Minnesota Health care News September 2012 by Minnesota Physician Publishing

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September 2012 Volume 10 Number 9

Amyotrophic lateral sclerosis (ALS) Ezgi Tiryaki, MD

Preserving the disability safety net John Tschida

Heart disease and oral health Elizabeth Klodas, MD

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CONTENTS

4 7 8

SEPTEMBER 2012 • Volume 10 Number 9

NEWS

PERSPECTIVE

Erich Mische Spare Key

16 18

CALENDAR

INSURANCE Medicare changes in 2013

Prostate cancer

Jen Van Liew, PhD, RN Minnesota Visiting Nurses Association

POLICY Preserving the disability safety net

By Kelli Jo Greiner

CARDIOLOGY Heart disease and oral health By Elizabeth Klodas, MD

By John Tschida

T H I R T Y- E I G H T H

SESSION

Background and Focus HEALTH CARE ROUNDTABLE Specialty pharmacy

10 QUESTIONS

MINNESOTAHEALTH HEALTH CARE ABLE MINNESOTA CAREROUNDT ROUNDTABLE

By Ezgi Tiryaki, MD

PEOPLE

NEUROLOGY Amyotrophic lateral sclerosis (ALS)

INFECTIOUS DISEASE Pertussis By Patricia Vincent, MD

The recent Supreme Court ruling on the Affordable Care Act clears the way for implementation of Health Insurance Exchanges. States have the option of creating their own exchange or joining one created by the federal government by January 2014. A Health Insurance Exchange would provide consumers a place to compare and shop for health insurance coverage. In Minnesota this idea was first proposed as part of the Assuring they are meaningful Pawlenty administration’s health care reform task force, Thursday, November 1, 2012 and Gov. Dayton is a strong 1:00 – 4:00 PM • Duluth Room supporter of creating a stateDowntown Mpls. Hilton and Towers run program. Though simple and compelling at first brush, creating a consumer-accessible, “apples to apples” website for comparing health insurance costs is challenging and very complex.

Health Insurance Exchanges:

Objectives

www.mppub.com PUBLISHER Mike Starnes mstarnes@mppub.com EDITOR Donna Ahrens dahrens@mppub.com

We will define what a health care insurance exchange is and, considering the detailed and proprietary design of health insurance coverage, how it can be meaningful. Health insurance policies contain terms like “medically necessary,” “investigative,” “cosmetic,” “not medically necessary” and “contract/benefit exclusion”—all terms that are defined differently by different insurers. This alone makes it virtually impossible for anyone to compare plans effectively. Further, networks of providers vary, depending on whether you choose the “bronze,” “silver,” “gold,” or “platinum” option within a given insurer, as will access to hospital-based facilities, DME providers, and ancillary services. Throw in features like “deductibles,” “co-insurance,” “maximum out-of-pocket expenses,” “formulary design” and “covered preventive services,” and you have a bewildering mathematical matrix. We will offer suggestions as to how an insurance exchange can address these issues and provide a meaningful, consumer-friendly comparison service.

ASSOCIATE EDITOR Janet Cass jcass@mppub.com ASSISTANT EDITOR Scott Wooldridge swooldridge@mppub.com ART DIRECTOR Elaine Sarkela esarkela@mppub.com OFFICE ADMINISTRATOR MaryAnn Macedo mmacedo@mppub.com BUSINESS DEVELOPMENT DIRECTOR Juline Birgersson jbirgersson@mppub.com ACCOUNT EXECUTIVE Iain Kane ikane@mppub.com Advisory Board: Minnesota Medical Association (MMA), Minnesota Hospital Association (MHA), Minnesota Medical Group Management Association (MMGMA), Buyers Health Care Action Group (BHCAG), Minnesota Business Partnership (MBP), Minnesota Healthcare Network (MHN), Advocates for Marketplace Options for Mainstreet (AMOM), Minnesota HomeCare Association (MHCA), Minnesota Physician-Patient Alliance (MPPA), Physicians Service Network (PSN), Minnesota Center for Rural Health, and Minnesota Council of Health Plans. Minnesota Health 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.

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SEPTEMBER 2012 MINNESOTA HEALTH CARE NEWS

NEWS

MDH Confirms New Swine Flu Strain A new strain of swine flu raised concerns among public health officials at the end of August. The Minnesota Department of Health (MDH) confirmed the state’s first two cases of the strain, H3N2v, on August 20 in two children from the same family who developed flu-like symptoms after visiting a live animal market. Neither child required hospitalization but the sudden rise in cases—more than 200 have been reported in the U.S. since the beginning of the year—have health officials across the country keeping a close eye on the spread of the disease. MDH officials say that this year’s seasonal flu vaccine will not protect against H3N2v, which tends to be similar in severity to recent strains of seasonal flu. The emergence of the new strain of swine flu in this state was announced shortly before the Minnesota State Fair was sched-

uled to open. As of August 21, state officials were not recommending drastic actions, but were encouraging Fair visitors to wash hands after exposure to animals and to avoid eating or drinking near animal exhibits. There is no evidence that H3N2v is contracted by eating pork.

ACA Ruling Leads State Agencies to Plan for Exchanges Now that the Supreme Court has found the Affordable Care Act (ACA) constitutional, top officials with the Dayton administration are moving ahead to implement one of the key provisions of the law, the state health insurance exchange. The exchange is one of the ACA’s main components for expanding health insurance to the nearly 50 million Americans who currently lack it. The exchange will allow individuals or employees of small businesses to shop for insurance plans through the

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Internet, with subsidies available to those under certain income levels. Under the ACA, each state will set up its own insurance exchange, or use one set up by the federal government. Gov. Mark Dayton and others have said it is important for the Minnesota exchange to be designed to fit the state’s unique health care market. The Legislature could not agree on a plan to establish an exchange last spring, but with the Supreme Court’s ruling, state agencies are moving forward to set up components of the insurance exchange. On July 16, Commerce Commissioner Mike Rothman, Human Services Commissioner Lucinda Jesson, and Health Commissioner Ed Ehlinger announced that the state has negotiated a $41 million contract with Maximus, Inc. (MMS) to design the technical side of the exchange, including a consumerfriendly website. MMS is a Reston, Va.-based consulting firm

that provides health and human services administration for governments throughout the United States and worldwide. “This contract is a significant milestone in the design and development of a Minnesota health insurance exchange,” says Rothman. “We can now move forward on developing the technology backbone of the exchange, a user-friendly tool that will help more than 1.2 million Minnesotans choose the quality coverage they need at a price they can afford.”

U.S. News Ranks Minnesota Hospitals Five Minnesota hospitals were nationally ranked in the latest U.S. News and World Report “Best Hospital” ratings. The annual feature looks closely at different specialties and ranks hospitals for quality through both data-driven measures and reputation. As has traditionally been the case, Mayo Clinic in Rochester is

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rated very highly by the report. Mayo Clinic ranks third in the nation overall in the U.S. News’ “Honor Roll,” a list of 17 hospitals that rank at or near the top in at least six of the 16 specialty areas the report rates. Mayo Clinic was ranked No. 1 nationally in three specialty areas: diabetes and endocrinology; gastroenterology; and gynecology. It was ranked in the top 20 in all 16 specialties. Minneapolis-based University of Minnesota Medical Center, Fairview, was nationally ranked in 11 specialty areas. Its highest ranking was 17, in pulmonology. Abbott Northwestern, part of the Allina Health system, was nationally ranked in seven specialty areas. The Minneapolis-based hospital’s highest ranking was 13 in orthopedics. United Hospital of St. Paul, also part of Allina Health, was nationally ranked as No. 40 in diabetes and endocrinology. CentraCare’s St. Cloud Hospital was nationally ranked for the ear, nose and throat specialty, where it was listed as No. 49.

DHS Expands Medicaid for Kids The Minnesota Department of Human Services (DHS) is expanding health insurance coverage to more than 16,000 children as part of changes to reduce barriers to insurance for kids in Minnesota. The announcement came shortly after the Annie E. Casey Foundation found Minnesota fifthbest in the nation for child wellbeing. The finding represented a step back for the state, which has traditionally been in the top three states. “Minnesota is a leader in health care, but having 70,000 kids without insurance is unacceptable and un-Minnesotan,” says House Minority Leader Paul Thissen (DFL–Minneapolis), who authored legislation to expand coverage for children. “The common sense reforms we passed in 2009—removing artificial barriers and patching gaps that kept many

kids from seeing a doctor or nurse—will help us keep kids healthier, which means they will do better in school and have fewer chronic health conditions later in life. I am very excited these reforms are becoming reality.” DHS began implementing changes to MinnesotaCare on July 1. Children from families with incomes below 200 percent of federal poverty guidelines will no longer face barriers to coverage such as the four-month waiting period and will be eligible for MinnesotaCare without premiums. Under the new rules, all children in the state will be eligible for MinnesotaCare.   “These changes move us closer to covering every child in Minnesota. Reducing barriers for children under 200 percent of the federal poverty guidelines creates access to health care coverage for children in low-income working families,” says Elaine Cunningham of Children's Defense FundMinnesota.

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Franken Cosponsors Bill to Protect Retiree, Employee Benefits Sen. Al Franken is cosponsor of a bill that would protect the benefits of workers and retirees when a company goes into bankruptcy. The Protecting Employees and Retirees in Business Bankruptcy Act would change Chapter 11 law to give employees and retirees more opportunities to recover benefits, restrict changes or cancellation of collective bargaining agreements, and provide more regulation of bonuses and other compensation for top officials of a company going into Chapter 11 bankruptcy. It would also prohibit top company officials from receiving retiree benefits while the company is in bankruptcy if workers have lost retirement or health benefits. “When a company enters bankruptcy, it’s just plain wrong that employees are left to fight for what they are duly owed while

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News to page 6 SEPTEMBER 2012 MINNESOTA HEALTH CARE NEWS

News from page 5 executives get to walk off with huge bonuses,” Franken says. “We’ve seen workers lose out too many times when a company reorganizes, especially on the Iron Range. Preserving jobs, pensions, and retiree health care benefits must be a priority—especially in this challenging economic climate—which is why I will fight to get this bill passed.”

Accretive to Pay $2.5 Million Settlement Accretive Health and Minnesota Attorney General Lori Swanson recently reached a settlement in the federal lawsuit that Swanson had filed over collection tactics and data privacy. Under the terms of the settlement, Accretive will pay approximately $2.5 million to the state, and will cease operations in the state for the next six years. Money from the settlement will go to a restitution fund used to

compensate patients, and any funds remaining will go to the state treasury. Swanson had sued Chicagobased Accretive over its management of revenue operations for several hospitals in the state, including hospitals with Fairview Health System, North Memorial Hospital, and Maple Grove Hospital. Swanson charged that Accretive used coercive tactics, such as demanding payment when patients were suffering in the emergency room, and violated patient privacy laws. For its part, Accretive did not admit to any wrongdoing. “Even though we believe the claims against us were either baseless or exaggerated, we have used this opportunity to carefully examine our own practices in order to ensure we are setting the very highest standards for our own performance and achieving the best possible outcomes for hospitals, patients, and communities,” said Mary Tolan, Accretive’s CEO. “Entering into this settlement

agreement allows our company to put this matter behind us and prevents further distraction from the important work that we do for our hospital clients.” The lawsuit has also had an impact on the hospitals that worked with Accretive; at the end of July, Fairview CEO Mark Eustis left the company after the Minneapolis-based system declined to renew his contract.

Commerce Warns Consumers About Mini-Med Plans The Minnesota Department of Commerce is again warning consumers about Limited Medical Benefit, or “Mini-Med” plans, which market themselves as health insurance plans but offer very limited medical coverage. “Insurance is an important way to minimize risk and protect yourself, but it is important to understand the product before you buy,” says Commerce Com-

missioner Mike Rothman. “Limited medical benefit insurance is not the same as comprehensive health insurance and should not be considered a substitute.” State officials have warned about such plans in the past, noting that they have limitations on what they cover and how much they will pay. State officials say they are closely monitoring the products sold by these companies.

Correction The title of the August issue’s Perspective essay was missing a word and should have read “Minnesota Area Agency on Aging.”

