Health plans and clients offering Medicare Part D to its members should have some level of oversight on the formulary submission process. This oversight is important to ensure that the formulary adheres to the minimum set of requirements established in statute and regulations with the Centers for Medicare and Medicaid Services (“CMS”) and ensure any changes to the formulary are appropriate. Reviewing formulary adherence is especially important for those plans or clients with a custom formulary.

Here at PillarRx, we help support our clients in this oversight process and can also complete the required submissions within the designated timeframe.  Below is a summary of what we look for when reviewing formulary files provided by the PBM.

For Medicare Part D plans, there are two main submission processes that happen within a year related to formularies: 1.) the annual formulary submission to CMS for the next plan year, and 2) the regular monthly formulary reference file updates for the current formulary.

During the Annual Formulary Submission process, PillarRx works through the entire process to help develop their formulary. This step includes:

  • Review of formulary changes proposed by the PBM. Including a review of drugs moving off formulary, new drugs added, PA criteria changes, Step therapy updates and Quantity limit changes, and member impact reports. This process usually starts early in the year and can take weeks to months to complete based on the number of changes.
  • As it gets close to the initial submission window, we also review the submission files to ensure they match the proposed formulary changes as agreed upon.
  • As formulary development moves into the Stage review, summer limited, and formulary update window for CMS, we also help ensure that the formulary gets updated accordingly based on the changes requested by CMS or any market changes that have happened since the initial submission.

As part of the Monthly Formulary Update process for their current formulary, PillarRx also works with the plan and their PBM to ensure any changes made are appropriate and the plan is staying compliant. As part of this process we:

  • Review weekly or monthly the new additions or any other updates to the FRF. Provide recommendations on proposed changes based on clinical value, cost, and regulatory requirements.
  • Review any negative change requests proposed and submit these to CMS if needed.
  • Review the updated files to ensure they match the proposed change and submit the updated files to CMS.

Having a knowledgeable partner who can manage this process for you is important to guarantee compliance with CMS. It is important to review any formulary changes, and potential impact, from the perspective of the member and financial outcomes. If you would like to have assistance with your formulary submission, please reach out to PillarRx at [email protected] and we would be happy to help!