Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and analyses; and other health policy news.
Highlight of the Week
This week, the Trump Administration issued an EO establishing a Task Force to Eliminate Fraud, and the House Energy & Commerce Committee held hearings on Medicare and Medicaid fraud and the role of providers in health care affordability.
Regulations, Notices & Guidance
- On March 16, 2026, the Centers for Disease Control and Prevention (CDC) released a notice entitled, Solicitation of Nominations for Appointment to the Advisory Committee on Breast Cancer in Young Women. CDC is seeking nominations for membership on the Advisory Committee on Breast Cancer in Young Women (ACBCYW). ACBCYW consists of 15 experts in fields associated with breast cancer, disease prevention, early detection, diagnosis, public health, social marketing, genetic screening and counseling, treatment, rehabilitation, palliative care, and survivorship in young women, or in related disciplines with a specific focus on young women.
- On March 17, 2026, the Food and Drug Administration (FDA) released guidance entitled, Physicochemical and Structural (Q3) Characterization of Topical Drug Products Submitted in ANDAs. This guidance is intended to assist applicants who submit abbreviated new drug applications (ANDAs) for liquid-based or other semisolid products applied to the skin, including integumentary and mucosal membranes. This guidance provides recommendations for physicochemical and structural characterizations that can be used to identify the dosage form of a proposed generic topical product, and to describe properties of the drug product that may be critical to its performance to support a demonstration of bioequivalence (BE). This guidance finalizes the draft guidance of the same title issued on October 21, 2022.
- On March 17, 2026, FDA released a proposed amendment entitled, Effective Date of Requirement for Premarket Approval Applications for Blood Irradiators Intended to Prevent Metastasis. FDA is proposing to require the filing of a premarket approval application (PMA) for blood irradiators intended to irradiate intraoperatively salvaged blood for cancer patients undergoing surgery to assist in prevention of metastasis, which are unclassified, preamendments devices. FDA is summarizing its proposed findings regarding the degree of risk of illness or injury designed to be eliminated or reduced by requiring the devices to meet PMA requirements of the Federal Food, Drug, and Cosmetic (FD&C) Act and the benefits to the public from use of the devices.
- On March 17, 2026, FDA released a proposed rule entitled, Medical Devices; Radiology Devices; Classification of Blood Irradiators. FDA is proposing to classify blood irradiator devices, unclassified preamendments devices, as follows: blood irradiator devices intended to prevent transfusion-associated graft-versus-host disease into class II with premarket notification and blood irradiator devices intended to prevent metastasis into class III to provide a reasonable assurance of safety and effectiveness of these devices.
- On March 17, 2026, FDA released a notice entitled, Advisory Committee; Obstetrics, Reproductive and Urologic Drugs Advisory Committee; Renewal. FDA is announcing the renewal of the Obstetrics, Reproductive and Urologic Drugs Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Obstetrics, Reproductive and Urologic Drugs Advisory Committee for an additional two years beyond the charter expiration date. The new charter will be in effect until the March 23, 2028, expiration date.
- On March 17, 2026, FDA released a notice entitled, Over-the-Counter Monograph Drug Facility Fee Rates for Fiscal Year 2026. The FD&C Act, as amended by the Over-the-Counter Monograph Drug User Fee Amendments (OMUFA II), authorizes FDA to assess and collect user fees from qualifying manufacturers of over-the-counter (OTC) monograph drugs and submitters of OTC monograph order requests (OMORs) for fiscal years (FY) 2026 through 2030. This notice publishes the OTC monograph drug facility (MDF) fee rates for FY 2026.
- On March 17, 2026, FDA released a notice entitled, Preparation for International Cooperation on Cosmetics Regulation Twentieth Annual Meeting (ICCR-20); Request for Comments. FDA is soliciting comments from the public on various topics pertaining to the regulation of cosmetics in preparation for the twentieth International Cooperation on Cosmetics Regulation annual meeting (ICCR-20). FDA may use this input to prepare for the ICCR-20 meeting that will be held July 7 to 9, 2026, in Tokyo, Japan.
