The following Federal Health Policy (FHP) Strategies Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from November 1 – November 7. 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 November 4, current Energy & Commerce Committee Ranking Member Frank Pallone, Jr. (D-NJ) sent a letter to House Democrats seeking their support for his candidacy to serve as the committee’s Chairman in the 120th Congress. His stated priorities include expanding the number of drugs selected annually for Medicare drug price negotiation and making negotiated prices available to the private insurance market.
On November 4, current Ways & Means Committee Ranking Member Richard Neal (D-MA) sent a letter to House Democrats seeking their support for his candidacy to serve as the committee’s Chairman in the 120th Congress. He highlighted defending, restoring, expanding the Affordable Care Act (ACA), and shoring up Medicare and Medicaid.
The House is in recess and is scheduled to return on November 9. Congressional Republicans are expected to hold their leadership elections for next Congress on November 10, with House Democrats doing the same the following week.
Senate
On November 4, current Finance Committee Ranking Member Ron Wyden (D-OR) issued a statement outlining the priorities he would pursue as committee Chairman in the next Congress, including seeking to guarantee health care for all and lower costs, and conducting oversight of pharmaceutical company CEOs on drug pricing and insurers on delays and denials of care.
On November 5, current Health, Education, Labor & Pensions (HELP) Committee Ranking Member Bernie Sanders (I-VT) released a video calling for Democrats to pursue Medicare for All legislation in the next Congress. He said he will also prioritize lowering the Medicare eligibility age from 65 to 55, expanding Medicare to cover dental, vision, and hearing services, and guaranteeing health coverage for all children from birth through age 19. He also called for reversing Medicaid changes enacted in the One Big Beautiful Bill Act (OBBBA), and stated that these policies could be passed through the budget reconciliation process. NOTE: The HELP Committee does not have jurisdiction over Medicare or Medicaid.
The Senate is in recess and is scheduled to return on November 9.
REGULATORY UPDATE
On October 30, CMS’ Office of Rural Health Transformation notified states that it would delay announcing the competitive portion of second-year awards under the $50 billion Rural Health Transformation Program, according to KFF Health News. As reported, an email to states from Office of Rural Health Transformation Director Alina Czekai stated that officials had discovered an additional administrative process requirement, and that each state’s $100 million in second-year base funding was available. The awards had been expected by October 31 under the program’s original funding notice. The email did not specify when the competitive portion would be announced. Ms. Czekai reportedly wrote that state budget revisions reflecting the new allocations would be due to CMS by November 30.
On October 30, the Food & Drug Administration (FDA) granted accelerated approval to Inovio Pharmaceuticals, Inc.’s Voceryq (doruxapapogene ralaplasmid and lalikinogene sifuplasmid-gxfd) for adults with recurrent respiratory papillomatosis (RRP), a rare disease caused by human papillomavirus (HPV) types 6 and 11. FDA stated it is the first plasmid DNA-based immunotherapy approved in the United States, and the therapy received Breakthrough Therapy and Orphan Drug designations. The approval was based on a reduction in the frequency of surgical procedures, an intermediate clinical endpoint, in an open-label trial of 32 adults, and the manufacturer must conduct post-approval trials to verify clinical benefit.
On November 2, FDA issued final guidance titled “Potency Assurance for Cellular and Gene Therapy Products,” which recommends that manufacturers adopt a risk-based Potency Assurance Strategy to verify that each product batch meets a defined potency standard. The guidance replaces FDA’s 2011 potency testing guidance for cellular and gene therapy (CGT) products. It addresses potency considerations from investigational new drug (IND) submissions through biologics license application (BLA) approval and post-market verification, including considerations for products with short shelf lives, viral vector gene therapies, and patient-specific therapies.
On November 3, the Department of Health & Human Services’ (HHS) Administration for Strategic Preparedness & Response (ASPR) announced a joint assessment with the Departments of Commerce and War to identify vulnerabilities in the U.S. pharmaceutical key starting materials industrial base and inform domestic manufacturing strategies. Commerce’s Bureau of Industry and Security is conducting a one-time survey under the Defense Production Act to collect information on production capacity, sourcing, supply chain disruptions, workforce, and research and development. The findings will be compiled into a report with recommendations to strengthen supply chain resilience and emergency preparedness.
On November 4, CMS issued the Calendar Year (CY) 2027 Medicare Physician Fee Schedule (PFS) final rule that sets a conversion factor of $32.63 for clinicians who are not qualifying alternative payment model (APM) participants, a 2.31% decrease from CY 2026, and $32.95 for qualifying APM participants, a 1.83% decrease. The rule also finalizes policies for the Medicare Prescription Drug Inflation Rebate Program established under the Inflation Reduction Act of 2022, including a requirement that 340B Drug Pricing Program covered entities submit certain claims data to CMS’ Medicare Part D Claims Data 340B Repository for Part D drugs dispensed by the entity or its contract pharmacies for which a manufacturer provided a 340B discount. The rule ends the traditional Merit-based Incentive Payment System (MIPS) reporting option beginning with the CY 2031 performance period and allows approved accountable care organizations (ACOs) to reduce or eliminate cost-sharing for eligible Part B items and services for assigned beneficiaries beginning April 1, 2027, excluding prescription drugs and durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS). A fact sheet on the Shared Savings Program can be found here. A press release can be found here.
