Holland & Knight Health Dose: May 19, 2026

Looking Ahead

With the Memorial Day recess next week, the U.S. House of Representatives and U.S. Senate will work to quickly wrap up pressing items before adjourning. In the House, bills on the floor for consideration span legislation related to foster youth, natural resources, veterans' affairs and other topics, while the Senate will continue processing nominations and will also consider a resolution related to the ongoing conflict with Iran. In the lead up to the August 2026 recess, it is expected that House leaders will consider bills on the floor that have been advanced by committees in an effort to "clear the decks." Meanwhile, the fiscal year (FY) 2027 process in both chambers is moving forward, with the House and Senate Committees on Appropriations continuing to draft, consider and advance various bills. The House Committee on Ways and Means is expected to hold a markup this week on several program integrity bills among others, though at the time of writing the markup has not been publicly noticed.

Upcoming Events

Congress

• The House Committee on Energy and Commerce Subcommittee on Health will hold a hearing on May 20, 2026, titled "Examining the Medicare Physician Fee Schedule, MACRA, and Opportunities for Payment Reforms."
• The Senate Committee on the Budget will hold an executive business meeting on May 20, 2026, to report on the reconciliation bill pursuant to S. Con. Res 33.
• The Senate Special Committee on Aging will hold a hearing on May 20, 2026, titled "Preventing Falls, Preserving Independence: Technology, Community Programs, and Innovation in Senior Safety."
• The Senate Appropriations Committee Subcommittee on Labor, Health and Human Services (HHS), and Related Agencies will hold a hearing on May 21, 2026, titled "A Review of the President's Fiscal Year 2027 Budget Request for the National Institutes of Health." National Institutes of Health (NIH) Director and Acting Director of the Centers for Disease Control and Prevention (CDC) Dr. Jay Bhattacharya will testify.
• The Senate Committee on Health, Education, Labor, and Pensions (HELP) will hold a hearing on May 21, 2026, titled "Protecting Our Children: Exposing the Dangers of Irreversible Gender Transition Procedures on Minors."

Federal Agencies

• The newly established HHS and Centers for Medicare & Medicaid Services (CMS) Healthcare Advisory Committee (HAC) met for the first time on May 18, 2026, to introduce its members, formalize its bylaws, discuss its scope and solicit public comments. The HAC has an extensive charge, including making non-binding recommendations to 1) prevent and manage chronic disease, 2) advance accountability for patient safety and outcomes while reducing administrative burden, 3) expand use of real-time data for claims processing and quality measurement, 4) enhance care for Medicaid patients and 5) address Medicare Advantage sustainability.

• The HHS Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria will hold a virtual meeting to discuss feedback in advance of developing the 2026-2031 National Action Plan on Combating Antibiotic Resistant Bacteria.

Administrative Updates

Holland & Knight's Health AI Navigator

Holland & Knight's Health AI (Artificial Intelligence) Navigator is a centralized, interactive resource designed to help healthcare stakeholders track and interpret the rapidly evolving legal and regulatory landscape for AI in healthcare. The Navigator provides regularly updated summaries of federal and state legislative, regulatory, and executive activity affecting the development, oversight and utilization of AI across the healthcare sector, including activity at Congress, HHS and the White House. In addition to a federal tracker, the Navigator features an interactive state‑by‑state map highlighting enacted and proposed laws impacting AI in healthcare, alongside curated analysis from Holland & Knight professionals. The tool is intended to support providers, payers, developers and investors seeking to understand emerging requirements, policy trends and compliance considerations as AI adoption continues to expand across healthcare.

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.

• President Donald Trump announced on May 18, 2026, an expansion of TrumpRx.gov, an online webpage that helps link patients with prescription drugs at cash prices. The website will now feature more than 600 generic medicines and allows patients to more readily compare the prices of drugs from various locations and ordering platforms.

