Marci Mutti: As 2025 unfolds, there’s certainly a lot of unknowns with the transition in administration. What we do know, based on the actions in the first Trump administration, in the second term we are expecting to see continued scrutiny in the Medicare part B payment space, certainly focused around the buy and bill model. Key questions are whether the action bill will be taken through administrative channels. There’s a number of ways that this could play out; one way is that CMS could consider eliminating the buy and bill model and revisit a vendor led model, a CAP 2.0. CMS could also reconsider a recent proposal from a former Trump staffer to tie part B drug payments to prices obtained by Medicare Advantage plans, or we might see the return of referencing international drug prices for part B drugs. Previously, the Trump administration focused on international reference pricing and this focus was squarely on Medicare part B drugs, so a revisit is certainly plausible in the second term. Key questions would be if we do see a return to a mandatory vendor program or international reference pricing, how different will it look from the attempts in the first term, and if and how CMS or how the new administration uses its authority with CMMI the innovation center. Lastly, how might these actions impact the bio and bill ecosystem and patient and provider access to innovative medicines.

As 2025 unfolds, a key threat in the buy and bill model, for example, is government negotiation for part B drugs. Our consulting team has been keenly focused on how CMS stood up the government negotiation program, which is certainly well underway with part D drugs. From a timeline perspective, government negotiation for part B drugs starts in 2026, with prices effective in 2028. But before then, there is a growing push for congress to change the way the current law incorporates the negotiated price in the ASP calculation. In simple terms without Congress acting, the part B negotiated prices would end up applying to the commercial and Medicaid markets as well. This is a key topic manufacturers and providers have been focused on and we expect a significant push for a fix before these prices go into effect in 2028.

Our policy team and market access experts are on top of these issues for the Inflation Reduction Act implementation and beyond. Our fingers squarely on the pulse of the potential administrative legislative and regulatory approaches that may limit patient and provider access to part B drugs and services. We can help cut through the complexities to help you and your stakeholders to understand the potential impact to access. We look forward to discussing this with you further in 2025.

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