On January 6, the Centers for Medicare and Medicaid Services (CMS) circulated a proposed rule that would remove antidepressants and immunosupressants from the protected class status they received under Medicare Part D in 2015, and to remove antipsychotics from that status in 2016. Despite a growing public recognition of America’s mental health treatment crisis, the Administration inexplicably proposed undoing one of Medicare’s signature protections for people with mental health conditions by suggesting that when it comes to drug treatment one size fits all.
“DBSA advocates for the right of people with mental health conditions like depression or bipolar disorder to choose their own paths to mental, emotional, and physical wellness,” stated Allen Doederlein, President of DBSA. “Implementation of this proposed ruling has the potential not only to undermine hard-won treatment advances a person with a mental health condition may have made, but also to undermine a person’s ability to choose the right treatment that a clinician identifies as the best fit for a serious, life-threatening condition.”
For nearly a decade, the “six protected class” policy has ensured that Medicare patients with mental health conditions, many of whom have severe, treatment-resistant symptoms, have access to the most appropriate drug without having to go through “fail-first” experiences or lengthy appeals and grievance processes. Often, delays caused by these processes can result in suicide and other tragic outcomes, and inadequate treatment leaves people open to relapse, co-occurring conditions which greatly shorten lifespans, and increased suicide risk.
Commenting on the proposed ruling, Joseph R. Calabrese, MD, Director, Mood Disorders Program, Bipolar Dis. Research Chair & Professor of Psychiatry and Dir. Bipolar Disorders Research Center at Case Western Reserve University, stated “the effectiveness and tolerability of antidepressants can vary greatly among people who choose this treatment option. Our extensive clinical experience demonstrates that the best therapy for one person may be ineffective or poorly tolerated in another individual. Moreover, successful treatment frequently involves trial of several different medications in a quest to find the best treatment in terms of efficacy and tolerability. As a result, it is important that people with mental health conditions have access to a wide variety of treatments and that clear information about these options is available both to clinicians and the individuals they serve and treat.”
We understand that the Administration's proposal represents an effort to save money. However, CMS has clearly failed to anticipate the predictable increase in costs to both Medicaid and Medicare Part A from the resulting spike in inpatient admissions. The Depression and Bipolar Support Alliance strongly opposes this proposed rule and is joining other stakeholders in the fight against it. These activities include submitting comments to the regulatory rulemaking process which are due on March 7.
Background: In 2005, CMS directed that Part D formularies include all or substantially all drugs in six drug classes, including: antidepressant; antipsychotic; anticonvulsant; immunosuppressant (to prevent rejection of organ transplants); antiretroviral (for the treatment of infection by retroviruses, primarily human immunodeficiency virus (HIV); and antineoplastic. The Medicare Improvements for Patients and Providers Act created the six protected classes, and the Affordable Care Act also defined them by name. Today, Medicare Part D plans must carry "all or substantially all" of the chemically distinct drugs in these categories on their formularies. For other categories, the plans can typically carry one brand-name drug and one generic drug.