Holland & Knight Health Dose: September 29, 2026

Looking Ahead

The U.S. Senate returns to Washington, D.C., this week for its final scheduled legislative work period before departing for the campaign-season recess. The Senate will begin the week by completing consideration of legislation governing college athletics, with limited healthcare-specific legislative activity scheduled. The Senate Committee on Health, Education, Labor, and Pensions (HELP) is scheduled to meet on September 30, 2026, to vote on several Trump Administration nominees, including the nomination of Heidi Overton to serve as commissioner of the U.S. Food and Drug Administration (FDA), following her September 24, 2026, confirmation hearing. The nomination of Chris Klomp to serve as deputy secretary of the U.S. Department of Health and Human Services (HHS) may also be scheduled.

The Senate may also focus this week on an announcement made by the White House on September 25, 2026, that the president would rescind almost $810 billion in funding, much of it from the HHS, specifically programs serving undocumented immigrants, as well as programs operated by the HHS Office of Minority Health. The pocket recessions may have implications for considerations of fiscal year (FY) 2027 bills and paths forward on extending government funding beyond the current continuing resolution (CR), which expires December 11, 2026. Senate Committee on Appropriations Chair Susan Collins (R-Maine) issued a statement critical of the recissions, calling the rescission a violation of the law.

The U.S. House of Representatives remains out of session until after the November 2026 midterm elections.

Upcoming Events

Congress

September 30, 2026

• Senate HELP Committee – An executive session to consider several pending nominations, including the nomination of Heidi Overton to serve as commissioner of the FDA

Federal Agencies

October 1, 2026

• FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) – A discussion on the strain selection for influenza vaccines for the 2027 Southern Hemisphere influenza season and recommendations to the agency

October 8, 2026

• Health Information Technology Advisory Committee (HITAC) – Meeting on federal health information technology and interoperability priorities

Administrative Updates

Holland & Knight's Health AI Navigator

Holland & Knight's Health AI Navigator is a centralized, interactive resource designed to help healthcare stakeholders track and interpret the rapidly evolving legal and regulatory landscape for artificial intelligence (AI) in healthcare. It provides regularly updated summaries of federal and state legislative, regulatory and executive activity, including developments from Congress, the HHS and the White House. The Navigator also features an interactive state map and curated analysis to support compliance and policy insights.

Visit From Chinese President Yields Fentanyl Progress

Last week, Chinese President Xi Jinping visited the U.S. and attended a series of high-level meetings at the White House. As part of the state visit, China announced it would place limits on a synthetic class of opioids called orphines and would establish new export controls for two precursor chemicals often used to manufacture illicit fentanyl. President Donald Trump and President Xi also announced new trade-related actions through a government-to-government body, including more favorable tariff treatment for $30 billion in non-sensitive goods, including U.S. exports of cosmetics and medical devices among other products, as well as imports of consumer products.

Personnel Updates

• The Senate Committee on Finance voted 15-12 to advance the nomination of Chris Klomp to be deputy secretary of the HHS. The committee also advanced the nomination of Ge Bai to be Assistant Secretary for Planning and Evaluation (ASPE) 14-13. Both nominations may now be considered on the Senate floor, though time is limited given the Senate will adjourn this week until after the midterm election.
• Ryan Giachetti will serve as general counsel for the House Committee on Energy and Commerce. He most recently served as chief counsel for the House Committee on Oversight and Government Reform.

Regulatory Updates: CMS

CMS Asks for Input on Medicare Part D Pharmacy Contracting Standards

The Centers for Medicare & Medicaid Services (CMS) issued a request for information (RFI) on September 24, 2026, seeking input on standards for determining whether Medicare Part D pharmacy contract terms and conditions are "reasonable and relevant." The RFI implements a provision of the Consolidated Appropriations Act, 2026, that requires Part D plan sponsors to permit any pharmacy meeting the plan's standard terms and conditions to participate as a network pharmacy. Beginning with plan year 2029, those standard terms and conditions must satisfy standards established by the HHS.

CMS is seeking feedback on the types of terms that should be subject to the standards, including reimbursement methodologies, credentialing and participation requirements, performance measures, network design, dispensing requirements and contract provisions affecting different pharmacy types. The agency also seeks input on how the standards should account for differences among retail, independent, specialty, long-term care, home infusion and other pharmacies. Comments are due November 23, 2026.

