Holland & Knight Health Dose: June 16, 2026

Looking Ahead

The U.S. House of Representatives is holding a district work period this week, with no floor activity expected after completing work on and passing in a 214-212 vote a reconciliation package to fund immigration enforcement activities. The U.S. Senate continues committee-level work centered on oversight and emerging policy areas, including a Committee on Health, Education, Labor, and Pensions (HELP) subcommittee hearing examining artificial intelligence (AI) in education, signaling continued congressional focus on AI governance. Additional committee activity is expected midweek as the HELP Committee convenes a full committee markup on June 17, 2026, to consider a variety of healthcare legislation.

At the U.S. Department of Health and Human Services (HHS), officials are convening multiple policy meetings this week, including a public meeting of the Physician-Focused Payment Model Technical Advisory Committee (PTAC) on patient safety and value-based care, alongside a stakeholder session to inform the next National Action Plan for Combating Antibiotic-Resistant Bacteria.

Time remains relatively constrained ahead of the summer recess, with remaining legislative days shrinking as midterms approach. The limited floor schedule continues to shift activity toward committee action and administrative processes, where incremental progress on targeted health policies is likely to continue in the near-term.

Upcoming Events

Congress

• The Senate HELP Committee will hold a markup on June 17, 2026, on legislation including:
  • S. 1782, Charlotte Woodward Organ Transplant Discrimination Prevention Act
  • S. 1954, Biosimilar Red Tape Elimination Act
  • S. 2339, EARLY Act Reauthorization of 2025
  • S. 2658, Medication Affordability and Patent Integrity Act
  • S. 3014, Ensuring Timely Access to Generics Act of 2025
  • S. 3799, Healthy Start Reauthorization Act of 2026
  • S. 4109, Stem Cell Therapeutic and Research Reauthorization Act of 2026
  • S. 4472, Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026
• The Senate HELP Committee's Subcommittee on Education and the American Family will hold a hearing on "The Future of K-12 Education in the Age of Artificial Intelligence" on June 16, 2026.
• The Senate Select Committee on Aging will hold a hearing on June 17, 2026, titled "Counting the Cost: Communist China's Toll on Older Americans' Health, Finances, and Security." Commissioners of the U.S.-China Economic and Security Review Commission are expected to testify.
• The Senate Committee on Small Business will hold a hearing on June 17, 2026, titled "250 Years of Main Street: Retail to Research."
• The Senate Committee on the Budget will hold a hearing on the nomination of Hal Duncan to serve as deputy director of the Office of Management and Budget (OMB) on June 16, 2026.

Federal Agencies

• HHS will convene the PTAC public meeting on June 15-16, 2026, focused on patient safety and value-based care.
• HHS will host the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria public meeting on June 16, 2026, focused on informing the next iteration of the National Action Plan on Combating Antibiotic-Resistant Bacteria, with written public comments accepted through June 19, 2026.
• The U.S. Food and Drug Administration's (FDA) Rare Disease Endpoint Advancement Pilot Program is accepting proposals through June 30, 2026.

Administrative Updates

Holland & Knight's Health AI Navigator

Holland & Knight's Health 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, 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. For the latest updates, see our "Trump's Second-Term Executive Orders (2025-2026)" tracking chart.

Congressional Updates

Key Congressional Race Update

• Graham Platner won the Senate Democratic Primary in Maine, beating Gov. Janet Mills (D-Maine). He will face Sen. Susan Collins (R-Maine) in the general election in November 2026.

