Holland & Knight Health Dose: March 17, 2026

Looking Ahead

Both the U.S. House of Representatives and the U.S. Senate are in session this week. The House delayed its return by one day due to severe weather across the Eastern portion of the country, which resulted in delayed and canceled flights. The Senate is expected to spend significant floor time considering the Safeguard American Voter Eligibility (SAVE) Act, which passed the House last year in a 220-208 vote and would require individuals to show proof of citizenship when registering to vote. Discussions continue on a path forward on funding for the U.S. Department of Homeland Security (DHS), which has yet to garner the requisite 60 votes in the Senate following another failed vote last week.

No major healthcare bills are currently slated for floor consideration in either chamber, keeping the focus on committee‑level work. The House Committee on Energy and Commerce will hold major healthcare hearings this week, with witnesses from across the hospital and healthcare provider spectrum testifying on affordability in healthcare. In addition, fiscal year (FY) 2027 funding discussions are ongoing, with appropriations requests due to committees in the coming days and a looming deadline of early summer to complete work on all 12 appropriations bills prior to the summer recess.

Upcoming Events

Congress

The House Committee on Appropriations will hold a full committee hearing on March 17, 2026, at 10:30 a.m. titled "Oversight Hearing – National Institutes of Health." Director of the National Institutes of Health and acting Director of the Centers for Disease Control and Prevention (CDC) Dr. Jay Bhattacharya will testify.

The House Energy and Commerce Committee's Subcommittee on Oversight and Investigations will hold a hearing on March 17, 2026, at 2 p.m. titled "Protecting Patients and Safeguarding Taxpayer Dollars: The Role of CMS in Combating Medicare and Medicaid Fraud."

The House Select Committee on China will hold a hearing on March 18, 2026, at 10 a.m. titled "From the Science Lab to the Medicine Cabinet: How China is Cornering the Market on Our Medicines."

The House Energy and Commerce Committee's Subcommittee on Health will hold a hearing on March 18, 2026, at 10:15 a.m. titled "Lowering Health Care Costs for All Americans: An Examination of the U.S. Provider Landscape."

The House Committee on Veterans' Affairs will hold a full committee markup on March 18, 2026, at 10:15 a.m., during which a multitude of bills to improve veterans' healthcare will be considered.

The House Committee on Ways and Means' Subcommittee on Health will hold a hearing on March 18, 2026, at 2 p.m. titled "Improving Kidney Health Through Better Prevention and Innovative Treatment."

Federal Agencies

The U.S. Food and Drug Administration (FDA) will hold a town hall on April 1, 2026, from 1 p.m. to 2 p.m. ET titled "FDA's Quality Management System Regulation (QMSR): Medical Device Risk-Based Inspections." The town hall will feature discussion on updates to the FDA's compliance program manual and processes that took effect on February 2, 2026.

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 Second-Term Executive Orders (2025-2026)" tracking chart.

Personnel Updates

Director of the FDA's Center for Biologics Evaluation and Research (CBER) Dr. Vinay Prasad will depart from the agency in April 2026. A replacement has not yet been identified.

Congressional Updates

MACPAC March 2026 Report to U.S. Congress

On March 12, 2026, the Medicaid and CHIP Payment and Access Commission (MACPAC) released its March 2026 Report to Congress on Medicaid and CHIP, with a primary recommendation to increase wage transparency for home and community based services (HCBS) workers. The report also examines behavioral health in Medicaid, the Medicaid Expansion Children's Health Insurance Program (M-CHIP), Medicaid's role for justice-involved youth and Medicaid coverage for children in foster care.

Chapter 1 focuses on the HCBS workforce and recommends that states be required to report hourly wages paid to HCBS workers so that payment rates can be more closely aligned with frontline compensation. Persistent workforce shortages continue to limit states' ability to meet long-term care needs in home and community settings, and MACPAC's proposal is intended to give states more reliable wage data, including cross-state comparisons, to inform rate setting and workforce strategies.

Chapter 2 addresses behavioral health in Medicaid and CHIP, highlighting Medicaid's central role in financing behavioral health services and the ongoing challenges in defining and tracking these services in claims data. Because behavioral health does not correspond to a single set of procedure codes, provider types or settings, national level analysis has been difficult. MACPAC presents analytic work on utilization and spending among M-CHIP enrollees with behavioral health conditions.

