Health Care Watch: September 13, 2026
The following Federal Health Policy (FHP) Strategies Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from September 6 – September 13 Where available, hyperlinks are included to the relevant documents. Please let us know if you have any questions or would like additional information on the items below.
LEGISLATIVE UPDATE
House
On September 10, Oversight and Government Reform Committee Ranking Member Robert Garcia (D-CA) and Subcommittee Ranking Member Maxwell Frost (D-FL) sent a letter to Florida Governor Ron DeSantis (R) requesting information about the handling of $10 million from a Medicaid fraud settlement. The letter cited recent reports and an August 2026 Florida grand jury finding indicating that the DeSantis administration had “misappropriated” the funds to the Hope Florida Foundation, a nonprofit connected to Casey DeSantis, rather than allocated to health care in the state.
During the week of September 14, the House is expected to consider the Protecting Taxpayers from Healthcare Fraudsters Act. This legislation would significantly increase funds available to Health Care Fraud and Abuse Control (HCFAC) Program from FY2027 to FY2030.
Senate
On September 10, Sen. Maggie Hassan (D-NH), Minority Leader Chuck Schumer (D-NY), Finance Committee Ranking Member Ron Wyden (D-OR), and three other Democratic senators sent a letter to Health & Human Services (HHS) Secretary Robert F. Kennedy, Jr., requesting information on the department's response to measles, cyclospora, and salmonella outbreaks and on spending related to two HHS-produced media projects, "The Secretary Kennedy Podcast" and "The Real Food Show." The letter argued that Kennedy has not adequately addressed the outbreaks and characterized the media projects as taxpayer-funded self-promotion, requesting responses to a series of questions by September 30.
Health, Education, Labor, & Pensions (HELP) Committee Chairman Bill Cassidy (R-LA) is developing legislation to revise the No Surprises Act, which attempted to address high medical bills associated with out-of-network providers, including provisions intended to address the backlog of payment disputes in the federal independent dispute resolution process. The committee was expected to hold stakeholder roundtables with physicians, insurers, employers, and independent arbitrators, with a committee roundtable later this month and a potential hearing with HHS in November. The House Ways & Means Committee is also working on changes to the law, which may not materialize until next Congress.
REGULATORY UPDATE
On August 27, the Centers for Medicare & Medicaid Services (CMS) allowed a six-month moratorium on accepting new Medicare enrollment applications from durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) to expire. Beginning October 15, CMS will implement a nationwide, one-year Probationary Prior Authorization process for certain DMEPOS items billed by newly enrolled suppliers and suppliers undergoing certain changes of ownership. Under the process, suppliers must obtain prior authorization (PA) for covered items before Medicare payment.
On September 8, the Substance Abuse & Mental Health Services Administration (SAMHSA) announced $383.4 million in grants for behavioral health treatment, prevention, and crisis response, including $252 million for the 988 Suicide & Crisis Lifeline, suicide prevention, and mobile crisis services. The awards also include $81.4 million for substance use treatment and prevention and $50 million for mental health programs, including initiatives supporting opioid overdose prevention, substance use disorder treatment, behavioral health integration, and community-based crisis services. SAMHSA stated that the awards include $205.8 million for state and territory 988 capacity, $19.9 million for Tribal 988 response, and $12.4 million for mobile crisis team partnerships.
On September 8, HHS announced the selection of four senior leaders at the Food & Drug Administration (FDA): Jared Seehafer as Deputy Commissioner for Technology and Artificial Intelligence; Michael Davis as Director of the Center for Drug Evaluation and Research (CDER); Karim Mikhail as Director of the Center for Biologics Evaluation and Research (CBER); and Bret Koplow as Director of the Center for Tobacco Products (CTP).
On September 8, CMS announced that 11 DMEPOS suppliers were placed on the Medicare Preclusion List following the identification of more than $3.4 billion in suspected fraudulent billing during 2025 and 2026. CMS stated that the suppliers had engaged in improper billing practices, including submitting claims for deceased beneficiaries and equipment that beneficiaries did not request or receive. CMS also reported that payment-suspension authorities prevented nearly $24 million in payments from reaching two suppliers.
On September 9, CMS announced $4.8 million in Rural Health Transformation Program (RHTP) funding for West Virginia to support rural health workforce recruitment and preventive care. The funding includes $2.4 million for a statewide recruitment and relocation program for licensed health care professionals, with a first-year goal of recruiting at least 125 professionals, and nearly $2.4 million for worksite clinics and employer-based health care services. The announcement also identified additional funding opportunities to support home dialysis, medical transportation, and telehealth services.
On September 9, FDA announced a public meeting of the Vaccines and Related Biological Products Advisory Committee to discuss and make recommendations on strain selection for influenza virus vaccines for the 2027 Southern Hemisphere influenza season. The meeting will be held virtually on October 1. Comments are due by September 29 and comments received by September 24 will be provided to the Committee.