CMS Marketplace and Medicare Plan-Year Milestones

CMS will reach several annual Medicare Advantage and Part D milestones this week. Organizations may begin marketing their calendar year 2027 plans on October 1, 2026, and CMS is scheduled to release 2027 plan and drug-benefit data through Medicare Plan Finder on the same date. The plan-year transition comes ahead of Medicare open enrollment, which begins October 15, 2026. Separately, CMS expects to update Nursing Home Care Compare with September 2026 Five-Star rating data on or around September 30, 2026.

Regulatory Updates: FDA

FDA Issues Draft Guidance for Robotically Assisted Surgical Devices

On September 25, 2026, the FDA issued draft guidance outlining recommendations for premarket submissions involving robotically assisted surgical devices. The draft addresses information that manufacturers should include to support evaluation of these systems and is intended to clarify FDA's expectations for devices in which robotic functions assist a surgeon in performing a procedure. FDA will accept comments on the draft guidance through November 24, 2026.

FDA Seeks Input on Oversight of Deceased Donor Islet Cell Treatments

On September 23, 2026, the FDA issued a RFI on the regulatory framework for deceased donor pancreatic islet cells and related cell products used to treat Type 1 diabetes. As part of an HHS effort to improve access to these treatments, the agency is evaluating whether regulating them as biological products creates barriers and whether an alternative framework could maintain appropriate oversight while expanding availability.

The RFI specifically requests input on whether these cells should instead be overseen through a transplantation framework involving the Health Resources and Services Administration (HRSA) and Organ Procurement and Transplantation Network (OPTN). It also seeks information on manufacturing and product characterization, donor eligibility, processing standards, clinical outcomes, adverse-event reporting and the respective roles of transplant centers, organ-procurement organizations and federal agencies. Comments are due November 8, 2026.

Regulatory Updates: NIH

NIH Launches PubMed Tool to Support Research Reproducibility

On September 24, 2026, the National Institutes of Health (NIH) launched Linked Discoveries, an experimental PubMed tool intended to help researchers assess how individual scientific findings relate to the broader body of biomedical evidence. The tool allows researchers to examine relationships among PubMed records and identify publications that support, challenge or otherwise provide context for a particular finding. NIH developed the tool to strengthen replication and reproducibility by making it easier for researchers to evaluate findings within the existing scientific literature

Other Healthcare Updates

ARPA-H Announces Initiative to Reduce Cell Therapies' Dependence on Cold-Chain Infrastructure

On September 25, 2026, the Advanced Research Projects Agency for Health (ARPA-H) announced a new initiative focused on reducing cell therapies' dependence on ultra-cold supply chains. Participating teams will develop technologies intended to protect cell-based products from temperature-related degradation and allow them to be stored and transported under less restrictive conditions. The initiative seeks to address manufacturing and distribution barriers that can limit the availability of cell therapies outside highly specialized medical centers.

HHS, EPA Announces Partnership on Glyphosate Review

HHS and the U.S. Environmental Protection Agency (EPA) announced a scientific partnership on September 22, 2026, to strengthen the review of glyphosate. The partnership was initiated through a memorandum of understanding (MOU) to strengthen scientific coordination and expand the evidence available to EPA's ongoing registration review of glyphosate under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Though the MOU does not create new authorities for either agency, it will allow for the establishment of a joint technical working group to bring together experts from across the HHS and EPA, share information, coordinate research and align work across the agencies.

OMB RFI on Domestic, Near Shore Manufacturing of Essential Medicines

The Office of Management and Budget (OMB) issued a RFI on September 24, 2026, to conduct market research to identify new and unused domestic, U.S.-based and near shore production capabilities for finished dose forms, active pharmaceutical ingredients and key starting materials associated with the 86 drug products included on the Administration for Strategic Preparedness and Response (ASPR) list of essential medicines. The RFI also seeks information on two antibiotic medicines that are not on the ASPR list: amoxicillin and ciprofloxacin. Comments are due in 30 days, and responses will be used to inform activities of federal agencies that have requirements for essential medicines or responsibilities for strengthening the domestic supply chain.

Information contained in this alert is for the general education and knowledge of our readers. It is not designed to be, and should not be used as, the sole source of information when analyzing and resolving a legal problem, and it should not be substituted for legal advice, which relies on a specific factual analysis. Moreover, the laws of each jurisdiction are different and are constantly changing. This information is not intended to create, and receipt of it does not constitute, an attorney-client relationship. If you have specific questions regarding a particular fact situation, we urge you to consult the authors of this publication, your Holland & Knight representative or other competent legal counsel.