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What would the recent proposed changes to Medicare Part D’s six protected classes mean for patients?

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What would the recent proposed changes to Medicare Part D’s six protected classes mean for patients?

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What would the recent proposed changes to Medicare Part D’s six protected classes mean for patients?

The existing Medicare Part D program of including “six protected classes” of medications is working. When the Centers for Medicare and Medicaid Services (CMS) first implemented Part D, CMS determined that limiting a class to only two drugs was simply not enough for certain patients, including those with HIV, mental illness, cancer, epilepsy, and those undergoing organ transplantation. As a result, “six protected classes” were to give patients access to all the drugs in these classes. Why then would the administration propose  to offer patients fewer treatment options for beneficiaries with critical conditions?

For people with HIV and other devastating diseases, new drug therapies have saved millions of lives and prolonged millions more. The advent of antiretroviral medications in the late ‘90s turned HIV from a near certain death to a more manageable disease for patients with access to quality care and medications. Medications aren’t one size fits all, and doctors and patients make careful decisions together about which therapies are most appropriate.  For people with HIV, drug resistance can occur, which often means switching to another drug without interruption.

While the proposed rule continues to protection antiretrovirals, that would not be the case for antidepressants and immunosuppressants in 2015 and antipsychotics in 2016 if passed.

We are worried and wonder who will be next? How much longer will people with HIV, cancer, or epilepsy have access to all the medications they need through Part D? It is estimated that about half of people living with HIV experience mental illness or substance abuse, and we are concerned that people with HIV who rely on antidepressants and antipsychotics will not be able to access the treatments they need. We are also concerned for the people with hepatitis who undergo liver transplants and may not be able to access their immunosuppressants. 

We see no reason why the protected classes should be changed, and if they were, we would like to see more classes of drugs gain “protection” status so that more patients can access the medications that are prescribed by their providers. We urge the administration to withdraw this proposal.

Carl Schmid
Deputy Executive Director, The AIDS Institute

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Carl Schmid
Deputy Executive Director, The AIDS Institute

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Carl Schmid was named Deputy Executive Director of The AIDS Institute, a national public policy, advocacy and research organization, in June, 2009. Prior to that he served as the Institute’s Director of Federal Affairs, a position he held since February 2004. Prior to joining The AIDS Institute, he served as a consultant to a number of HIV/AIDS and civil rights organizations. He has worked in Washington for over 20 years, and began his public policy work in the energy arena, which continued through 2003.

Mr. Schmid is co-chair of the AIDS Budget and Appropriations Coalition; a Convening Group member of the Federal AIDS Policy Partnership, and co-chair of an HIV Testing Reimbursement Work Group. He is a former chair of the HIV Prevention Action Coalition and the Ryan White Reauthorization Work Group. He remains active in those coalitions along with others that advocate for Medicaid, Medicare, and Healthcare Reform; the AIDS Drug Assistance Program (ADAP), and Hepatitis issues.

He was a member of the Presidential Advisory Council on HIV/AIDS from 2007 to 2009, and Chaired its Domestic Subcommittee. In 2010 he was named by POZ Magazine as one of the 100 most effective AIDS fighters in the nation and was recently named by Whitman Walker Health as one of the 25 individuals who have played prominent roles in the fight against HIV/AIDS in DC over the past 25 years.

Mr. Schmid earned a B.A. in Public Affairs and a M.B.A. in International Affairs from the George Washington University in Washington, D.C.

 

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What would the recent proposed changes to Medicare Part D’s six protected classes mean for patients?

It would mean that discriminatory plan design and patient centered protections are a dwindling concern of our leading health agency.  It would mean that a bureaucratic barrier is being constructed to block physician directed care and that short-term profit is outweighing long term health care costs – both individual costs and those to the Medicare program.

