The following Federal Health Policy (FHP) Strategies Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from October 18 – October 25. 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
The House is in recess and is scheduled to return on November 9.
Senate
On October 20, Finance Committee Ranking Member Ron Wyden (D-OR), Sen. Elizabeth Warren (D-MA), and Sen. Raphael Warnock (D-GA) released an interim minority staff report summarizing the findings from their investigation into five contractors that build, operate, or support state Medicaid eligibility and enrollment systems: Deloitte, Conduent, Gainwell, General Dynamics Information Technology, and Maximus. The report stated that the companies declined to provide requested information, including their state contracts, data on individuals referred to states as ineligible for coverage, and details on system testing for accuracy. All five companies stated that their contracts do not tie payment to the number of individuals removed from the Medicaid program. The report recommends Centers for Medicare & Medicaid Services (CMS) establish mandatory model contract terms, publicly disclose vendor contracts and performance data, require independent audits, and bar contractors from holding both eligibility and appeals contracts in the same state. A press release is available here. The letter initiating the investigation is available here.
On October 22, Sens. Chuck Grassley (R-IA) and Maria Cantwell (D-WA) urged the Federal Trade Commission (FTC) to complete its study of pharmacy benefit manager (PBM) business practices and publicly release a final report with recommendations to Congress. The senators noted that the investigation, launched in June 2022, remains unfinished despite interim reports issued in July 2024 and January 2025. They said a final assessment is needed to determine whether existing antitrust and consumer protection laws adequately address the identified practices or additional legislation is warranted.
The Senate is in recess and is scheduled to return on November 9.
REGULATORY UPDATE
On October 19, CMS announced $16.4 million in Rural Health Transformation Program (RHTP) funding for health care workforce projects in Maryland. The funding is intended to support training, registered apprenticeships, and recruitment and retention of nurses, physician assistants, physicians, dentists, and other providers in rural communities.
On October 19, the Food & Drug Administration (FDA) granted accelerated approval to GSK’s Jemperli (dostarlimab-gxly) as a standalone treatment for adults with previously untreated stage II or stage III locally advanced rectal cancer that is mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H). The approval is the 11th under the Commissioner’s National Priority Voucher pilot program, and FDA stated it completed the review nearly four months ahead of schedule.
On October 19, FDA approved Zydus Pharmaceuticals’ estradiol and levonorgestrel transdermal system, the first generic of Bayer’s Climara Pro, a once-weekly patch for women with an intact uterus. The product is indicated for the treatment of moderate to severe vasomotor symptoms due to menopause and the prevention of postmenopausal osteoporosis.
On October 19, National Institutes of Health (NIH) Director Dr. Jay Bhattacharya and National Institute of Allergy and Infectious Diseases (NIAID) Acting Director John Powers III issued a statement on the NIH Vaccinology and Immunology Center (VIC), a new research study within NIAID’s Vaccine Research Center clinic that NIH stated will investigate health problems following vaccination and infection. NIH stated that the center will examine symptoms and underlying biological mechanisms, identify risk factors, explore treatment options, and use findings to inform vaccine safety efforts. NIH anticipates launching the study before the end of 2026 and expects to initially enroll several hundred participants with the most serious symptoms following vaccination or infection.
On October 20, FDA approved GSK’s Hibsago (bepirovirsen) injection, in combination with existing antiviral therapy, for certain adults with chronic hepatitis B virus (HBV) infection without cirrhosis. FDA stated it is the first approved antisense oligonucleotide for chronic hepatitis B.
On October 20, FDA issued final guidance on how drug sponsors can develop, distribute, and label software used alongside prescription drugs, including when app content is treated as FDA-required labeling versus promotional labeling. The guidance states that apps connected to a medical device generally should be described in a drug’s prescribing information. The guidance additionally mentions that standalone apps, such as symptom trackers and dose reminders, should be referenced in the prescribing information if the sponsor demonstrates the app is essential for safe and effective use or provides a meaningful clinical benefit. FDA stated that in most cases, content displayed by companion apps will be treated as promotional material. A press release is available here.
