Holland & Knight Health Dose: March 24, 2026

Looking Ahead

The U.S. House of Representatives and U.S. Senate have one week remaining before they are scheduled to adjourn for the Easter holiday. However, in the Senate, the recess may be delayed, following comments from President Donald Trump over the weekend rejecting a potential compromise on U.S. Department of Homeland Security (DHS) funding and indicating he hopes the Senate remains in session until there is further action on the Safeguard American Voter Eligibility (SAVE) America Act (H.R. 22), a voter identification bill.

However, a subsequent meeting on March 23, 2026, between a group of Senate Republicans and the president may have generated momentum toward an agreement, now that Sen. Markwayne Mullin (R-Okla.) has been confirmed as the new secretary of DHS. The potential compromise would fund DHS – with the exception of certain U.S. Immigration and Customs Enforcement (ICE) functions – with additional details still to be worked out. Though some Senate Democrats shared certain optimism that this was a positive step forward, the agreement (as it has been reported) would increase the potential for a second reconciliation package to fund additional operations without requiring Democrat votes, which has been a goal of some in House Republican leadership. If a deal can be reached, the Senate will bring the agreement up for a vote to end the lapse in appropriations prior to adjourning for the recess.

Amid the uncertainty over whether a funding deal will be reached, healthcare hearings will continue despite the impasse this week, with congressional committees scheduled to hold a variety of healthcare-focused hearings, capping off a busy month of congressional activity regarding affordability, consolidation and transparency.

Upcoming Events

Congress

• The Senate Special Committee on Aging will hold a hearing on March 25, 2026, at 3:30 p.m., titled "Experience Matters: Seniors and the Workforce."
• The Senate Committee on the Budget will hold a hearing on March 25, 2026, at 10 a.m., titled "Hearing to Examine Social Security, Focusing on a Discussion on the Facts and the Path Forward."
• The House Committee on Armed Services Subcommittee on Military Personnel will hold a hearing on March 25, 2026, at 3:30 p.m., titled "The Military Health System (MHS) Restructure: Changes at Military Treatment Facilities (MTFs) and the Effects on Military Readiness and Beneficiary Access."
• The House Committee on the Budget will hold a hearing on March 26, 2026, at 10 a.m., titled "The Best Metric to Reverse the Curse: A 3% Deficit-to-GDP Path to Fiscal Sustainability."
• The Senate Committee on the Judiciary will hold a business meeting on March 26, 2026, at 10:15 a.m., to consider the Combating Illicit Xylazine Act (S. 545), a bill that would prohibit certain uses of xylazine, along with other non-healthcare related matters.
• The House Committee on Veterans' Affairs Subcommittee on Disability Assistance and Memorial Affairs will hold a markup of several veterans' bills.
• The House Committee on Energy and Commerce Subcommittee on Health will hold a legislative hearing on March 26, 2026, at 2 p.m., titled "Policies to Protect Our Communities from Illicit Drug Threats." The hearing will focus on the following bills:
  • H.R. 1266, Combating Illicit Xylazine Act (Reps. Jimmy Panetta (D-Calif.) and August Pfluger (R-Texas))
  • H.R. 5630, to amend the Public Health Service Act to require additional information in state plans for Substance Use Prevention, Treatment, and Recovery Services block grants (Rep. Erin Houchin (R-Ind.))
  • H.R. 5629, to provide that the final rule of the U.S. Department of Health and Human Services (HHS) titled "Medications for the Treatment of Opioid Use Disorder," except for the portion of the final rule relating to accreditation of opioid treatment programs, shall have no force or effect (Rep. Houchin)
  • H.R. 2004, Tyler's Law (Reps. Ted Lieu (D-Calif.) and Bob Latta (R-Ohio))
  • H.R. 7970, Strengthening Tools to Outlaw Poisonous (STOP) Nitazenes Act (Rep. Latta)
  • H.R. 8000, END 7-OH Act (Rep. Gus Bilirakis (R-Fla.))
  • H.R. 7184, Protect Reporters from Exploitative State Spying Act (PRESS) Act (Rep. Addison McDowell (R-N.C.))
  • H.R. 8005, Stop Pills That Kill Act (Rep. Gabe Evans (R-Colo.))
  • H.R. 5880, Fight Illicit Pill Presses Act (Reps. Harriet Hageman (R-Wyo.) and Melanie Stansbury (D-N.M.))
  • H.R. 1227, Alternatives to Pain Act (Reps. Mariannette Miller-Meeks (R-Iowa) and Nanette Diaz Barragán (D-Calif.))
  • H.R. 2715, Destruction of Hazardous Imports Act (Reps. Clay Higgins (R-La.) and Troy Carter (D-La.))
  • H.R. 1561, Advancing Life Saving Efforts with Rapid Test (ALERT) Communities Act (Reps. Jasmine Crockett (D-Texas) and Lance Gooden (R-Texas))
  • H.R. 7994, HERO Act (Rep. Raul Ruiz (D-Calif.))
  • H.R. 7407, Prohibiting Tianeptine and Other Dangerous Products Act of 2026 (Rep. Frank Pallone (D-N.J.))

