Health Care Watch: February 28, 2026
The following Federal Health Policy (FHP) Strategies Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from February 21 - February 28 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 24, the Ways & Means Health Subcommittee held a hearing titled Advancing the Next Generation of America’s Health Care Workforce. The hearing examined innovative ways to train the nation’s health care workforce with a focus on serving rural and underserved communities and leveraging technology to encourage healthier living.
On February 25, the Appropriations Committee released fiscal year (FY) 2027 guidance, outlining the framework and deadlines for members’ community project funding, programmatic funding, and report language requests. The deadline for members to submit requests for the bill is March 20.
Senate
On February 25, the Health, Education, Labor & Pensions (HELP) Committee held a confirmation hearing for President Trump’s nominee for Surgeon General, Dr. Casey Means. Dr. Means addressed questions regarding childhood vaccines and stated that vaccines save lives while emphasizing parental autonomy. Members from both parties sought clarification on her views regarding the hepatitis B birth dose and other routine immunizations.
On February 26, the Aging Committee held a hearing titled From Regulator to Roadblock: How Food & Drug Administration (FDA) Bureaucracy Stifles Innovation. The hearing framed FDA delays as a regulatory and bureaucratic problem requiring oversight and reform.
On February 26, the HELP Committee held a markup of four bills, including two health care bills: S. 1552, the Living Donor Protection Act of 2025 and S. 3315, the Health Care Cybersecurity and Resiliency Act of 2025. Both bills passed committee with a vote of 22 – 1, with Sen. Rand Paul (R-KY) voting no.
REGULATORY UPDATE
On February 23, the Centers for Disease Control and Prevention (CDC) announced that Principal Deputy Director Ralph Abraham resigned, effective immediately, citing “unforeseen family obligations.” He had served in the role for approximately three months.
On February 23, the Centers for Medicare & Medicaid Services (CMS) announced it is temporarily halting approximately $259 million in federal Medicaid payments to Minnesota following an audit that identified unsupported or potentially fraudulent claims. CMS stated the pause will remain in place pending corrective actions by the State.
On February 23, FDA issued draft guidance titled Considerations for the Use of the Plausible Mechanism Framework to Develop Individualized Therapies that Target Specific Genetic Conditions with Known Biological Cause. The guidance outlines a framework for sponsors seeking traditional approval of targeted individualized therapies, including genome editing and RNA-based treatments, when randomized controlled trials are not feasible due to small patient populations. FDA stated that therapies should demonstrate they address a known genetic, cellular, or molecular abnormality and provide substantial evidence of effectiveness and safety based on clinical outcomes or validated biomarkers. Comments are due on April 27.
On February 24, at a U.S. Department of Health & Human Services (HHS) press conference, FDA Commissioner Dr. Marty Makary discussed the agency’s position on mRNA vaccines and federal funding. Dr. Makary stated that FDA supports mRNA vaccines but indicated that taxpayers should not bear the cost.
On February 24, FDA posted a warning letter issued to MedisourceRx, an outsourcing facility that produces compounded medications. The letter dated December 12, 2025, cited deficiencies including failure to timely submit an adverse event report related to compounded semaglutide and concerns regarding reporting procedures.
On February 25, CMS issued a notice announcing a 6-month nationwide temporary moratorium on the Medicare enrollment of certain Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) medical supply companies. The moratorium applies to seven categories of medical supply company supplier types and is intended to address program integrity concerns related to fraud, waste, and abuse. The moratorium does not apply to currently enrolled suppliers or certain ownership and location changes. Medicaid and CHIP implementation decisions will be left to states.
On February 25, CMS issued a Request for Information (RFI) seeking stakeholder feedback on potential regulatory and programmatic changes under the Comprehensive Regulations to Uncover Suspicious Healthcare (CRUSH) initiative. The RFI requests input on strengthening provider enrollment screening, payment suspensions, identity proofing requirements, laboratory and DMEPOS oversight, use of the preclusion list in Medicare Advantage (MA), artificial intelligence use, beneficiary protections, and Medicaid and Marketplace program integrity authorities. Comments are due by March 20.
On February 25, CMS hosted a Burden Reduction Conference focused on identifying opportunities to reduce administrative burden and improve access to quality care. The conference included panels on transparency, artificial intelligence (AI), and chronic care, with participants discussing infrastructure modernization, data exchange, technology adoption, interoperability challenges across care settings, and the role of trust and privacy in health information use.
On February 26, CDC announced a March 18-19 Advisory Committee on Immunization Practices (ACIP) meeting to discuss updates from ACIP workgroups and discussions on COVID-19 vaccine injuries, Long-COVID, and ACIP recommendation methodology, with potential recommendation votes scheduled. Written comments must be submitted between March 2 and March 12.
