Health Care Watch: October 11, 2026
The following Federal Health Policy (FHP) Strategies Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from October 5 – October 10. 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 October 8, Energy & Commerce Committee Ranking Member Frank Pallone (D-NJ) introduced the Lower Premiums, Faster Payments Act, which would end the independent dispute resolution (IDR) process for out-of-network items and services furnished on or after January 1, 2028. The out-of-network payment amount would instead be the qualifying payment amount, recalculated as a plan's median contracted rate as of January 31, 2019, adjusted for inflation, and plans would be required to pay within 30 days after a provider transmits a bill. The bill would also bar judicial review of the qualifying payment amount methodology and require annual audits of plans' qualifying payment amount calculations. A press release can be found here.
The House is in recess and is scheduled to return on November 9.
Senate
On October 5, Sens. Angus King (I-ME), Patty Murray (D-WA), and Elizabeth Warren (D-MA) led 14 Senate colleagues in a letter to Department of Health & Human Services (HHS) Secretary Robert F. Kennedy, Jr., requesting information on recent changes to the U.S. Preventive Services Task Force (USPSTF) regarding the September 17 appointment of eight new members. The letter argued that the appointments break from the historic makeup of USPSTF membership that is typically composed of preventionists and primary care practitioners. The senators also questioned the shortened nomination timeline, the removal of the Task Force’s two vice chairmen in May, the absence of conflict-of-interest disclosures for new members, and staffing reductions at the Agency for Healthcare Research & Quality (AHRQ). The senators requested a response by October 15.
On October 7, Sen. Michael Bennet (D-CO) and Rep. Kim Schrier (D-WA) led 29 colleagues in a letter to Centers for Disease Control and Prevention (CDC) Director Dr. Erica Schwartz requesting information on CDC's role in implementing President Trump's executive order (EO) on childhood vaccine recommendations and a related HHS request for information (RFI) on the childhood immunization schedule. The lawmakers also asked about CDC's public reporting of measles-associated deaths reported by Pennsylvania, which the letter argued CDC excluded from its public count, and about the timing of COVID-19 vaccine ordering through the Vaccines for Children program. The lawmakers requested responses by October 16.
The Senate is in recess and is scheduled to return on November 9.
REGULATORY UPDATE
On October 2, the Food & Drug Administration (FDA) released a Transparency Roadmap describing fiscal year 2026 milestones and fiscal year 2027 priorities for public disclosure of agency information. FDA stated that it plans to continue disclosing complete response letters and to pursue rulemaking to publicly disclose the fact of submission of New Drug Applications (NDAs), Biologics License Applications (BLAs), Abbreviated New Drug Applications (ANDAs), and related major applications. The agency also stated that it plans to publish clinical study reports for approved applications and to proactively publish redacted Form 483s and establishment inspection reports. The roadmap further stated that FDA intends to issue a final rule requiring a one-page Patient Medication Information document for outpatient prescription drugs and is exploring new rules and guidance on direct-to-consumer advertising.
On October 3, the Centers for Medicare & Medicaid Services (CMS) released frequently asked questions (FAQs) on a one-time $90 Medicare Part B premium rebate, funded through the Medicare Improvement Fund, that President Trump announced on October 2. According to CMS, the rebate is available to approximately 20.8 million Original Medicare Part B enrollees living in the U.S. who do not receive Medicaid premium assistance or pay an income-related monthly adjustment amount. CMS stated that most eligible beneficiaries would receive the payment by direct deposit from the Social Security Administration on or around October 8, with paper checks from the Department of the Treasury to follow later in October.
On October 4, HHS announced President Trump's appointment of Michael Caputo, former HHS Assistant Secretary for Public Affairs, to the President’s Cancer Panel. The panel is a federal advisory body established under the National Cancer Act of 1971 that monitors the National Cancer Program and reports to the President on its progress.
