and St. Francis is in the process of upAccording to DHS, each hospital trained. grading patient rooms in the southern “The plan makes the best use of wing after completing operating room is licensed for 16 beds, however state upgrades and has plans to renovate the funding has kept the hospitals from our limited resources,” said Piper. admitting more than 12 patients at “Even a modest increase in beds is emergency and ambulance areas. a time. The new plan will provide a welcome relief in an over-strained funding to facilities in Alexandria, system. We’ll get more people into Annandale, Baxter, Bemidji, Fergus treatment sooner.”

Falls, and Rochester that will allow them to operate at full capacity.

The Community Behavioral Health Hospital in St. Peter stopped admisMinnesota’s state-run mental sions Oct. 1 and will close in early health hospitals will open additional November when its budget will be Summit Orthopedics will assume psychiatric beds under a plan ap- reallocated to the remaining hospifull operations of an orthopedic care proved by the state Legislature that is tals. A new Competency Restoration facility in Faribault and intends to now in the early states of implemen- Program will then open in St. Peter collaborate with Northfield Hospital tation by the Minnesota Department that will care for patients who don’t and Clinics on medical services in of Human Services (DHS). need treatment at a hospital or secure Northfield, Lakeville, and FarmingTo meet the rising demand for in- facility, which will help make room ton. The clinic locations are currently patient care, DHS plans to gradually at Anoka-Metro Regional Treatment staffed by Mankato-based Orthobring the state’s network of Com- Center. pedic and Fracture Clinic and will that our patients leave St. Francis with a healthier care experience.”

Community Behavioral Health Hospitals to Expand

The medical center chose to expand in order to make it more convenient for patients to fill prescriptions; create a distinguishable, easier to navigate front entrance; and make space for Park Nicollet Clinic to expand with the relocation of its retail stores. munity Behavioral Health Hospitals “It is estimated that more than 30 up to full operating capacity. The percent of prescriptions never get filled change will add another 12 psychiif a patient leaves a hospital without atric beds across the system and 20 them,” said Mike McMahan, pres- beds at the Anoka-Metro Regional ident of St. Francis. “Our new onsite Treatment Center will become availoutpatient pharmacy will help ensure able as patients who no longer need

4

MINNESOTA HEALTH CARE NEWS NOVEMBER/DECEMBER 2016

Summit Orthopedics to Expand

“The shortage of psychiatric beds and community based services statewide is a serious long-term problem,” said Emily Piper, DHS commissioner.

“While this isn’t a complete solution, it is a meaningful step in the right direction.”

become Summit Orthopedics clinical care sites in January 2017. Five of the current surgeons from Orthopedic and Fracture Clinic and the entire medical and support staff from the Faribault clinic will become Summit employees.

The study included blood samples of 16,000 people who currently smoked or had quit smoking. Researchers compared DNA methylation levels in the samples to levels in people who had never smoked. They discovered that smoking-related DNA methylation sites were associated with more than 7,000 genes, equating to one-third of known human genes. In addition, they found that when people quit smoking, the HealthEast is expanding the in- majority of DNA methylation sites patient mental health units at St. returned to levels seen in non-smokPaul’s St. Joseph’s Hospital. Once ers within five years of quitting. They the project is complete, it will serve note, however, that some DNA meth1,500 additional high acuity and ylation sites persisted long-term—up geriatric psychiatric patients. It will to 30 years after quitting. have a total of 36 rooms, increasing “This is the largest epigthe organization’s mental health in- enome-wide study of smoking to patient care by nearly 50 percent. date, and it shows how much and The health care system recently how long smoking might damage completed and opened the first phase the epigenome in the general popuof the expansion project at St. Jo- lation,” said Ellen Demerath, MS, seph’s Hospital and began admitting PhD, associate professor in the dipatients. The design process and vision of epidemiology and commuplanning are currently underway nity health at the School of Public for Phase II, which is set to begin in Health and co-author of the study.

January 2017. Phase II is expected to “This is important because the idea that smoking does this by changing open in summer 2017. particular parts of the epigenome is “There is a great need for addi- new.” tional inpatient mental health beds at HealthEast, as well as across Minnesota and the nation,” said Dr. John Kvasnicka, vice president of Medical Affairs, HealthEast. “Our new mental health expansion is a major contribution to meeting unmet mental health care needs across the UCare has introduced a new state.” h e a lt h pl a n d e s i g n e d to s e r ve An expansion is also planned in Eagan, with a new facility that will open spring 2017. The new location will provide an outpatient ambulatory surgery center and extended access to more advanced surgical procedures.

HealthEast Continues Mental Health Project

UCare Launches New Plan for Dual-Eligible Adults with Disabilities

Smoking Leaves Imprint on Human Genome In addition to the known health risks, new research has shown that smoking makes a long-term impact on the body’s genome. A collaborative study co-authored by the University of Minnesota School of Public Health focused on the epigenome, an aspect of human DNA expression that is regulated through the addition of chemical compounds to genes.

Researchers examined a chemical change made by cells to genes called DNA methylation, which involves the addition of one carbon and three hydrogen atoms known as a methyl group to the gene. The addition of a methyl group turns the gene “off” and keeps it from producing proteins.

Minnesotans who are dually eligible for Medicaid-only Special Needs BasicCare (SNBC) coverage and Medicare. The plan, called UCare Connect + Medicare, will be available Jan. 1, 2017, to individuals who are at least age 18 and under age 65, receive Medicaid from the state, have Medicare Parts A and B, and live in the service area. The service area includes several counties in the metro area—Anoka, Carver, Dakota, Hennepin, Ramsey, Scott, Sherburne, Stearns, Washington, and Wright— as well as Olmsted County in southeastern Minnesota.

According to UCare, the new plan will help “simplify coverage for Medicare- and Medicaid-eligible adults with certified physical, developmental and/or mental health News to page 6

NOVEMBER/DECEMBER 2016 MINNESOTA HEALTH CARE NEWS

5

News from page 5

disabilities because it combines their Medical Assistance, Medicare, and prescription drug coverage benefits into one easy-to-use plan.” Members will have no monthly premium, but may have small copays for select services.

“People with disabilities can now manage their care easier with UCare Connect + Medicare,” said Ghita Worcester, senior vice president of public affairs and chief marketing officer at UCare. “Our long history of serving this community enabled us to design a plan that simplifies the care process and helps improve health.

UCare Connect + Medicare members will receive Medicaid and Medicare benefits and services to which they are entitled, and enjoy a care management model well-matched to the level of care they require.”

Choices Psychotherapy Adds Chanhassen Location Choices Psychotherapy opened a new location in Chanhassen on Aug. 22. The location is its second in the metro area—Susan Davis, owner and executive director of Choices Psychotherapy, opened its St. Louis Park location in 1993.

“Since our founding, we have seen an increased interest in psychotherapy and therapy-based psychiatry among the general public and are pleased to see more people taking advantage of the benefits therapeutic counseling brings to whole person health and individual resilience,” said Davis.

discontinued in women who are not of women in the same age group who at a high risk for cancer, according to did not have the procedure done. researchers from Mayo Clinic.

The study showed that women The controversial practice of re- under 46 who underwent bilateral moving both ovaries, called bilat- oophorectomy experienced a higher eral oophorectomy, is often used as incidence of the 18 chronic condia preventive measure against ovar- tions considered one at a time, except ian cancer. However, this study has cancer, as well as an accelerated rate shown for the first time that the pro- of accumulation of combined concedure is linked to a marked increase ditions, or multimorbidity. In some in eight of the 18 chronic health cases, estrogen therapy helped reduce conditions the researchers mea- some of the risks in women who had sured—depression, hyperlipidemia, undergone the procedure. cardiac arrhythmias, coronary artery disease, arthritis, asthma, chronic obstructive pulmonary disease, and osteoporosis. Conclusions show that the effects of bilateral oophorectomy in premenopausal women are much broader and more severe than previously documented.

Nine researchers from multiple disciplines followed two groups of women for about 14 years through the Rochester Epidemiology Project. One group consisted of 1,653 women who UCare Connect has been availunderwent bilateral oophorectomy able since 2008 and currently serves The practice of ovary removal before the age of 50 between Jan. 1, eligible adults in 62 counties. UCare Connect + Medicare is an extension in premenopausal women to pre- 1988, and Dec. 31, 2007. The other vent ovarian cancer should be group consisted of the same number of this existing plan.

6

Ovarian Removal Associated with High Risks

MINNESOTA HEALTH CARE NEWS NOVEMBER/DECEMBER 2016

The researchers suggest that the premature loss of estrogen caused by bilateral oophorectomy may affect a series of aging mechanisms at the cellular and tissue level across the whole body, leading to diseases in multiple systems and organs.

“In the absence of a documented high-risk genetic variant,” said Walter Rocca, MD, professor of epidemiology and neurology at Mayo Medical School and lead author of the study, “bilateral oophorectomy before the age of 50 years (or before menopause) is never to be considered and should not be offered as an option to women.”

PEOPLE NICOLE GAPP, RN-BC, nurse at PrairieCare, has received the Nurse of the Year Award in the category of mental health from the Minnesota chapter of the March of Dimes for exemplifying an extraordinary level of patient care, compassion, and customer service. Gapp is in the process of earning her doctor of nursing practice and Nicole Gapp, completing the Psychiatric/Mental Health Nurse RN-BC Practitioner specialty program at the University of Minnesota School of Nursing. She also serves as a crisis prevention instructor at the Crisis Prevention Institute, an international training organization that specializes in the safe management of disruptive and assaultive behavior, and a volunteer at The Bridge for Youth, a youth crisis program and emergency shelter.

AMY CATALFAMO, MD, has joined the Noran Neurological Clinic as a pediatric neurologist.

Catalfamo earned her medical degree from State University of New York Downstate Medical Center College of Medicine, followed by her pediatric and pediatric neurology residencies at Strong Memorial Hospital in Rochester, NY. Amy Catalfamo, Her clinical interests include general pediatric MD neurology, epilepsy, and developmental delay. She sees patients at the Minneapolis and Lake Elmo clinics.

ROBERT SLOAN, MD, has joined Hennepin County Medical Center. Sloan is a staff physician in the Physical Medicine and Rehabilitation Division with special expertise in spine/back injuries. He also cares for patients with traumatic brain injuries. His special interests include spine care and scoliosis, and sports medicine, including Robert Sloan, performance arts (musicians and dancers), and MD concussion evaluation and care. He has spoken extensively on concussions and was a founding member of the Hawaii State Traumatic Brain Injury Advisory Board for the Department of Health. Sloan earned his medical degree from the University of California, Davis, School of Medicine in Sacramento where he also completed a residency in physical medicine and rehabilitation.

CHRISTINA OLSON, RN, FNP, has joined Entira Family Clinics North St. Paul Clinic. With special interests in prenatal care and gynecology, her goal as a health care practitioner is to provide personalized, holistic care using the most up-to-date recommendations and evidence-based medicine.

Olson received her master’s in nursing with a Christina Olson, specialty in women’s health from the University RN, FNP of Minnesota in 1999. After practicing as an obstetrician-gynecologist for nearly 17 years, she earned a post-graduate advanced practice registered nurse (APRN) certificate in family practice from George Washington University in Washington, DC.

NOVEMBER/DECEMBER 2016 MINNESOTA HEALTH CARE NEWS

7

PERSPECTIVE

Preventing HPV-related cancers Immunization is key

A

significant amount of funding and research is dedicated toward finding a cure for cancer. But what if cancer could be prevented in the first place? What if there was a way to mobilize the body’s natural defenses to develop immunity against cancer?

A shot of prevention

Sheldon Berkowitz, MD, FAAP Children’s Hospitals and Clinics of Minnesota Dr. Berkowitz is a pediatrician with Children’s Minnesota.

He is board-certified by the American Board of Pediatrics and is on the Board of Directors of the Minnesota Chapter of the American Academy of Pediatrics and the Minnesota Academy of Pediatrics Foundation. He is also the physician advisor for Children’s, assisting the Case Management, Clinical Documentation Improvement, and Revenue Management Programs, and has a special interest in bioethics, a subject on which he has written and lectured.

The good news is we finally have a way to prevent some cancers—those caused by the human papillomavirus (HPV)—as part of routine childhood immunizations at the doctor’s office. When given to young people within a certain window of time, it’s nearly 100 percent effective at preventing certain HPV-related types of cancer later in life.

According to the Centers for Disease Control and Prevention (CDC), 90 percent of people will potentially become infected with some strain of HPV during their life unless we act now. Each year 27,000 people in the United States are diagnosed with a cancer caused by HPV, including cervical cancer, throat cancer, penile cancer, and mouth cancer. In addition, HPV can also cause genital warts and can be transmitted to an unborn child, causing serious growths (papillomas) in the throat. About 4,000 deaths each year are attributed to HPV-associated cervical cancer. Unlike other types of cancers, however, some HPVrelated cancers can be prevented with a simple vaccine.

