In 2025, Republicans will hold majorities in both houses of Congress and the new Trump administration will preside over the executive branch. For health care issues at the intersection of access and equity, this trio of controls will undoubtedly impact legislative and regulatory processes, presenting both opportunities and challenges for parties stakeholders.
Although Republicans will control both houses of Congress, the margins are slim, with a majority of 218 to 212 in the House and 53 to 47 in the Senate. For those interested in telehealth, health equity, artificial intelligence (AI), and life sciences, the next few weeks will be crucial as the contours of a possible end-of-year health program year that could include telehealth, reauthorization of the Pediatric Priority Exam Voucher Program. , the law accelerating children’s access to care and the regulations on AI are still taking shape. Reports have surfaced that leaders have been asked to “clean house” of various health care priorities requiring extensions, including telehealth and funding for some programs that will expire at the end of the year . However, these discussions are ongoing and could evolve for various reasons.
All the implications of Loper-Luminous decision (cancellation of the Chevron doctrine) remain to be seen; However, it is essential to remember that court decisions are party blind. Favored by an administration focused on deregulation and a narrow-majority Republican Congress focused on achieving party goals, notoriously slow legislative progress could be slowed even further.
The Biden administration has focused on health equity, AI standards and oversight, access to Medicare and Medicaid, and drug pricing justified by executive orders and rules from the U.S. Department of Health. Health and Human Services (HHS), including the Centers for Medicare & Medicaid Services. (CMS) and the United States Food and Drug Administration (FDA). The new Trump administration will likely use its authority to reverse many Biden-era actions in these areas. CMS, for example, has come under scrutiny in recent years from both sides of the aisle, with Republicans focusing on inefficiencies and lack of sufficient savings and Democrats focusing on certain systemic barriers to care, as well as evaluating some CMS Innovation Center programs as potential. consolidation aggregator.
Continued evaluation of the effectiveness and savings of the CMS program and rollback of certain rules, particularly as they relate to health equity initiatives, are possible. Under the previous Trump administration, several steps were taken to reduce federal funding for Medicare and Medicaid, including funding for outreach and enrollment through increasing restrictions on coverage, as well as financial restrictions. Additionally, the new administration may seek to repeal and replace several recent rules, including the Medicaid Access Rule, Managed Care Rule, and the Medicaid Streamlining, Children’s Health Insurance Program rule. The FDA has also received criticism from the Republican Party, particularly in its handling of the COVID-19 pandemic. Some of the new administration’s ideological leaders have paid particular attention to conflicts of interest and the effectiveness of certain FDA-approved products.
Although various issues are addressed below in greater detail, it is essential to recognize that much of this prioritization will be determined first by Administration leadership (including the HHS Administrator, the FDA Commissioner and the CMS Administrator) and, subsequently, by Congressional leadership in the relevant committees. The first 100 days are traditionally critical, and the 119th Congress will be no exception.
Telehealth. The use of telehealth has grown significantly during the COVID-19 pandemic due to the implementation of certain telehealth flexibilities in the COVID era. This use has been supported by increased access to care, better patient outcomes and, in some cases, reduced hospital readmission. This issue has overwhelming bipartisan support from both chambers, leading to telehealth flexibilities being a likely candidate for a year-end health care package. Although concerns have been expressed about overuse or abuse, support outweighs these concerns. Negotiations regarding coverage and expenses are expected; however, bipartisan support on this issue will likely persist into 2025.
On November 15, 2024, the United States Drug Enforcement Administration (DEA) issued a temporary rule that extends flexibilities for telehealth prescribing of certain controlled substances without a prior in-person appointment through December 31, 2025. The previous Trump administration was the first to offer this flexibility in 2020, so it is likely that this policy, in one form or another, will be maintained.
AI. In October 2023, President Joe Biden signed a sweeping executive order and invoked the Defense Production Act to establish the first set of standards for the use of AI in health care and other sectors, calling for increased public oversight and regulation of AI. HHS, in accordance with this Executive Order, established an AI Safety Program to track harmful incidents involving AI in health care settings, created an AI Task Force, and finalized a rule requiring AI transparency in certain certified health information technologies. Additionally, in January 2025, HHS is expected to release a new AI strategy document in accordance with the executive order.
It is common for new administrations from opposing parties to repeal the previous administration’s executive orders, particularly if their stance on the issue is different. Unsurprisingly, the Republican Party’s 2024 platform explicitly outlined its intention to repeal President Biden’s executive order on AI. Under the new Trump administration, we will likely see a smaller approach, placing more emphasis on innovation and reducing government overreach. The emphasis on privacy, patient data protection, and end-user-centered design could persist into 2025, although the details remain unclear.
As of July 2024, 11 pieces of AI-focused legislation have been passed by the Senate Commerce, Science, and Transportation Committee. Although this legislation has stalled, Sen. Charles Schumer (D-N.Y.) has indicated his intention to incorporate AI-related bills into year-end legislation, with a primary focus on the regulation of AI-generated electoral deepfakes. That said, he will likely face partisan obstacles. In the future, substantive AI legislation may face similar challenges.
Health equity. Diversity, equity, and inclusion (DEI) has been a major campaign focus of the new Trump administration, with promises to scale back DEI programs at government institutions. Although the contours remain to be seen, explicit DEI language in government programs or initiatives will likely either be eliminated or experience a change in terminology.
The Biden administration released draft guidance earlier in 2024 outlining recommendations for action plans for diversity in clinical trial design. The new administration will likely reverse these guidelines.
Conversely, rural health care will remain a bipartisan issue, and many initiatives aimed at improving health in rural areas are policies that play a role in the health of many historically underserved groups. Therefore, attention previously focused on establishing equitable health may shift to population-based or rural health-focused initiatives.
Life sciences. The new administration will likely focus on reducing high drug prices, innovation, rectifying perceived conflicts of interest, transparency and improving agency efficiency. Some changes to the FDA could be made administratively through appropriations or authorizations, but others would require congressional approval. Because of FDA leadership’s potential focus on conflicts of interest, there may be an unforeseen opportunity for rare and chronic disease advocates to gain more of a foothold in conversations about drug development.
For over-the-counter (OTC) drugs, the user fee program is expected to be reauthorized next year, and the Biden administration has reauthorized the Prescription Drug User Fee Act (PDUFA VII) of the fiscal year 2023 to fiscal year 2027. Although the previous Trump administration had proposed higher user fees for prescription drugs, the potential new HHS secretary highlighted this as a conflict of interest issue and expressed general concerns regarding user fee programs. Therefore, the future of over-the-counter and prescription drug programs remains uncertain. Drug pricing will remain a major issue, and FDA approval processes may be evaluated based on their ability to assess safety and effectiveness.
In August 2024, CMS issued a final notice on the Transitional Coverage Pathway for Emerging Technologies (TCET). The rule outlines processes to expedite Medicare coverage of certain FDA-designated breakthrough devices, which was a reworked version of the Trump administration’s previous Medicare Coverage of Innovative Technologies (MCIT) and the rule’s definition of “reasonable and necessary”, which was never finalized. The new Trump administration may consider rescinding the TCET and attempt to revitalize the MCIT.
Conclusion and considerations
The challenges for stakeholders are particularly evident in the scale of the unknown. The opportunities are slightly more transparent, however. They may arise for companies who want less regulation in product and drug development, for patient groups seeking a greater seat at the table, and for creative advocates interested in engaging in a changing discourse . If there are lessons to be learned from the previous Trump administration, it is to not only expect the unexpected, but also to prepare for possibilities.