Looking Ahead
U.S. Congress returns from the August 2025 recess this week for a short session. Both chambers will be forced to address a looming to-do list, namely potentially extending government funding beyond Sept. 30, 2025.
The current continuing resolution (CR) expires on Sept. 30, 2025, leaving approximately 28 days for a potential agreement to be reached on extending funding further, which is expected to be into December 2025. A shutdown remains the likeliest outcome. Even if Congress manages to avoid one, federal agencies are expected to operate under a series of short-term CRs. With little chance that all 12 appropriations bills will be enacted before Oct. 1, 2025, at least one CR will be necessary – the only open question is the duration of the CR.
The U.S. House of Representatives Committee on Appropriations is expected to consider additional appropriations bills throughout September 2025, including the Labor, Health and Human Services, Education and Related Agencies Bill, which is often one of – if not the most – controversial spending bills considered, given the significant number of policy riders that are offered and considered.
Following the departure of several senior leaders from the Centers for Disease Control and Prevention (CDC), U.S. Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. is expected to testify before the U.S. Senate Committee on Finance on Sept. 4, 2025, and is expected to face a bevy of questions on the decisions that led up to the termination of the CDC director. HHS Deputy Secretary Jim O'Neill has been named the acting director of the CDC. O'Neill served at HHS during the George W. Bush Administration and is the former chief executive officer (CEO) of a foundation focused on science and technology.
Notably, the HHS secretary's appearance before the panel was planned before changes to CDC leadership in late August 2025 and was intended to focus on President Donald Trump's 2026 healthcare agenda.
Hearings This Week
The House Appropriations Committee will meet on Sept. 2, 2025, to mark up the fiscal year (FY) 2026 Labor, Health and Human Services, Education and Related Agencies Bill.
The House Committee on Energy and Commerce's Subcommittee on Health will hold a hearing on Sept. 3, 2025, titled "Examining Opportunities to Advance American Health Care through the Use of Artificial Intelligence Technologies."
The Senate Special Committee on Aging will hold a hearing on Sept. 3, 2025, titled "Protecting Older Americans: Leveling the Playing Field for Older Workers."
The Senate Finance Committee will consider nominations on Sept. 4, 2025, of Gustav Chiarello III to be an assistant secretary of HHS and the Honorable Michael Stuart to be general counsel of HHS. The committee will hold another hearing that day on "The President's 2026 Health Care Agenda." Secretary Kennedy will testify.
Other key dates:
Sept. 9, 2025: Target for House Appropriations Committee Labor/HHS full markup
Sept. 11, 2025: August Consumer Price Index (CPI) Report published
Sept. 12, 2025: Medicaid Physician Fee Schedule (MPFS) calendar year (CY) 2026 Proposed Rule comments are due
Sept. 15, 2025: Outpatient Prospective Payment System (OPPS) CY 2026 Proposed Rule comments are due
Sept. 22-24, 2025: Rosh Hashanah (Congress in recess)
Sept. 29, 2025: Deadline for drugmakers to meet the Trump Administration's most-favored-nation (MFN) pricing mandate
Sept. 30, 2025: Government funding deadline
Upcoming Events
ACIP Meeting Expected to Cover Vaccines
The Advisory Committee on Immunization Practices (ACIP) is scheduled to meet Sept. 18-19, 2025. The agenda will cover vaccines for COVID-19, Hepatitis B, Respiratory Syncytial Virus (RSV) and measles, mumps, rubella and varicella (MMRV). Following recent changes in CDC leadership and updates to national vaccine policies, the Senate Committee on Health, Education, Labor and Pensions (HELP) Chair Bill Cassidy M.D. (R-La.) has called for the meeting to be postponed indefinitely.
Holland & Knight's Hospital Horizons Symposium
Holland & Knight's Hospitals and Health Systems Team will host its second annual Hospital Horizons Symposium, where participants will hear from an impressive list of speakers who will provide healthcare regulatory, legislative and policy updates that are impacting hospitals and health systems. The event will begin with a reception on Oct. 6, 2025, and will continue with a full day of programming on Oct. 7, 2025.
Administrative Updates
Executive Order Updates
The Trump Administration has continued to release wide-ranging executive orders (EO). For the latest updates, see our "Trump's 2025 Executive Orders: Updates and Summaries" tracking chart.
- On Aug. 21, 2025, the White House issued a joint statement to announce a U.S.–European Union (EU) framework agreement on reciprocal, fair and balanced trade. As part of the framework, the announcement details tariffs on generic pharmaceuticals, their ingredients and precursors. The statement also sets the stage for future tariffs on other pharmaceutical products, if and when the findings are announced on the Section 232 investigation into whether pharmaceutical products imported from foreign nations jeopardize the national security of the U.S. Effective Sept. 1, 2025, tariffs on generic pharmaceuticals, their ingredients and precursors originating from the EU will be set at the U.S. MFN tariff rate. Certain nonpharmaceutical products, including unavailable natural resources (including cork) and all aircraft and aircraft parts, will have tariffs set at the same rate. Tariffs of either the MFN tariff rate or tariff rate of 15 percent, whichever is higher, will be applied to other goods originating from the EU. The announcement also details how Section 232 tariffs will be applied to brand name pharmaceutical products, if and when announced; however, that tariff will not exceed 15 percent.
