Holland & Knight Health Dose: June 30, 2026

Looking Ahead

Only the U.S. House of Representatives is in session this week and is expected to consider a limited number health-related items on suspension, which requires a two-thirds majority to pass. The House Committee on Ways and Means advanced the Health Care Efficiency Through Flexibility Act (H.R. 5347) by voice vote on June 29, 2026. In addition, the Kids Internet and Digital Safety (KIDS) Act (H.R. 7757) – a legislative package focused on children's online safety that was previously advanced by the U.S. House Committee on Energy and Commerce – passed the House in a bipartisan 267-117 vote, setting up potential consideration with the U.S. Senate. The National Defense Authorization Act (NDAA) and an appropriations bill are also expected to be considered; however, the path forward for the House version of the NDAA remains uncertain following the House Committee on Rules' addition of the SAVE America Act – a voter identification bill – to the overall defense package. The Senate adjourned for the holiday break on June 24, 2026, and will not return until July 13, 2026.

Upcoming Events

Congress

• The House Committee on Appropriations Subcommittee on Financial Services and General Government held an oversight hearing on June 30, 2026, regarding the Office of Management and Budget (OMB). OMB Director Russell Vought is expected to testify.
• The House Committee on Veterans' Affairs Subcommittee on Health held a legislative hearing on June 30, 2026, to consider a variety of bills impacting veterans' healthcare.
• The House Committee on Energy and Commerce will hold a full committee markup on July 1, 2026. Three health-related bills – the Combatting Illicit Xylazine Act (H.R. 1266), Tyler's Law (H.R. 2004) and the STOP Nitazenes Act (H.R. 7970) – will be considered alongside several technology-focused bills.
• The House Ways and Means Committee will hold a full committee markup on July 1, 2026, on seven tax-focused bills, including the Tax Exempt Hospital Transparency Act (H.R. 9504), which would impose additional reporting requirements on tax-exempt hospital organizations, including those with more than 100 staffed patient beds and those with patient revenues over $100 million.
• The House Committee on Education and Workforce Subcommittee on Health, Employment, Labor, and Pensions (HELP) will hold a hearing on July 1, 2026, titled "Direct Contracting: A Prescription for Lower Health Care Costs."

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.

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.

• Advancing Regenerative Agriculture and Strengthening American Farm Resilience: Following the U.S. Supreme Court's decision to allow a major company to avoid liability in a number of lawsuits related to an ingredient used in one of its products, President Donald Trump signed an EO to promote advances in precision agriculture and regenerative agriculture technologies. Among other provisions, the EO directs the U.S. Departments of Agriculture and HHS to expedite the development of a research and evaluation framework for cumulative exposure across chemical classes. The National Institutes of Health (NIH) is also directed to issue a "grand prize challenge" to researchers who identify creative solutions for evaluation the exposure, diagnosis and treatment of cumulative chemical exposures on health.

Personnel Updates

• Chris Klomp has been nominated to be deputy secretary of HHS. Klomp currently serves as chief counselor to HHS and head of the Medicare program.

Congressional Updates

Primaries in New York, Maryland Yield New Members; Colorado Primary Could Shift Delegation

Primary elections in New York and Maryland were held on June 24, 2026, resulting in the ousting of incumbents Rep. Adriano Espaillat (D-N.Y.), who serves as the Ranking Member of the House Committee on Appropriations Subcommittee on Legislative Branch, as well as Rep. Dan Goldman (D-N.Y.), who serves on the House Committees on the Judiciary and Homeland Security. In Maryland, Rep. April McClain Delaney (D-Md.) won her primary against former Rep. David Trone (D-Md.), who was seeking to retake his seat after running for Senate in 2024.

