Holland & Knight Health Dose: June 9, 2026

Looking Ahead

The U.S. Senate passed a reconciliation package on a 52-47 vote on June 5, 2026, that will provide $70 billion in funding to support U.S. immigration enforcement agencies and their activities. After nearly 18 hours of debate and consideration of more than 20 amendments, none of which were adopted, Sen. Lisa Murkowski (R-Alaska) joined all Senate Democrats in voting against the package. Ultimately, provisions funding security enhancements to the White House ballroom under construction, as well as funding to create an "anti-weaponization fund," were removed from the package to speed passage amid concerns from some Republicans.

The U.S. House of Representatives adjourned on June 4, 2026, before taking up the reconciliation package, but it is expected to be considered this week after the House Committee on Rules sets the floor procedures for debate. The House is also expected to consider legislation related to waste, fraud and abuse prevention, as well as student loans, while the Senate continues to advance judicial nominations. Discussions about the potential to proceed with a third reconciliation package are also in their early stages, though the focus remains passing "reconciliation 2.0" first.

Upcoming Events

Congress

• The House Committee on Education and Workforce will hold a hearing on June 9, 2026, titled "On Call for America: Strengthening Access Through Locum Tenens Providers."
• The House Committee on Appropriations on June 9, 2026, will hold a markup of the fiscal year (FY) 2027 Labor, Health and Human Services (HHS), Education and Related Agencies appropriations bill and the FY 2027 Homeland Security appropriations bill.
• The House Committee on Energy and Commerce Subcommittee on Health will hold a hearing on June 10, 2026, titled "Lowering Health Care Costs for All Americans: Examining Policies to Increase Health Care Transparency." Bills expected to be considered during the hearing include:
  • H.R. ____, Lower Costs, More Transparency Act of 2026
  • H.R. ____, To amend Title XXVII of the Public Health Service Act to require hospitals to post prices on the walls
  • H.R. ____, To amend Title XXVII of the Public Health Service Act and title XVIII of the Social Security Act to ensure health insurer accountability through publishing of overhead costs and claim payments
  • H.R. ____, To amend Title XVIII of the Social Security Act and title XXVII of the Public Health Service Act to require the displaying of claim denial rates
  • H.R. 5582, Patients Deserve Price Tags Act, introduced by Reps. John James (R-Mich.) and Maggie Goodlander (D-N.H.)
  • H.R. 9117, Clear Healthcare Expense Cost Knowledge Act of 2026, introduced by Rep. Nick Langworthy (R-N.Y.)
  • H.R. ____, To amend Title XVIII of the Social Security Act to require the inclusion of certain information in Medicare Advantage (MA) encounter data
  • H.R. ____, To amend Title XI of the Social Security Act to require mandatory reporting with respect to certain health-related ownership information
  • H.R. ____, To amend Title XVIII of the Social Security Act to limit the compensation that may be paid to agents and brokers by Medicare Advantage organizations
• The House Committee on Ways and Means Subcommittees on Social Security and Work and Welfare will hold a joint hearing with Frank J. Bisignano, the Commissioner of Social Security.
• The House Committee on Veterans' Affairs Subcommittee on Technology Modernization on June 12, 2026, will hold an oversight hearing in Michigan titled "Delivering Quality and Modern Healthcare to Michigan's Veterans and Servicemembers."
• The Senate Committee on Appropriations has rescheduled its hearing to consider the Agriculture-Food and Drug (FDA) Administration funding bill from last week, to a date yet to be announced. Chairwoman Susan Collins (R-Maine) and Ranking Member Patty Murray (D-Wash.) remain in conversations to set the topline funding numbers which to date remain in flux.

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.

• Promoting Advanced Artificial Intelligence Innovation and Security, issued on June 2, 2026, directs federal agencies to strengthen cybersecurity across national security systems, civilian networks and critical infrastructure by deploying AI‑enabled defenses, expanding access to cybersecurity tools and coordinating vulnerability detection and response. The EO establishes a voluntary framework for "covered frontier models," encouraging developers to provide the federal government with up to 30 days of pre‑release access for cybersecurity evaluation, while stopping short of imposing any mandatory licensing or approval requirements.
• Implementing Schedule/Policy Career in the Excepted Service, issued on June 3, 2026, amends the Civil Service Rules and Regulations, as well as previous EOs, to make it easier for certain government employees to be removed from their positions. The EO also seeks to advance merit in federal hiring and promotions opportunities by directing agency leaders to reward employees for outstanding work.

Personnel Updates

• Gei Bai, a professor and expert in healthcare accounting and finance, has been nominated to serve as assistant secretary at the U.S. Department of Health and Human Services (HHS).
• » Todd Blanche, who currently serves as acting U.S. Attorney General, has been nominated to be U.S. Attorney General. Blanche has held the acting position for several weeks, following the departure of former U.S. Attorney General Pam Bondi.

