On May 15, HHS released the final rule, Modernizing Part D and Medicare Advantage to Lower Drug Prices and Reduce Out-of-Pocket Expenses, which would reduce drug costs by allowing additional utilization management for protected classes. HHS initially proposed three exceptions to the protected class policy that would (1) implement broader use of prior authorization (PA) and step therapy (ST) for protected class Part D drugs, including to determine use for protected class indications; (2) exclude a protected class Part D drug from a formulary if the drug represents only a new formulation of an existing single-source drug or biological product, regardless of whether the older formulation remains on the market; and (3) exclude a protected class Part D drug from a formulary if the price of the drug increased beyond a certain threshold over a specified loopback period.
In the end, HHS decided not to further weaken the Medicare Part D six protected classes (anticonvulsants, antidepressants, antineoplastics, antipsychotics, antiretrovirals, and immunosuppressants for the treatment of transplant rejection). As a result of advocacy by organized psychiatry (APA in partnership with the MPS and other District Branches) and the mental health community, the rule only finalized one of the three proposed exceptions with a modification to the first exception related to PA and ST. The first exception permits Part D sponsors to use PA and ST for protected class Part D drugs. However, as modified, the exception is a codification of already existing policy and does not place additional limits on beneficiary access to medications. Specifically, the exception will permit PA and ST only for new starts (that is, enrollees initiating therapy), including to confirm the use is for a protected-class indication. The rule takes effect on January 1.