Holland & Knight Health Dose: April 28, 2026

Looking Ahead

Both chambers of the U.S. Congress are in session this week, with King Charles III of the United Kingdom invited to address a joint meeting of Congress on April 29, 2026. In addition, the U.S. House of Representatives will consider a number of bills on the floor, potentially including the long-awaited farm bill once the House Committee on Rules clears it, along with any potential amendments for consideration. The U.S. Senate is expected to consider several nominations, a bill to extend authorities under the Foreign Intelligence Surveillance Act (FISA) of 1978 and potentially a bill related to combating fraud in federal programs.

Much of the healthcare activity this week will take place before congressional committees, with U.S. Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. having finished visits to various healthcare committees of jurisdiction last week. Efforts will continue to address healthcare affordability, appropriations and the U.S. Food and Drug Administration's (FDA) regulation and oversight of food products.

The outstanding question remains the future of the budget resolution adopted by the Senate on April 22, 2026, which must be adopted by the House to allow progress on budget reconciliation to proceed. Many House Republicans appear divided on whether a budget reconciliation should be kept narrow, limited to addressing immigration and other items, or whether budget reconciliation should be broadened to include other outstanding priorities.

Upcoming Events

Congress

• The House Committee on Ways and Means will hold a full committee hearing with the CEOs of several health systems on April 28, 2026.
• The House Committee on Appropriations will hold a full committee markup of the fiscal year (FY) 2027 National Security, Department of State and Related Programs bill, as well as the FY 2027 Agriculture, Rural Development, FDA and Related Agencies bill, on April 28-29, 2026.
• The House Committee on Homeland Security and Governmental Affairs will hold a hearing on April 29, 2026, titled "Unmasked: How Biden Health Officials Purposely Turned a Blind Eye Toward COVID-19 Vaccine Safety Signals."
• The House Committee on Veterans' Affairs (VA) will hold a hearing to consider pending legislation on April 29, 2026. The hearing will focus on several bills regarding veterans' health.
• The House Committee on Energy and Commerce Subcommittee on Health will hold a hearing on April 29, 2026, titled "Healthier America: Legislative Proposals on the Regulation and Oversight of Food." For further analysis, see Holland & Knight's alert, "Congress Takes Up Slate of FDA Bills Aimed at Reforming Food Regulations," April 28, 2026. Legislation to be discussed includes:
  • H.R. 4958, Grocery Reform and Safety (GRAS) Act (Rep. Frank Pallone (D-N.J.))
  • H.R. 7291, GRAS Oversight and Transparency Act (Rep. Mike Lawler (R-N.Y.))
  • H.R. ____, [FDA Review and Evaluation for Safe, Healthy and Affordable Foods Act of 2026] (Rep. Kat Cammack (R-Fla.))
  • H.R. 4306, Food Chemical Reassessment Act of 2025 (Rep. Jan Schakowsky (D-Ill.))
  • H.R. 8385, Food Labeling Modernization Act of 2026 (Rep. Pallone)
  • H.R. 8429, Baby Food Safety Act of 2026 (Rep. Raja Krishnamoorthi (D-Ill.))
  • H.R. 7867, Infant Formula Safety Modernization Act of 2026 (Reps. Rosa DeLauro (D-Conn.) and Jefferson Van Drew (R-N.J.))
  • H.R. 4725, Transparency, Readability, Understandability, Truth, and Helpfulness (TRUTH) in Labeling Act (Rep. Schakowsky)
  • H.R. 2472, Improving Newborns' Food and Nutrition Testing Safety (INFANTS) Act of 2025 (Rep. Emilia Sykes (D-Ohio))
  • H.R. 2511, Sarah Katz Caffeine Safety Act (Reps. Rob Menendez (D-N.J.) and Chris Smith (R-N.J.))
  • H.R. 5882, No Tricks on Treat Act of 2025 (Reps. Sara Jacobs (D-Calif.) and Anna Paulina Luna (R-Fla.))
  • H.R. 8370, Dietary Supplement Listing Act of 2026 (Rep. Maxine Dexter (D-Ore.))
  • H.R. 8430, Federal and State Food Safety Information Sharing Act (Rep. Brad Sherman (D-Calif.))
  • H.R. 3722, Do or Dye Act (Reps. Luna and Grace Meng (D-N.Y.))
  • H.R. 5027, Ban Harmful Food Dyes Act (Rep. Meng)
  • H.R. 1394, Codifying Useful Regulatory Definitions (CURD) Act (Reps. Bryan Steil (R-Wis.) and Jim Costa (D-Calif.))
  • H.R. 1178, Alpha-gal Allergen Inclusion Act (Reps. Van Drew and Donald Davis (R-N.C.))
  • H.R. 2162, Honey Integrity Act (Reps. Greg Steube (R-Fla.) and Jimmy Panetta (D-Calif.))
  • H.R. 4987, Food Date Labeling Act of 2025 (Reps. Chellie Pingree (D-Maine) and Dan Newhouse (R-Wash.))
  • H.R. 5832, Requiring Ethical and Accurate Labeling of Lab-grown (REAL) Meats Act (Rep. Roger Williams (R-Texas))
  • H.R. 7366, Dietary Supplement Regulatory Uniformity Act (Rep. Nick Langworthy (R-N.Y.))
  • H.R. 2615, Stephen Hacala Poppy Seed Safety Act (Reps. Steve Womack (R-Ark.) and DeLauro)
  • H.R. 3324, Safer Shrimp Imports Act (Reps. Mike Ezell (R-Miss.), Troy Carter (D-La.) and Julia Letlow (R-La.))
  • H.R. 933, Defending Domestic Orange Juice Production Act of 2025 (Reps. Scott Franklin (R-Fla.) and Debbie Wasserman Schultz (D-Fla.))
  • H.R. 8414, Defending Against Imitations and Replacements of Yogurt, Milk, and Cheese to Promote Regular Intake of Dairy Everyday (DAIRY PRIDE) Act (Rep. John Joyce (R-Pa.))
  • H.R. 8431, Third-Party Certification and Inspection Modernization Act of 2026 (Reps. Deborah Ross (R-N.C.) and Michael Rulli (R-Ohio))
  • H.R. 8412, No False Formula Act (Rep. Jacobs)
  • H.R. 8432, To provide the Food and Drug Administration needed authorities to carry out its regulatory mission with respect to human foods, to provide additional resources and authorities with respect to human foods research, and for other purposes. (Rep. Diana DeGette (D-Colo.))
• The House Appropriations Committee Subcommittee on Military Construction, VA, and Related Agencies will hold a hearing on April 30, 2026, titled "A Review of the President's Fiscal Year 2027 Budget Request for the Department of Veterans' Affairs."
• The House Appropriations Committee Subcommittee on Interior, Environment, and Related Agencies will hold a budget hearing on April 30, 2026, on the Indian Health Service.