Federal Agencies

The U.S. Food and Drug Administration (FDA) announced on March 20, 2026, that it will hold a hybrid public hearing on June 12, 2026, related to the Commissioner's National Priority Voucher (CNPV) Pilot Program. The hearing will "provide the opportunity for the public to present information and views on the CNPV Pilot Program." Specifically, the FDA seeks the public's views, information and supporting data on the five identified national priority areas, types of applications eligible, potential changes to the scope of the program, the voucher selection process, enhanced regulatory engagement requirements and more.

Administrative Updates

White House Releases NIH Funding

The White House approved the National Institutes of Health (NIH)'s fiscal year (FY) 2026 spending plan on March 17, 2026, allowing the agency to obligate the full $48.7 billion that Congress appropriated earlier this year. The Office of Management and Budget signed off on the plan after missing the statutory 30‑day deadline, raising bipartisan concerns that funding for biomedical research could be delayed or clawed back. The issue was discussed during a House Appropriations Labor‑HHS Subcommittee hearing on March 16, 2026, where NIH Director Jay Bhattacharya said grant funding is now moving out the door and committed to accelerating awards after lawmakers flagged that grantmaking remains behind schedule.

White House Releases National AI Framework

The White House released a National Policy Framework for Artificial Intelligence (AI) on March 20, 2026, outlining legislative recommendations for Congress to establish a single federal approach to AI governance. The framework calls for preempting state‑level AI laws in favor of a national standard and directing lawmakers to focus federal guardrails on areas such as child safety, free speech protections, intellectual property, workforce impacts and national security.

The framework also urges Congress to codify President Trump's ratepayer protection pledge, requiring technology companies to supply or pay for the electricity used by AI data centers, and recommends streamlining federal permitting to support AI infrastructure development. Rather than creating a new AI regulator, the White House proposes relying on existing federal agencies for oversight and preserving limited state authority in areas such as child protection, fraud and consumer safeguards.

Executive Order Updates

The Trump Administration has continued to release wide-ranging executive orders (EOs). For the latest updates, see our "Trump's Second-Term Executive Orders (2025-2026)" tracking chart.

• March 16, 2026: EO titled "Establishing the Task Force to Eliminate Fraud" establishes a cross-agency anti-fraud task force, chaired by Vice President J.D. Vance and vice-chaired by Federal Trade Commission (FTC) Chair Andrew Ferguson. The initiative is intended to improve coordination across federal agencies to identify, prevent and recover improper payments by breaking down silos between agencies and improving information sharing. The EO directs two primary enforcement tools to be used, including the suspension of payments when fraud is suspected, and criminal enforcement efforts through the U.S. Department of Justice (DOJ).

Personnel Updates

• Adam Sherway, director of the Office of Infectious Diseases in the Center for Drug Evaluation and Research (CDER) at the FDA, will reportedly depart the agency in April 2026.
• Juli Tomaino, deputy director of the Gastroenterology Division in CDER's Office of New Drugs, will also reportedly depart the agency.

Congressional Updates

Senate Dear Colleague Letter Lays out Democratic Healthcare Priorities

On March 19, 2026, 12 senators – led by Senate Committee on Finance (SFC) Ranking Member Ron Wyden (D-Ore.) – sent a Dear Colleague letter to members of the Senate Democratic Caucus laying out priorities for potential healthcare reform. The letter notes that staff to the SFC will develop policies that lower costs, make obtaining and maintaining insurance easier, and address private healthcare insurance. The letter is a roadmap for the priorities of a potential, future Democratic majority in the Senate. Additional details will be released in the weeks and months ahead.

