Health Care Watch: February 15, 2026
The following Federal Health Policy (FHP) Strategies Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from February 8 – February 15. 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 February 10, Judiciary Committee Chairman Jim Jordan (R-OH) issued subpoenas to eight health insurance companies as part of an investigation into potential fraud involving Affordable Care Act (ACA) premium subsidies. The subpoenas were sent to Blue Shield of California, Centene, CVS Health, Elevance Health, GuideWell, Health Care Service Corporation, Kaiser Permanente, and Oscar Health requesting documents related to subsidized enrollment, broker compensation, fraud prevention efforts, and communications with federal regulators. The insurers are directed to provide the requested information by February 23.
On February 11, the Energy & Commerce Health Subcommittee held a hearing titled Lowering Health Care Costs for All Americans: An Examination of the Prescription Drug Supply Chain. This hearing is the second in the Committee’s health affordability series and examined the prescription drug supply chain. Members discussed a wide range of topics including TrumpRx, Most Favored Nation policies, the Inflation Reduction Act, they Medicare Drug Price Negotiation Program, pharmacy benefit manager (PBM) practices and reforms, Food & Drug Administration (FDA) oversight, vaccine policy.
The House is in recess until February 23.
Senate
On February 11, Senate Republicans participated in a closed-door briefing with FDA Commissioner Makary regarding the agency’s review of the abortion drug, mifepristone. Following the briefing, Health, Education, Labor and Pensions Committee Chairman Bill Cassidy (R-LA) and Sen. Josh Hawley (R-MO) stated that they had concerns about the pace and scope of the FDA’s safety review.
On February 12, Finance Committee Ranking Member Ron Wyden (D-OR) introduced the Nurses Belong in Nursing Homes Act. The legislation would require 24/7 on-site nursing coverage, establish a federal minimum staffing standard of at least 3.5 hours of nursing care per resident per day, require periodic updates to staffing standards, and provide funding for inspections and enforcement. A summary of the legislation can be found here.
On February 12, it was reported that Sen. Jim Banks (R-IN) sent a letter to FDA Commissioner Dr. Marty Makary on February 9 urging the agency to enforce restrictions on compounded GLP-1 weight-loss drugs and to provide additional information on planned enforcement actions. The letter requested details regarding the FDA’s approach to limiting active ingredients used in mass-marketed compounded GLP-1 products, identification of websites that may be violating federal drug law, and consideration of enhanced warning requirements.
The Senate is in recess until February 23.
REGULATORY UPDATE
On February 3, FDA issued a refuse-to-file letter to Moderna regarding its biologics license application for a seasonal influenza vaccine for adults age 50 and older. In the letter, the FDA’s Center for Biologics Evaluation and Research stated that the application did not contain an “adequate and well-controlled” trial, citing concerns that the study’s control arm did not reflect the best-available standard of care at the time of the study.
On February 10, it was reported that HHS hired Arman Sharma to serve as Deputy Chief Artificial Intelligence Officer. The appointment follows prior leadership changes in HHS’ AI office and comes as the department advances implementation of its artificial intelligence strategy.
On February 11, HHS announced that nearly 500 million health records have been exchanged through the Trusted Exchange Framework and Common Agreement (TEFCA), a significant increase from approximately 10 million in January 2025. HHS also highlighted recent regulatory actions intended to lower costs and reduce provider burden, including the adoption of standards under the HTI-4 Final Rule that support electronic prior authorization and require certified health IT to include real-time prescription benefit capabilities.
On February 11, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule titled Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2027 and Other Revisions, proposing updates to Federal and State-Based Exchanges. The proposal would revise standards related to plan design flexibility, catastrophic plan eligibility, agent and broker oversight, income verification, network adequacy, and Essential Health Benefits, and includes measures intended to strengthen program integrity and subsidy eligibility verification. Comments are due by March 13. The press release can be found here. A fact sheet can be found here.
On February 11, CMS issued a Health Plan Management System (HPMS) memo to manufacturers inviting them to a call on February 24 on the implementation of the MedicareDrug Price Negotiation Program and the Medicare Prescription Drug Inflation Rebate Program. As with previous manufacturer calls, the call provides a forum for manufacturers to ask questions and offer feedback. Registration is required by February 20 and can be done here.
