Holland & Knight Health Dose: February 24, 2026

Looking Ahead

The U.S. House of Representatives and U.S. Senate returned to session on February 24, 2026, having delayed their return by a day following winter weather on the East Coast. Both chambers return with a need to address the continued lapse in appropriations for the U.S. Department of Homeland Security (DHS).

Over the weekend, DHS added pressure to lawmakers by announcing it would suspend the use of certain expedited screening procedures for air travel passengers, only to change course after significant pushback. Democrats and Republicans remain far apart in negotiations on funding DHS, with the two sides continuing to trade offers and counteroffers.

Much of the attention in the U.S. Capitol will shift to President Donald Trump on February 24, 2026, for the State of the Union address, which is expected to include remarks on immigration, healthcare affordability and an overview of the administration's priorities during the first year of his second term.

Upcoming Events

Congress

• The House Committee on Ways and Means Subcommittee on Health held a hearing on February 24, 2026, at 10 a.m. ET titled "Advancing the Next Generation of America's Health Care Workforce."
• The House Committee on the Budget held a hearing on February 24, 2026, at 10:15 a.m. ET titled "The Congressional Budget Office's Budget and Economic Outlook." Director of the Congressional Budget Office (CBO) Phillip Swagle, Ph.D., is expected to testify.
• The Senate Committee on Health, Education, Labor and Pensions (HELP) will hold a hearing on February 25, 2026, on the nomination of Casey Means to be Medical Director in the Regular Corps of the Public Health Service and Surgeon General of the Public Health Service.
• The Senate Special Committee on Aging will hold a hearing on February 26, 2026, at 9:30 a.m. ET titled "From Regulator to Roadblock: How FDA Bureaucracy Stifles Innovation."
• The Senate HELP Committee will hold a full committee markup on February 26, 2026, at 10 a.m. ET to consider six education and healthcare bills, including the Charlotte Woodward Organ Transplant Discrimination Prevention Act (S.1782), Living Donor Protection Act of 2025 (S.1552) and Health Care Cybersecurity and Resiliency Act of 2025 (S.3315).

Federal Agencies

• The next meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) will take place on March 12, 2026, from 9 a.m. to 3:30 p.m. During the meeting, the committee will meet and discuss recommendations on the strain composition of influenza virus vaccines for use in the U.S. during the 2026-2027 flu season. The meeting will be available via livestream.
• A planned meeting of the Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) has been postponed due to ongoing litigation. The meeting was intended to take place February 25-27, 2026. A new date has yet to be shared.

Administrative Updates

Executive Order Updates

The Trump Administration has continued to release wide-ranging executive orders (EOs). For the latest updates, see our "Trump's 2025 Executive Orders: Updates and Summaries" tracking chart.

Supreme Court Strikes Down President's Use of IEEPA

In a 6-3 ruling on February 20, 2026, the U.S. Supreme Court struck down President Trump's ability to levy tariffs under the International Emergency Economic Powers Act (IEEPA). Chief Justice John Roberts was joined by Justices Sonia Sotomayor, Elena Kagan, Neil Gorsuch, Amy Barrett and Ketanji Brown Jackson on the judgement, while some justices filed concurring and dissenting opinions to certain parts of the ruling. The 6-3 ruling brought together a cross section of judicial leanings, with Justices Gorsuch and Barrett being on the side of stricter construction.

The court found that IEEPA's grant of authority to regulate imports fell short, finding that the government had cited no evidence that existing statute where Congress used the word "regulate" to authorize taxation. The court also found no examples where a previous president read IEEPA to confer the power to levy tariffs under IEEPA, and IEEPA does not authorize President Trump to impose tariffs. Justices Kagan, Sotomayor and Jackson wrote in part that they agreed IEEPA does not authorize the president to impose tariffs but concluded that the Supreme Court could arrive at that decision using "ordinary tools of statutory interpretation" – i.e., looking at what is in law as passed by Congress – instead of using the major questions doctrine. Justices Clarence Thomas, Brett Kavanaugh and Samuel Alito filed dissenting opinions.

