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Final rule for Medicare Advantage and Medicare Part D plans

The CMS (Centers for Medicare & Medicaid Services) issued a final rule on May 16, 2019 that modernizes and improves the Medicare Advantage and Part D programs. Now patient will have transparency into the cost of prescription drug in Part D and will also allow Medicare Advantage plans to negotiate better prices for physician-administered medicines in Part C.

This fact sheet discusses the provisions of the final rule (CMS-4180-F). The final rule can be downloaded from the Federal Register at:

Part D Protected Classes

Current Part D policy needs sponsors to consider on their formularies all drugs in six categories or classes except in limited circumstances. Following are the six categories:

  1. antidepressants
  2. antipsychotics
  3. anticonvulsants
  4. immunosuppressants for treatment of transplant rejection
  5. antiretrovirals
  6. antineoplastics

According to CMS, under current policy, Part D sponsors are only allowed to execute prior authorization and step therapy requirements for beneficiaries initiating therapy (i.e., new starts) for 5 of the 6 protected classes, with no prior authorization or step therapy allowed for antiretrovirals. The final regulatory provision codifies this existing policy, which has been in effect since 2006.

The first exception permits Part D sponsors to use PA and ST for protected class Part D drugs. They are finalizing this exception with modifications. As modified, the exception is a codification of existing policy and does not place additional limits on beneficiary access to medications.


Part D plan sponsors implement an electronic real-time benefit tool (RTBT) that is capable of integrating with at least one prescriber’s electronic prescribing (eRx) system or EHR. CMS is requiring that each Part D plan implement this no later than January 1, 2021. RTBTs can notify prescribers when lower-cost alternative therapies are available under the beneficiary’s prescription drug benefit.

Part D Explanation of Benefits

According to CMS, effective January 1, 2021, CMS will require the Part D Explanation of Benefits that Part D plans send members to include drug price increases and lower cost therapeutic alternatives. This information will inform Medicare beneficiaries about possible ways to lower their out of pocket costs by considering a lower cost medication.

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