On February 25, the Department of Justice (DOJ) filed a brief in federal appeals court supporting AbbVie’s effort to overturn a Colorado law that prohibits manufacturers from placing restrictions on 340B contract pharmacies. In the filing, the DOJ agreed with AbbVie that the state law violates the Supremacy Clause, arguing it interferes with the federal operation of the 340B program. The filing marks the first time the Trump administration has formally sided with manufacturers in the legal dispute with hospitals over contract pharmacy restrictions.
On February 26, FDA issued its second approval under the Commissioner’s National Priority Review Voucher (CNPRV) program, granting a new indication for Boehringer Ingelheim’s lung cancer drug HERNEXEOS (zongertinib). The application was filed on January 13, 2026. The approval allows the drug, which targets specific molecular alterations in a subset of non-small cell lung cancers, to be used as a first-line therapy.
On February 26, the Health Resources and Services Administration (HRSA) issued a notice extending the comment period for the 340B Rebate Model Pilot Program RFI from 30 days to 60 days. HRSA stated the extension will provide stakeholders additional time to submit comments regarding operational, financial, and patient access considerations under a rebate model. Comments are due by April 20.
On February 27, HHS Secretary Robert F. Kennedy, Jr., appointed two new members to ACIP: Dr. Angelina Farella, a pediatrician and COVID vaccine opponent from Texas, and Dr. Sean Downing, an internal medicine and pediatric doctor from Florida.
WHITE HOUSE
On February 24, during his State of the Union address, President Donald Trump addressed several health care policies , including Affordable Care Act (ACA) subsidies, prescription drug pricing, Medicaid program integrity, tariffs, retirement savings policy, and implementation of the One Big Beautiful Bill Act. During the speech, the President discussed health care affordability, Medicare and Medicaid oversight, and federal tax and benefit policy changes.
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
Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals; the Long-Term Care Hospital 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
Contract Year 2027 Policy and Technical Changes to Medicare Advantage, Medicare Prescription Drug Benefit, Medicare Cost Plan, and Programs of All-Inclusive Care for the Elderly Programs (CMS-4212); Final Rule; 02/18/2026
FY 2027 Inpatient Psychiatric Facilities Prospective Payment System Rate and Quality Reporting Updates (CMS-1847); Proposed Rule; 02/25/2026
FY 2027 Hospice Wage Index, Payment Rate Update, and Quality Reporting Requirements (CMS-1851); Proposed Rule; 02/26/2026
Medicare Drug Price Negotiation Program (CMS-4215); Proposed Rule; 02/26/2026
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
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
Statement of Policy – Considerations for Flavored Electronic Nicotine Delivery Systems (ENDS) Premarket Applications; Draft Guidance for Industry; Notice; 02/18/2026
Establishment Registration and Product Listing for Tobacco Products; Proposed Rule; 02/19/2026
HEARINGS
Senate
HELP Committee
Transforming Health Care with Data: Improving Patient Outcomes Through Next-Generation Care
March 5; 10:00 AM; 430 Dirksen
Witness: Thomas Keane, MD, Assistant Secretary for Technology Policy and National Coordinator for Health Information Technology, HHS
REPORTS
Congressional Budget Office
On February 23, the Congressional Budget Office (CBO) released updated projections estimating that the Medicare Hospital Insurance (HI) Trust Fund (Part A) will be exhausted in 2040, 12 years earlier than CBO projected last year. CBO attributed the change primarily to lower projected revenues, including reduced income from taxing Social Security benefits under the 2025 reconciliation law and lower payroll tax receipts, as well as higher beneficiary spending. CBO noted that, absent legislative action, total Part A benefits would need to be reduced by 8% in 2040, and then by 10% in 2056.
HHS Office of Inspector General (OIG)
On February 24, HHS OIG released a report titled National Institutes of Health Fiscal Year 2025 Detailed Accounting Submission and Fiscal Year 2027 Budget Formulation Compliance Report for National Drug Control Activities, and the Accompanying Required Assertions. OIG reviewed the National Institutes of Health’s (NIH) National Institute on Drug Abuse (NIDA) and National Institute on Alcohol Abuse and Alcoholism (NIAAA) submissions to the Office of National Drug Control Policy (ONDCP), including fiscal year 2025 drug control obligations and fiscal year 2027 budget formulation materials. OIG stated that it was not aware of any material modifications needed for the reports or management’s assertions to comply with ONDCP requirements.
