This week (September 22-26)

The House and Senate are scheduled to be out of session this week. With Congress scheduled to be out of session this week, This Week in Health Policy won't be published.

Last week (September 15-19)

Congressional Highlights

House passes GOP continuing resolution; Senate prospects unclear. On September 19, the House voted 217-212, mostly along party lines, to pass a continuing resolution (CR) (H.R. 5371) that extends government funding through November 21. The bill largely funds the government at current levels, with certain exceptions. It also includes several health extenders, including Medicare telehealth flexibilities. The bill additionally includes a reauthorization of the Over-the-Counter Drug Monograph user fee agreements.

The bill now goes to the Senate, where Democrats are asking for over $1 trillion for Medicaid changes and extending ACA enhanced subsidies in a funding bill that would run through Oct. 31 — items that are non-starters for Republicans. As such, passage in the Senate remains unclear. The House has adjourned until after the September 30 deadline deadline, which increases the risk of a government shutdown if the Senate is unable to gain enough Democratic support to pass the bill.

House passes veteran telemedicine bill. Last week, the House passed by voice vote the Protecting Veteran Access to Telemedicine Services Act of 2025 (H.R. 1107). The bill would extend the current exemption that allows Veterans Affairs health professionals to prescribe medically necessary controlled substances to veterans under certain conditions.

Democrats seek oversight of RHT Fund. On September 15, Senate Finance Committee Ranking Member Ron Wyden (D-OR) and Subcommittee on Fiscal Responsibility and Economic Growth Ranking Member Tina Smith asked the Government Accountability Office (GAO) to investigate the Rural Health Transformation (THT) Fund, citing concerns over limited oversight, broad disbursal authority granted to the Trump administration, and potential misuse of taxpayer funds.

Administrative Highlights

State Department published global health strategy. On Thursday (September 18), the U.S. State Department published its "America First Global Health Strategy." The policy outlines the U.S. new approach to global infectious disease outbreaks, including new outcomes and benchmarks for continued U.S. funding and new bilateral agreements with foreign governments that receive U.S. global health funding. The move would allow the U.S. government to work directly with foreign countries, as opposed to non-profits or contractors, which are typically used today.

CMS finalizes changes to MA provider directories. On Thursday (September 18), CMS finalized changes to provider directories included in the Medicare Plan Finder tool. Under the final rule, Medicare Advantage (MA) plans will have to submit their provider network lists by January 1, 2026, and then once a year, plus updates every 30 days to reflect changes in provider participation. Insurers will not have to attest that they meet network adequacy standards, as initially proposed, due to an assumption that they must do so under existing requirements.

HHS launches Long COVID Consortium. On Thursday (September 18), HHS Secretary Robert F. Kennedy announced plans to launch a Long COVID Consortium, including a public education campaign to raise awareness of long COVID symptoms and resources, a new open-source medical platform for physicians and researchers to share best practices, and the release of a new Agency for Healthcare Research and Quality report on health insurance coverage among adults with long COVID.

HHS decertifies Florida-based OPO. On Thursday (September 18), HHS announced plans to decertify an organ procurement organization (OPO) based in Florida after an investigation unveiled quality and safety issues. The effort is part of the Trump Administration's effort to reform the organ procurement system.

FDA publishes FY 2026 priority review voucher rate. On Wednesday (September 17), the FDA published the FY 2026 fee rate for using a priority review voucher for drug or biological products for use of tropical disease, rare pediatric disease, and material threat MCM. The rate of $1,962,472 is effective October 1, 2025.

CMS launches rural health transformation fund. On September 15, CMS published a Notice of Funding Opportunity (NOFO) on grants.gov for the Rural Health Transformation Fund, authorized by the One Big Beautiful Bill Act (OBBBA). Beginning in 2026 and continuing through 2030, CMS will distribute $10 billion to awarded states annually. State applications for the program are due November 5, and awards will be announced by December 31, 2025. The NOFO details permitted uses of funds, including chronic disease prevention and management, provider payments, and more, along with details regarding separate reimbursements pegged to rural health metrics and certain state policy efforts to enhance access and scope of practice.

FDA publishes DTC ad warning letters. On Tuesday (September 16), the FDA published dozens of compliance letters and warning notices sent to drug manufacturers and telehealth companies regarding direct to consumer (DTC) advertisements. The vast majority of the letters targeted GLP-1 advertisements or compounded semaglutide products. Violations cited included misleading portrayals of drug benefits, poor readability of safety information, and distracting visuals and audio. Companies have 15 working days to respond, with potential escalations including injunctions or other sanctions if the issues are not addressed.