However, nothing in the majority opinion addresses the topic of refunds, which are owed to importers who paid the tariffs previously. In his dissent, Justice Kavanaugh offered the only mention of refunds, noting that "the United States may be required to refund billions of dollars to importers who paid the IEEPA tariffs, even though some importers may have already passed on costs to consumers or others." He also wrote that the court says nothing about "whether, and if so how, the Government should go about returning the billions of dollars that it has collected from importers." This leaves a very opening remaining question on "whether" and "how" refunds may be processed – if at all.

For further analysis, see Holland & Knight's alert, "Supreme Court Strikes Down IEEPA Tariffs: What Importers Need to Know Now," February 20, 2026.

President Trump Issues EO Outlining New Tariffs Following Supreme Court Ruling

President Trump issued a proclamation on February 20, 2026, imposing a new temporary import surcharge following the Supreme Court's ruling that found President Trump's use of emergency authorities to levy tariffs to be illegal. The proclamation applies 10 percent global tariffs on all imports, per Section 122 of the Trade Act of 1974, which allows the president to apply tariffs to address fundamental international payment issues. The 10 percent tariffs may be applied for up to 150 days, effective February 24, 2026, with the tariff not being applied to certain products as outlined in Annexes I and II of the proclamation.

Leadership Changes at HHS

• U.S. Department of Health and Human Services (HHS) Secretary Robert F. Kennedy, Jr. announced a series of department leadership changes as of February 12, 2026. Each official will continue to serve in their current roles in addition to their new roles:
  • Chris Klomp, director of Medicare at the Centers for Medicare & Medicaid Services (CMS), became chief counselor at HHS in addition to his role at CMS. He will oversee all operations of the department.
  • Kyle Diamantas, deputy commissioner for human foods at the U.S. Food and Drug Administration (FDA), and Grace Graham, deputy commissioner for policy, legislation and international affairs at the FDA, both became senior counselors for the FDA.
  • John Brooks, deputy administrator and chief policy and regulatory officer for CMS, became senior counselor for the CMS.
• HHS Deputy Secretary and CDC Acting Director Jim O'Neill and HHS General Counsel Mike Stuart will both depart from their roles. O'Neill will become head of the National Science Foundation (NSF).
• Jay Bhattacharya, Director of the National Institutes of Health (NIH) will also become acting director of the CDC.
• Rick Abramson will be the director of the FDA's Digital Health Center of Excellence. He previously served as a counselor in the commissioner's office and worked in artificial intelligence (AI) medical imaging.
• Ralph Abraham on February 23, 2026, resigned as principal deputy director of the Centers for Disease Control and Prevention (CDC) to address unforeseen family obligations.

Congressional Updates

Senate Finance Democrats Introduce Nursing Home Staffing Standard

Democrats in the Senate Committee on Finance introduced legislation that would establish federal minimum staffing standards for nursing homes, closely mirroring requirements finalized by the CMS under the Biden Administration in 2024 and later rescinded as part of the One Big Beautiful Bill Act. The proposal would require a registered nurse (RN) on site 24/7 and mandate at least 3.5 hours of total nursing care per resident per day, along with other new requirements.   

Senate HELP Committee Releases Paper Detailing Potential FDA Reforms

The Senate HELP Committee released a new paper detailing potential FDA reforms, laying out changes that may be sought as Congress gears up to consider and advance user fee legislation for regulated industries over the next two years. Meetings between FDA staff and representatives from regulated industries such as medical device, pharmaceutical and others are actively underway. Key themes in the report along with recommendations to both the FDA and Congress included:

• need to improve review process through application of "least burdensome" approach across product categories
• expanding use of digital health technologies and other tools to conduct decentralized trials, including tailoring review to relevant risks
• targeted approach to regulating AI in a way that addresses "specific risks" but does not "deter discovery," as well as clear guidance on expectations for AI, including regulatory interactions and appropriate standards
• agency guidance around accelerated approval to make further improvements to the pathway
• more focus on rare disease not limited to the Rare Disease Innovation Hub
• creation of intermediate pathway for biologics, similar to that between a full biologics license application (BLA) and abbreviated BLA

Holland & Knight is reviewing this paper and will provide additional analysis. To receive this forthcoming analysis, please subscribe to our alerts. 