On February 24, HHS OIG released a report titled Food and Drug Administration Fiscal Year 2025 Detailed Accounting Submission and Fiscal Year 2027 Budget Formulation Compliance Report for National Drug Control Activities, and the Accompanying Required Assertions. OIG reviewed FDA’s fiscal year 2025 drug control accounting and fiscal year 2027 budget formulation materials submitted to ONDCP. OIG stated that it was not aware of any material modifications needed for FDA’s reports or related management assertions to comply with ONDCP criteria.
On February 24, the HHS OIG released a report titled Centers for Disease Control and Prevention Fiscal Year 2025 Detailed Accounting Submission and Fiscal Year 2027 Budget Formulation Compliance Report for National Drug Control Activities, and the Accompanying Required Assertions. OIG reviewed CDC's fiscal year 2025 drug control accounting and fiscal year 2027 budget formulation submissions to ONDCP. OIG stated that it was not aware of any material modifications needed for CDC’s reports or management’s assertions to comply with ONDCP requirements.
Government Accountability Office (GAO)
On February 26, GAO released a report examining CMS’ implementation of the voluntary Medicare Part D Premium Stabilization Demonstration. GAO reported that, under the demonstration, CMS reduced monthly premiums by up to $15 and limited monthly premium increases to $35 for 2025. For 2026, CMS provides for smaller premium reductions and allows for greater premium increases. Collectively, CMS officials estimated that the demonstration would cost a total of $9.8 billion in 2025 and 2026.
ADDITIONAL POLICY NEWS
On February 20, the New York State Nurses Association (NYSNA) announced a tentative contract agreement with New York-Presbyterian ending a 41-day nurse strike involving approximately 4,200 nurses. The union reported an affirmative ratification vote the following day. Details of the agreement were not immediately disclosed.
On February 21, Moderna announced results from a mid-stage clinical trial evaluating its combined seasonal influenza and COVID-19 vaccine candidate (mRNA-1073). The company reported that the vaccine produced an immune response in approximately 550 adults aged 18 to 75 and did not identify serious safety concerns. The study compared the combination vaccine with separately administered commercially available influenza and COVID-19 vaccines.
On February 23, Louisiana Attorney General Liz Murrill (R) asked a federal judge to halt nationwide telemedicine prescribing and mail distribution of mifepristone, challenging the FDA’s 2023 Risk Evaluation and Mitigation Strategy (REMS) modifications. DOJ argued that Louisiana lacks standing and requested that the case be paused pending federal review of the drug’s safety. Drug manufacturers Danco and GenBioPro petitioned to intervene to defend the FDA’s policy.
On February 24, a coalition of 15 states, led by Attorneys General in Arizona and California, filed a lawsuit seeking to overturn recent changes to the federal childhood vaccine schedule. The suit challenges a January decision memo modifying routine immunization recommendations and changes to ACIP. The plaintiffs requested that the court nullify the revisions.
On February 24, JAMA published a research letter reporting that hepatitis B vaccination rates among U.S. newborns declined from 83.5% in February 2023 to 73.2% in August 2025. The authors noted that the decline preceded CDC’s decision to shift from a universal birth-dose recommendation to a shared clinical decision-making approach.
On February 24, the American College of Obstetricians and Gynecologists (ACOG) announced its withdrawal as a liaison organization to ACIP. ACOG stated the decision follows recent changes to the committee’s structure and vaccine recommendation processes and indicated it will continue developing evidence-based immunization guidance for obstetric and gynecologic care.
On February 26, STAT reported that Cigna has acquired CarepathRx, a pharmacy services company that provides services to approximately 10% of U.S. hospitals. The acquisition, discovered in a review of Cigna’s financial filings, expands Cigna’s pharmacy services portfolio. CarepathRx dispenses prescription drugs and has been backed by private equity investment.
On February 26, health information network Health Gorilla filed a motion to dismiss a lawsuit brought by Epic Systems and several health systems alleging improper access to patient data. The motion argues that Epic did not complete dispute-resolution processes under Carequality and the Trusted Exchange Framework and Common Agreement (TEFCA). The litigation involves claims related to data access practices and oversight within national health information exchange networks.
On February 27, the Minnesota Department of Health issued a report finding that 340B covered entities in the state spent $1.53 billion to acquire drugs, plus an additional $165 million to administer or dispense them to patients, while billing commercial and federal payers more than $3 billion for these drugs and services. This generated at least $1.34 billion in additional revenue. In 2023, Minnesota was the first state to enact legislation calling for the collection and reporting of data from 340B providers.
On March 2 and 3, the Medicare Payment Advisory Commission (MedPAC) will hold its next round of public meetings. Topics include MA provider networks, using MA encounter data in its risk model, and access to hospice care for beneficiaries with end-stage renal disease and cancer.