Health Care Week in Review | CMS Rescinds Biden-Era EMTALA Abortion Guidance; CBO Projects 16 Million Could Lose Coverage Under Health Proposals

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.

Alston & Bird's multidisciplinary Executive Order, Action & Proclamation Task Force advises clients on the business and legal implications of President Trump's Executive Orders.

 Regulations, Notices & Guidance

• On June 2, 2025, the Food and Drug Administration (FDA) released guidance entitled, M13B Bioequivalence for Immediate-Release Solid Oral Dosage Forms: Additional Strengths Biowaiver. The draft guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The draft guidance is the second in the ICH M13 series of guidances and describes the scientific and technical aspects of study design and data analysis to support bioequivalence (BE) assessment for additional strengths of orally administered immediate-release (IR) solid oral dosage forms (i.e., tablets, capsules, and granules/powders for oral suspension), including considerations for biowaivers. The intent of this draft guidance is to provide harmonized criteria and data that support waivers for drug applications with multiple strengths when in vivo BE has been demonstrated for at least one strength using the principles outlined in the final guidance “M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms” published in October 2024.
• On June 4, 2025, FDA released guidance entitled, Recommendations for Complying With Over-the-Counter Monograph Procedure for Minor Changes C001: Minor Changes to Solid Oral Dosage Forms for Certain Over-the-Counter Monograph Drugs: Draft Guidance for Industry. This guidance provides recommendations for how requestors can comply with the requirements described in Proposed Administrative Order (OTC000038) titled “Over-the-Counter Monograph Procedure for Minor Changes C001: Minor Changes to Solid Oral Dosage Forms for Certain Over-the-Counter Monograph Drugs (hereinafter referred to as C001)”. The recommendations in this guidance are intended to assist requestors when making a minor change in the dosage form of an over-the-counter (OTC) monograph drug as described in section 505G(c) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and, if finalized, C001. Specifically, this guidance provides recommendations for demonstrating that a minor change in a solid oral dosage form from a tablet or capsule to a chewable tablet, orally disintegrating tablet (ODT), or film will not affect the safety or effectiveness of the drug. It also provides recommendations for demonstrating that such a change will not materially affect the extent of absorption or other exposure to an active ingredient in the drug comparison to a suitable reference product.
• On June 5, 2025, FDA released guidance entitled, Transfer of a Premarket Notification (510(k)) Clearance – Questions and Answers. This guidance provides information on the most frequently asked questions regarding the transfer or sale of a 510(k) clearance from one 510(k) holder to another. Under section 510(k) of the FD&C Act and its implementing regulations, any person required to register under 21 CFR 807.20 who plans to introduce a device into commercial distribution for the first time must, per 21 CFR 807.81(a)(2), submit a premarket notification submission, or “510(k),” if that device is not exempt from 510(k) requirements. This guidance discusses topics related to a transfer or sale of a 510(k) clearance in which the submission of a new 510(k) would not be required, and instances in which entities must use the existing 510(k) number to list a device.
• On June 5, 2025, the Centers for Medicare & Medicaid Services (CMS) released guidance entitled, Rescission of Guidance on Adding Sexual Orientation and Gender Identity Questions to State Medicaid and CHIP Applications for Health Coverage. CMS has rescinded the Center for Medicaid and CHIP Services (CMCS) Informational Bulletin that was issued on November 9, 2023, titled “Guidance on Adding Sexual Orientation and Gender Identity Questions to State Medicaid and CHIP Applications for Health Coverage.” CMS no longer intends to collect this information from state Medicaid and Children’s Health Insurance Program (CHIP) agencies as part of Transformed Medicaid Statistical Information System (T-MSIS) data submissions.
• On June 6, 2025, the Drug Enforcement Administration (DEA) released a notice entitled, Special Surveillance List of Chemicals, Products, Materials and Equipment Used in the Manufacture of Controlled Substances and Listed Chemicals. The Controlled Substances Act provides for civil penalties for the distribution of a laboratory supply to a person who uses, or attempts to use, that laboratory supply to manufacture a controlled substance or a listed chemical, if that distribution was made with reckless disregard for the illegal uses to which such laboratory supply will be put. The term laboratory supply is defined as a listed chemical or any chemical, substance, or item on a special surveillance list published by the Attorney General which contains chemicals, products, materials, or equipment used in the manufacture of controlled substances and listed chemicals. DEA is hereby publishing a notice to update the Special Surveillance List.

