Weekly Healthcare Roundup 9/29/2025

Weekly Healthcare Roundup Week of 9/29/2025

The Senate returns to session today, and the House is currently scheduled to come back next Tuesday, October 7.

Government Funding... Some government functions will shut down if lawmakers cannot reach an agreement before current funding expires on September 30. The Senate has the option when it returns today to take up the House-passed continuing resolution (CR) that extends funding through November 21, which the chamber previously failed to pass before its most recent recess. Senate Democrats proposed an alternative to the House CR that incorporates Affordable Care Act (ACA) enhanced premium tax credits that expire at the end of the year—a major sticking point between the two parties in the ongoing negotiations process—and unwinds some health provisions in H.R. 1. Senate Majority Leader John Thune (R-SD), Senate Minority Leader Chuck Schumer (D-NY), House Speaker Mike Johnson (R-LA), and House Minority Leader Hakeem Jeffries (D-NY) are scheduled to meet with President Trump later today. Interviews with all four lawmakers suggest misalignment on ACA subsidies remains a roadblock to an agreement.

Pharmaceutical Tariffs... President Trump announced on social media last week that branded and patented drugs would face a 100% tariff beginning October 1 of this year, but the tariff carves out an exception for manufacturers who have an existing domestic plant or who have broken ground on a manufacturing plant in the U.S. Additionally, the tariff does not apply to generic drugs or drugs produced in the European Union (EU). The United Kingdom (UK) and the U.S. have not negotiated a trade agreement for pharmaceuticals, so the UK will be subject to the 100% tariff. TCG will continue to monitor the status of pharmaceutical tariffs and will provide updates as soon as information is available.

ICYMI...

·     TCG's Health Policy Spotlight on the Rural Health Transformation (RHT) Program, the rural health fund created by the One Big Beautiful Bill Act, can be found here.

·     TCG's Fall Outlook Memo can be found here.

·     TCG's Health Policy Spotlight on expiring health extenders can be found here.

·     TCG's Health Policy Spotlight on ACA enhanced premium tax credits can be found here.

·     TCG's rolling tracker of the Trump Administration's Presidential actions is available here.

Recap of Congressional News

9/22 the Government Accountability Office (GAO) released a report on health care consolidation, including physician integration with hospital systems and physician-practice ownership by private equity (PE), insurers, or others.

·     9/23 Rep. Dan Newhouse (R-WA) and several Congressional Republicans sent a letter to Centers for Medicare and Medicaid Services (CMS) Administrator Dr. Mehmet Oz urging the agency to ensure Rural Health Transformation (RHT) Program funding is “allocated specifically to rural healthcare providers, rather than diverted to urban centers,” and supports rural communities with the greatest need, regardless of a state's political affiliation.

Recap of Administration News

·     9/22 HHS, through the Substance Abuse and Mental Health Services Administration (SAMHSA), announced the allocation of more than $1.5 billion in fiscal year (FY) 2025 continuation funding awards for the State Opioid Response (SOR) and Tribal Opioid Response (TOR) grants.

·     9/22 HHS announced the mobilization of 70 Public Health Service officers to support Indian Health Service (IHS) facilities across the country.

·     9/22 President Donald Trump held a White House press conference on the root causes of autism, claiming that evidence suggests acetaminophen use during pregnancy may cause long-term neurological effects for children.

·     9/22 the National Institutes of Health (NIH) launched the Autism Data Science Initiative (ADSI), a research effort intended to explore contributors to the causes and prevalence of autism spectrum disorder.

·     9/22 the Food and Drug Administration (FDA) initiated the process for a label change for acetaminophen to reflect evidence suggesting that the use of acetaminophen by pregnant women may be associated with an increased risk of neurological conditions in children.

·     9/22 the FDA initiated the approval of leucovorin calcium tablets for patients with cerebral folate deficiency (CFD), a neurological condition that the FDA says may be linked to "autistic features," seizures, and problems with movement and coordination.

·     9/22 the FDA launched a Real-World Evidence (RWE) webpage.

·     9/23 the HHS Office of Inspector General (HHS-OIG) released a report finding that 17 of 25 selected hospitals did not comply or may not have complied with the Provider Relief Fund (PRF) balance billing requirement.

·     9/23 CMS released additional guidance on Qualified Health Plan (QHP) certification, asking affected issuers to revise their QHP applications, rate filings, and form filings.

·     9/24 the Department of Commerce posted a notice on the Federal Register announcing that a Section 232 investigation had been opened on September 2 relevant to personal protective equipment, medical consumables, and medical equipment, including devices. 

·     9/24 HHS-OIG published a report that found four of 14 HHS information and communications technology (ICT) service contractors reported a total of 10 cybersecurity incidents to HHS.