Congressional Updates

Great American AI Act Discussion Draft Released

Bipartisan House lawmakers have released a discussion draft of the Great American AI Act that would give the federal government a clearer role in overseeing AI model development while limiting some state rules. The proposal would override certain state laws aimed at model development – including California requirements on training-data transparency and parts of its watermarking framework – and instead focus compliance on frontier developers. It also points to a more flexible federal approach, relying on voluntary standards developed through agencies such as the National Institute of Standards and Technology rather than a patchwork of state mandates.

At the same time, the draft leaves states with broad authority over how AI systems are used, distributed and applied after deployment, including under civil rights, labor, privacy and product liability laws. That narrower preemption approach has already faced resistance on Capitol Hill. Several House AI Commission co-chairs publicly rejected the draft, signaling it is more likely to shape future negotiations than move forward in its current form.

Labor-HHS Bill Considered by House Subcommittee, Full Committee Markup Scheduled June 9; Senate Postpones

The House Committee on Appropriations released the Labor-HHS appropriations bill, which would provide a total of $189.3 billion in funding for FY 2027. The funding level is three percent below the FY 2026 enacted level and places heavy focus on funding for biomedical research and rural health and returns educational programs back to state governments. HHS would receive a total of $110.8 billion in funding, $4 billion (or four percent) below the FY 2026 enacted level. The HHS section of the funding bill as written continues the Trump Administration's focus on countering China by prohibiting the purchase of supplies from China for use in the Strategic National Stockpile and provides $65 million in funding for the Administration for Strategic Preparedness and Response to support domestic manufacturing of essential medicines.

The funding bill provides $9.8 billion in total funding for the U.S. Department of Labor (DOL), $3.7 billion (or 27 percent) below the FY 2026 enacted level. The funding bill also provides the U.S. Department of Education with a total of $70.7 billion in funding – $8 billion or 10 percent below the FY 2026 enacted level. Chair Tom Cole's (R-Okla.) summary of the bill can be found online.

In the Senate however, a markup planned for last week on the Agriculture-FDA appropriations legislation was postponed and has not yet been rescheduled, as conversations remain ongoing regarding what the topline, overall funding numbers will be for the various departments. The House, however, passed its version of the Agriculture-FDA appropriations bill in a vote of 213-210 on June 4, 2026.

House Democrats Launch Issue Specific Working Groups in Pursuit of Affordability Agenda for 2027 and Beyond

In the lead up to the mid-term elections, House Democratic Leader Hakeem Jeffries (D-N.Y.) on June 8, 2026, announced a series of issue-specific workgroups to be led by "co-convener"' as the House Democrats prepare to draft an affordability agenda for 2027 and beyond. The co-conveners are expected to moderate discussions on topic areas such as housing, gas and utilities, groceries and goods, caregiving and healthcare. Co-conveners will also work with Ranking Members on Committees of jurisdiction to prepare the affordability provisions to be included. Co-conveners and the groups they will lead are below:

• Housing: Reps. Laura Friedman (D-Calif.) and Emilia Sykes (D-Ohio)
• Gas and Utilities: Reps. Nikki Budzinski (D-Ill.) and Mike Levin (D-Calif.)
• Groceries and Goods: Reps. Marie Glusenkamp Perez (D-Wash.), Hillary Scholten (D-Mich.) and Jill Tokuda (D-Hawaii)
• Caregiving: Reps. Sarah McBride (D-Del.) and Morgan McGarvey (D-Ky.)
• Healthcare: Reps. Alexandria Ocasio-Cortez (D-N.Y.) and Terri Sewell (D-Ala.)

Regulatory Updates

FDA Issues New Guidance Exempting Certain Medical Devices from 510(k), Updates Breakthrough Devices Program Metrics

The FDA issued new guidance on June 3, 2026, outlining the FDA's intent to exempt certain medical devices among various device categories from premarket notification. In the guidance, the FDA specifies that it believes the devices qualify for the exemptions and does not intend to enforce compliance with 510(k) requirements. In total, the FDA has granted 1,284 Breakthrough Device Designations since the establishment of the program in 2018 through March 31, 2026, as part of the 21st Century Cures Act. The vast majority of designations – 1,264 – have been granted by the Center for Devices and Radiological Health, while the remaining 20 designations have been granted by the Center for Biologics Evaluation and Research. A total of 198 marketing authorizations have been granted since the launch of the program.