Colorado will hold its primary election on June 30, 2026, with outcomes that could impact the Colorado delegation, as well as membership on key committees of jurisdiction over healthcare. The gubernatorial primary election race between Sen. Michael Bennet (D-Colo.), ranking member of the Senate Committee on Finance Subcommittee on Taxation and IRS Oversight, and Colorado Attorney General Phil Weiser could result in a new member of the Senate should Sen. Bennet win the nomination and the general election, as he would be able to select his successor. Sen. John Hickenlooper (D-Colo.), Ranking Member of the Senate Committee on HELP Subcommittee on Employment and Workplace Safety, faces state Sen. Julie Gonzales (D-Colo.) in the primary election for Senate. In addition, Rep. Diana DeGette (D-Colo.), who serves as ranking member of the House Committee on Energy and Commerce Subcommittee on Health, faces Melat Kiros in the primary election.

Oversight and Government Reform Committee Staff Report Lays Out Potential Priorities for 120th Congress

The Democratic Staff of the House Committee on Oversight and Government Reform published a report on June 23, 2026, outlining potential health priorities for the 120th Congress, particularly if Democrats were to win the majority in the House. The report, titled "Abandoning Americans to Disease: The Trump Administration's Reckless Crusade is Harming America's Health," draws on interviews with a variety of individuals, as well as a review of current HHS leadership and policies. Signed by Ranking Member Robert Garcia (D-Calif.), the report raises concerns about certain administration policies related to vaccines, public health and other topics, and their potential effects on the U.S. healthcare system. If Democrats win the majority in the House in the November 2026 midterm election, the report may provide insight into the types of oversight and investigative priorities the Committee could pursue.

Energy and Commerce Subcommittee on Health Advances 15 Bills Addressing Illicit Drugs, Healthcare Price Transparency

The House Committee on Energy and Commerce Subcommittee on Health held a markup on June 25, 2026, and advanced the following legislation to the full Committee for consideration, all by a voice vote indicating bipartisan support for the bills:

• H.R. 1266, Combatting Illicit Xylazine Act (Reps. Jimmy Panetta (D-Calif.) and August Pfluger (R-Texas))
• H.R. 2004, Tyler's Law (Reps. Ted Lieu (D-Calif.) and Bob Latta (R-Ohio))
• H.R. 7970, STOP Nitazenes Act (Rep. Latta)
• H.R. 1561, 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. 9389, Nutrition Education and Chronic Disease Prevention in Community Health Centers Act of 2026 (Rep. Diana Harshbarger (R-Tenn.))
• H.R. 8201, Expanding Community Access to Health Services Act (Rep. Susie Lee (D-Nev.))
• H.R. 9393, Lower Costs, More Transparency Act of 2026 (Reps. Brett Guthrie (R-Ky.) and Frank Pallone (D-N.J.))
• H.R. 9397, Premium Transparency Act (Reps. Pfluger and Nathaniel Moran (R-Texas))
• H.R. 9396, Prior Authorization Accountability Act (Rep. Craig Goldman (R-Texas))
• H.R. 9390, Prices on the Wall Act of 2026 (Rep. Mariannette Miller-Meeks (R-Iowa))
• H.R. 3514, Improving Seniors' Timely Access to Care Act of 2025 (Reps. Robin Kelly (D-Ill.) and Suzan DelBene (D-Wash.))
• H.R. 9392, Medicare Advantage Cost Transparency Act (Reps. DeGette and John Joyce (R-Penn.))
• H.R. 5243, To amend title XVIII of the Social Security Act to increase data transparency for supplemental benefits under Medicare Advantage. (Rep. Jennifer McClellan (D-Va.))
• H.R. 9395, Transparency in Medicare Advantage Steering Act (Rep. Alexandria Ocasio-Cortez (D-N.Y.))

Education Workforce Committee Marks Up 11 Bills, Several Health-Related Items Advance

The House Committee on Education and Workforce held a full committee markup on June 25, 2026, and advanced 11 bills, including the Health Data Access, Transparency, and Affordability Act of 2026 (H.R. 9228), which would require plan fiduciaries to have access to de-identified information relating to health claims.