- On March 17, 2026, FDA released a notice entitled, Labeling and Preventing Cross-Contact of Gluten for Packaged Foods; Request for Information; Extension of Comment Period. FDA is extending the comment period for the notice that appeared in the Federal Register on January 22, 2026. In the notice, FDA requested data and information on the issues raised in and specific questions related to a citizen petition from Celiac Journey related to labeling and preventing cross-contact of gluten for packaged foods. FDA is taking this action in response to a request for an extension to allow interested persons additional time to submit comments.
- On March 18, 2026, FDA released guidance entitled, Pyrogen and Endotoxins Testing: Questions and Answers. This guidance provides recommendations for biological product, drug, and device firms on FDA’s current thinking concerning the testing recommendations and acceptance criteria in the U.S. Pharmacopeia (USP) Chapter 85, Bacterial Endotoxins Test, Chapter 161, Medical Devices ‒ Bacterial Endotoxin and Pyrogen Tests, and the Association for the Advancement of Medical Instrumentation (AAMI) ST72:2002/R2010, Bacterial Endotoxins—Test Methodologies, Routine Monitoring, and Alternatives to Batch Testing (AAMI ST72). These three documents describe the fundamental principles of the gel clot, photometric, and kinetic test methods, and recommend that appropriate components and finished products be tested for the presence of pyrogens and endotoxins.
- On March 18, 2026, FDA released draft guidance entitled, General Considerations for the Use of New Approach Methodologies in Drug Development. The purpose of this draft guidance is to provide drug developers with a validation framework and general recommendations for using new approach methodologies (NAMs) in drug development. Although animal toxicity studies have proved to be a critical method to identify potential risks to human health, finding ways to improve human relevance while reducing the use of animals by developing reliable NAMs furthers an important Center for Drug Evaluation and Research (CDER) priority to move away from reliance on animal testing. The recommendations in this draft guidance are intended to highlight scientific principles of study design and reporting that can be applied broadly and flexibly in the validation of NAMs used in drug development. This draft guidance is not intended to address specific NAMs and does not address the use of NAMs in drug discovery. Rather, it encourages the use of NAMs in regulatory submissions, especially when they improve the predictivity of nonclinical studies for increased safety in clinical trials.
- On March 18, 2026, CDC released a notice entitled, World Trade Center (WTC) Health Program; Petition 026—Anti-Glomerular Basement Membrane (Anti-GBM) Glomerulonephritis; Finding of Insufficient Evidence. The Administrator of the World Trade Center (WTC) Health Program (the Administrator) received a petition to add Anti-Glomerular Basement Membrane (GBM) Disease Glomerulonephritis (Anti-Glomerular Basement Membrane Disease) to the List of WTC-Related Health Conditions. Upon reviewing the scientific and medical literature, including information provided by the petitioner, the Administrator has determined that there is insufficient evidence available to support taking further action at this time regarding anti-GBM glomerulonephritis. The Administrator also finds that insufficient evidence exists to request a recommendation of the WTC Health Program Scientific/Technical Advisory Committee, publish a proposed rule, or publish a determination not to publish a proposed rule.
- On March 19, 2026, the Administration for Children and Families (ACF) released a notice entitled, Notice for Public Comment on Administration for Native Americans’ Program Policies and Procedures. The Administration for Native Americans (ANA) is required to provide members of the public an opportunity to comment on proposed changes in interpretive rules and general statements of policy and to give notice of the proposed changes no less than 30 days before such changes become effective. ANA herein describes proposed interpretive rules and general statements of policy that relate to ANA’s Notices of Funding Opportunities (NOFOs) in FY 2026.
- On March 20, 2026, CDC released a notice entitled, National Committee on Vital Health and Statistics (NCVHS); Notice of Charter Renewal. CDC is providing notice of the renewal of the charter of National Committee on Vital Health and Statistics (NCVHS). This charter has been renewed for a two-year period through January 22, 2028.
