Holland & Knight Health Dose: March 10, 2026

Looking Ahead

The U.S. Senate will be the only chamber in session this week, as the U.S. House of Representatives adjourns for a district work period. Senate floor activity is expected to remain focused on resolving the ongoing impasse over funding for the U.S. Department of Homeland Security (DHS) following multiple failed attempts to advance the House‑passed appropriations measure. Negotiations are expected to continue as Senate leadership works to secure sufficient support to move the bill forward. Fiscal year (FY) 2027 appropriations deadlines continue to remain a focus for offices, with hearings and markups expected in the coming weeks.

No major healthcare legislation is currently scheduled for Senate floor consideration; healthcare policy activity is expected to remain concentrated at the committee level. Last week, the Senate Committee on Health, Education, Labor, and Pensions (HELP) held a full committee hearing titled "Transforming Health Care with Data: Improving Patient Outcomes Through Next‑Generation Care." The hearing examined the federal government's role in health information technology, including the use of health data, interoperability, cybersecurity and the emerging role of artificial intelligence (AI) in care delivery and administrative processes. Testimony was provided by Dr. Thomas Keane, MD, MBA, the Assistant Secretary for Technology Policy and National Coordinator for Health Information Technology at the U.S. Department of Health and Human Services (HHS), with members raising questions related to data sharing, prior authorization, system security and responsible adoption of advanced technologies in the healthcare system.

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.

Congressional Updates

Sens. Wyden and Grassley Send Letter to OPTN

Sens. Ron Wyden (D‑Ore.) and Chuck Grassley (R‑Iowa) sent a bipartisan letter to the Organ Procurement and Transplantation Network (OPTN) following reporting that raised questions about record‑keeping practices and patient safety transparency. The inquiry adds pressure on Health Resources and Services Administration (HRSA) as it works to implement congressionally mandated OPTN modernization reforms and reflects lawmakers' continued concern that governance and accountability gaps persist in the nation's organ transplant system. The national private-public organization that handles transplantation and organ donation  responded to the allegations and asserted that no files or data required by its contract with HRSA to serve the OPTN are missing.

Republican Leaders of House E&C Committee Expand Medicaid Fraud Investigation

House Committee on Energy and Commerce (E&C) Chair Brett Guthrie (R-Ky.), Subcommittee on Health Chair Morgan Griffith (R-Va.) and Subcommittee on Oversight and Investigations Chair John Joyce, MD (R-Penn.) have expanded their investigation into alleged fraud within the Medicaid program. The Republican lawmakers sent letters to the governors and leaders of state health agencies in 10 states on March 3, 2026 – including New York, California, Colorado, Massachusetts, Maine, Nebraska, Oregon, Pennsylvania, Vermont and Washington – with responses due by March 17, 2026. It remains to be seen whether states will be able to fully respond by that date and what steps the committee may take next. Health Subcommittee Ranking Member Diana DeGette (D-Colo.) issued a statement condemning the letters as a partisan exercise, noting that they overwhelmingly targeted Democratic states, with Nebraska as the sole exception.

Latest Congressional Retirements and Departures

Several members of Congress have recently announced plans to leave their seats, adding to what is shaping up to be an unusually high level of turnover ahead of the November 2026 elections. Among those stepping down is Rep. Ryan Zinke (R-Mont.), a former Navy SEAL who previously served as U.S. Department of the Interior Secretary during President Donald Trump’s first administration. Rep. Zinke currently sits on the House Committee on Appropriations.

Additional House Republicans have confirmed plans to leave Congress at the end of their terms. Rep. Burgess Owens (R-Utah), a member of the House Committee on Education and the Workforce, will not seek reelection. Rep. Darrell Issa (R-Calif.), who serves on the House Committee on the Judiciary and Committee on Science, Space, and Technology, has likewise indicated he will step down. Meanwhile, Rep. Dan Crenshaw (R-Texas), a member of the House E&C Committee, was defeated in a primary challenge in Texas' Second Congressional District earlier this week.

In the Senate, Steve Daines (R-Mont.) has announced he will retire. First elected in 2014, Daines serves on the Senate Finance Committee.

Separately, President Trump has tapped Sen. Markwayne Mullin (R-Okla.) to replace Kristi Noem as DHS Secretary at the end of the month. Mullin currently serves on the Senate HELP Committee, as well as the Committee on Appropriations Labor, Health and Human Services, Education, and Related Agencies Subcommittee and the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Subcommittee.

Overall, congressional turnover this cycle is approaching record levels, with nearly 60 House members and 10 senators planning to retire or otherwise leave their seats.

Regulatory Updates

Trump Administration and Medical Education Leaders Announce Nutrition Training Initiative

HHS Secretary Robert F. Kennedy Jr. and U.S. Department of Education Secretary Linda McMahon joined leaders from several physician and academic medicine organizations to announce a new initiative aimed at expanding nutrition education in medical training beginning with the next academic year. The effort includes commitments from 53 medical schools across 31 states to require at least 40 hours of nutrition education (or an equivalent competency) prior to graduation starting in fall 2026. Secretary Kennedy emphasized that the framework, which outlines 71 evidence‑based competencies across 10 domains, is intended as voluntary guidance rather than a federal mandate. HHS also announced a $5 million National Institutes of Health (NIH) challenge to support curriculum development and signaled the initiative could extend to residency programs, nursing and dietitian training, as well as continuing education for more than 5,000 U.S. Public Health Service Commissioned Corps officers. Secretary McMahon highlighted the link between diet‑related chronic disease, rising childhood obesity and long‑term health outcomes, and medical education leaders framed the announcement as a step toward strengthening prevention‑focused care and integrating nutrition more fully into medical education. Secretary Kennedy tied the initiative to the Trump Administration's broader Make America Healthy Again (MAHA) agenda, citing complementary efforts focused on physical activity, nutrition literacy and public health education.