HPV is a virus that infects human skin and mucosal surfaces, which are present in body openings, around organs, and within some body cavities. It is transmitted through touch and is classified as a carcinogen (a substance that can cause cancer). Most people will be infected with at least one type of mucosal HPV at some point in their lives, but their immune system will fight it off over time. Those who don’t are at high risk for developing cancers of the mouth, throat, anus, penis, and cervix. The vaccine works by blocking the infection and preventing the HPV-related cancer from starting in the first place.

Common side effects are generally mild. Most insurance plans cover the cost of the vaccination.

when given to younger adolescents, which is why the American Academy of Pediatrics (AAP) recommends vaccinating children starting at 11 years. Children should have three doses by their 13th birthday (although recent recommendations may decrease the number of doses needed to only two). The goal is to have them immunized before they are ever exposed to the virus.

However, older teenagers and young adults benefit from the vaccine as well, which is why the AAP recommends those under age 27 who haven’t been vaccinated or who haven’t completed the series to follow up with their physician to ensure they are up to date.

As of 2014, only 40 percent of girls ages 13–17 and 21 percent of boys that same age have completed the series. We can and should do better.

Let’s stop HPV-related cancers before they start.

Overcoming bad publicity Immunizations get a lot of bad publicity by anti-vaccine advocates. However, they have been one of the most remarkable advances in all of medicine and have either eradicated or significantly reduced illnesses that in the past caused significant illness and death around the world. Even during my career as a pediatrician over the last 30-plus years, I have witnessed the dramatic decline in cases of meningitis caused by Haemophilus bacteria and pneumococcal infections since we began immunizing children against these diseases. Polio, which my cousin contracted in one of the last epidemics in the 1950s, and which left him paralyzed for the rest of his life, is almost gone in the entire world. Now we have the chance to accomplish similar results against certain types of cancer, and we need to take advantage of it.

This year, health care institutions and cancer centers

Across age groups Since its advent in 2006, there has been a 56 percent decrease in the prevalence of HPV strains covered by the vaccine (some strains are not covered by the vaccine).

HPV vaccine produces its most effective immune response

8

MINNESOTA HEALTH CARE NEWS NOVEMBER/DECEMBER 2016

across the country are teaming up to call upon Americans to act to prevent cancer. Take advantage of this opportunity to prevent a type of cancer by immunizing against it. Let’s stop HPV-related cancers before they start. Let’s set our kids up for the healthiest future possible.

rehabilitate a body, we start T owith the mind and soul.

If you or someone you know needs rehabilitation after an accident, surgery, illness or stroke, we have a simple premise for you to consider: To recover physically, you need support mentally and emotionally. How positive and how determined someone is can make all the difference. We believe the most effective therapy treats your body, mind and soul. That’s our approach.

Post-acute rehabilitation services from the Good Samaritan Society are offered at multiple inpatient and outpatient locations throughout Minnesota and the Minneapolis/St. Paul area.

To make a referral or for more information, call us at (888) GSS-CARE or visit www.good-sam.com/minnesota.

The Evangelical Lutheran Good Samaritan Society provides housing and services to qualified individuals without regard to race, color, religion, gender, disability, familial status, national origin or other protected statuses according to applicable federal, state or local laws. Some services may be provided by a third party. All faiths or beliefs are welcome. Š 2015 The Evangelical Lutheran Good Samaritan Society. All rights reserved. 15-G1553

NOVEMBER/DECEMBER 2016 MINNESOTA HEALTH CARE NEWS

9

10 QUESTIONS

Dermatology PHILLIP KEITH, MD, is a board-certified dermatologist with

Dermatology Consultants, a dermatology practice with offices in Eagan, St. Paul, Vadnais Heights, and Woodbury.

Dr. Keith completed his residency training at the Mayo Clinic and received his medical degree from the Medical College of Wisconsin. He is a member of the American Academy of Dermatology and the Minnesota Dermatological Society.

What are the most common disorders that affect our skin?

T

he most common disorders that affect our skin include contact dermatitis (rashes caused by direct contact with an irritant); infections; skin cancer; acne; psoriasis; and atopic dermatitis, which can affect the skin’s ability to retain moisture. The incidence of different skin disorders varies among patients of different ages, backgrounds, and occupations.

What are the most common conditions and diseases that lead to referrals from primary care doctors?

Primary care doctors most commonly refer patients who have atypical rashes, or those who have skin lesions suggestive of skin cancer. Dermatologists often see patients with acne, atopic dermatitis, or infections like warts that do not respond to over-the-counter or conventional therapies.

What are some of the most surprising things that patients do not know about dermatology?

Patients are often surprised to learn just how much dermatologists can offer them; dermatology is a medical specialty that requires unique specialty training after medical school. Dermatologists are skilled to diagnose and treat infections, autoimmune diseases, systemic diseases, and cancers. The skin is a unique organ that provides clues to diagnosing underlying diseases.

Patients are surprised to know that dermatologists do more than take care of acne and cosmetic concerns. While dermatologists are trained to perform cosmetic procedures, medical and surgical dermatology constitute the majority of most dermatologists’ clinical practice.

What are the warning signs of skin cancer?

Basal cell and squamous cell carcinoma most commonly present as new, atypical lesions or non-healing sores that itch, bleed, and do not go away. Melanoma often presents itself as a new, large, atypical, dark mole with irregular

10

MINNESOTA HEALTH CARE NEWS NOVEMBER/DECEMBER 2016

borders, but melanoma can sometimes present as a pre-existing mole that changes in appearance. It is important to make an appointment with your local dermatologist if you are concerned about a new or changing lesion that exhibits any of these features.

Please tell us about some of the advances in treating skin cancer.

There have been multiple advances in treating skin cancer over the last few decades. Surgical treatments are the standard of care for the vast majority of skin cancers. The most significant development is the evolution of Mohs micrographic surgery, which allows dermatologists to effectively treat the majority of cancers on the face with the highest cure rates. New systemic medications and chemotherapies tailored specifically to treat advanced basal cell carcinoma, squamous cell carcinoma, and melanoma have also come to the market.

Sometimes small superficial skin cancers can be treated with topical creams.

What role does genetics play in the conditions or diseases that require the care of a dermatologist?

Genetic alterations play a significant role in the causation of several diseases dermatologists frequently encounter. People who have a family history of psoriasis, atopic dermatitis, and acne have an increased risk of developing these diseases.

Those with a significant family history of skin cancer may also be at increased risk of skin cancer.

Genodermatoses—unique cutaneous diseases caused by genetic aberrations—present in infancy or early childhood, and dermatologists specialize in their diagnosis and treatment.

What are some of the lifestyle issues that can cause conditions or diseases that require the care of a dermatologist?

A person’s lifestyle or occupation can predispose them to certain skin conditions. Individuals who enjoy spending time at outdoor recreational activities may be at an increased risk of skin cancer if they do not protect themselves from the sun. Construction workers, mechanics, and hair stylists are prone to developing contact dermatitis because they are exposed to numerous chemicals. People who have significant sun exposure at work, such as airline pilots, police officers, and public works employees, may be

photo credit: Greg Christensen

at an increased risk of skin cancers. Health care workers such as nurses and patient care assistants are more prone to developing infections in the skin.

The skin is a unique organ that provides clues to diagnosing underlying diseases.

What are some of the most common skin conditions that patients suffer silently from, not knowing that they could be treated?

Acne is the most common skin condition that patients suffer in silence. Acne can significantly impact a teenager’s self-esteem and be a source of embarrassment. Dermatologists are skilled in handling all types of acne so this condition can be controlled quickly and effectively before scarring ensues. Patients are also sometimes hesitant to address conditions that affect the skin folds, genitalia, or buttocks. These conditions are often symptomatic and can be treated with the right topical medications.

How will advances in genomics and individualized medicine affect the field of dermatology?

We have learned a lot about the molecular pathways involved in the pathogenesis of diseases such as psoriasis in the last few years. New discoveries have led to the development of multiple new systemic medications. These medications are more effective than the systemic medications that were previously used to treat this disease. Research targeting the genes involved in melanoma has driven the development of new chemotherapy medications that treat patients with advanced cases. New advances in genomics and individualized medicine will help dermatologists tailor treatments to the needs of individual patients to maximize the efficacy of topical and systemic therapy.

What are the three most important things you’d like patients to know about their skin?

The three most important things patients should know are: the skin can be a window to a variety of underlying diseases that require a dermatologist’s expertise, skin is dynamic and changes with age, and the skin is a unique organ system that should be protected from the sun and maintained like other organs in the body.

NOVEMBER/DECEMBER 2016 MINNESOTA HEALTH CARE NEWS

11

CARDIOLOGY

Stress tests What they can—and can’t—tell us

By Elizabeth Klodas, MD, FACC

S

tress tests provide crucial information about how the heart

Blood and muscle

performs under heavy exercise, but these procedures—which

Your heart is predominantly a muscular organ that requires blood,

often see patients running on treadmills while connected to

just like all the other muscles in your body. The coronary arteries

cardiac monitors—cannot reveal all of the factors contributing to

provide the heart muscle with its own blood supply, allowing it to

heart disease and heart attacks. Before we can understand what

beat faster and harder when you need it to do so.

stress tests can and can’t tell us, it might help to understand the big picture.

Coronary artery disease (CAD), also known as atherosclerosis, is the process by which gunk (plaque) builds up in the walls of these small blood vessels. As more and more gunk builds up, the interior channel, or lumen, becomes progressively smaller. Eventually, the blood flow is insufficient to meet the demands of the heart muscle.

At that point, people start to experience chest pain or shortness of breath with activity.

Why? As we begin to get active, say with a brisk walk or run, our leg muscles demand a more robust blood supply to deliver extra oxygen and nutrients, causing our hearts to pump faster and with greater pressure. The heart muscle works harder and begins to make its own demands for blood.

To help meet that need, the coronary arteries dilate, causing the coronary artery lumen to increase in size and deliver more oxygen and nutrients to the heart muscle. Blood flow down normal coronary arteries can increase up to five times over flow at rest.

Normal exercise demands just a two- to three-fold increase in flow over the baseline, so we have a big reserve built in.

But as gunk narrows the arteries even further, the ability of the arteries to dilate enough to meet the demands of the heart muscle diminishes. The balance between supply and demand tips, and strenuous activities become difficult. Most people miss this early warning sign, since they simply don’t do much strenuous activity.

At some point, though, the deposits of gunk can reach the point where this balance tips earlier, and progressively less strenuous activities overwhelm the blood supply. Eventually, the interference with activities becomes noticeable enough that patients seek medical attention.

12

MINNESOTA HEALTH CARE NEWS NOVEMBER/DECEMBER 2016

Because we have such a big reserve to begin with, it takes a lot of arterial gunk to overwhelm the supply/demand balance— especially if our reduced activities don’t demand too much from the heart. By the time people feel chest pain or shortness of breath with activities, by the time they have an abnormal stress test, patients often have severe arterial blockages that have obstructed over 70 percent—even over 90 percent—of their lumen.

Taking the test This is why you may have known someone who was “fine” until they had a stress test—and then all of a sudden needed bypass surgery. It’s not that the heart disease developed overnight. Stress tests assess the supply/demand balance, and it takes quite a bit of build-up (blocking over 70 percent of the lumen) to overwhelm that balance and result in an abnormal stress test.

Stress tests measure how well your heart performs under increasing workloads—one indication that you are facing dangerous levels of arterial plaque or other potential heart concerns. The most common stress test places the patient on a treadmill, with walking speeds that increase slowly. An electrocardiogram (EKG) records heartbeat and heart waves using electrodes attached to the chest, arm, or shoulders, while a blood pressure cuff measures blood pressure. Patients may also be asked to breath into a tube to measure respiration.

Exercise stress tests are typically performed on patients with chest pain that does not appear be related to heart trouble and who are in low pre-test categories for significant coronary artery disease. They are more frequently given to men, since women with little arterial blockage may appear to “fail” the test.

A normal stress test…does not mean that you are free of coronary artery disease.

Treadmill stress echocardiograms can provide additional information. In these tests, the patient is also connected to a device that uses high-frequency sound waves to generate an image of the heart while exercising. These tests, as well as others that administer a dye to enhance imaging capability, can reveal more information about heart health than standard treadmill stress tests.

Heart attacks Many patients assume that the build-up of arterial plaque, carried to the extreme and slowly reaching a 100 percent blockage, is what causes a heart attack. Actually, this is not what happens. Heart attacks happen by a completely different mechanism involving a break in the endothelium.

covering the tissues that comprise the artery wall—much as skin covers the tissues of our hands. As gunk builds up inside the artery walls— any amount of gunk—the endothelium gets distorted and becomes more vulnerable to injury, to breaking down, and to sloughing.

So, as plaque builds up, it might not necessarily do so quietly.

Sometimes plaque deposits (even minor ones) will burst open into the lumen of the artery—like a boil bursting.