- On March 20, 2026, the Department of Health and Human Services (HHS) released a final rule entitled, Administrative Simplification; Adoption of Standards for Health Care Claims Attachments Transactions and Electronic Signatures. The final rule implements requirements of the Administrative Simplification subtitle of the Health Insurance Portability and Accountability Act of 1996 (HIPAA), and the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010, enacted on March 30, 2010, collectively, the Affordable Care Act (ACA). Specifically, this final rule adopts standards for health care claims attachments transactions, which will support health care claims transactions, and a standard for electronic signatures to be used in conjunction with health care claims attachments transactions.
Event Notices
Please note that two asterisks (**) preceding the item indicate a new event.
- March 23, 2026: The Department of Veterans’ Affairs (VA) announced a meeting of the Veterans’ Rural Health Advisory Committee. This is a virtual meeting open to the public.
- March 24, 2026: VA announced a meeting of its National Research Advisory Council. This is a hybrid meeting open to the public.
- March 25, 2026: The National Institutes of Health (NIH) announced a meeting of the National Heart, Lung, and Blood Advisory Council. This is a hybrid meeting with some sessions open to the public.
- March 30-31, 2026: NIH announced a meeting of the National Institute on Aging. This is a hybrid meeting with some sessions open to the public.
- April 6, 2026: NIH announced a meeting of the National Advisory Allergy and Infectious Diseases Council. This is a virtual meeting with some sessions open to the public.
- April 7, 2026: NIH announced a meeting of the Advisory Committee on Research on Women’s Health. This is a hybrid meeting open to the public.
- April 9-10, 2026: NIH announced a meeting of the Sleep Disorders Research Advisory Board. This is a hybrid meeting open to the public.
- April 12, 2026: NIH announced a meeting of the Office of AIDS Research Advisory Council. This is a hybrid meeting open to the public.
- April 17, 2026: NIH announced a meeting of the National Center for Complementary & Integrative Health. This is a hybrid meeting with some sessions open to the public.
- April 23, 2026: NIH announced a meeting of the National Library of Medicine Board of Scientific Counselors. This is a hybrid meeting with some sessions open to the public.
- April 30, 2026: FDA announced a meeting of the Oncologic Drugs Advisory Committee. This is a hybrid meeting open to the public.
- May 4-5, 2026: NIH announced a meeting of the Eunice Kennedy Shriver National Institute of Child Health & Human Development. This is a hybrid meeting open to the public.
- May 5, 2026: NIH announced a meeting of the National Advisory Council on Alcohol Abuse and Alcoholism. This is a hybrid meeting with some sessions open to the public.
- May 7, 2026: The Assistant Secretary for Technology Policy (ASTP) announced a meeting of the Health Information Technology Advisory Committee. This is a hybrid meeting open to the public.
- May 12, 2026: NIH announced a meeting of the Board of Regents of the National Library of Medicine. This is a virtual meeting with some sessions open to the public.
- May 13, 2026: NIH announced a meeting of the National Institute on Aging. This is an in-person meeting with some sessions open to the public.
- May 13, 2026: NIH announced a meeting of the National Diabetes and Digestive and Kidney Diseases Advisory Council. This is a hybrid meeting with some sessions open to the public.
- **May 18-19, 2026: NIH announced a meeting of the National Advisory Council for Human Genome Research. This is a hybrid meeting with some sessions open to the public.
- May 19, 2026: NIH announced a meeting of the National Advisory Council for Nursing Research. This is a hybrid meeting open to the public.
- May 19, 2026: NIH announced a meeting of the Interagency Autism Coordinating Committee. This is a hybrid meeting open to the public.
- **May 21, 2026: NIH announced a meeting of the National Advisory General Medical Sciences Council. This is a virtual meeting open to the public.
- June 1-2, 2026: NIH announced a meeting of the Fogarty International Center Advisory Board. This is a hybrid meeting with some sessions open to the public.