Personnel Updates

• Kyle Diamantas will serve as acting commissioner of the U.S. Food and Drug Administration (FDA) following the departure of Dr. Martin Makary. The Trump Administration is reportedly moving quickly to identify, vet and nominate a new candidate to lead the FDA. Dr. Donald Prater, previously the deputy commissioner of the FDA Human Foods Program (HFP), will now serve as the acting deputy commissioner for the HFP.
• Tracy Beth Høeg has left her position as acting director of the Center for Drug Evaluation and Research. Deputy Director Michael Davis will take over as acting director until a new name is announced.
• Jeremy Walsh, the FDA's chief AI officer, has departed the agency.
• Katherine Szarema, previous acting director of Center for Biologics Evaluation and Research (CBER), and Jim Traficant, previous FDA chief of staff, have been removed from their positions but are reported to remain at the FDA in support positions, with Szarema remaining to support product-related issues and Traficant becoming a senior advisor.
• Karim Mikhail is now serving as acting head of CBER. He previously served as a senior advisor in the Office of the Commissioner.

Congressional Updates

House Democrats Pen Second Letter to HHS on Vaccines

Democrat leaders of the House Energy and Commerce Committee sent a letter on May 15, 2026, to HHS Secretary Robert F. Kennedy, Jr., Committee Ranking Member Frank Pallone Jr. (D-N.J.), Subcommittee on Health Ranking Member Diana DeGette (D-Colo.) and Subcommittee on Oversight and Investigations Ranking Member Yvette Clarke (D-N.Y.). The letter outlines concerns over the suppression of certain information related to COVID-19 vaccines, as well as the Shingles vaccine. The letter, which is the second letter committee Democrats have sent, alleges that the HHS has continued to prevent the publication of data highlighting the safety and efficacy of various vaccines. The previous letter, dated May 6, 2026, was sent to NIH Director and CDC Acting Director Dr. Bhattacharya.

Appropriations Process Moves Forward

The House passed the first appropriations subcommittee bill for FY 2027 on May 15, 2026, moving the Military Construction-Veterans Affairs Subcommittee to the Senate for consideration. The bill was passed by a vote of 400-15 and is likely to be either conferenced or negotiated by leaders from both chambers, along with other subcommittee legislation that remains pending. Several other appropriations bills have been advanced by the House Committee on Appropriations and await consideration by the House. Additional markups in the House Appropriations Committee's various subcommittees are planned for this week. Healthcare-related activity in the Subcommittee on Labor-HHS is planned for the first week of June, with the subcommittee markup tentatively planned for June 5, 2026, and the full committee markup tentatively planned for June 9, 2026. The Senate continues to move at a different pace than the House, with budget hearings in the Senate Committee on Appropriations planned throughout May. It remains likely that funding for the U.S. Department of Homeland Security (DHS) will be considered last or close to last among the other bills, given Congress' focus on moving forward with a reconciliation package to fund portions of DHS and the U.S. Department of War. Republican leaders continue to negotiate within the House and Senate caucuses to address concerns from some about provisions within the package, not limited to security funding for a portion of the redeveloped White House and others.

House Subcommittee on Health Advances Legislation

The House Energy and Commerce Committee's Subcommittee on Health advanced a broad mixture of bipartisan public health and FDA-focused bills on May 13, 2026, sending each measure to the full committee by voice vote, including:

• H.R. 4348, Kay Hagan Tick Act Reauthorization. Reauthorizes federal programs supporting research, surveillance, diagnostics, prevention and response to tick-borne and other vector-borne diseases.
• H.R. 4541, EARLY Act Reauthorization of 2025. Extends CDC-led education, outreach and provider training programs to improve breast cancer awareness and early detection among young and higher-risk women.
• H.R. 3747, Accelerating Access to Dementia and Alzheimer's Provider Training (AADAPT) Act. Expands access to virtual continuing education and training programs to improve provider capacity to detect, diagnose and manage Alzheimer's disease and related dementias, particularly in underserved areas.
• H.R. 8209, School-Based Health Centers Reauthorization Act of 2026. Reauthorizes funding for school-based health centers to support access to primary care and behavioral health services for children and adolescents.
• H.R. 5160, Stem Cell Therapeutic and Research Reauthorization Act of 2025. Reauthorizes federal support for cord blood collection and stem cell research to improve access to therapies for patients with serious conditions.
• H.R. 8205, Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026. Reauthorizes programs to support research, development and patient access for amyotrophic lateral sclerosis (ALS) therapies.
• H.R. 2715, Destruction of Hazardous Imports Act. Expands FDA authority to destroy refused imports determined to pose a significant public health concern and updates the agency's procedures for carrying out those actions.
• H.R. 2821, FDA Modernization Act 3.0. Requires FDA to issue an interim final rule within one year, updating regulations on nonclinical testing methods to accelerate adoption of alternatives to animal testing. Rep. Buddy Carter (R-Ga.) said the FDA Modernization Act 3.0 is intended to ensure FDA "finally carries out the will of Congress and the American people by fully embracing modern alternatives to animal testing," arguing the policy will reduce animal use in testing, improve drug development efficiency and accelerate access to treatments.
• H.R. 5347, Health Care Efficiency Through Flexibility Act. Modifies Medicare Shared Savings Program requirements to expand quality reporting options for accountable care organizations and test digital quality measurement approaches.
• H.R. 1703, Choices for Increased Mobility Act of 2025. Revises Medicare payment rules for manual wheelchairs to allow separate billing pathways for advanced materials, expanding beneficiary choice while maintaining base coverage.

House Committee Launches New Task Force, First Focus Is Medicaid

The House Committee on Oversight and Government Reform has launched a new Task Force on Defending Constitutional Rights and Exposing Institutional Abuses. The Task Force will be chaired by Rep. Brandon Gill (R-Texas) and began its work by sending a letter to Ohio's Medicaid director regarding alleged fraud in the state's Medicaid waiver program related to home and community based services. The letter is also signed by Committee Chair James Comer (R-Ky.).

HELP Chair Loses Primary Election

On May 16, 2026, HELP Committee Chair Bill Cassidy (R-La.) did not advance to the primary run-off, finishing outside the top two candidates eligible for the June 2026 run-off. Sen. Cassidy was elected to the Senate in 2014 and became ranking member of the HELP Committee in 2023 and chair in 2025. Sen. Cassidy finished third among the four candidates in the Republican primary race, with Rep. Julia Letlow (R-La.), who was endorsed by President Trump, finishing first overall and Rep. John Fleming (R-La.), who currently serves as Louisiana state treasurer, finishing second. Reps. Letlow and Fleming will now proceed to a run-off election on June 27, 2026, which will determine the Republican nominee for the Senate race. Sen. Cassidy is expected to finish his term as HELP Committee chair, though who will take over the gavel remains undetermined at this time, with Senate Committee on Homeland Security and Governmental Affairs Chair Rand Paul (R-Ky.) and Committee on HELP Subcommittee on Primary Health and Retirement Security Chairman Sen. Roger Marshall (R-Kan.) representing potential alternatives given their positions on the Committee.

Regulatory Updates

CMS Moratoriums

CMS has issued two six-month, nationwide moratoria on new Medicare enrollment applications for all hospice and home health agencies (HHAs) effective May 13, 2026. During the moratoria, CMS will also intensify targeted investigations, deploy advanced data analytics and accelerate the removal of hospice and HHA providers from the Medicare program that are suspected of committing fraud. The moratoria will not impact current enrollments, and existing providers can continue to deliver services to Medicare beneficiaries. For further analysis, see Holland & Knight's alert, "CMS Announces Nationwide Enrollment Moratoria for Hospices and Home Health Agencies," May 13, 2026. Note that this follows a six-month, nationwide moratorium on new Medicare enrollment of certain durable medical equipment, prosthetics, orthotics and supplies companies, which was issued in February 2026.