House Oversight, Appropriations Leaders Send Letter to CMS

House Committee on Oversight and Government Reform Chair James Comer (R-Ky.) and House Committee on Appropriations Subcommittee on Labor, HHS, Education and Related Agencies Chair Robert Aderholt (R-Ala.) sent a letter to Centers for Medicare & Medicaid Services (CMS) Administrator Mehmet Oz on March 19, 2026, urging CMS to use its oversight authority to prevent benefit designs that create barriers to appropriate care.

Chair Guthrie Reintroduces Bipartisan Rare Disease Legislation

House Energy and Commerce Committee Chair Brett Guthrie (R‑Ky.) reintroduced bipartisan legislation on March 10, 2026, aimed at expanding access to treatments for patients with rare diseases. The Medicaid Value-Based Purchasing (VBPs) for Patients (MVP) Act would allow states to voluntarily enter VBP arrangements in Medicaid, tying payment for high‑cost therapies to patient outcomes. Supporters say the bill is intended to improve access to innovative treatments, including gene and cell therapies, while giving states additional flexibility to manage costs.

CMS Faces Scrutiny Over Medicare and Medicaid Fraud Enforcement

The House Energy and Commerce Committee's Subcommittee on Oversight and Investigations held a March 17, 2026, hearing titled "Protecting Patients and Safeguarding Taxpayer Dollars: The Role of CMS in Combatting Medicare and Medicaid Fraud." CMS Deputy Administrator and Chief Operating Officer Kimberly Brandt testified on the agency's efforts to strengthen fraud prevention, emphasizing increased use of data analytics, real‑time monitoring and technology to move away from a "pay‑and‑chase" enforcement model. Lawmakers highlighted ongoing fraud risks in areas including durable medical equipment, hospice, home health and certain Medicaid services.

Republicans stressed the scale of improper payments and called for stronger federal oversight and enforcement, arguing that weak guardrails in some state Medicaid programs enable fraud. Democrats agreed on the need to address fraud but cautioned that aggressive enforcement or payment pauses could disrupt care for vulnerable populations, urging CMS to balance program integrity with beneficiary access.

Sen. Blackburn Releases Updated AI Legislation

Sen. Marsha Blackburn (R‑Tenn.) released an updated version of her AI legislation last week, unveiling a discussion draft of The Republic Unifying Meritocratic Performance Advancing Machine Intelligence by Eliminating Regulatory Interstate Chaos Across American Industry Act (TRUMP AMERICA AI Act), which builds on a framework she first introduced in December 2025. The proposal seeks to establish a single national standard for AI and would pre-empt states from adopting their own AI‑specific regulatory regimes. Like the earlier version, the updated draft incorporates the Kids Online Safety Act and the Nurture Originals, Foster Art, and Keep Entertainment Safe Act (NO FAKES Act), alongside provisions addressing AI developer duties of care, content transparency and protections for creators.

The updated blueprint was released just days before the Trump Administration published its own National Policy Framework for AI, which outlines legislative recommendations for Congress but does not carry the force of law. New in Sen. Blackburn's updated proposal is a provision that would codify President Trump's ratepayer protection pledge, requiring technology companies to supply or pay for the electricity used by the data centers they operate. The draft also reflects administration priorities on federal preemption, content authentication and limiting perceived ideological bias in government use of AI.

Regulatory Updates

CMS Announces HHS IDR Gateway

CMS announced it will transition later this year to a new centralized platform, known as the Independent Dispute Resolution (IDR) Gateway, to manage federal independent dispute resolution operations under the No Surprises Act. The agency will move away from single‑use web forms to the new system, which will allow users to initiate and respond to disputes, access organizational dashboards and reports, track dispute status and assignments to certified IDR entities, monitor disputes by process phase and receive dispute‑related notifications.

CDC Releases AI Strategy and Public Health Guidance

The Centers for Disease Control and Prevention (CDC) released a set of new AI resources, including its AI Strategy and two guidance documents, Considerations for Generative AI in Public Health and Considerations for Agentic Research in Public Health. The materials build on the HHS AI Strategy and outline CDC's approach to using AI to support public health decision making, operational efficiency and research, while emphasizing human oversight, transparency and risk management.

