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 During implementation of the Medicare Modernization Act (MMA), which created the Medicare Part D drug program in 2003, CMS (at the urging of Congress) issued sub-regulatory guidance directing prescription drug plans (PDPs), through contract provisions, to cover “all or substantially all” medications within six therapeutic classes and categories that the agency identified. CMS explained that it “instituted this policy because it was necessary to ensure that Medicare beneficiaries reliant upon these drugs would not be substantially discouraged from enrolling in Part D plans and to mitigate the risks and complications associated with an interruption of therapy for these vulnerable populations.” Consistent with that rationale, the policy protected access to: anticonvulsants (for epilepsy); antidepressants; antineoplastics to treat cancer; antipsychotics; antiretrovirals for HIV/AIDS; and immunosuppressants to prevent rejection of transplanted organs. Click below to view the guidance. 
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March 2021
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