Health Care Week in Review | HHS and ED Announce Medical School Commitments to Increase Nutrition Education; Energy & Commerce Majority Sends Medicaid Fraud Inquiry Letters to Ten States

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. 

Regulations, Notices & Guidance

• On March 2, 2026, the Food and Drug Administration (FDA) released a notice entitled, Recommendations on Scale-Up and Postapproval Changes Guidances for Industry; Request for Comments. FDA is announcing the opening of a public docket to solicit information and comments on the agency’s series of guidances for industry on scale-up and post-approval changes (SUPAC) for specific dosage forms. Specifically, FDA is seeking comment on the following guidances for industry: (1) Immediate Release Solid Oral Dosage Forms Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls, In Vitro Dissolution Testing, and In Vivo Bioequivalence Documentation (SUPAC-IR); (2) SUPAC-IR Questions and Answers about SUPAC-IR Guidance (SUPAC-IR Q&A); (3) Nonsterile Semisolid Dosage Forms Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls; In Vitro Release Testing and In Vivo Bioequivalence Documentation (SUPAC-SS); (4) SUPAC-MR: Modified Release Solid Oral Dosage Forms Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls; In Vitro Dissolution Testing and In Vivo Bioequivalence Documentation (SUPAC-MR); and (5) SUPAC: Manufacturing Equipment Addendum (SUPAC-MEA). FDA is seeking public information and comments on the continued utility of and potential revisions to the recommendations in these guidances.
• On March 3, 2026, FDA released draft guidance entitled, New Clinical Investigation Exclusivity (3-Year Exclusivity) for Drug Products: Questions and Answers. This draft guidance is intended to assist applicants requesting New Clinical Investigation exclusivity for a new drug application (NDA) or NDA supplement. The guidance discusses the statutory and regulatory criteria for eligibility for three-year exclusivity and provides recommendations on the content and format of requests for three-year exclusivity in the form of questions and answers. FDA intends to update this draft guidance document as appropriate.
• On March 3, 2026, FDA released guidance entitled, M14 General Principles on Planning, Designing, Analyzing, and Reporting of Non-interventional Studies That Utilize Real-World Data for Safety Assessment of Medicines. The guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The guidance outlines general principles on planning, designing, analyzing, and reporting non-interventional studies that utilize real-world data for safety assessment of medicines, including drugs, vaccines, and other biological products. The recommendations in this guidance, while focused on safety, are applicable to non-interventional studies assessing effectiveness and are aligned and complementary with FDA’s other guidances on the generation of real world evidence. The guidance is intended to streamline the development and regulatory assessment of postmarketing non-interventional safety studies that include real-world data. The guidance replaces the draft guidance entitled, M14 General Principles on Plan, Design, and Analysis of Pharmacoepidemiological Studies that Utilize Real-World Data for Safety Assessment of Medicines, issued in July 2024. FDA is also announcing the withdrawal of the guidance entitled Best Practices for Conducting and Reporting Pharmacoepidemiologic Safety Studies Using Electronic Healthcare Data Sets, published May 2013.
• On March 3, 2026, FDA released guidance entitled, E2D(R1) Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports. The guidance was prepared under the auspices of ICH. The guidance updates the 2003 guidance entitled, E2D Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting, by clarifying the use of new or increasingly used data sources, including social media, market research programs, patient support programs. This guidance clarifies the use of new post-approval safety sources and updates terminology and standards for post-approval adverse event reporting. The guidance replaces the draft guidance entitled, E2D(R1) Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports, issued on March 14, 2024, and the final guidance issued on September 15, 2003.
• On March 4, 2026, FDA released a final rule entitled, Revising the National Drug Code Format and Drug Label Barcode Requirements. FDA is issuing this final rule to standardize the format of the National Drug Code (NDC). Under this final rule, all FDA-assigned NDCs will be required to be 12 digits in length with three distinct segments and one uniform format. The first segment is a six-digit labeler code, the second segment is a four-digit product code, and the third segment is a two-digit package code. Additionally, FDA is revising the drug product barcode label requirements to permit the use of other data carriers that meet the standards of this final rule. This rule is effective March 7, 2033.
• On March 4, 2026, FDA released a notice entitled, Developing Specifications for In-Home Disposal Systems for Opioid Analgesics Dispensed in an Outpatient Setting; Establishment of a Public Docket; Request for Comments. FDA is announcing the establishment of a docket to solicit public comment on what specifications for in-home disposal systems, if application holders are required to make them available under the Opioid Analgesic Risk Evaluation and Mitigation Strategy, would be necessary to show that these systems may mitigate the serious risks of abuse or overdose involving these medications.
• On March 6, 2026, FDA released draft guidance entitled, Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection. This guidance is intended for foreign and domestic human and animal drug manufacturing establishments inspected by FDA whose drugs are regulated by the Center for Drug Evaluation and Research (CDER), the Center for Biologics Evaluation and Research (CBER), and the Center for Veterinary Medicine (CVM). The purpose of this guidance is to assist manufacturers who choose to respond to FDA when they receive an FDA Form 483 Inspectional Observations at the conclusion of a drug inspection to assess conformity with current good manufacturing practice (CGMP) requirements.

