Health Care Week in Review | Senate Committees Advance Key HHS Nominees and Consider FDA Commissioner Nomination; CMS Strengthens Federal ACA Marketplace Anti-Fraud Efforts

Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and analyses; and other health policy news. 

Regulations, Notices & Guidance

• On September 21, 2026, the Food and Drug Administration (FDA) released a direct final rule entitled, Nonclinical Testing Terminology. This direct final rule updates FDA’s drug and biological product regulations to replace references to “animal” and “preclinical” testing with the broader term “nonclinical” testing. The change aligns FDA regulations with recent statutory updates and clarifies that sponsors may use scientifically valid alternatives to animal testing, including cell-based assays, organ chips, computer modeling, and other new approach methodologies. The direct final rule does not impose new testing or reporting requirements, but is intended to provide greater flexibility and support the development and use of non-animal testing methods. The direct final rule is scheduled for publication on September 22, 2026, with comments due December 7, 2026, and an effective date of February 4, 2027, if FDA receives no significant adverse comments.

• On September 21, 2026, FDA released a proposed rule entitled, Nonclinical Testing Terminology. FDA issued this proposed rule to update its drug and biological product regulations by replacing references to “animal” and “preclinical” testing with the broader term “nonclinical” testing. The proposed rule would clarify that sponsors may use scientifically valid alternatives to animal testing, including cell-based assays, organ chips, computer modeling, and other new approach methodologies, while continuing to permit animal studies where appropriate. The proposed rule would impose no new testing or reporting requirements and is intended to align FDA regulations with recent statutory changes and encourage greater use of alternative testing methods. It is being issued alongside a companion direct final rule, which will take effect if FDA receives no significant adverse comments.

• On September 22, 2026, the Centers for Medicare & Medicaid Services (CMS) released an interim final rule entitled, Patient Protection and Affordable Care Act: Temporary Moratoria on Certain Agent and Broker Registration to Participate in the Exchanges. This interim final rule allows the Department of Health and Human Services (HHS) to temporarily pause certain agent and broker registrations with the Federally-facilitated Exchanges (FFEs) and State-Based Exchanges on the Federal Platform (SBE-FPs) when their participation poses unacceptable program-integrity risks. Effective September 22, 2026, CMS is using this authority to block agents and brokers without Plan Year 2026 Exchange agreements from registering for Plan Year 2027 until February 1, 2027, while the agency implements enhanced identity-verification, consumer-authorization, monitoring, and other safeguards. CMS cited persistent unauthorized enrollments, plan switching, misuse of consumer information, and other noncompliance, noting that newly registered agents and brokers have been disproportionately associated with these concerns. The moratorium does not apply to State-based Exchanges (SBEs) or web-brokers, and HHS is accepting public comments through November 21, 2026.

• On September 23, 2026, CMS released a request for information (RFI) entitled, Medicare Part D Reasonable and Relevant Pharmacy Contracting Standard. CMS issued this RFI seeking stakeholder input to inform future standards for “reasonable and relevant” contract terms and conditions between Medicare Part D plan sponsors and network pharmacies. Required under the Consolidated Appropriations Act, 2026, the standards must be established by April 2028 and will apply beginning with Plan Year 2029. CMS is requesting feedback across a broad range of pharmacy contracting issues, including reimbursement and dispensing fees, current contracting practices and transparency, specialty pharmacy arrangements, pharmacy quality and performance measures, auditing and recoupment practices, dispensing limitations, dispute resolution, and the role of pharmacy benefit managers (PBMs) and vertical integration. The agency also seeks input on whether reimbursement adequately reflects pharmacies’ acquisition and operational costs, the use of maximum allowable cost pricing and aggregate reimbursement guarantees, how Part D arrangements interact with commercial reimbursement, and whether CMS should establish specific reimbursement methodologies or other contracting protections. CMS is additionally seeking recommendations on implementation timelines, compliance documentation, and criteria to ensure future standards are transparent, objective, and enforceable. Comments are due 60 days after publication in the Federal Register.