On October 20, FDA released its Generic Drug User Fee Amendments (GDUFA) Science and Research Priority Initiatives for Fiscal Year 2027, which identify eight research areas informed by a June 8-9 public workshop and comments submitted to the docket. The priorities include methods to address nitrosamine impurities; equivalence approaches for complex active ingredients such as peptides and oligonucleotides; bioequivalence approaches for complex dosage forms, complex routes of delivery, drug-device combination products, and orally administered GLP-1 peptides; and expanded use of artificial intelligence and machine learning tools in generic drug assessments. FDA stated that it will continue to engage generic drug industry experts through the Center for Research on Complex Generics to advance the priorities, consistent with its GDUFA III commitments and the executive order on lowering drug prices.
On October 20, Department of Health & Human Services (HHS) released its Kidney Care National Plan, a department-wide strategy addressing kidney disease prevention, dialysis care, and organ transplantation. The plan identifies three priorities: preventing kidney failure through earlier detection and intervention, expanding competition and home-based options in dialysis care, and reforming the transplant system. As part of the plan, HHS stated it will advance a National Transplant Expansion Strategy focused on expanding access to living donation. HHS’ agencies will use the plan to guide policy, payment, research, regulatory, and oversight actions. A fact sheet is available here.
On October 20, the Health Resources & Services Administration (HRSA) announced seven awards under the Sickle Cell Disease Regional Care Excellence (SoRCE) Program. The awards establish Regional Coordinating Hubs, each of which will partner with at least three clinical-community spokes. Each spoke will pair a clinical center with at least one community-based organization. HRSA stated the program expands its regional sickle cell care network from five to seven regions and that it intends to award a separate contract for nationwide technical assistance and coordination.
On October 20, the Department of Justice (DOJ) and its National Fraud Enforcement Division announced the Fraud Whistleblower Incentive Program (WHIP), which will pay awards of $10,000 to $30,000 for information leading to criminal charges in certain fraud areas. DOJ stated that, unlike most existing government whistleblower programs, WHIP pays awards after charges are filed rather than after final resolution of a case, and that participants remain eligible for awards through other programs. The program covers federal health care offenses and fraud on programs administered by HHS and seven other federal departments and agencies, and DOJ stated that it will prioritize health care submissions involving hospice, home health, day care, and special services fraud. The Department of the Treasury committed $25 million to the program’s implementation.
On October 21, CMS announced $32 million in RHTP funding for Mississippi, consisting of 60 awards to rural health care providers and workforce programs. The funding is intended to support recruitment and retention of primary care physicians and other professionals, clinical training, and the establishment of three psychiatric emergency units adjacent to hospital emergency departments.
On October 21, CMS and the Department of Labor (DOL) announced that Amazon, Axon Enterprise, Google, Meta, and Oracle signed a statement of support to make capabilities developed through the 2025 Prior Authorization (PA) Pledge available to employers that sponsor self-funded health plans. CMS stated the effort builds on the June 2025 voluntary commitments from health plans and the Interoperability and PA Final Rule, which requires certain impacted payers to implement electronic PA for medical items and services beginning January 1, 2027.
On October 21, CMS sent a letter to New York Medicaid Director Amir Bassiri requiring the state to submit a corrective action plan (CAP) within 30 days on its oversight of plans in the state’s Medicaid Managed Long Term Care (MLTC) program. CMS stated that preliminary findings from Unified Program Integrity Contractor (UPIC) investigations indicated that most of the adult day care providers reviewed reported offering only social adult day care but also billed for more costly adult day health care services as authorized by the MTLC plans. CMS also cited wide variation in the fraud referrals the state reported for its MLTC plans and required the CAP to address state oversight, accountability for inappropriate billing, recovery of overpayments, and capitation rate development, with full resolution projected within 90 days of submission.
On October 22, CMS announced nearly $249 million in RHTP funding for 254 projects in Alaska, completing the state’s first-year RHTP funding cycle. The projects include a telehealth network for pregnancy and postpartum care, portable X-ray units in village clinics, certified nursing assistant training for high school students, and remote monitoring for patients with chronic conditions.