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Call to get helpp with: with s Planning for long-term care s Remaining independent in your community s Arranging for in-home services s Getting help from state agencies s Becoming involved in your community

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MINNESOTA HEALTH CARE NEWS SEPTEMBER 2012

PEOPLE Dee Thibodeau, CEO and cofounder of Charter Solutions, recently received the Jean Harris Award from the Women’s Health Leadership Trust in recognition of her outstanding contributions to health care leadership. Plymouth-based Charter Solutions is a management consulting company that specializes in health care. Before forming Charter Solutions, Thibodeau was president of EDI Dee Thibodeau

Solutions, an international electronic commerce

company. Thibodeau has been president of the National Association of Women Business Owners, chair of the Minnesota High Tech Association, and founder and president of the Twin Cities EDI Business Forum, and is a member of the Women Business Leaders of the U.S. HealthCare Industry Foundation. Karen Flanagan Kleinhans, MHA, has been named chief of strategy and business development at Consulting Radiologists Ltd (CRL). The Minnesota-based practice group provides on-site

Karen Flanagan Kleinhans, MHA

services at more than 37 hospitals and clinics, and teleradiology services to more than 100 radiology departments in the Midwest. Flanagan Kleinhans will lead and implement CRL’s overall strategic direction, business development, and marketing plans. Ruby Azurdia-Lee has been named the new president of Comunidades Latinas Unidas En Servicio (CLUES), a nonprofit agency that serves the Latino community in Minneapolis and St. Paul. For the past 16 years, Lee has worked for the Saint Paul Foundation and the Northwest Area Foundation in anti-racism and anti-poverty efforts, respectively. She also has provided leadership on several national philanthropic boards including Grantmakers Concerned with Immigrants and Refugees, based in California, and the Four Freedoms Fund, based in New York City. Ruby Azurdia-Lee

The American Public Human Services

Association has named Minnesota Department of Human Services Assistant Commissioner Erin Sullivan Sutton as the 2012 Outstanding Member Award winner for contributing to the transformation of human services and advancing the mission of the association. Sullivan Sutton was selected for her work to improve child welfare practice in Minnesota and for her work nationally. An attorney and social worker, Sullivan Sutton has worked for the department since

To CHANGE your life (For the better)

1987. Before being named assistant commissioner in June 2010, she served as director of the department’s Child Safety and Permanency Division, where she oversaw adoption, foster care, child protection, and other children’s services. Marva Bohen, MS, RN, has received the 2012 Darla Havlicek Spirit of Collaboration Award, given by the Minnesota Cancer Alliance. Bohen was involved in developing the state cancer plans and the Minnesota Cancer Alliance, and leading the Health Disparities Task Force and the Cervical Cancer Project Team from 2005 to 2009. The award is named in honor of Darla Havlicek, who died in April 2012 after living with cancer for three years. She had served as director

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SEPTEMBER 2012 MINNESOTA HEALTH CARE NEWS

PERSPECTIVE

Spare Key Helping families to pay the mortgage while a child is seriously ill

s young parents, Robb and Patsy wrestled for nearly two and a half years with the traumatic health care needs of their newborn son Derian. In her book, “Mothering an Angel,” Patsy writes about the couple’s constant struggle between wanting to spend time with Derian and their real-life need to work in order to pay bills. Outside of their son’s health, the most pressing issue for Patsy and Robb, month after month, was making sure their mortgage was paid. Erich Mische Spare Key

Erich Mische, a former Spare Key board member, was named executive director of Spare Key in February 2012, after having worked on local, state, and federal public policy issues for 30 years. To find out if Spare Key can help your family or someone you know, please review the program guidelines on our website, www.sparekey.org, or contact our program manager, Joyce Giedt, at (952) 406-8872 or Joyce@sparekey.org

Fortunately, they were the beneficiaries of the generosity of their friends, family, and faith community. Because of the commitment of those around them, Robb and Patsy never missed a mortgage payment. After Derian passed away in 1997, they founded the nonprofit organization Spare Key in his memory. Supporting family stability

MD; and others who serve on our grant program committee, including a social worker and a parent who received Spare Key mortgage assistance. Statistics show that the average number of days that a child spends in a hospital in Minnesota has dramatically decreased over the course of the past five years. In addition, since protocols for various types of illnesses are changing to focus more on outpatient or home care, Spare Key determined that the 21-days-out-of-90-days requirement was no longer relevant. New guidelines With that in mind, guidelines for qualifying for Spare Key Mortgage Grant assistance were updated Aug. 1, 2012, to allow a family to apply: • After a child under the age of 18 has been hospitalized for 14 of the previous 90 days

Since 1997, Spare Key has made mortgage pay- • If the applicant is a homeowner whose mortgage is current ments on behalf of more than 1,500 Minnesota families that have a seri• If the applicant can ously ill or critically injured demonstrate an increase Spare Key has made child under the age of 18. in expenses or a decrease This helps parents worry a in household income due mortgage payments on little less about finances so to the child’s health needs behalf of more than that they can take time off For approved applicants, from work to be with their 1,000 Minnesota families. Spare Key will make one child. Most families in need mortgage payment of up to of mortgage assistance find $1,200 during a revolving out about Spare Key from hospital social workers. calendar year. Eligible families may reapply one In 2010, we met the needs of all of the qualified year later. families that applied for mortgage grants, helping Payment is made directly to the applicant’s mort143 families stay in their homes and spend time gage lender. Typically, by the time a family has with their child. In 2011, the number of applicants been referred to Spare Key they have suffered a 54 jumped by 35 percent, to 201 families. percent reduction in household income, so having In 2012, the number of applicants is expected to a mortgage payment provided brings palpable increase by 10 percent or more and our total value relief. of mortgage payments is expected to exceed $1.6 Helping families bounce, not break million. We anticipate that demand for mortgage payment assistance will continue to increase as Spare Key’s goal is to give families some relief we expand our network of hospital social workers despite the stress of having a seriously ill child, and to afford them the precious gift of time with throughout the state. their child. As one recipient expressed it, Spare With that increase in demand, we predict greater Key helps families “bounce and not break.” challenges in providing mortgage grant assistance to Minnesota families, and are committed to We live in an age of remarkable advances in medexpanding our network of relationships to meet icine. These advances give children with grievous injuries the opportunity to lead long and fulfilling that need. lives and those born prematurely a better chance Updating, easing, application of survival than ever before. Originally, one of the requirements for applicants However, these advances come with a financial was that a child needed to have been hospitalized cost. While Spare Key cannot pay every bill, nor for 21 of the previous 90 days. However, the releheal every sick or injured child, we can give parvance of the 21-day requirement was recently ents an opportunity to breathe—and families a reviewed by Mark Bergeron, MD; Kevin Henseler, chance to bounce, not break.

MINNESOTA HEALTH CARE NEWS SEPTEMBER 2012

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10 QUESTIONS

Offering help from pregnancy to the end of life Jen Van Liew, PhD, RN Dr. Jen Van Liew is executive director and CEO of the Minnesota Visiting Nurses Association (MVNA). She has more than 33 years of experience in various health care settings and was recently included in “100 Influential Health Care Leaders,” published by Minnesota Physician magazine. Please tell us how the MVNA began. In 1900, a group of Minneapolis women met to address public health concerns of those unable to access health care. Infant mortality was a critical issue, as were communicable diseases, poverty, and unsanitary living conditions. Services began in 1902 with the hiring of our first nurse. MVNA led the fight against tuberculosis in 1907. Today, MVNA serves thousands of clients and families in the areas of home care, maternal and child health, hospice care, and community wellness and immunization. We are ranked the fourth-largest home care provider in the metro area. How is the MVNA funded? MVNA is funded by city, county, state, and federal monies; Medicare and managed care plans; grants; private donations; and the United Way of the Twin Cities. MVNA was recently involved in a pilot project with the U of M that sent pharmacists into your clients’ homes. What did you learn? Collaborating with the U of M College of Pharmacy provided an innovative approach to addressing a common problem among clients receiving home care. These clients often have a high rate of medication-related health issues and adverse outcomes. During the pharmacist’s visit, medications were evaluated to make sure they were appropriate for the patient’s condition and were effective, safe, and convenient for the patient to take. The pharmacist subsequently contacted the client’s physician with recommendations to resolve medication-related issues. Preliminary results of this project indicate that the visiting pharmacist’s care, in conjunction with follow-up care provided by MVNA nurses, reduced rehospitalization by 30 percent and emergency department visits by 50 percent. Please tell us about Hospice of the Twin Cities. Hospice of the Twin Cities (HOTC) is a community-based affiliate of MVNA, providing end-of-life care throughout the Twin Cities and in areas across Minnesota. HOTC assists those with life-limiting illness to live fully for as long as possible and is an appropriate choice when a traditional medical approach is no longer helpful or desired. Services are delivered wherever the patient lives and focus on enhancing physical, social, emotional, and spiritual comfort and maintaining independence. Hospice also provides bereavement services for the family for at least 13 months following the death of a loved one. HOTC is paid for through Medicare, medical assistance, and most private insurance providers.

Photo credit: Bruce Silcox

What can you share with us about the people you serve? MVNA and HOTC serve clients from pregnancy to the end of life. Over 90 percent of our pregnant and parenting families within Hennepin County live in poverty, and half are either non-Englishspeaking or English is not their first language. The majority of the adults receiving home health services experience multiple chronic diseases; often lack a caregiver; are impoverished; live in substandard conditions; and need ongoing support to stay safely in their homes. Our teams of nurses, therapists, and interpreters specialize in working with families whose infants and children are at risk of poor birth outcomes, developmental delays, childhood asthma, and obesity.

MINNESOTA HEALTH CARE NEWS SEPTEMBER 2012

How does MVNA care for people discharged from the hospital? Within 48 hours of receiving a referral from the hospital, an MVNA registered nurse visits the client to assess physical, psychosocial, and environmental factors that affect the client’s health and his or her ability to live safely at home. The MVNA nurse works with the client and family to create a plan of care. MVNA is active in several wellness initiatives. What are some of these? MVNA offers a full range of immunization services to the community at large. We also provide CPR-AED, first-aid training, and nurse consultant services for child-care centers and schools. MVNA has a long history here, having started the area’s first public school nurse program in 1907. Our newest service, Biometric Screening and Wellness Services, partners with employers and employees. MVNA nurses consult one-on-one with employees regarding baseline lab results, and discuss indicators of optimum health.

tionships with families and work to achieve goals including healthy birth outcomes; strong parenting skills; completion of high school; and enrollment in college or technical schools. There is strong longitudinal research indicating that if healthy development of a child and family is supported early in life, the child is much more likely to succeed in school and ultimately in other aspects of life, such as stable employment.

Meeting someone’s most basic needs provides some of the most significant improvements in quality of life.

What can you tell us about MVNA’s work with pregnant and parenting teens? The nurse home-visitor works to move two generations at a time out of poverty via intensive home-visiting, goal-setting, and health education. MVNA utilizes two evidence-based models (Nurse-Family Partnership and Healthy Families America), focusing on first-time pregnant and parenting teens and those families with multiple challenges that threaten their ability to parent effectively. Nurses and case managers build rela-

Are MVNA services available to anyone, or is a referral from another health care organization needed? Home health services are available across the metro area. Hospice services are available metro-wide and in Mankato, St. Peter, and surrounding areas. Wellness services, including biometric screening and flu vaccination clinics, are available across much of the state. Family health services are available in Hennepin County and by social service referral.

Can you share some examples of how health can be drastically improved by simple, nonmedical measures? Meeting someone’s most basic needs provides some of the most significant improvements in quality of life. Providing a crib reduces the risk of sudden infant death syndrome. A client suffering from pulmonary disease had fewer symptoms after receiving a donated fan that simply circulated the air, making it easier to breathe. Translating diabetic care instructions into Spanish enables Latino clients to gain independence in managing their disease and results in a remarkable decrease in emergency room utilization.

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www.nwhealth.edu/patients www .nwhealth.edu/patients SEPTEMBER 2012 MINNESOTA HEALTH CARE NEWS

POLICY

Preserving the disability safety net

Fraying, but not yet beyond repair By John Tschida

State government helps support the needs of Minnesotans with disabilities, but that safety net is badly fraying. One reason is that state budget deficits and reductions in federal money that helps support Minnesota have significantly reduced payments to providers. Another reason is that decisions

by policymakers, employers, and insurance companies have limited access to disability services even as the number of people who need those services grows in parallel with the growing percentage of the population over 65. Hereâ&#x20AC;&#x2122;s a closer look at what is happening and what you can do about it.

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Why it’s fraying

restrictive determination of eligibility for services based on age, diagnosis, or geographic location. The proposed changes would also give consumers more control over how their service dollars are spent. Increased efforts to measure quality would also make the system more accountable and help answer the question that has frustrated users of the system as well as policymakers: Is this a service that makes a positive impact, and where’s the data to prove it? If successful, these redesign efforts will decrease the need for

Budget deficits. Many disability services are funded by Medicaid, a program that is both funded and jointly operated by states and the federal government. The fastest growing portion of the Medicaid budget that supports people with disabilities is for nonmedical community-based social services critical for achieving overall health. This includes housing support services, independent living skills training, and day programs for those with developmental disabilities. However, Medicaid’s current expense trajectoProposed changes would give ry is unsustainable. At the state level, 30 cents of consumers more control over how every taxpayer dollar funds health services for their service dollars are spent. those who are disabled or impoverished and elderly. Whenever the state faces a budget deficit—the Minnewaivered services and eliminate the ‘benefits-for-a-lifetime’ mentality sota Management and Budget office predicts a deficit of more than $1 billion in 2013—it is nearly impossible to balance the overall state that now plagues the system. Waiver expenditures are breaking the (taxpayer-funded) bank and limiting investments in other areas of budget without additional cuts in this area. This is especially probpublic policy. lematic since Medicaid, formerly only a medical care program, has How will these changes occur, and when? The state Department expanded to fund housing, employment, and transportation services of Human Services (DHS) has requested permission from the federal as well. government to redesign the way that long-term care supports are Policy decisions. accessed and delivered. This is part of a broader reform effort Legislators are demanding not just cost reductions, but an understandunderway at the state level to deliver the right services at the right ing of what taxpayers are getting in return for money spent on safety time while improving overall population health and controlling net services. When it comes to disability services, this “return on costs. Approved changes are expected to start being implemented in investment” question has gone largely unanswered. While a great deal 2013 and unfold over several years. (Visit www.dhs.state.mn.us for of effort has been made since 2008 by the state’s health policy and more details on Medicaid reform efforts.) medical community to collect and analyze quality data for the general Preserving the disability safety net to page 34 population, virtually nothing has been done to address the most expensive group in our health system: people with disabilities. In the absence of information on the value of disability services (both medical and nonmedical supports), lawmakers have made decisions based on cutting costs. This included a 2011 law to mandate that people with disabilities within the Medicaid Do you know your numbers? program join a managed care plan. Opting out Medical is allowed, but far fewer people are doing so and non- than the state anticipated. However, it is still a financing challenge to better match the complex medical medical needs of this population with adequate support reimbursement for the services used. Since every are needed. health plan serving this population loses money, insurers in Minnesota refuse to enter the market to serve this expensive population.

