Assisting manufacturers and investors in evaluating product portfolios for DPNP application and risk, including the development of potential strategies to lessen that risk, as appropriate.
Supporting manufacturers prepare for selection for the DPNP, including the negotiation period of selected products, maximum fair price (MFP) ceiling price calculation and negotiation strategy, as well as drafting responses to CMS’s data requests and preparing for negotiation meetings with the agency.
Assisting clients in considering pathways for operationalizing MFPs, the timing and implementation of a rebate option, and how pathways could work to lessen or reinforce the use of 340B replenishment models.
Drafting comments for drug manufacturers and trade associations in response to the DPNP initial price applicability year (IPAY) 2026 proposed guidance in 40+ areas of concern.
Supporting clients with continued legislative advocacy efforts with respect to the DPNP, reviewing, revising, and drafting amendments to the statute where needed and where regulatory advocacy may not be sufficient.
Drafting policies to address the new Part D and Part B inflation rebates.
Helping clients submit comment letters on proposed guidance regarding the Part B and Part D inflation rebates.
Engagement with CMS regarding inflation rebate calculation mechanics and potential errors.
Insights and Analysis
10 June 2024
Insights and Analysis
15 August 2023