If the endothelium breaks down or the plaque bursts, the raw tissue underneath is exposed to the inside of the coronary artery, just as a burst boil on your hand would expose raw tissue to the air. The body would try to heal that raw tissue, forming a scab to isolate it from the environment and to allow both tissue and skin to grow back.

The process is similar on the inside of a coronary artery. If you slough/break down an area of your endothelium or burst a plaque “boil,” the body will recognize this as an injury and try to fix it. A little blood clot will form at the site to cover the raw area so it has a chance to heal and the endothelium has a chance to grow back.

That blood clot is the body’s equivalent of the scab on your hand.

Sress tests to page 34

It’s always

PERSONAL to us.

Personalized Assisted Living goes a long way toward optimizing the daily quality of life for our residents. If you have a loved one that needs a friendly environment with a personalized care plan designed just for them, call or visit a Brookdale Community near you. Because caring for our residents is what we do, and it’s always personal to us.

To learn more, visit us online at brookdale.com

The endothelium (en-dough-THEEL-yum) is the innermost lining inside the coronary arteries. It is a very thin, delicate layer of cells Alzheimer’s Association is a registered service mark of Alzheimer’s Disease and Related Disorders Association, Inc. ALL THE PLACES LIFE CAN GO is a trademark of Brookdale Senior Living Inc., Nashville, TN, USA. ®Reg. U.S. Patent and TM Office MNM3-RES20-0813 LMM

NOVEMBER/DECEMBER 2016 MINNESOTA HEALTH CARE NEWS

13

PEDIATRICS

Respiratory care Helping kids live at home

By Chad Muesing, RRT-NPS, LRT

J

oe is 9 years old. His favorite subject at school is science. Like other kids, he enjoys going places with his family and meeting new people, and he adores his two dogs.

But Joe also has Moebius syndrome, a rare neurological disorder that often causes respiratory problems. He breathes with help from an external ventilator, which connects to a permanent opening in his neck through a tracheostomy (trach) tube. He also uses a wheelchair and receives nutritional support, as well as occasional antibiotic infusion therapy.

Twenty years ago, many kids with major respiratory illnesses may not have survived. Today, many children just like Joe are living—and thriving—at home with their families.

Life-saving advancements in ventilators Pediatric respiratory therapists treat children with several illnesses and conditions, including those with neuromuscular disorders, premature babies whose lungs have not developed properly, and kids with congenital heart disease or chromosome abnormalities.

Technological advancements—particularly new generations of ventilators—have made it possible for these kids to live quality lives at home with their families, rather than in the hospital.

In the mid-1990s, ventilators weighed around 35 pounds.

Modern ventilators are less than half that—just 15 pounds— making them more portable. Newer vents also feature small external batteries—a vast improvement over the bulky car batterysized units of years past, which were difficult to fit onto wheelchairs and to transport. Portable vents allow kids like Joe to go to school, to restaurants, and to other places where kids without medical equipment can go.

In addition to being more reliable and efficient, today’s units also feature advanced custom setting modes such as air pressure support, pressure control, volume control, and BiPAP (Bilevel Positive Airway Pressure) or CPAP (Continuous Positive Airway Pressure).

The coordinated care plan Moving a child with respiratory care needs from hospital to home requires a coordinated care plan involving many individuals, often with the support of a professional home care company. Such plans start at the hospital, when a physician decides that the child can go home. The hospital discharge coordinator contacts the home care provider, which will determine what services are needed. Many respiratory patients also require additional services, including infusion nursing (intravenous administration of medications and

14

MINNESOTA HEALTH CARE NEWS NOVEMBER/DECEMBER 2016

fluids), pharmacy, home care nursing, feeding support, and social work. Selecting a home care agency that can provide all necessary services makes coordinated care that much easier.

Sometimes suctioning can cause small amounts of bleeding.

Caregivers can control this bleeding by adjusting suction depth or by changing other care practices that may have triggered the

Many children with complex respiratory needs require some home care nursing (for example, Joe has a home care nurse for around eight hours each day), but families often provide care as well.

Before a child leaves the hospital, a clinician or nurse trains parents and other caregivers to provide care at home. The goal is to make sure the family is familiar and comfortable with all equipment and therapies. Training continues after a child is discharged, when a respiratory therapist meets the family at home to review equipment and training materials specific to their child’s needs.

problem. Bleeding can also be caused by fragile blood vessels

To ensure that a family’s home is safe for their child and their needs, the home care provider will do a home assessment. During the visit, the provider will check for potential issues, such as safe operation of medical equipment in the home’s outlets and storage of prescribed medications, supplies, and formula. They will also create an emergency backup plan in case of extended power outages or severe weather. All information is shared with the family and the child’s primary physician(s). The family, home care agency, and physician will work together to address any concerns before care begins.

including nasal hair and mucus membranes. Infections can also

(granulation tissue) generated by the body as it attempts to close the trach wound. While it is nearly impossible to prevent, granulation tissue can make trach tube changes more difficult and can lead to infection. Granulation tissue at the trach site can be removed with creams; however, removing granulation tissue in the trachea typically requires laser surgery.

Kids with trach tubes are at high risk for respiratory infections because the air they breathe bypasses the body’s natural defenses, occur at the stoma (trach tube site). A home care company that offers infusion therapy in addition to respiratory therapy can be very advantageous. For example, when Joe has an infection that requires antibiotic infusion, our Pediatric Home Service infusion team goes to Joe’s home to administer the medication. This keeps him at home rather than in the hospital or in outpatient care, where he could miss school.

Respiratory care to page 32

Home respiratory therapists and nurses are the physician’s eyes and ears.

After the child moves from hospital to home, continued collaboration is crucial. Home respiratory therapists and nurses are the physician’s eyes and ears, carrying out physician orders in the home and adjusting equipment settings to better serve the patient.

Care conferences with a child’s entire medical team—from the primary care physician and respiratory therapist to pharmacists, social workers, home care nurses, and dietitians—ensure a continuum of care.

Minimizing the risks of home ventilation Home ventilation carries some risks that must be minimized under the coordinated care plan. The most common risks include trach tube obstruction from mucus plugging, tracheal bleeding, infection, and accidental removal of the trach tube (decannulation).

When a child has a trach tube, the air they breathe bypasses the upper airway, where it would normally be warmed, cleaned, and moistened. Since the air moving through the tube is bypassing the upper airway, the body naturally produces more mucus. It takes only minutes for this mucus to obstruct and plug the airways, so children on ventilators need to be closely monitored for signs of airway obstruction. Every situation is different, but typically a child’s trach tube requires suctioning to remove mucus every four to six hours.

NOVEMBER/DECEMBER 2016 MINNESOTA HEALTH CARE NEWS

15

ONCOLOGY

Breast cancer A look at new screening guidelines

By Dana Carlson, MD

S

urvival rates for breast cancer patients have improved substantially over the past several years, in large part due to early diagnosis, new treatment options, and advances in genetics. At the same time, popular press coverage regarding the timeline and frequency of routine mammograms—low-dose X-ray imaging tests used to detect breast cancer in its early stages—may have created confusion and uncertainty. The good news is that breast cancer survival rates are high, and the benefits of early

detection and treatment outweigh the risks presented by invasive breast cancer (which grows into normal, healthy tissues) and noninvasive breast cancer (which remains within the milk ducts).

Numbers and hope Breast cancer is the most common cancer in American women of all races and ethnicities, with nearly 300,000 new diagnoses expected this year. An additional 2,600 new cases of invasive breast cancer in men are expected. Breast cancer is also the most common cause of death from cancer among Hispanic women, and the second most common cause of death among white, black, and Asian-Pacific Islander women.

Breast cancer is the most common cancer in American women.

While these numbers are alarming, overall survival rates are very good. There are currently more than 2.8 million women with a history of breast cancer in the United States. This includes women currently being treated as well as women who have completed treatment. Overall long-term survival rates for breast cancer approach 80 percent, and are even higher in women with noninvasive cancer and early stage invasive cancer. The average 5-year survival rate for people with breast cancer is 89 percent. The 10year rate is 83 percent, and the 15-year rate is 78 percent. Improved survival is attributed to a decrease in post-menopausal estrogen use, increased screening, and better treatment options.

Risks and prevention Men can develop breast cancer, but the risk is much higher for woman. In addition to gender, the most significant risk factor for developing breast cancer is growing older. Most women who get breast cancer (more than 85 percent) do not have a family member with the disease, but their risk does rise if they have a first-degree relative (a mother, sister, or daughter) who has been diagnosed with breast cancer.

16

MINNESOTA HEALTH CARE NEWS NOVEMBER/DECEMBER 2016

The best overall preventive measure for breast cancer is to reduce other known risk factors as much as possible. Avoid weight gain and obesity, engage in regular physical activity, and minimize alcohol intake.

right decision for all women. Some women may wish to start screening early due to family history of early onset breast cancer. Other women may have significant health issues and may choose to delay or minimize screening. As with other preventive health measures, a discussion with your provider after assessing for risk is recommended.

Genetics About 5–10 percent of breast cancers can be attributed to mutated forms of the BRCA1 or BRCA2 genes, which may be inherited from either parent. Women born with these mutated genes have a 45–65 percent lifetime risk of developing breast cancer, and many of these cancers occur in younger women.

The same genetic mutations also increase the risk of ovarian cancer. It is important for families to consider genetic counseling if there is a family history of ovarian and/or breast cancer, especially if it occurs in multiple family members or in individual family members under the age of 50. Genetic testing starts with a simple blood test, often covered by insurance, followed by consultation with a physician and genetic counselor to shape decisions regarding

Screening recommendations Below is a summary of breast cancer screening recommendations from leading medical societies. These recommendations are for women over age 40 of average risk (no personal or family history of breast cancer, no previously diagnosed high-risk lesion, no known genetic mutation, no history of chest radiation at a young age).

Women who are considered to be at higher risk should consult their health care provider.

Additional recommendations The American Society of Breast Surgeons recently released five recommendations as part of Choosing Wisely, an initiative of the

cancer screening, prevention, and treatment.

USPSTF and American Academy of Family Physicians New recommendations on clinic and self-exams Physical exams—either at home or in the doctor’s office—were once considered helpful in detecting early signs of breast cancer.

Several medical societies now recommend against such exams, in part because studies have not demonstrated a clear benefit.

As with any medical matter, you should discuss any changes in your physical health or other concerns with your physician.

Mammography: risks, benefits, and controversy In 2009, the U.S. Preventive Services Task Force (USPSTF) recommended against regular breast cancer screenings for women aged 40–49 years—the first such change to annual screening recommendations. The result was a flurry of outrage from the public and many medical societies. These guidelines were based on current scientific evidence at that time, but there was great skepticism in

< 50:

i ndividual decision to start screening and to determine frequency

50–74: biennial mammograms 75+:

insufficient evidence to make a recommendation

American Cancer Society 40–44: i ndividual decision to start annual screenings with mammograms 45–54: recommended annual mammograms 55+: m ammograms every two years; annual screenings optional Life expectancy of 10 years or more: continue screening healthy patients American College of Radiology yearly mammography

both the medical community and general public as to the methods,

40+:

motivation, and end points of these recommendations. Despite

American Society of Clinical Oncology

these more restrictive recommendations, most women continued to have yearly mammograms.

The guidelines were revised in February 2016 and have begun to be more widely accepted, but controversy still exists, leaving

< 40:

omen with special concerns encouraged w to discuss needs with providers

40+:

iscuss individual risks and benefits with providers d and decide whether mammography screening is appropriate

women confused about what they should do for breast cancer screening. Most medical professionals agree that for women under the age of 50, the decision of when to start screening mammograms and how often to screen should be an individual one.

Women should discuss their risk factors, including family history, personal breast and medical history, and breast density in determining the right screening recommendations for them. Most women will choose annual screening starting at age 40. While this is widely accepted and encouraged by many medical societies, it may not be the

American Society of Breast Surgeons (ASBrS) 40–44: discuss risks and benefits of beginning mammography 45–54: annual mammogram screening 55–74+: a nnual or biennial screening based on a discussion of risks and benefits 75+:

iennial screening if estimated life expectancy b exceeds 10 years

Breast cancer to page 19 NOVEMBER/DECEMBER 2016 MINNESOTA HEALTH CARE NEWS

17

STOMACH CANCER AWARENESS MONTH Stomach (gastric) cancer is the fifth most common type of cancer worldwide, with about one million new cases each year. It is the third most common cause of cancer deaths. During the month of November, No Stomach For Cancer and other organizations work to increase awareness about stomach cancer risk factors and prevention strategies.

CALENDAR

DECEMBER ‘16 / JANUARY ‘17

DEC. 6

12

Melanoma Support Group

Allina Health hosts this monthly group meeting for people who have been diagnosed with melanoma and their families to share experiences and gain support from others.

The group is primarily aimed at stage III and IV melanoma, but anyone is welcome. Call (763) 236-5607 for more information.