Event Notices

Please note that two asterisks (**) preceding the item indicate a new event. 

• March 11-13, 2026: The Department of Health and Human Services (HHS) announced the 2026 National Conference on Women’s Health. This conference is free and open to the public.
• March 12, 2026: FDA announced a meeting of the Vaccines and Related Biological Products Advisory Committee. This is a virtual meeting open to the public.
• March 16, 2026: The National Institutes of Health (NIH) announced a meeting of the National Cancer Advisory Board. This is a hybrid meeting with some sessions open to the public.
• March 17, 2026: The Centers for Disease Control and Prevention (CDC) announced a meeting of the ICD-10 Coordination and Maintenance Committee. This is a virtual meeting open to the public.
• March 18, 2026: NIH announced a meeting of the National Institute of Environmental Health Sciences. This is a hybrid meeting with some sessions open to the public.
• March 18, 2026: NIH announced a meeting of the National Advisory Mental Health Council. This is a virtual meeting open to the public.
• March 18, 2026: NIH announced a meeting of the National Cancer Institute Clinical Trials and Translational Research Advisory Committee. This is a hybrid meeting open to the public.
• March 18, 2026: CDC announced a meeting of the Advisory Committee on Immunization Practices (ACIP). This is a virtual meeting open to the public.
• March 19, 2026: NIH announced a meeting of the Board of Scientific Counselors of the National Cancer Institute. This is a hybrid meeting with some sessions open to the public.
• 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: 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 of Diabetes and Digestive and Kidney Diseases. 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 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 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.
• 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 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 8-9, 2026: HHS announced a meeting of PTAC. This is a hybrid meeting open to the public.

Reports, Studies & Analyses

• In March 2026, Health Affairs released a report entitled, Private Equity Acquisition Of Primary Care Practices: Modest Growth In Clinicians Offset By Increased Clinician Exits. The report examined workforce changes in primary care practices following private equity acquisition. The analysis found that between 2018 and 2022, private equity acquisition was associated with modest growth in the total number of clinicians, driven by a 13.8 percent increase in advanced practice providers and an 11.0 percent increase in physicians. However, this increase in clinician staffing was accompanied, and in part offset, by a 27.5 percent rise in clinician exits, largely driven by a 37.5 percent increase in exits among advanced practice providers. Overall clinician staffing increased, potentially reflecting private equity’s roll‑up consolidation strategy, deliberate expansion of clinician capacity as part of a revenue‑maximizing approach, or greater flexibility in hiring. The increase in exits may indicate professional dissatisfaction and heightened workforce instability.

• On March 2, 2026, the Common Health Coalition released a report entitled, More Illness, Greater Cost Spotlight Brief: Childhood Immunizations. The report highlights the consequences of declining childhood vaccination rates, noting that rising vaccine hesitancy and policy‑driven weakening of the childhood immunization infrastructure are contributing to these declines. A sustained one percent annual decrease in measles, mumps, and rubella (MMR) vaccine coverage could result in more than 17,000 measles cases, 4,000 hospitalizations, and 36 preventable deaths each year, while adding billions of dollars in avoidable costs to the U.S. health system and economy by 2030. Over the next five years, declining measles vaccination rates alone could cost an estimated $1.5 billion annually and generate approximately $7.8 billion in cumulative costs.

