THIS WEEK’S DOSE
- Senate HELP Committee Chair Cassidy releases report on FDA reform. The report reflects Senate Health, Education, Labor, and Pensions (HELP) Committee Chair Cassidy’s (R-LA) priorities for the modernization of the US Food and Drug Administration (FDA).
- HHS publishes Medicaid data. The new data provides insights into how Medicaid dollars are distributed across providers and procedures nationwide.
- HHS continues personnel changes. Many US Department of Health and Human Services (HHS) high-level staffers will now serve in multiple roles.
- SCOTUS strikes down tariffs. The Supreme Court of the United States (SCOTUS) ruled that the Trump administration exceeded its authority.
CONGRESS
Senate HELP Committee Chair Cassidy releases report on FDA reform. Key health-related takeaways in the report include:
- FDA review of new applications and evidence. The report found that FDA review teams vary in predictability and flexibility, and presented concerns that FDA’s approach to clinical trials and artificial intelligence (AI) is outdated. Chair Cassidy recommended applying the “least burdensome” approach, launching a pilot program targeted at reshoring Phase I clinical trials, supporting the use of digital health technologies in clinical trials, and investing in the AI talent pipeline.
- Development of cutting-edge and rare disease therapies. In light of a rise in clinical holds and time-intensive requirements within the accelerated approval pathway, as well as limited drug approval frameworks for personalized medicines, Chair Cassidy recommended more judiciously using clinical holds, codifying recent agency actions related to therapies intended for small populations, and better coordinating reviews across FDA’s divisions and offices.
- Competition and innovation. The report found that not enough new biologics, biosimilars, and generics are being developed because of strenuous regulatory requirements and anticompetitive practices. Chair Cassidy recommended creating a new streamlined intermediate approval pathway for biologics, simplifying the biosimilar interchangeability designation, streamlining the biosimilar approval pathway, and passing legislation to address anticompetitive practices that prohibit generic entry into the market.
- FDA’s framework for software, medical device review, and innovation. The report discussed challenges related to predictability and transparency in medical device review and detailed FDA’s difficulty in creating regulatory pathways for software as a medical device and medical devices that integrate AI. It also stated that FDA has been inappropriately engaged in oversight of clinical decision support tools. Chair Cassidy recommended requiring FDA to provide clearer guidance on the clinical data and evidence needed to support premarket submissions, considering changes to the medical device review pathways, and ensuring that FDA implements clinical decision support guidance in the spirit of the 21st Century Cures Act.
Read the press release here.
ADMINISTRATION
HHS publishes Medicaid data. The new dataset shows provider-level Medicaid spending data, aggregated by billing or servicing provider, procedure code, and month. HHS notes that:
- The data is for every state as well as Washington, DC, and all US territories, and covers 2018 – 2024.
- The data only includes outpatient and professional claims, meaning volume billed by inpatient hospitals is excluded.
- The file is 10GB and requires database software to use.
- The file excludes providers and procedure code combinations representing fewer than 11 services, which will lead to an underestimate of national volume when summing total volume by procedure code.
- Identifying the names of providers requires linking to the National Plan Provider Enumeration System.
Individual researchers, citizen journalists, and others are already reviewing the files and identifying questionable activity in Medicaid billing, likely with significantly more analyses to come.
HHS continues personnel changes. Throughout the last two weeks, HHS has continued to reorganize high-level staff. Key changes include the following:
- Chris Klomp was promoted to chief counselor of HHS while keeping his role as director of the Center for Medicare.
- Jim O’Neill is leaving HHS and will serve as the director of the National Science Foundation. He was previously acting director of the Centers for Disease Control and Prevention (CDC) and deputy secretary of HHS.
- National Institutes of Health Director Jay Bhattacharya will also serve as CDC acting director.
- Matt Buckham, previously HHS chief of staff, will transition to his role as senior counselor for operations and personnel.
- John Brooks will serve as senior counselor of the Centers for Medicare & Medicaid Services (CMS) in addition to his role as deputy administrator and chief policy and regulatory officer of CMS.
- Grace Graham and Kyle Diamantas will assume the title of senior FDA counselor. Both will also maintain their previous roles; Graham is FDA deputy commissioner for policy, legislation, and international affairs, and Diamantas is FDA deputy commissioner for human foods.
- Mike Stuart will no longer serve as general counsel of HHS.
courts
SCOTUS strikes down tariffs. The 6 – 3 decision invalidates tariffs implemented using the International Emergency Economic Powers Act, with Chief Justice John Roberts stating in the ruling that the Trump administration exceeded its authority. The ruling blocks the administration’s reciprocal tariffs and the tariffs imposed on Canada, China, and Mexico. Since many medical supplies are imported, this will have an impact on the medical supply chain. It also decreases the likelihood of pharmaceutical tariffs being enacted in the future under the authority invalidated by SCOTUS.
QUICK HITS
- FDA finalizes changes to hormone replacement therapy labels. The changes were first announced in November 2025. FDA approved label changes to six products. Manufacturers will officially remove certain black box warnings on these treatments prescribed to address menopause symptoms. Warnings referencing risks of cardiovascular disease, breast cancer, and probable dementia will be removed, while warnings for endometrial cancer for systemic estrogen-alone products will remain.
- GAO releases report on No Surprises Act. The US Government Accountability Office (GAO) looked at network participation and payment rates before and after the law’s passage and found that the percentage of in-network claims increased and payment rates decreased among specialties likely to be affected (emergency medicine, radiology, anesthesiology, and air ambulance).
NEXT WEEK’S DIAGNOSIS
Congress will be back in session next week, likely working toward a funding agreement to reopen the US Department of Homeland Security. The House Ways and Means Health Subcommittee will hold a hearing on the healthcare workforce, and the House Budget Committee will hold a hearing on the Congressional Budget Office’s budget and economic outlook. The Senate Aging Committee will hold a hearing on bureaucracy at the FDA. The Senate HELP Committee will hold a nomination hearing for Casey Means as surgeon general and a markup with bills related to organ transplantation and healthcare cybersecurity. The president will also give his annual State of the Union address on February 24, 2026.
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