Health Care Watch: March 14, 2026
The following Federal Health Policy (FHP) Strategies Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from March 8 – March 14. 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 10, the Joint Economic Committee (JEC) released an issue brief titled The Part B Premium Pass-Through: Medicare Advantage Overpayments Inflate Premiums for All examining the impact of Medicare Advantage (MA) payments on Medicare Part B premiums. The analysis estimates that “overpayments” to MA plans increased Part B premiums by $212 per enrollee in 2025 ($13.4 billion in total). The JEC also released its Medicare Affordability Tracker, which provides state- and congressional district-level estimates of excess premiums associated with MA overpayments.
On March 11, Ways & Means Health Subcommittee member Kevin Hern (R-OK) announced that he will run for the Oklahoma U.S. Senate seat. On March 13, Rep. Hern received an endorsement from President Donald Trump.
On March 11, Democrat leaders of the committees with jurisdiction over health care policy sent a letter to the Centers for Medicare & Medicaid Services (CMS) Administrator Dr. Mehmet Oz expressing opposition to proposed Affordable Care Act (ACA) Marketplace rule changes. The lawmakers raised concerns about provisions to expand eligibility for high-deductible catastrophic plans, increase insurers’ plan design flexibility, loosen network and benefit requirements, expand broker-based enrollment systems, tighten special enrollment period eligibility verification requirements, and expand income eligibility requirements. The lawmakers argued the proposal could increase premiums, reduce enrollment, and weaken consumer protections in ACA Marketplace plans. They urged CMS to withdraw the proposed rule.
Senate
On March 10, Finance Committee Ranking Member Ron Wyden (D-OR), along with six Senate Democrats introduced the Nurses Belong in Nursing Homes Act. The legislation would establish federal nursing home staffing requirements, including requiring a registered nurse on-site 24 hours per day and setting a minimum standard of 3.5 hours of nursing care per resident per day. The bill would also require periodic updates to staffing standards and provide funding for nursing home inspections and enforcement activities. Lawmakers said the legislation is intended to strengthen oversight and improve quality of care for nursing home residents.
On March 11, the Aging Special Committee held a hearing titled Foreign Dependence: How China Captured America’s Drug Supply. The hearing examined U.S. reliance on foreign pharmaceutical supply chains and potential national security and health system implications.
REGULATORY UPDATE
On March 9, the Food & Drug Administration (FDA) issued draft guidance titled New and Revised Draft Q&As on Biosimilar Development and the Biologics Price Competition and Innovation Act of 2009 (BPCI Act) (Revision 4) to support the development of proposed biosimilars and interchangeable biosimilars. The draft guidance recommends streamlining certain clinical pharmacokinetic studies when scientifically justified and provides updated recommendations on the use of comparator products approved outside the U.S. FDA also withdrew its 2015 final guidance Scientific Considerations in Demonstrating Biosimilarity to a Reference Product to reflect updated scientific approaches.
On March 9, CMS’ Center for Medicare & Medicaid Innovation (CMMI) released requests for applications (RFAs) for the Better Approaches to Lifestyle and Nutrition for Comprehensive hEalth (BALANCE) Model. Under the RFAs issued to state Medicaid agencies and Medicare Part D plans, CMMI outlines coverage criteria that participating states and Part D plans must adopt without burdensome step therapy or prior authorization. CMMI also notes that they will only launch the Part D model if the projected enrollment in participating Part D plans is at least 80% of the total projected enrollment across all eligible plans nationwide. LINK
On March 10, CMMI issued an HPMS memo to Part D plans and manufacturers providing CY 2027 guidance for the BALANCE Model for contract year 2027. The memo outlines the Part D bid submission process, model participation specifications, and payment effectuation and rebate mechanics for manufacturers. The memo also provides detailed prescription drug event (PDE) reporting instructions for Part D sponsors.
On March 10, FDA approved expanded use of Wellcovorin (leucovorin calcium) tablets for the treatment of cerebral folate deficiency in adult and pediatric patients with a confirmed variant in the folate receptor 1 (FOLR1) gene. The approval was based on a review of published literature, including case reports and mechanistic data demonstrating clinical benefit. The approval represents the first FDA-approved treatment for this rare genetic neurological condition; however, it is a retreat from earlier claims made by Trump Administration officials suggesting the drug held broad promise as a treatment for autism.
On March 11, the Center for Clinical Standards and Quality (CCSQ) released its fiscal years (FYs) 2025-2028 Strategic Roadmap outlining priorities for the nation’s health and long-term care systems. The roadmap identifies five strategic goals: prevention, quality and safety, coverage innovation, data and technology, and burden reduction. CMS said the plan will guide efforts to strengthen national health and safety standards, expand digital quality measurement and interoperability, and streamline reporting requirements for providers. A strategic roadmap fact sheet can be found here.