HELP Chairman Releases 340B Discussion Draft

Senate HELP Committee Chair Bill Cassidy (D-La.) released a discussion draft on June 25, 2026, that would make changes to the 340B Drug Pricing Program administered by the Health Resources and Services Administration. The draft, titled "340B Drug Pricing Integrity and Affordability for Patients Act," reflects Sen. Cassidy's ongoing efforts to change and improve the program. Key provisions include:

Rebates and Discounts

• Allows drug manufacturers to offer covered entities a choice of upfront discount, discount after submission of claims data to an HHS-run repository or retroactive rebates within 10 days of data submission; covered entities must pass all discounts and rebates onto the patients
• Requires covered entities to maintain segregated inventory to distinguished drugs purchased at and outside the 340B ceiling price
• Establishes a "standardized claims dataset," including encounter data, biller ID, physician ID, Healthcare Common Procedure Coding System code and additional information for medical versus retail claims
• Requires covered entities to permit "routine" audits by manufacturers and the HHS Secretary for cause at either the manufacturers or Secretary's expense
• Requires certification or recertification submissions detailing spending and revenue related to covered outpatient drugs, with penalties for misrepresentations up to double the amount of discounts or rebates involved

Subgrantees

• Requires covered entities that qualify for 340B through the Ryan White HIV/AIDS Program subawards or certain sexually transmitted disease (STD) funding to submit information to the Secretary verifying their nonprofit status, confirming funds are used consistent with grant requirements and demonstrating they primarily serve low income or uninsured populations

New Definitions of Patient, Outpatient Healthcare Service, etc.

• Defines "patient" as an individual who has received outpatient services from a covered entity within the past two years, has an ongoing, auditable relationship with the covered entity and received a covered outpatient drug from a practitioner, or receives services through a state-operated AIDS drug assistance program
• Defines "outpatient healthcare service" as services paid by an insurer or third-party payer or, if unpaid, services involving care lasting fewer than 24 hours between registration and discharge
• Defines "practitioner" as an employee or independent contractor of a covered entity who bills for outpatient services, is responsible for patient care or furnishes care on the covered entity's behalf while the entity retains clinical responsibility

Contract Pharmacies

• Clarifies that manufacturers may ship drugs to contract pharmacies under agreement with covered entities
• Limits free-standing cancer hospitals and rural referral centers to no more than five contract pharmacy agreements for dispensing covered outpatient drugs (excluding mail order pharmacies)
• Sets limits on mail order pharmacy dispensing and directs the Secretary to issue guidance on compliance requirements and permissible terms in agreements
• Requires contract pharmacies to comply with covered entity procedures for dispensing covered outpatient drugs, with agreements submitted within 30 days of execution or modification; the Secretary may require revisions
• Establishes civil monetary penalties for contract pharmacy compliance violations

Transparency Requirements

• Requires certain covered entities, based on net patient revenue and care type, to report to the Secretary, including margins on covered outpatient drugs at each child site, Medicare cost report revenues, relevant government contracts and data on drug dispensing, administration and charity care
• Data reported will be published on an annual basis

A sliding fee scale would be established to ensure patients pay no more than the maximum out-of-pocket amount for covered outpatient drugs. The draft also allows child sites to register as off-campus outpatient facilities if they meet certain criteria, such as ownership, Medicare standards and location in a health professional shortage area as of December 1, 2025 (though the date is bracketed indicating changes may be made). It includes contracting changes, requires the Secretary to provide with at least two 340B prime vendor options and authorizes the Secretary to issue guidance and pursue rulemaking to implement these provisions.

