In 2025, Republicans will hold a majority in both houses of Congress, and the next Trump administration will control the executive branch. In healthcare issues where access and equity intersect, these three controls will undoubtedly impact both legislative and regulatory processes, creating both opportunities and challenges for stakeholders.
Republicans will control both chambers, but the margins are slim: 218-212 in the House and 53-47 in the Senate. For those interested in telemedicine, health equity, artificial intelligence (AI), and life sciences, the future outlines a year-end health package that could include telemedicine, reauthorization of the Pediatric Priority Review Voucher Program, and more. The next few weeks are critical. , the Child Access to Care Act and AI regulations are still taking shape. Reports have surfaced that leaders have been told to “whitewash” various health priorities that need an extension, including telemedicine and funding for certain programs set to expire at the end of the year. However, these discussions are ongoing and may evolve for a variety of reasons.
The full impact of the Roper-Bright decision (a cover for Chevronism) remains to be seen. However, it is important to remember that the court’s decision does not involve the parties. The administration’s focus on deregulation and a Republican majority in Congress aimed at achieving party goals could further slow progress on the notoriously slow legislation.
The Biden administration will improve health care equity, AI standards and oversight, Medicare and Medicaid access, and drug pricing supported by executive orders and rulemakings under the U.S. Department of Health and Human Services (HHS), including the Centers for Medicare and Medicaid Services. The focus was on settings. (CMS) and the U.S. Food and Drug Administration (FDA). The incoming Trump administration is likely to use its authority to reverse many Biden-era actions in these areas. As an example, CMS has come under intense scrutiny from both sides in recent years, with Republicans focusing on inefficiencies and a lack of adequate savings, and Democrats focusing on certain systemic barriers to care and We are evaluating the CMS Innovation Center program as a possibility. Integration aggregator.
Continuous evaluation of the efficiency of CMS programs and savings and rollbacks of certain rulemakings, particularly related to health equity efforts, are possible. The former Trump administration took several steps to reduce federal funding for Medicare and Medicaid, including increasing coverage limits and funding for outreach and enrollment. Additionally, the incoming administration may consider repealing and replacing several recent regulations, including the Medicaid Access Rule, Managed Care Rule, Medicaid Streamlining, and Children’s Health Insurance Program Rule. The FDA has also received criticism from Republicans, particularly in its management of the coronavirus pandemic. Some ideological leaders of the incoming administration are paying particular attention to conflicts of interest and the effectiveness of certain FDA-approved products.
Although we discuss various issues more specifically below, much of this prioritization is determined first by the direction of the administration (including the HHS Administrator, the FDA Commissioner, and the CMS Administrator), and second by the administration. It is important to realize that this is determined by Congressional leadership on jurisdictional committees. The first 100 days are usually critical, and the 119th Congress is no exception.
Telemedicine. During the COVID-19 pandemic, the use of telemedicine has expanded significantly with the introduction of certain COVID-era telemedicine flexibilities. This utilization was supported by increased access to care, improved patient outcomes, and, in some cases, reduced readmissions. The issue has received overwhelming bipartisan support from both chambers of Congress, making telehealth flexibility a leading candidate for the year-end health care package. Although there have been concerns about overuse and abuse, the support supersedes these concerns. Negotiations regarding coverage and expenses are expected. However, bipartisan support for this issue is likely to last until 2025.
On November 15, 2024, the U.S. Drug Enforcement Administration (DEA) announced an interim rule extending flexibility for telehealth prescribing of certain controlled substances without a prior in-person appointment until December 31, 2025 . The former Trump administration was the first. We plan to propose this flexibility in 2020, so this policy may remain in some form.
love. In October 2023, President Joe Biden signed a comprehensive executive order, activating the Defense Production Act to establish the first set of standards for the use of AI in health care and other industries, and creating new regulations for AI. He called for stronger public monitoring and regulations. Pursuant to this Executive Order, HHS will establish an AI Safety Program to track adverse incidents related to AI in health care settings, establish an AI Task Force, and improve AI transparency under certain certified health information technologies. Finalized rules requiring sex. Additionally, in January 2025, HHS plans to release a new AI strategy document pursuant to the Executive Order.
It is customary for the incoming opposition government to repeal the previous government’s executive order, especially when there is no clear position on the issue. Unsurprisingly, the 2024 Republican Party platform clearly states plans to repeal President Biden’s executive orders on AI. Under the incoming Trump administration, we are likely to see a more scaled-down approach that focuses on innovation and cuts back on government overreach. Although details are unclear, the emphasis on privacy, patient data protection, and end-user-focused design may continue into 2025.
In July 2024, 11 AI-focused bills passed the Senate Commerce, Science, and Transportation Committee. The bill has stalled, but Sen. Charles Schumer of New York has indicated he plans to incorporate AI legislation into his year-end bill, with a primary focus on regulating AI-generated election deepfakes. That said, it is likely to run into partisan obstacles. In the future, substantive AI legislation may face similar challenges.
Health equity. Diversity, equity, and inclusion (DEI) has become a key focus of the incoming Trump administration’s election campaign, which has promised to scale back DEI programs in government agencies. Although its contours are not yet visible, explicit DEI language in government plans and initiatives may be removed or a change in terminology may occur.
In early 2024, the Biden administration released draft guidance outlining recommendations for a diversity action plan in clinical trial design. The next administration will likely rescind this guidance.
Conversely, rural health care remains a bipartisan issue, and many initiatives aimed at improving rural health have a significant role to play in the health of many historically underserved populations. It is a policy that As a result, attention that has previously focused on establishing equitable health may shift to efforts that focus on population-based or local health.
Life science. The next administration is likely to focus on lowering high drug prices, innovation, redressing perceived conflicts of interest, transparency, and improving agency efficiency. Some changes to the FDA can be made administratively through appropriations or authorizations, while others require Congressional approval. Because FDA leadership may be focused on conflicts of interest, there may be unexpected opportunities to further elevate rare and chronic disease advocates in drug development discussions.
For over-the-counter (OTC) drugs, user fee programs are scheduled to be reauthorized next year, and the Biden administration reauthorized the Prescription Drug User Fee Act (PDUFA VII) for fiscal years 2023 through 2027. The former Trump administration proposed increasing user fees for prescription drugs, but the potential next HHS secretary has cited these as issues of conflict of interest and expressed general concerns about user fee programs. did. Therefore, the future of OTC and prescription drug programs remains uncertain. Drug pricing will continue to be a top priority, and the FDA’s approval process will likely be judged on its ability to assess safety and efficacy.
In August 2024, CMS issued a final notice on the Transition Compensation for Emerging Technologies (TCET) pathway. This rule outlines a process to expedite Medicare coverage for certain FDA-designated breakthrough devices. This is a reworking of the previous Trump administration’s definition of Medicare coverage of innovative technologies (MCIT) and “reasonable and necessary” regulations, which were not finalized. The next Trump administration may consider revoking TCET and try to revitalize MCIT.
Conclusion and discussion
The challenge for stakeholders is most evident in the magnitude of the unknown. However, the opportunities are a little more transparent. These can arise for companies seeking less regulation in the development of products and medicines, patient groups seeking a larger seat at the table, and creative advocates interested in joining the changing debate. If there’s a lesson to be learned from the Trump administration, it’s not just to anticipate the unexpected, but to prepare for it.