Event Notices

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

• June 9, 2025: The National Institutes of Health (NIH) announced a meeting of the National Advisory Child Health and Human Development Council. This is a virtual meeting with some sessions open to the public.
• June 10, 2025: NIH announced a meeting of the National Cancer Advisory Board. This is a virtual meeting with one session open to the public.
• June 11, 2025: NIH announced a meeting of the National Heart, Lung, and Blood Advisory Council. This is an in-person meeting with some sessions open to the public.
• June 12, 2025: The Department of Veterans’ Affairs (VA) announced a meeting of the Cooperative Studies Scientific Evaluation Committee. This is a virtual meeting partially open to the public.
• June 13, 2025: NIH announced a meeting of the National Advisory Eye Council. This is a virtual meeting with some sessions open to the public.
• June 17, 2025: NIH announced a meeting of the National Advisory Mental Health Council. This is a virtual meeting with some sessions open to the public.
• June 17, 2025: NIH announced a meeting of the Advisory Committee on Research on Women’s Health. This is a virtual meeting open to the public.
• June 17, 2025: 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.
• June 25, 2025: CMS announced a meeting of the Medicare Evidence Development and Coverage Advisory Committee. This is a virtual meeting open to the public.
• June 26, 2025: NIH announced a meeting of the Office of the Director. This is a virtual meeting open to the public.
• June 27, 2025: CMS announced a meeting regarding New and Reconsidered Clinical Diagnostic Laboratory Test Codes for the Clinical Laboratory Fee Schedule for Calendar Year (CY) 2026. This is a hybrid meeting open to the public.
• July 1, 2025: NIH announced a meeting of the National Advisory Council for Complementary and Integrative Health. This is a virtual meeting with some sessions open to the public.
• July 7, 2025: NIH announced a meeting of the Board of Scientific Counselors, National Cancer Institute. This is a virtual meeting with some sessions open to the public.
• July 14, 2025: FDA announced a meeting to discuss proposed recommendations for the reauthorization of the Prescription Drug User Fee Act for Fiscal Year 2028 through 2032. This is a hybrid meeting open to the public.
• July 14, 2025: FDA announced a meeting to discuss proposed recommendations for the reauthorization of the Generic Drug User Fee Amendments for FYs 2028 to 2032. This is a hybrid meeting open to the public.
• July 15, 2025: FDA announced a meeting entitled, “Second Annual Animal Drug User Fee Educational Conference.” This is a hybrid meeting open to the public.
• July 23-24, 2025: CMS announced a meeting of the Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests. This is a hybrid meeting open to the public.
• **June 25, 2025: CDC announced a meeting of the Advisory Committee on Immunization Practices (ACIP). This is a virtual meeting open to the public.
• **July 10, 2025: CMS announced a meeting of the Air Ambulance Quality & Patient Safety Advisory Committee. This is a virtual meeting open to the public.
• August 6-7, 2025: The Health Resources and Services Administration (HRSA) announced a meeting of National Advisory Council on Nurse Education and Practice (NACNEP). This is a hybrid meeting open to the public.
• August 8, 2025: HRSA announced a meeting of the Advisory Committee on Training in Primary Care Medicine and Dentistry. This is a hybrid meeting open to the public.
• September 11-12, 2025: HRSA announced a meeting of the Council on Graduate Medical Education. This is a hybrid meeting open to the public.
• **September 17-18, 2025: NIH announced a meeting of the National Institute on Aging. This is a virtual meeting with some sessions open to the public.
• **October 8-9, 2025: NIH announced a meeting of the National Institute of Diabetes and Digestive and Kidney Diseases. This is a virtual meeting with some sessions open to the public.
• **December 1-2, 2025: 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 4-5, 2025: HRSA announced a meeting of NACNEP. This is a hybrid meeting open to the public.