·     9/24 SAMHSA announced it awarded $98 million for the Hepatitis C Elimination Initiative Pilot.

·     9/24 the Office of Management and Budget (OMB) sent guidance to agencies directing them to prepare reductions in force (RIFs) in the event of a government shutdown after September 30.

·     9/25 OMB received a proposed rule from CMS entitled "Global Benchmark for Efficient Drug Pricing (GLOBE) Model," affiliated with an item from the Unified Agenda titled "Center for Medicare and Medicaid Innovation Payment Models."

·     9/25 HHS Secretary Robert F. Kennedy, Jr., explained in a post on X the U.S.'s reasoning for objecting to the United Nations Political Declaration on Noncommunicable Diseases.

·     9/25 the NIH announced it has awarded contracts to launch the Standardized Organoid Modeling (SOM) Center, aiming to leverage technology to create more standardized, reproducible, and accessible organoid models in order to reduce reliance on animal testing.

Relevant Legislation

·     S. 2857. A bill to require coverage of certain immunizations recommended by the Advisory Committee on Immunization Practices under the Medicare program, the Medicaid program, the Children's Health Insurance Program, group health plans, and health insurance coverage; to the Committee on Health, Education, Labor, and Pensions. Sponsored by Sen. Ron Wyden (D-OR)

·     S. 2858. A bill to improve research and data collection on stillbirths, and for other purposes; to the Committee on Health, Education, Labor, and Pensions. Sponsored by Sen. Cory Booker (D-NJ)

·     S. 2865. A bill to amend title XVIII of the Social Security Act to waive cost-sharing for advance care planning services, and for other purposes; to the Committee on Finance. Sponsored by Sen. Mark Warner (D-VA)

·     S. 2875. A bill to amend the Internal Revenue Code of 1986 to provide for the treatment of health reimbursement arrangements integrated with individual market coverage; to the Committee on Finance. Sponsored by Sen. Tim Sheehy (R-MT)

·     S. 2879. A bill to amend title XVIII of the Social Security Act to apply improved prompt payment requirements to Medicare Advantage organizations; to the Committee on Finance. Sponsored by Sen. Catherine Cortez Masto (D-NV)

·     S. 2882. A bill making continuing appropriations for the fiscal year ending September 30, 2026, and for other purposes; read the first time. Sponsored by Sen. Patty Murray (D-WA)

·     S. 2898. A bill to reauthorize the Traumatic Brain Injury program; to the Committee on Health, Education, Labor, and Pensions. Sponsored by Sen. Markwayne Mullin (R-OK)

·     S. 2903. A bill to amend the Employee Retirement Income Security Act of 1974 to require a group health plan or health insurance coverage offered in connection with such a plan to provide an exceptions process for any medication step therapy protocol, and for other purposes; to the Committee on Health, Education, Labor, and Pensions. Sponsored by Sen. Lisa Murkowski (R-AK)

·     S. 2907. A bill to prohibit health care professionals, hospitals, or clinics from participating in the chemical or surgical mutilation of a child and to provide a private right of action for children and the parents of children whose healthy body parts have been damaged by medical professionals practicing chemical and surgical mutilation; to the Committee on Health, Education, Labor, and Pensions. Sponsored by Sen. Marsha Blackburn (R-TN)

·     S.J. Res. 82. A joint resolution providing for congressional disapproval under chapter 8 of title 5, United States Code, of the rule submitted by the Office of the Secretary of the Department of Health and Human Services relating to “Policy on Adhering to the Text of the Administrative Procedure Act”; to the Committee on Health, Education, Labor, and Pensions. Sponsored by Sen. Angus King (I-ME)

·     H.R. 5448. A bill to require coverage of certain immunizations recommended by the Advisory Committee on Immunization Practices under the Medicare program, the Medicaid program, the Children's Health Insurance Program, group health plans, and health insurance coverage; to the Committee on Energy and Commerce, and in addition to the Committees on Ways and Means, and Education and Workforce, 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. Frank Pallone (D-NJ)

·     H.R. 5450. A bill making continuing appropriations for the fiscal year ending September 30, 2026, and for other purposes; to the Committee on Appropriations, and in addition to the Committees on Ways and Means, and the Budget, 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. Rosa DeLauro (D-CT)

·     H.R. 5454. A bill to amend title XVIII of the Social Security Act to apply improved prompt payment requirements to Medicare Advantage organizations; to the Committee on Ways and Means, and in addition to the Committee on Energy and Commerce, 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. Jodey Arrington (R-TX)

·     H.R. 5461. A bill to extend funding for Special Diabetes Programs for Type I diabetes; to the Committee on Energy and Commerce. Sponsored by Rep. Diana DeGette (D-CO)

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