15 September 2025

This Week in Health Policy for September 15

This Week (September 15-19)

The House and Senate will be in session next week as leadership continues discussions around ways to address the September 30 government funding deadline. The Ways and Means Committee also is expected to hold a markup of health care legislation, which had not been noticed at the time of publication.

House Ways and Means Oversight Subcommittee will hold a hearing on "Virtue Signaling vs. Vital Services: Where Tax-Exempt Hospitals are Spending Your Tax Dollars."

  • Date: Tuesday, September 16 at 2pm ET
  • More information available here.

Senate HELP Committee will hold a hearing on "Restoring Trust Through Radical Transparency: Reviewing Recent Events at the Centers for Disease Control and Prevention and Implications for Children's Health."

  • Date: Wednesday, September 17 at 10am ET
  • Witnesses: Susan Monarez, former CDC Director and Debra Houry, former chief medical officer, CDC
  • More information available here.

House Energy and Commerce Committee will hold a hearing on "Legislation Expanding Seniors' Access to Innovative Medical Care."

  • Date: Thursday, September 18 at 9:30am ET
  • More information available here.

Last Week (September 8-12)

Congressional Highlights

Government funding, appropriations discussions continue. This week, lawmakers continued discussion on how they may act to extend government funding that expires after September 30. The House Appropriations Committee continued work on FY 2026 appropriations, advancing the FY 2026 Labor-HHS funding bill (more details below), while the Senate Appropriations Committee delayed its scheduled appropriations markup. The House also voted this week to begin conference with the Senate on three FY 2026 appropriations bills, including the Food and Drug Administration (FDA).

With less than two working weeks remaining for the House and Senate to reach an agreement on all 12 appropriations bills, the bigger question has been whether a continuing resolution (CR) would last into later in 2025 or carry over into 2026. The White House also sent over its list of funding anomalies, which outlines programs the Administration would like to change funding levels for as part of a CR. Government funding bills need at least some Democratic support because they require 60 votes in the Senate, and some Democrats want any bill to extend government funding beyond September 30 to also include an extension of enhanced Affordable Care Act (ACA) premium tax credits expiring at the end of 2025. Senate Republican leaders maintain that any CR must be clean, or devoid of any policy add-ons. There are differences of opinion among Republicans over whether to extend the enhanced credits, allow them to expire, or modify them to reduce the cost.

House passes NDAA without Biosecure Act. On Wednesday (September 10), the House voted 231-196 to pass its version of the fiscal year 2026 National Defense Authorization Act (NDAA). The House-passed version did not include the updated Biosecure Act, which removes the named entities and instead relies on the U.S. Department of Defense's annual 1260H List to designate who qualifies as a "biotechnology company of concern." The Senate is expected to vote on amendments to its version of the NDAA, which includes the Biosecure Act, as soon as next week.

Ways and Means Republicans request action on NSA. On Monday (September 8), House Ways and Means Committee Republicans sent a letter to HHS Secretary Kennedy, Treasury Secretary Bessent, and Labor Secretary Chavez-DeRemer, voicing their support for the No Surprises Act (NSA) and requesting the Administration implement delayed provisions, including advanced explanations of benefits, and revise rulemaking issued by the Biden Administration to improve the Independent Dispute Resolution (IDR) process.

HSGAC Democrats publish report on science actions. On Tuesday (September 9), Democrats on the Senate Committee on Homeland Security & Governmental Affairs published a report called "Trump Administration Attacks on Scientific Integrity, highlighting 57 actions the Trump Administration has taken related to vaccines and science since assuming office.

House Energy and Commerce Democrats seek information on CDC leadership firing. On Thursday (September 11), House Energy and Commerce Committee Democratic leaders sent a letter to HHS Secretary Kennedy requesting information about the recent firing of Centers for Disease Control and Prevention (CDC) Director Susan Monarez. The members asked for responses by September 25, 2025.