Chapter 3 examines Medicaid's emerging role for justice-involved youth, with an emphasis on transitions from incarceration back to the community. The chapter reviews the demographics and health needs of justice involved youth, outlines the federal Medicaid policy framework for eligible incarcerated individuals, and summarizes findings from interviews with selected states on implementation efforts and operational challenges in improving care transitions.

Chapter 4 looks at how Medicaid serves children and youth in the child welfare system, a relatively small but high need subset of the Medicaid population. MACPAC describes the health status and utilization patterns of children in foster care, reviews key federal requirements for child welfare and Medicaid state agencies, and offers considerations for states based on a review of seven states' approaches to providing and overseeing healthcare for children in foster care.

Democrats on Senate Finance Committee Send Letters to Pharmaceutical Manufacturers on MFN

On March 3, 2026, Senate Committee on Finance Ranking Member Ron Wyden (D-Ore.), along with Sens. Amy Klobuchar (D-Minn.), John Hickenlooper (D-Colo.), Elizabeth Warren (D-Mass.), Dick Durbin (D-Ill.), Jeff Merkley (D-Ore.) and Chris Murphy (D-Conn.), sent letters to 11 pharmaceutical manufacturers seeking additional information about drug pricing agreements reached with the Trump Administration. The letters request specific information on the price of the prescription drugs that will be impacted by the agreements, including the "most-favored nation" (MFN) price for the drugs and what state Medicaid programs may expect to pay for the drugs following the agreements. In addition, the letters seek information on how the GENErating cost Reductions fOr U.S. Medicaid (GENEROUS) model – a voluntary demonstration program – may impact drug prices.

Congressional Healthcare Leaders Send Letters to White House and CMS Requesting MFN Details, Opposing ACA Proposed Rule

In addition to the letter sent by Ranking Member Wyden to individual pharmaceutical manufacturers, congressional healthcare leaders – including House Energy and Commerce Committee Ranking Member Frank Pallone Jr. (D-N.J.), House Ways and Means Committee Ranking Member Richard Neal (D-Mass.), House Committee on Education and Workforce Ranking Member Robert C. "Bobby" Scott (D-Va.) and Senate Finance Committee Ranking Member Wyden – sent a letter to President Donald Trump to request information on the MFN agreements it has struck with pharmaceutical manufacturers. The letter requests "complete and unredacted copies of the most-favored-nation deals immediately," a request that the Trump Administration may not seek to fulfill without bipartisan pressure, setting the stage for additional activity in the months ahead and particularly in the next Congress, should the Democrats take control of one of the chambers.

In a letter dated March 11, 2026, the members also wrote to Centers for Medicare & Medicaid Services (CMS) Administrator Dr. Mehmet Oz sharing their strong opposition to policies included in a proposed rule titled "Patient Protection and Affordable Care Act (ACA), Benefit and Payment Parameters for 2027 and Basic Health Program." The members urge CMS to withdraw the proposals and instead work with Congress. The letter outlines concerns with the proposed rule, including exacerbation of coverage losses and cost increases related to the removal and nonrenewal of advanced premium tax credits (APTCs) for ACA plans, reducing providers available to consumers and increasing accessibility to catastrophic plans that do not provide the same protections and often have significantly higher deductibles.

FDA Under Scrutiny Over Rare Disease Rejections

Sen. Ron Johnson (R‑Wis.) has launched an investigation into recent FDA complete response letters (CRLs) for rare disease therapies, raising questions about the agency's approval decisions. Sen. Johnson, who is the chair of the Senate Permanent Subcommittee on Investigations, has requested multiple CRLs and signaled he may call senior FDA officials to testify. The inquiry follows heightened exchanges between the FDA and a gene therapy developer over the agency's request for an additional sham‑controlled trial of the company's one‑time, intracranially administered Huntington's disease gene therapy.

Regulatory Updates

All 15 Drug Manufacturers Selected for Third Cycle of Drug Price Negotiation Elect to Participate

CMS announced on March 13, 2026, that all 15 drug manufacturers selected for the third cycle of drug price negotiation have elected to participate, as well as the 16th drug manufacturer whose product was selected by CMS for renegotiation. CMS will send initial proposed maximum fair price (MFP) and justification for the proposed MFP to manufacturers no later than June 1, 2026, with engagements between CMS and the drug manufacturers, as well as public engagement events, to occur from now until that time. The negotiation period ends November 1, 2026.