Cholesterol

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Efforts to preserve the safety net New ways to deliver social services. The safety net for people with disabilities grew out of the effort to deinstitutionalize people with developmental disabilities in the early 1970s. Since county, state, and federal budgets are tighter than they were in those days, innovative service models for both medical and nonmedical support are needed. Medicaid reforms now under discussion would fundamentally change how people with disabilities access nonmedical Medicaid-funded services, including accessing the waivered services that currently allow a family dealing with disability to spend Medicaid money as it sees fit. What’s being proposed is a system redesign that is more flexible and responsive to individual needs, rather than the current, more

The h Goodd = HDL Cholesterol: Keep it high The Bad = LDL Cholesterol: Keep it low The Ugly = too much cholesterol can lead to heart attack and stroke Visit www.heart.org for more information about cholesterol and heart health

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www.mn-dc.org SEPTEMBER 2012 MINNESOTA HEALTH CARE NEWS

NEUROLOGY

Amyotrophic lateral sclerosis (ALS) Symptoms, diagnosis, and enhancing quality of life By Ezgi Tiryaki, MD What is ALS?

ALS is a neurodegenerative disease characterized by progressive loss of the ability to control muscles, with evidence increasingly suggesting that the ability to think becomes altered in up to half of patients. In most cases, ALS does not affect eye movement or control of bowel or bladder. Symptoms can start anywhere in the body, and while pain is not an inherent part of this disease, ALS involves the emotional pain of losing skills and abilities and becoming dependent on others. Most people with ALS are diagnosed during their 50s, but the disease can affect anyone at any age. Most patients live about three to five years after onset of the disease, some live only for a few months, and a few survive for more than 10 years. Despite research for a cure, to date only one FDA-approved drug has been developed that extends life; it does so by an average of three months. No treatments that markedly slow or reverse the disease are known at this point. Who gets ALS?

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Nationwide, 30,000 people live with ALS, with an average of 5,600 new cases diagnosed annually. Each week, an average of two Minnesotans are diagnosed with ALS and two succumb to it. At any given time, approximately 400 Minnesotans have ALS. Men are more likely to be affected than women. About 10 Each week, percent of ALS is inherited; research has an average identified a multitude of new genes that are linked to ALS and thus may aid in diagnosis of two and the search for a cure. Minnesotans Military veterans are twice as likely to are diagnosed develop ALS as nonveterans, regardless of with ALS. the branch of service in which they served. The reason for this connection is unknown. ALS is listed as a disease entitled to presumptive service connection. This means that if a service member is diagnosed with ALS, his or her condition is presumed to have occurred during or to have been aggravated by military service. Consequently, that person is entitled to a full range of health care benefits, a monthly monetary benefit, adaptive equipment, an automobile grant, and a grant for adaptive housing. An overview of benefits available to veterans, survivors, and dependents is available at www.alsa.org/als-care/veterans /service-connected-benefits.html. Maximizing quality of life Much can be done to alleviate symptoms that can include depression, muscle cramps, and drooling. This is typically accomplished by a multidisciplinary team that takes an individualized approach to each

patient by addressing the patient’s specific areas of loss of control. The goal of ALS care is to help the patient make the most of the control they have in order to maximize his or her quality of life. ALS care is highly specialized and resource-intensive. On any given day in an ALS clinic, a team might include a nurse coordinator, clinic nurse, neurologist, physiatrist, pulmonologist, palliative care expert, physical therapist, occupational therapist, respiratory therapist, speech-language pathologist, dietitian, social worker, and a representative from the ALS Association or other nonprofit health agency.

Resources • The ALS Association, MN/ND/SD Chapter www.alsmn.org; (612) 672-0484; Toll-free: (888) 672-0484 • Muscular Dystrophy Association (MDA) www.mda.org; (952) 832-551744 • Spinal cord injury center for military veterans with ALS VA health care system www.minneapolis.va.gov; (612) 629-7005 • Military benefits www.alsa.org/als-care/veterans/service-connected-benefits.html

While some services are billed to health insurance companies, reimbursement for ALS’ heavily service-dependent care (as opposed to procedure-dependent care) usually does not cover

the cost of providing it. Fortunately, many health care systems understand the importance of such services and support ALS clinics. In addition, clinics may receive additional support through The ALS Association, nonprofit health agencies, or private donors. The ALS Association has certified two clinics in the state of Minnesota as “centers of excellence” based on the range of services offered and a patient-centered approach. These centers are at Hennepin County Medical Center and the Mayo Clinic. Alleviating symptoms Quality of life for an ALS patient can be severely affected by symptoms that would be merely annoying for a healthy individual. For example, as ALS progresses, symptoms such as leg cramps can make up an excruciating part of a patient’s day. Fortunately, symptoms of ALS can be alleviated through the use of a variety of prescription medications. A common example is drooling, one solution for which is prescription medications that reduce secretions inside the mouth. Another solution for drooling is to inject botulinum toxin, or Botox, into saliva-producing glands to decrease their activity. As patients’ swallowing and breathing muscles weaken, they can no longer get enough nourishment from eating. Having a physician place a feeding tube into the stomach facilitates proper nourishment, does not prevent patients from eating food by mouth if they wish, and the tube is easy to care for. To support weakening breathing muscles, noninvasive breathing devices assist breathing by nose or facemask. Patients may eventually Amyotrophic lateral sclerosis (ALS) to page 17

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September Calendar 6

Weathering Life’s Losses Join us for an adult grief group for those who have experienced the death of a loved one. Free—no registration required. Call (651) 430-4586 to find out more. Thursday, Sept. 6, 6–7:15 p.m., Lakeview Hospital, 927 Churchill St. W., Stillwater Essential Legal Documents for Cancer Survivors This seminar provides information about health care directives and other essential documents for cancer survivors. All sur vivors and loved ones welcome. Free. Register in advance by calling (651) 4725599 or at www.CancerLegalLine.org. Tuesday, Sept. 11, 6:30–8 p.m., Brookdale Library, 6125 Shingle Creek Pkwy., Brooklyn Center Dance from Your Chair Learn dance moves designed for people with movement challenges, like Parkinson’s disease. Everything can be done in chairs, with opportunities to experience movement standing up. Family members welcome; donations accepted. For more information, call We R Able at (320) 358-1220. Wednesday, Sept. 12, 10:30–11:30 a.m., Pine City Senior Ctr., 670 Main St. S., Pine City Dating Abuse Prevention: Talk it out Tuesday Your cell phone, IM, and online profile are all digital extensions of who you are. Learn to draw your digital line about what is, or is not, okay in your online relationships. Join online chats scheduled for Tuesdays at www.thatsnotcool.com. Other sources of help are at National Dating Abuse Helpline, www.loveisrespect.org or (866) 331-9474; TTY (866) 331-8453. Tuesday, Sept. 18; visit www.thatsnotcool.com anytime Camera Club For survivors of stroke, brain injury, or other neurological disorders. Learn about photography or brush up on your skills. We meet the first and third Thursdays of the month. For more information, call

Marilyn at (952) 993-7154. Thursday, Sept. 20, noon–1 p.m., Methodist Hospital Heart and Vascular Ctr., 6500 Excelsior Blvd., Rm. B., St. Louis Park

Prostate Cancer Awareness Month The prostate gland is part of the male reproductive system and is surrounded by other glands, nerves, and organs involved in sexual function. It is wrapped around the urethra and helps control the flow of urine. Sometimes cells keep growing beyond their natural lifespan and can swell up into a tumor, which can be harmless (benign) or harmful (malignant). Prostate cancer is a common but usually slow-growing cancer compared to other types of cancer. The American Urological Association says men at age 40 should have a blood test that measures prostate specific antigen (PSA), and a physical exam of the prostate called Digital Rectal Exam (DRE). Testing signals a prostate abnormality, such as an enlarged prostate, an infection, or perhaps cancer. The value of PSA is establishing a baseline for future comparison. More than 65 percent of all prostate cancers are diagnosed in men over age 65. African American men have a 60 percent higher risk of getting prostate cancer than Caucasian men and are nearly 2.5 times more likely to die from it. Prostate cancer is usually slow growing, so unless your doctor tells you otherwise, you should have plenty of time to learn and consider your options. Nearly 100 percent of men diagnosed with prostate cancer are still alive after five years. For more information from ZERO— The End of Prostate Cancer, visit www.zerocancer.org or call 202-463-9455. For specific questions about prostate health, please talk to your doctor. 26 Prostate Cancer Education and Support Group For men from all phases of a prostate cancer diagnosis and their support persons. Most meetings include an expert speaker on clinical and life management topics. Held the fourth Wednesday of most months. To register, call (763) 520-5285. Wednesday, Sept. 26, 5:30–7 p.m., North Memorial Outpatient Ctr., 3455 W. Broadway, Robbinsdale

Introduction to Brain Injury Participants will learn basic facts about the brain, brain injury, and living with brain injury. Many resources are provided; $5 donation appreciated. Registration required; call (612) 378-2742 or (800) 669-6442. Thursday, Sept. 27, 6–8 p.m., Minnesota Brain Injury Alliance, 34 13th Ave. N.E., Education Ctr., Minneapolis

Wellness Friday: Laughter Yoga The art of laughter invites more joy, play, health, and well-being into your life! This form of yoga does not include any physical poses and can be practiced by people of all ages. Register by calling (651) 298-5493 no later than Sept. 24. Friday, Sept. 28, 10:30–11:30 a.m., West 7th Community Ctr., 265 Oneida St., St. Paul

Oct. 1

Frontotemporal Dementia (FTD) Caregiver Support Group The entire family is affected by a dementia diagnosis. A support group is a safe place to learn, offer, and receive helpful tips from caregivers. This group meets the first Monday of the month. For information, call Moira Rummel at (612) 920-5502. Monday, Oct. 1, 6–7 p.m., United Methodist Church, 5835 Lyndale Ave. S., Richfield

Send us your news: We welcome your input. If you have an event you would like to submit for our calendar, please send your submission to MPP/Calendar, 2812 E. 26th St., Minneapolis, MN 55406. Fax submissions to 612-728-8601 or email them to jbirgersson@ mppub.com. 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 SEPTEMBER 2012 MINNESOTA HEALTH CARE NEWS

Amyotrophic lateral sclerosis from page 15

consider an operation called a tracheostomy, which inserts a plastic breathing tube directly into the patient’s windpipe through an opening in the neck.

Advance care planning • Honoring Choices: Health-care directive forms; www.honoringchoices.org • www.agingwithdignity.org/five-wishes.php • “Hard Choices for Loving People: CPR, Artificial Feeding, Comfort Care, and the Patient with a Life-Threatening Illness,” by Hank Dunn, www.hardchoices.com

Advance directive is vital Although nutritional and breathing support ease symptoms and enhance quality of life, these treatments do not stop the eventual progression of ALS. People diagnosed with this disease should fill out an advance care directive (also called a health care directive) when they are first diagnosed if they haven’t done so already. An advance care directive is a document that allows ALS patients to provide written instructions about their preferences regarding the care they want to receive as their illness progresses or if life-threatening complications develop. The patient and his or her family should revisit these documented wishes and preferences throughout the progression of disease. It is important for patients and their families to discuss the patient’s wishes and health care goals with their health care provider to achieve peace of mind, reduce feelings of helplessness and guilt among family members, and avoid futile, costly, or uncomfortable interventions that the patient does not want.

participating in research studies. Only through active participation of the ALS community can progress be made in beating this condition. Information about ongoing research into various treatments is at www.clinicaltrials.gov. Research is also helped by the national ALS Registry, which may be the single largest ALS research project ever created and is designed to identify ALS cases throughout the United States. The registry collects critical information about the disease and will help researchers learn what causes ALS and how it can be treated, and possibly even prevented. If you or someone you know has ALS, please consider enrolling in the national ALS Registry at www.cdc.gov/als.

Toward a cure

Ezgi Tiryaki, MD, is a neuromuscular neurologist and educator and the medical director of the ALS Center of Excellence at Hennepin County Medical Center. She was recognized in the 2012 edition of Mpls. St Paul magazine as a “Top Doctor” in neurology.

While the search for a cure continues, progress is not fast enough for many patients. One way for patients with ALS and their families to help is by

WHO’S A BIGGER BASEBALL FAN, YOU OR ME? You’ll find that people with Down syndrome have a passion for knowledge and learning that can rival anyone you’ve met before. To learn more about the rewards of knowing or raising someone with Down syndrome, contact your local Down syndrome organization. Or visit www.dsamn.org today. It is the mission of the Down Syndrome Association of Minnesota to provide information, resources and support to individuals with Down syndrome, their families and their communities. We offer a wide range of services, programs and materials at no charge. If you are interested in receiving one of our information packets for new or expectant parents, please email Kathleen@dsamn.org or For more information please call:

(651) 603-0720 • (800) 511-3696

SEPTEMBER 2012 MINNESOTA HEALTH CARE NEWS

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About the Roundtable MR. CHRISTENSON: How do we define specialty pharmacy? MS. DRAKE: Specialty pharmacy encompasses specialty pharmacy drugs and the infrastructure that delivers those products to the patient. Minnesota statute 256B states that specialty pharmacy products are those used by a small number of patients or patients with complex and chronic diseases that require expensive and challenging drug regimens. Specialty pharmacy products include injectables and infusion therapies, biotechnology drugs, antihemophilic factor products, high-cost therapies, and therapies that require complex care.