Administrative Highlights

White House releases latest MAHA report. On Tuesday (September 9), the White House unveiled the Make Our Children Healthy Again strategy report, outlining more than 120 initiatives, including policy reforms, deregulatory actions, and structural changes. The initiatives fall under four broad categories that aim to improve nutrition and diet, reduce environmental chemical exposure, increase physical activity and address mental health, and reduce overmedicalization.

Trump administration takes actions on DTC drug ads. On Tuesday (September 9), President Trump signed a presidential memo that directs the FDA to ensure transparency and accuracy in direct-to-consumer (DTC) prescription drug advertising, including increasing information on drug risks and increasing enforcement activities for compliance with the Federal Food, Drug, and Cosmetic Act's prescription drug advertising provisions. In response, the FDA sent "thousands of letters" to pharmaceutical companies warning them to review drug advertisements for misleading information. The agency also sent 100 cease-and-desist letters to companies over misleading ads.

CMS issues guidance on state-directed payments. On Tuesday (September 9), the Centers for Medicare and Medicaid Services (CMS) issued preliminary guidance to states outlining timelines and limits for state-directed payment changes under the One Big Beautiful Bill Act (OBBA). CMS in the guidance said it is working on rulemaking to implement the law. CMS on Wednesday (September 10) also sent states guidance on state-directed payment quality evaluations.

FTC urges health care companies to re-examine noncompete language. On Wednesday (September 10), the Federal Trade Commission (FTC) announced that FTC Chair Andrew Ferguson sent letters to "several" large health care employers and staffing firms, urging them to review their employment agreements for noncompete terms and other restrictions. The announcement comes after the FTC last week voted to withdraw its defense of a 2024 rule banning noncompete agreements in employment contracts.

FDA issues draft guidance on non-opioid treatments for chronic pain. On Wednesday (September 10), the FDA issued draft guidance outlining drug development approaches for non-opioid treatments for chronic pain. The guidance aims to reduce opioid use by increasing access to non-opioid options. Comments are due November 10, 2025.

CMS delays enforcement of MA supplemental benefits notification requirements. On Monday (September 8), CMS issued a notice stating that it is delaying enforcement of a requirement set to take effect in 2026 that requires Medicare Advantage (MA) plans to send annual notifications about unused supplemental benefits.

Legal Highlights

SCOTUS to hear IEEPA case. On Tuesday (September 9), the Supreme Court agreed to hear arguments in the IEEPA tariff cases on an expedited basis. In its brief ruling, the Court agreed to hear the Trump administration's appeal of a lower court's ruling, which found the President did not have the broad authority to issue sweeping tariffs on US imports. In addition, the Court agreed to take up a second case, Learning Resources, Inc., et al. v. Trump, that is on appeal to the D.C. Circuit Court of Appeals before judgment is issued in that case. The cases will be consolidated, and determine whether the President has the authority to issue tariffs on the majority of US trading partners under IEEPA. The Court agreed to an expedited briefing and hearing schedule. The timeline provides for briefing from the Parties throughout September and October, with oral arguments scheduled for the first week of November.

Trump signs EO updating reciprocal tariffs. Late Friday (September 5), President Trump signed Executive Order (EO) 14346, "Modifying the Scope of Reciprocal Tariffs and Establishing Procedures for Implementing Trade And Security Agreements." Among other things, the EO adds new products, including certain critical minerals and pharmaceutical products, to Annex II of the Liberation Day EO, which means those items are not subject to reciprocal tariffs but may be subject to existing or forthcoming Section 232 tariffs.

