Holland & Knight Health Dose: September 22, 2026

Looking Ahead

The U.S. Senate remains in session this week – potentially one of the last weeks the chamber will be in session until after the November 2026 midterm elections, pending the outcome of discussions around permitting reform and certain other non-healthcare items. Healthcare policy attention will largely center on the Senate Committee on Health, Education, Labor, and Pensions (HELP), which is scheduled to consider several key health leadership nominations, including Dr. Heidi Overton to serve as commissioner of the U.S. Food and Drug Administration (FDA).

The committee will also vote on the nominations of Nicole Saphier to serve as U.S. surgeon general, Timothy Westlake to serve as assistant secretary for mental health and substance use, and Mary Lazare to serve as assistant secretary for aging, all of whom have already had their hearings. The nomination hearings come amid ongoing congressional scrutiny of healthcare affordability, physician reimbursement, public health preparedness and implementation of recent changes to federal healthcare programs.

Beyond nominations, other healthcare committees are expected to continue oversight and stakeholder engagement on several healthcare issues, including potential reforms to the No Surprises Act (NSA), implementation of recent Medicaid policy changes and public health response efforts.

The U.S. House of Representatives has adjourned until after the midterm elections, and members remain focused on campaigns.

Upcoming Events

Congress

September 21, 2026

• House Committee on the Budget – America's Fiscal Future: Examining the Need for a Fiscal Commission

September 23, 2026

• Senate Committee on the Judiciary – Standing Up for Women in Sports: Ensuring Opportunity, Fairness and Safety for Female Athletes
• Senate Special Committee on Aging – Leveling the Playing Field: Restoring America's Edge in Generic Drug Manufacturing

September 24, 2026

• Senate HELP Committee – A hearing on the nomination of Dr. Heidi Overton to be commissioner of the FDA; the committee also intends to vote on other pending nominees who have already had their nomination hearings

Federal Agencies

September 24-25, 2026

• Medicaid and CHIP Payment and Access Commission (MACPAC) – A public meeting presentation on community engagement requirements in Medicaid, as well as discussion on proposed rules on state directed payments and healthcare related taxes, utilization management for opioid use disorder and other topics

September 26, 2026

• National Institute of Standards and Technology (NIST) and National Institute of Biomedical Imaging and Bioengineering (NIBIB) – A symposium on future medical imaging, diagnostics, interoperability and medical technology standards to inform development of a federal medical standards road map

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 U.S. Department of Health and Human Services (HHS) and the White House. The Navigator also features an interactive state map and curated analysis to support compliance and policy insights.

Trump Administration Announces all 50 States and Territories to Participate in GENEROUS Model

The Trump Administration on September 18, 2026, announced that all 50 states, as well as the District of Columbia and Puerto Rico, applied to participate in the GENErating cost Reductions fOr U.S. Medicaid (GENEROUS) Model. The GENEROUS Model will apply the administration's most favored nation (MFN) drug pricing initiative to Medicaid. Though 40 states and Puerto Rico have signed participation agreements, remaining states and territories have until September 30, 2026, to finalize their participation. 

Personnel Updates

• HHS Secretary Robert F. Kennedy Jr. appointed eight new members to the U.S. Preventive Services Task Force (USPSTF) on September 17, 2026, including:
  • Dr. Seth Corey, who will serve as Chair
  • Dr. Patrick Hunter
  • Dr. Ronald Karlsberg
  • Dr. Venkatesh Murthy
  • Dr. Stephen Parente
  • Dr. Goldie Strands-Over-Bull
  • Dr. Louis Wilson
  • Dr. Dennis Wulfeck