Federal Agencies

• The FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) will hold a meeting on May 28, 2026, regarding the formula for composition of the COVID-19 vaccine.

Administrative Updates

Holland & Knight's Health AI Navigator

Holland & Knight's Health Artificial Intelligence (AI) 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, the Centers for Medicare & Medicaid Services (CMS), and the FDA. 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.

Congressional Updates

Congress Begins Budget Reconciliation Process

In a 50-48 vote on April 23, 2026, the Senate adopted S. Con. Res. 33, a concurrent resolution that details the shell of the reconciliation package that the Senate and House will pursue to fund the U.S. Department of Homeland Security (DHS). Sens. Lisa Murkowski (R-Alaska) and Rand Paul (R-Ky.) voted no on the final adoption of the budget resolution. A number of amendments were considered but none were ultimately adopted. The budget resolution now goes to the House for consideration, and passage by the House will be required to formally instruct congressional committees to begin drafting their sections of the reconciliation package. Notably, the budget resolution does not direct Congress at this time to consider changes to federal healthcare programs – unlike the previous reconciliation package, which ultimately included significant, wide-ranging changes to federal healthcare programs to offset the cost of extending various tax credits. This budget resolution is limited to immigration activities, as it includes directions to committees with jurisdiction over immigration, homeland security and judicial issues, but no others. House Speaker Mike Johnson (R-La.) has not committed to passage of the budget resolution in its current form, as there are some within the House Republican caucus who wish to pursue a more wide-ranging reconciliation package to expand beyond only including funding for DHS and immigration activities currently not funded due to a lapse in appropriations. It is anticipated that decisions on a path forward in the House will be made in short order, given a deadline imposed by President Donald Trump to complete consideration of the package by June 1, 2026. The deadline becomes all the more pressing, given funding that has been used to pay DHS workers is slated to run out before May 1, 2026.

FY 2027 Appropriations in Full Swing

The process for the drafting, consideration and mark-up of appropriations bills for FY 2027 is in full swing, with the House Appropriations Committee Subcommittee on Agriculture, Rural Development, FDA, and Related Agencies advancing on a party line vote a bill to fund the U.S. Department of Agriculture and the FDA on April 23, 2026. The bill would increase FDA overall budgetary resources to $7.1 billion, a $200 million increase from the previous year and in line with President Trump's budget request for the FDA. Through the end of April 2026, the House Appropriations Committee will hold additional budget hearings and consider draft subcommittee bills in both subcommittees and the full committee. The Subcommittee on Labor, HHS, Education and Related Agencies is scheduled to hold a subcommittee markup of the Labor-HHS bill on June 5, 2026, and a full committee markup of the bill on June 9, 2026.

Regulatory Updates

CMS Sends Letter to All 50 Governors Directing Action on Provider Enrollment

CMS Administrator Mehmet Oz sent letters to all 50 governors on April 23, 2026, urging state Medicaid programs to undertake a "swift revalidation of Medicaid providers of services at high risk of waste, fraud, abuse, and corruption." Provider revalidations are being asked to be completed within 30 days, and states were asked to respond with a notification to CMS about whether states will complete the revalidation and proposed timeline for completion within 10 business days of receipt. If states do not do so, CMS indicated the potential to evaluate fraud will increase.