Factors that may increase the risk for developing stomach cancer include tobacco use, obesity, and diets low in fresh produce, as well as being over the age of 50, being male, having blood type A, and having a family history of certain cancers. Making lifestyle changes such as quitting tobacco products and eating a healthier diet can potentially reduce the risk of developing stomach cancer, along with knowing your family history and discussing it with your doctor to determine if you are at risk for inherited cancers.

Tuesday, Dec. 6, 6:30–8 p.m., Virginia Piper Cancer Institute–Unity Hospital, 550 Osborne Rd., Fridley

Typically, stomach cancer grows very slowly over the course of several years with few, or no symptoms, making early detection very difficult. It may present with vague gastrointestinal symptoms that can also be associated with other illnesses. It’s important to speak to your doctor if the symptoms don’t go away or get worse.

Tuesday, Dec. 6, 3–4:30 p.m., Methodist Hospital Women’s Center, 5th Floor, 6500 Excelsior Blvd., St. Louis Park

DEC. 13

Cancer Support Group

Minnesota Oncology hosts this monthly support group for anyone with esophageal, gastric, or head and neck cancers and their loved ones. Come share questions and concerns with others who are experiencing a similar diagnosis. The group is led by a licensed psychologist and an oncology registered nurse. For more information, call Jessica at (612) 863-4648.

Tuesday, Dec. 13, 3–4:30 p.m., Abbott Northwestern Hospital—Piper Building, 6th Flr., Ste. 602 Conference Rm., 913 E. 26th St., Minneapolis

6

Varicose Vein Screening

Park Nicollet offers free screenings for anyone bothered by visible, bulging veins in their legs that cause pain, swelling, or cramping.

Surgeons will perform the screening and recommend a course of action. Those covered

by Medicare or Medicaid are not eligible due to federal regulations. Call (952) 993-2651 to schedule your screening.

8

Brain Aneurysm Support Group

HealthEast invites people dealing with a brain aneurysm and their loved ones to join this free monthly support group to share experiences and learn more about brain aneurysms.

Registration not required. Call Tess at (651) 3263415 for more information.

Thursday, Dec. 8, 12:30–2 p.m., St. Joseph’s Hospital, dePaul Tower 2nd Flr., 3M Conference Ctr., Conference Rm. C/D, 45 W. 10th St., St. Paul

8

Tai Chi Chih Class

Special Education

PACER Center hosts this free workshop for parents of children with special needs.

Come learn about 10 important areas in special education and how they can be used to help your child be more successful. To sign up or for more information, call (952) 838-9000.

Monday, Dec. 12, 6:30–8:30 p.m., PACER Center, 8161 Normandale Blvd., Minneapolis

17

Ataxia Social Group

The National Ataxia Foundation offers this free social group for people living with ataxia, their family members, and friends. Join others who understand, make new connections, and gain new insights.

Call Lenore at (612) 724-3784 for more information.

Saturday, Dec. 17, 10–11:30 a.m., Langton Place, 1910 Cty. Rd. D W., Roseville

19

Effects of the Mediterranean Diet

The University of Minnesota School of Public Health hosts this free seminar about the effects of the Mediterranean diet on health outcomes.

Hannah Bloomfield, MD, MPH, will present on the topic. For more information, call (612) 624-6669.

Monday, Dec. 19, 12–1 p.m., University of Minnesota Mayo Memorial Building, Rm. 1155, 420 Delaware St. SE, Minneapolis

JAN. 5

Health Insurance Counseling for Seniors

The Lupus Foundation of Minnesota offers this free tai chi chih class specially designed for people living with lupus and other autoimmune diseases. Tai chi chih is a meditative, gentle form of exercise that can reduce fatigue, stress, and joint pain, and increase energy, circulation, and balance. For more information or to sign up, call Sandy at (952) 746-5151, ext. 105.

The Metropolitan Area Agency on Aging and Hennepin County Library host free sessions for seniors with a certified state health insurance counselor to assist with enrollment steps, plan choices, and determine low-income subsidies.

Sessions are private and are limited to one individual or couple per session. Other dates, times, and locations available. For more information or to sign up, call (612) 543-8400.

Thursday, Dec. 8, 6:30–8 p.m., St. Louis Park City Hall–Community Rm., 5005 Minnetonka Blvd., St. Louis Park

Thursday, Jan. 5, 10–11:30 a.m. or 11:30 a.m.–1 p.m., Walker Library, 2880 Hennepin Ave., Minneapolis

Send us your news: We welcome your input. If you have an event you would like to submit for our calendar, please send your submission to MPP/Calendar, 2812 E. 26th St., Minneapolis, MN 55406.

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

America’s leading source of health information online 18

MINNESOTA HEALTH CARE NEWS NOVEMBER/DECEMBER 2016

Breast cancer from page 17

American Board of Internal Medicine (ABIM) Foundation and Consumer Reports. This list of evidence-based recommendations about what care is really necessary is intended to help patients and physicians discuss treatment options and make informed choices about their health. If you have been diagnosed with breast cancer, you should review these five recommendations with your health care provider. Choosing Wisely recommends against:

4. Routinely re-operating on patients with invasive cancer if

the cancer is close to the edge of the excised lumpectomy tissue.

Research has shown that obtaining more tissue around an invasive tumor does not decrease risk of recurrence nor improve survival.

Overall long-term survival rates for breast cancer approach 80 percent.

1. Routine breast MRIs in new breast cancer patients. MRI may

be appropriate for select patients, but this can lead to further unnecessary imaging, biopsies, anxiety, and over treatment without proven benefit in reducing risk of recurrence or improving survival from breast cancer.

2. Routinely excising all lymph nodes beneath the arm in patients having lumpectomy for breast cancer. Sentinel lymph node biopsy (removal of select lymph nodes with highest probability of showing whether a cancer has metastasized) is the standard first procedure for evaluating lymph nodes in breast cancer.

5. Routinely performing a double mastectomy in patients

who have a single breast with cancer. With the exception of highrisk patients (young age, extensive family history, known BRCA gene mutation), the majority of patients with breast cancer obtain no benefit from removal of a healthy breast.

Visit ht t p: //tiny u rl.com / HC N2016 - 02 for add itional background on these recommendations.

3. Routine specialized tumor gene testing in all new breast

cancer patients. Tests such as Oncotype DX, which can help determine which patients will receive the greatest benefit from chemotherapy, should be considered only after a full discussion of treatment options.

Dana Carlson, MD, is a board-certified general surgeon and the medical director of North Memorial Health Careâ&#x20AC;&#x2122;s Breast Health Program. Her practice involves all aspects of general surgery, with an emphasis on breast surgery.

NOVEMBER/DECEMBER 2016 MINNESOTA HEALTH CARE NEWS

19

HEALTH INSUR ANCE

Demystifying Medicare Maximize your coverage

By Tom von Sternberg, MD

B

y the end of the decade, the United States will have more people over age 65 than in K–12 education. That milestone could mean retirement or other pursuits, but it also marks

the day you become eligible for Medicare, the federal government’s health insurance program. Medicare tries to make your options simple with names like Part A and Part B, but the reality is a bit more complicated.

The basics Funded primarily by payroll taxes, Medicare helps older individuals pay for doctor visits, hospital stays, surgeries, and other health care expenses. You can receive Medicare if you’re over 65, a U.S. citizen or legal resident, and/or the spouse of one. You must have worked in the U.S. long enough to be eligible for Social Security or railroad retirement benefits.

Each time you receive a paycheck during your working years, you pay taxes that will one day provide two key federal benefits: Part A (hospital coverage). The first part of Original Medicare covers hospital stays, home health care visits, and skilled nursing facilities.

Part B (medical coverage). The second part of Original Medicare covers doctor visits, outpatient medical services (care you receive without being admitted to a hospital), and screenings used to detect disease.

Expanding your coverage Many people find that Original Medicare isn’t enough, and purchase private plans to cover needs such as prescription drugs, dental care, routine eye and hearing exams, diabetic supplies, and acupuncture. Private plans include: Part C (Medicare Advantage plans). Run by private health plans, Part C provides all of your Part A (hospital insurance) and Part B (medical insurance) plus additional benefits. You usually pay less out-of-pocket than you would if you only had Part A and B. Medicare Cost plans. Offered by private health plans, these cover all Part B (medical) services, and often include additional coverage for Part A (hospital) services, as well as other benefits such as prescription drug coverage (Medicare Part D). These plans are only available in certain areas of the country, including Minnesota.

Medigap (Medicare supplement) plans. Offered by private health plans to fill in the coverage “gaps” left by Original Medicare,

20

MINNESOTA HEALTH CARE NEWS NOVEMBER/DECEMBER 2016

these supplemental plans pay some or all of the expenses not covered

by Medicare Parts A and B. Part D (prescription drug plans). This prescription drug coverage works with the medical plan of your choice—whether you buy Original Medicare from the government or opt for a private Medicare Advantage or Cost plan. Part D is only offered through private health plans.

Private plans help lower your personal costs in two ways. Unlike Original Medicare, most private plans have a defined annual outof-pocket-maximum. In addition, private plans replace most of the Original Medicare co-insurance costs with defined copays. Under Part B alone, you might pay 20 percent for a trip to a specialist ($200 for a $1,000 charge, for example). Under a private health plan with a defined copay, that could be a fixed charge of $40.

Too many patients misunderstand the benefits and end up spending unnecessarily on their care. Don’t learn the hard way.

Understand what’s covered and not covered by Parts A and B, and decide which private plan is right for you.

Before you can sign up for a private Medicare plan, you first need to enroll in Original Medicare. If you’re receiving Social Security benefits, you should get your Medicare card in the mail from the Social Security Administration (SSA) three months before you turn 65.

5-star plans. The Medicare Star Rating assigns each plan from one to five stars, with five being the highest rating. The rating is based on plan performance in several categories, including member experience and quality of care. HealthPartners Freedom (Cost) plan received an Overall 5 Star Rating from CMS in 2016 and 2017, and is the only health plan in Minnesota to receive this rating.

If you want to switch to a 5-star plan in your area, you can do it one time between Dec. 8 and Nov. 30 of the following year.

Special enrollment periods. Certain life changes make you eligible to change your plan: • Relocation outside the areas where your current plan is offered • Loss of current employer coverage • Qualifying for extra help paying for your plan For other special cases, visit www.medicare.gov.

Switching from one Medicare plan to another If you don’t have prescription drug (Part D) coverage, you can enroll in a Cost-medical only plan (no Part D) at any time, even outside of annual enrollment.

Demystifying Medicare to page 25

Check first to confirm that your doctors will be covered.

Enrolling for Medicare You have a seven-month window to enroll initially in Medicare— the three months before you turn 65, the month you turn 65, and the three months after. During this window, you can enroll in Parts A and B, or in a Medicare Advantage or Cost plan and/or Medicare Part D (prescription drug coverage). Most retirees sign up for private plans on their own; however, some employers offer private plans to their retirees and can help you review your options.

If you don’t enroll when you’re first eligible, you may end up paying a late penalty when you sign up later for Medicare Part B and/or D. You can delay your Part B (medical coverage) enrollment without penalty if you have health insurance through a current job or are a dependent on your spouse’s active plan. Once the last spouse stops working, you have eight months to sign up for Part B. Switching Medicare plans You can change your Medicare plan each year during Annual Enrollment Period (AEP), between Oct. 15 and Dec. 7. You usually can’t make changes to your plan outside of this window, but there are some exceptions:

NOVEMBER/DECEMBER 2016 MINNESOTA HEALTH CARE NEWS

21

AUDIOLOGY

Hearing aids Advances change lives

By Jason R. Leyendecker, AuD

M

odern hearing aid technology allows people to do much more than enjoy television or communicate one-on-one.

In a survey of hearing aid users conducted by the Better Hearing Institute, respondents said that their devices have positive impacts on their relationships, work performance, general ability to communicate, overall quality of life, and ability to participate in group activities, reporting satisfaction levels of 81 percent with their devices. But some consumers are still overwhelmed by the

process of selecting a device that matches their unique needs. Let’s start with the basics.

Three categories There are three main types of hearing loss: Conductive hearing loss stems from conditions or diseases that stop or reduce the amount of sound that can transfer from the outer and middle ear into the inner ear, where it is processed and transmitted to the brain. Conductive hearing loss is typically treated with surgical or medicinal intervention by an otolaryngologist or ENT (ear, nose, and throat physician). Examples of conductive hearing loss include wax impaction in the ear canal or ear infections that obstruct sound. While uncommon, hearing aids can be used to treat conductive hearing loss.

Sensorineural hearing loss refers to the areas involving the sensory and neural regions of the ear. This type of hearing loss, which produces permanent nerve damage to the inner ear, is treated with hearing aid technology.

Mixed hearing loss combines a middle ear (conductive) and an inner ear (sensorineural) hearing loss. For example, a patient might have sensorineural loss following 30 years of working as a mechanic in a loud repair shop, coupled with a conductive loss caused by heavy wax impaction. This patient would be treated first for the conductive loss to determine an accurate level of remaining hearing and to determine the optimal hearing aid solution.

