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ADVI Health Expert Lindsay Bealor Greenleaf Shares Insights from AVBCC

ADVI expert Lindsay Bealor Greenleaf, head of federal and state policy, sat down to share her key takeaways from the 2024 Association for Value-Based Cancer Care (AVBCC) Summit that took place in New York, NY. While there, Lindsay moderated the panel discussion, “Election 2024: A Tale of Two Futures,” which touched on several topics, including the ability for in-office dispenser to mail ship drug, Pharmacy Benefit Manager (PBM) reform, and 340B. Beyond these topics, conversations were heavily around the predicted implications of the upcoming 2024 presidential election.

Lindsay shares that the panelists agreed that a President Harris administration would be more punitive than a President Trump administration when it comes to government price setting referred to as Maximum Fair Prices, and that a President Harris administration might even be a bit more punitive than Biden on CMS. Panelists also revisted some of former President Trump’s previous focus areas, such as international reference pricing implementation, drug pricing efforts, and the OIG Rebate rule, debating if those would still be a priority if he were to be elected for a second term.

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Some of the key takeaways include 2024 presidential election policy predictions related to health policy and what we can expect to change with the new administration, as well as insights on the status of topics like in-office dispenser to mail-ship drug, PBM reform, and 340B.

Panelists

Lindsay Bealor Greenleaf, JD MBA

Head, 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.

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Full Transcript

Lindsay Bealor Greenleaf: Last week, I had the pleasure of moderating a panel at the Association for Value Based Cancer Care (AVBCC) Conference in New York City. Our panel discussed the 2024 presidential election and issues affecting cancer care. Panelists included top lobbyists and policy experts. We had John McManus, Tracy Spicer, John O’Brien, and Miranda Franco.

First, we talked about key issues that we are watching with lame duck, what might happen after the election and before the next president is sworn in. First and foremost is an issue that is really key for oncologists is the ability for in-office dispenser to mail ship drug. Right now, there is a prohibition underway due to some CMS guidance that came out related to the public health emergency, COVID. There is a bill that passed the House that would allow for in-office dispensers to mail-ship again. There’s hope that during lame duck, the Senate will get this enacted into law and fix this stark law issue that oncologists are currently facing. We also talked a bit about Pharmacy Benefit Manager (PBM) reforms, and our panelists are hopeful that something is going to happen by end of year, whether it is transparency, or potential de-linking of Medicare compensation for PBMs. We will be watching that in the coming months.

We then turned to the White House, and what to expect under a Harris presidency, and what to expect under a Trump presidency. We focused on the biggest topics of the day like Inflation Reduction Act (IRA) implementation, and our panelists agree that a President Harris administration would be more punitive than a President Trump administration when it comes to setting government-established prices referred to as Maximum Fair Price (MFP). A President Harris might even be a bit more punitive than Biden-led CMS, this price setting, is something we will certainly be watching closely from 2025 onward if Kamala Harris were to win the White House. Thinking about President Trump and the IRA, that outlook is a little bit more unclear. Even if Republicans were to sweep Congress, and you have a Republican in the White House, it’s quite unlikely that the government negotiation policy would get repealed just given the very high cost and the pay-for required to do something like that. So we expect that President Trump would have to implement the law in general, but maybe he would incorporate some kind of international reference pricing component to process, we know that this notion of foreign freeloading, and the difference between what other countries pay for drugs versus what we pay in the US, and this kind of “America First agenda,” that’s something that has historically been top of mind for President Trump.

We had a debate among our panel as to whether implementing something related to international reference pricing would still be a focus for Trump’s second term. It seems like he may have backed off of this theme, but it was such a big one for President Trump historically, it may come back around. From there, we turned back to our Pharmacy Benefit Manager (PBM) topic and talked about how while addressing the middlemen in the supply chain, President Trump made a big focus of his drug pricing efforts in his first term. As you know, President Trump did enact a regulation known as the OIG Rebate rule that would have fundamentally change the way rebating works in Medicare Part D, but Democrats essentially repealed that regulation through the IRA. So the question among our panel is would President Trump want to finish the fight with PBMs? And what might that look like?

Lastly, we turn to 340B, though we had so much else to talk about in our panel, we didn’t give it enough air time. There’s so much swirling on 340B, when it comes to contract pharmacies, different manufacturer actions, you know what’s going on with J&J and HRSA, and what’s coming out of Capitol Hill. There’s a lot there. We touched on some of it, but if only we’d had more time, we would have spent more time on it. It was a great panel, and at ADVI we are on top of all these issues. If any of these topics are of interest to you and your business, please reach out.

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