Holland & Knight Health Dose: June 23, 2026

Looking Ahead

The U.S. House of Representatives and U.S. Senate return to session after the federal holiday on June 19, 2026, with the House expected to consider additional appropriations bills and the Senate advancing a bipartisan housing reform package, which would send the package to President Donald Trump's desk following final action from the House. Healthcare committees will be busy with pressing topics, including fraud and program integrity in the House and appropriations bills in the Senate. In addition, Senate leaders are expected to pursue a path forward on reauthorization of the Foreign Intelligence Surveillance Act (FISA), which expired on June 12, 2026, after U.S. Congress did not extend authorities for the Section 702 program following disagreement from President Trump regarding his nominee to serve as the director of national intelligence.

Meanwhile, there are a few more than 100 days left until the current continuing resolution expires on September 30, 2026, giving Congress a limited number of legislative days in session to consider an alternative. Congress will adjourn for the summer recess on August 10, 2026.

Upcoming Events

Congress

• The Senate Committee on Finance Subcommittee on Social Security, Pensions and Family Policy will hold a hearing on June 24, 2026, titled "The Future of Social Security."
• The Senate Committee on Indian Affairs will hold a nomination hearing on June 24, 2026, regarding the nomination of Mark Cruz to be director of the Indian Health Service.
• The House Committee on Science, Space, and Technology Subcommittee on Investigations and Oversight will hold a hearing on June 24, 2026, titled "Safeguarding Federal Research Funds: The False Claims Act's Role in Combatting Grant Fraud."
• The Joint Economic Committee will hold a hearing on June 24, 2026, titled "Protecting Patients and Taxpayers: Combating Healthcare Fraud and Leakage to Strengthen Program Integrity."
• The Caucus on International Narcotics Control will hold a hearing on June 24, 2026, titled "Beyond Our Shores: The Global Reach of Mexican Drug Cartels and Risks to U.S. National Security."
• The House Committee on Energy and Commerce Subcommittee on Oversight and Investigations will hold a hearing on June 25, 2026, titled "State Medicaid Program Integrity: Examining Fraud Risks and Oversight Deficiencies." State Medicaid directors from several states are expected to testify.
• The Senate Committee on Appropriations is expected to hold several markups to consider pending appropriations bills this week, but may have to postpone due to the continued absence of Sen. Mitch McConnell (R-Ky.). While subject to change, the appropriations bills currently slated for consideration include the Agriculture, Rural Development, Food and Drug Administration (FDA), and Related Agencies; Military Construction, Veterans Affairs, and Related Agencies; Commerce, Justice, Science, and Related Agencies; and Legislative Branch.

Federal Agencies

• On June 25, 2026, the Office of the National Coordinator for Health Information Technology will host a webinar, "Adoption of AI in Clinical Care: Updates from the HHS RFI."

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. It provides regularly updated summaries of federal and state legislative, regulatory and executive activity, including developments from Congress, the U.S. Department of Health and Human Services (HHS) and the White House. The Navigator also features an interactive state map and curated analysis to support compliance and policy insights.

Congressional Updates

Senate HELP Committee Moves Health Bills Forward

The Senate Committee on Health, Education, Labor and Pensions (HELP) advanced a broad collection of bipartisan health bills, moving forward measures on infant mortality, transplantation, breast health education, neurodegenerative research and biosimilar substitution. Lawmakers also approved provisions to address disability discrimination in organ transplants and clarify drugmaker disclosures to FDA and the U.S. Patent and Trademark Office. The bills approved – which may now be considered on the Senate floor – include:

• Charlotte Woodward Organ Transplant Discrimination Protection Act
• Healthy Start Reauthorization Act of 2026
• Stem Cell Therapeutic and Research Reauthorization Act
• EARLY Act Reauthorization of 2025
• Accelerating Access to Critical Therapies for ALS Act of 2026
• Medication Affordability and Patent Integrity Act
• Biosimilar Red Tape Elimination Act

However, the markup exposed sharp divisions over drug pricing and competition policy. An effort to attach insulin affordability provisions, including a $35 monthly cap for certain privately insured patients, ultimately stalled a separate bill aimed at curbing misuse of FDA citizen petitions to delay generic and biosimilar entry. An additional markup in the committee is expected later this summer.

Energy and Commerce Democratic Leaders Send Letter to NIH Director on OMB Proposed Rule

Committee on Energy and Commerce Ranking Member Frank Pallone (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.) sent a letter to National Institutes of Health (NIH) Director Jay Bhattacharya outlining concerns with a rule recently proposed by the Office of Management and Budget (OMB), which would make significant changes to federal financial assistance and federal grantmaking processes. The letter focuses on the role of the NIH as the leading biomedical research and development hub in the U.S. as well as potential impacts should the rule be finalized as proposed. For additional analysis, see Holland & Knight's previous alert, "OMB Rule Proposes Significant Changes to Federal Financial Assistance Requirements," June 17, 2026.

Regulatory Updates

CMS Issues RFI on Implementation of New PBM Statute

The Centers for Medicare & Medicaid Services (CMS) issued a new request for information (RFI) on June 18, 2026, related to pharmacy benefit manager (PBM) compensation and data collection. Though CMS writes that all relevant comments from stakeholders on PBMs will be accepted, CMS stipulates it is specifically seeking technical input on two areas that will inform CMS implementation of new requirements for PBMs, enacted as part of the Consolidated Appropriations Act of 2026. Specifically, CMS seeks information to inform the implementation of legislative requirements that take effect in calendar year (CY) 2028, including restrictions on remuneration that PBMs and affiliates may receive for services in connection with utilization of covered Medicare Part D drugs, as well as data reporting requirements. Comments are due July 20, 2026.