Other concerns Tinnitus is a symptom of hearing loss where the ear is not sending sound to the brain consistently, producing false impressions of ringing or buzzing. When the inner ear nerve breaks down, our brain creates these signals in an effort to recreate the consistency of a signal it believes “should” be present. This is similar to phantom pain, where a person may perceive pain or movement after losing

22

MINNESOTA HEALTH CARE NEWS NOVEMBER/DECEMBER 2016

a limb. Tinnitus could be a sign that you have hearing damage or

ensure that you have ruled out any of the concerns we discussed

another potential medical concern. It is a good idea to get your

earlier. Once you’ve consulted with your physician, it’s best to see

hearing tested if you hear ringing or buzzing consistently. If you

an audiologist for a full diagnostic hearing exam. They can assist

do have tinnitus, a hearing aid might help by amplifying sound,

in determining the type of hearing loss you have, and give you the

adjusting certain pitches, or screening out background sounds.

best recommendation for amplification if needed.

In addition to hearing, balance is the main reason we have

Once medical clearance is achieved, and it has been determined

ears. The balance mechanism involves a series of fluid-filled canals

that hearing aids are in order, I recommend finding a clinic that

that tell the body whether it is moving or has stopped. If you are

offers multiple brands and uses software that is adjustable in any

concerned about your balance, or if you often feel dizzy, consult your primary doctor or an ENT for an evaluation. For Minnesotans, the risk of falling is already high due to snow and ice. People with a mild hearing loss are nearly three times more likely to fall than

Untreated hearing loss can increase your risk of dementia.

those with no hearing loss. More significant hearing losses increase the risk of falling tremendously. clinic—not just to achieve the best fit, but to tweak settings to Onset and impacts

produce the best individual results. There are a number of clinics

Hearing loss develops slowly and usually doesn’t show signs

that work with only one brand of technology, requiring you to visit

until it is well beyond the level that might have called for

only their clinics to get your device adjusted. There is no one best

amplification. Some early signs include asking people to repeat

hearing technology that works for everyone, so finding a clinic with

themselves frequently, or having trouble following conversations

a variety of options gives you the best value for your specific needs.

involving more than two people. You may also believe that people are mumbling more, or that they sound muffled. Women’s and children’s voices may be more difficult than men’s to hear or

Hearing aids to page 24

understand. If you have to turn the television up to levels that are too loud for others in the room, you may also be experiencing the early signs of hearing loss.

Hearing loss has a greater impact on quality of life than what we might think. Trouble with hearing reduces confidence, which can lead to depression and anxiety. Diabetics are more than two times more likely than non-diabetics to have hearing loss. Your risk of heart-related diseases is significantly higher if you have untreated hearing loss.

Recent research has identified another serious concern: A direct connection between untreated hearing loss and cognitive decline.

Untreated hearing loss can increase your risk of dementia by 30–40 percent—a risk that can be slowed or reduced significantly with the use of hearing aids. The culprit? When we start showing signs of hearing loss, we start to use our brains less. We don’t engage in conversations as we once did, and as it becomes more difficult to communicate, we shut down. We may nod and smile when we have no idea what has been said. If we don’t actively use our cognitive skills, we may lose them.

Getting started When it comes to taking care of your hearing health, primary physicians are the place to start. They are the gatekeepers for your health and can point you in the right direction. Hearing loss is a medical condition and should be looked at medically first to NOVEMBER/DECEMBER 2016 MINNESOTA HEALTH CARE NEWS

23

Hearing aids from page 23

programmed for the patient’s hearing loss. This huge range of technology also creates a huge range of costs. It is important to find the best technology for you that also fits your budget and lifestyle.

The good news is that almost all major hearing aid manufacturers offer advanced technology. The traditional behind-the-ear devices are still on the market, with some that deliver sound via an unobtrusive receiver in the ear canal. Other units fit completely within the ear or in the ear canal, making them far less visible to other people. There are even completely invisible technologies that can stay in the ear for 6–8 weeks at a time.

Expect some trial and error, though, as you grow familiar with your new hearing aid and its features.

Conclusion Hearing technology can be overwhelming, but your audiologist will walk you through the selection and configuration process to produce successful results. As great as the technology is today, it is still important to realize that this is an interactive process. Take the time to work with your hearing professional to get things right. They know how to program the technology to meet your needs, but it takes working together to know how the

Hearing loss develops slowly.

This last unit meets the needs of those who want a truly invisible device, but it utilizes analog technology, which can only amplify existing sounds. Most current technology today is digital, which is more adjustable to the patient’s needs and to their hearing loss. Digital information can be adjusted to separate levels of volume and pitch, achieving results that are more crisp and more natural-sounding than would have been possible just 10 years ago.

Communication with today’s hearing technology can be a breeze due to Bluetooth connections. It is possible to hear a phone conversation directly through the hearing aids, while still being

24

MINNESOTA HEALTH CARE NEWS NOVEMBER/DECEMBER 2016

programing should be set. You can be successful with hearing aids.

Jason R. Leyendecker, AuD, is a licensed audiologist practicing at Audiology Concepts, Inc., in Edina. He also practices at the Tinnitus and Hyperacusis Clinic in Edina. An adjunct assistant professor for A.T. Still University in Mesa, Arizona, he is a member of the American Academy of Audiology and the Academy of Doctors of Audiology.

Demystifying Medicare from page 21

from the company can walk you through the plan options offered by their company and answer your questions. It’s a great place to

You can also disenroll from a Cost-medical only plan at any time. This means you can switch from one Cost-medical to another Cost medical plan.

You can also leave a Cost plan and join Original Medicare.

learn more about Medicare and get one-on-one time with a trusted source. Most companies post their community meetings on their website.

Start now

When you make a change to your enrollment, it is effective the first

It’s never too soon to research and get comfortable with Medicare.

day of the following month.

Think about the amount of care you’re getting now to better understand the type of care and coverage you may need in the future.

It’s never too soon to research and get comfortable with Medicare.

Make sure you choose a plan, and a company, that fits your lifestyle and health needs and offers the service and support you need.

It may not be as easy as ABC, but there are plenty of resources

One other note: If you have Part D drug coverage, you most

and companies available to help you with your search.

likely will be locked into your plan for one year. If that’s the case, check to see if one of the enrollment periods listed above might apply.

Tom von Sternberg, MD, is the senior medical director of geriatrics, home care, hospice, and case management for HealthPartners. He has been practicing as a geriatrician for over 30 years. He also contributes regularly to

If you want to change your plan:

the HealthPartners Medicare blog.

• Contact your current health insurance company for help.

• Visit www.medicare.gov or call Medicare at 1-800-633-4227 to see if you’re eligible, or to discuss your enrollment status.

• Work with a licensed health insurance broker or agent.

Tools and resources The Medicare Plan Finder on www.medicare.gov allows users to research and compare options. Unlike private plan websites, it compares how separate plans stack up against each other.

Once you find a plan that suits your needs, go to the private health plan websites. Dig deeper to determine benefit levels, which are the maximum amount a health insurance company will pay for a specific benefit. And learn more about plan offerings and any extras that may be included, such as fitness benefits or discounts.

Want to keep your favorite doctors? Visit Physician Compare on www.medicare.gov. If you choose a private plan, check first to confirm that your doctors will be covered. Providers who accept Medicare may be listed as “Medicare certified” or “accepting Medicare assignment.”

Understanding

Medicare

often

requires

some

human

interaction. Talk to private insurance companies about their plans and press them to help you understand all of your options.

Most health insurance companies that offer Medicare plans host informational meetings around your area. A Medicare expert

NOVEMBER/DECEMBER 2016 MINNESOTA HEALTH CARE NEWS

25

OPHTHALMOLOGY

Glaucoma Preventing vision loss

By Elena Bitrian, MD

G

laucoma is one of the leading causes of irreversible

brain. Light enters the eye, travels through the pupil, and reaches

blindness in the United States. It causes damage in

the retina (the inner layer on the inside wall of the eye). The optic

the optic nerve and can produce loss of vision. With

nerve carries images to the brain.

early detection and treatment, however, vision loss can often be prevented.

Eye anatomy The eye is an organ that perceives images and transmits them to the

The eye contains two different types of fluids: aqueous humor and vitreous humor. The anterior part of the eyeâ&#x20AC;&#x201D;the front third portion containing the cornea, iris, ciliary body, and lensâ&#x20AC;&#x201D;is filled with aqueous humor, and new amounts of this fluid are produced every day.

The amount of fluid produced needs to be equal to the amount of fluid that leaves the eye through the drainage area, which is known as the angle. If the amount of aqueous fluid produced is higher than the amount that leaves the eye, the fluid pressure within the eye (intraocular pressure, or IOP) will increase.

If the pressure in the eye is high for an extended period of time, damage to the optic nerve will occur. The higher the intraocular pressure is and the longer it remains elevated, the more likely it is that the nerve will be damaged.

What causes glaucoma?

Glaucoma is usually, but not always, associated with elevated pressure in the eye. In the past, intraocular pressure was considered to be normal if it was lower than or equal to 21 mmHg. However, we now know that adequate and safe levels of pressure must be individualized for each patient, based on the level of pressure that their eyes can tolerate without being damaged. Your ophthalmologist can determine the pressure that is adequate for you by performing an eye exam and some tests.

Some people with high pressure do not develop glaucoma (we call this ocular hypertension), and some people develop glaucoma without having high pressure (we call this normal tension glaucoma).

26

MINNESOTA HEALTH CARE NEWS NOVEMBER/DECEMBER 2016

Whether you develop glaucoma depends on the level of pressure that your optic nerve can tolerate.

Types of glaucoma

What to expect in an eye exam Your vision will be checked in each eye individually. The side vision will also be checked. Expect your examination to include:

Glaucoma can be divided into open angle and closed angle glaucoma (also known as angle closure glaucoma).

Open angle glaucoma, the most common type, initially has no symptoms and does not produce pain. The drainage angle remains

Glaucoma is one of the leading causes of irreversible blindness.

open, but is partially blocked by tissue located near the base of the cornea, causing fluid pressure to build. The first symptoms— appearing after the optic nerve has already been damaged—can

Visual field test. A technician will cover your left eye first to

be blind areas in the peripheral vision. Advanced cases will present

allow testing the side vision in your right eye. A machine will test

with tunnel vision, where only the central vision remains and the

your ability to discern lights on the side of your vision. When a

peripheral vision is lost.

light is presented, you will be asked to press a button. This will

Acute angle closure glaucoma, in which the drainage angle

help identify areas that are not able to see light as clearly as others.

is blocked, produces pain in the eye, headache, red eye, nausea,

Slit lamp exam. Your ophthalmologist will ask you to position

blurred vision, and halos around lights.

Risk factors Anyone can develop glaucoma, but some people are at higher risk

your head in a machine that allows him or her to see the different structures of the eye under magnification. Your doctor will examine the front part of the eye and the drainage of the eye.

than others. Risk factors include: • Age. Patients older than 40 should have their IOP checked and their eyes tested by an ophthalmologist.

Glaucoma to page 31

• Family history. Glaucoma runs in families and it is recommended to have an eye exam at age 40 if you have family members with glaucoma. This could help diagnose the disease early on and prevent damage to your vision.

• Race. Some races are more susceptible to glaucoma damage than others. For example, African American and Hispanic people have a higher incidence of glaucoma and often have faster progression.

• Other conditions. Glaucoma can be associated with other eye and systemic medical conditions, such as myopia (nearsightedness) and diabetes.

Stopping and slowing damage Prevention is essential in glaucoma. The damage produced by glaucoma is irreversible, so early diagnosis and treatment are crucial.

Treatment can stop or slow down the progression of damage.

It is extremely important to test for and to detect glaucoma early, because patients with open angle glaucoma do not have pain or discomfort in their eyes, and may not be aware that their vision is at risk. By the time someone experiences physical signs of glaucoma, usually 50 percent of the optic nerve has already been damaged. This is why having a screening eye exam is important.

NOVEMBER/DECEMBER 2016 MINNESOTA HEALTH CARE NEWS

27

R ADIOLOGY

Addiction and relapse Brain imaging suggests new hope

By Jazmin Camchong, PhD, Kelvin Lim, MD, and Kathryn Cullen, MD

P

eople suffering from mental illness and addiction often show signs of distinct brain abnormalities, raising hopes that we might uncover “biomarkers”—measurable indicators of disease—that could help us treat those in need. The very complexity of the brain has complicated this effort to date, but ongoing research at the University of Minnesota now shows promise. Using imaging techniques and brain stimulation, this research could enhance our ability to assess and to treat psychiatric disorders such as addiction,

schizophrenia, and depression, leading to novel new treatment approaches, particularly for disorders with low rates of successful recovery.

The cost of addiction and relapse Addiction is one such disorder. Addiction costs the nation more than $700 billion each year in the form of crime, lost work productivity, and health care costs. The National Survey on Drug Use and Health estimates that, as of 2013, more than 22 million Americans had sought treatment for drug or alcohol abuse. Opioid addiction, in particular, has grown sharply in the last decade. In less than 20 years, opioid overdose deaths have almost quadrupled, with more than 28,000 deaths in 2014 alone. Some patients overcome their addictions, but too many of them—40 to 60 percent, according to the National Institute on Drug Abuse—will relapse, returning to their patterns of substance abuse, endangering their health, and, often, risking their lives.

