Health Care Watch: September 20, 2026
The following Federal Health Policy (FHP) Strategies Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from September 13 – September 19. 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 14, Energy & Commerce Committee Ranking Member Frank Pallone, Jr. (D-NJ), Health Subcommittee Ranking Member Diana DeGette (D-CO), and Oversight & Investigations Subcommittee Ranking Member Yvette Clarke (D-NY) wrote to Centers for Disease Control and Prevention (CDC) Director Dr. Erica Schwartz requesting a briefing on the agency's handling of two measles-related deaths in Pennsylvania. The lawmakers argued in the letter that CDC had departed from routine reporting practices and removed prior references to the deaths from its public database. The letter stated that Pennsylvania's Department of Health had provided CDC with the relevant epidemiological data. The lawmaker requested that CDC officials brief Committee staff by September 28.
On September 14, the Judiciary Administrative State, Regulatory Reform, and Antitrust Subcommittee held a field hearing on “Examining Healthcare Markets: Fraud and Competition.” The hearing examined the effects of mergers, certificate-of-need laws, regulation, vertical integration, and fraudulent insurance practices on healthcare access and affordability.
On September 15, the Oversight and Government Reform Health Subcommittee held a hearing titled, “Unequal Treatment: Addressing the Drivers of Unaffordability for Oral Chemotherapy.”
On September 15, the Energy & Commerce Health Subcommittee held a legislative hearing titled, “Examining Legislative Proposals to Reform Medicare Provider Payment and Bolster Health Care Cybersecurity.” Members discussed modernizing the Medicare physician fee schedule, supporting rural hospitals and practitioners, expanding Medicare coverage for certain pharmacist services, and improving cybersecurity preparedness against breaches affecting health care providers and health insurance plans. The hearing agenda also included two kidney reform bills.
On September 16, the Science, Space, and Technology Committee Oversight Subcommittee held a hearing titled, “Balancing Biotechnology Innovation and Biosecurity: Securing U.S. Leadership in a Global Race.” Members discussed whether the U.S. biotechnology enterprise is adequately protected, the role of artificial intelligence in both accelerating drug discovery and biomanufacturing and lowering barriers to biological misuse, and U.S. competitiveness with China in the sector.
On September 16, the Ways & Means Committee held a markup of health care legislation, including the Apples-to-Apples Comparison Act of 2025 which would provide more data and greater transparency around Medicare spending; the Alzheimer’s Screening and Prevention (ASAP) Act of 2025, which would provide Medicare coverage of Alzheimer’s and dementia early detection screening tests; and the Medically Tailored Home-Delivered Meals Program Pilot Act, which would create a Medicare pilot to provide Medically Tailored Meals (MTMs) to seniors with diet-related diseases like heart disease, diabetes, or COPD across 40 hospitals. The three bills were favorably reported to the full House.
On September 16, the Budget Committee advanced the Preventive Health Savings Act (H.R. 4464), sponsored by Rep. Jay Obernolte (R-CA), by a vote of 29-0. The bill would establish a mechanism for the Congressional Budget Office (CBO) to assess, upon a bipartisan request, the budgetary savings of preventive health care legislation over a 30-year window, rather than the standard 10-year scoring window.
The House is in recess and is scheduled to return on November 9.
Senate
On September 15, the Finance Committee held a nomination hearing which included Deputy Secretary of the Department of Health & Human Services (HHS) nominee Chris Klomp and Assistant Secretary nominee Ge Bai. Senate Finance Committee Ranking Member Ron Wyden (D-OR) and Sen. Elizabeth Warren (D-MA) pressed Klomp for details about Most Favored Nation (MFN) agreements. Klomp responded that maintaining the agreements’ confidentiality is necessary to secure similar deals with other manufacturers.
On September 16, the Health, Education, Labor & Pensions (HELP) Committee held a hearing for the nominations of 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 the Substance Abuse and Mental Health Services Administration (SAMHSA).
On September 16, Sen. Elizabeth Warren (D-MA) and Rep. Val Hoyle (D-OR) introduced the Stop Corporate Takeovers of Physicians Act, which would prohibit private equity funds, insurance companies, and other for-profit corporations from owning or controlling medical practices. The sponsors stated the bill would close the "friendly physician" loophole used to circumvent state-level bans, prohibit management services organizations (MSOs) from controlling clinical and business functions, and bar certain restrictive contract terms such as non-compete agreements. A press release can be found here. A one pager can be found here.
REGULATORY UPDATE
On September 14, CMS announced nearly $17 million in funding for rural health care providers in Kansas through the Rural Health Transformation Program (RHTP). Of that total, $16 million will support Emerging Technology Grants for 14 rural providers to adopt tools such as remote patient monitoring and diagnostic technology, and $780,000 will fund an Interfacility Transport Project to improve regional patient transportation. CMS stated the awards build on more than $80 million in RHTP funding previously announced for Kansas.