HHS Finalizes Rule on Reducing Bureaucracy and Burden for Community Services Programs

The HHS issued a final rule on June 8, 2026, to amend regulations related to block grants and certain other funds related to community service projects. The final rule rescinds certain regulations that HHS found to be unnecessary or "wholly obsolete," duplicative or otherwise. The final rule takes effect 60 days from publication in the Federal Register. The rule focuses on programs within HHS' Administration for Children and Families Office of Community Services.

DEA Issues Final Rule to Implement Part of SUPPORT Act

The U.S. Department of Justice's Drug Enforcement Administration (DEA) issued a final rule to ensure conformity with subsequent reauthorization legislation related to the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act of 2018 (the SUPPORT Act). The final rule outlines a number of provisions it is removing from its regulations following provisions passed as part of the Restoring Hope for Mental Health and Well-Being Act of 2022, which was signed into law as part of the 2023 omnibus spending package.

Pending Rulemaking Activities: Upcoming Healthcare Policy and Regulatory Developments

Several significant rulemaking activities by the Centers for Medicare & Medicaid Services (CMS) and FDA remain under review by the Office of Management and Budget (OMB) or remain in the early stages of development across federal agencies. The list below highlights expected timelines for proposed and final rules in the months ahead and points to key deadlines that could shape broader healthcare policy discussions later this year.

That timeline may shift, especially for rules under review at the Office of Information and Regulatory Affairs (OIRA), so actual publication dates could differ from these estimates.

Near-Term (June-July 2026)

• CMS Inflation Reduction Act Drug Negotiation Proposed Rule – under OIRA review since February 26, 2026
• Federal Trade Commission (FTC) pharmacy benefit manager (PBM) 6(b) Final Report – timing uncertain; may be delayed by pending FTC settlements
• DOL Final Rule on Pharmacy Benefit Managers (PBMs) – late spring/summer 2026
• Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) meeting – June 24-26, 2026
• FDA Publication of Negotiated User Fee Commitment Letters Outlining Agency Goals for the Next Authorization Cycle – June/July 2026
• CMS launch of Medicare GLP-1 Bridge – July 1, 2026
• CMS launch of Advancing Chronic Care with Effective, Scalable Solutions (ACCESS) Model – July 5, 2026
• CMS Calendar Year (CY) 2027 Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Proposed Rule – July 2026
• CMS CY 2027 Physician Fee Schedule (PFS) Proposed Rule – July 2026
• CMS CY 2027 End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) Quality Incentive Program Proposed Rule/CMS-1846 – July 2026
• CMS CY 2027 Home Health PPS/Home Infusion Proposed Rule – July 2026
• CMS Medicaid/Children's Health Insurance Program Managed Care, Financing and Access Integrity Proposed Rule – at OIRA since May 12, 2026
• CMS Exchange Pre-Enrollment Eligibility Verification Proposed Rule – at OIRA since April 22, 2026
• CMS Short-Term, Limited-Duration Insurance Proposed Rule – at OIRA since May 30, 2026

Fall 2026

• CMS Final FY 2027 Inpatient Prospective Payment System/Long-Term Care Hospital (LTCH), Psych, Inpatient Rehabilitation Facility, Skilled Nursing Facility (SNF) and Hospice rules – August 2026
• Temporary Adjustment to LTCH Site Neutral Payment Rates Expires – September 30, 2026
• Supplemental Nutrition Assistance Program Authorization – September 30, 2026
• CMS Launch of Global Benchmark for Efficient Drug Pricing (GLOBE) Model in Medicare Part B – October 1, 2026
• CMS MA/Part D Proposed Rule – October/November 2026
• CDC ACIP Meeting – October 21-23, 2026
• CMS Final CY 2027 OPPS/ASC, PFS, Home Health and ESRD Rules – early November 2026
• Midterm Elections – November 3, 2026
• Deadline for CMS to Publish 2028 Negotiated Maximum Fair Prices – November 30, 2026

Late 2026-2027

December 2026

• CMS CY 2027 Clinical Lab Fee Schedule – late December 2026
• CMS Sunsets REACH Accountable Care Organization (ACO) Model – December 31, 2026
• Temporary Payment Increase Under the MPFS – December 31, 2026
• Advanced Alternative Payment Model Bonus – December 31, 2026
• Community Health Center Funding – December 31, 2026
• National Health Service Corps Funding – December 31, 2026
• Special Diabetes Programs for Type I and Indians – December 31, 2026
• Low-Volume Hospital Payment Adjustment – December 31, 2026
• Medicare-Dependent Hospital Program – December 31, 2026
• Geographic Practice Cost Indices (GPCI) Floor – December 31, 2026
• Pandemic and All-Hazards Preparedness Act Reauthorization – December 31, 2026