• On September 24, 2026, FDA released draft guidance entitled, Robotically-Assisted Surgical Devices-Premarket Submissions. This draft guidance addresses nonclinical and clinical testing and the content manufacturers should include in premarket submissions for robotically assisted surgical devices (RASDs), which FDA describes as teleoperated, software-controlled systems that use robotic technologies to assist practitioners in positioning and controlling surgical instruments during open, minimally invasive, or endoluminal procedures. The recommendations are intended to promote consistency and facilitate more efficient FDA review of RASD submissions. The draft guidance is not yet final or binding, and FDA will consider stakeholder feedback before issuing a final version. Comments on the draft guidance are due 60 days after publication in the Federal Register.

Event Notices

Please note that two asterisks (**) preceding the item indicate a new event. 

• September 23, 2026: The National Institutes of Health (NIH) announced a meeting of the National Advisory Allergy and Infectious Diseases Council. This is a virtual meeting with some sessions open to the public.
• September 23, 2026: NIH announced a meeting of the AIDS Research Advisory Committee. This is a virtual meeting open to the public.
• September 25, 2026: NIH announced a meeting of the National Advisory Eye Council. This is a hybrid meeting with some sessions open to the public.
• September 28-29, 2026: NIH announced a meeting of the National Advisory Council for Human Genome Research. This is a hybrid meeting with some sessions open to the public.
• October 1, 2026: FDA announced a meeting of the Vaccines and Related Biological Products Advisory Committee. This is a virtual meeting open to the public.
• October 8, 2026: The Centers for Disease Control and Prevention (CDC) announced a meeting of the Advisory Board on Radiation and Worker Health (ABRWH). This is a virtual meeting open to the public.
• October 8, 2026: The Office of the National Coordinator for Health IT (ONC) announced a meeting of the Health Information Technology Advisory Committee (HITAC). This is a virtual meeting open to the public.
• October 9, 2026: NIH announced a meeting of the National Center for Advancing Translational Sciences (NCATS). This is a virtual meeting open to the public.
• October 14, 2026: NIH announced a meeting of the Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD) National Advisory Child Health and Human Development Council. This is an in-person meeting with some sessions open to the public.
• October 16, 2026: NIH announced a meeting of the NIH Clinical Center Research Hospital Board. This is a hybrid meeting open to the public.
• October 20, 2026: NIH announced a meeting of the Advisory Committee on Research on Women’s Health. This is a virtual meeting open to the public.
• October 20, 2026: NIH announced a meeting of the Office of AIDS Research Advisory Council. This is a hybrid meeting open to the public. 
• October 22, 2026: NIH announced a meeting of the Board of Scientific Counselors, National Library of Medicine. This is a virtual meeting with some sessions open to the public.
• **October 26, 2026: FDA announced a meeting to discuss proposed recommendations for the reauthorization of the Biosimilar User Fee Act. This is a hybrid meeting open to the public.
• October 28, 2026: NIH announced a meeting of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). This is a virtual meeting with some sessions open to the public.
• October 28, 2026: CDC announced a meeting of the Subcommittee on Procedures Reviews (SPR) of the ABRWH. This is a virtual meeting open to the public.
• October 28, 2026: NIH announced a meeting of the National Heart, Lung, and Blood Advisory Council. This is a hybrid meeting open to the public.
• October 29, 2026: NIH announced a meeting of the Board of Scientific Counselors, National Institute on Aging. This is a virtual meeting with some sessions open to the public.
• **October 30, 2026: FDA announced a meeting of the Dermatologic and Ophthalmic Drugs Advisory Committee. This is a hybrid meeting open to the public.
• November 2-3, 2026: CMS announced the second biannual Healthcare Common Procedure Coding System (HCPCS) Level II public meeting of 2026. This is a hybrid meeting open to the public.
• **November 4, 2026: NIH announced a meeting of the Scientific Advisory Committee on Alternative Toxicological Methods (SACATM). This is a virtual meeting with some sessions open to the public.
• November 5, 2026: ONC announced a meeting of HITAC. This is a virtual meeting open to the public.
• **November 18, 2026: NIH announced a meeting of the National Cancer Institute (NCI). This is a virtual meeting open to the public.
• November 19, 2026: FDA announced a meeting of the Microbiology Devices Panel of the Medical Devices Advisory Committee. This is a hybrid meeting open to the public.
• November 20, 2026: NIH announced a meeting of the Board of Scientific Counselors, NIDDK. This is a virtual meeting with some sessions open to the public.
• December 1, 2026: NIH announced a meeting of the NCI. This is an in-person meeting with some sessions open to the public.
• December 3, 2026: NIH announced a meeting of the Sleep Disorders Research Advisory Board (SDRAB). This is a virtual meeting open to the public.
• December 7-8, 2026: NIH announced a meeting of NICHD. This is a hybrid meeting open to the public.
• December 8-9, 2026: HHS announced a meeting of the Physician-Focused Payment Model Technical Advisory Committee (PTAC). This is a hybrid meeting open to the public.