House Bill to Fund Labor-HHS Clears Committee

The House fiscal year (FY) 2027 Labor-HHS bill was released on June 4, 2026, and approved by the full House Committee on Appropriations following a lengthy markup on June 9, 2026. The bill has not yet been considered by the full House and will likely be one of the last – if not the very last bill – to be considered, given HHS' large budget and the presence of several historically controversial provisions. However, advancement of the Labor-HHS bill marks 11 of 12 appropriation bills advanced by the House Appropriations Committee, before the Senate has begun the appropriations process in earnest. The following compares President Donald Trump’s FY 2027 budget request for HHS with the funding levels proposed in the House Labor-HHS bill:

• Health Resources and Services Administration (HRSA)/Administration for a Healthy America (AHA): The Trump Administration proposes consolidating HRSA and several other agencies into the new AHA, with approximately $19 billion in total funding, including $14.7 billion in discretionary funding and $2.2 billion from proposed mandatory sources. The House bill maintains the existing agency structure, indicating the committee will work with the Trump Administration and the committee of jurisdiction on a legislative proposal to reorganize the department, indicating short-term change is unlikely.
• Telehealth: The Trump Administration requests $70 million for telehealth activities broadly, compared to $45.55 million provided in the House bill for the Office for the Advancement of Telehealth.
• Primary Healthcare: Direct comparisons are challenging because the Trump Administration consolidates funding under AHA. The House bill provides approximately $1.86 billion for programs authorized under Titles II and III of the Public Health Service Act and the Native Hawaiian Health Care Act.
• Health Workforce: The Trump Administration requests $1.15 billion for Health Workforce activities. The House bill provides approximately $1.44 billion for programs authorized under Titles III, VII and VIII of the Public Health Service Act and related authorities.
• Maternal and Child Health: The Trump Administration requests $1.86 billion, compared to approximately $1.06 billion in the House bill.
• National Institutes of Health (NIH): The Trump Administration requests $41.2 billion, while the House bill provides approximately $48.4 billion.
• Advanced Research Projects Agency for Health: The Trump Administration requests $945 million. The House bill provides $1.5 billion, available through September 30, 2029.
• Administration for Strategic Preparedness and Response: Funding is generally comparable, with $3.34 billion requested by the Trump Administration and approximately $3.31 billion provided in the House bill.
• Biomedical Advanced Research and Development Authority (BARDA): In one of the more significant differences, the Trump Administration requests $1.8 billion, while the House bill provides approximately $1.06 billion available through September 30, 2028.
• Centers for Medicare & Medicaid Services (CMS): Funding is largely aligned across both documents, with approximately $3.7 billion requested by the Trump Administration and $3.67 billion provided in the House bill. The House bill includes provisions that would bar CMS from spending money to implement the Wasteful and Inappropriate Service Reduction Model.
• Federal Hospital Insurance and Supplementary Medical Insurance Trust Funds: The House bill provides approximately $686.9 billion from the Medicare Trust Funds. This funding is not separately identified in the Budget in Brief.
• Healthcare Fraud and Abuse Control: The Trump Administration requests $976 million, compared to $969 million provided in the House bill. The House bill specifically identifies transfers from the Medicare Trust Funds as the funding source.
• Office of the Secretary: The House bill provides approximately $298.6 million for a broad range of activities, including Public Health Service Act authorities, Social Security Act research activities, the Border Health Commission and Secretary protection activities. Many of these activities are not separately discussed in the Budget in Brief.

Regulatory Updates

CMS Creates OHTP to Oversee Healthcare Technology Modernization, Digital Products and Services Transformation

CMS on June 10, 2026, announced it established the Office of Health Technology and Products (OHTP) to provide leadership on and oversee CMS healthcare technology modernization, digital products and service transformation for federal healthcare programs, including Medicare, Medicaid, the Children's Health Insurance Program and others. The OHTP will work closely with the CMS chief information officer (CIO) and will have other responsibilities as outlined in the notice in the Federal Register, such as leading interagency coordination on standards and interoperability, working with Congress as well as internal CMS and external stakeholders.

Notably, the OHTP will be tasked with leading "enterprise strategy and implementation of artificial intelligence across CMS digital products and platforms, and advise the CMS Administrator and senior leadership on Artificial Intelligence (AI) opportunities, risks, and governance, in coordination with the CIO as required under statutory responsibilities." The OHTP will have several groups as part of its structure, including an open source group, a standards and interoperability group, a division of data and interoperability platforms, a division of policy, a product development group, a division of core products and a division of external products. The OHTP will also oversee digital service at CMS.

