Health Care Watch: October 4, 2026
The following Federal Health Policy (FHP) Strategies Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from September 27 – October 4. 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 29, Energy & Commerce Committee Republicans, led by Chairman Brett Guthrie (R-KY), released "Continuing the Fight Against Fraud," a 14-bill, Medicaid program integrity package. The package includes bills that would require the Department of Health & Human Services (HHS) to make standardized data-analytics technology available to states, expand electronic visit verification to non-emergency medical transportation and applied behavior analysis services, require states to conduct annual Medicaid fraud risk assessments, and require each state to designate an official responsible for Medicaid fiscal integrity. A staff report on the package can be found here.
On October 1, Rep. Alexandria Ocasio-Cortez (D-NY) and Senate Democratic Leader Chuck Schumer (D-NY) introduced the Restoring Essential Plan Coverage Act. The bill would repeal premium tax credit eligibility restrictions enacted under the One Big, Beautiful Bill Act (OBBBA). The bill would also give all states the option to expand coverage through the Basic Health program under the Affordable Care Act (ACA). A one pager can be found here. A press release can be found here.
The House is in recess and is scheduled to return on November 9.
Senate
On September 29, Health, Education, Labor, & Pensions (HELP) Committee Chairman Bill Cassidy (R-LA) and Sen. Warner reintroduced the Ensuring Accurate Payments to Specialty Pharmacies Act. The bill would expand participation in the surveys used to determine the National Average Drug Acquisition Cost (NADAC), which currently include retail community pharmacies, to specialty and mail-order pharmacies. The sponsors stated that the bill would improve the accuracy of the drug acquisition cost data that Medicaid programs and PBMs use to set pharmacy reimbursement rates. A press release can be found here.
On September 30, the HELP Committee voted 12-11 along party lines to favorably report three HHS nominees: Dr. Nicole Saphier to be Surgeon General, Dr. Timothy Westlake to be Assistant Secretary for Mental Health and Substance Use, and Mary Lazare to be Assistant Secretary for Aging.
The Senate is in recess and is scheduled to return on November 9.
REGULATORY UPDATE
On September 28, HHS, through the Centers for Disease Control and Prevention (CDC) and the National Institutes of Health (NIH), announced nearly $3 million in awards for research on reducing tick populations and tickborne diseases, including Lyme disease and alpha-gal syndrome. The funding went to two CDC Centers of Excellence in Vector-Borne Diseases: the New England Center of Excellence in Vector-borne Diseases and the Midwest Center of Excellence for Vector-Borne Disease. The pilot projects will study whether acaricide-treated feed for deer, and bait boxes that deliver acaricides, antibiotics, or both to rodents, reduce local tick populations.
On September 28, the Food & Drug Administration (FDA) approved Emcitate (tiratricol) tablets for oral suspension to treat peripheral thyrotoxicosis in patients with monocarboxylate transporter 8 (MCT8) deficiency, also known as Allan-Herndon-Dudley syndrome, granting approval to Egetis Therapeutics. FDA stated that Emcitate is the first FDA-approved treatment for the condition. Emcitate received Orphan Drug, Rare Pediatric Disease, Fast Track, and Breakthrough Therapy designations, as well as Priority Review.
On September 28, the Centers for Medicare & Medicaid Services (CMS) announced $169.6 million in Rural Health Transformation Program (RHTP) funding for 91 grantees and approximately 250 projects in Colorado. The projects include telemedicine, remote patient monitoring, mobile clinics, community paramedicine, behavioral health and maternal care, electronic health record modernization, and expanded prehospital whole-blood transfusion capacity. CMS stated that the funding is one part of Colorado's overall fiscal year 2026 RHTP award. The RHTP was established under H.R. 1, the budget reconciliation law enacted in July 2025.
On September 28, CMS announced $51 million in RHTP funding for 68 rural hospital districts and authorities in Texas. The funding will support community-based chronic disease prevention, wellness, and nutrition programs for rural Texans with or at risk for diabetes, cardiovascular disease, chronic respiratory disease, or obesity. CMS stated that the funding is one part of Texas's overall fiscal year 2026 RHTP award.
