During implementation of the Medicare Modernization Act (MMA), which created the Medicare Part D drug program in 2003, the Centers for Medicare and Medicaid issued guidance directing prescription drug plans to cover “all or substantially all” medications within six classes and categories that the agency identified. These categories included: anticonvulsants, antidepressants, antineoplastic, antipsychotics, antiretrovirals, immunosuppressants. However, in time, it became clear that the guidance was uneven among plans. Therefore, Congress pursued legislative action, led by Senators Gordon H. Smith (R-OR) and John Kerry (D-MA) to establish a standard for protected classes. In 2008, Congress established the so-called “six protected classes” of drugs under Medicare Part D. Medicare Improvements for Patients and Providers Act (MIPPA) codified CMS’ existing guidance and carried the force of law. It required Medicare Part D drug plans to include in their list of available medications access to all or substantially all drugs in the six identified classes and categories of priority. The law also specified two criteria that CMS had to use in identifying additional prescription classes of concern:
restricted access to the drugs in the class would have major or life-threatening consequences for individuals with a disease or disorder treated by drugs in such class; and
there is a significant need for such individuals to have access to multiple drugs within a class due to unique chemical actions and pharmacological effects of the drugs within a class.
This policy stood unchanged until enactment of the Affordable Care Act (ACA). Under the ACA, Congress provided the Secretary of Health and Human Services (HHS) with authority to “identify, as appropriate, categories and classes of drugs for which the Secretary determines are of clinical concern.” It added that the Secretary shall have the authority to develop the criteria used to make the designation.
However, the ACA also codified in law the six existing protected classes and categories by name, and expanded coverage to include all drugs within these six classes and categories until such time as the Secretary makes changes. The clear intent of Congress was for the six identified classes of medications to maintain protected status.