Legal Highlights

Appeals court rejects bid to revive portion of ACA integrity rule. On Thursday (September 18), a three-judge panel of the Fourth Circuit Court of Appeals denied the Trump administration's motion to revive a piece of CMS' 2026 program integrity final rule that was placed on hold in an August court ruling. The provision gave plans more flexibility in how they meet the actuarial value requirements for the ACA's metal-tiered plans, allowing them to deviate by up to 2 percentage points above or 4 percentage points below the actuarial values. In light of the ruling, CMS said exchange plans would need to refile their plan designs and rates using the previous guidance by September 19. CMS on Wednesday (September 17) postponed several submission deadlines and allowed insurers who wish to withdraw their proposals to do so by Sept. 25.

Hearings, Markups, and Other Committee Activity

House Ways and Means Oversight Subcommittee held a hearing on "Virtue Signaling vs. Vital Services: Where Tax-Exempt Hospitals are Spending Your Tax Dollars." On Tuesday (September 16), the Subcommittee held a hearing during which members heard from a panel representing health care providers, economists, academics, and market researchers. During the hearing, most witnesses and Republicans spoke critically of the amount of community benefits non-profit hospitals provide and the types of services considered community benefits, raising specific concerns about diversity, equity, and inclusion (DEI) initiatives, gender-affirming care in children, and brand recognition activities. Democrats and the Democratic witness generally spoke critically of the projected impact of the One Big Beautiful Bill Act (OBBA) on providers and patients, as well as the need to extend the Affordable Care Act's (ACA) enhanced subsidies. Policy solutions discussed during the hearing included reforming Schedule H (Form 990), clarifying the definition of a community benefit, increasing competition in health care, and more.

• More information available here.

Senate HELP Committee held 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." On Wednesday (September 17), the Committee held a hearing during which members heard testimony from Susan Monarez, former Director of the CDC who was recently fired following disagreements with Department of Health and Human Services (HHS) Secretary Kennedy, and Debra Houry, former Chief Medical Officer at the CDC, who resigned following Dr. Monarez's firing. Chairman Cassidy has invited Secretary Kennedy, who disputes the assertions of Monarez and Houry, to come before the committee at a future date, stating, "This is how we fulfill the President's mandate - giving Americans the full picture so they can judge for themselves."

• More information available here.

House Ways and Means Committee held a mark up of health and tax legislation. On Wednesday (September 17), the Committee voted to advance several pieces of legislation, including four health care bills:

• H.R. 842, the Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act, which would allow Medicare to cover multi-cancer early detection screening tests, passed unanimously.
• H.R. 4313, "Hospital Inpatient Services Modernization Act," passed unanimously.
• H.R. 5347, "Health Care Efficiency Through Flexibility Act," passed unanimously.
• H.R. 5343, the "Ensuring Patient Access to Critical Breakthrough Products Act," passed in a 38-3 vote.
• More information available here.

House Energy and Commerce Subcommittee on Health held a hearing on "Legislation Expanding Seniors' Access to Innovative Medical Care." On Thursday (September 18), the Subcommittee held a hearing to discuss legislation to increase Medicare beneficiaries' access to breakthrough medical devices. During the hearing, lawmakers and witnesses discussed legislation related to early detection cancer screening, diabetes management tools, and more.

• More information available here.

House Energy and Commerce held a markup of public health reauthorization bills. On Wednesday (September 17), the Committee unanimously advanced six health bills:

• 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. 1262, Give Kids a Chance Act of 2025
• H.R. 1843, To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications
• More information available here.

Reports, Studies, and Journals

• HHS Office of Inspector General: The Patient Safety Organization Program: Key Barriers Impeding Nationwide Progress Toward Reducing Patient Harm in Hospitals. The report detailed four recommendations to improve the Patient Safety Organization program to better improve patient safety, including increase alignment of the PSO program with other HHS patient safety efforts and promote involvement of patients and families.
• Congressional Budget Office: The Estimated Effects of Enacting Selected Health Coverage Policies on the Federal Budget and on the Number of People With Health Insurance. In a letter to Senate Democrat Committee leaders, the CBO estimated permanently expanding the ACA's enhanced premium tax credits prior to fiscal year 2026 would increase the insured population by 3.8 million people over the next decade and grow the federal deficit by $350 billion.
• Government Accountability Office: Medicaid Demonstrations: Action Needed to Address New Cost Concerns. The report, which was requested by Republican members of Congress, calls for CMS to fully implement GAO's past recommendations to use valid methods for budget neutrality in the Section 1115 Medicaid demonstrations.