On October 5, HHS, the Department of Labor, and the Department of the Treasury released the "Transparency in Coverage" final rule, which amends price transparency reporting requirements for group health plans and health insurance issuers. The rule restructures the in-network rate and out-of-network allowed amount machine-readable files and changes their reporting frequency from monthly to quarterly. It also requires plans and issuers to provide personalized cost-sharing information by phone. HHS stated that the agencies plan to begin developing the prescription drug file in November, with plans and issuers expected to publish those files starting in December 2027. A fact sheet can be found here. A press release can be found here.
On October 5, FDA issued an RFI on approaches the agency is considering for the design of early-phase clinical trials of ibogaine drug products. The RFI seeks comments, data, and information on general study design, dose selection and escalation, including a starting dose not exceeding 10 mg/kg, safety monitoring for cardiac and neurologic adverse events, and ethical and oversight considerations. Comments are due November 20.
On October 7, CMS announced more than $17 million in Rural Health Transformation Program (RHTP) funding for mental health and substance use disorder services in rural North Carolina. According to CMS, the funding includes $4 million for three new mental health clinics, $3 million to expand access to medications for opioid use disorder in five counties, $4 million for mobile crisis teams in six additional counties, and $6.7 million for early intervention, regional crisis partnerships, and perinatal mental health care.
On October 7, FDA filed a court-ordered status report in State of Louisiana v. FDA in the U.S. District Court for the Western District of Louisiana on its ongoing review of the mifepristone Risk Evaluation and Mitigation Strategy (REMS). FDA reported that it is conducting a safety study using data from its Sentinel system that compares outcomes for approximately 100,000 women who used mifepristone with a comparator group of similar size, and that it expects study results by mid-December and a completed report no later than March 2027. FDA stated that its REMS review also covers pending citizen petitions, including requests to reinstate the in-person dispensing requirement, as well as reconsideration of its 2023 REMS modifications as directed by federal courts in Hawaii and Virginia.
On October 8, the HHS Office of the Assistant Secretary for Planning and Evaluation (ASPE) released a report examining growth in the 340B Drug Pricing Program and financial incentives associated with the difference between discounted drug acquisition costs and reimbursement. ASPE argued that these margins may encourage higher-cost drug use, provider consolidation, and revenue generation over patient needs. Its analysis of Medicare hospital outpatient claims found that inflation-adjusted payments for 340B drugs furnished by providers subject to the former payment reduction increased from $7.1 billion in 2021 to $10.7 billion in 2023, following the reversal of the average sales price (ASP) minus 22.5% payment policy. The report also discusses CMS’ current proposal to reimburse certain 340B-acquired drugs at ASP minus 33.4% under the Calendar Year (CY) 2027 Hospital Outpatient Prospective Payment System proposed rule, which ASPE stated could better align payments with acquisition costs and reduce beneficiary coinsurance.
On October 8, CMS released the 2027 Medicare Advantage (MA) and Part D Star Ratings, which will appear on Medicare Plan Finder for the open enrollment period running October 15 through December 7 and will affect 2028 MA quality bonus payments. CMS reported that 188 MA prescription drug (MA-PD) contracts earned four or more stars, covering approximately 71% of MA-PD enrollees, and that the enrollment-weighted average MA-PD rating was 3.99 (compared with 4.01 in 2026). CMS also reported that 15 MA-PD contracts earned five stars, and four received a low-performing icon. Among standalone prescription drug plans (PDPs), 11 contracts earned four or more stars, the share of PDP enrollees in such plans rose to approximately 22% from 2% in 2026, and the enrollment-weighted average PDP rating increased to 3.22 from 3.01. Methodology changes for 2027 include two new Part D measures on concurrent use of opioids and benzodiazepines and on use of multiple anticholinergic medications in older adults, an increase in the weight of the Improving or Maintaining Physical Health and Mental Health measures from one to three, and the temporary removal of the Medication Therapy Management (MTM) Program Completion Rate for Comprehensive Medication Review measure, which CMS stated will return beginning with the 2029 Star Ratings.
