The following Federal Health Policy (FHP) Strategies Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from October 10 – October 17. 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 16, Finance Committee Ranking Member Ron Wyden (D-OR) released a request for information (RFI) titled “Delivering an Affordable Home Care Guarantee for American Families,” the third in a series following RFIs on prescription drug pricing in June and health coverage in July. The RFI outlined five principles for long-term care reform (universality, simplicity, flexibility, workforce investment, and safeguards) and requested feedback on three policy areas: establishing a universal home care benefit that leverages the Medicare and Medicaid programs, improving the quality of care in nursing homes, and strengthening the long-term care workforce. The RFI seeks feedback on a number of policies including a new Medicare home care benefit and the role of Medicare Advantage (MA) in providing it, the Home and Community-Based Services Access Act (S. 5321), minimum direct care spending requirements, federal staffing standards for nursing homes, and restrictions on private equity and corporate influence over nursing homes. Comments are due by December 18. A press release can be found here.
The Senate is in recess and is scheduled to return on November 9.
REGULATORY UPDATE
On October 9, the Food & Drug Administration (FDA) issued final guidance on the information applicants should submit to support post-approval manufacturing changes to licensed biosimilar and interchangeable biosimilar products, including reporting categories, comparability data, and reference materials. The guidance also addresses introducing biosimilars into multiproduct manufacturing facilities and supplements for new dosage forms or strengths, which FDA stated generally require prior approval.
On October 13, the Centers for Medicare & Medicaid Services (CMS) announced more than $177 million in FY 2026 Rural Health Transformation Program (RHTP) funding for Nebraska to support rural workforce recruitment, remote-monitoring technology, mobile and community-based care, and related initiatives.
On October 13, CMS announced more than $2.3 million in RHTP funding for Missouri, including $1.46 million to expand a childcare cost-sharing program for rural health care workers and $879,000 to establish a certified nurse midwife training program.
On October 13, the Department of Justice (DOJ) announced that CVS Pharmacy Inc. and related entities agreed to pay $315 million to resolve allegations that CVS filled invalid prescriptions for opioids and other controlled substances in violation of the Controlled Substances Act and sought payment for many of them from Medicare and other federal health care programs in violation of the False Claims Act. The settlement resolves a whistleblower lawsuit filed by a former CVS employee, in which the United States intervened, covering conduct DOJ alleged occurred from October 2013 through December 2025. CVS also entered into a memorandum of agreement with the Drug Enforcement Administration (DEA) requiring it to establish a reporting hotline, monitor pharmacy dispensing patterns, and create a process to evaluate prescribers suspected of illegal prescribing. DOJ stated that the claims are allegations only and that there has been no determination of liability.
On October 14, U.S. Customs and Border Protection (CBP) announced a 90-day delay in new electronic entry requirements for certain international mail shipments, including medicines subject to FDA oversight, moving the compliance date from October 22, 2026, to January 20, 2027. The rule will require drugs mailed from abroad to go through a customs process that mandates a licensed broker and a financial guarantee in the form of an entry bond. CBP stated that the extension will give importers, brokers, and logistics providers additional time to prepare and help avoid shipment disruptions.
On October 14, CMS announced more than $1 million in RHTP funding for Delaware to support two educational awards for medical students and an expected 61 housing and relocation awards for medical residents. Recipients must commit to five years of practice in rural Delaware, with at least half of their practice serving qualified rural areas.
On October 14, FDA expanded the approval of Anktiva (nogapendekin alfa inbakicept-pmln), given with Bacillus Calmette-Guérin (BCG), to include adults with BCG-unresponsive, high-grade papillary-only non-muscle invasive bladder cancer (NMIBC), which FDA stated is the first approval specifically for this population. FDA based the decision on trial evidence supporting Anktiva’s earlier approval for carcinoma in situ and on scientific similarities between the two forms of the disease.
On October 14, the National Institutes of Health (NIH) issued a notice of proposed reorganization that would establish the Office of the NIH Chief Artificial Intelligence (AI) Officer within the Division of Program Coordination, Planning, and Strategic Initiatives and move the Office of Dietary Supplements under the Office of Nutrition Research. NIH stated that the changes would establish leadership for an NIH-wide artificial intelligence priority and align closely related scientific areas. Comments are due October 28.
