IHPP - Weekly, September 15, 2025

Summary

House Republicans are planning to vote this week on a short-term CR to extend government funding through November 20^th, with CR text expected to be released as early as this morning. However, Democrat leaders, including Senate Minority Leader Chuck Schumer (D-NY) and House Minority Leader Hakeem Jefferies (D-NY), have indicated that they will note vote for a CR unless Republicans agree to negotiate on health care issues, which could potentially include addressing the impact of H.R. 1 and the expiring enhanced premium tax credits. This hardline is likely to increase the potential for a government shutdown as the CR text is expected to be free of any policy riders at this point. If House Republicans are able to push through their CR this week, pressure is on the Senate Democrats on whether to force the shutdown or accept the CR as they did earlier this year.

CDC ACIP Meeting

This week, the Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Prices (ACIP) will meet to discuss COVID-19 vaccines, the Hepatitis B vaccine, the MMRV vaccine. The agenda of the meeting was updated this morning to remove RSV vaccine from the docket. This is the first meeting since Secretary Kennedy replaced all 17 ACIP members with 7 vaccine skeptics and fired CDC Director Dr. Susan Monarez for refusing to “rubber-stamp” HHS Secretary Kennedy’s vaccine directives. Dr. Monarez is also slated to testify before the Sente HELP Committee on Wednesday. For additional information on vaccine policy, Impact Health recently released an Insights for Impact on vaccines under RFK Jr.

Regulatory Update

The Trump Administration recently released the Spring 2025 Unified Agenda. The Impact Health team is working on a summary memo that we will share this week.

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

• Drug and Biological Product Labels. 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titled, “Safety Labeling Changes–Implementation of Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry; Availability.”

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
  • CY 2027 Medicare Advantage/Part D Policy. Proposed CY 2027 policy and technical changes to Medicare Advantage, Medicare Prescription Drug Benefit, Medicare Cost Plan, and PACE
  • Procurement of Domestic PPE. An advance notice of proposed rulemaking that would detail program incentives and requirements for Medicare providers and suppliers to invest and phase-in the procurement of American made personal protective equipment (PPE) and essential medicine to secure our nation’s health and safety.

• 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 proposed rule titled, “Improving Transparency into Pharmacy Benefit Manager Fee Disclosure.”

• FDA Guidance:
  • Medical Devices. An FDA noticed titled, “Use of Real-World Evidence To Support Regulatory Decision-Making for Medical Devices; Guidance for Industry and Food and Drug Administration Staff; Availability.”
  • Laboratory Developed Tests. A final rule that will rescind the amendment to the Food and Drug Administration’s regulations at 21 CFR 809.3(a) that added the words “including when the manufacturer of these products is a laboratory”, reverting to the prior text of the regulation.
  • 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 Programs