CMS Initiates First Formal Rulemaking for Medicare Drug Price Negotiation Program

After previously seeking to implement the Inflation Reduction Act's provisions related to the Medicare Drug Price Negotiation Program through guidance documents since its establishment, CMS issued the first proposed rule to implement the program on June 12, 2026, through formal notice-and-comment rulemaking. The proposed rule includes a variety of significant changes, which if finalized would impact fixed-combination products and small biotechnology programs, as well as establish enforcement mechanisms for CMS. Public comments will be accepted through August 17, 2026. For a detailed analysis, see Holland & Knight's previous alert, "CMS Issues First Proposed Rule for IRA Medicare Drug Price Negotiation," June 18, 2026.

USTR Initiates Section 301 Investigation into Germany Regarding Underpayment for Pharmaceutical Products

U.S. Trade Representative (USTR) Jameison Greer announced on June 18, 2026, that USTR has initiated a Section 301 investigation into Germany, which will seek to determine whether "persistent underpayment for innovative pharmaceutical products by Germany is unreasonable or discriminatory and burdens or restricts U.S. commerce." A Section 301 investigation under the Trade Act of 1974 allows the U.S. to investigate and, as a result of the findings from the investigation, potentially levy sanctions on foreign nations, often ranging in the form of 10 percent to 25 percent tariffs. Written comments and requests to appear before a public USTR hearing must be submitted by August 10, 2026, and a hearing will be held on September 22, 2026.

On June 16, 2026, 23 Senate Republicans sent a letter to USTR Greer, advocating in favor of the initiation of a Section 301 investigation into Germany and other trading partners, mirroring a similar letter from a group of House Republicans earlier this month.

HHS OIG Releases RFI on Anti-Kick Back Statute, Beneficiary Inducements

The HHS Office of the Inspector General (OIG) on June 22, 2026, issued a new RFI related to Medicare and State Health Care Programs, specifically related to the Anti-Kick Back Statute and beneficiary inducements. The RFI seeks input from the public on whether any additions or modifications to safe harbor regulations under the federal Anti-Kickback Statute, which authorizes penalties for offering, paying, soliciting or receiving inducements or reward for the referral of business, or exceptions to the civil monetary penalty (CMP) provision, which prohibitions renumeration for beneficiaries in connection with participation in clinical trials.

Specifically, the OIG states that it has not previously issued any advisory opinions or guidance related to renumeration provided to clinical trial participants, such as transportation or childcare costs, and is issuing an RFI to identify ways to:

1. modify or add new safe harbors to the federal Anti-Kickback Statute as provided at 42 C.F.R. 1001.952 or exceptions to the Beneficiary Inducements CMP’s definition of “remuneration” at 42 C.F.R. 1003.110
2. publish or amend other guidance to foster arrangements that facilitate clinical trial participation, while also protecting against harms caused by fraud and abuse.

Comments are requested and are due by August 23, 2026.

FDA Updates Authorized Digital Health Tools

The FDA updated three core digital health device lists on June 16, 2026, covering AI-enabled technologies, augmented reality and virtual reality applications, and sensor-based tools, bolstering the agency's effort to track how advanced technologies are moving through regulatory pathways. The lists compile devices that have already received FDA authorization and are intended to improve visibility into where and how AI, immersive technologies and digital health tools are being deployed in clinical care. Though not comprehensive, the updates function as a snapshot of the evolving market and regulatory expectations, giving developers a clearer benchmark for submissions and intending to offer clinicians greater transparency into technology embedded in medical devices.

FDA Moves Forward on Gene Therapy Submission

A gene therapy for Huntington's disease is moving closer to FDA review following FDA's agreement to a resubmission pathway, effectively reversing an earlier high-visibility regulatory setback. The decision is being interpreted by some as a broader recalibration in how FDA is approaching gene therapies for rare, high-burden conditions, particularly where traditional evidentiary standards are difficult to meet. It suggests a return to a more iterative regulatory posture that allows sponsors to address deficiencies without permanently stalling development, particularly in light of significant changes in leadership of the FDA following departures of former Commissioner Martin Makary and others, as well as the uptick in personnel holding their roles in acting capacities until formal replacements are identified or named.

FDA Issues New Guidance Documents, RFI on Expedited IND Pilot Program

The FDA issued three new guidance documents and a new RFI on June 22, 2026, including "Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products," "Master Protocols for Drug and Biological Product Development" and "Quantitative Systems Pharmacology-Based Dose Selection for Minimum Anticipated Biological Effect Level in First-in-Human Trials." The RFI, for which comments are due by July 22, 2026, seeks input on a proposal to establish the Expedited Investigational New Drug (IND) Pilot Program, which would aim to shorten the time from drug identification to first-in-human (FIH) study. The pilot would establish a network of qualifying research institutions to partner with sponsors to develop and review protocols for FIH clinical trials intended for IND submission to the FDA.

The FDA hopes to speed early-stage clinical trials by six to 12 months and will issue subsequent guidance in the coming days to reaffirm the FDA's view that a single, high-quality Phase 3 trial with supporting, confirmatory evidence provides enough to inform a drug approval.

Legal Updates

20 States and Washington, D.C., Sue Agencies Over Proposed Rule for Federal Funding

A group of 20 states and Washington, D.C., filed a lawsuit on June 18, 2026, against HHS, the OMB and several other federal agencies following the release of a proposed rule directing agencies to update their policies and procedures for reviewing and distributing federal funding. The states argue the Federal Acquisition Regulation Council implemented new requirements without going through formal notice-and comment rulemaking and the new proposals would be arbitrary and capricious, as the EO on which the proposed rule is based raises a host of issues, including but not limited to violated long-standing fairness and non-discrimination practices for federal contracting.

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.