This week (May 4-8)

Both the House and Senate are scheduled to be in recess this week. During the recess, the Senate Health, Education, Labor, and Pensions Committee is scheduled to hold two field hearings in Louisiana:

Making Health Care Affordable Again Part 2: Perspectives from Employers, Patients, and Providers

• Date: Tuesday, May 5 at 9AM CDT
• More information available here.

From Crisis to Care: Mental Health and Substance Use Treatment Across the Continuum of Care.

• Date: Wednesday, May 6 at 9AM CDT
• More information available here.

Last week (April 27-May 1)

Congressional Highlights

Senate Democrats release policy framework to lower healthcare costs. On Tuesday (April 28), Senate Minority Leader Chuck Schumer (D-NY) unveiled a policy framework that outlines Democrats' vision for health care. The framework is focused on lower costs, reliable access to care in every community, and a simpler to navigate health system.

Administrative Highlights

Trump nominates new Surgeon General. On Thursday (April 30), President Trump announced he has rescinded his nomination of Casey Means to serve as U.S. Surgeon General, and instead will nominate Nicole Saphier, a radiologist and medical contributor on Fox News. President Trump made the announcement in a Truth Social post, in which he suggested Sen. Bill Cassidy (R-LA) objected to Means' nomination.

CMS defers more Minnesota Medicaid funds. On Thursday (April 30), CMS said it will defer an additional $91 million in federal Medicaid funding for Minnesota over concerns of fraud. The move comes after CMS withheld nearly $260 million earlier this year, which the state is challenging in court.

FDA proposes drug exclusions from 503B Bulks List. On Thursday (April 30), FDA proposed to exclude semaglutide, tirzepatide, and liraglutide on the 503B bulks list, which identifies bulk drug substances that outsourcing facilities may use in compounding. FDA found no clinical need for outsourcing facilities to compound those three products. FDA will accept comments until June 29.

DOE issues final rule on student loan policies. On Thursday (April 30), the Department of Education issued a final rule to implement student loan provisions of the One Big Beautiful Bill Act, including establishing annual borrowing limits of $20,500 for graduate students and $50,000 for professional students. The rule also finalizes a narrower definition of a "professional" degree that omits physician assistants/associates, nurses, physical therapists and others, subjecting them to the lower borrowing limits for graduate students.

CMS extends application deadlines for GENEROUS model. On Wednesday (April 29), CMS announced it has extended until June 11 the application deadline for drug manufacturers to apply to the GENErating cost Reductions fOr U.S. Medicaid (GENEROUS) Model. CMS said the deadline extension aims to give interested drug manufacturers, particularly those that are small to mid-sized, more time to apply to the model. CMS also extended the deadline for drug manufacturers to enter into participation agreements from June 30, 2026, to July 17, 2026. In addition, CMS said it will give states until September 10 to apply to the GENEROUS model and until September 30 to finalize their participation agreements.

DOJ to file appeal in ACIP case. On Wednesday (April 29), the Department of Justice indicated it will appeal a court ruling staying HHS Secretary Robert F. Kennedy Jr.'s appointments to the Advisory Committee on Immunization Practices and its recent policy changes.

FDA releases results on infant formula safety examination. On Wednesday (April 29), the FDA published the results of its examination of infant formula, concluding that infant formula in the U.S. is "safe." As part of the effort, the FDA tested more than 300 infant formula samples representative of products sold at retail across the U.S. for lead, mercury, cadmium, arsenic, pesticides (including glyphosate and glufosinate), per- and polyfluoroalkyl substances (PFAS), and phthalates, finding "undetectable or very low levels of contaminants" in the "overwhelming majority of samples." The FDA said it will continue to conduct testing.

