Holland & Knight Health Dose: March 3, 2026

Looking Ahead

U.S. Congress returns to session this week after the U.S. military launched strikes against Iran and defended against retaliatory actions against U.S. military personnel and presences across the Middle East. Both the U.S. Senate and U.S. House of Representatives are expected this week to vote on war powers resolutions, which are typically intended to attempt to "check" the president's deployment and commitment of U.S. military personnel without congressional approval, which is expected to be the central focus of both chambers.

In addition to the consideration of a war powers resolution, the House is expected to hold votes on a package to fund the U.S. Department of Homeland Security (DHS), which it has previously voted on. Compromise on a bill to fund DHS has been elusive, with conversations ongoing regarding funding and potential directives to rein in U.S. Immigrations and Customs Enforcement (ICE) activities. The two sides continue having conversations about a potential path forward, with no agreement in sight currently.

Upcoming Events

Congress

• The Senate Committee on Commerce, Science, and Transportation Subcommittee on Science, Manufacturing, and Competitiveness held a hearing on March 3, 2026, titled "Less Hype, More Help: AI That Improves Safety, Productivity, and Care." Witnesses were expected to include representatives of robotics, digital health and artificial intelligence (AI) companies.
• The House Committee on Oversight and Government Reform will hold a hearing on March 4, 2026, titled "Oversight of Fraud and Misuse of Federal Funds in Minnesota: Part II."
• The House Committee on Veterans' Affairs Subcommittee on Oversight and Investigations will hold a hearing on March 4, 2026, titled "Hidden Wounds: Effectively Supporting Veterans with TBI."
• The Senate Committee on Health, Education, Labor, and Pensions (HELP) will hold a hearing on March 5, 2026, titled "Transforming Health Care with Data: Improving Patient Outcomes Through Next-Generation Care." Assistant Secretary for Technology Policy and National Coordinator for Health Information Technology Thomas Keane will testify.
• The House Committee on Appropriations will hold a member day on March 5, 2026, for the Labor, Health and Human Services, Education, and Related Agencies (LHHS) appropriations bill. Member day allows committee and non-committee members to make statements in support of or in opposition to the inclusion of certain funding in the LHHS appropriations bill.
• The House Committee on Veterans' Affairs Subcommittee on Health Oversight will hold a hearing on March 5, 2026, titled "Delivering for Veterans and Caregivers: Year One of the Dole Act."

Federal Agencies

• The Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) will meet March 18-19, 2026.
• The Medicare Payment Advisory Commission (MedPAC) hosted its next monthly meeting on March 2-3, 2026. MedPAC will meet virtually to discuss Medicare ground ambulance data collection, access to certain healthcare services for Medicare beneficiaries with end stage renal disease (ESRD) and cancer, provider participation in Medicare Advantage (MA) networks, and other topics related to Medicare enrollment and Part B premium payment.

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.

SOTU Address Features Continued Focus on Healthcare, Prescription Drug Affordability

During his State of the Union (SOTU) address on February 24, 2026, President Donald Trump made healthcare and prescription drug affordability a central feature of his remarks. During the address, President Trump called on Congress to codify most-favored-nation (MFN) drug pricing agreements and highlighted the success of TrumpRx in connecting patients to discounted medications. He also continued to tout efforts to address the price of health insurance, highlighting a continued focus on shifting government funding away from healthcare tax credits toward individual consumers, however Congress has yet to coalesce around legislative text to do so. President Trump also referenced the administration's efforts on waste, fraud and abuse in federal healthcare programs. Notably, the address did not feature remarks on vaccines, reductions in staffing capacity at U.S. Department of Health and Human Services (HHS), implementation of Medicaid changes as a result of the One Big Beautiful Bill Act or an update on any potential discussions regarding a path forward on enhanced advanced premium tax credits (APTCs).