On October 8, HHS announced a series of actions related to the reporting, study, and care of health problems reported following vaccination. According to HHS, the actions include a National Institutes of Health (NIH) clinic that opened on October 5 to evaluate and treat such patients, a CMS proposal to reimburse physicians for submitting suspected vaccine-injury reports to the Vaccine Adverse Event Reporting System (VAERS), and a requirement that electronic health records capture vaccine-related adverse events. HHS also stated that CDC announced a contract on September 28 to modernize VAERS, including mobile access and updated tools for researchers.
On October 9, HHS, through the Administration for Community Living (ACL), announced up to $27.8 million over three years for three falls prevention initiatives for older adults. The awards include $7.5 million to the National Council on Aging (NCOA) to operate the National Falls Prevention Resource Center, approximately $4.8 million to NCOA for a demonstration scaling falls prevention through clinical-community partnerships, and approximately $1.8 million to $1.9 million each to eight state and local organizations to expand evidence-based programs. The funded programs include CDC’s Stopping Elderly Accidents, Deaths & Injuries (STEADI) initiative and the Stepping On community program.
On October 9, HHS launched the Newborn Essentials Support Toolkit (NEST) Program, which provides families with a one-time kit of newborn and postpartum supplies and health information around the time of birth. HHS stated that the program, led by its Office of Intergovernmental and External Affairs in coordination with the Health Resources & Services Administration (HRSA), builds on the Newborn Supply Kit initiative launched in 2023 and will prioritize maternal care deserts, rural communities, and other medically underserved areas. HRSA awarded $5 million to the CDC Foundation to support implementation, and kits will be distributed through hospitals, federally qualified health centers, and other maternity care providers.
On October 9, CMS outlined Iowa’s use of more than $209 million in fiscal year 2026 RHTP funding, which the state is implementing through its Healthy Hometowns initiative. According to CMS, the funding supports clinical and maternal health services, including what CMS described as Iowa’s first Maternal-Fetal Medicine Telehealth Network, as well as rural workforce development, cancer prevention and screening, emergency medical services (EMS) and mobile health, and health information exchange tools connecting more than 100 facilities.
On October 9, CMS announced $37.7 million in fiscal year 2026 RHTP funding for rural health care workforce initiatives in Louisiana, which CMS stated is one part of the state’s overall fiscal year 2026 award. The funding includes up to $20 million to connect Louisiana’s public universities and community and technical colleges with rural health care providers, $12.7 million for recruitment and retention incentives at 53 rural providers, and $5 million for health care career pathways across 39 campuses.
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
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
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
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
CY 2027 Home Health Prospective Payment System Rate Update and Home Infusion Therapy Services Payment Update (CMS-1844); Final Rule; 09/21/2026
CY 2027 Revisions to Payment Policies under the Physician Fee Schedule and Other Revisions to Medicare Part B (CMS-1848); Final Rule; 09/29/2026
Expanding Access to Individual Coverage Health Reimbursement Arrangements (CMS-9876); Proposed Rule; 10/05/2026
FDA
Cannabidiol (CBD) Products Compliance and Enforcement Policy; Notice; 03/13/2026
Requirements For Additional Traceability Records For Certain Foods: Compliance Date Extension; Final Rule; 06/03/2026
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
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
Clinical Trial Enrollment Action Plans to Improve Representation of the U.S. Intended Use Population in Clinical Studies; Notice; 10/06/2026
REPORTS
Office of Inspector General (OIG)
On October 7, HHS OIG released an audit finding that HHS had not made additional progress toward compliance with the Geospatial Data Act of 2018 since OIG’s 2024 audit. OIG found that HHS had not fulfilled certain responsibilities under the law, did not maintain a departmentwide inventory of geospatial data assets, and did not properly prepare its required annual report because its self-assessment did not include all HHS divisions. OIG made four recommendations, including that HHS fulfill the seven remaining covered agency responsibilities under the law and develop an inventory of all geospatial data assets, and HHS concurred with all of them.