On September 9, FDA announced a proposed information collection to survey health care providers about barriers to patient enrollment in pregnancy exposure registries and approaches to improve pregnancy safety data collection. The voluntary survey would target 400 physicians, pharmacists, and other health care providers and examine their awareness of registries, referral practices, and barriers to enrollment. FDA stated that the results would inform regulatory guidance for sponsors and investigators developing pregnancy exposure registry protocols. Comments are due by November 9.
On September 10, CMS announced $11.7 million in RHTP funding for Vermont to expand rural nursing home capacity and strengthen the health care workforce. Vermont will use $9 million for tuition benefits for health care professionals who commit to serving rural communities for at least five years after graduation, while $2.7 million will support three rural nursing homes and training for Licensed Nursing Assistants. The funding will also support ventilators for rural nursing homes and a dialysis facility within a Vermont nursing home.
On September 10, CMS finalized an updated national coverage determination (NCD) for transcatheter aortic valve replacement (TAVR). The updated NCD provides Medicare coverage, under Coverage with Evidence Development (CED), for TAVR in certain patients with asymptomatic severe aortic stenosis. Additionally, the updated NCD ends CED requirements for TAVR for symptomatic severe aortic stenosis and for uses that are not FDA approved. Previously approved and ongoing TAVR CED studies will be transitioned to the Investigational Device Exemption (IDE) coverage pathway without interruption.
WHITE HOUSE
On September 10, the White House announced that the federal government will issue $500 refunds to nearly 1 million federal health insurance exchange enrollees in 30 states that do not receive premium assistance. The White House stated that eligible enrollees will begin receiving checks next month and attributed the refunds to excess exchange user fees collected under the Biden Administration. The announcement also referenced prior administration actions involving Marketplace integrity, health care price transparency, prescription drug prices, and health savings accounts.
RULES AT THE WHITE HOUSE OFFICE OF MANAGEMENT & BUDGET (OMB)
Pending Review
CMS
Exchange Pre-Enrollment Eligibility Verification (CMS-9873); Proposed Rule; 04/22/2026
Strengthening the Integrity of Medicaid and CHIP Managed Care, Financing, and Access to Care (CMS-2450); Proposed Rule; 05/12/2026
Short-Term, Limited-Duration Insurance (CMS-9881); Proposed Rule; 05/30/2026
Guarding U.S. Medicare Against Rising Drug Costs (GUARD) Model (CMS-5546); Final Rule; 06/15/2026
Global Benchmark for Efficient Drug Pricing (GLOBE) Model (CMS-5545); Final Rule; 06/26/2026
Cutting Administrative Requirements for Excellence in Patient Care (CMS-3484); Proposed Rule; 07/02/2026
Patient Protection and Affordable Care Act; State Innovation Waivers and Health Care Choice Compacts (CMS-9877); Proposed Rule; 07/13/2026
Contract Year 2028 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicare Cost Plan Program, and PACE (CMS-4214); Proposed Rule; 07/20/2026
Clinical Laboratory Improvement Amendments of 1988 (CLIA) Virtual Access, Gynecologic Cytology Proficiency Testing (PT), Personnel Qualification Requirements, and Other Changes (CMS-3478); Proposed Rule; 07/20/2026
Transparency in Coverage (CMS-9882); Final Rule; 07/27/2026
Comprehensive Regulations to Uncover Suspicious Healthcare (CRUSH) (CMS-6098); Proposed Rule; 08/07/2026
Request for Information: Medicare Part D Reasonable and Relevant Pharmacy Contracting Standards (CMS-4217); Notice; 08/19/2026
Amendments to Rules Governing Organ Procurement Organizations (CMS-3409); Final Rule; 08/20/2026
Private Health Insurance; New Agent/Broker Registrations for Plan Year 2027 Moratorium Guidance; Notice; 09/04/2026
Medicare Drug Price Negotiation Program (CMS-4215); Final Rule; 09/09/2026
FDA
Cannabidiol (CBD) Products Compliance and Enforcement Policy; Notice; 03/13/2026
Action Levels for Cadmium in Processed Food Intended for Babies and Young Children; Draft Guidance for Industry; Notice; 05/22/2026
Requirements for Additional Traceability Records for Certain Foods: Enforcement Policy for Certain Retail Food Establishments and Restaurants; Notice; 06/01/2026
New Dietary Ingredient (NDI) Notifications and Related Issues; Identity and Safety Information About the NDI: Guidance for Industry; Notice; 06/02/2026
Requirements For Additional Traceability Records For Certain Foods: Compliance Date Extension; Final Rule; 06/03/2026
Rulemaking to Provide by Regulation that an Ingredient Is Not Excluded From the Dietary Supplement Definition; Proposed Rule; 06/05/2026
Administrative Detention of Tobacco Products; Proposed Rule; 07/09/2026