• December 9-10, 2026: CMS announced a town hall meeting to discuss fiscal year (FY) 2028 applications for add-on payments for new medical services and technologies under the hospital inpatient prospective payment system (IPPS). This is a virtual meeting open to the public.

• January 16, 2027: HHS announced a meeting of the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria (PACCARB). This is a virtual meeting open to the public. 

Reports, Studies & Analyses

• On September 21, 2026, the HHS Office of Inspector General (OIG) issued a report entitled, Medicaid Managed Care: CMS’s Accuracy Check Process for State-Submitted Medical Loss Ratio Data Has Limitations. OIG examined CMS’s process for verifying the accuracy of medical loss ratio (MLR) data submitted by states, which is used to help states establish appropriate Medicaid managed care capitation rates. OIG found that CMS conducted only limited accuracy checks on the four required MLR data elements, did not follow up with states that submitted potentially inaccurate data, and did not consistently share the results of its reviews with CMS staff responsible for reviewing capitation rates. OIG made three recommendations, including establishing procedures to address potentially inaccurate state-submitted MLR data, improving communication of MLR review findings across CMS staff, and improving the efficiency and effectiveness of CMS’s oversight of MLR data accuracy. CMS agreed with all three recommendations.

• On September 21, 2026, the U.S. Government Accountability Office (GAO) released a report entitled, Medical Devices: FDA Should Strengthen Policies Guiding Audits of Third Party Review Organizations. GAO examined FDA’s oversight of its Third Party Review Program, which allows FDA-accredited organizations to conduct initial reviews of certain 510(k) submissions for low-to-moderate risk medical devices before FDA makes a final marketing decision. GAO found gaps in FDA’s policies for auditing these third-party organizations, including the absence of target time frames for completing audits and communicating findings, which contributed to some recent audits with identified deficiencies taking more than six months to close. GAO recommended that FDA update its audit policies to include criteria for selecting organizations for audits, reflect current post-audit practices, and establish target time frames for completing audits and communicating findings. HHS agreed with GAO’s recommendation. 

Hearings & Markups

• On September 23, 2026, the Senate Aging Committee held a hearing entitled, Leveling the Playing Field: Restoring America’s Edge in Generic Drug Manufacturing. Witnesses included: Mr. Kurt Orlofski, Chief Executive Officer (CEO), PAI Pharma; Ms. Christine Baeder, President, Apotex USA and Latin America; and Mr. Mihir Torsekar, Coalition for a Prosperous America.

• On September 24, 2026, the Senate Committee on Health, Education, Labor, and Pensions (HELP) held an executive session to consider S. 4428, No Aid for Ghost Students Act of 2026 and the following nominations:
  • Dr. Nicole Saphier to be Medical Director in the Regular Corps of the Public Health Service;
  • Mr. Timothy Westlake to be Assistant Secretary for Mental Health and Substance Use, HHS;
  • Ms. Mary Lazare to be Assistant Secretary for Aging, HHS;
  • Ms. Loren E. Sweatt to be a Member of the National Mediation Board; and
  • Mr. Douglas Ralph to be a Member of the National Mediation Board.