Minnesota Physician Publishing’s 37th Minnesota Health Care Roundtable examined the topic of specialty pharmacy. Five panelists and our moderator met on June 7, 2012, to discuss this issue. The next roundtable, on Nov. 1, will explore the subject of health insurance exchanges.

DR. HEATON: CMS has a definition in terms of high cost. That is $600 a month. DR. BEECHER: Specialty pharmacy is part of the whole management program. It has a lot to do with cost and with the special nature of these products. But, in fact, the questions that we’re going to be talking about today will also have to do with how resources will be allocated. MR. CHRISTENSON: What problems do patients face in accessing specialty pharmacy medicines? MR. JOHNSON: The number one barrier is out-of-pocket cost for the consumer. Close to 20 percent of Minnesotans who are prescribed a specialty MS drug are either reducing or not taking it at all because of the cost. DR. STRATTON: There could be concern about how effective many of these medications are. They have been tested in relatively small numbers of patients because of the special nature of many of these conditions, and we need clinical evidence before we do well-designed cost-effectiveness studies. Many times we don’t have adequate clinical evidence of effectiveness—comparing one product to another for a given disease— to talk about which approach is the costeffective way to treat a particular disease. DR. BEECHER: The way access to these expensive drugs is structured, the patient has an awful lot of hoops to jump through and so does the doctor. It depends on how the doctor is reimbursed, whether he or she is an independent practitioner, etc.

Specialty pharmacy Controlling the cost of care MS. DRAKE: Sometimes distribution channels for specialty drugs present a challenge for the patient. Many of these products are only available through specialty pharmacies or mail order pharmacies, which is a switch for patients who are used to having their prescription filled by their local pharmacist. Making sure that the product gets from the specialty pharmacy either to the patient or to the clinic and then delivered to the patient presents a challenge. Another barrier is some of the administrative requirements. Most payers have prior authorization requirements. We’ve run into situations where patients are not able to get their drug because they haven’t received a response from their insurance company yet. MR. JOHNSON: For a condition like MS, that can present significant negative repercussions for a patient. We’ve heard stories that those appeals processes or step programs lead to marked differences in physiological measures of someone with multiple sclerosis. The appeal process needs to be prompt.

MINNESOTA HEALTH CARE NEWS SEPTEMBER 2012

MR. CHRISTENSON: How does utilization of specialty pharmacy create conflict among health care stakeholders? MS. DRAKE: What we’ve seen in Medicaid is around some of the drugs that span between what has traditionally been the medical benefit, which is buy-and-bill in the physician office, versus what is now specialty pharmacy benefit. There is the question of who buys the product, who stores the product, and who bills for the product. Different payers have different requirements. There is not a standard, and there are questions about what is Medicare Part D versus Medicare Part B. That back-and-forth between the medical benefit and the pharmacy causes confusion. MR. CHRISTENSON: There are multiple stakeholders in specialty pharmacy, including pharmaceutical manufacturers, pharmacy benefit managers, physicians, and DHS. What are their priorities? DR. STRATTON: Pharmaceutical manufacturers have an obligation to their shareholders to bring in as much profit as they can on these products. When you’re talking about a smaller market to recoup the costs involved, you have to charge more. DR. HEATON: From a pharmaceutical manufacturer perspective, you always want to find the unmet need. Now we have drugs for Pompe disease that we never had before. If you’re first in the market for the Pompe drug, you set the price. The PBM, depending on how they’re reimbursed by the plan, could have a similar aligned interest. If rebate contracts are available, the PBM will take advantage of that if they are reimbursed by the plan on a PMPM [per member per month] target. On the other hand, they may have a direct conflict in that type of scenario and will put barriers, prior authorization, step edits, you name it, in front of that. It all depends, unfortunately, on the money flow. DR. BEECHER: I want to stay in business as a physician, otherwise I’m not going to be of any help to anyone. As a psychiatrist, I want patients to take responsibility for their own health and be able to enjoy the benefits of their insurance as much as possible. All of these specialty drugs require insurance to some degree.

MS. DRAKE: Our priority in managing the drug benefit is to give the best possible health care and drug benefit to individuals who need our program and, at the same time, provide the best value to the Minnesota taxpayer. MR. CHRISTENSON: With all of these priorities, can we get them in sync? MR. JOHNSON: We’re hopeful. How do we help people become more intelligent about making informed decisions about their health? That challenge is compounded by the nature of MS. People with MS who have visual impairments, mobility issues, cognitive issues, come to the process in a state that adds to the potential confusion, from the perspective of the client. We need to strive toward making it simpler for consumers. DR. HEATON: The system to treat a population works reasonably well; we have to be exquisitely sensitive to the exceptions to the population, the individual patient. Right now, it drives a disproportionate amount of cost. MR. CHRISTENSON: What makes a physician hesitant to prescribe specialty pharmacy? DR. BEECHER: In most cases, we don’t know about rare diseases. The difficulties of producing, storing, and distributing the drugs: We aren’t aware of them. That’s why the pharmaceutical industry is going to the airwaves, to prompt patients to spur the doctor to prescribe this or that. MR. JOHNSON: In the case of multiple sclerosis drugs, for the most part, these disease-modifying drugs didn’t exist 15, 20 years ago. Neurologists who have an MS specialty practice understand the benefits of prescribing. Up to 20 percent of people with MS in Minnesota don’t have access to an MS specialist who’s a neurologist. Some people in rural parts of North and South Dakota travel as far as 600 miles to see an MS specialist. The issue is education, working with clinicians. MS. DRAKE: Some of the concentration into certain provider groups as far as prescribing might not be bad. Some of the new regimens, such as the new hepatitis C regimens that are making a great difference in cure rates for this disease—these regimens are not easy. For a prescriber who only has to prescribe it once a year, I think it would be a

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huge challenge. Whereas specialists in hepatitis C who write these prescriptions over and over become better over time. Maybe at some point there can be better communication between specialists and practitioners in rural areas to share information so that rural practitioners can get specialist knowledge without having to know everything about everything. MR. CHRISTENSON: Many physicians believe that specialty meds don’t work; some are not aware of what a drug can do. Is this general within the physician world? DR. BEECHER: Yes. You have to know what you don’t know if you’re a physician. MR. CHRISTENSON: One of the biggest issues is spending money on high-priced drugs, hoping in the future to reduce hospitalizations and other costs. DR. HEATON: That’s a very good point, one that all payers are struggling with. I may make a decision to cover an MS drug or an oral oncology agent, and I may not reap the benefit of that decision. I have all the up-front costs, but to see that the patient continues to work, continues to pay taxes, or is cured of their disease may occur someplace down the road. Ultimately, we have to take a much broader societal picture of that. Covering a drug today for the promise of tomorrow is fraught with problems because nobody knows how far off is “tomorrow.” The rest of the world does very good pharmacoeconomics studies—I can think of the National Institute of Clinical Excellence in England— trying to answer questions such as, is it cost effective and looking at a life saved. We don’t do that in the United States. MR. JOHNSON: There’s evidence that there are enough dollars currently in this country devoted to care and treatment that, if managed correctly, we’d have much better outcomes. We still haven’t figured out how to manage those dollars. In the case of people with multiple sclerosis who are being prescribed an MS disease–modifying drug—no generic equivalent, unlike some specialty drugs—there’s a high likelihood that they will be on that drug for the rest of their lives, and they will likely not die of MS, they’ll die from another condition. If the cost

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A B O U T T H E PA N E L I S T S Lee Beecher, MD, maintains a solo practice in adult and addictions psychiatry in St. Louis Park. He is an adjunct professor of psychiatry at the University of Minnesota Medical School, a Distinguished Life Fellow of the American Psychiatric Association, a fellow of the American Society of Addiction Medicine, a past trustee for the Minnesota Medical Association, and was medical director for psychiatric services at PreferredOne from 1991 to 1995. He also serves as president of the Minnesota PhysicianPatient Alliance (MPPA), a nonprofit organization committed to improving health care. MPPA believes that efficient, quality health care depends on strong doctor-patient relationships and that interference in the doctor-patient relationship by third parties can alter market-based reimbursement and undermine the traditional ethics of the medical professions. Sarah Drake, RPh, MPH, MBA, is the pharmacy program manager for the Minnesota Department of Human Services (DHS), where she oversees all pharmacy-related activities for the Medical Assistance program. This includes drug utilization review, formulary and preferred drug management, two drug rebate programs, establishment of state maximum allowable costs, prior authorization, utilization management, policy development, and legislative activities. Before working at DHS, she was a senior consultant for Deloitte Consulting in its strategy and operations practice, served in product management at Blue Shield of California, and worked as a pharmacist in both inpatient acute care and in retail pharmacies. Alan Heaton, PharmD, RPh, director of pharmacy management for UCare, is responsible for all facets of the pharmacy benefit program for more than 300,000 Medicaid and Medicare Part D members. He is an adjunct clinical instructor in the University of Minnesota School of Public Health and a clinical assistant professor in the College of Pharmacy, University of Minnesota, Minneapolis, where he lectures on diseases and their relationship to drug therapy. Previously, he was pharmacy director for Blue Cross Blue Shield of Minnesota and vice president for health outcomes integration at Prime Therapeutics. In the latter role, he directed medical and pharmacy data integration applications and outcomes research, including retrospective database studies and clinical trials of a wide variety of therapeutic agents. Daniel Johnson, MEd, is vice president of public policy and mission advancement for the National Multiple Sclerosis Society Upper Midwest Chapter, leading its consumer advocacy, political engagement, client programs, and professional outreach and education. Reducing the financial burden of MS specialty drugs is a chapter priority; more than 17,000 people live with MS in Iowa, Minnesota, North Dakota, South Dakota, and several counties in western Wisconsin and Nebraska. Previously, as vice president of UnitedHealth Group, he led its social responsibility culture to focus on chronic disease. He has also served as executive director of Blue Cross and Blue Shield of Minnesota Foundation. Early in his career, he provided direct care to people living with chronic illnesses, including MS. Timothy Stratton, PhD, BCPS, FAPhA, is a board-certified pharmacotherapy specialist and a professor of pharmacy practice in the University of Minnesota College of Pharmacy, Duluth, where he teaches ethics and supervises medicine and pharmacy students at the HOPE free clinic. He also practices occasionally at the Min No Aya Win Clinic in Cloquet. Stratton earned his MS in hospital pharmacy and PhD in pharmacy administration from the University of Arizona and completed a pharmacy residency at Arizona Health Sciences Center. He previously taught at the University of British Columbia and the University of Montana and has practiced pharmacy in Alaska and with the Indian Health Service in Montana. Bruce Silcox Photography

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Robert Christenson, with 40 years’ experience in health care policy and consulting, helps solo and smallgroup practitioners build a full practice of ideal clients and improve their net revenue.

SEPTEMBER 2012 MINNESOTA HEALTH CARE NEWS

M I N N E S O T A is such that they’re not able to afford it and therefore compliance with treatment is not followed, there’s some argument to be made that they’re being discriminated against. They’re paying a premium, they’re eligible for a government program, they can’t gain access to the drug, and so their health is harmed as a result. Again, it goes back to the question: How do we manage the overall resource in ways that are smarter than we’re currently doing? DR. STRATTON: Part of it’s a cultural bias, comparing a city of cure versus a city of care. City of cure: We go in, we replace the organ, we cure the patient. Then we have the city of care, patients who have chronic illnesses. We’re never going to cure them. We can only provide care for them. The U.S. does not like things to draw out that long. We like to get in there and fix it and move on and stop paying for it. MR. JOHNSON: We haven’t talked enough about investment in prevention and the cost benefit of that. Evidence shows that if you stop smoking, if you deal with issues around obesity, nutrition, and stress, that chronic disease will most likely diminish. What does that mean long term in terms of health care dollars? There’s the argument that you’re prolonging people’s lives and what’s the cost there; but I think that in terms of quality of life factors, that is indisputable. MS. DRAKE: Over 10 percent of the population is on some kind of specialty drug in this country. If most specialty drugs run between $20,000 and $30,000 a year, spread that across the whole U.S. population and that’s $2,500 a year for every man, woman, and child in this country. Is that an acceptable amount that we’re willing to pay for these advances in therapy? Those are questions we need to ask. MR. CHRISTENSON: If it’s $25,000 a year for an AIDS drug and there are a million people who are HIV-positive, that amounts to $2.5 billion a year in costs. DR. STRATTON: Let’s talk about spending $25,000 a year for one patient’s medication. How many patients could we vaccinate against influenza that year at $20 apiece? 1,250. We know there’s a certain percentage of patients with flu every year who die from that after an expensive hospital stay, versus one patient whose quality of life will improve dramatically with that $25,000. This

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is where, from an ethics standpoint, it becomes a justice issue. Justice is the fair distribution of scarce resources. That’s one of the big issues we’re struggling with as a society. DR. HEATON: It also points out why many health care plans have medical ethicists and medical policy committees. We, also, are struggling with what is fair. Is it fair for an MS patient to have 20 percent coinsurance on a drug that’s $3,000 a month? MR. JOHNSON: There was a story last night on NPR that spoke to increasing concern about cancer rates among people who have been exposed to radiation through CT scans, and some suggestion that we could probably cut the number of CT scans in the country and

there wouldn’t be any adverse effect. At the same time, a CT scan is the No. 1 way that MS is diagnosed and the progression of the disease is modified. So how do we apply resources that are already on the table in much more informed and educated ways so that we make sure that there’s not waste— that we can still provide flu immunization for all those folks that should be getting a flu vaccination, and at the same time be able to provide the AIDS drug? MR. CHRISTENSON: The issue of medical benefits and pharmacy benefits: What challenges does this present for the state Medicaid program?

