Holland & Knight Health Dose: September 15, 2026

Looking Ahead

Both chambers of the U.S. Congress will return for what is expected to be a quick sprint of legislating prior to returning home until after the midterm elections. Several healthcare committees of jurisdiction will hold legislative hearings on physician payment, cybersecurity and healthcare fraud. Committees in the U.S. Senate will hold two back-to-back days of hearings on various healthcare nominees but not include the nomination of Dr. Heidi Overton to be commissioner of the U.S. Food and Drug Administration (FDA).

This week in the U.S. House of Representatives, the floor will see legislation related to Tribal health and environmental policy, as well as the Senate-passed Lindsey O. Graham Sanctioning Russia and Iran Act of 2026, which includes language that would expand the executive's tariff authority – a change that could impact future tariffs on a range of products from nations such as China and India, as well as pharmaceutical products or ingredients.

Upcoming Events

Congress

September 14, 2026

• House Committee on the Judiciary – Examining Healthcare Markets: Fraud and Competition

September 15, 2026

• House Committee on Energy and Commerce Subcommittee on Health – Examining Legislative Proposals to Reform Medicare Provider Payment and Bolster Health Care Cybersecurity; 17 bills will be discussed, including:
  • H.R. 9693, Patients First Act of 2026 (Reps. John Joyce (R-Pa.) and Kim Schrier (D-Calif.))
  • H.R. 8163, Provider Reimbursement Stability Act of 2026 (Reps. Greg Murphy (R-N.C.) and Brad Schneider (D-Ill.))
  • H.R. 8622, Medicare Physician Data-driven Performance Payment System Act of 2026 (Reps. Mariannette Miller-Meeks (R-Iowa) and Herb Conaway (D-N.J.))
  • H.R. 7863, Promoting Fairness for Medicare Providers Act of 2026 (Reps. Gus Bilirakis (R-Fla.) and Raul Ruiz (D-Calif.))
  • H.R. 4331, Access to Claims Data Act (Reps. Joyce and Schrier)
  • H.R. 5737, Radiology Outpatient Ordering Transmission (ROOT) Act (Reps. Diana Harshbarger (R-Tenn) and Blake Moore (R-Utah))
  • H.R. ___, Health Care Cybersecurity and Resiliency Act of 2026
  • H.R. 9908, Rural Hospital Cybersecurity Enhancement Act (Reps. Erin Houchin (R-Ind.) and Schrier)
  • H.R. 3164, Ensuring Community Access to Pharmacist Services Act (Reps. Adrian Smith (R-Neb.)) and Schneider)
  • H.R. 1521, Dental and Optometric Care (DOC) Access Act of 2025 (Reps. Buddy Carter (R-Ga.)) and Yvette Clarke (D-N.Y.))
  • H.R. 6130, Alzheimer's Screening and Prevention (ASAP) Act (Reps. Vern Buchanan (R-Fla.) and Paul Tonko (D-N.Y.))
  • H.R. 1189, National Plan for Epilepsy Act (Reps. Jim Costa (D-Calif.) and Murphy)
  • H.R. 1254, Rural Obstetrics Readiness Act (Rep. Robin Kelly (D-Ill.))
  • H.R. 7905, Diabetes Foot Health Access and Modernization Act of 2026 (Reps. Joyce and Diana DeGette (D-Colo.))
  • H.R. 1616, Promoting Access to Diabetic Shoes Act (Reps. Darin LaHood (R-Ill.) and Nanette Barragán (D-Calif.))
  • H.R. 6214, Kidney Care Access Protection Act (Reps. Carol Miller (R-W.Va.) and Terri Sewell (D-Ala.))
  • H.R. 8319, Keeping Individuals with Dialysis Needs Equipped through Year-round Remote Monitoring Act (KIDNEY Remote Monitoring Act) (Reps. Rudy Yakym (R-Ind.), Schneider, Miller-Meeks and Debbie Dingell (D-Mich.))
• Senate Committee on Finance – A hearing on the nominations of Chris Klomp to be deputy secretary of the U.S. Department of Health and Human Services (HHS) and Ge Bai to be assistant secretary of HHS, among other nominations
• House Committee on Oversight and Government Reform – Unequal Treatment: Addressing the Drivers of Unaffordability for Oral Chemotherapy

