Health Care Watch: March 7, 2026
The following Federal Health Policy (FHP) Strategies Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from March 1 – March 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 March 5, Energy and Commerce Committee Chairman Brett Guthrie (R-KY) and Subcommittee Chairs John Joyce, M.D. (R-PA) and Morgan Griffith (R-VA) sent letters to officials in ten states requesting information on efforts to address fraud and strengthen program integrity in state Medicaid programs. The letters are part of the committee’s ongoing investigation into waste, fraud, and abuse in Medicaid and follow a February 3 Oversight hearing examining common fraud schemes in Medicare and Medicaid. The lawmakers requested documents and communications detailing state oversight activities and actions taken to prevent fraudulent billing and improper payments.
On March 5, Democrat leaders of the committees with jurisdiction over health care policy sent a letter to President Donald Trump requesting copies of the most-favored-nation (MFN) drug pricing agreements made with pharmaceutical manufacturers. The letter requests that Congress receive complete and unredacted copies of the agreements.
On March 5, Democrat leaders of committees with jurisdiction over Medicare sent a letter to U.S. Department of Health & Human Services (HHS) Secretary Robert F. Kennedy, Jr., seeking clarity on the Centers for Medicare & Medicaid Services (CMS) Center for Medicare & Medicaid Innovation (CMMI) GLOBE and GUARD models. The lawmakers expressed concern that 16 major pharmaceutical manufacturers may be exempt from these models due to separate MFN pricing agreements they reached with the White House. The letter requests that HHS provide an analysis of which drugs will remain subject to the models and calls for the public release of the MFN agreements by March 19.
The House will return to session on March 16.
Senate
On March 4, Sen. Steve Daines (R-MT), a member of the Finance Committee, announced he will not run for re-election.
On March 5, the Health, Education, Labor & Pensions (HELP) Committee held a hearing titled Transforming Health Care with Data: Improving Patient Outcomes Through Next-Generation Care. Dr. Thomas Keane, Assistant Secretary for Technology Policy and National Coordinator for Health Information at HHS, testified on the role of health data and digital infrastructure in improving patient outcomes. The hearing examined the use of health information technology and data systems to support care delivery and health system performance.
On March 5, President Trump announced that he will nominate Sen. Markwayne Mullin (R-OK), a member of the HELP Committee, for Secretary of the U.S. Department of Homeland Security after the President announced that current Secretary Kristi Noem will be moving to be Special Envoy for The Shield of the Americas, a new Security Initiative in the Western Hemisphere.
On March 5, Finance Committee Ranking Member Ron Wyden (D-OR) along with six Democrat Senators sent letters to several large pharmaceutical manufacturers requesting information on agreements with the Trump administration related to prescription drug pricing. The letter asked the companies to provide details regarding which drugs are subject to the agreements and whether the agreements would reduce costs for Medicaid programs and taxpayers.
REGULATORY UPDATE
On February 28, HHS Secretary Kennedy, discussed several health policy topics during an appearance on the Joe Rogan podcast, including alleged Medicare and Medicaid fraud involving foreign actors. He also said the Food & Drug Administration (FDA) is reviewing the scientific evidence on certain peptides and may announce an action affecting approximately 14 peptides related to compounding policies.
On March 2, CMS announced it is extending the deadline for prescription drug manufacturers to apply to participate in the GENErating cost Reductions fOr U.S. Medicaid (GENEROUS) Model from March 31 to April 30. CMS also invited small and midsize manufacturers interested in the model to request a meeting with CMS to discuss potential participation. The final deadline for manufacturer participation in the GENEROUS Model is June 30. The Request for Applications for drug manufacturers can be found here.
On March 3, a federal judge ruled that HHS’ Health Resources & Services Administration (HRSA) cannot use its 340B registration process to restrict use of 340B drugs by hospital “child sites” otherwise eligible to participate in 340B. The court determined that HRSA’s requirement for off-site facilities to be listed on a Medicare cost report and registered in the OPAIS database before accessing 340B discounts conflicts with the 340B statute.
On March 3, the FDA issued 30 warning letters to telehealth companies regarding the marketing of compounded glucagon-like peptide-1 (GLP-1) products. FDA said the letters addressed false or misleading claims, such as that the compounded drugs are the same as FDA-approved products or obscure the identity of the compounder. The action is part of an ongoing FDA effort to monitor and address misleading direct-to-consumer pharmaceutical advertising. The warning letters can be found here.
On March 3, CMS issued a memorandum addressing frequently asked questions about the Medicare GLP-1 Bridge demonstration, a short-term initiative designed to provide early access to certain weight-loss drugs for eligible Medicare Part D beneficiaries. The demonstration will operate from July 1 through December 31 and will serve as a transition to the Better Approaches to Lifestyle and Nutrition for Comprehensive hEalth (BALANCE) Model scheduled to begin in 2027. CMS said eligible beneficiaries may access certain GLP-1 drugs through a centralized claims and prior authorization process outside the Part D benefit structure.
