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Rebecca Farley

Director, Policy & Advocacy, National Council for Behavioral Health

CMS Finalizes Part D Rule; Leaves Opening for Future Action on Protected Classes

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The Centers for Medicare and Medicaid Services (CMS) last week issued its final rule on Medicare Part D changes for fiscal year 2015. While codifying a range of fraud and abuse-related proposals, the rule – as signaled in an earlier letter to Congress – does not adopt controversial proposed modifications that would have stripped mental health drugs of their protected status in Part D.

CMS affirms that “we are not finalizing any new criteria [for protected classes] and will maintain the existing six protected classes” in Part D, noting that “based on the comments received, we have concluded that our proposed criteria did not strike the balance among beneficiary access, quality assurance, cost-containment, and patient welfare that we were striving to achieve.”

However, CMS left the door open for future rulemaking on protected classes, pointing out that current regulations on this matter are obsolete in light of the Affordable Care Act. Last week’s final rule stated that the current six protected classes would remain intact “until such time as we undertake rulemaking to establish criteria to identify, as appropriate, categories and classes of drugs for which we determine” protected status is necessary.

CMS’ initial proposed regulation, announced in January, established criteria that would have excluded antidepressant, antipsychotic, and immunosuppressant medications from protected status. The National Council joined with other national patient and disease groups to form the Partnership for Part D Access, a coalition to fight the proposed rule. Following a deluge of opposition to the proposed changes – including from key Congressional committees with jurisdiction over Medicare – CMS announced in March that it would not move forward with the protected classes changes.

The National Council and the Partnership for Part D Access continue to actively monitor CMS and congressional action on protected classes. Stay tuned to Capitol Connector to keep informed about future efforts to modify Medicare beneficiaries’ access to these important drugs.