The six protected class policy has been a safety net for some of the most medically fragile Medicare beneficiaries by requiring plans to cover “all or substantially all drugs” for six critical lifesaving drug classes.  It has successfully protected basic access for patients who need non-interchangeable medications to treat and manage serious and often life-threatening conditions, such as epilepsy.  This policy has been a weapon against discriminatory plan design and a true protective measure for patient access to physician directed care.  The Epilepsy Foundation has championed this policy as model guidance for all health insurance formulary designs, including the essential health benefits under the Affordable Care Act.  It is disappointing that a narrowly designed policy that is a strong protection against discrimination in plan design would be threatened by CMS.  Although anti-convulsants remain protected, the Epilepsy Foundation fears the precedent of allowing HHS to make such a change with questionable clinical basis, is not patient-centered, and appears to be focused on short-sighted financial considerations that ignore other health care and individual costs.

For the vulnerable patients that rely on therapies in the six protected classes, including epilepsy patients, it is essential that physicians be able to prescribe the medications that are best for the patient.  Access to physician directed care should be based on independent clinical judgment and patients should have access to these medications under Part D plan coverage.  Limiting access to the most appropriate medications will lead to higher overall costs to the Medicare program, including higher out-of-pocket costs for beneficiaries and increased costs in Medicare Part A and Part B and Medicaid, due to the destabilization of patients’ conditions and increased physician visits and hospitalizations.

CMS should rescind this short-sighted policy threat to patients. 

 

Angela Ostrom
VP, Public Policy & Advocacy, Epilepsy Foundation

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Angela Ostrom
VP, Public Policy & Advocacy, Epilepsy Foundation

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Angela Ostrom is the Vice President of Public Policy & Advocacy for the Epilepsy Foundation. 

Ms. Ostrom has spent the last 15 years working in disability and health policy.  Prior to joining the Foundation, Ms. Ostrom was Assistant Director of Advocacy for the National Osteoporosis Society and worked for over five years at the National Multiple Sclerosis Society as Senior Director of Public Policy & Advocacy Research. 

At the Foundation Angela oversees advocacy efforts on federal and state public policy and heads the legal advocacy efforts of the Foundation’s Legal Defense Fund.  She serves as Co- Chair of the National Health Council FDA Issue Team and as a Steering Committee Member for the Partnership to Improve Patient Care. 

Angela earned her Bachelor of Arts degree from The Ohio State University in 1996 and her law degree from the University of Maryland School of Law in 1999.  Upon graduation, Ms. Ostrom was selected as a Presidential Management Fellow.  Through this federal program she worked for the Social Security Administration Office of Public Policy, Office of the General Counsel and Office of Disability Policy.   Angela completed her fellowship program in the office of United States Representative Stephanie Tubbs Jones (Ohio).   She is a member of the Maryland Bar.

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What would the recent proposed changes to Medicare Part D’s six protected classes mean for patients?

The Depression and Bipolar Support Alliance (DBSA) provides information, programs, and tools that educate and empower those of us who—like me—live with mood disorders towards directing the treatment plans that will help us achieve wellness. DBSA advocates for the rights of individuals to choose the most appropriate treatments based on our own needs and concerns and the advice and guidance of our clinicians.

We at DBSA are heartened that, over the past several decades, significant and important progress has been made to help those of us with mental health conditions. Increased understanding and new therapies and treatments mean that prosperous, meaningful lives can and should be possible for all people affected by mental health conditions.

It is clear to us at DBSA that the Centers for Medicare and Medicaid Services (CMS) proposed rule change is a step in the wrong direction, undoing the beneficial progress we have fought for over many years. Ultimately, if the CMS rule to remove antidepressants, immunosuppressants, and eventually antipsychotics from Medicare Part D's protected class status is approved, there will be severe human, economic, and societal consequences for not only people with mental health conditions, but also our families, friends, and communities.

The CMS proposed rule is intended to save the Medicare Part D program, and seniors, money, but—if we take the long view—we doubt that this will be the outcome over time. Mental health conditions are unique in that, with each additional unsuccessful course of therapy, there is a progressively lower likelihood of remission and higher relapse rates. Lack of appropriate treatments can also increase the frequency of costly hospitalizations and emergency room visits. So to remove the best chance for first-line success in treatment—the protection of being able to follow our doctors’ direction and advice—seems not only misguided in terms of harm to our health, but also with regard to the bottom line.