September 16, 2026

• House Committee on Science, Space, and Technology Subcommittee on Investigations and Oversight – Balancing Biotechnology Innovation and Biosecurity: Securing U.S. Leadership in a Global Race
• Senate Committee on Health, Education, Labor and Pensions (HELP) – A hearing on the nominations of Chris Klomp to be deputy secretary of HHS, Nicole Saphier to be U.S. Surgeon General, and Timothy Westlake to be assistant secretary for the Substance Abuse and Mental Health Services Administration (SAMHSA)
• Senate Special Committee on Aging – Half the Country, Zero Hearings: Meeting the Moment to End the Menopause Care Gap in America

Federal Agencies

• HHS Health Information Technology Advisory Committee – Meeting rescheduled to October 8, 2026, instead of September 24, 2026
• Centers for Medicare & Medicaid Services (CMS) – A virtual town hall meeting will be held December 9-10, 2026, to discuss fiscal year (FY) 2028 applications for New Technology Add-On Payments (NTAP) for new medical services and technologies under the hospital inpatient prospective payment system (IPPS); deadline to register as a presenter is November 2, 2026, at 5 p.m.
• CMS – A second advisory panel meeting on Clinical Diagnostic Laboratory Tests will be held September 15-16, 2026, focusing on crosswalking and gapfilling recommendations for new and reconsidered tests. The panel will also consider a number of codes for which CMS did not receive private-payer data sufficient to calculate a Medicare payment rate, including many Proprietary Laboratory Analysis codes. This comes ahead of proposed and final payment determinations this fall, with new rates scheduled to take effect January 1, 2027.
• FDA – Public meetings September 16-17, 2026, will kick off the next phase of discussions around reauthorization of Prescription Drug User Fee Act and Generic Drug User Fee Amendments for FY 2028-2032. Though the reauthorization deadline is not until September 30, 2027, the user-fee package will be one of next year's major must-pass healthcare vehicles and could become a vehicle for broader policy riders, which includes "America First" policies (drug supply chain transparency reforms and Regulatory Alignment for Predictable and Immediate Device (RAPID) Reserve Act), anti-China bills (pre-IND clinical trial ban from countries of concern, Biotech Investment National Security Act), biosimilar and generic reforms, rare disease reforms and codification of FDA 2025 pro-innovation initiatives e.g., plausible mechanism, pre-IND pilot speeding First-in-Human trials.

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, HHS and the White House. The Navigator also features an interactive state map and curated analysis to support compliance and policy insights.

Personnel Updates

• The FDA on September 8, 2026, announced several leadership changes:
  • Jared Seehafer will serve as the FDA's first deputy commissioner for technology and AI
  • Michael Davis will serve as director of the Center for Drug Evaluation and Research (CDER)
  • Karim Mikhail will serve as director of the Center for Biologics Evaluation and Research (CBER)
  • Bret Koplow will serve as the director of the Center for Tobacco Products (CTP)

Congressional Updates

Democratic Doctors Caucus Presses CMS on Medicaid Rules

Members of the Democratic Doctors Caucus – including Reps. Maxine Dexter (D-Ore.), Ami Bera (D-Calif.), Herb Conaway Jr. (D-N.J.), Kelly Morrison (D-Mo.), Kim Schrier (D-Wash.) and Raul Ruiz (D-Calif.) – wrote to CMS Administrator Mehmet Oz on September 3, 2026, concerning medical frailty provisions included in the CMS Interim Final Rule (IFR) regarding community engagement requirements in Medicaid. The letter raises concerns regarding beneficiary access to and maintenance of Medicaid coverage, as well as administrative burdens on healthcare providers. As part of the IFR, CMS' definition of "medically frail" requires that an individual's "physical, mental, or other behavioral health condition" significantly impairs their compliance with the requirement. In addition, beneficiaries would be required to self-attest that their condition qualifies them for the exemption.

House SST Writes DOE on Protections for Biotechnology Research

House Committee on Science, Space, and Technology (SST) Chair Brian Babin (R-Texas) and Subcommittee on Investigations and Oversight Chair Rich McCormick (R-Ga.) wrote to U.S. Department of Energy Secretary Chris Wright on September 9, 2026, regarding biotechnology and biosecurity. The letter details the rising use of and innovation in AI and growth in applications such as genetic sequencing and the subsequent need for oversight of these advances. The letter highlights possible security concerns regarding AI and biotechnology stemming from inadequate safety practices, underscoring the need for a strong oversight framework. To inform the committee's ongoing work, the chairs request information regarding the department's programs, initiatives and policies related to biotechnology research, development, innovation and biosecurity, such as how the department assesses risks of dual-use research or identifies and mitigates biosecurity risks.

