Last month, the Centers for Medicare and Medicaid Services proposed a new rule that would revise the requirements for Medicare Part D prescription drug plans, which would remove two, and possibly three, of the six protected classes of drugs. Currently, PDPs must include all, or substantially all, drugs within six classes on their formularies. The classes are antidepressants, antipsychotics, anticonvulsants, immunosupporessants (used to prevent transplant rejection), antiretrovirals (used to treat HIV/AIDs), and antineoplastics (used to treat cancers). The proposed rule would exclude antidepressants and immunosuppressants starting in 2015. Antipsychotics would remain on the list until 2016, to give CMS time to "determine if additional transitional consideration is necessary for any individuals taking these medications" before potentially excluding them as well. The rule change was prompted by CMS' concern that requiring such broad coverage of these categories of drugs "presents both financial disadvantages and patient welfare concerns for the Part D program as a result of increased drug prices and overutilization."
The Affordable Care Act revised certain elements of the Part D Program by replacing specific criteria to identify "protected classes" with a requirement that the Secretary "establish criteria through notice and comment rulemaking to identify drug categories or classes of clinical concern." This rule proposes new criteria which would limit protected classes to those for which access to all drugs in a category or class for a typical individual with a disease or condition treated by the drugs in the class is required within seven days to avoid hospitalization, persistent or significant disability or incapacity, or death. Additionally, “more specific formulary requirements would not suffice to meet multitude of specific applications of the drugs within the category or class”.
The comment period on the proposed rule is open through March 7. Specifically, CMS has asked for public comment regarding additional considerations for transitioning some patients taking antipsychotics to alternative drug therapies and ho to identify the patient populations or individual patient characteristics that would require additional transition protections.