Since each person and each case history is different, it is urgent to identify subgroups of patients who are at greatest risk for relapse and to develop enhanced forms of personalized treatment.

Addiction is a disease with underlying neurological abnormalities.

If we identify a robust biological marker of relapse vulnerability, we pave the way to develop targeted treatments for those at greatest risk of relapse.

Identifying the risks Personalized treatment has already improved the lives of many suffering from other diseases. In the case of breast cancer, significant strides in the ability to spot biomarkers led to targeted treatments and contributed to a 25–77 percent jump in survival rates. Biomarkers help physicians spot risks of disease onset, predict illness course, and predict response to treatment, but a lack of identified biomarkers has stalled similar progress in helping those suffering from addiction.

28

MINNESOTA HEALTH CARE NEWS NOVEMBER/DECEMBER 2016

One of the University of Minnesota’s most promising research initiatives in this area utilizes a form of brain scanning to identify biomarkers present in the brains of individuals with addiction problems. Functional magnetic resonance imaging (fMRI) allows us to measure brain organization, the mechanism by which regions of the brain work together and organize into neural networks to communicate and solve programs, a concept known as “functional connectivity.” Using fMRI, researchers have shown evidence of abnormal functional connectivity in individuals with substance use disorder.

Research has also identified biological mechanisms associated with the ability of these individuals to recover from their addiction or their tendency to relapse. Addiction involves a dysregulation of two brain mechanisms: executive control, which governs our higher-level control of behavior and thought processes; and reward, which motivates us to repeat behaviors that cause us pleasure.

Patients with long periods of relapse-free recovery from alcohol dependence are less susceptible to relapse than are addicts with shorter recovery times. Those with long-term abstinence also have higher resting functional connectivity—meaning that the neural connections between their executive control and reward-processing regions are stronger. In other words, when the brain regions supporting reward and control fail to work together effectively, the patient is more likely to relapse.

shows that working memory can be improved when stimulating the brain’s dorsolateral prefrontal cortex (DLPFC) while patients practiced a working memory task.

In patients with alcohol use disorders, tDCS studies have shown that a single stimulation to this same region can decrease alcohol craving. In control studies of patients who do not have alcohol abuse disorders, stimulation of this part of the brain has been shown to enhance interactions between reward and control regions. Both findings suggest a new target for those suffering from addiction.

Through fMRI brain imaging, we can identify people at risk for relapse.

The next steps These reports are encouraging. It is critical that we investigate them further and determine follow-up approaches. Could multiple stimulations to the brain decrease substance cravings entirely? How

Addiction and relapse to page 30

Other studies confirm this association between the brain’s reward and control network and the patient’s ability to achieve longterm abstinence. In fact, long-term studies of individuals who do relapse show that their functional connectivity drops significantly over time. If confirmed by further studies, this could prove to be a useful brain biomarker that would allow us to predict future relapse and guide the development of new treatments. Researchers at the University of Minnesota continue to conduct fMRI and other brain imaging research to determine the reproducibility of this brain biomarker and to document its changes throughout periods of abstinence.

From scanning bench to bedside The identification of a robust brain biomarker of a psychiatric disorder prompts the next question: how to intervene and modulate it for better treatment outcomes. One approach might build on recent developments in psychiatry that utilize non-invasive techniques such as TMS (transcranial magnetic stimulation) or tDCS (transcranial direct current stimulation). Used to treat addiction and other psychiatric disorders such as depression and schizophrenia, these techniques apply electrical energy to the scalp to stimulate distinct brain regions identified through neuroimaging.

A low-risk procedure, tDCS has promising potential to modulate brain networks and produce long-term positive effects on behaviors and symptoms associated with several psychiatric disorders. In patients with schizophrenia or schizoaffective disorder, pilot data

NOVEMBER/DECEMBER 2016 MINNESOTA HEALTH CARE NEWS

29

Addiction and relapse from page 29

much stimulation is needed? Can we utilize tDCS with patients lacking this biomarker? Is there another way to pinpoint patients with this biomarker? Could we stimulate the brain to prevent addiction before it starts? To begin this investigation, we are currently measuring brain function and connectivity in individuals with alcohol dependence before and after tDCS interventions.

Biologically based treatments could bring new hope for… the most psychiatrically ill patients.

More studies with larger sample sizes, examining long-term effects and underlying neural mechanisms, need to be conducted.

TDCS has the potential to provide a much more direct, biologically targeted intervention in comparison to traditional psychiatric treatments such as medication or psychotherapy.

30

MINNESOTA HEALTH CARE NEWS NOVEMBER/DECEMBER 2016

Summary Recent technological advances show promise for both assessment and treatment of addiction, and may be useful in guiding personalized treatment. Through fMRI brain imaging, we can identify people at risk for relapse. These patients represent a subgroup in need of specialized treatments. Ongoing research at the University of Minnesota is examining the feasibility and efficacy of using neuromodulation techniques such as tDCS to enhance neural networks and prevent relapse in those patients who are at greatest risk. The combination of these two approaches may hold promise for advancing personalized, biologically based treatments that could bring new hope for restoring health for the most psychiatrically ill patients—not just those suffering from addiction.

Jazmin Camchong, PhD, an assistant psychiatry professor at the University of Minnesota, is a member of the Research Society on Alcoholism. Her clinical interests and research include addiction and schizophrenia.

Kelvin Lim, MD, is a psychiatry professor with the University of Minnesota’s Center for Neurobehavioral Development and an affiliate faculty member with the Institute for Health Informatics.

Kathryn Cullen, MD, is an assistant professor and division chief for child and adolescent psychiatry at the University of Minnesota. She is currently leading two research projects testing novel treatments for severe depression in teenagers.

Glaucoma from page 27

Laser. Laser procedures can improve natural drainage of the eye and help to reduce the pressure.

Dilated eye exam. Eye drops that dilate your pupils will be placed in your eyes. The widened pupils allow your doctor to check the health of your retina and optic nerve.

Tonometry measures the pressure inside the eye. A numbing drop will be placed in your eye and an instrument will come close to the eye to check the pressure. There are different methods to check intraocular pressure that gently tap on the surface of your eye. This is not painful and your eye will be numbed.

Surgery. There are surgical procedures that create a drain for the fluid of the eye to exit. This can be done by using the own tissues of the eye (trabeculectomy) or by inserting a plastic tube (glaucoma shunt or valve).

Research shows that marijuana lowers eye pressure, but only for a few hours. The American Academy of Ophthalmology does not recommend the use of marijuana for glaucoma treatment.

Prognosis

Corneal thickness. The thickness of the cornea (the transparent

The prognosis of glaucoma depends on how much damage the

front part of your eye) can vary from person to person, potentially

eye has at the time of diagnosis and the compliance of the patient

skewing the results of intraocular pressure tests. Expect your exam

with treatment and adherence to follow-up appointments. It is very

to include a test of corneal thickness.

important to take glaucoma eye drops every day and to see your

Optical coherence tomography (OCT). Your ophthalmologist

ophthalmologist regularly.

might run a test that performs a scan around your optic nerve to detect whether some areas are thinner than others. This test uses light to obtain measurements of the optic nerve, with no radiation applied to the patient. The result of the test gives an image with measurements of the thickness of the optic nerve at its top and bottom (superiorly and inferiorly) and on both sides (nasal and

Elena Bitrian, MD, is a glaucoma specialist and assistant professor in ophthalmology at the Mayo Clinic in Rochester, Minnesota.

temporal). The results show red areas when a part of the nerve is thinner than that of the normal population, yellow when it is borderline, and green when it is within the range of normal thickness. Those values are adjusted to the age of the patient.

Treatment can stop or slow down the progression of damage.

Treating glaucoma There are several treatments available for glaucoma, including medicines, laser procedures, and surgery.

Eye drops. Different types of drops may be used to treat glaucoma, and your ophthalmologist will assess which one is best for you. Some eye drops make the eye produce less fluid, while others help the fluid drain naturally from the eye. Eye drops need to be taken regularly as instructed by your ophthalmologist. Because glaucoma often has no symptoms, some patients stop or forget to take their drops, risking further damage to the eye.

NOVEMBER/DECEMBER 2016 MINNESOTA HEALTH CARE NEWS

31

Respiratory care from page 15

Accidental decannulation, which can be life threatening, could occur for a variety of reasons. A child may be moving during trach changes, trach ties may be loose, the trach tube may be too short, respiratory equipment may be pulling on the trach tube, or a child

Having a child with medical complexities can also be challenging for siblings. The family may be unable to do certain activities due to the child’s physical limitations. Siblings may develop behavior issues because their brother or sister receives more attention. It can be helpful to find therapy centers and home care companies that offer sibling support groups to help kids process their feelings about having a brother or sister who is dependent on medical technology.

may remove the trach tube themselves. All caregivers should be trained in emergency interventions for decannulation.

Kids with trach tubes are at high risk for respiratory infections.

Family support Having a child requiring long- or even short-term respiratory care often places multiple stressors on the family. The very idea of caring for a child’s trach tube can be scary, especially at first. Caregiver education is crucial, as a well-informed and confident family will usually experience less anxiety. Family members typically become more comfortable as they become accustomed to caring for the trach tube and it becomes routine.

Finances are one of the most prevalent stressors for families

Letting kids be kids Advancements in modern technology and medicine have made it possible for kids to be kids, despite extreme medical challenges.

Joe—and other children with respiratory illnesses—are outliving expectations and successfully transitioning to adulthood. They are living high-quality lives at home, where they are with their families and are most comfortable.

with a child who requires respiratory support. Not only do parents need to deal with insurance and pay medical bills, but they also often miss work to take the child to routine or emergency medical visits. There also needs to be a heightened awareness of potential illness, especially in Minnesota’s climate.

Chad Muesing, RRT-NPS, LRT, is the respiratory service manager at Pediatric Home Service, a Minnesota-based home care company that cares for children with medical complexities. He is a neonatal and pediatric specialist and a licensed respiratory therapist.

October 2016 Survey

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

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

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

1. I felt the outcomes of the medical care that I, or a member of my family, received in the hospital exceeded my expectations.

2. I felt that, upon discharge from the hospital, the responsibilities for ongoing care were made very clear.

50

30 25 20 15 10 5 Strongly Agree

Agree

No Opinion

Disagree

4. The behavior of members of the care team involved with this hospital stay exceeded my expectations.

20 10 Strongly Agree

Agree

No Opinion

Disagree

Strongly Disagree

50

30

Percentage of respondents

Percentage of respondents

32

30

5. The opportunity to be involved in making decisions with a physician about the care received during this hospital stay was adequate for my needs.

35 25 20 15 10 5 0

40

0

Strongly Disagree

40 Percentage of respondents

35

Percentage of respondents

Percentage of respondents

40

0

3. I understood the bills related to this hospital stay.

Strongly Agree

Agree

No Opinion

Disagree

Strongly Disagree

40 30 20 10 0

Strongly Agree

Agree

MINNESOTA HEALTH CARE NEWS NOVEMBER/DECEMBER 2016

No Opinion

Disagree

Strongly Disagree

35 30 25 20 15 10 5 0

Strongly Agree

Agree

No Opinion

For more information, please visit www.mnhcca.org.

We are pleased to present results of the most recent survey.

Disagree

Strongly Disagree

JOIN US.

Be heard in debates and discussions that shape the future of health care policy. There is no cost to join this informed and informative online community.

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

www.mnhcca.org NOVEMBER/DECEMBER 2016 MINNESOTA HEALTH CARE NEWS

33

Sress tests from page 13

If the blood clot is big enough, it can completely block flow down the narrow coronary artery—an inadvertent bad consequence of an initially beneficial self-healing process. This is how a heart attack happens: by a sudden change in blood supply to the heart muscle.

This is why you may have heard of someone passing a stress test with flying colors on Monday and then dropping dead on Wednesday.

That person did not have significant coronary artery disease (so they passed the stress test), but they did have vulnerable endothelium or unstable plaque that broke down and caused a heart attack.

The vast majority of risk factors for heart disease can be modifed.

The reason why people who have extensive coronary disease (and fail a stress test) are at higher risk of having a heart attack is that they have more gunk in their arteries in general. More of their endothelium is at risk of breaking down, and more of their plaque could be unstable. They also start off with smaller coronary lumens, so a smaller clot could plug up the flow.

34

MINNESOTA HEALTH CARE NEWS NOVEMBER/DECEMBER 2016

Takeaway points Stress tests represent an important tool to measure heart health, but remember: • A normal stress test, while reassuring and a good baseline, does not mean that you are free of coronary artery disease.

• A normal stress test result is not a free pass to poor lifestyle choices or to ignoring any risk factors for heart disease.