The inquiry also aligns with broader concerns being raised by the National Security Commission on Emerging Biotechnology (NSCEB), which has repeatedly highlighted the increasingly close convergence of AI and biotechnology. In recent analyses and its final report to Congress, the commission identified AI-enabled biological design, rapidly expanding biological and genomic data resources, and advances in genetic sequencing as transformative capabilities that could accelerate biomedical innovation while creating new biosecurity and dual-use research risks. The commission has urged the federal government to strengthen coordination of biotechnology policy, improve oversight of emerging biological technologies and develop safeguards to address potential misuse of AI-enabled biological tools.

NSCEB Releases Analysis on U.S. Leadership in Brain-Computer Interfaces

On September 2, 2026, NSCEB released a policy paper warning that the U.S. risks losing its long-standing leadership position in brain-computer interfaces (BCIs) as China advances a coordinated national strategy for commercialization, manufacturing and data development. The commission highlighted BCIs as an emerging technology with applications ranging from treating paralysis, amyotrophic lateral sclerosis (ALS) and stroke to supporting military operations, as well as training future AI models using neural data. The report notes that China became the first country to approve an implantable BCI for commercial use in March 2026 and argues that the U.S. lacks a comparable national strategy.

To address these concerns, the commission recommended establishing a National Biotechnology Coordination Office to align federal activities across agencies, including the FDA, National Institutes of Health (NIH), Defense Advanced Research Projects Agency (DARPA), Advanced Research Projects Agency for Health (ARPA-H), U.S. National Science Foundation (NSF) and U.S. Department of Veterans Affairs (VA). The report also calls for the creation of a national "Web of Biological Data" to improve access to and integration of biological, clinical and neural datasets, which the commission argues will be necessary to support next-generation AI development and accelerate BCI research. Additional recommendations include streamlining clinical trial requirements, modernizing FDA review processes for rapidly evolving neurotechnology products and ensuring implantable BCIs are included in the new FDA-CMS RAPID program to establish clearer reimbursement pathways and reduce delays between FDA approval and Medicare coverage. The commission argues these reforms are necessary to address regulatory, funding and data infrastructure barriers that could otherwise slow U.S. innovation in the field.

Regulatory Updates: CDC

CDC Announces NCIRD Reorganization

The Centers for Disease Control and Prevention (CDC) announced on September 8, 2026, a reorganization of the National Center for Immunization and Respiratory Diseases (NCIRD) to consolidate offices, rename certain divisions and branches, and modify the center's mission statement and functions. According to the notice, the reorganization was approved by HHS Secretary Robert F. Kennedy Jr. on August 18, 2026, and took effect on September 4, 2026. Notable changes include merging the Influenza Division and the Coronavirus and Other Respiratory Viruses Division into a newly established Influenza and Respiratory Viruses Division, which will also house the Influenza and Respiratory Viruses Division (CJH), Office of the Director (CJH1), Virology and Laboratory Surveillance Branch (CJHB), Respiratory Virus Detection and Immunology Branch (CJHC), Surveillance, Epidemiology, and Modeling Branch (CJHD), Public Health Interventions Branch (CJHE) and Emerging Viral Respiratory Threats Branch (CJHG).

Regulatory Updates: CMS

CMS Continues Focus on Durable Medical Equipment, Blocks 11 Suppliers

CMS announced on September 8, 2026, that it barred 11 durable medical equipment, prosthetics, orthotics and supplies (DMEPOS) companies from receiving future Medicare Advantage (MA) Part C and Part D payments after claiming more than $3.4 billion in suspected fraudulent billing in 2025 and 2026. According to CMS, the suppliers had no claims history before 2025, used improper billing practices and, in some cases, billed for equipment associated with deceased beneficiaries or equipment that beneficiaries did not request or receive. Four of the suppliers had previously been revoked from Original Medicare and subsequently began billing MA plans. CMS placed all 11 suppliers on its Preclusion List in coordination with the HHS Office of Inspector General, preventing payment for items, services or drugs furnished, ordered or prescribed by the suppliers.

Regulatory Updates: FDA

FDA Holds Public Hearing on Potential Therapeutic Uses of Psychedelic Drugs

The FDA held a public hearing on September 14, 2026, in collaboration with other federal partners to receive feedback on issues surrounding the potential therapeutic use of drug products containing psychedelic substances in supervised and supportive settings. The hearing held almost four hours of public commentary on provider training and credentialing, promotion of patient safety, considerations for access, and best practices for data collection and standardization. Public commenters addressed considerations relevant to future therapeutic use and regulatory development. The agency will accept written comments through October 5, 2026.