OPM Issues Proposed Rule Revising Federal RIF Process

The U.S. Office of Personnel Management (OPM) issued a proposed rule this week to revise the federal Reduction in Force (RIF) process. The proposal follows a series of RIFs conducted across federal agencies – including the U.S. Department of Health and Human Services (HHS) – and subsequent litigation challenging those workforce reductions last year. Under the proposal, agencies would place greater emphasis on employee performance rather than tenure when determining which employees are retained during a RIF. Public comments on the proposed rule are due May 4, 2026. This proposal builds on a separate OPM rulemaking issued in February 2026, which would centralize appeals of RIF decisions within OPM rather than the Merit Systems Protection Board (MSPB). Comments on that proposal are due March 12, 2026.

MACPAC and MedPAC March Meetings 

The Medicaid and CHIP Payment and Access Commission (MACPAC) meeting included discussion of draft policy options and recommendations related to prior authorization automation, youth access to residential treatment, managed care state and federal accountability tools, and the transition of care for children with special health care needs to adult coverage. The Medicare Payment Advisory Commission (MedPAC) meetings included discussion of a draft recommendation on the Medicare ground ambulance data collection system, as well as broader discussions on Medicare beneficiary enrollment, Medicare Advantage provider networks and risk adjustment, and access to hospice care.

CMS Extends GENEROUS Application Deadline

The Centers for Medicare & Medicaid Services (CMS) announced on March 2, 2026, it would extend the deadline for manufacturers to apply to the GENErating cost Reductions fOr U.S. Medicaid (GENEROUS) Model to April 30, 2026. The GENEROUS Model aims to align drug prices in Medicaid with those set through CMS Drug Price Negotiations. States still have until July 31, 2026, to apply. The previous deadline was March 31, 2026. CMS will begin scheduling meetings with interested manufacturers to discuss potential participation beginning April 1, 2026, and those interested in scheduling a meeting should send an email to generousmodel@cms.hhs.gov. CMS will also host a manufacturer town hall in Spring 2026 to discuss the model.

New FDA Guidance on Clinical Investigational Exclusivity

The U.S. Food and Drug Administration (FDA) released draft guidance on March 4, 2026, titled "New Clinical Investigation Exclusivity (3-Year Exclusivity) for Drug Products: Questions and Answers; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request." The guidance is intended to assist applicants requesting New Clinical Investigation exclusivity, which is three years for new drug applications (NDAs).

FDA Issues Final Rule on NDCs, Effective March 2033

The FDA issued a final rule on March 4, 2026, titled "Revising the National Drug Code Format and Drug Label Barcode Requirements." The final rule – set to take effect March 7, 2033 – will standardize the format of National Drug Codes (NDCs), with NDCs continuing to consist of three segments: labeler code, product code and package code. However, the labeler code will be six digits, the product code will be four digits, and the package code will be two digits. The FDA will begin assigning new NDCs in the uniform, 12-digit format and existing 10-digit format assigned prior to the effective date will be required to convert to the new 12-digit format. The effective date of the final rule is 2033 to ensure parties that use FDA-assigned NDCs have runway time to handle the new uniform 12-digit format. The rule also allows for a three-year transition period following the March 2033 effective date, and during the transition, the FDA does not intend to object to continued use of 10-digit NDCs on products that remain in interstate commerce.

HHS OIG Issues Report on Improper Payments as Federal Scrutiny Amps Up

The HHS Office of the Inspector General (OIG) released a report on February 2, 2026, on its findings following a review of state Medicaid fee-for-service payments for certain behavioral treatments provided to children. The report indicates that the state of Colorado made $77.8 million in improper payments for applied behavioral analysis and made five recommendations, some of which the state concurred with, including to refund to the federal government the federal share of payments that didn't comply with federal and state requirements, provide additional guidance to certain facilities, complete periodic post-payment reviews and prior authorization procedures. The issuance of this report indicates the HHS OIG is expected to continue its focus on potential waste, fraud and abuse particularly for states, highlighted by the recent move to withhold Medicaid payments to Minnesota, as well as the potential for investigations into other states' practices such as New York.

CMS Medicare Beneficiary Consumer App Library

CMS has rolled out a Medicare beneficiary consumer app library featuring third‑party digital tools that allow beneficiaries to view and use their Medicare data. The library is intended as a resource for consumers exploring health apps, rather than an endorsement or direct CMS product, and places responsibility for functionality, privacy and usability with app developers. While the launch highlights growing availability of Medicare data through digital tools, questions remain about beneficiary awareness, adoption and oversight of how these apps are used in practice.

Holland & Knight Launches CMS Payment Model Navigator

Holland & Knight recently launched a new CMS Payment Model webpage designed to help stakeholders track and assess newly announced and implemented payment models from CMS. The interactive hub allows users to filter models by stakeholder type, model status (announced vs. implemented) and participation structure, including mandatory and voluntary programs. Each model page provides high‑level context and key considerations, with the Firm offering additional insights, predictions and recommendations for providers, life sciences companies, health technology developers and other impacted stakeholders navigating CMS' rapidly expanding portfolio of payment reforms.

Watch For: CMS' Proposed State Directed Payment Rule Under Review At OMB

CMS sent its proposed rule on February 27, 2026, on Medicaid state‑directed payments to Office of Management and Budget (OMB) for review. The rule is expected to formalize statutory Self Determination Program (SDP) payment caps and potentially expand the SDP cap list.

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.