• Even if you have no symptoms of heart disease, the process may be progressing inside your body and you could be faced with a sudden major life-altering event if you continue to ignore risk factors.

• The same risk factors that cause gunk to build up also make the endothelium more vulnerable to breaking down and make plaque more likely to burst. Those risk factors include smoking, high blood pressure, cholesterol abnormalities, diabetes, poor diet, inactivity, family history, and age.

• The vast majority of risk factors for heart disease can be modifed. Controlling your risk factors not only prevents abnormal stress test results but also heart attacks and strokes.

Elizabeth Klodas, MD, FACC, is founder of Preventive Cardiology Consultants.

In addition to her private practice, she works with several primary care groups including Multicare Associates, Northwest Family Physicians, Williams Integracare, and Entira Clinics. She is also co-founder of Step One Foods, a company dedicated to helping patients reduce their reliance on prescription medications.

S:9.75”

Victoza® (liraglutide [rDNA origin] injection) Rx Only BRIEF SUMMARY. Please consult package insert for full prescribing information.

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

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

VICU3X1498_B_2_0_Journal_Ad_Tabloid_Resize_BS_r5.indd 1

for neutralizing effect against native GLP-1, and thus the potential for clinically significant neutralization of native GLP-1 was not assessed. Antibodies that had a neutralizing effect on liraglutide in an in vitro assay occurred in 2.3% of the Victoza®-treated patients in the double-blind 52-week monotherapy trial and in 1.0% of the Victoza®-treated patients in the double-blind 26-week add-on combination therapy trials.

Among Victoza®-treated patients who developed anti-liraglutide antibodies, the most common category of adverse events was that of infections, which occurred among 40% of these patients compared to 36%, 34% and 35% of antibody-negative Victoza®-treated, placebo-treated and active-control-treated patients, respectively. The specific infections which occurred with greater frequency among Victoza®-treated antibody-positive patients were primarily nonserious upper respiratory tract infections, which occurred among 11% of Victoza®-treated antibody-positive patients; and among 7%, 7% and 5% of antibody-negative Victoza®-treated, placebo-treated and active-control-treated patients, respectively. Among Victoza®-treated antibody-negative patients, the most common category of adverse events was that of gastrointestinal events, which occurred in 43%, 18% and 19% of antibody-negative Victoza®-treated, placebo-treated and active-control-treated patients, respectively. Antibody formation was not associated with reduced efficacy of Victoza® when comparing mean HbA1c of all antibody-positive and all antibody-negative patients. However, the 3 patients with the highest titers of anti-liraglutide antibodies had no reduction in HbA1c with Victoza® treatment. In the five double-blind clinical trials of Victoza®, events from a composite of adverse events potentially related to immunogenicity (e.g. urticaria, angioedema) occurred among 0.8% of Victoza®-treated patients and among 0.4% of comparator-treated patients. Urticaria accounted for approximately one-half of the events in this composite for Victoza®-treated patients. Patients who developed anti-liraglutide antibodies were not more likely to develop events from the immunogenicity events composite than were patients who did not develop anti-liraglutide antibodies. Injection site reactions: Injection site reactions (e.g., injection site rash, erythema) were reported in approximately 2% of Victoza®-treated patients in the five double-blind clinical trials of at least 26 weeks duration. Less than 0.2% of Victoza®-treated patients discontinued due to injection site reactions. Papillary thyroid carcinoma: In clinical trials of Victoza®, there were 7 reported cases of papillary thyroid carcinoma in patients treated with Victoza® and 1 case in a comparator-treated patient (1.5 vs. 0.5 cases per 1000 patient-years). Most of these papillary thyroid carcinomas were <1 cm in greatest diameter and were diagnosed in surgical pathology specimens after thyroidectomy prompted by findings on protocol-specified screening with serum calcitonin or thyroid ultrasound. Hypoglycemia :In the eight clinical trials of at least 26 weeks duration, hypoglycemia requiring the assistance of another person for treatment occurred in 11 Victoza®-treated patients (2.3 cases per 1000 patient-years) and in two exenatidetreated patients. Of these 11 Victoza®-treated patients, six patients were concomitantly using metformin and a sulfonylurea, one was concomitantly using a sulfonylurea, two were concomitantly using metformin (blood glucose values were 65 and 94 mg/dL) and two were using Victoza® as monotherapy (one of these patients was undergoing an intravenous glucose tolerance test and the other was receiving insulin as treatment during a hospital stay). For these two patients on Victoza® monotherapy, the insulin treatment was the likely explanation for the hypoglycemia. In the 26-week open-label trial comparing Victoza® to sitagliptin, the incidence of hypoglycemic events defined as symptoms accompanied by a fingerstick glucose <56 mg/ dL was comparable among the treatment groups (approximately 5%).

Table 5: Incidence (%) and Rate (episodes/patient year) of Hypoglycemia in the 52-Week Monotherapy Trial and in the 26-Week Combination Therapy Trials Victoza® Treatment Active Comparator Placebo Comparator None Monotherapy Victoza® (N = 497) Glimepiride (N = 248) Patient not able to self-treat 0 0 — Patient able to self-treat 9.7 (0.24) 25.0 (1.66) — Not classified 1.2 (0.03) 2.4 (0.04) — ® Add-on to Metformin Victoza + Metformin Glimepiride + Placebo + Metformin (N = 724) Metformin (N = 242) (N = 121) Patient not able to self-treat 0.1 (0.001) 0 0 Patient able to self-treat 3.6 (0.05) 22.3 (0.87) 2.5 (0.06) ®+ ® None Insulin detemir + Continued Victoza Add-on to Victoza Metformin Victoza® + Metformin + Metformin alone (N = 158*) (N = 163) Patient not able to self-treat 0 0 — Patient able to self-treat 9.2 (0.29) 1.3 (0.03) — Rosiglitazone + Placebo + Add-on to Glimepiride Victoza® + Glimepiride (N = 695) Glimepiride (N = 231) Glimepiride (N = 114) Patient not able to self-treat 0.1 (0.003) 0 0 Patient able to self-treat 7.5 (0.38) 4.3 (0.12) 2.6 (0.17) Not classified 0.9 (0.05) 0.9 (0.02) 0 Placebo + Metformin Add-on to Metformin + Victoza® + Metformin None + Rosiglitazone + Rosiglitazone Rosiglitazone (N = 175) (N = 355) Patient not able to self-treat 0 — 0 Patient able to self-treat 7.9 (0.49) — 4.6 (0.15) Not classified 0.6 (0.01) — 1.1 (0.03) Add-on to Metformin + Victoza® + Metformin Insulin glargine Placebo + Metformin + Glimepiride + Metformin + Glimepiride + Glimepiride (N = 114) Glimepiride (N = 232) (N = 230) Patient not able to self-treat 2.2 (0.06) 0 0 Patient able to self-treat 27.4 (1.16) 28.9 (1.29) 16.7 (0.95) Not classified 0 1.7 (0.04) 0 *One patient is an outlier and was excluded due to 25 hypoglycemic episodes that the patient was able to self-treat. This patient had a history of frequent hypoglycemia prior to the study.

In a pooled analysis of clinical trials, the incidence rate (per 1,000 patient-years) for malignant neoplasms (based on investigator-reported events, medical history, pathology reports, and surgical reports from both blinded and open-label study periods) was 10.9 for Victoza®, 6.3 for placebo, and 7.2 for active comparator.

After excluding papillary thyroid carcinoma events [see Adverse Reactions], no particular cancer cell type predominated. Seven malignant neoplasm events were reported beyond 1 year of exposure to study medication, six events among Victoza®-treated patients (4 colon, 1 prostate and 1 nasopharyngeal), no events with placebo and one event with active comparator (colon). Causality has not been established. Laboratory Tests: In the five clinical trials of at least 26 weeks duration, mildly elevated serum bilirubin concentrations (elevations to no more than twice the upper limit of the reference range) occurred in 4.0% of Victoza®-treated patients, 2.1% of placebo-treated patients and 3.5% of active-comparator-treated patients. This finding was not accompanied by abnormalities in other liver tests. The significance of this isolated finding is unknown.

Vital signs: Victoza® did not have adverse effects on blood pressure. Mean increases from baseline in heart rate of 2 to 3 beats per minute have been observed with Victoza® compared to placebo. The long-term clinical effects of the increase in pulse rate have not been established. Post-Marketing Experience: The following additional adverse reactions have been reported during post-approval use of Victoza®. Because these events are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to drug exposure: Dehydration resulting from nausea, vomiting and diarrhea; Increased serum creatinine, acute renal failure or worsening of chronic renal failure, sometimes requiring hemodialysis; Angioedema and anaphylactic reactions; Allergic reactions: rash and pruritus; Acute pancreatitis, hemorrhagic and necrotizing pancreatitis sometimes resulting in death.

OVERDOSAGE: Overdoses have been reported in clinical trials and post-marketing use of Victoza®. Effects have included severe nausea and severe vomiting. In the event of overdosage, appropriate supportive treatment should be initiated according to the patient’s clinical signs and symptoms.

More detailed information is available upon request.

For information about Victoza® contact: Novo Nordisk Inc., 800 Scudders Mill Road, Plainsboro, NJ 08536, 1−877-484-2869 Date of Issue: April 16, 2013 Version: 6 Manufactured by: Novo Nordisk A/S, DK-2880 Bagsvaerd, Denmark Victoza® is covered by US Patent Nos. 6,268,343, 6,458,924, 7,235,627, 8,114,833 and other patents pending.

Victoza® Pen is covered by US Patent Nos. 6,004,297, RE 43,834, RE 41,956 and other patents pending. © 2010-2013 Novo Nordisk 0513-00015682-1 5/2013

11/19/13 8:09 PM

S:12.25”

INDICATIONS AND USAGE: Victoza® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Important Limitations of Use: Because of the uncertain relevance of the rodent thyroid C-cell tumor findings to humans, prescribe Victoza® only to patients for whom the potential benefits are considered to outweigh the potential risk. Victoza® is not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exercise. Based on spontaneous postmarketing reports, acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victoza®. Victoza® has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for pancreatitis while using Victoza®. Other antidiabetic therapies should be considered in patients with a history of pancreatitis. Victoza® is not a substitute for insulin. Victoza® should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis, as it would not be effective in these settings. The concurrent use of Victoza® and prandial insulin has not been studied.

CONTRAINDICATIONS: Do not use in patients with a personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Do not use in patients with a prior serious hypersensitivity reaction to Victoza® or to any of the product components.

WARNINGS AND PRECAUTIONS: Risk of Thyroid C-cell Tumors: Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors (adenomas and/or carcinomas) at clinically relevant exposures in both genders of rats and mice. Malignant thyroid C-cell carcinomas were detected in rats and mice. A statistically significant increase in cancer was observed in rats receiving liraglutide at 8-times clinical exposure compared to controls. It is unknown whether Victoza® will cause thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as the human relevance of liraglutide-induced rodent thyroid C-cell tumors could not be determined by clinical or nonclinical studies. In the clinical trials, there have been 6 reported cases of thyroid C-cell hyperplasia among Victoza®-treated patients and 2 cases in comparator-treated patients (1.3 vs. 1.0 cases per 1000 patient-years). One comparator-treated patient with MTC had pre-treatment serum calcitonin concentrations >1000 ng/L suggesting pre-existing disease.

All of these cases were diagnosed after thyroidectomy, which was prompted by abnormal results on routine, protocol-specified measurements of serum calcitonin. Five of the six Victoza®-treated patients had elevated calcitonin concentrations at baseline and throughout the trial. One Victoza® and one non-Victoza®-treated patient developed elevated calcitonin concentrations while on treatment. Calcitonin, a biological marker of MTC, was measured throughout the clinical development program. The serum calcitonin assay used in the Victoza® clinical trials had a lower limit of quantification (LLOQ) of 0.7 ng/L and the upper limit of the reference range was 5.0 ng/L for women and 8.4 ng/L for men. At Weeks 26 and 52 in the clinical trials, adjusted mean serum calcitonin concentrations were higher in Victoza®-treated patients compared to placebo-treated patients but not compared to patients receiving active comparator. At these timepoints, the adjusted mean serum calcitonin values (~1.0 ng/L) were just above the LLOQ with between-group differences in adjusted mean serum calcitonin values of approximately 0.1 ng/L or less. Among patients with pre-treatment serum calcitonin below the upper limit of the reference range, shifts to above the upper limit of the reference range which persisted in subsequent measurements occurred most frequently among patients treated with Victoza® 1.8 mg/day. In trials with on-treatment serum calcitonin measurements out to 5-6 months, 1.9% of patients treated with Victoza® 1.8 mg/day developed new and persistent calcitonin elevations above the upper limit of the reference range compared to 0.8-1.1% of patients treated with control medication or the 0.6 and 1.2 mg doses of Victoza®. In trials with on-treatment serum calcitonin measurements out to 12 months, 1.3% of patients treated with Victoza® 1.8 mg/day had new and persistent elevations of calcitonin from below or within the reference range to above the upper limit of the reference range, compared to 0.6%, 0% and 1.0% of patients treated with Victoza® 1.2 mg, placebo and active control, respectively. Otherwise, Victoza® did not produce consistent dose-dependent or time-dependent increases in serum calcitonin.

