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ADVI Health’s Lindsay Bealor Greenleaf, head of federal and state policy, shared insight on key takeaways from 2024 in the federal and state policy realm, what our ADVI expert’s are looking out for ahead for the new year, in addition to what our clients can prepare for in the new year.
Lindsay touches on several topics, discussing the 2024 presidential election, IRA implementation, CMS’ negotiated prices, Part D redesign, and 2025 policy changes with the Republican sweep. Get in touch to discuss how ADVI’s federal and state policy team actively tracks what these changes mean for clients and helps prepare them for what is coming next.
Learn more about ADVI’s federal and state policy expertise.
ADVI Health’s head of federal and state policy, Lindsay Bealor Greenleaf, sat down to share her key takeaways from 2024 and what the team is looking ahead for in 2025.
Lindsay Bealor Greenleaf, JD MBA
Head of Federal and State Policy
Lindsay leads ADVI’s policy team and guides legislative, regulatory, and market access efforts across payers for clients spanning the pharmaceutical, biotechnology, device, diagnostic, and digital health industries, as well as physician practices and specialty societies.
Lindsay Bealor Greenleaf: The most significant policy change in the federal and state policy world throughout 2024 had to do with IRA implementation as well as the election that we just had in November. For IRA implementation, top of mind is this government negotiation policy, which is actually the government price setting policy that’s well underway. We have had prices announced from the government for those first ten drugs that have been targeted for those negotiated prices to apply in 2026, and we are gearing up for the next announcement coming from CMS. It is likely to come in February 2025, where they will release the next fifteen drugs that are going to be target for this negotiation process where the price will apply in 2027. A lot of big implications for clients with products on those lists, a lot of implications for clients that are competing with those products that are on the list. A lot of cross-payer impact of what CMS is doing for this negotiation program.
Throughout the year we have also been very focused on Part D redesign, January 1, 2025, that’s when the $2,000 out-of-pocket cap will finally be here, which is great news for patients. There will be significant implications for Part D plans and potentially new access barriers at play. Plans are expected to respond with new utilization management, prior authorization, so while out-of-pocket costs are going to be a lot better, we are closely tracking what we are expecting from the Part D plans and any new access barriers going forward.
With the election this November, that was obviously a big focus of our year in the policy world. We will have a new incoming president, and a new incoming control of congress with the Republican sweep. We are looking for a lot of changes coming in 2025, and right now we are still learning of President-elect Trump’s incoming healthcare picks as he fills out his cabinet, tracking that and planning out our scenario planning is a big focus of our work going into 2025.
So as we look to 2025, key trends or developments that our clients should expect or prepare for? For that I would say everyone should be prepared for anything. This new Trump administration is going to look a lot different than what we had in Trump’s first term. We have RFK. Jr. leading HHS, we have Dr. Oz coming in as CMS administrator, things are going to look a lot different than they did under Trump’s first term and are certainly going to look a lot different than they did under President Biden, so be prepared for anything.
The good news is, that’s where ADVI comes in. We are tracking all of these policy developments on the federal and state level, but we also get to the takeaways really quickly, about what these changes mean for your business, in addition to working with clients, helping them prepare for what’s coming next. That’s what we are here for and that’s what we do. If of interest, please get in touch with us.
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