CMS Announces Data Identification Is Live

CMS announced on March 11, 2026, during the Healthcare Information and Management Systems Society (HIMSS) Global Health Conference and Exhibition that enhanced digital identity verification is now live on Medicare.gov. CMS is offering beneficiaries the option to verify their identity using CLEAR, ID.me or Login.gov, allowing individuals to choose the credential they prefer to securely access and manage their personal health information online. The update is intended to strengthen account security and expand consumer choice and access as CMS continues to modernize Medicare.gov's digital infrastructure.

CMS Announces MVPs for CMS Health Tech Ecosystem

CMS announced the MIPS Value Pathway (MVP) for each pledge category under the CMS Health Tech Ecosystem. Alongside the MVP designations, CMS broke down more specific requirements for patient-facing apps, participant type and CMS infrastructure of the Medicare app library and National Provider Directory. CMS continues to position the voluntary framework as an effort to improve patient access to data, reduce administrative burden and support more seamless data exchange across networks, providers, payers and patient‑facing technologies.

CMS Seeks MAHA Model Applicants

The CMS Innovation Center announced on March 13, 2026, that applications are now open for its new Make America Healthy Again: Enhancing Lifestyle and Evaluating Value-based Approaches Through Evidence (MAHA ELEVATE) model, a voluntary initiative designed to test evidence‑based, whole‑person functional or lifestyle medicine interventions within Original Medicare. CMS is seeking applicants that can demonstrate a track record of delivering functional or lifestyle medicine services, support their proposed interventions with research evidence and show the potential to improve outcomes while generating cost savings. The model will evaluate approaches that emphasize prevention and behavior‑based care, with findings intended to inform future CMS policy and coverage considerations related to whole‑person care. Applicants must submit a mandatory letter of intent by April 10, 2026, with the model set to launch in October 2026.

EPA Issues Proposed Rule, Reconsideration of EtO Rule

The U.S. Environmental Protection Agency (EPA) announced on March 12, 2025, that it was reconsidering a 2024 rule finalized by the previous administration related to Commercial Sterilization Facilities. Ethylene oxide (EtO) is a gas that is used to sterilize a significant portion of medical devices and other medical equipment annually in the U.S. The rule had previously been subject of scrutiny in the courts as well as pushback from some in the medical device industry. As part of the reconsideration process, the EPA has proposed a repeal of the policy and will complete a review of the statutory authority for the rule. The EPA will accept comments for 45 days and intends to hold a virtual public hearing.

FDA Issues New Draft and Final Guidance Documents

The FDA recently released several draft and final guidance documents, including:

• March 9, 2026. Draft guidance document, titled "New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 4) Guidance for Industry," answers questions commonly raised by prospective applicants and others submitting 351(k) biosimilar applications for approval. The draft guidance replaces previous guidance from September 2021 titled "New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 3)" and lays out the FDA's thinking on the use of certain data to support demonstrations that a proposed product is biosimilar to a reference product, such as clinical data from outside the U.S. without additional data derived from clinical pharmacokinetics (PK) testing. The FDA also seeks to streamline requirements related to PK testing to support the submission of 351(k) applications by removing a requirement that at least one PK study be completed to directly compare a proposed biosimilar with the U.S.-licensed reference product.
• March 9, 2026. Final guidance document, titled "Questions and Answers on Biosimilar Development and the BPCI Act" includes a variety of answers to common questions related to 351(k) submissions. FDA Commissioner Martin Makary extrapolated in a scientific journal article published in tandem with the publication of the two guidance documents above on the need for action on biosimilars, writing that the efforts "will eliminate recommendations for unnecessary clinical trials when analytical and pharmacokinetic data can sufficiently demonstrate biosimilarity, help encourage pharmacy-level substitution as appropriate to mirror the successful generic drug model, and provide clearer guidance to expedite development and accelerate market entry."
• March 9, 2026. Draft guidance titled "Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection" is open for public comment until May 8, 2026. The draft guidance is intended to support entities who choose to respond to the FDA when they receive a Form 483 at the conclusion of an inspection.
• March 11, 2026. Draft guidance titled "Flavored Electronic Nicotine Delivery Systems (ENDS) Premarket Applications – Considerations Related to Youth Risk" is intended to assist applicants submitting premarket tobacco product applications (PMTAs) for electronic nicotine delivery systems (ENDS) products. The draft guidance outlines the FDA's thinking on how it may consider scientific evidence regarding differential youth appeal and initiation risks across flavor categories and how the FDA may separate relevance to adult populations who may benefit from nontobacco flavors.
• March 12, 2026. Final guidance titled "Medical Devices with Indications Associated with Weight Loss – Premarket Considerations" provides recommendations on nonclinical testing and clinical study design for medical devices indicated for use associated with weight loss. The guidance document is intended to support pre-market submissions.