• On September 24, 2026, the Senate HELP Committee held a hearing to consider the nomination of Dr. Heidi Overton to be Commissioner of Food and Drugs.

Other Health Policy News

• On September 21, 2026, CMS posted the preliminary contract year (CY) 2027 weighted median private payor rates for the Medicare Clinical Laboratory Fee Schedule (CLFS). Although final rates will not be released until later this year, CMS is releasing the data and information used to determine these preliminary rates and has alleged that Medicare has been overpaying by 16 percent for lab tests and that the new rates better reflect the commercial payer rates and would save Medicare $1 billion annually. Laboratory tests that did not have available commercial data will have rates set by CMS using information from a public meeting held on September 15 and 16, 2026. These rates will be published in early October 2026 and will have a separate comment window.

  The public has until October 21, 2026 to comment on the preliminary rates published on September 21, 2026, which will go into effect beginning on January 1, 2027.

  The CLFS Payment Rates may be found here. The CMS press release may be found here, and the CMS fact sheet may be found here.

• On September 22, 2026, CMS announced several actions to address fraud and improper enrollments in the Federal Marketplace, which includes FFE and SBE-FPs. On August 31, 2026, CMS announced the cancellation of 315,000 unauthorized enrollments on the Federal Marketplace covering over 760,000 individuals. CMS noted that the impacted individuals’ insurance coverage was terminated in August 2026 following an investigation into these enrollments. The agency estimates that it will recoup $2.2 billion in advance payments of income-based premium tax credits from the canceled enrollments. As part of the White House Task Force to Eliminate Fraud’s efforts, CMS has established a FFE anti-fraud coordination group that will meet regularly to coordinate enforcement and program integrity efforts in the FFE.

  CMS also announced several additional actions to eliminate fraud in the FFE, including issuing over 200 termination notices for non-compliant agents and brokers since January 2026 and 596 notices of intent to terminate Exchange Agreements to agents and brokers who submitted incomplete 2026 applications. Further, CMS is releasing an interim final rule with comment period entitled, Patient Protection and Affordable Care Act; Temporary Moratoria on Certain Agent and Broker Registration To Participate in the Exchanges. Through this interim final rule, CMS is announcing a temporary moratorium on new registration for the 2027 plan year for FFE and SBE-FP agents and brokers without an active Exchange Agreement for 2026. Provisions in the rule are effective on September 22, 2026, and comments must be submitted by November 21, 2026.

  The affiliated CMS press release may be found here, while the CMS fact sheet on Federal Marketplace anti-fraud efforts may be found here. The interim final rule as published in the Federal Register may be found here.

• On September 23, 2026, the Senate HELP Committee convened a closed-door bipartisan roundtable to discuss potential changes to the No Surprises Act (NSA), the 2020 law that protects patients from surprise medical bills and established an independent dispute resolution (IDR) process for out-of-network payment disputes. Senators Bill Cassidy (R-LA), Roger Marshall (R-KS), Josh Hawley (R-MO), and Maggie Hassan (D-NH) met with a small group of stakeholders representing providers, insurers, employers, patients, and academia to identify areas of consensus for possible legislative reforms.

  Discussions focused on addressing the growing backlog of IDR claims, including proposals to screen out ineligible disputes earlier in the process and strengthen enforcement of arbitration decisions when insurers fail to make required payments. Participants also debated whether additional payment benchmarks could help reduce large arbitration awards and improve transparency in reimbursement calculations. Some stakeholders suggested removing certain non-emergency services from the dispute process, while provider representatives largely defended the arbitration framework and emphasized the need for stronger payment enforcement. The roundtable did not result in a formal legislative proposal, but highlighted claim eligibility, payment enforcement, and reimbursement transparency as potential areas for bipartisan reform.