Hearings, Markups, and Other Committee Activity

House Energy and Commerce Health Subcommittee held a "Public Health Reauthorization Markup." On Wednesday (September 10), the Subcommittee advanced all seven bills by voice vote. During the hearing, Ranking Member Diana DeGette (D-CO) urged Chairman Morgan Griffith (R-VA) to advance bipartisan bills to prevent maternal deaths and increase funding for the Special Diabetes Programs, which were left out of a package in December 2024. Rep. DeGette also called on the Chairman to schedule a hearing with HHS Secretary Robert F. Kennedy Jr. and former CDC director Susan Monarez. The bills advanced by voice vote are:

  • H.R. 4262, To reauthorize programs related to health professions education, and for other purposes.
  • H.R. 3593, Title VIII Nursing Workforce Reauthorization Act of 2025
  • H.R. 2493, Improving Care in Rural America Reauthorization Act of 2025
  • H.R. 3419, To amend the Public Health Service Act to reauthorize the telehealth network and telehealth resource centers grant programs
  • H.R. 3302, Healthy Start Reauthorization Act of 2025
  • H.R. 2846, To amend title II of the Public Health Service Act to include as an additional right or privilege of commissioned officers of the Public Health Service (and their beneficiaries) certain leave provided under title 10, United States Code to commissioned officers of the Army (or their beneficiaries).
  • H.R. 4709, Newborn Screening Saves Lives Reauthorization Act of 2025.
  • More information available here.

Senate Homeland Security & Governmental Affairs Permanent Subcommittee on Investigations held a hearing on "How the Corruption of Science Has Impacted Public Perception and Policies Regarding Vaccines." On Tuesday (September 9), the Subcommittee heard testimony from legal experts, academics, and medical experts on vaccine policy. During the hearing, witnesses discussed their experience representing patients in vaccine injury lawsuits and first-hand experiences with childhood autism diagnoses. Republicans and witnesses questioned the efficacy of existing scientific data on vaccine safety, while Democrats and the Democratic witness spoke favorably of current vaccine safety standards and science.

  • More information available here.

House Appropriations Committee marked up the FY 2026 funding bill for HHS. On Tuesday (September 9), The House Appropriations Committee voted 35-28, along party lines, to advance its FY 2026 Labor-HHS funding bill. The House bill would provide HHS with $108 billion, which is below the Senate's $117 billion, but above the $96 billion requested by the White House. During the markup, the Committee adopted eight amendments by voice vote, including one that blocks federal funding for the Center for Medicare and Medicaid Innovation's Wasteful and Inappropriate Service Reduction (WISeR) Model.

  • More information available here.

House Committee on Oversight and Government Reform Subcommittees on Healthcare and Financial Services held a hearing on "Better Meals, Fewer Pills: Making Our Children Healthy Again." On Tuesday (September 9), The Subcommittees held a joint hearing on childhood chronic diseases during which members heard testimony from representatives of HHS and the U.S. Department of Agriculture. During the hearing, there was bipartisan support for improving the health and wellness of children. Republicans largely focused on improving nutrition, increasing physical activity, and reforms to federal food assistance programs that limit ultra-processed foods, while Democrats focused on the need to protect and expand access to Medicaid, the Supplemental Nutrition Assistance Program, and school meal programs. Democrats also spoke critically of HHS leadership and changes to vaccine policy.

  • More information available here.

Reports, Studies, and Journals

  • Congressional Budget Office: Growth in the 340B Drug Pricing Program. CBO estimates that 340B drug spending grew by an average of 19% annually from 2010 to 2021, with most of the growth attributed to market wide growth in drug spending and drug classes that account for more spending in the 340B program than in the overall market.
  • Government Accountability Office: Medicare: National Coverage Determinations Are Generally Timely, but Improvements Are Needed. GAO found that CMS met deadlines to complete national coverage determinations within the required nine or 12 months for 83% of reviewed NCDs, but those that missed those deadlines took six to 365 additional days to complete.
  • Congressional Budget Office: CBO's Current View of the Economy From 2025 to 2028. CBO released updated economic projections factoring in the OBBA, tariffs, and immigration changes, noting a slight uptick in GDP growth (0.1%) compared with CBO's January 2025 estimate.
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Contact Information

For additional information concerning this Alert, please contact:

Washington Council Ernst & Young

Document ID: 2025-1855