- June 2, 2026: NIH announced a meeting of the National Arthritis and Musculoskeletal and Skin Diseases Advisory Council. This is a hybrid meeting with some sessions open to the public.
- June 5, 2026: NIH announced a meeting of the Eunice Kennedy Shriver National Institute of Child Health & Human Development. This is a hybrid meeting with some sessions open to the public.
- June 8-9, 2026: FDA announced a public workshop entitled, Fiscal Year 2026 Generic Drug Science and Research Initiatives Workshop. This is a hybrid meeting open to the public.
- **June 10-11, 2026: NIH announced a meeting of the National Institute of Diabetes and Digestive and Kidney Diseases. This is a hybrid meeting with some sessions open to the public.
- **June 12, 2026: FDA announced a public hearing related to the Commissioner’s National Priority Voucher (CNPV) Pilot Program. This is a hybrid meeting open to the public.
- **June 15, 2026: NIH announced a meeting of the National Institute of Environmental Health Sciences Board of Scientific Counselors. This is a hybrid meeting with some sessions open to the public.
- June 15-16, 2026: HHS announced a meeting of the Physician-Focused Payment Model Technical Advisory Committee (PTAC). This is a hybrid meeting open to the public.
- June 29, 2026: NIH announced a meeting of the National Cancer Advisory Board. This is a hybrid meeting with some sessions open to the public.
- July 8, 2026: NIH announced a meeting of the National Advisory Child Health and Human Development Council. This is a hybrid meeting with some sessions open to the public.
- September 10-11, 2026: NIH announced a meeting of the Fogarty International Center Advisory Board. This is a hybrid meeting with some sessions open to the public.
- September 14-15, 2026: HHS announced a meeting of PTAC. This is a hybrid meeting open to the public.
- September 15-16, 2026: NIH announced a meeting of the National Advisory Council on Aging. This is a hybrid meeting with some sessions open to the public.
- September 24, 2026: ASTP announced a meeting of the Health Information Technology Advisory Committee. This is a virtual meeting open to the public.
- November 5, 2026: ASTP announced a meeting of the Health Information Technology Advisory Committee. This is a virtual meeting open to the public.
- **December 7-8, 2026: NIH announced a meeting of the Eunice Kennedy Shriver National Institute of Child Health & Human Development. This is a hybrid meeting open to the public.
- December 8-9, 2026: HHS announced a meeting of PTAC. This is a hybrid meeting open to the public.
Reports, Studies & Analyses
- On March 19, 2026, the HHS Office of Inspector General (OIG) released a report entitled, Nursing Homes’ Inappropriate Use of Antipsychotic Drugs Poses a Risk to Residents. The report summarizes a review of 40 nursing home inspections conducted by the Centers for Medicare & Medicaid Services (CMS) and identifies alarming instances of inappropriate antipsychotic drug use. For example, some nursing homes administered antipsychotic drugs to residents with dementia to manage behavior for the benefit of staff, despite FDA warnings that these drugs may increase the risk of death. The review also found that nursing homes failed to take required steps to protect residents receiving these medications, and that medical directors did not adequately prevent inappropriate antipsychotic use. In addition, nursing home pharmacists failed to identify medical concerns or recommend dose reductions, and inadequate nursing home policies and procedures undermined safeguards intended to protect residents. The inspections revealed vulnerabilities in care with implications for the broader nursing home population.