• On September 23, 2026, the Senate Special Committee on Aging held a hearing entitled, Leveling the Playing Field: Restoring America’s Edge in Generic Drug Manufacturing. The hearing addressed domestic production, permitting and regulatory barriers, FDA oversight, and federal purchasing and reimbursement incentives of generic drugs.

  Witnesses urged Congress to consider economic incentives alongside regulatory streamlining, arguing that low generic-drug prices can make reliable domestic production commercially unsustainable. Witness testimony also included support for greater transparency regarding the country of origin of finished drugs and active pharmaceutical ingredients.

  During the hearing, Committee Chair Rick Scott (R-FL) highlighted the bipartisan CLEAR LABELS Act, which would add country-of-origin disclosure requirements to prescription-drug labeling. The bill cleared the Senate HELP Committee in July 2026; Senator Scott said he expects a Senate floor vote before year-end, but no floor vote has been scheduled.

  More information on this hearing is available here. The full text of the CLEAR LABELS Act is available here.

• On September 23, 2026, Senators Mark Warner (D-VA) and Marsha Blackburn (R-TN) sent CMS Administrator Mehmet Oz a letter urging the agency not to finalize proposed Calendar Year 2027 Medicare Physician Fee Schedule changes to remote patient monitoring as written. The letter focused particularly on a proposal that would require remote monitoring clinical services to be performed by staff employed by the billing practitioner or practice, rather than through contracted clinical and technology partners. The Senators also raised concerns about proposed reimbursement changes and additional visit requirements related to remote monitoring. The letter argued that the policies could conflict with bipartisan efforts to expand remote monitoring in rural areas, including the Rural Patient Monitoring Access Act, which the House Ways and Means Committee previously advanced unanimously and which Senators Warner and Blackburn introduced in the Senate.

  A press release and full text of the letter are available here.

• On September 24, 2026, the Senate Finance Committee advanced two senior HHS nominees. The committee voted 15-12 to advance Mr. Chris Klomp to serve as Deputy Secretary of HHS, with Senator Sheldon Whitehouse (D-RI) joining all committee Republicans in supporting the nomination. Mr. Klomp currently serves as a senior advisor to HHS Secretary Robert F. Kennedy Jr. The committee also voted 14-13 to advance Dr. Ge Bai to serve as HHS Assistant Secretary for Planning and Evaluation (ASPE). Both nominations now move to the full Senate for consideration.

  A Senate Finance Committee press release on these votes is available here.

• On September 24, 2026, the Senate HELP Committee held a hearing to consider the nomination of Dr. Heidi Overton to be Commissioner of Food and Drugs. The hearing examined Dr. Overton’s views on FDA independence, vaccines, mifepristone, tobacco regulation, food safety, drug development, and prescription drug pricing. Dr. Overton said her priorities would include accelerating clinical trials and product reviews, strengthening U.S. biotechnology competitiveness, expanding access to treatments, improving food safety and transparency, and addressing illicit vaping products.

Of note, in response to questions from Ranking Member Bernie Sanders (I-VT), Dr. Overton defended the Administration’s drug-pricing efforts, citing agreements with certain branded-drug manufacturers to lower prices and pointing to “Most Favored Nation” policies as contributing to lower prescription-drug inflation. On rare disease therapies, she expressed support for more flexible, risk-based review pathways for small patient populations, including the use of expedited-approval approaches where traditional trial sizes may not be feasible.

Committee members also raised questions about the coverage and cost implications of potential changes to vaccine schedules, including whether separate or “micro-dosed” vaccine products would increase pediatric visits and shift costs to insurers, families, or taxpayers. Separately, members’ discussion of the ongoing safety review of mifepristone’s Risk Evaluation and Mitigation Strategy (REMS) highlighted potential telehealth and rural-network-access implications if FDA were to revisit remote prescribing or in-person dispensing requirements. Dr. Overton also linked chronic disease prevention, including childhood obesity and type 2 diabetes, to food quality and transparency around ingredients and nutritional information.

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