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MS. DRAKE: One of the biggest challenges is waste. There’s a push toward white bagging, where the specialty pharmacy bills the pharmacy benefit directly and then ships it to the doctor’s office for administration. We run into the situation where a specialty pharmacy will ship the drug to the clinic, we’re billed for it, and the patient doesn’t show up. Patients have things going on in their lives, there’s disruption, and that drug sits at the clinic and ultimately gets thrown away. When it’s a 10-cent pill, we don’t care, but when we’re talking a $5,000-a-month infusion that we’re billed for and it gets

Over 10 percent of the population is on some kind of specialty drug in this country. Sarah Drake, RPh, MPH, MBA

thrown away, that’s a problem. We have gone to our policy of, “It’s administered in the clinic, it needs to be billed on medical,” because then we’re not billed for it until it’s actually used. Some commercial plans have specialty pharmacies they contract with, and the specialty pharmacies have an incentive to dispense the drug because they make a margin on that. It’s a difficult tug in each direction. MR. CHRISTENSON: One of the components of finding solutions to this is good data. DR. HEATON: We have a wealth of data, but it’s the wrong data. I can tell you to the penny how much we spent on PMPM basis on both the pharmacy and the medical side

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M I N N E S O T A for the drug for hepatitis C, for example. Plans have a wealth of data. It’s retrospective, not forward-looking, and that’s what we need. I’ll give you a practical example: the new oral therapies for hepatitis C on top of the IV therapies. You can literally eradicate the virus now. The trouble is, you’ve got be on these oral drugs for three to six months. This is a particularly acute problem in Medicaid, where you have month-to-month enrollment changes, so when suddenly someone leaves a plan, we’ve lost continuity of care. Huge societal cost problem looming. Huge problem in the short term because it breeds resistance to the drugs. Data almost has to always follow the patient.

Many consumers continue to be insulated from cost.

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patients. They could go to clinics and get stuff as needed for their kids and for themselves, and their costs would be accounted. They would have some kind of fallback for hospitalization. There would be no doughnut hole or anything like that. I don’t see why their meds couldn’t be done the same way. We need to look at different methods of payment based on individual experience and then get data. MS. DRAKE: Laws state that any willing provider, as long as there is not some reason as far as a license issue, can enroll as a Medicaid provider and provide specialty drugs. I think one of the challenges might be access to products at prices that are similar to what the big providers get. Some of the bigger providers negotiate better pricing on the products. Independent

MR. JOHNSON: Many consumers continue to be insulated from cost. That’s changing with the advent of copay and coinsurance. I hope that people would be making decisions about their specialty drugs or other kinds of treatment based on how they perceive the outcome and the desired benefit. If they see that they improve their health, however they define it, that should be the driving force. How do they become more educated and informed of options in that regard? MS. DRAKE: We need to think about multidisciplinary efforts to ensure that patients are using their medications and using their medications correctly. It probably needs to go beyond the physician and the pharmacist to maybe social workers in Medicaid cases, or other kinds of care coordinators or providers. If we’re going to, as payers, invest in high-cost products at $25,000 a year, it makes sense that we make another nominal investment to make sure they’re using these medications appropriately. Studies show that by getting the pharmacist involved in spending time understanding what’s going on with the patient, you achieve better adherence.

Daniel Johnson, MEd

MS. DRAKE: If we invest in this drug today, where is the advantage in the future? We don’t have a good way to track a patient’s health care outcomes across time.

physicians might need to join a buying group in order to get better negotiated rates on those drugs.

MR. CHRISTENSON: Can physician-owned, independent medical practices provide specialty pharmacy unless they join provider networks? DR. BEECHER: We’ve got to learn how to costaccount the individual case. I want to know how much a patient is costing. Then, I want to design my system around the best venue to provide the care that patient needs without wasting anything. My colleague, Dr. Geist, has come up with a solution. Medical Assistance could have a card that would be given to AFDC-type medical assistance

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macists, nursing staff. We identified 16 different things that touch compliance, not including cost. From a plan perspective, there have been plans that have said, these lifesaving drugs are free or low cost or the $4 generic. Other attempts have been, if you’re compliant for three months, the fourth month is free. Then there are patient assistance programs. Cost is what scares everybody off right off the bat, but once you tackle the cost issue you still have all these other factors to contend with.

MR. CHRISTENSON: How do we make patients more compliant with instructions? DR. BEECHER: There is a direct relationship between decreased adherence to medications and copayments. Expensive drugs with a high copayment, that’s going to further complicate our problem. DR. HEATON: We have instances of Medicaid where there is no cost and yet there still is noncompliance, and it gets to a wide variety of social issues: denial that they’re sick; educational effort among physicians, phar-

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DR. STRATTON: Whether it’s a pharmacist or physician sitting down with a patient, identifying what’s important to the patient, involving the patient in that discussion. Patients who have rheumatoid arthritis may know fairly soon if they’ve missed a dose. Patients who have high blood pressure may skip doses. A recent patient we had at the HOPE Clinic—it had been two years since they’d been on their blood pressure medicine. Their numbers concerned us, but the patient felt fine. So, taking the time to figure out what’s important to that patient is important. MR. CHRISTENSON: Once you find out what’s important to the patient, which works more

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M I N N E S O T A effectively—penalty or positive incentive? DR. BEECHER: Positive incentive. Motivating the patient though different ways, including the family and social work, to do the right thing is a process involving the pharmacist, involving the physician. How do you get them to do the right thing? You do what you do with your children: You keep working on it. Punishment, penalties, copayments—all that does is to make things worse. DR. HEATON: If I put a $125 copay on something, I’m intending to decrease utilization and that’s exactly what I get. We’ve got to get more creative than upping coinsurance and copays. One individual did a very good cost-utility analysis. He was asking about the treatment of rheumatoid arthritis and the doughnut hole. He came up with the observation he’d be spending roughly the equivalent of two big-screen TVs annually. He said, “I think I’ll get more satisfaction out of watching the Vikings than I will taking the drug.” That is what a lot of the rest of the world does. They’ll do that cost-utility analysis and say, it’s more important to our population to treat potholes than it is to treat rheumatoid arthritis. When patients are less insulated against the true cost of these drugs and their outcomes or nonoutcomes, they start making those judgments to say what’s more important to them. DR. STRATTON: Involving the patient in that discussion, we may learn that the patient may be willing to use a less effective medication, live with some level of discomfort, versus a very expensive medication that would provide complete relief. We need to ask the patient those questions. MR. JOHNSON: All eight of the current MS-modifying drugs have patient assistance programs. There is a copayment assistance program. There are nonprofit organizations that provide support when patients run into financial binds within the doughnut hole. Nonfinancial assistance programs, educational programs: There are a lot of those, by and large, available from pharmaceutical companies. Not to say those aren’t valid, but they would have some bias toward the medication that the company represents. MR. CHRISTENSON: What is the role of the PBM in expanding use of specialty pharmacy?

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MS. DRAKE: It depends on the PBM. As far as expanding the role: Should we be expanding the role of specialty pharmacy? From our perspective at the state, we’re not really a PBM; we’re managing a public program. We’re trying to make sure that patients get the best care for the best dollar. As far as commercial PBMs, they have a split role where they’re accountable to the ultimate payer—whoever’s hired them as a PBM—to try to get them the best value in their drug benefit. They also have an incentive to make a profit and many are doing that through their contracted or in-house specialty pharmacies. So they’re expanding the role of specialty by being a distributor as well as a payer.

I would like to have a relationship with the pharmacy team where I, as a physician, know that pharmacist is looking over what I’m doing. That’s the role of the retail pharmacist, and I think they are getting cut out of the deal here. MS. DRAKE: In some instances that does happen, and it’s a challenge for the patients as well as for the pharmacist. Maybe your patient goes to their corner drugstore for all their medications, but [this time] they need a specialty drug, and either their insurance requires it or, sometimes, the drug manufacturers have exclusive arrangements with a particular specialty pharmacy—so the only way the patient can get that product is through mail order. There are a lot of questions about how information is shared be-

You have to know what you don’t know when you’re a physician. Lee Beecher, MD

MR. CHRISTENSON: Are there concerns with PBMs having their own pharmacies? DR. HEATON: I’d say there are some inherent conflicts. Along those lines, if you look where PBMs are going, they’re not necessarily buying a lot of pharmacies. They’re going to mail order and specialty. The recent merger/acquisition of Medco by Express Scripts underlines that because that was predicated on increasing mail order business and increasing specialty pharmacy business. Those are the two high-profitability items they have. DR. BEECHER: Pharmacists have special expertise to do counseling, to look at utilization patterns, to look at multiple drug prescriptions, to do all kinds of things for which we in our offices don’t have the data.

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tween those two pharmacy providers. Who’s really looking over that patient’s whole regimen? Is the doctor being informed that the patient is using multiple pharmacies? The physician could end up getting refill requests from multiple places. It does add complexity to the regimens of folks who have complicated medical conditions. MR. CHRISTENSON: What do employers need to know about specialty pharmacy? DR. STRATTON: Many times, employers look at their drug spend for the health benefit they’re offering their employees separately from the medical spend. When you consider cost as separate silos, you don’t get the big picture. Spending on specialty pharmaceuticals that keep patients out of the hospital often gets lost when you look at increase in drug spend for a given year. Employers generally will not use the entire spectrum of information available to them in making determinations in benefit design. DR. HEATON: I agree. The usual knee-jerk response to something like this is to create a carve-out scenario. Pharmacy has been a

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M I N N E S O T A victim of being carved out for years. We’re even seeing that nationwide, when mandatory specialty pharmacy gets carved out of pharmacy benefit. You get into this scenario where if I’m a member and see my rheumatologist or neurologist or oncologist, and they write me a prescription, and I go to the drugstore or the specialty pharmacy, I’m typically looking at 20 percent coinsurance. However, if I stay in the office and they infuse the drug into me, I’m looking at maybe just my office copay. I may not be paying anything at all for the drug. Perversely, the usual employer group reaction to this type

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hire a PBM and they’ll take care of it. The employers need to be ready to ask those kinds of questions and really get into the weeds of what is the PBM doing for me and how are they helping to make sure that there’s not waste and I’m getting the best deal. Another thing that employers should consider is some of the changes in the Affordable Care Act and what that might mean in terms of specialty pharmaceuticals. Part of that was elimination of lifetime limits on employer and insurance policies. In a world with no lifetime limits, someone who’s a million-dollar-a-year patient could have big implications for an employer. MR. JOHNSON: The other thing I want the employer to be aware of, beyond medical or pharmacy costs, is the broader cost to the employer—the return from specialty drugs that allows the person to con-

Ultimately, we have to take a much broader societal picture. Alan Heaton, PharmD, RPh

Minnesota Department of Health has, that all payers are required to accept. We’re not seeing a lot of use of that right now because most payers use existing forms. The hope is, and I think legislation specifies, that in 2015, there will be national standards for electronic PA. I know the National Council on Prescription Drug Plans, the standards organization for pharmacy, is working on how to do PA in a standard way electronically. I know the AMA has been involved, as have other stakeholder groups, looking at what needs to be standardized. Is it just the form, is it the question, can it be integrated with e-prescribing, can there be a real-time check to see if a drug needs a PA before the prescriber puts in for the PA? There’s a lot of work in this area because I think all stakeholders agree that it is out of control as far as the administrative burden. Most people understand the need for PA to make sure the drug is being used at safe and effective doses for the right populations. How can we make that process easier? DR. HEATON: On the Pharmacy and Therapeutics committees that I am on, safety is the first criterion. We’ll go safety, efficacy, uniqueness, first drug to market for a condition. Cost is the last factor we consider. MR. CHRISTENSON: What role does the FDA play in measuring efficacy?

of thing sets up the fact that their pharmacy cost drops, and it becomes a self-fulfilling prophecy. Unfortunately, their medical costs on the delivery of this drug go through the ceiling. Then they’re trying to figure out what happened because they come back and say, “Well, you said if I do all this my medical costs will drop.” No. It sets up a perverse incentive. Unless you’re a fully integrated system, you’re going to be fighting that all the time. MS. DRAKE: What an employer needs to know as well is to think about, who is my PBM and what are my PBM’s incentives? How are they looking out for me and how are they looking out for my bottom line versus how is the PBM making their money? Sometimes, employers will say, I’m going to

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DR. STRATTON: None, in this country. In Canada, they pay some attention to that. Australia has been leading that charge over the years. The Brits have done a better job through their National Institute of Clinical Excellence. The U.S., we’re way behind the curve.

tinue to work and be productive. MR. CHRISTENSON: What criteria should be used when evaluating new specialty products for inclusion in a standard insurance benefit set? Will authorization approaches be a criterion? MR. JOHNSON: Does the medical, physiological, or emotional benefit outweigh the risks? DR. HEATON: About three years ago, legislation was passed for uniform prior authorization that was then delayed until 2015. The health plans are in favor of that because it is an administrative burden on us. For those who have Medicare, any administrative burden now goes to MLR [medical loss ratio]. This is a big issue with Medicare. MS. DRAKE: There is a standard prior authorization, or PA, form that the

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MR. CHRISTENSON: How is efficacy measured? DR. STRATTON: A randomized clinical trial. Those types of well-designed trials provide groundwork information for cost-effectiveness studies between different products or cost-benefit analyses, of which there are even fewer well-done studies because of challenges in conducting a proper costbenefit analysis. Testing should be transparent so that that another research team could go back and replicate the study to see if they get similar results. That includes reporting studies that fail. DR. BEECHER: There seems to be little incentive from the pharmaceutical industry to do comparative analyses. They even have some reluctance to compare their own products.