The change was approved and took effect on June 9, 2026. Amy Gleason, who currently serves as acting administrator of the U.S. Department of Government Efficiency, will lead the OHTP.

FDA Extends Comment Period for RFI; Reopens RFI on Scale-Up and Post-Approval Changes Guidance

The U.S. Food and Drug Administration (FDA) on June 10, 2026, announced it would extend for 30 days its request for information (RFI) on repurposing certain drugs for unmet medical needs. The original notice, published on May 12, 2026, sought input on priority disease areas and potential candidates for drug repurposing, with a focus on FDA-approved drug products for which there appears to be no commercial interest in added approved uses for via a supplement to a new drug application.

The FDA also on June 10, 2026, announced it would reopen for another RFI related to recommendations for scale-up and post-approval changes as part of a guidance for industry it is developing. The RFI seeks input on scale-up and post-approval changes for specific dosage forms. Public comments will now be accepted until July 13, 2026.

Medicare, Social Security Trustees Warn of Looming Trust Fund Shortfalls

The Board of Trustees for the Medicare and Social Security Trust Funds released its 2026 annual reports on June 9, 2026, warning that both programs continue to face significant solvency pressures. The Medicare Hospital Insurance Trust Fund is projected to be depleted in 2033, while the combined Social Security Trust Funds are projected to be depleted in 2034, consistent with last year's forecast.

The reports also account for provisions in the One Big Beautiful Bill Act (H.R. 1), which the trustees project will negatively affect Social Security's financial outlook by reducing income tax revenue from Social Security benefits. Among other changes, the legislation makes permanent lower income tax rates, adjusted tax brackets and the expanded standard deduction enacted under the 2017 Tax Cuts and Jobs Act, while adding a temporary additional standard deduction for taxpayers over age 65.

The Medicare report reiterates longstanding concerns that physician payment updates under the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) are not keeping pace with practice cost growth. Although MACRA resolved the short-term instability created by the Sustainable Growth Rate formula, the trustees caution that fixed statutory updates could widen the gap between physician costs and Medicare reimbursement over time, potentially affecting beneficiary access and quality of care absent legislative action.

Proposed Rule Would Codify and Amend Medicare Drug Price Negotiation Program

CMS published a proposed rule on June 12, 2026, that would codify and amend certain policies related to the Medicare Drug Price Negotiation Program. In the proposed rule, CMS codifies policies previously established through sub-regulatory guidance documents issued, beginning with initial price applicability year (IPAY) 2029. Several policies have been proposed, including modifying CMS' fixed combination drug policy to identify a single source drug using all dosage forms and strengths of the drug or biological product with shared active components and the same New Drug Application/Biologics License Application holder, regardless of formulation or route of administration to close a potential loophole. The proposals also include implementing a temporary floor for small biotechnology drugs for IPAYs 2029-2030 while limiting CMS from offering or agreeing to a counteroffer from a manufacturer below the floor. In addition, the proposed rule would clarify how the CMS measures the seven- to 10-year time since approval and licensure for drugs previously under the Organ Drug Exclusion.

The proposed rule also includes details on the next cycle of negotiation, which the CMS expects to publish the next list of up to 20 drugs covered under Medicare Parts B and D by February 1, 2027, along with any other drugs selected for renegotiation. Finally, several changes impacting Medicare Part D plans such as formulary inclusion are detailed, with opportunity for public comment by August 17, 2026. The CMS anticipates finalizing the rule in Fall 2026.

CMS Final Rule on Accrediting Organizations

CMS on June 12, 2026, published a final rule addressing concerns related to accrediting organizations, which are entities that determine whether healthcare providers and suppliers meet health and safety requirements as a condition of participating in Medicare or Medicaid. The changes outlined in the final rule related to survey performance, retention of accreditation after termination and others are included and take effect on June 16, 2027. Following publication in the Federal Register, comments will be accepted until September 8, 2026.

