IHPP - Weekly, September 2, 2025

Summary

Congress is back in session and has until September 30 to address fiscal year 2026 appropriations and the expiring package of health care extenders. The House Appropriations Committee will mark up the Department of Health and Human Services (HHS) bill today, which includes a 6 percent budget cut ($7 billion decrease) for the Department, well below the President’s requested budget decrease of $31.3 billion. At the end of July, the Senate Appropriations Committee advanced its version of the HHS funding bill, which included level funding for the department.

The largest question that remains will be whether Congress can avert a shutdown. Last week, Democrat leaders, Sen. Schumer (D-NY) and Rep. Jeffries (D-NY) sent a letter to Republican leadership calling on the party to resolve government funding in a bipartisan way, while “addressing the healthcare crisis Republicans have trigged in America.” However, with only 14 legislative days to come to bipartisan agreement, the potential for a shutdown is growing. If an agreement is reached, lawmakers remain split on how long the Continuing Resolution (CR) will be. Some Republicans are in favor of pursuing a short-term CR, including Senate Appropriations Chair Susan Collins (R-ME), to allow time to put together a larger funding package at the end of the year, while other Republicans would prefer full-year CR at current funding levels.

RFK Jr. to Testify Before Senate Finance; Vaccine Policy Likely to be Highlighted

HHS Secretary Robert Kennedy Jr. is scheduled to testify before the Senate Finance Committee on Thursday to speak to the President’s health care agenda. This comes amid the firing of Center for Disease Control and Prevention (CDC) Director Susan Monarez and the resignation of other key personnel. The Secretary is likely to face scrutiny for his handling of the situation, as well as his stance on vaccine policy, particularly as his hand-appointed Advisory Committee on Immunization Practices (ACIP) is scheduled to meet later this month to discuss COVID-19 vaccines recommendations. The Administration’s Make American Health Again agenda is also likely to be heavily featured throughout the hearing.

Regulatory Update

The Office of Management and Budget (OMB) completed reviewing the following:

• Prescription Drugs: Non-Opioid Analgesics. An FDA notice titled, “Development of Non-Opioid Analgesics for Chronic Pain, Draft Guidance for Industry; Availability.”

OMB is also reviewing the following:

• Medicare:
  • CY 2026 Medicare Advantage/Part D Policy. Final CY 2026 policy and technical changes to the Medicare Advantage, Medicare Prescription Drug Benefit, and Medicare Cost Plan Programs, and PACE

• Medicaid:
  • Gender-Affirming Care.
    • A proposed rule titled, “Medicaid Program; Prohibition on Federal Medicaid Funding for Sex Trait Modification Procedures Furnished to Children and Youth.”
    • A proposed rule titled, “Medicare and Medicaid Programs; Hospital Condition of Participation: Limiting Participation Based on the Performance of Sex Trait Modification Procedures on Children.”

Immigration Status. A final rule titled, “Medicaid Eligibility Changes Under the Affordable Care Act of 2010; Giving States Freedom to Use Immigration Information to Determine State Residency for Medicaid Eligibility.” The final rule is part of the Trump administration’s efforts to increase federal oversight on states using Federal Medicaid funding for the health care of undocumented immigrants.

• State Directed Payments. A proposed rule titled, “Medicaid Managed Care-State Directed Payments.” The proposed rule appears intended to advance a presidential memorandum released on June 6, which directs HHS to “eliminate waste, fraud, and abuse in Medicaid, including by ensuring Medicaid payments rates are not higher than Medicare, to the extent permitted by applicable law.”
• Prescription Drugs:
  • A notice from the Food and Drug Administration titled, “Safety Labeling Changes–Implementation of Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry; Availability.”
  • Investigational Drugs. An FDA notice titled, “Expanded Access to Investigational Drugs for Treatment Use: Questions and Answers; Guidance for Industry; Availability.”

• Nutrition:
  • Head Start. A notice from the Administration for Children and Families titled, “Publish Request for Information: Nutrition Services in Head Start Program.