Regulatory Updates

HHS Releases Road Map for Clinical Trial Improvements

As part of HHS' unveiling of a slate of reforms to improve research and development of new drugs, HHS released "Operation Trailblazer," a roadmap for how HHS intends to make improvements to clinical trial processes. The road map lays out a series of initiatives across the entire medical product development spectrum, from early-stage research to late-stage trials and beyond. The report specifically notes continued progress in other nations such as China in both numbers of active clinical trials as well as quicker regulatory approvals in Australia as rationale for why improvements in U.S. processes are needed to keep pace with drug development worldwide. Priorities across HHS components include:

• U.S. Food and Drug Administration (FDA). Address regulatory requirements for investigational new drug applications (INDs) by streamlining chemistry, manufacturing, controls, pharmacology and toxicology IND requirements for sponsors; potential rulemaking to require the use of a single institutional review board (IRB) model for multi-site studies; improve clinical trial participation by reducing potential barriers for clinicians and patients
• NIH. Identify and use metrics for overseeing clinical research, enhance collaboration among NIH institutes and networks, incorporate use of real-world data in product development and expand clinical research by decentralizing NIH trial models
• Advanced Research Projects Agency for Health. Support new approaches to clinical trial development models
• HHS Office of the National Coordinator for Health Information Technology. Integrate clinical trial systems into electronic health records using entities with health information technology certifications; investing in standards development activities

To fully implement the reforms, most of the reforms outlined in the road map will require HHS to issue a variety of requests for information (RFI), industry guidance or pursue formal notice-and-comment rulemaking. However some of the initiatives are underway related to reducing the use of animal testing, pursuing a new IND pilot program and others. Specific action items highlighted in the report include:

• HHS will host a series of roundtables to gather public input on ways to streamline the IRB process.
• FDA will open a public docket on the issue to gather feedback from stakeholders on improving early phase research.
• NIH will issue a RFI to gather data that can inform clinical trial start up efficiency.

CMS Issues CY 2027 ESRD Prospective Payment System Proposed Rule

The Centers for Medicare and Medicaid Services (CMS) issued the calendar year (CY) 2027 End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) proposed rule on June 24, 2026, proposing updates to the payment rate for renal dialysis services furnished by ESRD facilities, to individuals with acute kidney conditions. Comments are due August 25, 2026. The proposed rule rebases and revises the ESRD bundled market basket to a 2024 base year as well as updates the labor-related share of the ESRD PPS base rate. The proposed CY 2027 ESRD PPS base rate is $299.55 – an increase from the CY 2026 base rate of $281.71 – reflecting proposed wage index budget neutrality factor of 1.00267 and the proposed addition of phosphate binders at $15.96. Other changes proposed include modifications and adjustments for pediatric ESRD patients, individuals with acute kidney injury and replacement of the hypercalcemia reporting measure with a hyperphosphatemia clinical measure beginning plan year 2029.

Several RFIs included in the proposed rule, including the potential inclusion of the Dialysis Facility Discussion of Patient Life Goals Patient-Reported Outcome Performance Measure in the ESRD quality improvement measure, as well as others on increasing uptake of home dialysis, improve palliative dialysis care and supporting alternative dialysis schedules.

FDA Releases Proposed Rule on Tobacco Establishment Registration and Product Listing

The FDA issued a proposed rule titled "Establishment Registration and Product Listing for Tobacco Products" on June 26, 2026. It would extend existing requirements for domestic owners and operators to register establishments and list their tobacco products with the FDA to foreign owners and operators. The preamble of the proposed rule states the action will close "significant gaps" in FDA information, as well as ensure foreign owners and operators that manufacture tobacco products sold, distributed or imported into the U.S. comply with federal law including FDA premarket authorization requirements. Comments on the proposed rule will be accepted through September 12, 2026.

FDA Launches Phase 1 IND Navigator Page

Building on announcements made on June 22, 2026, regarding initiatives to improve clinical trials and accelerate the development of drugs, the FDA launched a new, centralized webpage on June 26, 2026, called the Phase 1 IND Navigator. The webpage will centralize FDA resources, including tools guidance documents, educational resources and regulatory information from the Centers for Drug Evaluation and Research and Biologics Evaluation and Research. Items on the webpage are intended to assist sponsors in the preparation and submission of Phase 1 IND materials.

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.