Congressional Updates

Ranking Member Pallone Sends CDC Director Letter on Measles Response

House Committee on Energy and Commerce Ranking Member Frank Pallone (D-N.J.) on September 14, 2026, wrote to Centers for Disease Control and Prevention (CDC) Director Erica Schwartz to request a briefing on the CDC's response to increasing numbers of measles cases nationwide and the decision to not include two deaths related to measles from overall measles reporting metrics. The letter details changes to federal databases for tracking measles deaths, contrasting data included on the federal database with the Pennsylvania Department of Health's database, which showed a different overall total. Given variances between the federal and state databases, Ranking Member Pallone, as well as Energy and Commerce Committee Subcommittee on Health Ranking Member Diana DeGette (D-Colo.) and Subcommittee on Oversight and Investigations Ranking Member Yvette Clarke (D-N.Y.), who are also signatories on the letter, requested a briefing from the CDC as well as requested that the agency "preserve all documents and communications that may be responsive to this topic, including all call records, memoranda, emails, text messages." The request at the end of the letter is notable, signifying the committee may return to this topic should the House flip following the midterm elections.

House Democrat Cost of Living Healthcare Work Group Sends Recommendations to Leader Jeffries

The House Democrat Cost of Living Healthcare Working Group, co-led by Reps. Alexandria Ocasio-Cortez (D-N.Y.) and Terri Sewell (D-Ala.), transmitted a memo detailing a host of recommendations on healthcare policies House Democrats may elect to pursue in the next Congress. The recommendations will inform the caucus' overall healthcare agenda, with recommendations serving as an initial menu of options for consideration rather than representing an agenda agreed upon by the caucus. The memo included recommendations that could be prioritized for the first several days, months and year of the next Congress and include several long-standing priorities for Democrats, including a restoration and expansion of advanced premium tax credits (APTCs) for plans through the Affordable Care Act (ACA), reversing changes to Medicaid signed into law as part of H.R. 1, expanding the Medicare Drug Price Negotiation Program, expanding Traditional Medicare to include hearing, dental and vision.

The recommendations are also framed around several key themes, including reversing policies implemented or advanced by the current administration, pursuing universal health coverage, making healthcare more affordable, reinvesting in the health infrastructure by improving the healthcare workforce and expanding access to innovative medical treatments.

Senate Committee on HELP Holds NSA Roundtable

The Senate HELP Committee held roundtable discussions with healthcare stakeholders to discuss potential reforms to the NSA, a federal law intended to protect patients from surprise medical bills. Since the law took effect, stakeholders and patients have increasingly called for changes to the law. Participants included employers, physicians, insurers, labor representatives and certified independent dispute resolution (IDR) entities. Though no consensus proposal emerged from the initial roundtables, discussions focused on reducing the IDR backlog by filtering out ineligible claims, improving payment timeliness, increasing transparency and auditing, and reevaluating the role of the qualifying payment amount (QPA) and arbitrator responsibilities. Committee staff are expected to continue stakeholder engagement, with a member-level discussion anticipated in the coming days as lawmakers explore potential legislative options. The roundtables also come after House Energy and Commerce Committee Ranking Member Pallone sent letters to several certified IDREs requesting additional information on dispute volumes and eligibility determinations, among other criteria.

The stakeholder roundtables come at a time of significant attention to the NSA in Congress, the administration and healthcare industry. Several organizations have released proposals calling for changes to the current IDR framework, including organizations representing employer-sponsored health plans, healthcare-oriented think tanks and patient advocacy organizations. Proposals range from restoring the QPA as the primary benchmark in IDR, creating a limited appeals process, reducing allegedly abusive dispute filings and increasing transparency around arbitration outcomes. Other proposals include eliminating federal IDR for most elective services when patients receive meaningful advance notice and provide informed consent, while limiting or potentially eliminating IDR for emergency services, or replacing the IDR with a more defined benchmark payment system.

Though Congress remains active in considering reforms the IDR, the HHS, U.S. Department of Labor (DOL) and U.S. Department of the Treasury have certified additional federal IDR entities, raising the total number of IDREs to 17. The Centers for Medicare & Medicaid Services (CMS) has also opened registration for a new Federal IDR Gateway to serve as the platform for initiating, managing and tracking IDR disputes. The administration also continues to assess implications of an August 2026 court ruling that invalidated portions of the NSA regulations related to calculating the QPA.