On September 14, CMS announced a $1.25 million investment to expand school-based health centers, telehealth, and mobile care for children in rural North Carolina through the RHTP. CMS stated the funding would support new and expanded school-based health centers and increased capacity at existing rural locations. The agency stated the award builds on $10 million previously announced for 39 local EMS agencies in the state.
On September 15, CMS announced that it will expand the Advancing Chronic Care with Effective, Scalable Solutions (ACCESS) Model beginning in spring 2027 to provide technology-supported, ongoing care options for Original Medicare beneficiaries with heart failure, COPD, substance use disorders, and nicotine dependence. The model supports participating organizations in delivering care between regular provider visits, including through virtual care, health coaching, remote monitoring, and connected devices. ACCESS uses an outcomes-based payment approach that ties payment to measurable improvements in patient health rather than solely to individual services. CMS stated 160 organizations are participating at launch.
On September 15, SAMHSA announced supplemental funding for Alabama, Kansas, and West Virginia to expand the role of faith-based organizations in substance use prevention. Each state is receiving an additional $500,000 under its Strategic Prevention Framework-Partnerships for Success grant. HHS stated the funding would support regional needs assessments, new partnerships with faith communities, and youth-focused prevention planning.
On September 15, CMS announced more than $104 million in RHTP funding for Mississippi to support 167 grants across rural provider technology, care-gap closure, and telehealth. CMS stated the awards would fund technology and cybersecurity upgrades, diagnostic and surgical equipment, expanded maternal and behavioral health services, and remote patient monitoring. CMS stated the funding is part of a larger fiscal year 2026 RHTP allocation to the state.
On September 15, FDA announced the final design of its Expedited Investigational New Drug (IND) Pilot. FDA stated the pilot pairs drug sponsors with qualified research institutions (QRIs) to prepare IND applications, allowing the agency to review individual components on a rolling basis during the pre-IND phase rather than waiting for a complete submission. FDA stated the pilot is intended to shorten the time from drug identification to first-in-human clinical trials and is part of HHS’ Operation TrialBlazer. Applications are open until October 30. FDA expects to select 8-10 sponsor-QRI pairs for the initial cohort. A press release can be found here.
On September 17, CMS announced a $50 million investment for four rural hospital systems in Connecticut through RHTP to modernize facilities, expand service capacity, and stabilize infrastructure. CMS stated the funding is part of a larger fiscal year 2026 RHTP allocation to the state.
On September 17, the Agency for Healthcare Research and Quality (AHRQ) announced the appointment of eight new members to the U.S. Preventive Services Task Force (USPSTF). HHS stated the new members will join eight members currently serving. Seth J. Corey, MD, MPH, a pediatric hematologist-oncologist at Cleveland Clinic, was named Chairman.
On September 17, the Advanced Research Projects Agency for Health (ARPA-H) announced the launch of the Systems for Phenotypic Evaluation, Clinical Trajectories, Response, and Agency (SPECTRA) program, a research effort focused on autism diagnosis and care. ARPA-H stated the program will integrate biological, clinical, behavioral, and real-world data with computational tools to enable earlier diagnosis and more individualized approaches to care. ARPA-H is seeking cross-disciplinary proposals across four focus areas: analysis, modeling, precision intervention, and enabling technologies.
On September 17, HHS issued a Request for Information (RFI) seeking evidence on the potential health effects of electromagnetic fields (EMFs), radiofrequency (RF) radiation, and wireless radiation exposure. HHS stated the RFI would help it evaluate the state of the science, compare U.S. and international safety standards, identify research gaps, and develop recommendations for policymakers. HHS is seeking input across six areas, including existing scientific evidence, exposure standards, and potentially sensitive populations such as children and people with implanted medical devices. Comments are due by October 21.
On September 17, CMS announced a $167 million investment for South Carolina through the RHTP to support 228 grants for rural care sites, health technology upgrades, and prevention. CMS stated the funding is to access primary care, maternal and infant health, pediatrics, wellness, and behavioral health through new and modernized care locations, mobile units, telehealth, and other healthcare technologies such as local 24-hour pharmacy kiosks.
On September 17, FDA approved Fayuvi (rebisufligene etisparvovec-hopf), the first gene therapy for pediatric patients with mucopolysaccharidosis type IIIA (MPS IIIA), also known as Sanfilippo syndrome type A. FAYUVI, developed by Ultragenyx Pharmaceutical, is a one-time intravenous adeno-associated virus serotype 9 (AAV9) gene therapy that delivers a functional copy of the SGSH gene to enable production of sulfamidase, the enzyme deficient in MPS IIIA.