January 2027

• CMS Launch of Guarding U.S. Medicare Against Rising Drug Costs (GUARD) Model in Medicare Part D – January 1, 2027
• CMS MFP Effective Date for 2027 Selected Drugs – January 1, 2027
• CMS Launch of Long-term Enhanced Design ACO Model – January 1, 2027
• CMS Launch of the Ambulatory Specialty Model – January 1, 2027
• Medicaid Work Requirements Must be in Effect – January 1, 2027

September-December 2027

• Medicaid Disproportionate Share Hospital funding – September 30, 2027
• Puerto Rico Medicaid Funding Reauthorization – October 1, 2027
• Maternal, Infant and Early Childhood Home Visiting (MIECHV) Program – October 1, 2027
• FDA User Fee Reauthorization (PDUFA VIII, MDUFA VI, GDUFA IV, and BsUFA IV) – September 30, 2027
• Medicare Telehealth Flexibilities – December 31, 2027
• Ground Ambulance Add-On Payments – December 31, 2027

HHS Issues RFI on Improving Mental Health, Substance Use Disorder Treatment

HHS' Agency for Healthcare Research and Quality (AHRQ) issued a new request for information (RFI) on June 8, 2026, regarding research, policy and strategies to improve the prevention, treatment, recovery and prevalence of mental health disorders. The purpose of the RFI is to identify research, programs and policies that have been successful, as well as recommend novel ideas and gaps in research that could support additional efforts related to mental health and substance use disorder. The RFI is issued under the auspice of a new initiative called the Great American Recovery. Responses are due by July 5, 2026.

DOW Issues New List of Designated Chinese Military Companies

The Department of War (DOW) issued a notice on June 8, 2026, identifying several companies operating in the U.S. that it determined qualify as "Chinese military companies." The BIOSECURE Act – signed into law on December 18, 2025, as part of the FY 2026 National Defense Authorization Act (NDAA) – limits the U.S. government's ability to provide federal funding to or contract with biotechnology companies of concern. Those companies of concern are those found on the DOW's list of Chinese military companies, which is referred to as 1260H and was established as part of a prior year's NDAA. The updated list of biotechnology companies of concern was updated earlier this year and published in the Federal Register, only to be taken down. The updated list has now been published and outlines which previously listed companies have been removed. Companies listed on the 1260H list include parent and subsidiary companies. Those listed on the notice may petition to be removed through a reconsideration process. There will likely be impacts to the biotechnology sector if the list remains as is, given certain contract development and manufacturing organizations (CDMOs) are listed as of publishing.

Legal Updates

Supreme Court Rules in Favor of Generic Manufacturer on "Skinny Labels"

The U.S. Supreme Court issued a unanimous opinion on June 4, 2026, in a case regarding "skinny labels," concluding that a generic drugmaker did not infringe on the patent of a brand name company's product. "Skinny labeling" is intended to encourage generic drug competition by allowing generic drug manufacturers to market products for specific uses that are not covered by brand name company patents. The ruling – authored by Justice Ketanji Brown Jackson – overturned a lower court ruling, stating that the central question was whether the brand name company had "plausibly alleged" that the generic drug company actively encouraged use that infringed upon its patents. The Supreme Court found that the generic company did not do so, nor did the company actively encourage uses that could be seen as infringing on the brand name product. The case was announced as the House was holding a hearing on intellectual property as it relates to drug products, indicating the issue is likely to receive congressional attention in the coming months.

Novel Product Liability AI Case

Florida Attorney General James Uthmeier filed suit against a major public-facing large language model, alleging the technology poses risks to users' mental health and public safety. The case advances a novel application of product liability law to AI systems, drawing on legal strategies used in ongoing social media litigation and earlier actions against the tobacco industry to impose accountability and shape industry practices.

H1-B Fee Found to be Unauthorized Tax, Federal Judge Vacates Case in Its Entirety but Government Appeal Likely

A federal judge in Massachusetts on June 8, 2026, ruled that a $100,000 visa fee the Trump Administration had placed on applicants for H1-B visas was an unauthorized tax and therefore unlawful. The judge vacated the case, likening the fee to the ruling that upheld the Affordable Care Act that found the mandate to obtain health insurance a tax and the Supreme Court's rejection of the use of emergency tariffs without congressional approval. Many stakeholders, including healthcare organizations, raised concerns about the potential for the fee to cause additional workforce shortages, as certain employers such as rural hospitals or others may not be able to afford the fee for each applicant, especially those entities that rely on highly skilled foreign workers. A separate ruling by the D.C. Circuit Court is also reviewing another district court decision, which reached a different conclusion, finding that existing language in statute could cover the ability to require the additional visa payment. The divergence of opinions makes it likely that a higher court reviews the cases, either separately or jointly, as the Trump Administration is likely to appeal the June 8, 2026, 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.