FDA announces new real-time clinical trial data sharing model. On Tuesday (April 28), FDA Commissioner Martin Makary unveiled a new initiative to modernize the clinical trial process under which drug manufacturers will report data in real time, leveraging AI to streamline regulatory review. FDA said AstraZeneca and Amgen will be piloting clinical trials under the new model. The agency also released a request for information asking stakeholders to weigh in on pilot design, infrastructure and how success should be measured ahead of a broader program expected to launch later this year.

Hearings, Markups, and Other Committee Activity

House Ways and Means Committee will hold a hearing with "Health System CEOs." On Tuesday (April 28), the Committee held a hearing with health system CEOs to discuss hospital pricing and business practices and how it impacts health care affordability. During the hearing, members discussed a range of topics, with Republicans questioning hospitals' tax-exempt status and community benefits and raising concerns about policies that disfavor rural hospitals, including CMS's rural reclassification system and the wage index, and expressing support for expanding site-neutral payments. Democrats, meanwhile, focused on criticisms of H.R. 1 and the expiration of the Affordable Care Act (ACA) enhanced premium tax credits. There was bipartisan concern about prior authorization practices and general acknowledgment that addressing the health care affordability crisis will require action from all stakeholders. The hospital executives expressed a willingness to work with Congress to address health care affordability and specifically spoke in favor of proposals to reduce administrative and regulatory burdens.

House Oversight Committee held a markup of fraud-related bills. On Wednesday (April 29), the Committee held a markup during which it advanced several antifraud bills, as well as two bills focused on state-administered federal programs, such as Medicaid. The state-administered bills were:

• Timely and Accurate Benefits Act (H.R. 1755), approved unanimously, would require states to use a platform to use real-time income data to proactively identify and verify indicators of potential ineligibility or improper payments as a condition of receiving federal funding.
• Government Audit and Accountability of Federally Funded State-Administered Programs Act (H.R. 8107), approved unanimously, would instruct the Government Accountability Office (GAO) to produce a high-risk list for federally funded state-run programs to track practices and programs suspectable to fraud, waste, and abuse.

House Energy and Commerce Health Subcommittee held a hearing "Health Hearing: Healthier America: Legislative Proposals on the Regulation and Oversight of Food." On Wednesday (April 29), the Subcommittee held a hearing during which members discussed more than two dozen bills focused on nutrition and food safety. During the hearing, members expressed bipartisan support for modernizing the FDA food chemical review process and improve information sharing between states and the federal government during food safety incidents. Democrats raised concerns about FDA staffing reductions under the Trump Administration, while Republicans spoke in favor of the Make America Healthy Again movement and called for a single national food labeling and safety standard.

House Appropriations Committee held a markup of "FY 2027 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Bill." On Wednesday (April 29), the Committee held a markup during which it advanced a bill in a 35 to 25 vote that increases FDA funding by about $200 million. The committee adopted amendments that would bar FDA from considering clinical trial data conducted at a site located in a foreign adversary nation, as well as amendments mandating reports on domestic infant formula supply and harmful food dyes and encourages food nutrition and safety in daycares. During the hearing, some Democrats raised concerns that the bill does not protect FDA's role in vaccine approvals and raised concerns about HHS Secretary Robert F. Kennedy Jr.'s leadership.

Reports, Studies, and Journals

• HHS Office of Inspector General: Most Nursing Homes Throughout the United States Do Not Have Adequate or Reliable Emergency Power Systems. The report found 72 of the 100 sampled nursing homes had emergency power system deficiencies, stemming from inadequate nursing home resources and frequent management and staff turnover. OIG recommended CMS share the results with nursing homes and emphasize the importance of having adequate and reliable emergency power systems.
• HHS Office of Inspector General: CMS Could Strengthen Medicare Program Safeguards To Prevent and Detect Potentially Improper Payments for Virtual Check-in and E-visit Services. The report found Medicare made potentially unallowable payments to providers for virtual check-ins and e-visit services because CMS and Medicare Administrative Contractors did not have system edits in place to detect certain payments at risk for noncompliance and CMS failed to educate providers on proper billing requirements for virtual check-in and e-visit services.