On May 16, 2019, the Centers for Medicare & Medicaid Services (CMS) put on public display at the Federal Register a final rule providing for revisions to the Medicare Advantage (MA) and Voluntary Prescription Drug Program (Part D) regulations to support plan negotiations for lower drug prices and lower out-of-pocket costs for enrollees of MA and Part D plans.
Major changes finalized in the rule include:
- Permitting plan sponsors to use prior authorization and step therapy for protected class drugs (other than antiretrovirals) only for new starts, including to confirm that the use is for a protected class indication;
- Requiring plan sponsors to implement an electronic real-time benefit tool (RTBT) that can integrate with at least one prescriber’s e-Prescribing (eRx) or electronic medical record (EMR) systems by 2021;
- Allowing Medicare Advantage Prescription Drug (MA-PD) plans to impose step therapy utilization management practices on beneficiaries initiating therapy (new starts) of Part B drugs; and
- Requiring MA and Part D plan sponsors to provide enrollees with information about drug price changes and lower-cost therapeutic alternatives.