Regulatory Updates: CDC

CDC Issues Guidance for 2026-2027 Flu Season

The CDC released updated guidance for the 2026-2027 influenza season, including recommendations for healthcare providers and public health officials on vaccine use and administration. The guidance reflects updates to all three influenza virus components included in this season's vaccines and is intended to improve protection against strains expected to circulate during the upcoming flu season. CDC officials stated they anticipate an adequate and diverse supply of influenza vaccines for the 2026-2027 season and continue to recommend annual vaccination for individuals six months of age and older.

CDC Seeks Input on Strengthening Public Health Data Exchange

On September 21, 2026, the CDC issued a request for information (RFI) seeking public input on the use of data intermediaries to support secure, scalable and standards-based public health data exchange. The agency seeks to determine how intermediary organizations, networks, platforms and governed services could improve the flow of health information among healthcare providers, public health agencies and other stakeholders. CDC indicated that feedback will help inform efforts to address persistent interoperability and data-sharing challenges, building on ongoing data modernization initiatives such as electronic case reporting, electronic laboratory reporting and the agency's broader public health data infrastructure investments. Comments are due November 20, 2026.

Regulatory Updates: CMS

CMS Extends ACCESS Model to Original Medicare Beneficiaries

CMS on September 15, 2026, announced that it would extend the Advancing Chronic Care with Effective, Scalable Solutions (ACCESS) Model – which seeks to provide beneficiaries greater access to health technologies – to beneficiaries with Original Medicare who also have certain common chronic conditions such as substance use disorder, heart failure, nicotine dependence or chronic obstructive pulmonary disease (COPD). The new condition tracks will begin in spring 2027. To date, more than 160 organizations have agreed to participate in the model, which is slated to run for 10 years.

MPFS Comment Period Closes

Responses to the CMS proposed rule for the calendar year (CY) 2027 Medicare Physician Fee Schedule (PFS) were due on September 14, 2026, and the comment period has now closed. CMS received more than 40,000 comments on the proposed rule, reflecting widespread interest across the healthcare sector. Several key themes from the comments include:

• Opposition to Proposed Payment Reductions. Commenters broadly opposed the proposed CY 2027 conversion factor reductions of approximately 1.19 percent for qualifying Alternative Payment Model participants and 1.68 percent for all other clinicians. Many noted that Medicare physician payments have declined roughly 33 percent since 2001 when adjusted for practice cost inflation, even as hospital payments increased significantly over the same period. Commenters urged CMS to work with Congress to establish a permanent, inflation-based annual update tied to the Medicare Economic Index.
• Concerns About Practice Expense Methodology Changes. CMS proposed multiple interrelated changes to its practice expense methodology, and commenters expressed concern that the agency had not provided sufficient specialty-level and code-level impact analyses for stakeholders to evaluate the proposals. Many called on CMS to delay implementation until more detailed data is available and phase in any changes over multiple years. A recurring concern was that the cumulative effect of the proposed changes would fall hardest on small, independent and rural physician practices, potentially accelerating consolidation, reducing patient access and undermining competition.
• Opposition to the Proposed 50 Percent Payment Reduction for Same-Day Evaluation and Management (E/M) Services. Commenters strongly opposed the proposal to reduce payment by half when a separately identifiable evaluation and management visit is furnished on the same day as a procedure. Many argued the reduction was not supported by evidence and could fragment care by incentivizing physicians to schedule services on separate days.
• Concerns About Remote Monitoring Service Restrictions. Several commenters opposed the proposed restrictions and payment reductions for remote physiologic monitoring (RPM) and remote therapeutic monitoring (RTM) services, warning they would disrupt care for patients managing chronic conditions.
• Support for Continued Telehealth Flexibilities. Commenters expressed broad support for maintaining telehealth access and called on CMS and Congress to make temporary telehealth flexibilities permanent before they expire at the end of CY 2027.
• Quality Program and Administrative Burden Concerns. Many commenters raised concerns about the pace of changes to the Merit-based Incentive Payment System (MIPS), including the phase out of Traditional MIPS and the transition to MIPS Value Pathways. There was also widespread opposition to making electronic prior authorization measures mandatory before the underlying technology is broadly available and proven effective.