On November 4, CMS issued the CY 2027 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) final rule. The rule increases OPPS and ASC payment rates by 2.3% for facilities meeting applicable quality reporting requirements, reflecting a 3.2% hospital market basket increase reduced by a 0.9% productivity adjustment. CMS also finalized payment for applicable separately payable drugs, biologicals, biosimilars, and radiopharmaceuticals acquired under the 340B program at average sales price (ASP) minus 28% for CY 2027 and subsequent years. CMS estimated the 340B policy will reduce Medicare drug payments by $4.35 billion and beneficiary drug payments by $1.1 billion in CY 2027, with offsetting increases in OPPS payments for non-drug services to maintain budget neutrality. The rule also adds eight botulinum toxin injection codes to the list of hospital outpatient services requiring prior authorization and continues phasing out the inpatient only list. A fact sheet can be found here. A press release can be found here.
On November 4, CMS issued the CY 2027 Home Health Prospective Payment System (HH PPS) final rule. CMS estimated the rule will increase aggregate Medicare payments to home health agencies by 2.4% compared with CY 2026, and the rule finalizes a 3% temporary reduction to the CY 2027 base payment rate. The rule also strengthens Medicare enrollment-integrity authorities across provider and supplier types, including allowing revocations to take effect as of the date noncompliance began. CMS estimated these enrollment changes will save approximately $82 million annually. It also adds grounds for denying or revoking enrollment, including circumstances in which an excessive concentration of providers and suppliers in a limited geographic area presents a high risk of fraud, waste, and abuse. A fact sheet can be found here. A press release can be found here.
On November 5, CMS issued a final rule codifying Medicare Drug Price Negotiation Program policies for initial price applicability year 2029 and beyond, including drug selection, manufacturer requirements, and negotiation and renegotiation procedures. CMS finalized a new policy for certain fixed combination drugs that are new formulations. When products with the same new drug application (NDA)/BLA holder differ because an added active moiety, active ingredient, or (for vaccines for infectious diseases) antigen component creates a new formulation and enables an alternative route of administration for the co-administered components, CMS will identify the potential qualifying single source drug using all dosage forms and strengths containing the shared components offered by that holder. The rule also clarifies negotiation eligibility timing for former orphan drugs, implements the Temporary Floor for Small Biotech Drugs, and provide additional details on manufacturer obligations. A fact sheet can be found here.
On November 5, the National Institutes of Health (NIH) announced findings from a study that associated higher blood levels of two per- and polyfluoroalkyl substances (PFAS), perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid (PFOS), with a higher incidence of estrogen receptor-negative (ER-negative) breast cancer. The study, published in the Journal of Clinical Oncology and drawing on NIH’s Sister Study, found that women with the highest PFOA and PFOS levels had a 67% and 93% higher rate of ER-negative breast cancer, respectively, than women with the lowest levels, though it found no clear association with overall breast cancer risk. The authors stated that the study did not test possible biological mechanisms and recommended further research, including on newer replacement PFAS chemicals.
On November 5, CMS issued the “Medicare and Medicaid Programs; Cutting Administrative Requirements for Excellence in Patient Care (CARE)” proposed rule, which would revise the Conditions of Participation (CoPs) and related requirements for Medicare- and Medicaid-participating providers and suppliers. Among other changes, the rule would remove obstetric care staff training and quality improvement requirements for hospitals and critical access hospitals, remove COVID-19 vaccine education and offering requirements for staff in long-term care facilities and intermediate care facilities, and rescind certain Medicaid payment transparency reporting requirements for nursing facilities. CMS estimated the proposals would save $320 million and more than 3.26 million hours of staff time. The proposed rule also solicited comments on topics including revisions to initial certification criteria for transplant programs, which CMS stated would aim to reduce barriers to entry for new programs while maintaining patient safety, and expanding the scope of practice for physician assistants and nurse practitioners in skilled nursing facilities. Comments are due January 11. A fact sheet can be found here.
On November 5, FDA granted accelerated approval to Janssen Biotech’s Rybrevant Faspro (amivantamab and hyaluronidase-lpuj) for adults with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) whose disease has progressed on or after platinum-based chemotherapy and immunotherapy. The approval was based on an open-label, multicenter trial of 102 patients in which the drug had an overall response rate of 42%, and FDA required confirmatory studies to verify clinical benefit. FDA stated that this is the first approval in 10 years of a drug for patients with recurrent or metastatic HNSCC previously treated with platinum-based chemotherapy.
On November 6, HHS’ Health Resources & Services Administration (HRSA) announced a Notice of Funding Opportunity (NOFO) for the Women’s Initiative for Screening and Health (WISH) program, which will award up to $1 million in fiscal year 2027 to one organization to update the HRSA-supported Women’s Preventive Services Guidelines. The awardee will convene a multidisciplinary panel of at least 10 experts, conduct evidence reviews to update or reaffirm the guidelines’ recommendations, and disseminate information on the guidelines to communities with limited resources. Under the Public Health Service Act, non-grandfathered private health plans generally must cover HRSA-supported preventive services without cost sharing. Applications for the program are due January 8.