On September 28, CMS released projected 2027 premium, enrollment, and plan availability data for Medicare Advantage (MA) and Medicare Part D ahead of the Medicare Open Enrollment period, which runs from October 15 to December 7. CMS projected that the weighted average monthly MA premium will decrease from $14.37 in 2026 to $12 in 2027, the average monthly Part D premium for MA plans with drug coverage will decrease from $11.32 to $7, and the total average monthly premium for stand-alone Part D prescription drug plans will increase from $35.09 to $36. CMS projected that MA enrollment will reach 34 million in 2027, approximately 47.4% of Medicare enrollees, and that 93% of non-low-income beneficiaries will have access to an enhanced Part D plan for less than $6 per month. CMS stated that Part D premiums remain stable following the narrowing of the voluntary Part D Premium Stabilization Demonstration for 2026 and its planned discontinuation in 2027. A press release can be found here.
On September 29, CMS announced $8.7 million in RHTP funding for 79 rural emergency medical services agencies in Montana. The funding will provide new ambulances for four agencies and equipment such as IV pump systems, ventilators, cardiac monitors, and patient transport systems for 75 agencies, including three tribal governments. CMS stated that the funding is one part of Montana's overall fiscal year 2026 RHTP award.
On September 30, HHS, through the Advanced Research Projects Agency for Health (ARPA-H), announced the Simulation-augmented, Real-time Platform Adaptive Seamless Trials (SURPASS) program, which will support development of predictive computational models, real-time analysis methods, and automated operations for adaptive platform trials of drugs and biologics. ARPA-H stated that the program aims to shorten clinical trial timelines and reduce the number of participants and size of control groups needed. ARPA-H also announced three related projects, STACK, COMMONS, and CINCH, which focus on clinical site activation, national data and consent infrastructure, and patient-contributed real-world data, respectively.
On September 30, CMS announced $20 million in RHTP funding for North Carolina's Rural Health Innovation Fund, which will make funding available to eligible rural providers for health care technology upgrades. Eligible projects include expanding telehealth, upgrading electronic health records, strengthening cybersecurity, and adopting clinical decision support technology. CMS stated that the funding builds on $11.25 million in previously announced RHTP funding for school-based health centers and the rural emergency medical services (EMS) workforce in North Carolina and is one part of the state's overall fiscal year 2026 RHTP award.
On September 30, CMS issued a final rule establishing the Global Benchmark for Efficient Drug Pricing (GLOBE) Model, a mandatory model that will test an alternative method for calculating Medicare Part B drug inflation rebate amounts for certain separately payable Part B drugs and biological products. The alternative method uses international drug pricing information to set a benchmark reflecting prices paid in a set of economically comparable countries. The model will apply in a randomly selected subset of geographic areas covering approximately 25% of Original Medicare beneficiaries, and will run from January 1, 2027, through March 31, 2032, with manufacturer rebate invoicing and reconciliation continuing until March 31, 2034. The final rule states that CMS intends to waive the mandatory participation requirements for manufacturers that participate in the GENEROUS Model. CMS estimates that the GLOBE Model will generate $440 million in overall Part B net-spending savings during the seven-year payment period, down from the $11.9 billion savings estimated for the model as proposed. A press release can be found here.
On September 30, FDA announced a nationwide recruitment effort to expand the range of qualified voices and perspectives on its advisory committees. As part of the effort, FDA is publishing two Federal Register notices, one noticeseeking qualified scientific, technical, and professional voting members across all committees with current or anticipated vacancies, and a companion notice seeking consumer representatives. To receive first consideration for current and near-term vacancies, nominations for consumer representative positions should be submitted no later than November 15, and nominations for scientific, technical, professional, and other voting-member positions should be submitted no later than November 30.
On October 1, CMS announced nearly $55 million in RHTP funding for 34 grants to health care providers and institutions serving rural Alabama. CMS stated that the projects will equip at least 20 rural hospitals with emergency labor and delivery resources; expand maternal-fetal medicine through telehealth and telerobotic ultrasound; expand mobile and community-based cancer screening; strengthen trauma, stroke, and EMS coordination; and build health care workforce training pipelines. According to CMS, the announcement completes Alabama's initial Year 1 award cycle under the RHTP.
On October 1, FDA approved Edwards Lifesciences' Autus Size-Adjustable Valve, a surgically implanted pulmonary heart valve for pediatric patients with congenital pulmonary valve disease, through the premarket approval pathway. FDA stated that the device is the first heart valve designed to be expanded after implantation to accommodate a child's growth and the first valve approved in the U.S. to use polymeric rather than animal-derived tissue leaflets. According to FDA, it is the first pediatric approval under the agency's Total Product Life Cycle Advisory Program, and the device previously received Breakthrough Device designation.