House Judiciary Committee Issues Subpoenas to Eight Health Insurance Companies

House Committee on the Judiciary Chair Jim Jordan (R-Ohio), Subcommittee on the Administrative State, Regulatory Reform and Antitrust Chair Scott Fitzgerald (R-Wis.) and Subcommittee on Oversight Chair Jeff Van Drew (R-N.J.) issued subpoenas on February 10, 2026, to eight large healthcare insurance companies seeking information about each company's fraud protection measures as they relate to health plans available through the Affordable Care Act (ACA) exchanges. The letters are part of the committee's ongoing investigations into advanced premium tax credits (APTCs) provided to certain individuals enrolled in ACA plans and following a U.S. Government Accountability Office (GAO) report detailing findings following use of a sample-size covert testing of federal marketplace enrollment processes and controls. The letters to the insurance companies requested information to be provided by February 23, 2026.

Regulatory Updates

FDA Plausible Mechanism Guidance for Gene Therapies

The FDA released guidance on February 23, 2026, outlining a new regulatory pathway focused on expediting the development and operationalization of personalized therapies for rare and ultra‑rare diseases. The approach builds on FDA's recently described "Plausible Mechanism Pathway," outlined by FDA Commissioner Marty Makary and Center for Biologics Evaluation and Research (CBER) Director Vinay Prasad in a New England Journal of Medicine article, which proposes a flexible approval framework for bespoke therapies where randomized trials are not feasible and the disease's biological mechanism is well understood.

ACCESS Model Rates Announced

CMS released payment rates and performance parameters for the new Advancing Chronic Care with Effective, Scalable Solutions (ACCESS) Model, a voluntary Medicare Innovation Center model focused on technology‑enabled chronic care. For care periods beginning July 5, 2026, through 2027, participating organizations will receive fixed, outcome‑aligned annual payments per aligned beneficiary, varying by clinical track (cardio‑kidney‑metabolic, musculoskeletal and behavioral health).

Though the model signals the Trump Administration's push toward technology‑supported, outcomes‑based care, the finalized payment levels came in lower than many hospitals and Medicare Part B providers expected, raising questions about the viability of the model. Because ACCESS replaces traditional fee‑for‑service billing during active care periods and requires upfront investment in digital tools, data infrastructure and patient engagement, providers may find it difficult to participate without additional financial upside or rate adjustment. As a result, early adoption may skew toward technology‑first, non‑traditional care organizations or large hospital systems, unless CMS adjusts incentives or clarifies pathways that make participation economically viable for rural or less resourced hospitals and physician‑led Part B practices.

HHS/DOGE Open-Source Medicaid Claims Dataset

HHS' Department of Government Efficiency (DOGE) released the largest open‑source Medicaid dataset in federal history, publishing aggregated, provider‑level claims data covering 2018-2024. The dataset includes fee‑for‑service, managed care and Children's Health Insurance Program (CHIP) claims and is intended to support transparency, research and fraud detection while applying privacy safeguards such as cell suppression for small claim volumes. The data is now publicly available through HHS' open data platforms, enabling outside analysts, researchers and other stakeholders to examine Medicaid spending patterns across states and provider types.

CMS Announces Public Engagement Opportunities Regarding Current Drug Price Negotiation Cycle

CMS announced on February 9, 2026, that it will hold a variety of public sessions to allow stakeholders to share their experience with drugs selected for the current cycle of drug price negotiation and renegotiation. There will be a virtual, patient-focused roundtable focused on clinical considerations for the drugs selected in April 2026. Those interested in participating must submit an interest form by March 6, 2026. A separate Drug Price Negotiation Information Collection Request (ICR) form is also available, and responses may be submitted until March 1, 2026.