CDC's AI Strategy is organized around four pillars:

1. accelerating AI adoption for public health
2. strengthening governance and public trust
3. advancing enterprise data platforms
4. building an AI-ready workforce

The accompanying guidance provides practical considerations for state, tribal, local and territorial public health organizations, including illustrative prompt examples and recommended use cases for both generative and agentic AI tools. Across the documents, CDC aligns its guidance with the National Institute of Standards and Technology (NIST) AI Risk Management Framework, reinforcing principles such as accountability, transparency and appropriate oversight for higher risk uses.

CMS Expands Fraud Probe to Include Florida

CMS Administrator Oz announced on social media on March 17, 2026, that the agency had initiated an investigation into Medicare and Medicaid payments in Florida through the Center for Program Integrity. The letter notes CMS is currently reviewing Florida's program integrity activities due to "well-documented history" of healthcare fraud related to both Medicare and Florida Medicaid. The letter includes a variety of questions related to the structure of Florida's Medicaid program integrity unit, organizational charts, guidance and training materials, with specific focus on durable medical equipment (DME), applied behavioral analysis (ABA), adult day care and personal care services, and corrective actions.

CMS Finalizes Rule to Streamline Electronic Submissions

CMS issued a final rule on March 20, 2026, titled "The Administrative Simplification; Adoption of Standards for Health Care Claims Attachments Transactions and Electronic Signatures Final Rule," which seeks to establish national standards for the electronic exchange of clinical documents to support and substantiate healthcare claims. For administrative transaction data, the final rule adopts Version 6020 of the X12N 275 and X12N 277 standards as finalized for healthcare claims attachment transitions, and provides implementation specifications for the secure, efficient exchange of electronic healthcare data. For clinical data integration, Health Level 7 (HL7) Implementation Guides (IGs) adopted will be attachment information to be included in healthcare attachments transactions. The final rule also adopts other facets of HL7 standards and requires a secure, verified electronic signature standard. CMS touted the rule as a burden reduction and cost savings effort, estimating the final rule will save $781 million per year. The rule takes effect on May 26, 2026. Entities the standards will apply to – specifically those covered by the Health Insurance Portability and Accountability Act (HIPAA), including health plans, healthcare clearinghouses and healthcare providers that conduct electronic transactions – will be expected to comply two years after the effective date.

FDA Releases 2024 Report on Outbreak Investigations

The FDA released the 2024 Office of Coordinated Outbreak Response, Evaluation (CORE) and Emergency Preparedness (EP) annual report on March 17, 2026. CORE and EP were consolidated as part of the larger FDA Human Foods Program (HFP) reorganization, initiated and completed during the Biden Administration. The report includes information on incidents investigated by CORE that were linked to regulated human foods in 2024. The investigations were conducted in coordination with the CDC and other partners to the FDA. The report details 72 incidents evaluated by CORE, including potential outbreaks, confirmed outbreaks and adverse events. A total of 26 responses were initiated related to FDA-regulated food, and 10 public health advisories were issued. The majority of identified products linked to illness in 2024 were produce, specifically vegetables, followed by multi-ingredient products and dairy, including semi and solid dairy products.

FDA Issues Draft Guidance on use of NAMs in Drug Development

The FDA issued draft guidance on March 18, 2026, titled "General Considerations for the Use of New Approach Methodologies in Drug Development." The public has 60 days to comment. The draft guidance seeks to provide drug developers with a validation framework and general recommendations for using new approach methodologies (NAMs) in drug development. In addition, the draft guidance focuses squarely on consideration for the validation of NAMs, not qualification of drug development tools. The release of the draft guidance builds on the FDA's efforts to move away from and reduce reliance upon animal studies, as well as facilitate broader integration of NAMs in regulatory submission packages. NAMs include a variety of methods, including complex in vitro, 2D in vitro, in chemico and in silico studies. The release of the draft guidance was followed by an announcement that the NIH would invest $150 million in human-based research to reduce reliance on animal studies.

FDA Seeks Comments in Advance of 20th Annual ICCR Meeting

The 20th Annual International Cooperation on Cosmetics Regulation (ICCR) meeting will take place July 7-19, 2026, in Tokyo. In advance of that meeting, the FDA is seeking comments related to the regulation of cosmetics. Comments on the following questions are requested by May 18, 2026, as well as additional cosmetics topics of interest related to future ICCR work.