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M I N N E S O T A You can’t do head-to-heads very often. If you do, at least in our field, there’s not enough time to tell. Usually there’s only a month or two to get the outcome. It’s very difficult to get meaningful data. DR. HEATON: About 30 years ago, I was a study coordinator on antidepressant studies. We compared drug versus placebo, which is the randomized trial that gets it FDA-approved, and we had a 54 percent response rate on drug. We had a 46 percent response rate on placebo. That means for every 10 people the doctor would see in his office, 5.4 responded to the drug, and 4.6 responded to placebo. It’s roughly five out of 10 both ways. That’s statistically significant. That was the second confirmatory trial. The drug got approved. There were 27 other trials in which there was no difference, and in fact there were a few trials in which the placebo performed better than the drug. Conventional wisdom at the time said, that can’t happen. We know now, it could happen. Even with randomized controlled clinical trials, we are lacking in good information. MS. DRAKE: A lot of times what’s presented to us is that a drug is more efficacious than placebo statistically, but what does that mean clinically? What does that mean for the patient, that their score on this metric is 10 percent better? What does that mean in terms of their quality of life? Sometimes it’s really difficult to pull those answers out of the data. MR. CHRISTENSON: Lee, how can consumers make their perspectives known when these criteria are being set? DR. BEECHER: First of all, I think they have to have a choice of providers. Secondly, they have to have some control of dollars on the front end. I alluded earlier to how public assistance patients could do that. We are in a reality of high-deductible plans in Minnesota now, somewhere around 14 percent. There are issues around how much discretion the patients have on the front end, before they get to their deductible, and the rates. But patients need to understand the economics of their own care. I think we’re just emerging into an era where, although some of us have a public health view of a right to health care, we haven’t thought, as patients, about how much things cost. We don’t know how much our pharmaceuticals really cost.

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MR. CHRISTENSON: What is the Minnesota Physician-Patient Alliance doing in this regard? DR. BEECHER: I mentioned a program to empower Medical Assistance patients with a debit card and let them do some front-end shopping and select their own providers. We’re working with legislators on those issues. We have to become more costconscious. MR. CHRISTENSON: What causes the time lapse between when a new pharmaceutical product is proven to achieve superior results and when it becomes widely used? DR. HEATON: One of the big causes is lack of clear evidence. We have seen over the last 10, 15 years—independent of specialty pharmacy but now it’s linked because of cost issues—a surge of noninferiority trials or nonsuperiority trials: “It’s just as good as something else,” or it’s randomized

against placebo. Placebo is not one of my treatment options in the real world. So there’s a lack of high-quality information that says, “This works.” With a drug that’s $3.28 a day, like Lipitor was, versus something that’s $34,000 a month, like Revlimid, scrutiny is exponentially higher. We don’t have good comparative trials like there are in the rest of the world, so we’re left with a lot of uncertainty. DR. STRATTON: A well-designed cost-effectiveness study first and foremost would be based upon a well-designed clinical trial with an adequate number of patients in both the innovative drug arm and the comparator arm, whether that was placebo or another comparative drug in the same therapeutic category. Collecting that data, you would need to conduct a cost-effectiveness compo-

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nent of the trial from the get-go. Many times, cost-effectiveness studies are conceived after the fact, after the clinical trial has been completed. You’ll see researchers saying, I wish we had collected that data during the clinical trial. It takes a lot of planning up front. Again, it’s a very complex process to adequately design those kinds of trials, and we don’t have a lot of expertise in North America to conduct those kinds of trials. Expertise aside, they are very expensive to undertake, so who’s going to pay for that? Pharmaceutical company? National Institutes of Health [NIH]? NIH is underfunded and that’s not going to improve any time soon. Those are some of the barriers. It’s

Taking the time to figure out what’s important to the patient is important. Timothy Stratton, PhD, BCPS, FAPhA

complex to do these studies properly. MR. CHRISTENSON Could the FDA’s approval process be more efficient without compromising quality? DR. HEATON: It’s a two-edged sword question. FDA approved Avastin on a fast-track scenario. Lo and behold, at least in breast cancer, it did not seem to be effective and, arguably, may have caused excess mortality. Yes, we do have a need to speed to get these drugs to a susceptible population, but we can’t overlook the safety issue. Unfortunately, those trials take a long time. The drug I saw yesterday had two studies, and I think there was a grand total of 31 patients, worldwide, that were studied. So the odds of seeing efficacy diminish but, more importantly, the odds of seeing something that

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M I N N E S O T A will kill you or cause an adverse reaction, are very difficult to find in these studies. The FDA is caught by the need to speed, but on the other hand, it has to be conducted with a large enough number of patients and a sufficient period of time to see safety signals that often come out after the fact. MR. JOHNSON: There is a great need for additional resources for medical research. With NIH funding, unfortunately, politics are getting in the way of making informed decisions and supporting things that are important for the health and well-being of the population. MR. CHRISTENSON: What are the biggest developments coming in specialty pharmacy? DR. BEECHER: The biggest opportunity will be learning about genetics. Pharmaceutical companies are keying on tailoring drugs. Specialty pharmacy is based on genetics. DR. HEATON: Two words come to mind: “prevalence” and “oral.” Look out on the pipelines of many drug manufacturers and where the research is in specialty pharmaceuticals. Increasingly, these are oral drugs. I’ve had the conversation with quite a few members who have multiple myeloma, went to the drugstore, and found their 20 percent specialty charge was $3,000 if they wanted to get their drug. That’s for basically a threeweek supply. Increasingly, these are oral. They’re not injectable any more. They’re not infusion. The other aspect of this that’s scary is prevalence. If you recall, I said, 99 percent of claims are not specialty pharmaceutical. It is relatively isolated, small numbers of unique conditions. That’s changing. Dr. Beecher pointed out the issue of genomics. Suddenly, we will have specialty drugs for hypertension, hyperlipidemia, diabetes. We can see that coming: prevalent conditions that account for 30 percent to 40 percent of

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claims volume and huge amounts of cost. The future looks, depending on one’s perspective, very scary. MR. JOHNSON: The National MS Society has looked at this issue, and leaped to seeking relief via insurance regulation. Just in the last month or so, there have been stories about specialty drugs and the costs in the New York Times, the Washington Post, the LA Times. It’s important that we inform all the various stakeholders about what’s playing out because in many ways, this has been somewhat of an invisible movement despite the decades that specialty drugs have been around. It’s fair to say that increased attention will fuel a lot of hand-wringing that often leads to “let’s create a bill, let’s regulate this issue.” On one hand, that’s something we need to take a close look at. We know that mandating some kind of benefit is not going to be a solution, and it’s not necessarily the approach that I want to take as the Midwest Chapter of the National MS Society. We’re contemplating convening a small group of stakeholders to sort out from a public perspective, whether it’s a policy solution or an education solution, what’s the best way for us to move forward—not in an adversarial relationship with health plans, but [rather], how do we come up with a common solution? MS. DRAKE: There’s going to be more attention to this topic, partly because of the prevalence of the conditions that they’re treating. Also, during the last several years, most plans have been able to stabi-

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lize a lot of it on the drug side with the introduction of generics for what have typically become blockbluster drugs like Lipitor, Seroquel, Zyprexa. All of those have gone generic in the last year, and that has decreased cost for pharmacy benefit managers. The generic tide is ending soon, probably within the next few years, and at that point we’re left with a trend that is going to be driven by these specialty pharmaceutical products. Pharmacy benefit managers, employers, public payers that traditionally haven’t looked closely at specialty pharmacy because it has been a small portion of their cost, are going to have to start looking because that’s what going to be driving the trend in the future. The other development I would mention is health reform and the Affordable Care Act. There is a lot of talk about ACOs— accountable care organizations—and different payment reform methodologies. How does specialty pharmacy fit into that? If you’re talking about a total-cost-of-care arrangement with a provider group, what does it mean if that provider group treats a lot of patients who need specialty drugs, and how is that adjusted for? I think that’s going to be an important development, too. DR. STRATTON: With the advent of accountable care organizations, having a pharmacist on that patient care team on the patient level, as well as on a health system level—it’s going to be very important to have a pharmacist’s input on a lot of the decisions that are going to be coming down the pipeline in terms of including particular specialty pharmaceuticals on a formulary.

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INSURANCE Be informed

Medicare changes in 2013 Every January, Medicare changes. Not all of next year’s changes are known yet, but what is known is provided here to help you start planning choices to make during Medicare annual open enrollment, which begins Oct. 15, 2012, and ends Dec. 7, 2012. During that time, you can make changes to your Medicare plan; changes take effect Jan. 1, 2013.

Medicare-related materials will arrive by mail this fall. Read them to learn about upcoming changes to your current Medicare plan that will take effect Jan. 1. This will help you avoid potential surprises such as: • Showing up at the pharmacy to find that your prescription drug is no longer covered by your Medicare Prescription Drug Plan • Discovering at the pharmacy that your Medicare Prescription Drug Plan has shifted a prescribed drug to a higher cost-sharing tier, increasing your out-of-pocket cost • Being unprepared for Medicare Prescription Drug Plan cost-sharing changes such as monthly premium and deductible increases • Finding out that you no longer qualify for Extra Help with Prescription Drug Costs (also called Low Income Subsidy, or LIS), which reduces out-ofpocket costs • Learning that your Medicare Prescription Drug Plan is no Kelli Jo Greiner longer a “benchmark plan,” so that even if you qualify for LIS, your monthly Medicare Prescription Drug Plan premium has increased • Discovering at the pharmacy that prescription drug coverage provided as part of your retiree plan has changed, either because of increased monthly costs or because your plan is no longer considered “creditable coverage.” Creditable coverage allows you to remain in your retiree prescription drug plan and avoid a premium penalty should you later enroll in a Medicare Prescription Drug Plan.

Navigating open enrollment By

Leg Pain Study Do your legs hurt when you walk? Does it go away when you rest? Or, have you been diagnosed with PAD? You may have claudication, caused by lack of blood supply to the leg muscles The University of Minnesota is seeking volunteers to take part in an exercise-training program, funded by the National Institutes of Health

To see if you qualify, contact the EXERT Research Team at

612-624-7614 or email EXERT@umn.edu or visit EXERTstudy.org

Tips In addition to reading Medicarerelated materials you receive in the mail, follow these tips:

Every January, Medicare changes.

1. If you receive LIS, follow mailed instructions you’ll receive from the Social Security Administration (SSA) and/or the Centers for Medicare & Medicaid Services (CMS). This will help ensure you receive LIS in 2013. If you are asked to send in something, make sure to do so, or your LIS eligibility could be revoked. 2. If you have retiree coverage, mail you get from the insurer will inform you of changes for 2013 and whether or not your retiree prescription drug coverage will be considered creditable coverage.

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MINNESOTA HEALTH CARE NEWS SEPTEMBER 2012

3. Information you receive about other Medicare Prescription Drug Plan and Medicare Advantage options can help you decide which plan is best for you in 2013.

2012 Choices

Annual deductible $320

2013 $320

Definition

$2,970 Prescription drug costs Initial cover$2,930 Medicare open enrollment from $325 through age limit begins Oct. 15, 2012 and ends $2,970 are covered as Dec. 7, 2012. Changes to your follows: Plan pays 75% plan take effect Jan. 1, 2013. of the cost and you pay During open enrollment, 25% of the cost. you can do any of the following: Coverage gap $4,750 is the amount $2,970–$6,733.75 $2,930–$6,657.50 • Change from Original (Doughnut that you pay out-ofDoughnut hole amount Doughnut hole amount Medicare to a Medicare hole) pocket before having in 2013 will increase to in 2012 has been Advantage Plan catastrophic coverage. $4,750 $4,700 • Change from a Medicare Catastrophic Begins after $6,733.75 Began after $6,657.50 Advantage Plan back to coverage in total prescription in total prescription Original Medicare drug costs drug costs • Switch from one Medicare Catastrophic You will be responsible You are responsible for Advantage Plan to another coverage for copayments of $2.65 copayments of $2.60 Medicare Advantage Plan cost-sharing per generic prescription per generic prescription • Switch from a Medicare drug and $6.60 per drug and $6.50 per Advantage Plan that doesn’t brand-name prescripbrand-name prescription drug. offer drug coverage to a tion drug. Medicare Advantage Plan that does offer drug coverage Medicare Advantage disenrollment is from Jan. 1, 2013, through • Switch from a Medicare Advantage Plan that offers drug coverage Feb. 14, 2013. to a Medicare Advantage Plan that doesn’t offer drug coverage During disenrollment, YOU CAN: • Join a Medicare Prescription Drug Plan • Leave a Medicare Advantage plan and switch to Original • Switch from one Medicare Prescription Drug Plan to another Medicare. Original Medicare coverage begins the first day of the Medicare Prescription Drug Plan following month. • Drop your Medicare prescription drug coverage completely Medicare changes in 2013 to page 28

NOW hear this!