FDA Issues RFIs on BPDs and Rare Disease Clinical Investigations

The FDA issued a new request for information (RFI) on September 4, 2026, on efforts to advance the development of botanical drug products (BPDs). In issuing the RFI, the FDA notes it hopes to better understand stakeholder perspectives on the state of BPD development, challenges and potential solutions to information gathering processes required by the law. BPDs refer to "drug products that include or may be derived from plant materials, algae, macroscopic fungi, or combinations thereof and that are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans." To date, four botanical products have been approved for marketing as prescription drugs under new drug applications (NDAs) and biologics licensing applications (BLAs) pathways. Comments are due November 3, 2026.

The second RFI issued by the FDA was published in the Federal Register on September 14, 2026, titled "Statistical Considerations for the Design of Rare Disease Clinical Investigations," along with the establishment of a public docket opened in conjunction with a Rare Disease Innovation, Science, and Exploration (RISE) workshop. Comments are due November 13, 2026.

FDA, SEC Enter New MOU to Share Non-Public Data

The FDA and U.S. Securities and Exchange Commission (SEC) on August 31, 2026, announced a new memorandum of understanding (MOU) to enhance information sharing and coordination between the two agencies. Through the MOU, the FDA will share certain nonpublic data with regulators at the SEC to enhance oversight and enforcement, as well as formalize the long-standing information sharing framework between the agencies. Though the MOU will not allow the SEC to access all nonpublic information possessed by the FDA, it may be easier for the SEC to access information on interactions between the FDA and applicants, as well as allow the SEC to provide the FDA additional information to inform its own regulatory activities.

FDA Schedules VRBPAC Meeting

The FDA on September 8, 2026, announced the next meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) will hold its next meeting to discuss the 2027 Southern Hemisphere Influenza Virus Vaccine on October 1, 2026. The FDA established a public docket for comments in the lead-up to the meeting that will close on September 29, 2026. The meeting is particularly important for vaccine makers that manufacture influenza vaccines: The committee will discuss strain selection for the 2027 Southern Hemisphere influenza season and provide recommendations on which strains to incorporate into vaccinations.

FDA Issues Final Administrative Order on Sunscreen Ingredients

On September 11, 2026, the FDA issued a final administrative order removing para-aminobenzoic acid (PABA) and trolamine salicylate from the over-the-counter (OTC) sunscreen monograph, concluding that available evidence does not support their continued recognition as safe and effective sunscreen active ingredients. The action is the latest step in the agency's ongoing modernization of the OTC sunscreen framework and follows FDA's June 2026 order adding bemotrizinol, the first new sunscreen active ingredient permitted under the monograph in more than 25 years. FDA noted that other elements of FDA's 2021 proposed sunscreen rulemaking, including additional proposed revisions to the conditions under which sunscreen products may be marketed without prior approval, will be addressed through separate administrative orders at a later date.

Regulatory Updates: NIH

NIH Highlights Draft Biosafety Policy

The NIH issued a draft policy following its RFI on August 19, 2026, related to biosafety policy for research involving biohazards. As part of the draft policy, the NIH will set requirements for oversight of biomedical research involving biohazards, including any with known or potential risk to human health such as bacteria, viruses, fungi or parasites, toxins or prions. The policy will apply to research supported in whole or part by the NIH, regardless of the level of funding of funding mechanism. The draft policy also seeks to strengthen the role of Institutional Biosafety Committees (IBCs) and other institutional oversight functions for research. Comments are due by October 19, 2026.

Other Healthcare Updates

HHS Awards $383.4 Million for 988 Lifeline, Crisis Response and Behavioral Health Services

HHS, through SAMHSA, announced $383.4 million in behavioral health grants on September 8, 2026. Of that amount, $252 million will support the 988 Suicide & Crisis Lifeline, suicide-prevention activities and mobile crisis services. The funding includes $205.8 million for state and territorial 988 Lifeline capacity, $19.9 million for Tribal 988 Lifeline response, $13.9 million for Tribal youth suicide prevention and $12.4 million for behavioral health mobile crisis teams.

HHS Expands Rural and Tribal Medical Residency Development

HHS, through the Health Resources and Services Administration, awarded $11.2 million on September 4, 2026, to support the development of 15 physician residency programs in rural communities across 14 states. The Rural Residency Planning and Development Program awards cover family medicine, internal medicine, preventive medicine, psychiatry and general surgery. Each recipient may receive up to $750,000 over three years for activities such as accreditation, curriculum development, faculty recruitment, resident recruitment and long-term financing plans.

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.