On October 2, CMS announced $7.2 million in RHTP funding for 25 EMS projects in South Dakota. CMS stated that the projects, led by local ambulance services, hospitals, community organizations, education partners, and statewide EMS support organizations, will expand ambulance-based telemedicine, fund EMS workforce training, improve data sharing between EMS crews and hospitals, and modernize dispatch and communications systems. CMS stated that the award is one part of South Dakota's overall fiscal year 2026 RHTP funding.
On October 2, CMS released the agenda for the Second Biannual 2026 Healthcare Common Procedure Coding System (HCPCS) Level II Public Meeting which will be held on November 2, 2026, with an overflow date of November 3, if necessary. The meeting will discuss CMS’ preliminary coding for non-drug and non-biological items and services, Medicare benefit category, and Medicare payment determinations. CMS also released the final coding determinations for drugs and biologicals under the Third Quarter 2026 HCPCS Level II code application review cycle.
On October 2, CMS released the HCPCS Level II Drug and Biological Product Coding Development Manual, a technical reference guide describing the agency’s methodology and decision-making framework for developing HCPCS Level II codes for drugs and biological products. The manual is intended to help manufacturers and other external stakeholders understand coding considerations before submitting requests to establish, revise, or discontinue a HCPCS code.
WHITE HOUSE
On September 30, President Donald Trump signed into law S. 2398, the Kay Hagan Tick Reauthorization Act, which reauthorizes federal vector-borne disease activities through fiscal year 2030. The law extends authorization for the national strategy and regional centers of excellence in vector-borne disease, as well as enhanced support to state and local health departments for addressing vector-borne diseases, which were originally authorized under the 2019 Kay Hagan Tick Act.
On October 2, President Trump announced that he will use the $2 billion in the Medicare Improvement Fund (MIF) to send $90 to more than 20 million Medicare Part B enrollees to help offset the cost of their premiums. Congress has traditionally used the MIF to pay for end of year legislation to extend Medicare provider payment policies or increase physician reimbursement rates.
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
Draft Program Instructions for Identifying Essential Pharmacies and Affiliated Retail Pharmacy Data Collection: Section 6223(b) of the Consolidated Appropriations Act, 2026 – 30-Day Comment Period; Notice; 09/21/2026
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
FDA
Cannabidiol (CBD) Products Compliance and Enforcement Policy; Notice; 03/13/2026
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
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
House
Ways & Means Committee
October 6; 9 AM CDT; Collierville, TN
Witnesses: Boyden Moore, President & CEO, Orgill; Alex Grover, Owner & CEO, IZM; Wade Thompson, Owner & President, Thomson Prestress; and Mike Miller, Owner, Patrick’s Neighborhood Bar & Patio.
REPORTS
Office of Inspector General (OIG)
On September 28, HHS OIG released an audit of the kidney transportation costs that independent organ procurement organizations (OPOs) reported on their fiscal year (FY) 2023 Medicare cost reports. Of 43 independent OPOs reviewed, OIG found that 21 reported $188,147 in kidney transportation costs that were improperly allocated or inadequately supported, and 26 reported an additional $240,178 in costs that did not meet Medicare requirements, for a total of $428,325 in unallowable costs. OIG also found that four OPOs did not meet Medicare requirements for organ preparation and transport. OIG recommended that CMS instruct its Medicare Administrative Contractor to recover the $428,325 and provide additional education to independent OPOs, and CMS concurred with both recommendations.
On September 28, HHS OIG released an audit of diagnosis codes that UnitedHealthcare (UHC) Benefits of Texas, Inc. submitted to CMS under contract H0609 for use in MA risk adjustment. OIG found that medical records did not support the diagnosis codes for 172 of 230 sampled enrollee-years, resulting in $622,927 in overpayments, and estimated from the sample that UHC received at least $24.4 million in overpayments for 2020 and 2021. OIG made four recommendations, including that UHC refund the estimated $24.4 million to the federal government. UHC disagreed with some of OIG's findings and requested that OIG withdraw all of its recommendations.
