Healthcare Roundup - October 20, 2025

AGENDA FOR THE WEEK

The Senate is in session this week, and the House remains in recess.

 Government Shutdown... Entering the third week of the government shutdown, there remains little progress toward an agreement on funding. The Senate again failed to move forward on the House-passed continuing resolution (CR) last week, and Senate Majority Leader John Thune (R-SD) reiterated that he will not negotiate with Democrats on Affordable Care Act (ACA) subsidies—their primary priority for inclusion in a CR—until the shutdown ends. The Senate is scheduled to vote on the House-passed CR this afternoon for the 11th time.

 Drug Pricing... Last week, President Trump announced a third Most-Favored-Nation (MFN) drug pricing deal, this one with EMD Serono, focused on fertility drugs. EMD Serono has agreed to provide MFN prices under Medicaid; offer its fertility drug, GOLAN-F, on TrumpRx at a discount, and an even steeper discount for women whose income falls below 550 percent of the Federal Poverty Line (FPL); introduce all new medicines at MFN prices; and repatriate increased foreign revenue on existing products. The company will also receive the Food and Drug Administration's (FDA) new Commissioner's National Priority Voucher (CNPV) for its fertility drug, Pergoveris. In addition to this deal, the Trump Administration announced new guidance for employers to offer supplemental fertility benefit plans.

TCG Health Policy Spotlights...

·    Our Spotlight on the Trump Administration's MFN agreements with Pfizer and AstraZeneca can be found here.

·    Our Spotlight on six key takeaways from the final guidance for the third cycle of Medicare Drug Price Negotiation can be found here.

·    Our Spotlight on the Section 232 investigation and potential tariffs on pharmaceuticals and on how reciprocal trade agreements apply to the pharmaceutical industry can be found here.

·    Our Spotlight on ACA enhanced premium tax credits can be found here.

UPCOMING HEALTHCARE HEARINGS

·    10/22 at 3:30 PM the Senate Special Committee on Aging holds a hearing titled "Modernizing Health Care: How Shoppable Services Improve Outcomes and Lower Costs."

·    10/23 at 10:00 AM the Senate Health, Education, Labor, and Pensions (HELP) Committee holds a hearing titled "The 340B Program: Examining Its Growth and Impact on Patients."

RECAP OF CONGRESSIONAL NEWS

·    10/16 Senate HELP Committee Chairman Bill Cassidy (R-LA) and 16 Republican Senators sent a letter to FDA Commissioner Marty Makary about the recent approval of a generic form of mifepristone.

RECAP OF ADMINISTRATION NEWS

·    10/14 some Centers for Disease Control and Prevention (CDC) employees who were released due to RIFs related to the government shutdown are receiving notification that they are no longer being terminated.

·    10/15 in a series of posts on X, FDA Commissioner Marty Makary highlighted clips from a NewsNation appearance where he discussed the Administration's direct-to-consumer (DTC) pharmaceutical platform, TrumpRx.

·    10/15 the Centers for Medicare and Medicaid Services (CMS) told Medicare Administrative Contractors (MACs) to continue to hold claims for dates of service on or after October 1 that are impacted by Medicare payment policies that expired September 30.

·    10/15 the Department of Health and Human Services Office of Inspector General (HHS-OIG) released a report finding that Indiana has not fully complied with federal waiver and state health, safety, and administrative requirements at thirty residential settings.

·    10/16 the FDA announced nine drugs have been selected to receive the Commissioner's National Priority Voucher (CNPV). 

·    10/16 the Trump Administration announced a new MFN agreement with EMD Serono focused on drugs for fertility treatments. TCG's memo on the announcement can be found here.

·    10/16 the Trump Administration announced new guidance to give employers to ability to offer fertility supplemental benefit plans to employees, effective immediately. 

RELEVANT LEGISLATION

·    S. 2997. A bill to protect the independent judgment of health care professionals acting in the scope of their practice in overriding AI/CDSS outputs, and for other purposes; to the Committee on Health, Education, Labor, and Pensions. Sponsored by Sen. Ed Markey (D-MA)

·    S. 3006. A bill to amend the SUPPORT for Patients and Communities Act to reauthorize the youth prevention and recovery initiative, and for other purposes; to the Committee on Health, Education, Labor, and Pensions. Sponsored by Sen. Gary Peter (D-MI)

·    S. 3011. A bill to amend the Patient Protection and Affordable Care Act to exclude coverage of gender-transition procedures for minors and abortion under health plans offered through the American Health Benefits Exchanges, and for other purposes; to the Committee on Health, Education, Labor, and Pensions. Sponsored by Sen. Josh Hawley (R-MO)

·    H.R. 5733. A bill to authorize the Secretary of Health and Human Services, acting through the Assistant Secretary for Mental Health and Substance Use, to award grants to train community mental wellness workers, and for other purposes; to the Committee on Energy and Commerce. Sponsored by Rep. Adriano Espaillat (D-NY)

·    H.R. 5736. A bill to amend title XVIII of the Social Security Act to include penicillin allergy verification and evaluation as part of the initial preventive physical examination under the Medicare program; to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned. Sponsored by Rep. Morgan Griffith (R-VA)

·    H.R. 5737. A bill to amend title XVIII of the Social Security Act to modify data collection requirements for appropriate use criteria for applicable imaging services, and for other purposes; to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned. Sponsored by Rep. Diana Harshbarger (R-TN)

·    H.R. 5747. A bill to require the Secretary of Health and Human Services, acting through the Assistant Secretary for Preparedness and Response, to carry out a program under which the Secretary requires each covered distributor of a highly pathogenic agent to comply with certain logbook requirements, and for other purposes; to the Committee on Energy and Commerce. Sponsored by Rep. Jim Costa (D-CA) 

·    H. Res. 803. A resolution urging the Director of the Food and Drug Administration to reevaluate the safety of all chemical abortion drugs in light of recent independent studies, and for other purposes; to the Committee on Energy and Commerce. Sponsored by Rep. John Rose (R-TN)

·    H. Res. 805. A resolution recognizing October 2025 as “American Pharmacists Month” in honor of the contribution of pharmacists to provide safe, accessible, affordable, and beneficial patient care services and products to all residents and protect the public health of our communities; to the Committee on Energy and Commerce. Sponsored by Rep. Buddy Carter (R-GA)

·    H. Res. 806. A resolution supporting the recognition of October 2025 as “National Breast Cancer Awareness Month”; to the Committee on Oversight and Government Reform. Sponsored by Rep. Buddy Carter (R-GA)