Government Accountability Office (GAO)
On October 5, GAO released a report examining drug utilization and payments at pharmacies owned by four large Medicare Part D plan sponsors that are vertically integrated with pharmacy benefit managers and pharmacies. GAO found that, in 2023, pharmacies owned by the four sponsors accounted for about 28% of the Part D drugs provided to their enrollees and about 24% of total payments to pharmacies, primarily through mail-order pharmacies. When paying for a 30-day supply for the 100 most commonly used drugs, which were primarily generics, GAO found that payments and cost sharing were lower at owned pharmacies for at least 94% of the drugs. Payments and cost sharing were also generally lower at owned pharmacies for the drugs with the 100 highest payments, which were primarily brand-name drugs, although for about half of the 20 drugs with the highest payments per 30-day supply, cost sharing was up to about $340 higher at owned pharmacies. GAO stated that its results are not generalizable to other plan sponsors or years.
On October 6, GAO released a report on CMS’ early implementation of the RHTP and its plan to monitor the program. GAO found that CMS awarded $10 billion in first-year funding to all 50 states, ranging from $147 million for New Jersey to $281 million for Texas, for a budget period running December 29, 2025, through October 30, 2026. GAO also found that CMS’ planned monitoring activities, including audits and site visits, are generally consistent with selected federal award monitoring requirements. GAO reported that CMS plans to allot up to $40 billion in remaining funds over the next four years based in part on states’ progress and may withhold, reduce, or recover funding from noncompliant states, and that CMS is still determining how it will handle disputes, as the authorizing law limits states’ ability to appeal funding changes.
ADDITIONAL POLICY NEWS
On October 6, the API Innovation Center (APIIC), a nonprofit that receives federal funding through the Administration for Strategic Preparedness & Response (ASPR), released its National Fragility Index, which scores the structural supply chain fragility of more than 400 medicines. APIIC found that 14 medicines were rated “Severe” and 71 were rated “High”, and that more than 550 million prescriptions were filled in 2023 for medicines in those categories. The analysis rated pantoprazole “Severe”, with no identified U.S. source of its active pharmaceutical ingredient, and rated metoprolol “High”.
On October 7, the Pharmaceutical Research and Manufacturers of America (PhRMA) filed a complaint in the U.S. District Court for the District of Columbia against HHS, CMS, and CMS’ Center for Medicare & Medicaid Innovation (CMMI) challenging the Global Benchmark for Efficient Drug Pricing (GLOBE) Model final rule. The rule would require manufacturers of certain Medicare Part B drugs to pay rebates when U.S. prices exceed an international benchmark based on prices in 19 countries. PhRMA alleges that the rule exceeds CMS’ authority under Section 1115A of the Social Security Actand violates statutory restrictions on using quality-adjusted life years to determine Medicare reimbursement, as well as federal appropriations law. PhRMA also argues that CMS’ interpretation of Section 1115A would violate the Presentment Clause and the nondelegation doctrine.
On October 8, Eli Lilly filed complaints in several federal courts against five vendors alleging that they unlawfully sell and promote purported copies of retatrutide, the company’s investigational drug being studied for obesity and diabetes. The lawsuits target American Peptides, LiveWell Peptides, Cenexa Labs, Medrein Health & Aesthetics, and Medshape Weight Loss Clinic. The filings follow six related lawsuits Lilly filed in August against companies marketing what the company described as black-market versions of the drug.
On October 9, the American Hospital Association (AHA), the Maine Hospital Association, and four safety-net hospitals fileda lawsuit in the U.S. District Court for the District of Maine challenging HHS’ revised 340B Rebate Model Pilot Program, scheduled to begin January 1, 2027. The plaintiffs allege that HRSA violated the Administrative Procedure Act by inadequately evaluating costs and benefits, disregarding reliance interests, and failing to consider less burdensome alternatives. They allege annual administrative costs for 340B hospitals would exceed $1 billion, while HRSA’s approximately $537 million estimate covers only claims-data submission across covered entities under the program.