RFI on EHB Signals Reassessment of Framework to Come

HHS and CMS published an RFI on June 12, 2026, requesting comments on essential health benefits (EHBs) – specifically comments on state selection of EHB-benchmark plans, national standards and variation, affordability and the scope of benefits that should be included in EHBs. The RFI comes amid significant changes in the landscape of federal healthcare insurance and commercial insurance. Comments are due by July 15, 2026. The issuance of the RFI signals that HHS intends to potentially engage in future rulemaking, especially as it considers expansion of fertility benefits through tri-agency rulemaking, as well as restrictions on care that may be reimbursed.

HHS Sends More than 500 Price Transparency Requirement Warning Letters

HHS has escalated enforcement of federal hospital price transparency requirements, issuing warning notices or corrective action plan requests to 519 hospitals nationwide since April 2026 for failing to adequately disclose pricing information. Under this enforcement framework, CMS issues a 90-day warning notice outlining compliance deficiencies, followed by a 45-day deadline to submit a corrective action plan. Penalties can reach up to $5,500 per day or up to $2 million annually. At the time of this posting, 28 hospitals have received penalty notices.

CMS Releases Plans to Implement New Budget Neutrality Standards on Section 1115 Demonstrations

CMS released a State Medicaid Director letter on June 11, 2026, outlining its plans to implement new budget neutrality standards for Medicaid Section 1115 demonstrations. Section 1115 demonstrations allow states to test experimental approaches to Medicaid, including changes to eligibility, benefits, delivery systems and coverage that would not otherwise be permitted under traditional Medicaid authorities. The guidance is intended to support implementation of a statutory requirement enacted in the July 2025 reconciliation bill, which generally prohibits approval of a new, renewed or amended Section 1115 demonstration unless the CMS chief actuary certifies that the demonstration is projected to be budget neutral.

HRSA Issues ICR for 340B Rebate Model Pilot Program

The HRSA issued an information collection request (ICR) related to the planned revision to the 340B Rebate Model Pilot Program. The ICR outlines the information that will be collected from drug manufacturers, purchase data reports from manufacturers to support monitoring, and overall surveillance and program integrity. The anticipated pilot will be limited to manufacturers with current Medicare Drug Price Negotiation agreements with CMS for IPAY 2026 and 2027. The notice states that OMB may act on HRSA's ICR only after the 30-day comment period closes, indicating HRSA may move ahead with the new 340B rebate model as soon as this summer, as the notice states: "OPA plans to publish a Federal Register Notice to notify 340B stakeholders of criteria and standards for implementation of the Pilot." To date, the proposed rule related to the rebate model remains at OMB for review.

HHS Seeks Comment on Proposed Health People 2030

HHS published a notice on June 16, 2026, requesting comments to inform the objectives for Healthy People 2030, a set of objectives to improve the nation's well-being. Comments requested pertain to screen time objectives and the potential to refine or expand, given shifts in technology uses among most age groups over the past several years.

Legal Updates

Federal Judge Vacates Portions of 2025 ACA Rule

A federal judge on June 15, 2026, vacated eight portions of the 2025 final rule titled "Patient Protection and Affordable Care Act; Marketplace Integrity and Affordability." The final rule, which was issued in June 2025, sought to address improper enrollment in Affordable Care Act (ACA) marketplaces and reduce federal expenditures on healthcare. The final rule sought to end special enrollment periods, addressing the ability for some brokers and agents to enroll individuals in policies without their knowledge, as well as establish income verification processes for some individuals, among other provisions. Additional changes were finalized in a separate rule issued in May 2026. However, many of the provisions were codified in some form as part of H.R. 1. In addition, the Trump Administration may seek to appeal the ruling.

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.