Reports, Studies & Analyses

• On June 2, 2025, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) released a report entitled, Spring 2025 Semiannual Report to Congress. This report to Congress describes OIG's work identifying significant risks, problems, abuses, deficiencies, remedies, and investigative outcomes relating to the administration of HHS programs and operations that were disclosed during the semiannual reporting period running from October 1, 2024 to March 31, 2025. Of note, the report identifies $16.61 billion in total monetary impact, over 1,400 oversight activities, and over 3,750 enforcement actions carried out by OIG.
• On June 3, 2025, professors from the Yale School of Public Health and the University of Pennsylvania sent a letter to Senate leaders warning that proposed changes to Medicaid and other health programs could lead to over 51,000 preventable deaths. Addressed to the Senate Finance Committee Ranking Member Sen. Ron Wyden and Senate Health, Education, Labor, and Pensions (HELP) Committee Ranking Member Sen. Bernie Sanders, the letter presents projections of the human toll of eliminating key health protections. The findings point to catastrophic public health consequences from mass insurance losses and cuts to nursing home standards—provisions included in the budget reconciliation bill passed by the House of Representatives. The researchers estimate that 42,500 lives could be lost each year from disenrollments in Medicaid and Marketplace coverage and the rollback of nursing home staffing rules. An additional 8,811 deaths are projected from the expiration of the enhanced Affordable Care Act (ACA) premium tax credits, bringing the total to more than 51,000.
• On June 4, 2025, the Congressional Budget Office (CBO), at the request of senior Democrats on the Senate Finance Committee and House Energy & Commerce and Ways & Means Committees, released projections of the change in the uninsured population if the Republicans’ budget reconciliation package is enacted. CBO predicted that, due to policy changes in both Medicaid and ACA marketplace eligibility, the number of Americans who do not have health insurance would increase by 10.9 million. In addition, the expiration of the expanded premium tax credit and the promulgation of the “Patient Protection and Affordable Care Act; Marketplace Integrity and Affordability” proposed rule from HHS would result in an additional 5.1 million uninsured Americans, bringing the total increase of the uninsured over the next ten years to 16 million. The full projection from CBO can be viewed here.
• On June 4, 2025, the Government Accountability Office (GAO) released a report entitled, Public Health Preparedness: HHS Needs a Coordinated National Approach for Diagnostic Testing for Pandemic Threats. In this report, GAO described how infectious diseases with pandemic potential – such as avian influenza – pose a threat to American lives, national security, and economic interests. To lead federal diagnostic testing efforts related to such diseases, the GAO recommended that HHS must work with public and private stakeholders who, among other things, administer tests and collect data. The report outlines four additional recommendations to HHS related to developing a national diagnostic testing strategy and establishing a national testing forum. HHS noted it is committed to carefully reviewing the recommendations and providing a future update.
• On June 5, 2025, the Congressional Research Service (CRS) released a report entitled, Most-Favored-Nation Prescription Drug Pricing Executive Order: Legal Issues. This report examines the legal implications of the Trump Administration’s recent executive order titled Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients. Issued on May 12, 2025, the order aims to lower prescription drug prices in the United States by requiring that Americans pay no more than the lowest price available in comparable developed countries. The report outlines how the executive order directs federal agencies, particularly HHS, to take steps to enforce this pricing model, focusing specifically on brand-name drugs that lack generic or biosimilar competition.