On March 3, FDA announced the establishment of a public docket seeking comment on industry guidance related to scale-up and post-approval manufacturing changes for certain drug dosage forms. The agency is requesting feedback on the continued utility of the guidances and potential revisions to the recommendations they contain. Comments are due by June 1.
On March 3, HHS announced that the March 2026 meeting of the U.S. Preventive Services Task Force (USPSTF) has been postponed, marking the third consecutive cancellation or postponement for the 16-member advisory panel. The USPSTF has not convened since March 2025. HHS indicated that the meeting will be rescheduled in the coming months.
On March 4, CMS Administrator Dr. Mehmet Oz sent a letter to New York officials requesting information about spending and program integrity in the state’s Medicaid program. The letter asked the state to respond to a series of questions regarding Medicaid expenditures, benefit structures, and potential fraud risks.
On March 4, the Department of Justice (DOJ) filed a brief in federal court outlining potential regulatory actions FDA could take regarding access to the abortion pill mifepristone. The filing described possible approaches under existing law, including changes to labeling requirements or regulatory restrictions if safety concerns were identified. The brief was submitted in response to a request from a federal judge overseeing litigation brought by Louisiana challenging FDA’s policies on telemedicine prescribing and mail delivery of the drug.
On March 5, FDA issued a Request for Information (RFI) seeking public comment on potential standards for in-home opioid disposal products. FDA is evaluating whether opioid manufacturers should be required to provide in-home disposal systems through pharmacies and other dispensers in addition to existing mail-back options. The agency said the request aligns with requirements in the SUPPORT for Patients and Communities Reauthorization Act of 2025 and efforts to address opioid misuse. Comments are due by April 6. The RFI can be found here.
On March 5, HHS and the Department of Education joined leaders from 53 medical schools across 31 states to announce commitments to expand nutrition training for medical students. The schools agreed to provide at least 40 hours of nutrition education, or a 40-hour competency equivalent, beginning in the fall 2026 academic term. HHS also announced a $5 million National Institutes of Health (NIH) nutrition education challenge to support curriculum development and training opportunities.
On March 5, FDA approved teclistamab in combination with daratumumab hyaluronidase-fihj (Tec-Dara) to treat adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy. The approval was issued 55 days after filing and represents the third authorization under the Commissioner’s National Priority Voucher (CNPV) pilot program.
On March 6, CMS announced that it extended the registration deadline for public engagement events related to the Medicare Drug Price Negotiation Program. The events will allow patients, caregivers, clinicians, researchers, and other stakeholders to provide input on selected drugs included in the current cycle of negotiation and renegotiation. CMS stated that registration for the virtual roundtables and town hall meeting will remain open through March 18, and that the public engagement events will be held in April.
On March 6, FDA announced that it held a meeting with several states to discuss the Section 804 Importation Program (SIP), which allows states and Indian tribes to import certain prescription drugs from Canada.
On March 6, CMS issued a memo clarifying how the agency will address missing October 2025 Consumer Price Index (CPI-U) data for the Medicare Part B Inflation Rebate Program. Due to the unavailability of the October data, CMS intends to use November 2025 CPI-U data as a substitute for calculating inflation-adjusted beneficiary coinsurance and rebate amounts for the second quarter of 2026. CMS added that that a more permanent methodology to address the missing data for future Part B and Part D inflation rebates will be established through future rulemaking in the Physician Fee Schedule.
On March 6, CMS announced it will host a virtual webinar on March 11 to discuss the BALANCE Model. The session will cover model background and application details, followed by a live Q&A. All attendees can register individually here.
On March 6, the Wall Street Journal reported that Dr. Vinay Prasad, who serves as the FDA Chief Medical and Scientific Officer and the Director of the Center for Biologics Evaluation and Research (CBER), will depart the agency in April. The report indicated that FDA Commissioner Marty Makary confirmed the move and indicated that Federal health officials are searching for his replacement.