On February 12, FDA approved Optune Pax, a first-of-its-kind portable, non-invasive device developed by Novocure for the treatment of adults with locally advanced pancreatic cancer. The device delivers tumor treating fields (TTFields) and was approved through the premarket approval pathway based on a randomized clinical study showing that adding TTFields to standard chemotherapy improved overall survival compared to chemotherapy alone. The FDA previously granted the device Breakthrough Device designation in December 2024.
On February 12, HHS Secretary Robert F. Kennedy, Jr,. announced management team appointments at HHS. CMS’ Center for Medicare Director Chris Klomp was named Chief Counselor and will oversee Department operations, while Kyle Diamantas and Grace Graham were appointed Senior Counselors for FDA, and John Brooks was appointed Senior Counselor for CMS. The appointees will continue serving in their current roles in addition to their responsibilities in the Secretary’s office. These changes were followed by press reports that both HHS Deputy Secretary and Acting Director of the Centers for Disease Control Jim O’Neill and HHS General Counsel Mike Stuart will be departing the Department.
On February 12, FDA approved labeling changes to six menopausal hormone therapy products to remove certain risk statements related to cardiovascular disease, breast cancer, and probable dementia from the boxed warning. FDA initiated the review in November 2025 and reported that 29 drug companies submitted proposed labeling updates, with the first six approvals spanning systemic combination, systemic estrogen-alone, systemic progestogen-alone, and topical vaginal estrogen therapies.
On February 13, HHS’ Health Resources and Services Administration (HRSA) issued a request for information (RFI) regarding the development and implementation of a future 340B Rebate Model Pilot Program. This action follows a February 5 court filing in which HHS agreed to vacate the previous 340B rebate pilot program that was scheduled to be implemented on January 1, 2026. The RFI seeks feedback on whether HRSA should implement a 340B rebate model pilot and how best to operationalize such a framework to assess the financial and operational impact on covered entities, manufacturers, and patient access. HRSA stated it will use the feedback to determine if a pilot program is in the “public’s interest” and, if so, an implementation strategy, consistent with the 340B statute. Comments on the RFI are due by March 19.
RULES AT THE WHITE HOUSE OFFICE OF MANAGEMENT & BUDGET (OMB)
Pending Review
CMS
Amending the Indirect Hold Harmless Threshold of Health Care-Related Taxes (CMS-2452); Proposed Rule, 12/31/2025
Administrative Simplification: Adoption of Standards for Health Care Attachment Transactions and Electronic Signatures (CMS-0053); Final Rule, 01/09/26
Interoperability Standards and Prior Authorization for Drugs (CMS-0062); Proposed Rule; 01/16/2026
Comprehensive Regulations to Uncover Suspicious Healthcare (CRUSH) (CMS-6098); Notice; 01/16/2026
Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals; the Long-Term CareHospital Prospective Payment System; and FY 2027 Rates (CMS-1849); Proposed Rule; 01/22/2026
Independent Dispute Resolution Operations (CMS-9897); Final Rule; 01/29/2026
Strengthening Oversight of Accrediting Organizations (AO), Burden Reduction, and Related Provisions (CMS-3367); Final Rule; 02/04/2026
FDA
Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to their Microbiological Effects on Bacteria of Human Health Concern; Guidance for Industry; Notice; 7/10/25
Post approval Pregnancy Safety Studies; Guidance for Industry; Availability; Notice; 8/21/25
New Clinical Investigation Exclusivity (3-Year Exclusivity) for Drug Products: Questions and Answers; Draft Guidance for Industry; Availability; Notice; 12/01/25
Substances Generally Recognized as Safe; Proposed Rule; 12/01/25
Medical Devices with Indications Associated with Weight Loss--Premarket Considerations; Guidance for Industry and Food and Drug Administration Staff; Availability; Notice; 12/18/25
General Considerations for the Use of New Approach Methodologies; Draft Guidance for Industry; Availability; Notice; 01/09/25
Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection: Draft Guidance for Industry; Availability; Notice; 01/27/2026
E2D(R1) Postapproval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports; International Council for Harmonisation; Guidance for Industry; Availability; Notice; 02/11/2026
Developing Individualized Therapies Using a Plausible Mechanism Framework; Draft Guidance for Industry; Availability; Notice; 02/12/2026
REPORTS
Office of Inspector General (OIG)
On February 12, the HHS OIG released a report titled West Virginia Did Not Obtain Rebates Associated With Millions of Dollars in Medicaid Physician-Administered Drugs Dispensed to Enrollees of Medicaid Managed-Care Organizations. OIG found that West Virginia did not invoice or collect an estimated $6.1 million (Federal share) in manufacturer rebates for physician-administered drugs dispensed to Medicaid managed-care organization (MCO) enrollees, citing internal control gaps in using collected drug utilization data to invoice manufacturers.