CBO Releases New Estimates on Savings Related to Skin Substitute Payment Policy

The CBO issued new estimates detailing that recent changes to skin substitute payment policies would reduce federal spending by approximately $245 billion over 10 years, according to updated projections released on February 11, 2026. While the savings are significant, the magnitude of the estimate underscores the significance of the reductions from previously existing payment levels, raising concerns about the effect of changes on market viability, innovation and patient access.

HRSA Publishes New RFI to Inform Potential 340B Rebate Model Program

The Health Resources and Services Administration (HRSA) issued a new request for information (RFI) on February 13, 2026, regarding whether HRSA should implement a rebate model for the 340B Program and how best to operationalize any such rebate framework.

The RFI follows the conclusion of litigation earlier this month that sought to prohibit implementation of the 340B Rebate Model Pilot Program. A federal court found that a group of hospital stakeholders were likely to succeed in their lawsuit on the grounds of violations of the Administrative Procedures Act (APA) due to lack of certain cost information. HHS and the plaintiffs agreed in a joint motion filed with the court on February 5, 2026, that should HHS move forward with another 340B rebate program, HHS would issue a new notice and solicit comments from the public. HHS also agreed to set the effective date for any new potential pilot to no earlier than 90 days, following approval of any drug manufacturer applications to participate.

In a nod to the court's findings, the RFI specifically seeks information on costs that covered entities may incur, including financial and staffing implications, as well as payment timing and cash flow impacts. Comments are due March 19, 2026.

FDA Launches Assessment of Common Food Chemical Preservative

The FDA launched an assessment on February 10, 2026, of butylated hydroxyanisole (BHA), a common food chemical preservative, to determine whether BHA is safe under its current conditions of use in food and as a food contact substance. As part of the post-market assessment, the FDA issued an RFI on the use and safety of BHA based on the latest scientific information. Comments in response to the RFI are due on April 13, 2026. The RFI requests answers to 12 specific questions, including general food categories BHA is used in, typical and maximum use levels, other dietary sources of BHA, safety data relevant to the use of BHA in food or as a food contact substance, and documentation of generally recognized as safe (GRAS) conclusions or "prior sanctions" related to BHA in food or as a food contact substance.

The initiation of the post-market assessment of BHA and corresponding RFI comes as the Trump Administration continues to weigh efforts to address the use of GRAS as it relates to food additives – for which a proposed rule at the time of writing remains under OMB review – and as the Make America Healthy Again (MAHA) Commission continues its work.

MDUFA VI Meeting Minutes Released

The FDA released minutes from its January 21, 2026, meeting with medical device industry representatives as part of the informal engagement process for reauthorization of the Medical Device User Fee Act (MDUFA). During the meeting, the FDA unveiled principles related to "America First," and discussion centered on device approval pathways, industry feedback on FDA use of real-world evidence and total time to decision (TTD) goals for 510(k) approvals. An additional meeting was held on February 4, 2026, and future meetings will be held in March 2026.

ACA Market Change CMS Proposed Rule

On February 11, 2026, CMS released a proposed rule outlining significant changes to ACA marketplaces for plan year 2027, including new flexibility in plan design and marketplace operations. The proposal would allow certification of non‑network qualified health plans, expand multi‑year plan terms for catastrophic coverage and seek comment on applying similar approaches to other metal‑level plans – potentially introducing products that depart from traditional provider‑network models. The rule also proposes tighter standards for agents, brokers and web brokers and signals a shift toward a more decentralized enrollment structure, reducing reliance on web‑based brokers while strengthening federal oversight of consumer enrollment practices. Public comments are due March 13, 2026.

Legal Updates

Supreme Court Schedules Arguments in "Skinny Label" Case

The Supreme Court announced it will hear oral arguments on April 29, 2026, in a case regarding "skinny labels," where generic drug manufacturers may seek approval from the FDA on uses for a medication that are not patented by the brand drug manufacturer.

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.