CMS is now actively reviewing the comments it received and is expected to issue a final rule on or around November 1, 2026. Policies included in the Final Rule will largely take effect on January 1, 2027.

CMS Expected to Launch Audit Program for IDREs

Amid significant attention to the NSA and arbitrators of disputes between doctors and insurance companies, the CMS is expected in the coming days to launch a new audit program to assess certified independent dispute resolution entities (IDREs) compliance with the NSA and regulations that implemented the law. The audit program will be the next effort of the agency to audit the performance of IDREs amid analysis, highlighting how frequently IDREs sided with providers vs. insurance companies, as well as where disputes were not able to be resolved. Additional details on the new audit program are expected to be forthcoming.

Regulatory Updates: FDA

FDA Launches Expedited IND Pilot, Begins Accepting Applications

The FDA on September 15, 2026, announced the launch of the Expedited Investigational New Drug (IND) Pilot Program to reduce the amount of time from identification of a potential new drug product to initiation of human clinical trials. The FDA will accept applications until October 30, 2026, and the FDA will select eight to 10 drug companies that have partnered with qualified research institutions (QRIs) to participate. The eight to 10 QRIs will participate in the first cohort, though the FDA does not note in the official announcement whether there will be future cohorts or whether the pilot is time limited. Participation in the pilot is voluntary. The Expedited IND Pilot Program is an initiative under the auspices of the HHS' Operation TrialBlazer, launched this summer to improve the research and development ecosystem for medical products in the U.S.

The FDA will prioritize submissions for consideration that are novel candidates under the review jurisdiction of the Center for Drug Evaluation and Research (CDER) Office of New Drugs, Center for Biologics Evaluation and Research (CBER) Office of Therapeutic Products, or Oncology Center of Excellence. Other characteristics that the FDA will prioritize submissions for include an IND classified as commercial, IND program targeting first-in-human IND submission, clinical trials that will be run in the U.S. and sponsors with sufficient nonclinical data at time of submission. QRIs prioritized will include those that are a legal entity organized or incorporated in the U.S., a QRI that commits to provide IND development of advisory support or commitment to clinical trial initiation in the U.S. through owned infrastructure. There are also conflict of interest restrictions, such as written procedures for a prospective QRI that also owns or operates an Institutional Review Board (IRB) that will review clinical protocols.

Regulatory Updates: NIH

New NIST RFI on Medical Imaging, Standards and Diagnostics

The NIST issued a new RFI in the Federal Register on September 17, 2026, to request input on future needs for medical metrology and standards around medical imaging, devices and diagnostics. NIST intends to use the input it receives to inform a joint NIST-NIBIB medical standards road map to identify future needs, identify major stakeholders and provide guidance for federal programs. The RFI seeks input on future standards needs related to medical imaging, diagnostics, interoperability and measurement science, including how federal agencies can support the development and validation of next-generation AI-enabled diagnostic technologies. There will also be a symposium on the topic held on September 24, 2026.

FDA Updates Regulations on Alternatives to Animal Testing

The FDA on September 21, 2026, issued a final rule to update its regulations related to non-animal testing methods, clarifying that non-animal methods can be used where appropriate for testing the safety of drugs and biological products intended for human use and before being tested in humans. The final rule brings FDA regulations in line with the Food and Drug Omnibus Reform Act of 2022 (FDORA) to recognize newer testing methods that do not involve animals and traditional animal studies. The FDA also launched a new database featuring specific New Approach Methodologies (NAM) with 25 examples drawn from publicly available materials.