Personnel Updates

• In advance of the next ACIP meeting, HHS Secretary Robert F. Kennedy Jr. announced on February 27, 2026, two new appointees to the committee, including Dr. Sean G. Downing and Dr. Angelina Farella. Both focus on pediatrics as part of their practices, with Dr. Farella being a proponent of alternative, non-vaccine related treatments to COVID-19 in 2021.

Congressional Updates

Committee on Energy and Commerce Democratic Staff Releases Report on TrumpRx

In advance of the SOTU address, Democrats on the House Committee on Energy and Commerce released a report comparing the prices of prescription drugs available on TrumpRx to other discounted prices or generic alternatives. The report argues that drugs listed on the website have cheaper generic alternatives, are priced at a similar discount on other platforms or are priced at a higher amount on the website than other out-of-pocket costs listed. The report is a likely roadmap for future oversight and other efforts, and signals continued interest in additional details on the Trump Administration's' efforts on prescription drugs, should the House chamber flip as a result of the mid-term elections.

Surgeon General Nominee Faces Questions on Vaccines, Medicine in HELP Hearing

Casey Means appeared before the Senate HELP Committee on February 25, 2026, for her nomination hearing for U.S. Surgeon General. During the hearing, Means faced questions from both parties on whether children should receive certain vaccines, including COVID-19, influenza and hepatitis B. Questions were also asked about access to birth control medications and whether she would support the CDC's vaccine guidelines. A date to vote on whether to advance her nomination has not yet been scheduled, with some Republican members indicating they are not able to share whether they will support her nomination at this time.

Senate Aging Committee Highlights FDA Processes, Potential Areas for Improvement

The Senate Committee on Aging held a hearing on February 26, 2026, to discuss the U.S. Food and Drug Administration's (FDA) processes for approving new medicines, with a focus on treatments for rare diseases and conditions. Witnesses shared their experiences as clinicians and stories of interactions with the FDA on the review and approval of treatments for rare diseases. The hearing was held during Rare Disease Week and highlighted areas for improvement, particularly regarding approval pathways and flexibilities granted to the FDA by Congress, such as accelerated approval. Members and witnesses argued the processes in place today are not working as intended, with solutions for beginning clinical trials more quickly and different ways to measure endpoints discussed.

House Appropriations Committee to Allow Earmarks in LHHS Bill, Sets Deadlines

House Committee on Appropriations Chair Tom Cole (R-Okla.) released guidance on February 25, 2026, for fiscal year (FY) 2027 programmatic, language and Community Project Funding (CPF) requests. The announcement marks the official beginning of the FY 2027 appropriations process, with members allowed to begin submitting requests immediately. The deadline for members to submit appropriations requests is either March 13, 2026, or March 20, 2026, depending on the subcommittee, with requests for the Subcommittee on LHHS due March 20, 2026. Many member offices set their deadlines to receive requests from stakeholders for this week, if deadlines had not already passed.

Notably, this appropriations cycle, members are able to submit requests for CPF requests – also referred to as "earmarks" – as part of the LHHS bill, a change from prior years when funding requests were not allowed to be made to that subcommittee. The deadline for LHHS CPF submissions is March 20, 2026, at 6 p.m. ET, with individual member offices setting their own respective deadlines. Not every member accepts CPF requests for any subcommittee, let alone within LHHS. For LHHS, the only account accepting CPF requests is HHS-Health Resources and Services Administration (HRSA) and HRSA-Wide Activities and Program Support, with notable exceptions on the entities that are considered ineligible for funding.

Eligible recipients for Health Facilities Construction and Equipment CPF include:

• state, local and tribal governments
• nonprofit entities that are certified rural health clinics, Federally Qualified Health Centers, designated Critical Access Hospitals or hospitals located in areas that meet HRSA's definition of rural.

