Health Care Week in Review | House Passes GOP Health Care Bill; CMS Announces Proposed Rules Restricting Federal Funding for Gender-Affirming Care

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 December 15, 2025, the Food and Drug Administration (FDA) released guidance entitled, Sponsor Responsibilities—Safety Reporting Requirements and Safety Assessment for Investigational New Drug Application and Bioavailability/Bioequivalence Studies. This guidance provides recommendations for sponsors and sponsor-investigators to comply with the requirements of investigational new drug application (IND) safety reporting and safety reporting for bioavailability and bioequivalence studies. This guidance finalizes the draft guidance of the same title issued on June 28, 2021.
• On December 15, 2025, FDA released guidance entitled, Investigator Responsibilities—Safety Reporting for Investigational Drugs and Devices. This guidance is intended to help clinical investigators comply with the safety reporting requirements for IND studies and investigational device exemption (IDE) studies. Recommendations are provided in this guidance to help investigators identify safety information that needs to be reported to sponsors and institutional review boards (IRBs). This guidance finalizes the draft guidance of the same title issued on September 30, 2021.
• On December 17, 2025, FDA released guidance entitled, Questions and Answers Regarding Mandatory Cosmetics Recalls. This guidance provides answers to common questions that might arise about FDA’s mandatory recall authority for cosmetics. It is intended to inform regulated industry about FDA’s current thinking on implementation of certain aspects, including the criteria, process, and expectations, for mandatory recalls of cosmetic products.
• On December 17, 2025, FDA released guidance entitled, Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices. This guidance clarifies how FDA evaluates real-world data to determine whether they are of sufficient quality for generating real-world evidence that can be used in FDA regulatory decision-making for medical devices. This final guidance supersedes the final guidance entitled, Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices, issued August 31, 2017, and provides expanded and updated recommendations.
• On December 17, 2025, the National Institutes of Health (NIH) released a notice entitled, Controlled-Access Data Policy and Proposed Revisions to Genomic Data Sharing Policy. NIH is requesting public input on its proposal to establish harmonized and transparent policy requirements for protecting human participant research data. Specifically, NIH proposes (1) establishing policy requirements for which data should be controlled-access under NIH data sharing policies, and (2) revising the NIH genomic data sharing policy to simplify and harmonize requirements.
• On December 18, 2025, the Department of Health and Human Services (HHS) released a proposed rule entitled, Nondiscrimination on the Basis of Disability in Programs or Activities Receiving Federal Financial Assistance. This proposed rule would clarify that the definitions of “disability” and “individual with a disability” specifically exclude “gender dysphoria not resulting from physical impairments.” The HHS Office of Civil Rights (OCR) states that this clarification is necessary to resolve ambiguity introduced in the preamble to the 2024 Final Rule and to ensure compliance with the best reading of the plain language of the governing statute.
• On December 18, 2025, the Centers for Medicare & Medicaid Services (CMS) released a proposed rule entitled, Medicaid Program: Prohibition on Federal Medicaid and Children's Health Insurance Program Funding for Sex-Rejecting Procedures Furnished to Children. This proposed rule would require that a State Medicaid plan must provide that the Medicaid agency will not make payment under the plan for sex-rejecting procedures (SRPs) for children under 18 and prohibit the use of Federal Medicaid dollars to fund SRPs for individuals under the age of 18. In addition, it would require that a separate State Children’s Health Insurance Program (CHIP) plan must provide that the CHIP agency will not make payment under the plan for SRPs for children under 19 and prohibit the use of Federal CHIP dollars to fund SRPs for individuals under the age of 19.
• On December 18, 2025, CMS released a proposed rule entitled, Medicare and Medicaid Programs: Hospital Condition of Participation: Prohibiting Sex Rejecting Procedures for Children. This proposed rule would revise the requirements that Medicare and Medicaid certified hospitals must meet to participate in the Medicare and Medicaid programs. The agency states that these changes are necessary to protect the health and safety of children and reflect HHS’ review of recent information on the safety and efficacy of SRPs on children. The revisions to the requirements would prohibit hospitals from performing SRPs on children.
• On December 18, 2025, CMS released a notice entitled, Approval of the Commission on Laboratory Accreditation as an Accreditation Organization for the Specialties of Clinical Cytogenetics and Radiobioassay under the Clinical Laboratory Improvement Amendments of 1988. This notice announces the application of the Commission on Laboratory Accreditation (COLA) for approval as an accreditation organization for clinical laboratories under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) program for the specialties of Clinical Cytogenetics and Radiobioassay. CMS has determined that COLA meets or exceeds the applicable CLIA requirements. Consequently, CMS is granting COLA deeming authority for the specialties of Clinical Cytogenetics and Radiobioassay for a period of 5 years.