• What new International Organization for Standardization (ISO) standards and technical reports should be considered for inclusion in the Updated Annex of International Standards in Cosmetics Report?
• What new non-animal testing methods should be considered for inclusion in the Inventory of Validated Non-Animal Testing Methods Applicable for Cosmetic Products and their Ingredients in all ICCR Regions?
• What are your suggestions to help make risk assessment using non-animal data a more common approach for safety assessments of cosmetic ingredients?
• What general principles should be considered for electronic labeling and digital information for cosmetics across ICCR member jurisdictions?
• What are common questions and misconceptions, and ways to improve understanding related to cosmetics use, safety and regulation that arise across ICCR member jurisdictions?
• What are your suggestions for any changes to or considerations for ICCR's purpose, mission and future direction?

FTC Launches Healthcare Task Force

FTC Chair Ferguson announced on March 20, 2026, the launch of a FTC Healthcare Task Force to protect patients, healthcare workers and taxpayers against fraud. The Task Force will lead targeted enforcement and advocacy initiatives, undertake agencywide strategies on investigations, proactively identify opportunities to provide amicus briefs and statements of interest, as well as identify new and emerging areas for enforcement. The establishment of the Task Force follows the White House's recent anti-waste, fraud and abuse efforts. The Task Force will be co-chaired by representatives from the Bureaus of Competition and Consumer Protection and will include at least three members from each FTC Bureau, along with representatives from the Offices of Policy Planning, Technology and General Counsel. The Task Force is expected to meet monthly and provide quarterly updates to the chair, reinforcing its role as an ongoing, coordinated enforcement body within the agency.

NIH Issues RFI to Inform Development of 2027-2031 Strategic Plan

The NIH published a request for information (RFI) in the Federal Register on March 23, 2026, to gather input as the NIH develops its NIH-Wide Strategic Plan for FY 2027-2031. The public has 60 days to comment. As part of the 21st Century Cures Act, the NIH is to update its strategic plan no more than once every six years. Though the strategic plan will not focus on specific missions of the NIH's components, it will outline the organization's approach to achieving its overall mission while being a good steward of taxpayer funding. The strategic plan will also touch on three main areas: research areas of focus, research capacity and research operations.

Legal Updates

Changes to Vaccine Policies Paused by Court

A federal judge in Massachusetts issued a preliminary ruling on March 16, 2026, finding that HHS Secretary Robert F. Kennedy's efforts to change the members of the Advisory Committee on Immunization Practices (ACIP) and change the vaccine schedule for children were likely illegal. The judge grounded his preliminary ruling in violations of the Administrative Procedures Act (APA), writing in the ruling that "the Government bypassed ACIP to change the immunization schedules, which is both a technical, procedural failure itself" and that "the Government removed all duly appointed members of ACIP and summarily replaced them without undertaking any of the rigorous screening that had been the hallmark of ACIP member selection for decades." The next meeting of the ACIP has been postponed as litigation remains ongoing, and this preliminary ruling is unlikely to be the last step in the legal process, as the HHS is expected to appeal. The lawsuit was brought by an association representing pediatricians and specialists in pediatric care.

Judge Vacates HHS Declaration on Gender-Affirming Care

A federal judge in the U.S. District Court for the District of Oregon on March 19, 2026, vacated HHS' December 2025 declaration on gender-affirming care, siding with 21 plaintiff states, and finding that HHS Secretary Kennedy exceeded his statutory authority. The court rejected HHS' determination that gender-affirming care for minors is unsafe, ineffective and inconsistent with professionally recognized standards of care. The now-vacated declaration had also asserted that HHS could exclude providers or entities from participation in federal healthcare programs if they were found to be furnishing care that does not meet such standards. It remains unclear whether HHS will appeal the decision and comes after public comment periods closed on two proposed rules related to prohibitions on gender-affirming care.

Information contained in this alert is for the general education and knowledge of our readers. It is not designed to be, and should not be used as, the sole source of information when analyzing and resolving a legal problem, and it should not be substituted for legal advice, which relies on a specific factual analysis. Moreover, the laws of each jurisdiction are different and are constantly changing. This information is not intended to create, and receipt of it does not constitute, an attorney-client relationship. If you have specific questions regarding a particular fact situation, we urge you to consult the authors of this publication, your Holland & Knight representative or other competent legal counsel.