On October 1, HHS OIG released a data brief examining the Preclusion List maintained by CMS, which identifies providers, suppliers, and prescribers barred from receiving payment for Medicare Part C and Part D services. OIG found that MA organizations and Part D prescription drug plans paid $72 million during calendar years 2022 through 2024 for services associated with 249 of 1,017 National Provider Identifiers (NPIs) that had been revoked from Medicare Parts A and B enrollment but were not on the Preclusion List. OIG attributed the payments to what it described as vulnerabilities in CMS' preclusion process, including timing issues and errors in updating the list, the omission of some organizations whose owners were excluded or had felony convictions, and a regulatory exemption for pharmacies that fill but do not prescribe Part D drugs. The data brief did not include recommendations to CMS.
On October 2, HHS OIG released an audit of Wisconsin's Medicaid school-based program, examining $505.5 million in Medicaid reimbursement the state claimed over a four-year period using random moment time studies (RMTSs) conducted by a contractor. OIG estimated that Wisconsin improperly claimed at least $67 million based on unsupported RMTS coding and services from unlicensed providers, and that it may have improperly claimed an additional $387.9 million because it could not document the ratios used to allocate costs to Medicaid, for a total of $454.9 million in federal reimbursement. OIG made six recommendations, including that Wisconsin refund the $67 million and either refund the $387.9 million or provide documentation supporting its allocation ratios. The state agency generally disagreed with OIG's findings, disagreed with some recommendations, and described actions it has taken to improve compliance with federal requirements.
On October 2, HHS OIG released an audit examining whether South Carolina accurately calculated and reported the federal share of Medicaid and Children's Health Insurance Program (CHIP) collections subject to the temporarily increased Federal Medical Assistance Percentage (FMAP) authorized by the Families First Coronavirus Response Act. OIG found that South Carolina did not accurately calculate and report the federal share of approximately $108.6 million in collections during the audit period. OIG made four recommendations, including that South Carolina adjust its future reports to CMS, refund the federal share of the underreported collections, and develop written policies for calculating the federal share during periods of unexpected or retroactive FMAP changes. South Carolina officials concurred with three of the four recommendations and described steps it has taken and plans to take in response.
ADDITIONAL POLICY NEWS
On September 24, the Peterson-KFF Health System Tracker released an analysis comparing prices for 32 brand-name drugs listed on TrumpRx.gov, the federal direct-to-consumer drug purchasing website, with publicly listed prices in 11 peer countries. The analysis found that, as of August 25, TrumpRx prices were lower than the peer-country average for 17 of the drugs, by an average of 31%, and higher for 15, by an average of 262%. It also found that TrumpRx prices were the highest among the countries compared for 13 of the drugs and the lowest for five. The authors stated that the analysis compared listed prices converted to U.S. dollars without adjusting for cost of living, and that listed prices in other countries may not reflect what patients or payers there actually pay.
On September 29, the Board of Directors of the Pharmaceutical Research and Manufacturers of America (PhRMA) announced that former House Majority Leader Eric Cantor (R-VA) has been named the organization's next President and Chief Executive Officer, effective November 9. Mr. Cantor represented Virginia in the U.S. House of Representatives and served as House Majority Leader from 2011 to 2014. He has since served as Vice Chairman and Managing Director at Moelis & Company, a global independent investment bank, where he will continue to serve on the Board of Directors.
On October 1, the U.S. District Court for the Eastern District of New York denied a motion by The New York and Presbyterian Hospital (NYP) to dismiss a putative class action alleging that the hospital's contracts with insurers violate federal and state antitrust law. The plaintiffs, three self-funded union health plans, allege that NYP requires insurers to include all of its facilities in all networks at the highest tier, to pay its flagship-hospital rates at every NYP hospital, and to keep its prices and contract terms confidential, which they argue blocks narrow networks, tiering, and price transparency. In the decision, District Judge Brian Cogan found that, accepting the allegations as true at this stage, the plans had standing as direct purchasers of NYP's services and had plausibly alleged market power and anticompetitive effects.
On October 2, the Medicare Payment Advisory Commission (MedPAC) released its October 8-9, 2025 public meeting schedule and agenda. Meeting topics will include physician participation in MA provider networks; comparing provider directories with encounter data; issues affecting the payment accuracy of the physician fee schedule and the clinical laboratory fee schedule; clinician quality initiatives in fee-for-service Medicare; Medicare’s late-enrollment penalties; and assessing the accuracy of the skilled nursing facility and home health prospective payment systems.