Panoramic: Automotive and Mobility 2025
Life sciences and health care companies are facing a landmark shift in how the Medicare program pays for drugs through several changes.
- The creation of the Drug Price Negotiation Program (DPNP)
- The redesign of the Medicare Part D prescription drug benefit
- New inflation rebates for Part B and Part D drugs
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.
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Our capabilities at a glance
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Judicial review wins
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Ex-government policy advisors
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Pieces of legislation changed
Hear from our clients and industry leaders
The whole team is super smart. They are all really easy to work with and they know our business inside out. They come to us proactively with issues and are incredibly responsive."
Chambers & Partners, UK Guide, 2025
An intellectually brilliant and commercially astute public law team. One of the very best in the city."
Chambers & Partners UK 2025
Hogan Lovells has a high capability in solving complex issues that involve both legal and technical perspectives."
Chambers & Partners, Germany, 2025
The lawyers are just experts. They are there when you need them and happy to entertain all my questions. They understand the wider context and the politics and sensitivities of it."
Chambers & Partners, UK 2025
Representative experience
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.
Navigate change with our latest insights
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Hogan Lovells Events
Tokyo: Life Sciences and Health Care Horizons 2023
04 October 2023
Hogan Lovells Events
Tokyo: Life Sciences and Health Care Horizons 2023
04 October 2023