On March 11, CMS issued guidance that clarifies the responsibilities of Organ Procurement Organizations (OPOs) and donor hospitals, both in providing patients full medical care regardless of potential donor status and allowing families the time to make decisions regarding organ donation without coercion. CMS notes that the guidance follows reports that some OPOs have rushed aspects of the organ donation and procurement process, pressuring families to make decisions during moments of grief. CMS also directed surveyors to cite noncompliance with these requirements when identified, even if deficiencies are corrected during the survey process.
On March 11, FDA launched the FDA Adverse Event Monitoring System (AEMS), a unified platform for analyzing adverse event reports across regulated products. The system consolidates multiple existing databases and provides a single dashboard for reports related to drugs, biologics, vaccines, cosmetics, and animal food. FDA said the platform will support post-market safety monitoring and expand real-time access to adverse event data.
On March 11, FDA announced actions to address unapproved animal-derived thyroid medications used to treat hypothyroidism. FDA stated that these products, including desiccated thyroid extract therapies, have not been reviewed for safety, purity, or effectiveness and may present risks related to inconsistent dosing or impurities. The agency said it plans to issue draft guidance by August 2026 outlining its compliance and enforcement priorities for manufacturers, importers, and distributors of these medications.
On March 12, the Department of Health & Human Services (HHS) Office on Women’s Health (OWH) announced a memorandum of understanding with the American Urological Association (AUA), the American Urological Education and Research, and the Urology Care Foundation to promote evidence-based use of local estrogen therapy for postmenopausal women. The collaboration will focus on educating clinicians and patients about treatment for genitourinary syndrome of menopause and recurrent urinary tract infections. Under the agreement, HHS and AUA will exchange information, develop educational resources, and conduct outreach to improve awareness and appropriate use of local estrogen therapy.
On March 13, FDA issued final guidance titled Medical Devices with Indications Associated with Weight Loss - Premarket Considerations outlining recommendations for manufacturers seeking premarket approval for weight-loss medical devices. The guidance provides nonbinding recommendations on device description, labeling, sterility, biocompatibility, and other nonclinical testing considerations, as well as recommendations for clinical study design and endpoints used to evaluate device safety and effectiveness.
On March 13, CMS invited organizations to apply for the Making America Healthy Again: Enhancing Lifestyle and Evaluating Value-based Approaches Through Evidence (MAHA ELEVATE) Model and said it will award up to 30 three-year cooperative agreements totaling up to $100 million to support programs focused on interventions such as nutrition, physical activity, sleep, stress management, and other behavioral health strategies aimed at preventing chronic disease. Letters of intent are due April 10, and applications are due May 15.
On March 13, the FDA’s Vaccines and Related Biological Products Advisory Committee voted unanimously to recommend including a viral strain of the flu, subclade K, in vaccines beginning in the fall, consistent with the recommendation of the World Health Organization.
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
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
Appropriations Subcommittee on Labor, HHS, Education, and Related Agencies
Hearing on Oversight Hearing National Institutes of Health
March 17; 10:30 AM; 2358-C Rayburn
Witness: Dr. Jay Bhattacharya, Director, National Institutes of Health (NIH)
Energy & Commerce Oversight & Intelligence Subcommittee
March 17; 2:00 PM; 2123 Rayburn
Witnesses: TBD
Energy & Commerce Health Subcommittee
Hearing on Lowering Health Care Costs for All Americans: An Examination of the U.S. Provider Landscape
March 18; 10:15 AM; 2123 Rayburn
Witnesses: TBD
Ways & Means Health Subcommittee
Hearing on Improving Kidney Health Through Better Prevention and Innovative Treatment
March 18; 2:00 PM; 1100 Longworth
Witnesses: TBD
Senate
Health, Education, Labor & Pensions Committee
Member Day hearing
March 19; 10:00 AM; 430 Dirksen
REPORTS
Office of Inspector General (OIG)
On March 6, HHS OIG issued a report titled Psychosocial Characteristics and Their Association With Kidney Transplant Programs Waitlist Rates examining psychosocial patient selection criteria used by Medicare-certified kidney transplant programs. The report found that the most common psychosocial criteria relate to substance use, adherence to medical treatment, mental health, ability to pay transplant-related costs, and social or family support. OIG reported that half of patients evaluated for a kidney transplant in 2023 were not added to the waitlist, and among those not added, about half did not meet at least one psychosocial criterion, most related to adherence to medical treatment. The analysis also found that patients under age 65 and those with private insurance were more likely to be added to the waitlist compared with older patients and those with Medicare or Medicaid coverage.