U.S.-Origin Statements on Seafood; Draft Guidance for Industry; Notice; 07/10/2026
White Paper: Proposed Definition of Ultra-Processed Food; Notice; 08/03/2026
Use of Formaldehyde and Formaldehyde-Releasing Chemicals as an Ingredient in Hair Smoothing Products or Hair Straightening Products; Proposed Rule; 08/06/2026
Cheeses and Related Cheese Products; Proposal to Permit the Use of Ultrafiltered Milk and Microfiltered Milk; Final Rule; 08/28/2026
Sunlamp Products; Amendment to the Performance Standard; Final Rule; 09/09/2026
Validation of Certain In Vitro Diagnostic Devices for Emerging Pathogens During a Section 564 Declared Emergency; Guidance for Industry and Food and Drug Administration Staff; Availability; Notice; 09/10/2026
HEARINGS
House
Judiciary Administrative State, Regulatory Reform, and Antitrust Subcommittee
Examining Healthcare Markets: Fraud and Competition
September 14; 9 AM EST; Charlotte, NC
Witnesses: Brian Miller, Associate Professor of Medicine, Johns Hopkins University and Vice Chairman, North Carolina State Health Plan; Brian Blase, President, Paragon Health Institute; and Katherine Martin, Vice President of Health Affairs, University of North Carolina System
Oversight and Government Reform Health Care and Financial Services Subcommittee
Unequal Treatment: Addressing the Drivers of Unaffordability for Oral Chemotherapy
September 15; 10 AM EST; 2154 Rayburn
Witnesses: TBA
Energy & Commerce Health Subcommittee
September 15; 9:15 AM EST; 1334 Longworth
Health care legislation under considered:
H.R. 9693, Patients First Act of 2026
H.R. 8163, Provider Reimbursement Stability Act of 2026
H.R. 8622, Medicare Physician Data-driven Performance Payment System Act of 2026
H.R. 7863, Promoting Fairness for Medicare Providers Act of 2026
H.R. 4331, Access to Claims Data Act
H.R. 5737, Radiology Outpatient Ordering Transmission (ROOT) Act
H.R. ___, [Health Care Cybersecurity and Resiliency Act of 2026]
H.R. 9908, Rural Hospital Cybersecurity Enhancement Act
H.R. 3164, Ensuring Community Access to Pharmacist Services Act
H.R. 1521, Dental and Optometric Care (DOC) Access Act of 2025
H.R. 6130, ASAP Act
H.R. 1189, National Plan for Epilepsy Act
H.R. 1254, Rural Obstetrics Readiness Act
H.R. 7905, Diabetes Foot Health Access and Modernization Act of 2026
H.R. 1616, Promoting Access to Diabetic Shoes Act
H.R. 6214, Kidney Care Access Protection Act
H.R. 8319, KIDNEY Remote Monitoring Act
Science, Space, and Technology Committee
Oversight Subcommittee
Balancing Biotechnology Innovation and Biosecurity: Securing U.S. Leadership in a Global Race
September 16; 10 AM EST; 2318 Rayburn
Witnesses: Anemone Franz, Visiting Research Fellow, American Enterprise Institute; Joshua Hodges, Visiting Fellow, Hoover Institution; and Dr. Gigi Gronvall, Professor, Bloomberg School of Public Health, Johns Hopkins
Ways & Means Committee
Markup of health care legislation
September 16; Time TBA; Location TBD
Bills to be considered: TBA
Senate
Finance Committee
September 15; 10 AM EST; 215 Dirksen
Health care nominations under consideration: Chris Klomp to be Deputy Secretary of HHS; and Ge Bai to be an Assistant Secretary of HHS
HELP Committee
September 16; 10 AM EST; 430 Dirksen
Health care nominations under consideration: Chris Klomp to be Deputy Secretary of HHS; Nicole Saphier to be Medical Director in the Regular Corps of the Public Health Service and Surgeon General of the Public Health Service; and Timothy Westlake to be Assistant Secretary for Mental Health and Substance Use
REPORTS
Office of Inspector General (OIG)
On September 8, HHS OIG posted an audit report finding that South Carolina did not ensure that three selected Medicaid managed care organizations (MCOs) complied with mental health and substance use disorder (MH/SUD) parity requirements related to PA during CY 2023. OIG stated the three MCOs could not provide accurate and complete data on services requiring PA, that the state did not review and validate the MCOs' denial data, and that two of the three remained noncompliant more than six years after the October 2017 compliance deadline. OIG recommended that South Carolina implement monitoring policies and procedures, and the state agreed.
On September 8, HHS OIG posted an audit report finding that California should have reported $231.2 million in Medicaid overpayments ($99.3 million federal share) identified by its Medicaid Fraud Control Unit (MFCU) across 26 cases during federal fiscal year 2023. OIG stated that California did not report and return $113.3 million ($47.8 million federal share) for 14 cases and did not report $74.9 million ($32.1 million federal share) for another 14 cases within the required timeframe. OIG made four recommendations, including that California return the federal share of the unreported overpayments; the state concurred with three and did not concur with one.