OIG outlined recommendations to CMS, including: (1) further developing resources for nursing homes and increasing transparency to reduce inappropriate antipsychotic drug use and improve dementia care; (2) taking steps to ensure that nursing home medical directors fulfill their role in reducing inappropriate antipsychotic use; (3) taking steps to ensure that nursing home pharmacists fulfill their role in reducing inappropriate antipsychotic use; and (4) assisting nursing homes in improving their policies and procedures related to antipsychotic drug use. CMS did not explicitly concur or nonconcur with the first and fourth recommendations and nonconcurred with the second and third recommendations. - On March 20, 2026, KFF released a report entitled, Cost Concerns and Coverage Changes: A Follow-Up Survey of ACA Marketplace Enrollees. KFF conducted a poll of 1,117 adults covered by ACA Marketplace plans following the expiration of enhanced premium tax credits (EPTCs). Eighty percent of returning Marketplace enrollees reported that their 2026 plan premiums, deductibles, or coinsurance and co‑pays are higher than last year, including 51 percent who say costs are “a lot higher.” In addition, 73 percent of returning enrollees said they are “very worried” or “somewhat worried” about being able to afford costs for emergency care or hospitalizations, while about half are worried about affording costs for routine medical visits or prescription drugs. Concerns are even greater among those with lower incomes and those with chronic health conditions. Further, 17 percent of returning Marketplace enrollees say they are not confident they will be able to afford their monthly health insurance premium for the entirety of 2026. Moreover, 55 percent say they are, or will be, cutting back spending on food or basic household items in order to afford the costs of coverage and care. Among returning enrollees with chronic health conditions, 62 percent report that they are, or will be, cutting back on food and other household items in order to help them afford their health care costs.
Hearings & Markups
- On March 17, 2026, the House Committee on Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies held a hearing entitled, Oversight Hearing – National Institutes of Health. Jay Bhattacharya, M.D., M.P.H., Ph.D., Director, NIH, was the sole witness.
- On March 17, 2026, the House Committee on Energy and Commerce Subcommittee on Oversight & Investigations held a hearing entitled, Protecting Patients and Safeguarding Taxpayer Dollars: The Role of CMS in Combatting Medicare and Medicaid Fraud. Kim Brandt, Deputy Administrator & Chief Operating Officer, CMS, was the sole witness.
- On March 18, 2026, the House Select Committee on the Strategic Competition Between the United States and the Chinese Communist Party held a hearing entitled, From the Science Lab to the Medicine Cabinet: How China is Cornering the Market on Our Medicines. Witnesses included: Jacob Becraft, Chief Executive Officer (CEO) and Co-Founder, Strand Therapeutics Inc.; Patrick Cashman, President, USAntibiotics; Francisco Gimenez, Partner, 8VC; and Marta Wosińska, Senior Fellow – Economic Studies, Center on Health Policy at Brookings.
- On March 18, 2026, the House Veterans Affairs Committee held a Full Committee Legislative Hearing on 27 bills, including: H.R. 6733, VISN Reform Act of 2025; H.R.6580, VA National Formulary Act of 2025; H.R.210, Dental Care for Veterans Act; H.R.4114, EVEST Act; H.R.4876, Reproductive Freedom for Veterans Act; and Discussion Draft, To provide for the modernization of the electronic health record system and other health information technology activities and systems of the Department of Veterans Affairs, and for other purposes.
Other Health Policy News
- On March 16, 2026, the Trump Administration released an executive order (EO) entitled, Establishing the Task Force to Eliminate Fraud. The EO establishes a Task Force to Eliminate Fraud (Task Force) within the Executive Office of the President (EOP) to investigate fraud across federal programs and coordinate enforcement efforts across agencies. It designates the Vice President as Chair, the Chairman of the Federal Trade Commission (FTC) as Vice Chair, and the Assistant to the President for Homeland Security as Senior Advisor. The EO directs the Task Force to coordinate and accelerate a comprehensive national strategy to combat fraud, waste, and abuse in federal benefit programs, including those administered jointly with state, local, tribal, and territorial partners, such as Medicaid. The EO also highlights reports of fraud in Minnesota’s state Medicaid program and Supplemental Nutrition Assistance Program (SNAP). This action follows a February 25, 2026, announcement by Vice President Vance and CMS Administrator Mehmet Oz outlining several measures to address Medicare and Medicaid fraud, including: (1) deferring $259.5 million of quarterly federal Medicaid funding to Minnesota; (2) imposing a six-month moratorium on Medicare enrollment for certain Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) suppliers; and (3) implementation of the Comprehensive Regulations to Uncover Suspicious Healthcare (CRUSH) initiative.