Staffing Changes
- Susan Monarez has departed the CDC following a brief tenure as director. Other senior leaders leaving include Dr. Daniel Jernigan, director of the National Center for Emerging and Zoonotic Infectious Diseases; Chief Medical Officer Dr. Deb Houry; Dr. Demetre Daskalakis, director of the National Center for Immunization and Respiratory Diseases; and Dr. Jennifer Layden, who oversaw the CDC's data and surveillance efforts. Until a replacement is named, Jim O'Neill, who currently serves as deputy secretary of the HHS, will serve as acting director of the CDC.
- Vinay Prasad has returned to the U.S. Food and Drug Administration (FDA) as director of the Center for Biologics Evaluation and Research (CBER).
Legislative Updates
White House Rescinds $5 Billion in Foreign Aid
The White House used a pocket rescission on Aug. 29, 2025, to cancel nearly $5 billion in foreign aid without congressional approval, raising questions under the Impoundment Control Act. The rescinded funds include major cuts to the U.S. Agency for International Development's (USAID) Development Assistance account and the U.S. Department of State's Democracy Fund, targeting programs the Trump Administration labeled as "woke, weaponized, and wasteful." These include initiatives focused on climate change, global peacekeeping efforts and items deemed "DEI" issues, such as efforts focused on women, LGBTQ+ people and indigenous people.
The move raised some bipartisan concern, with Senate Appropriations Committee Chair Susan Collins (R-Maine) calling the action illegal and urging the administration to return to negotiations. Democrats warn the rescission raises the risk of a government shutdown, especially with fewer than 45 days left in the FY.
Regulatory Updates
CMS Releases RHTP Updates
The Rural Health Transformation Program (RHTP) was authorized by H.R. 1, also known as the One Big Beautiful Bill Act, and aims to improve rural healthcare quality and outcomes. On Sept. 3, 2025, the Centers for Medicare & Medicaid Services (CMS) launched a RHTP website that details additional information on strategic goals, program structure, uses of funds, eligibility and application timing. Applications are to be released by mid-September 2025, with introductory webinars to be held in late September 2025. For more information, see the CMS landing page or the System for Award Management (SAM) assistance listing.
FDA Rescinds EUAs for COVID-19 Vaccines
The FDA revoked the remaining emergency use authorizations (EUAs) for COVID-19 vaccines on Aug. 27, 2025. Though individuals aged six months to 65 years who are at higher risk of severe COVID-19 can still receive immunization, the vaccines will no longer be broadly accessible to all Americans. Younger, healthy individuals without pre-existing conditions will need to consult their doctors before vaccination to determine if off-label use is medically appropriate. For those at higher risk, the FDA has granted marketing authorization for Moderna's vaccine (ages six months and older), Pfizer's vaccine (ages five and older) and Novavax's vaccine (ages 12 and older).
MedPAC and MACPAC to Hold September Meetings
The Medicare Payment Advisory Commission (MedPAC) will hold its September 2025 public meeting on Sept. 4-5, 2025, broken down into three sessions.
Sept. 4, 2025, morning session (10:15 a.m. to 12:45 p.m.)
Topics covered: Medicare payment operations and improving payment accuracy, oversight needed to ensure Medicare's sustainability and a report from the U.S. Government Accountability Office (GAO)
Sept. 4, 2025, afternoon session (2:15 to 4:15 p.m.)
Topics covered: Context for Medicare payment policy
Sept. 5, 2025, session (9 a.m. to 12 p.m.)
Topics covered: Access to hospice and certain services under the hospice benefit for beneficiaries with end-stage renal disease or cancer; the association between changes in Medicare Advantage enrollment and hospital finances
Medicaid and CHIP Payment and Access Commission (MACPAC) will hold its September 2025 meetings on Sept. 18 and 19, 2025, with topics yet to be announced.
NIH Guidance on AI in Research Applications
The National Institutes of Health (NIH) issued a new policy NOT-OD-25-132 on July 31, 2025, aimed at preserving fairness and originality in the grant application process. The guidance responds to a surge in high-volume submissions, with potentiality for some being assisted by artificial intelligence (AI) that NIH says could compromise the integrity of peer review. According to the policy, while limited AI assistance is permitted to reduce administrative burden, applications must reflect original thought. NIH will not consider applications that are substantially AI-generated. Peer reviewers are also prohibited from using AI tools in their critiques. Effective for Sept. 25, 2025, and beyond, NIH will accept no more than six new, renewal, resubmission or revision applications per principal investigator (PI) per CY. This cap excludes T activity codes and R13 Conference Grant Applications.
Crushing Fraud Chili Cook-Off Competition
CMS has announced the Crushing Fraud Chili Cook-Off Competition, a market-based research challenge focused on applying explainable AI, particularly machine learning (ML), to Medicare claims data. The initiative aims to identify anomalies and patterns that could serve as new indicators of fraud. In addition to improving detection capabilities, the challenge encourages the development of scalable technologies that reduce manual effort while maintaining meaningful human oversight and ensuring interoperability.
CDC Vaccine Panel to Convene Amid Leadership Turmoil
The CDC's ACIP is preparing for a Sept. 18-19, 2025, meeting to review several cornerstone vaccines, including those for MMRV, hepatitis B, RSV and COVID-19. Votes may be held on updates to the immunizations, which could impact coverage under the Vaccines for Children Program. The meeting comes as the CDC faces internal upheaval, with its director contesting a dismissal and broader political pressure mounting.
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