On October 22, HHS announced the 2026 Update to the National Plan to Address Alzheimer’s Disease and Related Dementias. The update replaces the plan’s six previous goals with four goals covering dementia risk reduction, research and treatment development, dementia care, and services and supports for people living with dementia and their families. HHS stated that 10 agencies are carrying out initiatives under the plan, including an Alzheimer’s Prevention Accelerator launched by FDA and up to $48.8 million in Advanced Research Projects Agency for Health (ARPA-H) awards for earlier detection and intervention.
On October 22, HHS Senior Adviser Calley Means announced his resignation from the administration. He had worked on policies including revisions to the Dietary Guidelines for Americans, psychedelic policy, removal of soda from Supplemental Nutrition Assistance Program (SNAP) coverage, removal of food dyes, and generally recognized as safe (GRAS) reform.
On October 22, FDA announced the launch of the Neuroscience Advancement and Innovation Nexus (NAIN), a program that will coordinate expertise across its drug, biologics, and device centers on scientific and regulatory approaches to medical product development for conditions affecting the brain and nervous system, including neurologic and psychiatric disorders, substance use disorders, and pain. NAIN's first initiative, the Alzheimer's Prevention Accelerator, will explore approaches to clinical trials for Alzheimer's disease prevention and early-intervention drug development, with emphasis on trial populations, stage-appropriate endpoints, and evidentiary approaches for demonstrating prevention or delay of cognitive decline. FDA stated that both efforts support federal action under the National Alzheimer's Project Act.
On October 22, CMS announced $8 million in RHTP funding for 28 rural health care providers in Texas through the state's Rural Texas Strong initiative. CMS stated that the funding will support chronic disease prevention and management, recruitment and retention of health care professionals, and medical equipment and facility improvements.
On October 23, CMS announced nearly $219 million in RHTP funding for Georgia, which CMS stated represents the state's full fiscal year 2026 award. CMS stated that the funding supports five initiatives across Georgia's 126 rural and partially rural counties, including mobile clinics and telehealth services; clinician recruitment, training, and residencies; and electronic health record and cybersecurity upgrades for rural hospitals.
On October 22, the Department of the Treasury issued a proposed rule to implement the Comprehensive Outbound Investment National Security (COINS) Act and expand its Outbound Investment Security Program to include biotechnology. The proposal would prohibit certain U.S. investments in biotechnology companies located in or connected to China and other countries of concern, including investments involving certain bio-derived compounds or materials, biomanufacturing equipment and facilities, sequencing technologies, bioinformatics tools, and hardware or software for automated scientific discovery or experimentation. Treasury is seeking feedback on the scope of covered transactions and technologies, key definitions, notification requirements, and enforcement provisions. Comments are due by December 7. A fact sheet can be found here.
On October 23, CMS announced nearly $219 million in RHTP funding for Georgia, which CMS stated represents the state's full fiscal year 2026 award. CMS stated that the funding supports five initiatives across Georgia's 126 rural and partially rural counties, including mobile clinics and telehealth services; clinician recruitment, training, and residencies; and electronic health record and cybersecurity upgrades for rural hospitals.
On October 23, CMS announced the Nurses for Nursing Homes initiative, a $275 million effort offering licensed nurses and nursing students up to $40,000 in student loan repayment and/or a $10,000 stipend in exchange for a three-year commitment to work in a qualifying nursing home in a rural or higher labor-shortage area. The initiative is funded through civil monetary penalties collected by CMS and states from nursing homes. CMS stated that all 50 states and the District of Columbia are participating and that the initiative is expected to support more than 4,000 nurses. Frequently asked questions are available here.
WHITE HOUSE
On October 19, President Donald Trump signed an Executive Order (EO) titled “Advancing Women’s Health to Improve Outcomes in All Phases of Life.” The EO directs HHS to establish a Women’s Health Division at the NIH within 90 days. The division is directed to coordinate research on women’s health conditions, increase inclusion of women and girls in clinical trials, and strengthen grant recipients’ adherence to NIH policy on sex as a biological variable. The EO also establishes a White House Women’s Health Task Force. A fact sheet is available here.