On February 12, the HHS OIG released a report titled ACF’s $529 Million Sole Source Contract Award for Unaccompanied Alien Children Services Was Based on an Unsolicited Proposal, Double the Cost Estimate, and Noncompliant With Pre-Award Requirements. OIG found that the awarding of the $529 million sole source contract to Family Endeavors, Inc. by the Administration for Children and Families (ACF) was not in accordance with Federal requirements, including failing to conduct a timely price analysis or evaluate contractor responsibility prior to award. OIG reported that the contract was awarded three days after receipt of an unsolicited proposal and that a subsequent price analysis showed the award exceeded ACF’s $245 million cost estimate.
ADDITIONAL POLICY NEWS
On February 4, the Governors Public Health Alliance sent a letter to CMS Administrator Dr. Mehmet Oz requesting that the agency reverse its decision to remove mandatory childhood immunization reporting from the Medicaid and CHIP Child Core Set beginning in 2026. The governors stated that standardized federal reporting is necessary to monitor vaccination coverage, compare performance across states, and coordinate public health responses to outbreaks. The letter follows CMS’ December notice indicating that vaccination measures would become optional and could not be used to incentivize or penalize health plans.
On February 9, the American Academy of Pediatrics (AAP) released a 30-second public service announcement encouraging families to speak with pediatricians about childhood vaccination. The announcement highlights the role of pediatricians in providing guidance on immunizations as part of routine care.
On February 10, the American Medical Association and the Vaccine Integrity Project at the University of Minnesota Center for Infectious Disease Research and Policy (CIDRAP) announcedthe launch of a structured, evidence-based review process to assess vaccine safety and effectiveness for the 2026-27 respiratory virus season. The review will focus on influenza, COVID-19, and respiratory syncytial virus immunizations and will include systematic literature reviews, expert panels, and publicly available evidence briefs to inform clinical guidance.
On February 10, New York Governor Kathy Hochul (D) announced that the New York State Department of Health joined the World Health Organization Global Outbreak Alert and Response Network (GOARN). Through GOARN, the Department will contribute technical expertise, laboratory capacity, and workforce support to international outbreak detection and response efforts, including through the Wadsworth Center’s diagnostic and surveillance capabilities.
On February 11, AbbVie filed a lawsuit in the U.S. District Court for the District of Columbia challenging CMS’ decision to select Botox for the third cycle of the Medicare Drug Price Negotiation Program. The complaint argues that the agency exceeded its statutory authority under the IRA because Botox qualifies as a “plasma-derived product,” a category explicitly excluded from the negotiation process. Additionally, the lawsuit claims the selection violates the Administrative Procedure Act, the Takings Clause of the Fifth Amendment, and the First Amendment.
On February 11, the Attorneys General of California, Colorado, Illinois, and Minnesota filed a lawsuit challenging the Trump administration’s decision to withdraw more than $600 million in public health grant funding. According to the complaint, HHS notified Congress in early February that it would terminate 108 grants, including awards administered through CDC’s Public Health Infrastructure Block Grant program. The affected grants include funding for state and local public health departments and academic institutions. The states are seeking to block the funding withdrawal in federal court.
On February 11, World Health Organization (WHO) Interim Director of Epidemic and Pandemic Management Maria Van Kerkhove stated that the United States will participate in the WHO meeting to determine the composition of the 2026–2027 northern hemisphere influenza vaccine. The meeting is scheduled for February 26 in Turkey and will address recommendations for the upcoming flu season. The participation follows the United States’ formal withdrawal from WHO earlier this year.
On February 12, Public Citizen filed a petition with HHS requesting that the Department authorize generic competition for semaglutide and tirzepatide to address access and cost concerns. The petition asks HHS to use existing statutory authorities to overcome patent barriers and permit generic manufacturing for certain GLP-1 products used to treat type 2 diabetes, weight loss, and other conditions.
On February 14, the American Academy of Pediatrics is scheduled to appear before the U.S. District Court for the District of Massachusetts for a hearing on its request to temporarily block implementation of recent federal vaccine policy changes while litigation proceeds. A second hearing on additional aspects of the motion is scheduled for March 4.