On March 9, the HHS OIG issued a report titled Emergency Department Procedure Codes Used on Medicare Claims for Services Billed With Nonemergency Department Sites of Service Resulted in Over $15 Million in Improper and Potentially Improper Payments. The report found that CMS did not ensure compliance with Medicare billing requirements when emergency department procedure codes were used for services billed with nonemergency places of service or revenue center codes. OIG identified $922,524 in improper payments to physicians and approximately $14.2 million in potentially improper payments to hospitals for such claims in 2021 and 2022. OIG recommended that CMS recover improper payments, assess the allowability of potentially improper hospital payments, strengthen claims processing controls, and clarify billing guidance to providers.
Government Accountability Office (GAO)
On March 9, GAO released a report titled Private Dental and Vision Insurance: Market Concentration Varied Among States examining insurer concentration and vertical integration in stand-alone dental and vision insurance markets. The report found that market concentration varied widely across states, with the three largest insurers accounting for 38-98% of enrollment in the dental group market and between 41-96% in the vision group market based on 2024 data. GAO also reported limited available research on the effects of market concentration and vertical integration, though some studies and stakeholder interviews suggested that concentrated markets may affect provider reimbursement and contract negotiations. GAO noted that vertical integration appears limited in the dental market but is more present in the vision market, including insurer ownership of provider practices and eyewear manufacturers.
On March 12, GAO released a report titled Health Care Workforce: Federal Grants Supporting Mental Health examining HHS grant programs that support mental health among health professionals. The report found that HHS provided $103.2 million in COVID-19 relief funding to 45 grantees through three grant programs between 2022 and 2024 to support activities such as mental health screening, services, and resilience training. GAO also reviewed literature showing that health professionals experienced high rates of mental health conditions during the COVID-19 pandemic, including depression, anxiety, and burnout. GAO reported that HHS oversees the programs through annual grantee reports, regular meetings, and external evaluation of program outcomes.
ADDITIONAL POLICY NEWS
On March 8, the Chair of the Interagency Autism Coordinating Committee (IACC) announced that its first meeting under newly appointed members, originally scheduled for March 19, has been postponed and will be rescheduled at a later date. The committee said it is working to set a new meeting date and will share additional information through HHS channels when available. IACC noted that members will begin work on priorities established under the Autism CARES Act once the meeting is rescheduled.
On March 9, the American Federation of State, County and Municipal Employees (AFSCME) and its Illinois affiliate filed a lawsuit challenging the Trump Administration’s decision to terminate approximately $600 million in Centers for Disease Control and Prevention (CDC) grant funding awarded to several states. The complaint alleges that OMB directed the terminations and that HHS and CDC cited misalignment with agency priorities when cancelling the grants. The affected funding supported programs related to environmental public health, infectious disease prevention, and HIV and AIDS awareness in states including California, Colorado, Illinois, and Minnesota.
On March 9, Novo Nordisk and Hims & Hers announced an agreement to resolve ongoing litigation related to compounded GLP-1 drugs. Under the agreement, Hims & Hers will stop selling compounded GLP-1 alternatives and will offer Novo Nordisk’s branded GLP-1 medications, including Ozempic and Wegovy, through its telehealth platform. Novo Nordisk said it will drop its lawsuit related to the dispute over compounded versions of the drugs.
On March 11, the American Hospital Association (AHA) released its annual Costs of Caring report examining financial pressures facing hospitals. The report found that workforce expenses remain hospitals’ largest cost and highlighted rising spending on drugs, supplies, and administrative processes related to insurance requirements such as prior authorization and claims denials. AHA also reported that hospitals have been treating patients with more complex conditions since 2019, contributing to longer hospital stays and increased strain on clinicians.
On March 12, Lilly urged the FDA to recall all compounded versions of its GLP-1 drug tirzepatide mixed with vitamin B12, warning of potential patient safety risks. Lily maintains that compounders are adding B12 to evade FDA regulations and claims that testing revealed a concerning, unknown impurity caused by a chemical reaction between the two substances.
On March 12, the Medicare Payment Advisory Commission (MedPAC) released its March 2026 Report to the Congress: Medicare Payment Policy. The report includes recommendations for reimbursement updates to Medicare Fee-For-Service payment systems in 2027 and provides status reports on the MA and Part D program.
On March 13, the Kaiser Family Foundation (KFF) released a Health Tracking Poll examining public views on prescription drug affordability and price regulation. The survey found that nearly 60% of Americans said they are at least somewhat concerned about affording prescription drugs for themselves or their families, and more than 70% said the federal government does not do enough to regulate drug prices. KFF also reported that 35% of adults who take prescription drugs said they had heard at least some information about the Trump Administration’s TrumpRx platform, while 7% said they had visited the website to compare drug prices.