WHITE HOUSE
On November 3, President Donald Trump signed the Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026 (H.R. 8205) into law, which reauthorizes the Accelerating Access to Critical Therapies for ALS Act through fiscal year 2031. The law also amends the Act’s grant program for research on amyotrophic lateral sclerosis (ALS) therapies and FDA’s rare neurodegenerative disease action plan.
On November 5, National Security Advisor Marco Rubio and Office of Science and Technology Policy (OSTP) Director Michael Kratsios issued a memorandum releasing the 2026 National Policy for Nucleic Acid Synthesis Screening to implement Executive Order 14292. The policy requires recipients of federal life sciences funding to procure synthetic nucleic acids and benchtop synthesis equipment only from suppliers that screen orders through a screener verified by the National Institute of Standards and Technology (NIST), conduct know-your-customer verification, and report flagged orders to federal authorities. Under the policy, NIST is to issue screening standards within 90 days, HHS is to publish an initial list of adherent suppliers within 160 days, and funding recipients must procure nucleic acids and benchtop equipment from adherent suppliers within 250 and 340 days, respectively. The policy replaces the 2024 Framework for Nucleic Acid Synthesis Screening, and violations may result in revocation of federal funding and up to five years of funding ineligibility.
On November 6, President Trump announced that White House Deputy Chief of Staff Stephen Miller will replace Susie Wiles as Chief of Staff.
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
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
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
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; 10/26/2026
Medicare Drug Price Negotiation Program: Final Guidance, Manufacturer Effectuation of the Maximum Fair Price in 2028; Notice; 10/29/2026
CY 2027 Part A Premiums for the Uninsured Aged and for Certain Disabled Individuals Who Have Exhausted Other Entitlement (CMS-8093); Notice; 11/04/2026
Medicare Part B Monthly Actuarial Rates, Premium Rates, and Annual Deductible Beginning January 1, 2027 (CMS-8094); Notice; 11/04/2026
CY 2027 Inpatient Hospital Deductible and Hospital and Extended Care Services Coinsurance Amounts (CMS-8092); Notice; 11/04/2026
FDA
Cannabidiol (CBD) Products Compliance and Enforcement Policy; Notice; 03/13/2026
Administrative Detention of Tobacco Products; Proposed Rule; 07/09/2026
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
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 November 2, HHS OIG released a report finding that only 23% of Medicaid beneficiaries with hepatitis C received treatment within six months of testing. Among those treated within six months, treatment typically began after seven weeks, despite recommendations for immediate treatment. State treatment rates ranged from 7% to 41%, with lower rates among newly infected beneficiaries, Medicare-Medicaid dual-eligible beneficiaries, older adults, and children. OIG recommended that CMS take additional steps to increase Medicaid treatment rates, building on data from the hepatitis C quality measure beginning in 2027, and take targeted action for dual-eligible beneficiaries, whose treatment is primarily covered by Medicare. CMS concurred with both recommendations.
On November 2, HHS OIG released an audit finding that HRSA made $658 million in potential overpayments to selected providers under Phase 3 of the Provider Relief Fund (PRF) program, which distributed COVID-19 relief funds to health care providers. OIG reviewed 165 sampled providers and found that all met eligibility requirements but that HRSA’s payments to 72 of them were not correctly calculated or not supported by appropriate documentation, resulting in potential overpayments to 45 providers and $132.4 million in potential underpayments to 27 providers. OIG recommended that HRSA review the providers with potential overpayments and seek repayment of up to $658 million. HRSA did not indicate whether it concurred with the recommendations but described actions it plans to take in response.
ADDITIONAL POLICY NEWS
On November 4, CVS Health announced that it intends to separate into two independent, publicly traded companies. Its pharmacy benefit manager (PBM), CVS Caremark, and its specialty pharmacy, CVS Specialty, will remain with Aetna, Oak Street Health, and Signify Health in a company that will keep the CVS Health name in the interim. CVS Health’s approximately 9,000 retail pharmacies, mail pharmacy, MinuteClinic and the Health100 technology services business will form a separate company named CVS Pharmacy, which CVS Health stated will pursue partnerships with payers, PBMs, and manufacturers. CVS Health stated it expects to complete the separation in the first half of 2028, subject to conditions including final approval by its board.
On November 5, JAMA Pediatrics published a research letter by researchers at Virginia Commonwealth University examining trends in vitamin K deficiency (VKD) and vitamin K–deficient bleeding (VKDB) among more than 11 million U.S. infants from 2017 to 2025. Using electronic health record data from Epic’s Cosmos database, the study found that the share of newborns receiving injectable vitamin K decreased from 97.7% to 95.0%, while the rate of VKD rose from 11.8 to 37.3 per 100,000 infants and the rate of VKDB rose from 24.0 to 107.4 per 100,000. The authors stated that the association does not prove causality but that the findings raise concerns about increased parental refusal of vitamin K injections.