New CMS Medicare Drug Price Guidance: Navigating Price Negotiations, 340B Drugs, CMPs for Violations

Description

In March 2023, the CMS issued guidance related to the implementation of the Medicare Drug Price Negotiation Program. The guidance provides the criteria for the selection of the drugs subject to negotiation. Under the negotiation program, Medicare is permitted to negotiate prescription drug pricing. The guidance also provides the program's requirements.

Negotiated prices are referred to as the drug's maximum fair price (MFP). Manufacturers of drugs with MFPs must provide pharmacies and other dispensers access to the MFPs for the drugs they dispense to those enrolled in Part D plans. Similarly, Part D plans must provide their enrollees with access to the MFPs.

The guidance sets forth requirements for manufacturers subject to the 340B program and what must be provided to 340B covered entities. Further, the guidance describes the process for the issuance of CMPs for violations under the negotiation program. Manufacturers that do not comply with the program's requirements could pay a stiff price and be removed from Part D or Part B coverage and excise tax liability.

Listen as our authoritative panel of healthcare attorneys examines CMS' guidance for the Medicare Drug Price Negotiation Program. The panel will discuss the drug selection criteria and the negotiation process. The panel will also address other areas of guidance and offer best practices for navigating drug price negotiations. The panel will frame the discussion with the precedent changes to the Medicaid drug rebate program in the American Rescue Plan Act, as well as the newly announced Center for Medicare and Medicaid Innovation (CMMI) drug pricing models.