The following entities are not eligible for LHHS CPF funding:

• entities that 1) perform or promote abortions, including providing referrals, counseling, lobbying and training related to abortions, 2) furnish or develop any item intended to procure abortions or 3) provide financial support for such entities; exceptions described in Section 507(a) of Division B of the Consolidated Appropriations Act, 2026 (P.L. 119-75) shall apply
• entities that conduct research using embryonic stem cells (if such tissue is obtained pursuant to an induced abortion) or human germline gene modification
• entities that facilitate, promote access to or refer for psychological, behavioral or medical interventions performed for the purposes of intentionally changing the body of an individual (including by disrupting the body's development, inhibiting its natural functions or modifying its appearance) to no longer correspond to the individual's biological sex

The full guidance document is available online.

Senate HELP Committee Advances Healthcare Legislation

The Senate HELP Committee advanced several healthcare bills to the floor for consideration on February 26, 2026, including bills to establish protections for living organ donors and improve cybersecurity practices in healthcare systems. Both the Living Donor Protection Act and the Health Care Cybersecurity and Resiliency Act were approved by votes of 22-1 and now may receive a vote by the full Senate.

Regulatory Updates

CMS Issues RFI, Moratorium on Enrollment for DMEPOS

The Centers for Medicare & Medicaid Services (CMS) issued a request for information (RFI) on February 25, 2026, related to potential regulatory changes that may be included in a future proposed rule titled "Comprehensive Regulations to Uncover Suspicious Healthcare" (CRUSH). The RFI requests comments by March 29, 2026. Topics the CMS solicits comment on include:

• provider enrollment screening, suspending payment when there are credible allegations of fraud or indications of overpayment, automatic pre-payment claims edits
• potential requirements for U.S. citizenship or legal permanent residency for all individuals with ownership or control interest of greater than 5 percent in a Medicare-enrolled provider or supplier, and potential other solutions to address potential involvement of foreign actors in Medicare-related fraud
• reducing fraud related to laboratory tests such as genetic or molecular diagnostic tests
• potential changes to limit fraud within the Durable Medicare Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) program in MA
• addressing the potential for fraud within Medicare Parts A and B claims
• the efficiency, use and cost of AI in addressing MA coding oversight and hospital billing

In addition to the RFI, CMS issued a notice announcing a six-month moratorium on the Medicare enrollment of DMEPOS supplier medical companies. CMS based the need for the moratorium in part on an assessment of volume and trend data on 80 types of DMEPOS suppliers in the Medicare fee-for-service (FFS) program, which found that a large volume (85 percent) of DMEPOS supplier payments went to small DMEPOS suppliers from 2023 to 2025, among other data cited.

The temporary moratorium does not apply to changes in practice location (except if the location is changing from a location outside the moratorium area to a location inside the moratorium area), changes in provider or supplier information, such as phone number or address, or changes in ownership (except changes in ownership of home health agencies that would require an initial enrollment). A temporary moratorium also does not apply to any enrollment application that has been received by the Medicare contractor prior to the date the moratorium is imposed.

Beginning February 2026, the suppliers of seven types seeking to enroll will not be able to enroll, including:

• medical supply company
• medical supply company with orthotics personnel
• medical supply company with pedorthic personnel
• medical supply company with prosthetics personnel
• medical supply company with prosthetic and orthotic personnel
• medical supply company with registered pharmacist
• medical supply company with respiratory therapist

Each action was detailed by CMS Administrator Dr. Mehmet Oz as initial enforcement steps which extended to a $259 million deferral of Medicaid payments to Minnesota pending a corrective action plan, in addition to the DMEPOS moratoriumand the launch of the CRUSH initiative. During a Q&A session, Vice President J.D. Vance defended CMS' authority to defer Medicaid funds, arguing that aggressive enforcement is necessary to protect beneficiaries and the long‑term sustainability of federal health programs.