Hearings & Markups

• On June 4, 2025, the Senate HELP Committee held a hearing entitled, Reauthorization of the Over-the-Counter Monograph Drug User Fee Program. Dr. Jacqueline Corrigan-Curay, Acting Director, Center for Drug Evaluation and Research, FDA, served as the sole witness.
• On June 5, 2025, the House Committee on Science, Space, and Technology held a joint hearing of the Subcommittee on Research and Technology and Subcommittee on Energy entitled, Pursuing the Golden Age of Innovation: Strategic Priorities in Biotechnology. Witnesses included: Dr. Drew Endy, Hoover Institution Science and Senior Fellow, Martin Family Fellow in Undergraduate Education for Bioengineering, Stanford University; Ms. Deborah Gracio, Associate Lab Director, National Security Directorate, Pacific Northwest National Laboratory; Dr. Stephen Techtmann, Associate Professor of Biological Sciences, Michigan Technological University; and Dr. Kelvin Lee, Institute Director, National Institute for Innovation in Manufacturing Biopharmaceuticals.
• On June 5, 2025, the House Appropriations Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Subcommittee held a hearing entitled, Markup of Fiscal Year 2026 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Bill. No witnesses present.

Other Health Policy News

• On May 29, 2025, CMS rescinded guidance and the accompanying letter issued by the Biden Administration regarding Emergency Medical Treatment and Active Labor Act (EMTALA) obligations for patients who are pregnant or experiencing pregnancy loss. The Biden-era guidance clarified that providers could provide abortions to pregnant patients presenting at the emergency department if that abortion was a necessary stabilizing treatment, regardless of any state laws banning abortions. This guidance was subject to an ongoing lawsuit and unenforceable but has now been rescinded by the Trump Administration. While CMS has yet to issue alternative guidance, in a press statement it said that it “will continue to enforce EMTALA, which protects all individuals who present to a hospital emergency department seeking examination or treatment, including for identified emergency medical conditions that place the health of a pregnant woman or her unborn child in serious jeopardy.” The rescinded guidance can be viewed here and here. The letter that had accompanied that guidance can be viewed here. The CMS press release on the rescission of the guidance can be viewed here.
• On May 30, 2025, the deadline for FDA file an appeal to a decision made in a U.S. District Court on laboratory-developed tests (LDTs) passed without any such appeal being filed. The case in question had been regarding two lawsuits from the American Clinical Laboratory Association (ACLA) and the Association for Molecular Pathology (AMP) who had argued that FDA exceeded its authority in its final rule attempting to regulate LDTs as devices under the in vitro diagnostic product (IVD) umbrella. The rule was largely struck down due to the definition of devices: the judge agreed with the plaintiffs that LDTs are better categorized as “professional medical services that are qualitatively and categorically distinct” from medical devices. The lack of any appeal effectively ends FDA’s current attempts to regulate LDTs.
• On June 4, 2025, the U.S. House of Representatives passed H.R. 2483, the SUPPORT for Patients and Communities Reauthorization Act of 2025, by a vote of 366-57. Originally enacted in 2018, the SUPPORT Act authorized funding for community-based substance use disorder (SUD) treatment and recovery programs, many of which expired in 2023. Some SUPPORT Act provisions were reauthorized in the 2024 government funding package, including mandating state Medicaid coverage for medication-assisted treatment for opioid use disorder and expanding state-by-state behavioral health data collection efforts. H.R. 2483 would reauthorize many of the expired programs and extend funding for HHS opioid use disorder prevention, treatment, and recovery programs for FY 2026 through FY 2030. The bill includes reauthorization of grants supporting residential SUD treatment for pregnant and postpartum women, youth prevention and recovery programs, student loan repayment for certain SUD treatment providers, and behavioral health education and training for medical and allied health students. While the House passed the bill on a largely bipartisan vote, many Democrats raised concerns that HHS funding cuts and the decision to fold the Substance Abuse and Mental Health Services Administration (SAMHSA) into a new HHS office may undermine the same programs that H.R. 2483 reauthorizes. H.R. 2483 will now move to the Senate for consideration. The full bill passed by the House can be viewed here.

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