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Rebecca Farley

Director, Policy & Advocacy, National Council for Behavioral Health

CMS Proposes to Strip Mental Health Drugs of Protected Status in Part D

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The Centers for Medicare and Medicaid Services (CMS) this week announced a proposed rule that would eliminate protected status for antidepressants and antipsychotics in Medicare Part D prescription drug plans.

The proposed rule, announced Monday, revises prior agency policy that required Part D plans to include on their formularies “all or substantially all” drugs within six classes: antidepressants, antipsychotics, anticonvulsants, antineoplastics, and immunosuppressants. This policy, known as the “six protected classes” policy, has been in effect since the inception of Part D and has enjoyed strong bipartisan support in Congress. The Affordable Care Act strengthened this policy by codifying it in federal statute, while granting CMS the authority to specify what criteria it would use to identify protected classes.

In this week’s proposed rule, CMS laid out its new criteria for deciding whether a class of drugs should have protected status: 1) failure to receive the drug would result in the patient’s hospitalization within 7 days (the timeframe for the appeals process); and 2) drugs in that class are not interchangeable.

The new criteria exclude antidepressants and immunosuppresants from protected status beginning in 2015. CMS argued that many of the drugs within these classes are interchangeable and will not cause hospitalization if patients do not immediately take them upon receiving a prescription. CMS determined that antipsychotics also fail to meet the new criteria; however, they will not immediately be excluded from protected status. CMS is soliciting comments on whether a transitional policy for antipsychotics is needed and will preserve their protected status pending further review.

Although drug costs are not part of the formal criteria, CMS openly and extensively discussed its concerns about pricing in the proposed rule, noting that the six protected classes policy “substantially limits Part D sponsors’ ability to negotiate price concessions in exchange for formulary placement of drugs in these categories or classes.” Mental health providers and advocates expressed concern that drug prices were the primary driver of the new rule, with the two criteria developed only so as to be able to selectively exclude several costly drug classes from protected status.

The National Council has long supported the six protected classes policy and preserving open access to all FDA-approved medications. The public comment period is open through March 7; stay tuned to Capitol Connector to see our comments.