Pentagon Declares Major AI Company a Supply Chain Risk, Directs Federal Agencies to Halt Use of its Products

U.S. Department of War (DOW) Secretary Pete Hegseth issued an order on February 27, 2026, to bar the department and other federal agencies from using products provided by a major AI company, citing supply chain risks. The directive comes amid ongoing conversations and tensions among the federal government and certain AI and other technology companies. President Trump posted his direction that federal agencies stop using the technology that precipitated Secretary Hegseth's announcement. The impact of the directive is expected to be significant: The order prohibits any "contractor, supplier, or partner" from conducting commercial activity with the company in question, which could have a ripple effect across federal agencies, including those within HHS that operate in partnerships with other technology companies. The directive was spurred by the publishing of a strategy document by the DOW, which sought to support increased flexibility with the use of frontier models and reducing barriers to their use by federal employees and the military.

DOL Issues Proposed Rule on Independent Contractor Status

The U.S. Department of Labor (DOL) Wage and Hour Division (WHD) issued a long-awaited proposed rule on February 27, 2026, to rescind and replace a rule issued by the Biden Administration related to determining whether a worker is an employee or independent contractor. The proposed rule rescinds a 2024 final rule and replaces it with a new proposed rule that DOL believes provides a better capturing of certain economic factors as well as providing what DOL describes as more clear, predictable guidance to businesses. The public comment period closes on April 28, 2026.

FDA, HHS Release Draft Guidance on Plausible Mechanism Framework

The HHS and FDA released draft guidance on February 23, 2026, titled "Considerations for the use of the Plausible Mechanism Framework to Develop Individualized Therapies that Target Specific Genetic Conditions with Known Biological Cause; Draft Guidance for Industry; Availability." The draft guidance, available for public comment until April 27, 2026, outlines a new framework to accelerate the development and review of treatments for ultra-rare diseases that target specific genetic conditions. The draft guidance is intended to address the development of individualized therapies that target a specific genetic condition among a small group of patients where a controlled clinical trial is generally not feasible. The draft guidance does not define how many patients a rare disease or condition would need to have as part of its definition for ultra rare. The draft guidance does however discuss where data generated from individualized therapy development may be adequate to support approval under regulatory pathways that already exist, not limited to genome editing and RNA-based therapies.

FDA Solicits Comment on Scale-Up Guidance and Post-Approval Changes

The FDA published a notice on March 2, 2026, soliciting public comment and information to inform a series of guidance documents on scale-up and post-approval changes for specific dosage forms. The notice seeks comment and information on the following guidance, as well as responses on the continued utility of and suggestions for potential revisions:

• Immediate-Release Solid Oral Dosage Forms: Scale-Up and Post-Approval Changes: Chemistry, Manufacturing, and Controls, In Vitro Dissolution Testing, and In Vivo Bioequivalence Documentation (SUPAC-IR)
• SUPAC-IR Questions and Answers about SUPAC-IR Guidance (SUPAC-IR Q&A)
• Nonsterile Semisolid Dosage Forms Scale-Up and Post-Approval Changes: Chemistry, Manufacturing, and Controls; In Vitro Release Testing and In Vivo Bioequivalence Documentation (SUPAC-SS)
• SUPAC-MR: Modified Release Solid Oral Dosage Forms Scale-Up and Post-Approval Changes: Chemistry, Manufacturing, and Controls; In Vitro Dissolution Testing and In Vivo Bioequivalence Documentation (SUPAC-MR)
• SUPAC: Manufacturing Equipment Addendum (SUPAC-MEA)

HRSA Moves Forward on 340B Rebate Model Program

In light of litigation that concluded earlier this year, HRSA released two notices on February 25, 2026, related to its work on a 340B rebate model program. Notably, HRSA issued a notice that it would extend an RFI it had released to collect additional information to help inform its work on a new program. The new deadline for public comment is April 20, 2026. In addition, HRSA published a notice indicating it will submit an information collection request (ICR) to the Office of Management and Budget. Similar to the previous 340B rebate model program that was halted by the courts, HRSA notes it intends to limit the scope of the potential 340B Rebate Model Pilot Program to manufacturers with Medicare Drug Price Negotiation Program Agreements with CMS for the initial price applicability years (IPAY) 2026 and 2027.

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.