Hearings & Markups

• On March 4, 2026, the House Committee on Oversight and Government Reform held a hearing entitled, Oversight of Fraud and Misuse of Federal Funds in Minnesota: Part II. Witnesses included: The Honorable Tim Walz, Governor, State of Minnesota; The Honorable Keith Ellison, Attorney General, State of Minnesota; and Reverend Mariah Tollgaard, Senior Pastor, Hamline Church United Methodist.
• On March 5, 2026, the Senate Committee on Health, Education, Labor, and Pensions (HELP) held a hearing entitled, Transforming Health Care with Data: Improving Patient Outcomes Through Next‑Generation Care. Dr. Thomas Keane, ASTP and National Coordinator for Health Information Technology, HHS, was the sole witness.

Other Health Policy News

• On March 2, 2026, Senators Jeff Merkley (D-OR) and Roger Wicker (R-MS), alongside Representatives Jen Kiggans (R-VA-02) and Suzanne Bonamici (D-OR-01), led a letter signed by 150 Members of Congress urging the Department of Education (ED) not to finalize its proposal to exclude post-baccalaureate nursing degrees from its definition of a “professional degree.” If finalized, the proposal would classify post-baccalaureate nursing degrees as “graduate degrees,” which would be subject to an annual limit of $20,500 and an aggregate lifetime limit of $100,000, compared to the higher borrowing limits applicable to “professional degrees,” subject to an annual limit of $50,000 and an aggregate lifetime limit of $200,000. The letter highlights the current nursing workforce shortage and argues that the lower borrowing limit would prohibit many nurses from pursuing degrees such as Master of Science in Nursing (MSN), Doctor of Nursing Practice (DNP), and PhDs in nursing, as well as limit the number of available Certified Registered Nurse Anesthetist (CRNAs).
  
  The letter can be found here.
• On March 3, 2026, House Energy & Commerce Committee Chair Brett Guthrie (R-KY-02), Oversight and Investigations Subcommittee Chair John Joyce (R-PA-13), and Health Subcommittee Chair Morgan Griffith (R-VA-09) sent letters to ten states requesting information related to program integrity and fraud, waste, and abuse in the state Medicaid program. The states include California, Colorado, Massachusetts, Maine, Nebraska, New York, Oregon, Pennsylvania, Vermont, and Washington.
  
  The letters highlight recent reports of fraud in Minnesota and note the Committee’s concern that the respective state Medicaid programs may be similarly vulnerable to fraud, waste, and abuse. The letters request that state leadership respond by March 17, 2026, to ten questions regarding Medicaid program integrity, including actions the state is taking to prevent, identify, and address Medicaid fraud; active Section 1115 and 1915 demonstrations and waivers; and actions taken to sanction or disenroll fraudulent Medicaid providers, among other topics.
  
  The press release can be found here.
• On March 5, 2026, the Senate HELP Committee held a hearing entitled, Transforming Health Care with Data: Improving Patient Outcomes Through Next-Generation Care. Dr. Thomas Keane described federal efforts to implement provisions of the 21st Century Cures Act, expand nationwide health information exchange through the Trusted Exchange Framework and Common Agreement (TEFCA), address information blocking, and modernize health information technology (IT) certification. Senators examined efforts to reduce administrative burden and costs in the health care system, including streamlining workflows and increasing transparency, while emphasizing the need to protect patient privacy and data security. Significant attention was also given to cybersecurity threats, particularly for rural hospitals, and to the implications of expanding digital tools and artificial intelligence (AI) in health care. Members also emphasized ensuring that patients can access and control their own electronic health information, while strengthening enforcement against information blocking and maintaining appropriate privacy protections as data is shared across the health system.
  
  More information on this hearing can be found here.
• On March 5, 2026, HHS and ED announced that 53 medical schools have committed to requiring nutrition education in their curricula. Beginning in the fall of 2026, the medical schools will provide at least 40 hours of nutrition education, or implement a 40-hour competency equivalent. HHS also announced that it will allocate $5 million through a multi-phase NIH nutrition education challenge to support medical schools, nursing residencies, and nutrition science and dietician programs that integrate nutrition education. Programs and institutions can use the funding to develop coursework, clinical training opportunities, and research initiatives focused on evidence-based nutrition science. Moreover, Public Health Service officers will be required to complete nutrition-focused continuing education hours as part of their career development.
  
  A press release can be found here.

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