On September 18, the Office of the Assistant Secretary for Financial Resources (ASFR), announced a new department-wide policy establishing a recurring forecast of anticipated HHS purchases of personal protective equipment (PPE) covered by the Make PPE in America Act. HHS stated the forecast will require every HHS division to maintain and quarterly update projections of anticipated PPE needs, which will be consolidated and published to give domestic manufacturers visibility into future demand. HHS stated the first department-wide quarterly update is due October 15, with subsequent updates due January 15, April 15, and July 15 each year.
WHITE HOUSE
On September 14, President Trump sent to the Senate the nomination of Dr. Heidi Overton to be Commissioner of the FDA.
On September 18, President Trump held a White House briefing announcing that all 50 states, the District of Columbia, and Puerto Rico had agreed to participate in the GENEROUS Model. President Trump noted that all states “signed up almost immediately.” The model will provide participating Medicaid programs access to MFN pricing for certain prescription drugs. CMS Innovation Center Director Abe Sutton who attended the briefing stated that as a result of the states’ participation, GENEROUS is estimated to generate ~$5.2 million in annual savings and ~$64 billion over 10 years.
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
Amendments to Rules Governing Organ Procurement Organizations (CMS-3409); Final Rule; 08/20/2026
Medicare Drug Price Negotiation Program (CMS-4215); Final Rule; 09/09/2026
Patient Protection and Affordable Care Act; Temporary Moratorium on Certain Agent and Broker Participation in the Exchanges (CMS-9872); Interim Final Rule; 09/16/2026
CY 2027 Hospital Outpatient PPS Policy Changes and Payment Rates and Ambulatory Surgical Center Payment System Policy Changes and Payment Rates (CMS-1850); Final Rule; 09/17/2026
CY 2027 Changes to the End-Stage Renal Disease (ESRD) Prospective Payment System and Quality Incentive Program (CMS-1846); Final Rule; 09/17/2026
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
Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products: Questions and Answers; Guidance for Industry; Availability; Notice; 09/11/2026
Improving Patient Access to Deceased Donor Islet Cells and Cell Products; Request for Information; Notice; 09/15/2026
Regulatory Considerations for Prescription Drug Use-Related Software; Guidance for Industry; Availability; Notice; 09/15/2026
Potency Assurance for Cellular and Gene Therapy Products; Guidance for Industry; Availability; Notice; 09/17/2026
HEARINGS
Senate
Aging Committee
Leveling the Playing Field: Restoring America’s Edge in Generic Drug Manufacturing
September 23; 3:30 PM EST; 216 Hart
Witnesses: TBA
HELP Committee
Nomination of Heidi Overton to be Commissioner of Food and Drugs
September 24; 10:30 AM EST; 430 Dirksen
Witness: Dr. Heidi Overton
REPORTS
Office of Inspector General (OIG)
On September 14, the HHS OIG posted an issue brief that found Medicare Advantage organizations (MAOs) and CMS can do more to prevent durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) fraud in the Medicare Advantage (MA) program, noting that CMS’ fraud-prevention efforts have focused mainly on fee-for-service Medicare even though the Agency spends more money on MA. OIG identified the following gaps in supplier screening: MAOs conduct fewer checks of out-of-network suppliers than in-network suppliers, CMS does not screen all DMEPOS suppliers before they bill MA because not all are enrolled in Medicare, and the Preclusion List has limitations in preventing fraud. OIG recommended that CMS ensure MAOs strengthen checks of out-of-network suppliers, strengthen use of the Preclusion List, and require that all DMEPOS suppliers billing MA be enrolled in Medicare (or seek statutory authority to do so). CMS concurred with or said it would take into consideration all of the recommendations.
On September 15, HHS OIG posted an MA compliance audit that found most of the high-risk diagnosis codes UnitedHealthcare (UHC) of Wisconsin submitted to CMS for use in the risk adjustment program did not comply with federal requirements. For 183 of 250 sampled enrollee-years, medical records did not support the submitted diagnosis codes, resulting in $722,280 in overpayments. OIG estimated the plan received at least $46.9 million in overpayments for 2020 and 2021. The audit is part of an ongoing OIG series reviewing high-risk diagnosis codes MAOs submitted for risk adjustment. OIG made four recommendations, including that UHC refund the estimated $46.9 million. UHC disagreed with some of the findings and requested that OIG withdraw all recommendations.
On September 15, HHS OIG posted an MA compliance audit that found most of the high-risk diagnosis codes HumanaChoice submitted to CMS for use in the risk adjustment program did not comply with federal requirements. For 178 of 220 sampled enrollee-years, medical records did not support the submitted diagnosis codes, resulting in $669,237 in overpayments. OIG estimated HumanaChoice received at least $130.9 million in overpayments in 2020 and 2021. OIG made four recommendations including that Humana refund the estimated $130.9 million. Humana disagreed with some of the findings and all of the recommendations.
