What’s Next for Health Care Policy in the US?
Adam Colborn, JD, Associate Vice President, Congressional Affairs, AMCP
With the election mostly behind us (recounts and legal challenges notwithstanding), Washington, DC, is abuzz with rumors and reactions to cabinet picks for the incoming Trump Administration and questions about the health care policy agenda in 2025. While the 2 are linked—leaders drive the agenda—I’m going to leave the intrigue of political nominees to the pundits and focus instead on some policy issues that could see action in the coming months.
Shifting Power Dynamics and New Faces Bring Uncertainty
Objectively, the health care policy agenda in Washington is a bit… uncertain. But that’s not cause for concern. First, despite some “unconventional” nominees for key positions, we’re embarking on a period of tremendous turnover across the federal government.
With nearly 80 members of Congress retiring and others losing their bid for reelection, the 119th Congress will have a lot of new faces, most of whom don’t have records on health and managed care policy issues. Indeed, health care policy was featured less on the 2024 campaign trail than past cycles, with candidates stumping on the economy, taxes, tariffs, and other issues that will drive President-Elect Trump and the Grand Old Party's (GOP’s) agenda come January.
So, 2025 could be a low-volume year for health care policy. There are, however, still several items underway that will fight for attention in the coming months.
Lame Duck Brings a Limited Opportunity
Let’s start with the lame duck session between now and the new congress on January 3, 2025. With the GOP sweeping control of the White House, Senate, and House of Representatives, party leaders are likely to push major decisions into next year when they have a stronger hand to guide policy outcomes. This could result in one of the lamest of lame duck sessions we’ve seen in a while, focused on the bare necessities to avoid a government shut down.
Even in this minimalist frame, progress is possible and I am hopeful that robust bipartisan support can help push the Equitable Community Access to Pharmacist Services (ECAPS) Act over the finish line and into law. Provisions in this bill underscore the vital role pharmacists play on the front line of health care in our communities. The bill will help implement lessons learned from the COVID-19 pandemic to improve patient access to safe, reliable, potentially life-saving care across America—particularly in rural communities where pharmacists are often the most accessible health care provider to individuals and families in need of care. Me and many others are united in support for the ECAPS Act, and our advocacy has garnered strong bipartisan support in Congress. We are hopeful this support can translate to swift action and will continue working to get this bill signed into law.
Another issue that could end up taking flight during the lame duck is pharmacy benefit manager (PBM) reform. I know. We’ll believe it when we see it, but there’s enough bipartisan support for doing something that it’s possible we see a package between now and January. Key items of any new reforms will likely focus on transparency—increasing PBM reporting to health plan sponsors and to the federal government—and fees, including a curb on longstanding practices like spread pricing.
The devil is always in the policy details. Action in the near-term likely depends on whether Democrats and Republicans can agree on the scope of a bill, as Democrats want to regulate private and commercial plans, while Republicans want to focus immediate changes on government programs only. Key leaders in Congress, like House Energy & Commerce Health Subcommittee Chair Brett Guthrie (R-KY) have suggested we may see a 2-phase approach to PBM legislation, with something advancing in the lame duck and additional work on the agenda in 2025. With industry and interest groups entrenched in their positions, there’s going to be a lot of attention on what does—or doesn’t—happen with PBMs in the next few months.
Will 2025 Bring New Scrutiny of the IRA, 340B, or New Treatments Coming Online?
Looking into 2025, the uncertainty could get interesting—and very busy—if Trump and Congressional Republicans decide to make the health care provisions in the Inflation Reduction Act (IRA) a priority for review or repeal. Implementation of the landmark law is well underway with several key milestones coming up, including prices negotiated for the next round of 15 drugs covered under Medicare Part D in January. While patients won’t see the impact of these changes until the prices take effect in 2026, Centers for Medicare & Medicaid Services (CMS) is required to publish an explanation of the negotiated prices for the first 10 drugs by March 1, 2025 as well as the maximum fair price for the second round of drugs by November 2025. Both milestones, along with the massive undercurrent of IRA implementation work sweeping through industry and government alike, will keep the IRA front and center and could present an opportunity for reconsideration or revision if lawmakers feel there is a need for reform.
Another issue bubbling just beneath the surface that could burst onto the agenda is reform of the 340B program that allows hospitals and other entities serving low-income populations to purchase outpatient drugs at a discount from manufacturers. This has always been a niche issue, but there’s growing consensus the program needs an update. Policymakers are divided on whether to “protect” 340B in its current form or seek more substantive changes. Like we’ve seen with heated debate on PBMs, suggestions for reforming 340B focus on transparency, preventing duplicate discounts, and improving patient savings that result from the program. With hospitals under growing scrutiny for a variety of reasons, we can expect critics to angle for a closer look at whether hospitals are providing adequate charity care or misusing designations that entitle them to support from the 340B program.
As I prepare for meetings with new congressional offices in 2025, I’m spending a little extra time on background related to 340B to help provide important detail and context as lawmakers and staff build their briefs on key health care items. Even absent immediate action by Congress, we may see changes to 340B as a result of ongoing litigation between the Health Resources and Services Administration (HRSA) and pharmaceutical manufacturers, with Eli Lilly and Johnson & Johnson filing suit against HRSA in November.
Finally, there are some issues that are on our radar that could impact managed care pharmacy if they can find space on the agenda. We live in a period of unprecedented innovation. As new products come to market, we need to make sure manufacturers and payers have all the tools they need to get these treatments to patients who need them. To do so, we should expand the use of value- or outcomes-based contracts. the Academy of Managed Care Pharmacy (AMCP) is an ardent supporter of the Medicaid Value-Based Payments for Patients (MVP) Act. While the name doesn’t quite roll off the tongue, the provisions in the bill codify the existing “multiple best price” rule and expand the use of value-based agreements to drugs administered in inpatient settings. We believe this bill will help better connect patients with Medicaid with the therapies they need.
Similarly, as we expect new therapies to drive substantial conversation inside the Beltway and across the health care marketplace, we need to make sure the existing health care system—which is built by policy—is modernized to accommodate safe, reliable access for patients. At AMCP, we’re strong advocates for increased access to prescription digital therapeutics, as well as biologics, biosimilars, and cell and gene therapies. We will continue working to educate policymakers about the promise these treatments hold for millions of patients across America and ways we can update our health care system to accommodate them.
Advocacy and Education are Always in Cycle
So, while it feels like uncertainty is the only sure thing at the moment, there’s a lot happening in health care policy that could have a tremendous impact on managed care and millions of patients. There’s a tendency to look for the next big thing in politics and policy, but times like this are a good reminder that change can be slow to take shape. Landmark legislation like the Affordable Care Act, Medicare Modernization Act, and the IRA represent the culmination of months—and years—of discussion and deliberations. We may not be on the cusp of passing another round of generational health care reform, but good, important things are happening that will shape the future of managed care and delivery of lifesaving treatments to patients. We’re excited to get to work with lawmakers and regulators to reinforce the many important ways that managed care pharmacy improves the lives of millions of Americans each and every day.