In the next issue..

o you know of family members, friends or neighbors who have difﬁculty using their telephone? Do they have trouble hearing, speaking or have a physical disability that prevents them from using a standard telephone?

The Minnesota Telephone Equipment Distribution Program can provide special telephone equipment at NO CHARGE to Minnesota residents of all ages!! The equipment includes ampliﬁed (corded and cordless) phones, speakerphones, captioned telephones, telephone ring signalers, deafblind equipment and other special equipment. To learn more about this program visit our Web site at: www.tedprogram.org or contact us at (800) 657-3663, (888) 206-6555 TTY. Eligibility requirements do apply. The Telephone Equipment Distribution Program is administered by the Department of Commerce Telecommunication Access Minnesota (TAM) and funded by a telephone surcharge.

• Diabetes • Pacemakers for pain • Indoor air quality SEPTEMBER 2012 MINNESOTA HEALTH CARE NEWS

Plans. Enrollees of plans with a Quality Star Rating of 4.5 or lower can use a Special Enrollment Period (SEP) to enroll in a plan with a Quality Star Rating of 5 anytime during 2013, but it can be used only once per calendar year. Beginning Jan. 1, 2013, CMS will notify plan enrollees if they are enrolled in a Medicare Prescription Drug Plan and/or Medicare Advantage Plan that has not achieved a Quality Star Rating of at least 3 Stars for three years in a row. These enrollees will be eligible for a Special Enrollment Period (SEP) to enroll in a plan with a higher Quality Star Rating.

Medicare changes in 2013 from page 27

• Switch to Original Medicare. If you switch, you have until February 14 to join a Medicare Prescription Drug Plan to add prescription drug coverage. This drug coverage begins the first day of the month after the plan receives the enrollment form. During disenrollment, YOU CANNOT: • Switch from Original Medicare to a Medicare Advantage Plan • Switch from one Medicare Advantage Plan to another • Switch from one Medicare Prescription Drug Plan to another • Join, switch, or drop a Medicare Medical Savings Account Plan Medicare prescription drug changes in 2013 Plan changes become public information on Oct. 1, 2012, and can be read at www.Medicare.gov as of that date. Quality Star Rating In January 2012, the Centers for Medicare & Medicaid Services launched the Special Enrollment Period for Quality Star Ratings for Medicare Prescription Drug Plans and Medicare Advantage

Health Care Choices in 2013 Senior LinkAge Line: This one-stop shop for Minnesota seniors offers free, personalized assistance to Minnesota Medicare beneficiaries of all ages. Senior LinkAge Line also helps Minnesotans of all ages access programs that provide free or discounted medications, and provides long-term care options counseling. Call (800) 333-2433 or visit www.MinnesotaHelp.info to chat with a specialist.

The Minnesota Board on Aging will publish the 2013 edition of Health Care Choices for Minnesotans on Medicare this fall. The 2013 edition will include all Medicare Prescription Drug Plan and Medicare Advantage Plan options available in Minnesota. Long-term care planning information will be included, plus 2013 Medicare Part A and Part B information. To obtain a copy of the 2013 publication, call Senior LinkAge Line at (800) 333-2433 after Oct. 15, 2012. Kelli Jo Greiner is team lead for the Minnesota Board on Aging Consumer Choices Team.

Minnesota

Health Care Consumer August survey results ... Association

1. I understand what a health insurance exchange is.

Each month, members of the Minnesota Health Care Consumer Association are invited to participate in a survey that measures opinions around topics that affect our health-care delivery system. There is no charge to join the association, and everyone is invited. For more information, please visit www.mnhcca.org. We are pleased to present the results of the August survey.

3. I feel health insurance exchanges should be available to anyone, regardless of employer size.

20.5%

6.8% 2.3%

Strongly agree

Agree

Percentage of total responses

50 40 30 20.5%

18.2% 9.1%

10 Strongly agree

No opinion Disagree

Strongly disagree

Agree

Disagree

MINNESOTA HEALTH CARE NEWS SEPTEMBER 2012

27.3%

18.2%

15 9.1%

6.8%

5 Strongly agree

15.9% 15

11.4%

Strongly disagree

Agree

Does not apply

Disagree

Strongly disagree

2.3% Strongly agree

Agree

Does not apply

Disagree

Strongly disagree

5. It won’t matter if I know what insurance costs if I do not know what care costs. 30

25 20

38.6%

31.8%

Percentage of total responses

27.3%

38.6%

52.3%

40 43.2%

4. I think a health insurance exchange will lower my health care costs.

2. If eligible, I will use a health insurance exchange when one is available.

27.3%

25 20.5% 20 15.9% 15 9.1%

10 5 0

Strongly agree

Agree

No opinion Disagree

Strongly disagree

Minnesota

Health Care Consumer Association

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

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

www.mnhcca.org

Join now.

â&#x20AC;&#x153;A way for you to make a differenceâ&#x20AC;? SEPTEMBER 2012 MINNESOTA HEALTH CARE NEWS

CARDIOLOGY

Heart disease and oral health Could brushing your teeth save your life? By Elizabeth Klodas, MD Cardiovascular disease remains the No. 1 killer and disabler in the United States, accounting for one of every three deaths. The most common underlying cause of cardiovascular disease is atherosclerosis, or the buildup of fatty, cholesterol-laden plaque in artery walls. Atherosclerotic cardiovascular disease (ASCVD) is an expensive disease to treat and manage, costing the U.S. more than $300 billion annually. It’s no wonder that identifying and, if feasible, treating risk factors for ASCVD is a high

Read us online

wherever you are!

priority. Well-known risk factors include family history, age, cholesterol abnormalities, diabetes, high blood pressure, tobacco use, excess weight, and inactivity. Less well known is periodontal disease, currently under scrutiny as a potential risk factor. Periodontal disease Periodontal disease (PD) refers to a spectrum of disorders that affect the gums. These disorders are characterized by inflammation that occurs in response to the accumulation of dental plaque. PD becomes more common as people age, with moderate to severe periodontal disease affecting 5 percent of 35- to 49-year-olds, gradually increasing with age to affect 20 percent of those over age 75. Factors that predispose someone to develop PD include poor oral hygiene, cigarette smoking, diabetes, rheumatoid arthritis, and, perhaps, obesity. A link between oral health and ASCVD has been proposed for more than a century, but only recently has the health care community started to investigate this potential association at an accelerated pace. During the past 20 years, multiple studies have shown that people with PD seem to have more cardiovascular disease, and that people with advanced ASCVD seem to have more advanced PD. And although firm conclusions regarding a role for PD as a cause of ASCVD have not been reached, some of the data are intriguing. Intriguing data

www.mppub.com 30

MINNESOTA HEALTH CARE NEWS SEPTEMBER 2012

Circulating bacteria. The adult mouth contains more than a billion bacteria. These bacteria can enter the bloodstream, which circulates them throughout the body. This transient circulation of bacteria is fairly common in healthy people, especially during tooth brushing and chewing. It’s more likely in someone with PD, however, because PD makes gums bleed, making it easier for oral bacteria to find a route into the bloodstream. It turns out that those bacteria can end up in atherosclerotic plaque—indeed, the same bacteria in the human mouth have been identified in the walls of arteries. Although this would seem to pro-

vide a direct link between what’s going on in our mouths and what’s happening in our arteries, it is not yet known whether bacteria in arteries is an innocent bystander or an active promoter of arterial plaque formation.

Bacteria in the human mouth have been identified in the walls of arteries.

Inflammation. In recent years, a growing appreciation of inflammation’s association with ASCVD has emerged. It turns out that people with higher levels of inflammatory markers in their blood (such as C-reactive protein, or CRP) experience more heart attacks, strokes, and sudden death than people who have lower levels of inflammatory markers in their blood, even after accounting for all other risk factors. PD, itself an inflammatory condition, also is associated with higher levels of circulating inflammatory markers. Autoimmunity. There is molecular similarity between the walls of oral bacteria and the walls of the endothelium, which is a delicate layer of cells lining the arteries. This molecular similarity could lead to inadvertent damage to the endothelium, caused by the body’s immune system as it tries to destroy the circulating bacteria but mistakes endothelium for bacteria. The endothelium is a critical barrier between the blood flowing through our arteries and the contents of artery walls, and anything that affects the health of the endothelium will affect the health of the arteries. Current understanding Despite the fact that these associations suggest a plausible biologic link between the gums and the heart, we are far from proving that PD actually causes ASCVD. For one thing, there are underlying risk factors common to both conditions, It makes including increasing age, diabetes, and smoking. This makes it harder to tease out sense for all the independent contribution that PD of us to start might make to ASCVD. And it’s not certain if people with PD are simply less thinking attentive to their health in general, and differently thus engage in behaviors that are not conabout our ducive to health maintenance—gum, heart, or otherwise. bodies and In addition, research that has been about our published has not used an apples-to-apples approach in comparing populations or health in evaluating markers of PD and ASCVD. general. And not every published study has found a link. Finally, there have been no sizeable trials that assessed whether treating PD ultimately affects rates of heart attack, stroke, or death due to cardiovascular disease.

weight, exercising regularly, eating a healthful diet, and treating high blood pressure, diabetes, and high cholesterol levels ensure that you will live longer and will be less likely to suffer a heart attack or stroke. Interconnected The broader takeaway from all of this is that it makes sense for all of us to start thinking differently about our bodies and about our health in general. After all, it’s not intuitive that we would find mouth bacteria in the walls of arteries. In medicine, we tend to compartmentalize various bodily concerns: It’s a heart problem, or it’s a joint problem, or it’s a gum problem. The possible link between our gums and our heart illustrates that this is probably not the best way to think about our health. What we’re discovering is that everything in our body is interconnected. And what affects one body system may have farreaching consequences somewhere else within the body. We are amazing, complicated, miraculous machines. So take good care of your body—every part of it. You likely will be rewarded many times over, and perhaps even in surprising ways. Elizabeth Klodas, MD, is a cardiologist in private practice at Preventive Cardiology Consultants in Edina.

Common sense Nevertheless, even though the jury is still out on the issue, common sense should always prevail. Even though we may not be able to say definitively that brushing your teeth can save your life, taking care of your teeth and gums is simply a smart thing to do in its own right. Brushing and flossing regularly, and seeing your dentist twice a year for regular cleanings and maintenance, help keep your teeth and mouth healthy and your smile bright. And treating ASCVD risk factors is smart too, even if it turns out that doing so doesn’t prevent PD. Quitting smoking, losing

SEPTEMBER 2012 MINNESOTA HEALTH CARE NEWS

INFECTIOUS DISEASE

Pertussis

The current whooping cough epidemic

So you have a severe cough that has hung on for a few weeks. A hearty Minnesotan might dismiss it as just a bad cold. But it could be caused by something much more dangerous, especially for infants and those with respiratory problems. The culprit could be pertussis, also known as whooping cough. According to the Minnesota Department of Health (MDH), this disease tends to peak every three to five years. It has been rising steadily in Minnesota since 2008 and has shown a dramatic and disturbing resurgence this year in several states, including Minnesota. In fact, 2,367 cases were reported to the MDH between Jan. 1 and Aug. 16 of this year, with 442 of those cases reported in July alone. More are occurring every day. What is pertussis, and how can you protect yourself and your loved ones against the current epidemic?

By Patricia Vincent, MD What is it?

Living with gout? Keep enjoying life’s simple pleasures.

Gout is the most common form of inﬂammatory arthritis in men and affects millions of Americans. In people with gout, uric acid levels build up in the blood and can lead to an attack, which some have described as feeling like a severe burn. Once you have had one attack, you may be at risk for another. Learn more about managing this chronic illness at www.goutliving.org

MINNESOTA HEALTH CARE NEWS SEPTEMBER 2012

Pertussis is a vaccine-preventable lung disease caused by the highly contagious bacteria Bordetella pertussis. This bacterium is spread from person to person through the air on respiratory droplets during activities such as talking, sneezing, and kissing. It attaches itself to respiratory cilia, the hair-like structures in a person’s airway that normally move mucus and bacteria out of the lungs. Because the bacteria prevent the cilia from working properly, mucus accumulates. The body responds with strenuous coughing to rid itself of that mucus. The persistent strenuous coughing typical of this condition can last for two to three months. All that coughing can produce vomiting, break ribs, and can even make a person pass out. Those and additional symptoms of pertussis can make older children, teenagers, or otherwise healthy adults feel miserable and cause them to miss work or school. However, pertussis in these people is rarely serious enough to require hospitalization. Unfortunately, if pertussis remains undiagnosed, it can spread to others at much greater risk: those whose lungs are already weakened by age, asthma, or other breathing problems; people who can’t fight off the bacteria because their immune systems are compromised by chemotherapy or immune diseases; and babies who aren’t yet fully immunized because they haven’t received all of their vaccinations. Symptoms In older children and adults, initial symptoms during the first week or so can resemble those of the common cold: low-grade fever, runny nose, and a cough. If the person has pertussis, the cough becomes worse during the second week of the illness. Newborns and babies with the disease sometimes make a “whooping” sound when they gasp for breath at the end of a coughing fit. More commonly, babies less than 6 months of age do not make this sound. Babies may, however, quit breathing. This is just one example of how newborns and babies can become seriously ill if they contract pertussis.