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
FY 2027 Inpatient Rehabilitation Facility (IRF) Prospective Payment System Rate Update and Quality Reporting Program (CMS-1845); Proposed Rule; 02/26/2026
Medicaid Managed Care State Directed Payments and Medicaid Fee-For-Service Targeted Medicaid Practitioner Payments (CMS-2449); Proposed Rule; 02/27/2026
FY 2027 Skilled Nursing Facility (SNFs) Prospective Payment System and Consolidated Billing and Updates to the Value-Based Purchasing and Quality Reporting Programs (CMS-1843); Proposed Rule; 02/27/2026
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
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
Drug Establishment Registration and Drug Listing Requirements for Establishments Engaged in Distributed Manufacturing and Certain Foreign Establishments; Rule; 03/04/2026
HEARINGS
House
Energy & Commerce Committee
Oversight Subcommittee
March 17
Possible hearing on Medicaid fraud in post-acute care
Health Subcommittee
March 18
Possible hearing on health care affordability (potential focus on providers)
Senate
Aging Committee
Foreign Dependence: How China Captured America’s Drug Supply
March 11; 03:30 PM; 216 Hart
Witnesses: Former Rep. Ted Yoho (R-FL), Senior Advisor, Kyle House Group; Gordon Chang, Author, Plan Red: China’s Project to Destroy America; Rosemary Gibson, Author, ChinaRX; Chan Harjivan, Visiting Fellow, Duke Margolis Institute for Health Policy
REPORTS
HHS Office of Inspector General (OIG)
On March 2, HHS OIG posted a report examining Colorado’s fee-for-service Medicaid payments for applied behavior analysis (ABA) services provided to children in 2022 and 2023. HHS OIG found that the state made at least $77.8 million in improper or potentially improper payments that did not fully comply with federal and state requirements. The report recommends that Colorado refund $42.6 million to the federal government, strengthen billing and documentation guidance for providers, and conduct periodic statewide post payment reviews of ABA claims.
Government Accountability Office (GAO)
On March 2, GAO released testimony before the House Veterans’ Affairs Oversight and Investigations Subcommittee examining the Department of Veterans Affairs’ (VA) community care and caregiver programs related to the Senator Elizabeth Dole 21st Century Veterans Healthcare and Benefits Improvement Act. GAO reported that the Veterans Health Administration (VHA) has not fully implemented several prior recommendations aimed at improving access to the Veterans Community Care Program, including actions related to staffing levels, appointment scheduling metrics, and referral coordination.
On February 2, GAO issued a report examining HHS oversight of Sexual Risk Avoidance Education (SRAE) grants that support sex education programs for youth ages 10 to 19. GAO found that HHS collects information to assess whether grantees meet requirements related to medical accuracy and cultural appropriateness but lacks near-term performance goals to measure youth outcomes and program experiences. GAO recommended that the Administration for Children and Families (ACF) establish specific targets and timelines for these performance measures to better assess program effectiveness.
On March 3, GAO issued a report examining federal incentives for the development of new animal drugs regulated by FDA. GAO found that high development costs and limited market incentives have contributed to a shortage of FDA-approved drugs for minor animal species and rare conditions in major species. The report recommends that FDA incorporate benefit-risk assessments into evaluations of drugs using alternative study designs and develop related guidance for industry. GAO also stated that Congress should consider whether to expand the statutory five-year limit on conditional approval for certain animal drugs to encourage additional development.
ADDITIONAL POLICY NEWS
On February 27, the Better Medicare Alliance and more than 100 organizations sent a letter to CMS Administrator Dr. Oz requesting revisions to CMS’ proposed 2027 Medicare Advantage (MA) payment update. CMS proposed a 0.09% payment increase, which the groups said may not cover rising medical costs and utilization in the program. The organizations asked the Agency to revise the proposed rate upward to support program stability for MA enrollees and participating providers.
On March 3, the American Hospital Association (AHA) sent a letter to HRSA urging the Agency to stop Novo Nordisk’s new policy requiring 340B covered entities to submit claims data for all dispensations of all the company’s drugs, regardless of setting. AHA requested that HRSA take enforcement action and noted that the policy is similar to a data reporting requirement recently announced by Lilly.
On March 4, the US District Court for the District of Massachusetts heard arguments on whether HHS Secretary Kennedy has authority to restructure the Advisory Committee on Immunization Practices (ACIP).
On March 4, the Federal Reserve Bank of New York released survey findings indicating that rising employer health insurance costs are slowing wage growth at some businesses. Firms reporting higher health insurance expenses increased wages by an average of 3.8% in 2025, which the survey said was lower than the increases they otherwise planned to provide. The survey included responses from manufacturers in New York and service firms in New York, New Jersey, and southwestern Connecticut.
On March 4, autism researchers affiliated with the Autism Science Foundation and the Coalition of Autism Scientists announced the formation of an Independent Autism Coordinating Committee. The group said the committee will provide scientific input on autism research and policy issues in parallel with the federal Interagency Autism Coordinating Committee. Organizers said the effort follows recent changes to the membership of the federal advisory body by HHS Secretary Kennedy.
On March 5, Lilly launched the Lilly Employer Connect platform that allows employers to subsidize the cost of the obesity medication Zepbound® KwikPen® through third-party payment models rather than traditional insurance. Under this model, Lilly offers the drug at a fixed cash price of $449 per month and employers can then choose to cover a specific portion of that cost with the employee paying the remainder.