January 6, 2025
They’re back! New Congress faces unfinished business and an aggressive Trump-backed agenda
The 119th Congress convened on Friday, kicking off an ambitious 2025 calendar. While Congress traditionally weaves several weeks into its congressional calendar to allow members to be back in their districts, there aren’t many scheduled for 2025 as leaders of both the Senate and House have released calendars limiting “in district work periods” to those surrounding major holidays and the traditional month of August recess. The combined congressional calendar can be accessed here. It’s a clear sign that majority Republicans want to pass major policy priorities in the first year of President Trump’s second administration. At the top of that list: border security, immigration reform, trade policy and extension of the 2017 tax cuts. The House narrowly re-elected Rep. Mike Johnson (R-LA) to the role of House Speaker on Friday, but not without some drama from a handful of hard right conservatives critical of what they perceive as too much compromise from Speaker Johnson in the 118th session. While the new Congress has a bold, proactive policy agenda, it also has major issues that it needs to address before the end of March after leaders passed a very slim stopgap funding measure in late December. House and Senate leaders had agreed on a major funding deal before Christmas, but criticism from Tesla’s Elon Musk and eventually President Trump, tanked the package. Musk attacked certain provisions in the deal (such as a 3.8% pay raise for members of Congress, details surrounding an NFL stadium deal in Washington, D.C., and reauthorization of funding for regional biocontainment laboratories), calling it the “worst bill ever written”. That was enough for some Republicans to pledge to oppose the bill. With a narrow GOP majority last session (and an even narrower majority this session), House Republicans withdrew the proposal, opting instead to pass another time-limited continuing resolution that keeps the government running until the end of March. Health care priorities were the biggest losers in the slimmed down package. It didn’t include reauthorization of the FDA’s rare pediatric priority review voucher (PRV) program, a full extension of Medicare telehealth benefits (they’re only covered through March) or major physician payment reforms. The long list of outstanding issues will now face the new Congress right out of the gate because a new proposal will need to be crafted and advanced before the end of March. The exclusion of reauthorization of the PRV program drew immediate outrage from patient advocates who cited that it was one of the few bipartisan health care priorities and critical to continuing innovation for rare disease therapies. Advocates will redouble their efforts in the next two months to ensure any March package includes a full five-year reauthorization of the program.
FDA approved fewer drugs in 2024; Manufacturers announce modest annual price increases on existing drugs
Ten fewer drugs were approved last year than 2023, yet many of the drugs approved included breakthrough therapies for unmet medical needs. Leading the way: Lilly’s amyloid-targeting Alzheimer’s drug, new treatments to treat the rare condition Niemann-Pick disease, Pfizer’s new hemophilia medication and Bristol Myers Squibb’s new schizophrenia drug. In all, the FDA approved 50 new drugs in 2024. We will be watching how these numbers compare to 2025 approvals, as the approval pipeline is robust, but there is uncertainty about how incoming leadership at HHS and FDA could reform the approval process (for the better…or not). Meanwhile, the biopharma industry drew its annual round of criticism as companies announced annual price increases for medications. While the average price increase is 4.5% (the same as the 2024 increase and down substantially from a decade ago when annual price increases were around 9%), some industry critics called the increases “absurd”. U.S. Senator Bernie Sanders (I-VT) used the price increases to release a 9-point plan to overhaul the U.S. health care system. The calls for a 50% reduction in U.S. prescription drug prices and matching prices to what consumers in Canada pay for medications.
Key cabinet nominations facing imminent hearings and votes: where things stand with Trump’s HHS, CMS and FDA picks
As Congress begins its busy schedule, President Trump’s nominees for multiple leadership posts continue to meet with Senators whose votes are necessary for official confirmation. While Trump has announced all of his nominations for key positions, confirmation hearings won’t begin until after the president is inaugurated on Monday, January 20. HHS secretary nominee Robert F. Kennedy, Jr. has held multiple meetings with key Republican senators, some of whom have pressed him on his pro-choice position on abortion. Allegedly, RFK assured senators that he would support reinstating anti-abortion policies from Trump’s first term, most related to abortion funding and conscience protections. Observers feel these promises, if accurate, could assure adequate Republican support for the nomination as it moves forward. He’ll still need to answer questions related to his vaccine skepticism and other public health issues. There have not been major concerns noted on two other key health care nominees, Dr. Mehmet Oz to lead CMS and Dr. Marty Makary to head FDA. Makary has already begun assembling a transition team, according to a January 3 STAT article, which includes key congressional staffers and former advisers to ex-commissioners.
State legislatures reconvene, with many quickly diving into health care legislation
As state legislators head to state capitols to begin their sessions, health care policy will be front and center. On the biopharmaceuticals front, expect ongoing battles over the 340B program and whether manufacturers can restrict participation from contract pharmacies. Six states passed laws last year on the topic and bills were filed in 20 states. The future of the 340B program will be debated on multiple fronts—from new leadership at the federal Health Resources and Services Administration (HRSA) within HHS, the U.S. Congress and in multiple federal courts, as manufacturers try to identify strategies to rein in ballooning of the program. By the end of 2024, four biopharma companies (J&J, Sanofi, BMS and Lilly) had filed lawsuits.Other state issues will include prior authorization reform where proposals to expand “gold carding” (the payer practice of waiving prior authorization requirements for providers with a strong track record of prior authorization approvals) will be under consideration along with hospital certificate of need reform and surprise billing proposals.
Health Policy Snippets
- The future of AI in health care – top of mind for policymakers. As federal and state regulators continue their quest to set appropriate guidelines around the use of artificial intelligence (AI) in such health care practices as prior authorization and utilization management, state and federal legislators are still a few steps behind. First, lawmakers are focusing on expanding their understanding of AI generally. Next, they’re looking to explore what laws, if any, should be put in place surrounding AI in health care—with some arguing that restrictions are important to ensure patient access and others believing that intervening too early could stifle innovation. You can access an overview of the existing regulatory framework here. We’ll be watching how legislators, especially state legislators who often use their bodies as true “laboratories of democracy” on health care policy, will continue to wade into the AI discussion in their 2025-2026 legislative sessions.
- Top Medicaid reform proposal likely to focus on “work requirements”. Requiring those on Medicaid to “work” (which is generally considered paid employment, volunteering, attending school part-time, participating in certain rehab programs, job training or other approved community engagement activities) will remain a top priority in the Trump 2.0 Administration and among conservative policymakers. This is one area where details matter and how so-called “work requirements” are defined and how various populations are impacted is critical. While critical of work requirements in Medicaid, the recently-released Kaiser Family Foundation issue brief on work requirements does a great job capturing where things stand in the courts, Congress and state legislatures.