States will be required to submit plans within 30 days detailing how they will revalidate Medicaid providers in high risk service areas as part of an expanded effort to address fraud, waste and abuse. Administrator Oz said in remarks that some states have struggled to verify the identities and qualifications of large numbers of enrolled providers and emphasized that states must take greater responsibility for ensuring program integrity. CMS will develop best practices to help states clarify eligibility and oversight standards, citing ambiguity in personal care service criteria as a barrier to enforcement in some states.

CMS, FDA Announce New Pathway to Streamline Medicare Beneficiary Access to Medical Devices

CMS and the FDA announced on April 23, 2026, a new coverage pathway for certain FDA-designated class II and III breakthrough devices for Medicare beneficiaries, called the Regulatory Alignment for Predictable and Immediate Device (RAPID) coverage pathway. The new coverage pathway aims to improve communication between CMS, FDA and innovators earlier in the development life cycle so evidence generated can support Medicare coverage determinations. The coverage pathway is intended to reduce delays in the time between a device receiving FDA approval and coverage by Medicare.

The RAPID coverage pathway is for breakthrough devices that address unmet medical needs among Medicare beneficiaries and will be available to certain class II devices in the FDA's Total Product Life Cycle Advisory Program (TAP), as well as class III devices regardless of whether they are a part of TAP. To be eligible, devices must be subject of an Investigational Device Exemption (IDE) study to enroll Medicare beneficiaries and study clinical outcomes.

As part of the pathway, CMS will issue a proposed national coverage determination (NCD) the same day an eligible device receives FDA market authorization, triggering a 30-day public comment period. CMS will continue to offer existing pathways to support access to medical technologies, however the Transitional Coverage for Emerging Technologies (TCET) Pathway will be paused for new candidates as CMS focuses on implementation of the RAPID coverage pathway. A notice will soon be published in the Federal Register, and the public will have 60 days to comment.

BALANCE Model Delayed

CMS confirmed on April 21, 2026, that implementation of the Better Approaches to Lifestyle and Nutrition for Comprehensive Health (BALANCE) Model would be delayed. The BALANCE Model aims to enhance access to weight loss medications for Medicare beneficiaries enrolled in Part D. The model was scheduled to begin January 2027 but is delayed due to private insurance resistance to participating in the demonstration model, though the Medicaid version of the model remains at this time scheduled to launch in May 2026. In its place, CMS will pursue a bridge program through December 2027 using existing funds; however, the specific funds are not stated at this time. States may continue to apply for the Medicaid version of the model through July 31, 2026.

DEA Issues Final Order to Place Certain Marijuana Products in Schedule III of CSA

The U.S. Drug Enforcement Administration (DEA) issued a final rule – constituting a final order – on April 23, 2026, to place drug products containing marijuana approved by the FDA in schedule III of the Controlled Substances Act (CSA). The final order follows a December 18, 2025, EO issued by President Trump regarding increasing access to medical marijuana and cannabidiol (CBD) research. The changes take effect immediately. A new administrative hearing scheduled for June 29, 2026, will provide an update on pathways to evaluate broader changes to marijuana's status under federal law.

The issuance of the final order parallels the FDA's awarding of three priority review vouchers (PRVs) to three companies working on psychedelic treatments for mental health conditions on April 24, 2026, as part of the Commissioner's National Priority Voucher (CNPV) program. The FDA, in addition to making the three awards, will allow for a clinical trial of an ibogaine derivative, a compound that can cause certain hallucinogenic effects.

Trump Administration Warns of Adversarial AI Distillation Risks

A White House Office of Science and Technology Policy memo underscores that though the U.S. continues to lead globally in AI, leadership is increasingly viewed as vulnerable to exploitation by foreign actors, particularly in China. The memo distinguishes between legitimate AI distillation – a widely used technique for producing smaller and more efficient models – and unauthorized or adversarial distillation efforts aimed at extracting capabilities from U.S. frontier systems without authorization. From a policy perspective, the Trump Administration frames such activity as both an economic threat to U.S. innovation and a national security concern, signaling increased federal attention to protecting proprietary AI systems and coordinating with industry to address emerging risks.

Legal Updates

DOJ Requests Stay in CDC ACIP Case

The U.S. Department of Justice (DOJ) filed a motion on April 23, 2026, to request a stay in a pending federal court case related to changes made to the Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP), pending the resolution of any appeal related to the court's injunction. An injunction is currently in place, preventing changes to ACIP's membership and the appointment of new members from taking place, as well as any effectuation of changes made to the vaccine schedule or further meetings of the ACIP unless new members are appointed. The federal judge issued a corresponding request to a coalition of medical organizations to respond by May 1, 2026. The government may next file an appeal should it choose to do so.

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.