On September 16, HHS OIG posted a Medicare hospital provider compliance audit of McLeod Regional Medical Center (Florence, SC), part of an ongoing series auditing hospitals with a high volume of claims identified as high-risk for noncompliance. Of 115 inpatient and outpatient claims reviewed (totaling $1,516,496), OIG found the hospital did not fully comply with Medicare billing requirements for 17 claims, resulting in net overpayments of $38,676 for the 2020-2021 audit period. OIG recommended the hospital refund the overpayments, conduct internal audits of post-audit-period claims, and provide additional billing training. Hospital officials agreed with most findings and said it would refund the amount.
On September 14, HHS OIG issued a Medicare hospital provider compliance audit finding that Methodist Hospital (San Antonio, Texas) received at least $12.4 million in estimated net Medicare overpayments. Of 100 inpatient and outpatient claims reviewed (totaling $1,426,020), OIG found the hospital did not fully comply with Medicare billing requirements for 27 and extrapolated an estimated $12.4 million net overpayment against the roughly $62 million Medicare paid the hospital during the 2020-2021 audit period. OIG recommended the hospital refund the overpayments, conduct internal audits of post-audit-period claims, and provide additional billing training. Hospital officials did not concur with the first two recommendations but said it is willing to conduct education.
Government Accountability Office (GAO)
On September 17, GAO released a report finding that CMS needs improved oversight of state Medicaid eligibility-error corrective action plans (CAPs). GAO reviewed state-specific Payment Error Rate Measurement (PERM) reports for reporting years 2019 through 2025 and Medicaid Eligibility Quality Control (MEQC) results and CAPs from seven selected states. It found that caseworker errors were generally the most prevalent root cause of eligibility errors and identified two oversight gaps: CMS has accepted PERM CAPs that lacked elements required by federal regulations, and it does not systematically analyze errors and corrective actions across states and reporting years to identify common issues. GAO recommended that CMS ensure states’ PERM CAPs contain all required elements before accepting them and systematically analyze PERM and MEQC eligibility-error results and associated corrective actions across states and reporting years to help states reduce eligibility errors. CMS agreed with the second but asked that the first be closed, stating its routine oversight is sufficient.
On September 15, GAO released a report examining coverage of non-excepted abortion services by qualified health plans (QHPs) on the health insurance exchanges in 2026. Under federal law, QHPs may cover such services consistent with federal and state law but are prohibited from using federal funds (such as income-based tax credits) to pay for abortion services outside limited exceptions. GAO found that 26% of QHPs across the 50 states and DC covered non-excepted abortion services in 2026, with coverage varying largely by state law. Among 15 selected issuers, all complied with the federal requirement to estimate the cost of this coverage at no less than $1 per enrollee per month, though GAO identified instances where issuers' practices may have been inconsistent with other federal requirements. CMS said in August 2026 it would determine what actions to take based on the facts.
ADDITIONAL POLICY NEWS
On September 10, BMJ published a population-based retrospective cohort study examining potentially inappropriate prescribing cascades (PIPCs) among community-dwelling older adults in Ontario, Canada. The study drew on a source population of roughly 2.3 million adults aged 66 and older and assessed 65 prescribing cascades identified through a 2025 international expert consensus. The authors identified 24 high-priority drug combinations in which a drug prescribed to treat one medication's side effect may itself be unnecessary or harmful, and stated the prioritized list could inform prescribing, deprescribing, and clinical decision-support efforts.
On September 13, Lancet published a cohort study modeling the projected effect of CMS’ MFN payment models for prescription drugs (GLOBE for Medicare Part B and GUARD for Medicare Part D) on Medicare spending. The authors estimated net Medicare spending reductions of $5.2 billion (16.1%) under GLOBE and $6.4 billion (17.6%) under GUARD across 195 brand-name drugs. The study estimated that excluding drugs made by the initial 17 manufacturers with announced confidential agreements with the Administration would reduce projected savings by 71.3%. The authors noted that projected Medicare reductions would often exceed the drugs' total annual sales in reference countries, which they stated could incentivize manufacturers to delay launches or raise prices abroad.
On September 15, Johnson & Johnson (J&J) imposed a new claims-data reporting requirement for 340B covered entities seeking to receive discounted J&J drugs at the point of sale. Under the policy, covered entities must submit claims data for each J&J drug dispensed or administered. Entities that do not comply may lose access to 340B discounts on J&J products. J&J stated that the requirement is intended to identify and address prohibited duplicate discounts and diversion.