On October 14, CMS announced that it identified 189,000 people in 2026 with subsidized Affordable Care Act (ACA) coverage through the Federal Marketplace who also had Medicare, Medicaid, or Children’s Health Insurance Program (CHIP) coverage or were deceased, and removed their subsidies. CMS estimated the action could save approximately $1.5 billion over the next year. Affected individuals have 30 days to dispute the finding and may appeal afterward.
On October 14, FDA announced the Rare Disease Framework Initiative and released a white paper outlining plans to develop a regulatory framework for rare disease drugs and biologics that accounts for individual diseases, product types, and the evidence available in small patient populations. FDA will hold a public meeting facilitated by the Reagan-Udall Foundation on October 28 at its White Oak campus, followed by roundtables and requests for information. FDA stated that the resulting framework may include new or revised guidance, regulatory revisions, staff training, and organizational changes.
On October 15, CMS announced $78 million in RHTP funding for 216 rural health care providers in Texas through the Rural Texas Strong initiative. CMS stated that the funding will support chronic disease prevention, health care workforce recruitment and retention, and medical equipment and facility upgrades.
On October 15, CMS announced resources and flexibilities for health care providers and beneficiaries in Alabama and Florida in response to Hurricane Isaias, following public health emergency declarations that HHS Secretary Robert F. Kennedy, Jr., issued on October 13 for both states. The flexibilities include blanket waivers under section 1135 of the Social Security Act, replacement of lost or damaged durable medical equipment for Medicare beneficiaries, and activation of the Kidney Community Emergency Response program for dialysis patients. CMS also stated that Part D plans must ensure enrollees can obtain covered drugs at out-of-network pharmacies, and that affected individuals in HealthCare.govstates may qualify for a Marketplace special enrollment period.
On October 16, CMS issued a proposed rule that would implement three provisions of the Consolidated Appropriations Act, 2026, including MA provider-directory accuracy requirements, Medicare Part D pharmacy benefit manager reforms, and elimination of generic-drug copayments for full-benefit dual-eligible beneficiaries with incomes at or below 100% of the federal poverty level beginning in 2028. A fact sheet is available here. Comments are due by December 15.
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
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
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
ADDITIONAL POLICY NEWS
On October 8, a JAMA research letter analyzing U.S. acute care hospital closures and openings from 2010 to 2025 found that closures outpaced openings, producing a net loss of 216 hospitals and 24,399 beds. The study found that closure rates did not differ between urban and rural hospitals, and that closures increased about 4% year over year while openings decreased about 3%. The authors noted that urban safety-net hospitals, which depend heavily on Medicaid revenue, may face added stress from Medicaid coverage losses, state-directed payment cuts, and caps on Medicaid provider taxes under the One Big, Beautiful Bill Act (OBBBA), and observed that no funding comparable to the RHTP has been extended to urban safety-net hospitals.
On October 15, Epic Systems announced Prescription Marketplace, a feature that will allow clinicians and patients at health systems using Epic to compare a medication’s cash price at participating pharmacies with the patient’s insurance cost before a prescription is sent. Epic stated that any pharmacy will be able to share cash prices and identified Mark Cuban Cost Plus Drugs and Amazon Pharmacy as contributing to the feature’s development. The announcement also included supportive statements from Costco and LillyDirect. Epic plans to release the feature in summer 2027.
On October 15, the National Association of Benefits and Insurance Professionals (NABIP) filed a lawsuit in the U.S. District Court for the District of Maryland challenging both the HHS interim final rule with comment period that authorizes CMS to pause agent and broker registrations with the federally facilitated Marketplace and the moratorium CMS imposed under that authority. The moratorium, in effect September 22, 2026 until February 1, 2027, bars agents and brokers without a Plan Year 2026 registration from registering for Plan Year 2027, and would prevent an estimated 19,000 agents and brokers from registering. NABIP alleged that HHS lacked good cause to bypass notice-and-comment rulemaking, that the rule exceeds HHS’ statutory authority, and that the moratorium is arbitrary and capricious, and the group requested a temporary restraining order, preliminary injunction, and writ of mandamus to compel CMS to provide new agent and broker training. Comments on the interim final rule are due by November 21.
On October 15, the Pharmaceutical Research and Manufacturers of America (PhRMA) asked a federal court in Maine to allow it to intervene in a hospital-led lawsuit challenging the 340B Rebate Model Pilot Program, following a similar request from AbbVie, Bristol Myers Squibb, and Boehringer Ingelheim on October 14. PhRMA and the manufacturers argued that blocking the pilot could harm their financial and operational interests and that the government may not adequately represent those interests.