The EO can be found here. - On March 17, 2026, the House Committee on Energy and Commerce Subcommittee on Oversight and Investigations held a hearing entitled, The Role of CMS in Combatting Medicare and Medicaid Fraud. The hearing examined actions CMS has taken to address fraud across the Medicare and Medicaid programs, the available authorities, tools, and approaches for CMS to detect, prevent, or remedy fraudulent claims and payments, and whether CMS’s recent enforcement actions are appropriately targeting fraud in these programs. Republicans emphasized the need to address fraud in claims for durable medical equipment (DME), genetic testing, skin substitute products, home health, and hospice services, and examined the agency’s existing authorities, strategies, and tools for combating fraud. Democrats expressed support for addressing fraud and criticized the Trump Administration for politicizing anti-fraud efforts and targeting Democratic-led states, such as Minnesota. Ms. Brandt focused on describing CMS’s new approaches to detecting and preventing fraudulent claims and defended CMS’s recent enforcement actions as data-driven, fact-based program integrity actions to address and mitigate suspected fraud in the Medicare and Medicaid programs.
A recording of the hearing can be found here. - On March 17, 2026, the H.R. 7961, the Physicians and the Healthcare Workforce Act, was introduced to exempt physicians and other health care workers from the new $100,000 fee for the H-1B visa petitions. On September 19, 2025, the Trump Administration established new fees of $100,000 on employers that petition for new H-1B visas. Due to the prevalence of H-1B visas for highly skilled physicians, nurses, and allied health workers, health care providers have been especially impacted by this action. Sponsors of H.R. 7961, including Representatives Mike Lawlor (R-NY-17), Sandford Bishop (D-GA-02), Maria Elvira Salazar (R-FL-27), and Yvette Clarke (D-NY-09), also led a congressional letter with more than 100 cosigners to the Department of Homeland Security (DHS) last month urging the exemption.
A press release can be found here. The bill text can be found here. - On March 18, 2026, the House Committee on Energy and Commerce Health Subcommittee held a hearing entitled, Lowering Health Care Costs for All Americans: An Examination of the U.S. Provider Landscape. The hearing was the third in the Committee’s broader affordability series and focused on how provider consolidation, reimbursement policy, workforce shortages, administrative burden, and inadequate price transparency are affecting the cost and accessibility of care across the healthcare system. Members and witnesses discussed the financial strain facing hospitals, independent physicians, primary care providers, employers, and home- and community-based service (HCBS) providers, while also debating the effects of Medicaid and ACA policy changes, the role of competition in the provider market, and potential reforms to improve affordability, access, and quality for patients.
A recording of the hearing can be found here. - On March 20, 2026, the White House released its National Policy Framework for Artificial Intelligence (AI). The Framework outlines legislative recommendation in seven policy areas including: (1) measures to protect children and empower parents to control their children’s digital environment and upbringing; (2) using AI development, including data infrastructure buildout, to strengthen American communities and small businesses through economic growth and energy dominance, while ensuring communities are protected from harmful impacts; (3) protecting American creators, publishers, and innovators from AI-generated outputs that infringe their protected content, without undermining lawful innovation and free expression; (4) defending free speech and First Amendment protections while preventing AI systems from being used to silence or censor lawful political expression or dissent; (5) removing barriers to innovation, accelerating deployment of AI applications across sectors, and ensuring broad access to the testing environments needed to build world-class AI systems; (6) implementing youth development and skills training, the creation of new jobs in an AI-powered economy, and expanded opportunities across sectors so that American workers benefit from AI-driven growth; and (7) establishing a federal AI policy framework to protect American rights, support innovation, and prevent a fragmented patchwork of state regulations that would hinder U.S. national competitiveness, while respecting federalism and State rights.
The framework can be found here.
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