CMS Releases 2027 ACA, NBPP, BHP Final Rule

CMS released the Patient Protection and Affordable Care Act (ACA), HHS Notice of Benefit and Payment Parameters (NBPP) for 2027 and Basic Health Program (BHP) final rule on May 15, 2026, making significant changes to the ACA Exchanges and BHP. The changes will impact Exchange coverage and provider access. According to CMS, the final rule is expected to reduce average 2027 Exchange enrollment by 1.2 million to 2 million enrollees compared with baseline estimates. In the final rule, CMS limits payment of advance premium tax credits (APTC) eligibility for lawfully present noncitizens to those who are "eligible noncitizens" beginning in plan year 2027, which also affects BHP payments because federal BHP funding is tied in part to PTC eligibility. CMS also disallowed APTC for individuals ineligible for Medicaid due to immigration status with income below 100 percent of the federal poverty level. Many of these changes are also in line with provisions from H.R. 1, the One Big Beautiful Bill Act. The NBPP final rule also added marketing standards and prohibited marketing practices for agents, brokers and web-brokers. Brokers will be required to use the HHS-approved eligibility review and consumer consent form for plan years beginning January 1, 2028. The final rule also clarified that HHS has authority to audit issuers for APTC, cost sharing reduction, and user-fee compliance and impose civil money penalties (CMPs) against issuers in State Exchanges and State-based Exchanges on the Federal Platforms for identified violations of Exchange requirements. CMS also finalized procedures for appealing sanctions against a Qualified Health Plan issuer. The NBPP final rule will have significant implications for Exchange coverage and require providers to adjust to Exchange network changes, including the introduction of non-network plans in 2028.

FDA Launches Moms.gov

On Mother's Day 2026, the FDA launched moms.gov for new and expecting mothers, offering several resource categories, including preconception health, breastfeeding, nutrition and medication use during pregnancy. The launch of the website comes in tandem with the release of a proposed rule regarding fertility benefits, which was published in the Federal Register on May 13, 2026.

May 2026 MACPAC Draft Recommendations

The Medicaid and Children's Health Insurance Plan (CHIP) Payment and Access Commission (MACPAC) met May 7, 2026, to vote on draft recommendations for its June 2026 report to Congress, with a focus on automation in Medicaid prior authorization and the implementation of community engagement requirements. Commissioners advanced four recommendations on prior authorization automation aimed at strengthening oversight and transparency, including clarifying that all prior authorization denials and service reductions must be reviewed by a qualified human reviewer rather than automated tools (including AI) alone, extending those requirements to Medicaid fee-for-service programs, directing CMS to issue guidance to states and plans on how to oversee the use of automation within existing regulatory frameworks, and requiring states to ensure Medicaid managed care plans disclose how they use automation in coverage and authorization decisions.

MACPAC also considered a draft recommendation on implementing community engagement requirements, which would direct CMS to develop and publicly release a transparent monitoring and evaluation plan with stakeholder input, including meaningful metrics to track impacts on Medicaid eligibility and enrollment.

Commissioners unanimously approved the four prior authorization automation recommendations, while the community engagement recommendation passed on a 15-2 vote. All proposals will be included in MACPAC's June 2026 report to Congress.

TEFCA Enforcement

The Trusted Exchange Framework and Common Agreement (TEFCA) is gaining a formal enforcement mechanism as concerns grow around how patient data is accessed and shared across the network. A nonprofit that serves as the federal government's Recognized Coordinating Entity for TEFCA and oversees network compliance, released a new standard operating procedure establishing a tiered framework for Qualified Health Information Network non-compliance. Consequences range from written warnings and required remediation plans to potential termination from the network, along with enhanced monitoring, reporting requirements and temporary restrictions on participation in TEFCA governance activities. The policy takes effect June 4, 2026, signaling a more structured approach to oversight as nationwide data exchange scales.

Legal Updates

Supreme Court Declines to Hear Challenge to IRA Drug Price Negotiation Program

The U.S. Supreme Court declined to take up six pharmaceutical company petitions challenging the Inflation Reduction Act's (IRA) Medicare drug negotiation program, leaving lower court rulings in place that have upheld the law's constitutionality. The justices denied review without comment, allowing the negotiation program to continue moving forward as implemented by CMS.

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.