Young children who develop breathing problems from pertussis may have symptoms that are serious enough to require hospitalization and placement on a ventilator to alleviate respiratory distress. Youngsters with pertussis may also require treatment for dehydration and pneumonia. In rare cases, the disease can cause brain damage, permanent lung damage, and even death. Babies and toddlers are especially at risk for contracting pertussis because they do not develop maximal immunity against the disease until they have received four doses of vaccine by age 18 months via a series of DTaP shots (Diphtheria, Tetanus, acellular Pertussis). Older children receive a booster vaccination before entering kindergarten and again before they enter seventh grade. It’s a mistake to assume that someone doesn’t have whooping cough just because he or she doesn’t make the classic whoop at the end of a coughing fit. Although whooping may be present in young children, it is not a typical symptom of pertussis in adults or adolescents. For this reason, it is important to consider the possibility of pertussis in a person of any age who has been coughing strenuously for two or three weeks. That individual must seek medical attention promptly. Diagnosis and treatment The reason for a person who is experiencing undiagnosed severe coughing episodes to see his or her health care provider is that early treatment keeps the disease from spreading to others and can also help alleviate the patient’s symptoms. This disease is treatable with prescription antibiotics. Testing must be done by the provider to either confirm or rule out pertussis. Although it can take several days to get test results, a patient who sees a doctor for a serious persistent cough may be prescribed an antibiotic right away, just in case the illness is pertussis. In addition, if someone in your household is diagnosed with it, you should contact your health care provider because there is treatment to prevent you from getting the disease in this situation.

Babies can become seriously ill if they contract pertussis.

Pertussis is a vaccinepreventable lung disease. Prevention The most important way to limit the current pertussis epidemic is to make sure that your vaccinations and your children’s vaccinations are up to date. If there is an outbreak in your school or community, avoid close contact with those who are coughing or appear ill. If you are diagnosed with and treated for pertussis, stay home for at least five days to avoid passing the illness to others. Vaccination Pertussis vaccines are made from components of killed bacteria and do not cause the disease. Side effects of pertussis vaccination can include fever, or soreness/redness at the location on the body where the shot is given; more serious side effects of these vaccinations are exceedingly rare. What’s more serious? Not vaccinating against pertussis. In 2010, 10 babies died of pertussis during an outbreak of the disease in California. So make sure your vaccinations are up to date. You and your family need to take the first step to protect yourselves and your community from this vaccine-preventable disease. Patricia Vincent, MD, is board-certified in family medicine and practices with Northwest Family Physicians in Crystal. She is the president of the Minnesota Academy of Family Physicians Foundation.

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Adults, pregnant women need boosters

Be aware that the vaccine’s effectiveness decreases as a person ages. Not surprisingly, about half the pertussis cases in Minnesota occur among youth 8 to 18 years of age, with about 25 percent of cases occurring among adults. Therefore, because of the increased prevalence of pertussis, the U.S. Centers for Disease Control and Prevention (CDC) recommends that all adults get a one-time booster shot of the pertussis vaccine. This booster is given in combination with a diphtheria/ tetanus vaccination. Do not wait until 10 years have passed since your last tetanus vaccine to get a booster containing the pertussis vaccine. It’s important to get the pertussis vaccine to protect not only yourself, but also the babies, elderly, and other susceptible people with whom you come into contact. Pregnant women should be given the vaccine if they have not already received it; the MDH has made the vaccination of all pregnant women a top priority.

Name/Title ____________________________________________________________________ Company ______________________________________________________________________ Address ______________________________________________________________________ City/State/Zip _____________________________________________________ Phone (________)_______________________ Fax (________)_________________________ ANNUAL SUBSCRIPTION $36.00

Credit card orders may also be phoned in to (612)728-8600 or faxed to (612)728-8601

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SEPTEMBER 2012 MINNESOTA HEALTH CARE NEWS

Preserving the disability safety net from page 13

Individuals make a difference

New ways to deliver medical services.

Individuals with disabilities and those who support them need to understand the implications of the current economy’s tenuous recovery and the predicted state budget deficit. Without increased state revenue, it will be nearly impossible to balance the state budget without trimming services used by people with disabilities. Trimming might include limiting access to services by tightening eligibility requirements, further reducing payments made to providers, or eliminating services. Each of these options would adversely affect Minnesotans with disabilities. People who rely on state-funded programs for their health and independence should be proactive and engaged in determining where political candidates stand on supporting Minnesota’s most vulnerable citizens. They can and should learn to interact with policymakers by attending public forums hosted by organizations such as the Minnesota Consortium for Citizens with Disabilities (www.mnccd.org), a nonpartisan, statewide coalition of disability provider and advocacy organizations. Individual engagement, in addition to health care reform and other policy reforms at the state and federal levels, must continue for the safety net to remain intact.

New medical service models also are being created. Many are based on the concept of the health care home, a primary care-based approach involving comprehensive care planning and coordination of services for people with disabilities. Additional provider-based networks, similar to accountable care organizations (ACOs) created by the federal Affordable Care Act, are being tested by DHS. While the state has struggled to address how to finance these care innovations for the most complex Medicaid enrollees, it continues to try to better integrate medical and nonmedical services. Progress continues, but there aren’t many national models to look to for guidance. A plan for change. The Olmstead Planning Committee, created by the DHS in December 2011 as the result of a lawsuit, includes individuals with disabilities, family members, providers, advocates, and senior decision-makers from DHS. It is charged with developing a plan to “fulfill the promise of the Americans with Disabilities Act,” according to the committee’s website (www.dhs.state.mn.us). One of the ways this plan aims to improve delivery of medical and social services to people with disabilities is by simplifying and standardizing the multiple assessments that people must go through to become qualified to receive disability support. DHS hopes to begin implementing the committee’s plan in early 2013.

John Tschida, vice president of public affairs and research at Courage Center, has worked for decades to improve the financing and delivery of health services for people with disabilities. He can be reached at johnt@courage.org.

Now accepting new patients

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

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

We are dedicated to creating a true partnership between doctor and patient working together to maximize heart health. We spend time getting to know each patient individually, learning about their lives and lifestyles before customizing treatment programs to maximize their health. Whether you have experienced any type of cardiac event, are at risk for one, or

are interested in learning how to prevent one, we can design a set of just-for-you solutions. Among the services we provide • One-on-one consultations with cardiologists • In-depth evaluation of nutrition and lifestyle factors • Advanced and routine blood analysis • Cardiac imaging including (as required) stress testing, stress echocardiography, stress nuclear imaging, coronary calcium screening, CT coronary angiography • Vascular screening • Dietary counseling/Exercise prescriptions

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

MINNESOTA HEALTH CARE NEWS SEPTEMBER 2012

• Serious low blood sugar (hypoglycemia) may occur when Victoza® is used with other diabetes medications called sulfonylureas. This risk can be reduced by lowering the dose of the sulfonylurea.

Important Patient Information This is a BRIEF SUMMARY of important information about Victoza®. This information does not take the place of talking with your doctor about your medical condition or your treatment. If you have any questions about Victoza®, ask your doctor. Only your doctor can determine if Victoza® is right for you. WARNING During the drug testing process, the medicine in Victoza® caused rats and mice to develop tumors of the thyroid gland. Some of these tumors were cancers. It is not known if Victoza® will cause thyroid tumors or a type of thyroid cancer called medullary thyroid cancer (MTC) in people. If MTC occurs, it may lead to death if not detected and treated early. Do not take Victoza® if you or any of your family members have MTC, or if you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). This is a disease where people have tumors in more than one gland in the body. What is Victoza® used for? • Victoza® is a glucagon-like-peptide-1 (GLP-1) receptor agonist used to improve blood sugar (glucose) control in adults with type 2 diabetes mellitus, when used with a diet and exercise program. • Victoza® should not be used as the first choice of medicine for treating diabetes. • Victoza® has not been studied in enough people with a history of pancreatitis (inflammation of the pancreas). Therefore, it should be used with care in these patients. • Victoza is not for use in people with type 1 diabetes mellitus or people with diabetic ketoacidosis. ®

• It is not known if Victoza® is safe and effective when used with insulin. Who should not use Victoza®? • Victoza should not be used in people with a personal or family history of MTC or in patients with MEN 2. ®

• Victoza® may cause nausea, vomiting, or diarrhea leading to the loss of fluids (dehydration). Dehydration may cause kidney failure. This can happen in people who may have never had kidney problems before. Drinking plenty of fluids may reduce your chance of dehydration. • Like all other diabetes medications, Victoza® has not been shown to decrease the risk of large blood vessel disease (i.e. heart attacks and strokes). What are the side effects of Victoza®? • Tell your healthcare provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath while taking Victoza®. These may be symptoms of thyroid cancer. • The most common side effects, reported in at least 5% of people treated with Victoza® and occurring more commonly than people treated with a placebo (a non-active injection used to study drugs in clinical trials) are headache, nausea, and diarrhea. • Immune system related reactions, including hives, were more common in people treated with Victoza® (0.8%) compared to people treated with other diabetes drugs (0.4%) in clinical trials. • This listing of side effects is not complete. Your health care professional can discuss with you a more complete list of side effects that may occur when using Victoza®. What should I know about taking Victoza® with other medications? • Victoza® slows emptying of your stomach. This may impact how your body absorbs other drugs that are taken by mouth at the same time. Can Victoza® be used in children? • Victoza® has not been studied in people below 18 years of age. Can Victoza® be used in people with kidney or liver problems? • Victoza® should be used with caution in these types of people. Still have questions?

What is the most important information I should know about Victoza®? • In animal studies, Victoza® caused thyroid tumors. The effects in humans are unknown. People who use Victoza® should be counseled on the risk of MTC and symptoms of thyroid cancer. • In clinical trials, there were more cases of pancreatitis in people treated with Victoza® compared to people treated with other diabetes drugs. If pancreatitis is suspected, Victoza® and other potentially suspect drugs should be discontinued. Victoza® should not be restarted if pancreatitis is confirmed. Victoza® should be used with caution in people with a history of pancreatitis.

This is only a summary of important information. Ask your doctor for more complete product information, or • call 1-877-4VICTOZA (1-877-484-2869) • visit victoza.com Victoza® is a registered trademark of Novo Nordisk A/S. Date of Issue: May 2011 Version 3 ©2011 Novo Nordisk 140517-R3 June 2011

FOR TYPE 2 DIABETES

Victoza® helped me take my blood sugar down…

and changed how I manage my type 2 diabetes. Victoza® helps lower blood sugar when it is high by targeting important cells in your pancreas—called beta cells. While not a weight-loss product, Victoza® may help you lose some weight. And Victoza® is used once a day anytime, with or without food, along with eating right and staying active.

Model is used for illustrative purposes only.

Indications and Usage: Victoza® is an injectable prescription medicine that may improve blood sugar (glucose) in adults with type 2 diabetes when used along with diet and exercise. Victoza® is not recommended as the first medication to treat diabetes. Victoza® is not insulin and has not been studied in combination with insulin. Victoza® is not for people with type 1 diabetes or people with diabetic ketoacidosis. It is not known if Victoza® is safe and effective in children. Victoza® is not recommended for use in children. Important Safety Information: In animal studies, Victoza® caused thyroid tumors—including thyroid cancer—in some rats and mice. It is not known whether Victoza® causes thyroid tumors or a type of thyroid cancer called medullary thyroid cancer (MTC) in people which may be fatal if not detected and treated early. Do not use Victoza® if you or any of your family members have a history of MTC or if you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). While taking Victoza®, tell your doctor if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer. Inflammation of the pancreas (pancreatitis) may be severe and lead to death. Before taking Victoza®, tell your doctor if you have had pancreatitis, gallstones, a history of alcoholism,

If you’re ready for a change, talk to your doctor about Victoza® today.

or high blood triglyceride levels since these medical conditions make you more likely to get pancreatitis. Stop taking Victoza® and call your doctor right away if you have pain in your stomach area that is severe and will not go away, occurs with or without vomiting, or is felt going from your stomach area through to your back. These may be symptoms of pancreatitis. Before using Victoza ®, tell your doctor about all the medicines you take, especially sulfonylurea medicines or insulin, as taking them with Victoza® may affect how each medicine works. Also tell your doctor if you are allergic to any of the ingredients in Victoza®; have severe stomach problems such as slowed emptying of your stomach (gastroparesis) or problems with digesting food; have or have had kidney or liver problems; have any other medical conditions; are pregnant or plan to become pregnant. Tell your doctor if you are breastfeeding or plan to breastfeed. It is unknown if Victoza® will harm your unborn baby or if Victoza® passes into your breast milk. Your risk for getting hypoglycemia, or low blood sugar, is higher if you take Victoza® with another medicine that can cause low blood sugar, such as a sulfonylurea. The dose of your sulfonylurea medicine may need to be lowered while taking Victoza®.

Victoza® may cause nausea, vomiting, or diarrhea leading to dehydration, which may cause kidney failure. This can happen in people who have never had kidney problems before. Drinking plenty of fluids may reduce your chance of dehydration. The most common side effects with Victoza® include headache, nausea, and diarrhea. Nausea is most common when first starting Victoza®, but decreases over time in most people. Immune system-related reactions, including hives, were more common in people treated with Victoza® compared to people treated with other diabetes drugs in medical studies. Please see Brief Summary of Important Patient Information on next page. If you need assistance with prescription drug costs, help may be available. Visit pparx.org or call 1-888-4PPA-NOW. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit fda.gov/medwatch or call 1-800-FDA-1088. Victoza® is a registered trademark of Novo Nordisk A/S. © 2011 Novo Nordisk 0611-00003312-1 August 2011

To learn more, visit victoza.com or call 1-877-4-VICTOZA (1-877-484-2869).

Non-insulin • Once-daily