Other Healthcare Updates

ARPA-H Launches SPECTRA Initiative to Improve Autism Research Efforts

The Advanced Research Projects Agency for Health (ARPA-H) on September 17, 2026, announced a new initiative called the Systems for Phenotypic Evaluation, Clinical Trajectories, Response, and Agency (SPECTRA) program, a new effort to improve understanding, diagnosis and treatment of autism spectrum disorder. The program will seek to utilize data, such as genetic factors, to match appropriate medical interventions and accelerate clinical research. The program will seek proposals related to analysis, modeling, precision intervention and enabling technologies. Potential solutions will be accepted beginning October 4, 2026, with a deadline to submit by October 18, 2026, for the first solution area and through January 2027 for the remaining three.

ARPA-H Selects Initial Awardees for ADVOCATE Program

On September 9, 2026, the ARPA-H announced the initial awardees for its ADVOCATE (Agentic AI-EnableD CardioVascular CAre TransfOrmation) program, an initiative intended to develop what the agency describes as the first FDA-authorized clinical agentic AI system for cardiovascular care. ARPA-H has committed up to $62.7 million over four years to support development of AI systems capable of serving as clinician extenders, with the goal of providing continuous patient monitoring, treatment optimization and clinical decision support for individuals with heart failure and other cardiovascular conditions.

The program is structured around three complementary project areas. First, participating technology developers will create patient-facing AI systems designed to monitor symptoms, support medication adherence, identify potential clinical deterioration and facilitate day-to-day disease management. Second, hospital systems, academic medical centers and healthcare delivery organizations will develop supervisory AI platforms intended to synthesize patient information, coordinate care recommendations and support clinical oversight. Third, participants will develop implementation and deployment strategies focused on integrating the technology into real-world care settings and establishing pathways for regulatory review and broader adoption across the healthcare system.

ARPA-H officials have framed the initiative as a response to persistent shortages in specialty cardiovascular care, particularly in rural and underserved communities.

HHS RFI on Electromagnetic Fields, Radiofrequency Radiation and Wireless Radiation Exposure

The HHS issued a RFI on September 17, 2026, seeking input on electromagnetic field emissions and exposure, as well as potential impacts on human health. The notices state that responses will help identify and assess the current state of scientific evidence related to RF radiation exposures and health outcomes, compare domestic and international standards, identify gaps in research and areas for potential future study, as well as inform recommendations for policymakers.

Commerce Releases Guidance and Procedures for Tariffs on Specialty Pharmaceuticals and Ingredients

The U.S. Department of Commerce's Bureau of Industry and Security on September 21, 2026, issued a notice titled "Guidance and Procedures for Implementing Tariff Adjustments for Specialty Pharmaceuticals and Associated Pharmaceutical Ingredients," which defines the pharmaceutical products that qualify for an effect tariff rate of zero percent. The notice defines the products and lists the jurisdictions that are eligible to receive an ad valorem tariff rate of zero percent under Presidential Proclamation 11020 issued April 2, 2026. Pharmaceutical products include drugs and associated ingredients with organ designations (all approved indications are designated as orphan), nuclear medicines, plasma derived therapies, fertility drugs, cell therapy products, gene therapy products, antibody drug conjugates, medical countermeasures related to chemical, biological, radiological and nuclear threats, as well as animal health. These products and associated ingredients receive a zero tariff under Section 232 if they are products of a current or forthcoming trade and security framework, or if they meet an urgent national healthcare need.

Jurisdictions eligible for tariff adjustments under Proclamation 11020 include: Argentina, Bangladesh, Cambodia, Ecuador, El Salvador, European Union, Guatemala, India, Indonesia, Japan, Jordan, Malaysia, North Macedonia, Republic of Korea, Switzerland, Liechtenstein, Taiwan, Thailand, United Kingdom and Vietnam. Companies may request approval from the Department of Commerce for imports of pharmaceutical products or other specialty products if the imports meet an urgent U.S. health need.

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.