Patients with MTC usually have calcitonin values >50 ng/L. In Victoza® clinical trials, among patients with pre-treatment serum calcitonin <50 ng/L, one Victoza®-treated patient and no comparator-treated patients developed serum calcitonin >50 ng/L. The Victoza®-treated patient who developed serum calcitonin >50 ng/L had an elevated pre-treatment serum calcitonin of 10.7 ng/L that increased to 30.7 ng/L at Week 12 and 53.5 ng/L at the end of the 6-month trial. Follow-up serum calcitonin was 22.3 ng/L more than 2.5 years after the last dose of Victoza®. The largest increase in serum calcitonin in a comparator-treated patient was seen with glimepiride in a patient whose serum calcitonin increased from 19.3 ng/L at baseline to 44.8 ng/L at Week 65 and 38.1 ng/L at Week 104. Among patients who began with serum calcitonin <20 ng/L, calcitonin elevations to >20 ng/L occurred in 0.7% of Victoza®-treated patients, 0.3% of placebo-treated patients, and 0.5% of active-comparator-treated patients, with an incidence of 1.1% among patients treated with 1.8 mg/ day of Victoza®. The clinical significance of these findings is unknown. Counsel patients regarding the risk for MTC and the symptoms of thyroid tumors (e.g. a mass in the neck, dysphagia, dyspnea or persistent hoarseness). It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate the potential risk of MTC, and such monitoring may increase the risk of unnecessary procedures, due to low test specificity for serum calcitonin and a high background incidence of thyroid disease. Patients with thyroid nodules noted on physical examination or neck imaging obtained for other reasons should be referred to an endocrinologist for further evaluation. Although routine monitoring of serum calcitonin is of uncertain value in patients treated with Victoza®, if serum calcitonin is measured and found to be elevated, the patient should be referred to an endocrinologist for further evaluation. Pancreatitis: Based on spontaneous postmarketing reports, acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, has been observed in patients treated with Victoza®. After initiation of Victoza®, observe patients carefully for signs and symptoms of pancreatitis (including persistent severe abdominal pain, sometimes radiating to the back and which may or may not be accompanied by vomiting). If pancreatitis is suspected, Victoza® should promptly be discontinued and appropriate management should be initiated. If pancreatitis is confirmed, Victoza® should not be restarted. Consider antidiabetic therapies other than Victoza® in patients with a history of pancreatitis. In clinical trials of Victoza®, there have been 13 cases of pancreatitis among Victoza®-treated patients and 1 case in a comparator (glimepiride) treated patient (2.7 vs. 0.5 cases per 1000 patient-years). Nine of the 13 cases with Victoza® were reported as acute pancreatitis and four were reported as chronic pancreatitis. In one case in a Victoza®-treated patient, pancreatitis, with necrosis, was observed and led to death; however clinical causality could not be established.

Some patients had other risk factors for pancreatitis, such as a history of cholelithiasis or alcohol abuse. Use with Medications Known to Cause Hypoglycemia: Patients receiving Victoza® in combination with an insulin secretagogue (e.g., sulfonylurea) or insulin may have an increased risk of hypoglycemia. The risk of hypoglycemia may be lowered by a reduction in the dose of sulfonylurea (or other concomitantly administered insulin secretagogues) or insulin Renal Impairment: Victoza® has not been found to be directly nephrotoxic in animal studies or clinical trials. There have been postmarketing reports of acute renal failure and worsening of chronic renal failure, which may sometimes require hemodialysis in Victoza®-treated patients. Some of these events were reported in patients without known underlying renal disease. A majority of the reported events occurred in patients who had experienced nausea, vomiting, diarrhea, or dehydration.

Some of the reported events occurred in patients receiving one or more medications known to affect renal function or hydration status. Altered renal function has been reversed in many of the reported cases with supportive treatment and discontinuation of potentially causative agents, including Victoza®. Use caution when initiating or escalating doses of Victoza® in patients with renal impairment. Hypersensitivity Reactions: There have been postmarketing reports of serious hypersensitivity reactions (e.g., anaphylactic reactions and angioedema) in patients treated with Victoza®. If a hypersensitivity reaction occurs, the patient should discontinue Victoza® and other suspect medications and promptly seek medical advice. Angioedema has also been reported with other GLP-1 receptor agonists. Use caution in a patient with a history of angioedema with another GLP-1 receptor agonist because it is unknown whether such patients will be predisposed to angioedema with Victoza®. Macrovascular Outcomes: There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Victoza® or any other antidiabetic drug.

ADVERSE REACTIONS: Clinical Trials Experience: Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of Victoza® has been evaluated in 8 clinical trials: A double-blind 52-week monotherapy trial compared Victoza® 1.2 mg daily, Victoza® 1.8 mg daily, and glimepiride 8 mg daily; A double-blind 26 week add-on to metformin trial compared Victoza® 0.6 mg once-daily, Victoza® 1.2 mg once-daily, Victoza® 1.8

mg once-daily, placebo, and glimepiride 4 mg once-daily; A double-blind 26 week add-on to glimepiride trial compared Victoza® 0.6 mg daily, Victoza® 1.2 mg once-daily, Victoza® 1.8 mg once-daily, placebo, and rosiglitazone 4 mg once-daily; A 26 week add-on to metformin + glimepiride trial, compared double-blind Victoza® 1.8 mg once-daily, double-blind placebo, and open-label insulin glargine once-daily; A doubleblind 26-week add-on to metformin + rosiglitazone trial compared Victoza® 1.2 mg once-daily, Victoza® 1.8 mg once-daily and placebo; An open-label 26-week add-on to metformin and/or sulfonylurea trial compared Victoza® 1.8 mg once-daily and exenatide 10 mcg twice-daily; An open-label 26-week add-on to metformin trial compared Victoza® 1.2 mg once-daily, Victoza® 1.8 mg once-daily, and sitagliptin 100 mg once-daily; An open-label 26-week trial compared insulin detemir as add-on to Victoza® 1.8 mg + metformin to continued treatment with Victoza® + metformin alone. Withdrawals: The incidence of withdrawal due to adverse events was 7.8% for Victoza®-treated patients and 3.4% for comparator-treated patients in the five double-blind controlled trials of 26 weeks duration or longer. This difference was driven by withdrawals due to gastrointestinal adverse reactions, which occurred in 5.0% of Victoza®-treated patients and 0.5% of comparator-treated patients. In these five trials, the most common adverse reactions leading to withdrawal for Victoza®-treated patients were nausea (2.8% versus 0% for comparator) and vomiting (1.5% versus 0.1% for comparator). Withdrawal due to gastrointestinal adverse events mainly occurred during the first 2-3 months of the trials. Common adverse reactions: Tables 1, 2, 3 and 4 summarize common adverse reactions (hypoglycemia is discussed separately) reported in seven of the eight controlled trials of 26 weeks duration or longer. Most of these adverse reactions were gastrointestinal in nature. In the five double-blind clinical trials of 26 weeks duration or longer, gastrointestinal adverse reactions were reported in 41% of Victoza®-treated patients and were dose-related. Gastrointestinal adverse reactions occurred in 17% of comparator-treated patients. Common adverse reactions that occurred at a higher incidence among Victoza®-treated patients included nausea, vomiting, diarrhea, dyspepsia and constipation. In the five double-blind and three open-label clinical trials of 26 weeks duration or longer, the percentage of patients who reported nausea declined over time. In the five double-blind trials approximately 13% of Victoza®-treated patients and 2% of comparator-treated patients reported nausea during the first 2 weeks of treatment. In the 26-week open-label trial comparing Victoza® to exenatide, both in combination with metformin and/or sulfonylurea, gastrointestinal adverse reactions were reported at a similar incidence in the Victoza® and exenatide treatment groups (Table 3). In the 26-week open-label trial comparing Victoza® 1.2 mg, Victoza® 1.8 mg and sitagliptin 100 mg, all in combination with metformin, gastrointestinal adverse reactions were reported at a higher incidence with Victoza® than sitagliptin (Table 4). In the remaining 26-week trial, all patients received Victoza® 1.8 mg + metformin during a 12-week run-in period. During the run-in period, 167 patients (17% of enrolled total) withdrew from the trial: 76 (46% of withdrawals) of these patients doing so because of gastrointestinal adverse reactions and 15 (9% of withdrawals) doing so due to other adverse events. Only those patients who completed the run-in period with inadequate glycemic control were randomized to 26 weeks of add-on therapy with insulin detemir or continued, unchanged treatment with Victoza® 1.8 mg + metformin. During this randomized 26-week period, diarrhea was the only adverse reaction reported in ≥5% of patients treated with Victoza® 1.8 mg + metformin + insulin detemir (11.7%) and greater than in patients treated with Victoza® 1.8 mg and metformin alone (6.9%).

Table 1: Adverse reactions reported in ≥5% of Victoza®-treated patients in a 52-week monotherapy trial All Victoza® N = 497 Glimepiride N = 248 (%) (%) Adverse Reaction Nausea 28.4 8.5 Diarrhea 17.1 8.9 Vomiting 10.9 3.6 Constipation 9.9 4.8 Headache 9.1 9.3 Table 2: Adverse reactions reported in ≥5% of Victoza®-treated patients and occurring more frequently with Victoza® compared to placebo: 26-week combination therapy trials Add-on to Metformin Trial All Victoza® + Metformin Placebo + Metformin Glimepiride + Metformin N = 724 N = 121 N = 242 (%) (%) (%) Adverse Reaction Nausea 15.2 4.1 3.3 Diarrhea 10.9 4.1 3.7 Headache 9.0 6.6 9.5 Vomiting 6.5 0.8 0.4 Add-on to Glimepiride Trial ® Placebo + Glimepiride Rosiglitazone + All Victoza + Glimepiride N = 695 N = 114 Glimepiride N = 231 (%) (%) (%) Adverse Reaction Nausea 7.5 1.8 2.6 Diarrhea 7.2 1.8 2.2 Constipation 5.3 0.9 1.7 Dyspepsia 5.2 0.9 2.6 Add-on to Metformin + Glimepiride ® Victoza 1.8 + Metformin Placebo + Metformin + Glargine + Metformin + + Glimepiride N = 230 Glimepiride N = 114 Glimepiride N = 232 (%) (%) (%) Adverse Reaction Nausea 13.9 3.5 1.3 Diarrhea 10.0 5.3 1.3 Headache 9.6 7.9 5.6 Dyspepsia 6.5 0.9 1.7 Vomiting 6.5 3.5 0.4 Add-on to Metformin + Rosiglitazone ® Placebo + Metformin + Rosiglitazone All Victoza + Metformin + Rosiglitazone N = 355 N = 175 (%) (%) Adverse Reaction Nausea 34.6 8.6 Diarrhea 14.1 6.3 Vomiting 12.4 2.9 Headache 8.2 4.6 Constipation 5.1 1.1 Table 3: Adverse Reactions reported in ≥5% of Victoza®-treated patients in a 26-Week Open-Label Trial versus Exenatide Exenatide 10 mcg twice daily + Victoza® 1.8 mg once daily + metformin and/or sulfonylurea metformin and/or sulfonylurea N = 232 N = 235 (%) (%) Adverse Reaction Nausea 25.5 28.0 Diarrhea 12.3 12.1 Headache 8.9 10.3 Dyspepsia 8.9 4.7 Vomiting 6.0 9.9 Constipation 5.1 2.6 Table 4: Adverse Reactions in ≥5% of Victoza®-treated patients in a 26-Week Open-Label Trial versus Sitagliptin All Victoza® + metformin Sitagliptin 100 mg/day + N = 439 metformin N = 219 (%) (%) Adverse Reaction Nausea 23.9 4.6 Headache 10.3 10.0 Diarrhea 9.3 4.6 Vomiting 8.7 4.1 Immunogenicity: Consistent with the potentially immunogenic properties of protein and peptide pharmaceuticals, patients treated with Victoza® may develop anti-liraglutide antibodies. Approximately 50-70% of Victoza®-treated patients in the five double-blind clinical trials of 26 weeks duration or longer were tested for the presence of anti-liraglutide antibodies at the end of treatment. Low titers (concentrations not requiring dilution of serum) of anti-liraglutide antibodies were detected in 8.6% of these Victoza®-treated patients.

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

®

Victoza —a force for change in type 2 diabetes.

A change with powerful, long-lasting benefits

Reductions up to -1.1%a

Weight loss up to 5.5 lba,b

Low rate of hypoglycemiac

1.8 mg dose when used alone for 52 weeks.

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

b

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

The change begins at VictozaPro.com.

Indications and Usage

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

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

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

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

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

Important Safety Information

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Please see brief summary of Prescribing Information on adjacent page.

1013-00018617-1

December 2013