Inflation Reduction Act and The Medicare Program
Life sciences and health care companies are facing a landmark shift in how the Medicare program pays for drugs through several changes.
Industry stakeholders turn to our interdisciplinary team of CMS, FDA, and intellectual property experts to understand the details of these new programs and how they impact commercialization of existing drug products as well as the funding and future commercialization of those products still in the early stages of development. Our team is well positioned to support clients in creating IRA-based business strategies at all stages of product development, from clinical trials through commercialization and potential generic entry, as well as in administrative and legislative advocacy as the IRA is implemented.
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