FDA Holds Meetings with States on Drug Importation Programs

The FDA on March 3, 2026, held meetings with and gave a presentation to state representatives on drug importation programs under Section 804 of the Federal Food, Drug, and Cosmetic Act. As part of an EO issued on April 15, 2025, titled "Lowering Drug Prices by Once Again Putting Americans First," President Trump directed the FDA to "take steps to streamline and improve" the drug importation program under Section 804. The meetings were the next step for the Trump Administration to make prescription drugs more affordable by allowing them to be imported from other countries. To date, Florida is the only state to have its program authorized, allowing it to import prescription drugs from Canada; however, no shipments have been made due to requirements Florida must meet prior to receiving the medicines. During the meetings, FDA representatives shared with attendees how states and state representatives may request various meetings with the FDA on Section 804 Importation Program (SIP) submissions and detailed what an SIP submission should include.

FDA Issues RFI on At-Home Opioid Disposal

The FDA on March 6, 2026, issued a request for information (RFI) on specifications or requirements it should consider for at-home disposal systems for opioid medications. The FDA is considering whether to modify the Opioid Analgesic (OA) Risk Evaluation and Mitigation Strategy (REMS) to require that patients prescribed opioid medications for outpatient use receive the prescription medication along with safe disposal packaging or a safe disposal system. The SUPPORT Act Reauthorization of 2025 directed the U.S. Department of Health and Human Services (HHS) secretary, in consultation with the Drug Enforcement Administration (DEA), to publish guidance to facilitate the use of in-home safe disposal systems for certain drugs. Public comments will be accepted through April 6, 2026.

FDA Launches Consolidated Platform for Adverse Events

The FDA on March 11, 2026, announced the launch of FDA Adverse Event Monitoring System (AEMS), a unified platform that consolidates previous adverse event reporting systems into one streamlined dashboard. Using the new AEMS, adverse events reported to the FDA related to drugs, biologics, vaccines, cosmetics and animal foods will be displayed on the dashboard, and all other product centers will begin processing reports in AEMS. The FDA aims to have AEMS contain real-time adverse event reports by the end of May 2026, which will include migrated legacy report systems into the new, unified system. The FDA believes the new systems will reduce costs associated with maintaining the previous adverse event reporting systems and reduce time spent by agency staff in reviewing and responding to Freedom of Information Act (FOIA) requests, given information will be more easily accessible to the public.

Existing systems to be replaced by AEMS includes the FDA Adverse Event Reporting System (FAERS), Vaccine Adverse Event Reporting System (VAERS) – with the caveat that because VAERS is comanaged by the FDA and the CDC, the data will only be displayed – and Adverse Event Reporting System (AERS). In May 2026, AEMS will also replace the Manufacturer and User Facility Device Experience (MAUDE), Human Foods Complaint System (HFCS) and Center for Tobacco Products' Adverse Event Reporting System (CTPAE).

USTR Announces Initiation of Section 301 Investigations into Various Economies Related to Manufacturing Sectors, Forced Labor

U.S. Trade Representative (USTR) Jamieson Greer announced on March 11, 2026, the initiation of investigations under Section 301(b) of the Trade Act of 1974 related to "structural excess capacity and production in manufacturing sectors." The announcement includes 16 economies that will be subject to the investigations: China, the European Union, Singapore, Switzerland, Norway, Indonesia, Malaysia, Cambodia, Thailand, Korea, Vietnam, Taiwan, Bangladesh, Mexico, Japan and India. As part of the investigation, the USTR has requested consultations with governments of the 16 economies. The investigations may result in tariffs in addition to those that have been levied under Section 232 national security investigations as a result of the U.S. Supreme Court's decision, which struck President Trump's use of emergency tariffs. Public comments will be accepted on the investigations starting March 17, 2026, and comments or requests to appear at a public hearing should be submitted by April 15, 2026. There will be a hearing held in connection to the investigations starting May 5, 2026.

The USTR also announced a second set of investigations into more than 60 economies related to the failure to impose and effectively enforce a prohibition on the importation of goods produced with forced labor. Written comments are due April 15, 2026, in advance of a public hearing that will be held beginning April 28, 2026, until May 1, 2026, as needed.

It is possible additional investigations will be announced, as well as the potential for the release of long-awaited additional action on pharmaceutical products.

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.