Among DBSA’s programs is the Care for Your Mind blog, an online forum where people with mood disorders, their families, community stakeholders, and policymakers can learn about and weigh in on important mental health topics. The site has spotlighted the CMS proposed rule over the past several weeks, and people with diagnoses and physicians alike have voiced their concerns, urgently demanding that CMS rescind its proposed rule change. With nearly a hundred comments on this topic, we've seen one common theme: cookie cutter medicine is bad policy.

We need to ensure that all people with mental health conditions have access to the appropriate treatments that their doctors recommend and they need in order to thrive. We at DBSA strongly feel that the CMS rule is a step in the wrong direction, potentially vitiating the work of many years—the efforts of thousands of people, like me, who live with and are concerned about mental health issues.

Allen Doederlein
President, DBSA

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Allen Doederlein
President, DBSA

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Allen Doederlein is President of the Depression and Bipolar Support Alliance (DBSA), the nation’s premier peer-led mental health organization focusing on mood disorders. DBSA reaches 2,000,000 people each year with current, readily understandable information about depression and bipolar disorder and empowering tools focused on an integrated approach to wellness. DBSA’s reach is further expanded by its national network of 15 state organizations, 300 chapters, and 900 support groups, which provide life-saving, free peer support to tens of thousands of individuals who seek information and support on their paths to the healthy lives they want to lead.

Allen works with the Board of Directors and Scientific Advisory Board to develop, articulate, and steward DBSA’s vision, mission, and core values. As the staff leader, Allen facilitates DBSA’s strategic initiatives, organizational alliances, and partnerships; serves as organizational spokesperson; and oversees generation of both contributed and earned revenues. 

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What would the recent proposed changes to Medicare Part D’s six protected classes mean for patients?

When we look at the Medicare Part D prescription drug program as a whole, we see that it is unquestionably making a positive difference in the lives of the millions of seniors and beneficiaries with disabilities who depend on it.  Enrollees have affordable plans and medications and those with severe health conditions have the guarantees that they will have access to the drugs they and their physicians have determined they need.

It’s difficult to understand why there would be an effort to fundamentally change a program that is fulfilling its mission as well as Part D has for the past decade.  The program has maintained stable, affordable average monthly premiums and enjoys a 90 percent approval rating from the nation’s seniors.  Additionally, program spending for Part D is 46 percent less than what was originally projected by the Congressional Budget Office.  Any federal program that spends less, not more, than budget officials predict should be celebrated, not upended.

This proposed rule, though, threatens to disrupt the positive effect the program is having on beneficiaries’ health and the Medicare program as a whole.  Recently, HLC initiated a letter, which now has signatures from approximately 300 organizations, asking the Center for Medicare and Medicaid Services to withdraw the rule, citing four compelling reasons:

These proposed changes to Medicare Part D will have a significantly negative effect on beneficiaries, taxpayers and the Medicare program itself.  If we do not protect Part D’s ability to keep beneficiaries healthy through affordable, accessible medications, then we will undoubtedly see escalating rates of illness and chronic disease drive overall Medicare spending upward.  There is simply no compelling rationale to reduce choice, impose higher costs on beneficiaries and risk a less healthy patient population.  Let’s allow the Medicare Part D success story to continue.

Mary R. Grealy
President , HLC

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Mary R. Grealy
President , HLC

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Mary Grealy is president of the Healthcare Leadership Council, a coalition of chief executives of the nation’s leading healthcare companies and organizations.  The HLC advocates consumer-centered healthcare reform, emphasizing the value of private sector innovation.  It is the only health policy advocacy group that represents all sectors of the healthcare industry.  She was appointed to the position in August 1999.

Ms. Grealy has an extensive background in healthcare policy.  She has led important initiatives on the uninsured, improving patient safety and quality, protecting the privacy of patient medical information and reforming the medical liability laws.  She testifies frequently before Congress and federal regulatory agencies.

She is a frequent public speaker on health issues and has been ranked many times by Modern Healthcare as one of the 100 Most Powerful People in Healthcare.

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