Election Implications for Telehealth, Health Equity, AI and Life Sciences
In 2025, Republicans will hold the majority in both chambers of Congress, and the incoming Trump Administration will preside over the executive branch. For healthcare issues at the intersection of access and equity, this trifecta of control will undoubtedly impact both the legislative and regulatory processes, presenting both opportunities and challenges for stakeholders.
Though Republicans will control both chambers of Congress, the margins are slim, with a 218-212 majority in the House and a 53-47 majority in the Senate. For those interested in telehealth, health equity, artificial intelligence (AI) and life sciences, the next few weeks are critical as the contours of a potential end-of-year health package that could include telehealth, reauthorization of the Pediatric Priority Review Voucher program, the Accelerating Kids Access to Care Act and AI regulations are still taking shape. Reports have surfaced that leadership has been told to "clear the decks" of various healthcare priorities requiring extensions, including telehealth and funding for certain programs set to expire at the end of the year. However, these discussions are ongoing and may evolve for various reasons.
The full implications of the Loper-Bright ruling (overturning of the Chevron doctrine) remain to be seen; however, it is essential to remember that court decisions are party-blind. Furthered by a deregulation-focused administration and a slim-majority Republican Congress aimed at meeting party goals, a notoriously slow legislative progress may be slowed even further.
The Biden Administration had a focus on health equity, AI standards and oversight, Medicare and Medicaid access, and drug pricing substantiated by executive orders and rulemaking under the U.S. Department of Health and Human Services (HHS), including the Centers for Medicare & Medicaid Services (CMS) and U.S. Food and Drug Administration (FDA). The incoming Trump Administration will likely utilize its authority to roll back many Biden-era actions in these areas. CMS, for one, has received scrutiny in recent years from both sides of the aisle, with Republicans focused on inefficiencies and lack of sufficient savings and Democrats focused on certain systemic barriers to care, as well as evaluating certain CMS Innovation Center programs as a potential aggregator of consolidation.
Continued evaluation of CMS program efficiency and savings and rollbacks of certain rulemaking, especially as they pertain to health equity initiatives, are possible. In the prior Trump Administration, several actions were taken to decrease federal funding in Medicare and Medicaid, including funding for outreach and enrollment through increasing restrictions on coverage, as well as finance restrictions. Additionally, the incoming administration could look to repeal and replace several recent rules, including the Medicaid Access Rule, Managed Care Rule, and Streamlining the Medicaid, Children's Health Insurance Program Rule. FDA also received criticism from the Republican party, particularly in the management of the COVID-19 pandemic. Some of the incoming administration's ideology leaders have paid particular attention to conflicts of interest and the efficacy of certain FDA-approved products.
Though various issues will be discussed below with more specificity, it is central to recognize that much of this priority-setting will be determined first by the direction of the administration (including the HHS administrator, FDA commissioner and CMS administrator) and, second, by congressional leadership in the committees of jurisdiction. The first 100 days are conventionally critical, and the 119th Congress will not be an exception.
Telehealth. Telehealth utilization expanded significantly during the COVID-19 pandemic due to the implementation of certain COVID-era telehealth flexibilities. This utilization was supported by increased access to care, improved patient outcomes and, in some cases, reduced hospital readmittance. This issue has overwhelming bipartisan support from both chambers, which has led to telehealth flexibilities being a likely contender for a year-end healthcare package. Though there has been some concern about overutilization or abuse, support supersedes these concerns. Negotiations regarding coverage and spending are expected; however, bipartisan support on this issue will likely persist in 2025.
On Nov. 15, 2024, the U.S. Drug Enforcement Administration (DEA) released a temporary rule that extends flexibilities for the telehealth prescribing of certain controlled substances without a preceding in-person appointment through Dec. 31, 2025. The previous Trump Administration was first to propose this flexibility in 2020, so it is likely this policy, in some form, will remain.
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 using AI in healthcare and other industries, calling for greater public oversight and regulation of AI. HHS, in compliance with this executive order, established an AI Safety Program to track harmful incidents involving AI in healthcare settings, established an AI Task Force and finalized a rule requiring transparency for AI under certain certified health information technology. Additionally, in January 2025, HHS is slated to release a new AI strategy document in compliance with the executive order.
It is conventional for incoming administrations of opposing parties to repeal the previous administration's executive orders, particularly if positioning on the issue is distinct. Unsurprisingly, the 2024 Republican party platform explicitly laid out its plans to repeal President Biden's executive order on AI. Under the incoming Trump Administration, we are likely to see a more scaled-back approach, with a stronger emphasis on innovation and reducing government overreach. Emphasis on privacy, patient data protection and end-user-focused design may persist in 2025, though the specifics remain unclear.
In July 2024, 11 pieces of AI-focused legislation passed out of the Senate Commerce, Science, and Transportation Committee. Though that legislation has stalled, Sen. Charles Schumer (D-N.Y.) has indicated plans to incorporate AI-related bills into year-end legislation, with a primary focus on regulating AI-generated election deepfakes. That said, it will likely encounter partisan roadblocks. Looking ahead, substantive AI legislation may face similar challenges.
Health Equity. Diversity, equity and inclusion (DEI) has been a significant campaign focus of the incoming Trump Administration, with promises to roll back DEI programs in government institutions. Though the contours remain to be seen, explicit DEI language in government programming or initiatives is likely to either be eliminated or experience a shift in terminology.
The Biden Administration published a draft guidance earlier in 2024 that outlined recommendations for diversity action plans in clinical trial design. The incoming administration will likely roll back this guidance.
Conversely, rural healthcare 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. Consequently, attention previously focused on establishing equitable health may shift to population-based or rural health-focused initiatives.
Life Sciences. The incoming administration will likely focus on reducing high drug prices, innovation, rectifying perceived conflicts of interest, transparency and improving agency efficiency. Some changes to FDA could be made administratively through appropriations or authorizations, but others would need congressional approval. Due to the potential focus of FDA leadership on conflicts of interest, there may be an unforeseen opportunity for rare and chronic disease advocates to be further elevated in drug development conversations.
For over-the-counter (OTC) drugs, the user fee program is slated for reauthorization next year, and the Biden Administration reauthorized the Prescription Drug User Fee Act (PDUFA VII) from fiscal year (FY) 2023 through FY 2027. Though the previous Trump Administration proposed higher user fees for prescription drugs, the potential incoming HHS secretary has pointed to these as an issue of conflict of interest and has expressed general concerns with user fee programs. Therefore, the future of the OTC and prescription drug programs remains unclear. Drug pricing will remain a top issue, and FDA approval processes may be evaluated for their ability to assess safety and efficacy.
In August 2024, CMS issued a final notice on the Transitional Coverage for Emerging Technologies (TCET) Pathway. The rule outlines processes to expedite Medicare coverage of certain FDA-designated breakthrough devices, which was a reworked version of the previous Trump Administration's Medicare Coverage of Innovative Technology (MCIT) and Definition of "Reasonable and Necessary" Rule, which was never finalized. The incoming Trump Administration may consider reversing TCET and attempt to revitalize MCIT.
Conclusion and Considerations
Challenges for stakeholders are most evident in the magnitude of the unknown. Opportunities, however, are slightly more transparent. They may arise for companies seeking less regulation in product and drug development, patient groups seeking a bigger seat at the table and creative advocates interested in engaging in a shifting discourse. If there are lessons to be learned from the prior Trump Administration, it is to not only expect the unexpected, but prepare for the possibilities.