RULES AT THE WHITE HOUSE OFFICE OF MANAGEMENT & BUDGET (OMB)
Pending Review
CMS
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
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
HHS Notice of Benefit and Payment Parameters for 2028 (CMS-9875); Proposed Rule; 10/19/2026
FDA
Cannabidiol (CBD) Products Compliance and Enforcement Policy; Notice; 03/13/2026
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
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
Infant Formula Nutrient Requirements; Proposed Rule; 10/14/2026
Interim Access Policy for Compounding Using Certain Peptides; Notice; 10/14/2026
Patient-level data for drugs and biological products submissions containing real-world data and real-world evidence; Request for Information; Notice; 10/15/2026
Individualized Human Genome Editing Products: Considerations for BLA Submission and Postapproval Management; Draft Guidance for Industry; Notice; 10/21/2026
REPORTS
Office of Inspector General (OIG)
On October 22, the HHS OIG released an audit of Kentucky’s compliance with federal and state requirements for children in foster care placed in qualified residential treatment programs (QRTPs), a category of facilities created by the Family First Prevention Services Act. OIG found 70 instances of noncompliance in 25 of the 30 children’s case files it reviewed and 165 instances across the 15 QRTPs it reviewed for the period October 1, 2023, through September 30, 2024. OIG identified $571,306 ($416,009 federal share) in improper Title IV-E payments under the Social Security Act and made four recommendations, including that Kentucky work with the Administration for Children and Families (ACF) to determine how much of the federal share must be refunded. Kentucky concurred with two of the recommendations and did not concur with the other two.
ADDITIONAL POLICY NEWS
On October 20, the Institute for Clinical and Economic Review (ICER), in collaboration with West Health, released its 2026 Launch Price and Access Report, examining launch prices for novel drugs approved from 2022 through 2025 and patient access to recently approved medicines. ICER found that the inflation-adjusted median annual net launch price increased 35% from 2022 to approximately $257,000 in 2025, although it declined 2% from 2024. Nearly one-quarter of drugs launched in 2025 had annual net prices exceeding $500,000, and another 34% were priced between $200,000 and $500,000. A fact sheet is available here.
On October 22, the Commonwealth Fund released findings from its 2026 Biennial Health Insurance Survey, which found that the uninsured rate among adults ages 19 to 64 rose from 8.9% in 2024 to 11.2% in 2026. Over the same period, enrollment in Affordable Care Act (ACA) marketplace and individual market coverage declined from 8.5% to 6.4%, and the survey found that 46% of working-age adults were inadequately insured, meaning they were uninsured, had a coverage gap, or were underinsured. The share of working-age adults who reported not getting needed care because of cost, including not filling a prescription, rose from 46% in 2022 to 50% in 2026. The authors attributed the coverage declines in part to the expiration of the enhanced ACA premium tax credits and pandemic-era Medicaid continuous enrollment protections.
On October 22, KFF released its 2026 Employer Health Benefits Survey, which found that average annual premiums for employer-sponsored family coverage reached $28,303, a 5% increase from 2025. The survey found that covered workers contributed an average of $7,471 toward family coverage, up 9% or $621 from 2025. Among workers in plans with a general annual deductible, the average deductible for single coverage was $1,955, an increase from $1,866 in 2025. The survey, based on interviews with 1,937 non-federal public and private firms, also asked employers about coverage of GLP-1 drugs and in vitro fertilization (IVF). Among large firms with at least 200 workers, 18% covered GLP-1 drugs specifically for weight loss and 27% covered IVF services. Among firms covering GLP-1 drugs for weight loss, 29% reported a significant impact on prescription drug spending and 27% reported a moderate impact.
On October 22, U.S. District Judge Lance Walker allowed the Pharmaceutical Research and Manufacturers of America (PhRMA), AbbVie, Bristol Myers Squibb, and Boehringer Ingelheim to intervene in hospitals’ lawsuit challenging HRSA’s 340B Rebate Model Pilot Program. The pilot, scheduled to begin January 1, 2027, would allow participating manufacturers to provide rebates instead of upfront 340B discounts.