• On December 18, 2025, the Administration for Children and Families (ACF) released a rule recission entitled, COVID-19 Mitigation Policy Requirement in Head Start Programs. This direct final rule (DFR) removes the requirement that Head Start programs have a COVID-19 mitigation policy. This requirement was included in the final rule entitled, Mitigating the Spread of COVID-19 in Head Start Programs, which ACF published on January 6, 2023. Specifically, this rescission removes the requirement from the Head Start Program Performance Standards that Head Start programs have a COVID-19 mitigation policy developed in consultation with their Health and Mental Health Services Advisory Committee (HMHSAC), formerly the Health Services Advisory Committee (HSAC). ACF states that this DFR meets the deregulatory requirements of Executive Order (EO) 14192, Unleashing Prosperity Through Deregulation, and is aligned with EO 14148, Initial Rescissions of Harmful Executive Orders and Actions.
• On December 18, 2025, FDA released a final order entitled, Medical Devices: Neurological Devices; Classification of the Electrical Tongue Nerve Stimulator to Treat Motor Deficits. FDA is classifying the electrical tongue nerve stimulator to treat motor deficits into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the classification of the electrical tongue nerve stimulator to treat motor deficits. FDA determined that classifying the device into class II will provide a reasonable assurance of safety and effectiveness of the device.
• On December 18, 2025, FDA released guidance entitled, Processes and Practices Applicable to Bioresearch Monitoring Inspections. This final guidance is being issued to comply with the Food and Drug Omnibus Reform Act of 2022, which directs FDA to issue guidance describing the processes and practices applicable to inspections of sites and facilities inspected under FDA’s Bioresearch Monitoring inspection program, to the extent not specified in existing publicly available FDA guides and manuals. The guidance covers the following: the types of records and information required to be provided, best practices for communication between FDA and industry in advance of or during an inspection or request for records or other information, and other inspections-related conduct.
• On December 19, 2025, the Health Resources and Services Administration (HRSA) released a notice entitled, Recommended Uniform Screening Panel: Addition of Duchenne Muscular Dystrophy. HRSA published a Federal Register notice on August 14, 2025 (90 FR 39197), requesting comments from the public on the potential recommendation of adding Duchenne Muscular Dystrophy (DMD) to the Recommended Uniform Screening Panel (RUSP). After consideration of public comments and evidence-based reports, HRSA recommended to the HHS Secretary that DMD be added to the RUSP. The HHS Secretary accepted the recommendation as detailed in this notice. Conditions listed on the RUSP are part of the evidence-informed preventive health guidelines supported by HRSA for infants, children, and adolescents. Non-grandfathered group health plans and health insurance issuers are required to cover screenings included in these HRSA-supported comprehensive guidelines without cost-sharing (e.g., copayment, co-insurance, etc.).
• On December 19, 2025, HRSA released a notice entitled, Recommended Uniform Screening Panel: Addition of Metachromatic Leukodystrophy. HRSA published a Federal Register notice on August 14, 2025 (90 FR 39196), requesting comments from the public on the potential recommendation of adding Metachromatic Leukodystrophy (MLD) to the RUSP. After consideration of public comments and evidence-based reports, HRSA recommended to the HHS Secretary that MLD be added to the RUSP. The HHS Secretary has accepted the recommendation as detailed in this notice. Conditions listed on the RUSP are part of the evidence-informed preventive health guidelines supported by HRSA for infants, children, and adolescents. Non-grandfathered group health plans and group health insurance issuers are required to cover screenings included in these HRSA-supported comprehensive guidelines without cost-sharing
• On December 19, 2025, CMS released a proposed rule entitled, Global Benchmark for Efficient Drug Pricing Model. This proposed rule would implement the Global Benchmark for Efficient Drug Pricing Model (GLOBE Model), a new Medicare payment model under section 1115A of the Social Security Act. The GLOBE Model would test whether a payment model that uses an alternative method for calculating Part B inflation rebate amounts for certain separately payable Part B drugs and biologicals products reduces costs for Medicare fee-for service (FFS) beneficiaries and the Medicare program while preserving quality of care.
• On December 19, 2025, CMS released a proposed rule entitled, Guarding U.S. Medicare against Rising Drug Costs Model. This proposed rule would implement the Guarding U.S. Medicare Against Rising Drug Costs (GUARD) Model to test a new Medicare payment model under section 1115A of the Social Security Act. The model proposes to test an alternative payment method for calculating inflation rebates for certain Part D drugs and biological products. The proposed GUARD Model would test whether changing the calculation of the Part D inflation rebate would reduce costs for the Medicare program while preserving or enhancing quality of care for Part D enrollees.
• On December 19, 2025, HHS released a proposed rule entitled, Transparency in Coverage. The proposed rule proposes changes to the payer price transparency regulations to improve the accessibility of pricing disclosures to participants, beneficiaries, and enrollees, and the standardization and reliability of the public pricing disclosures from non-grandfathered group health plans and health insurance issuers offering non-grandfathered group and individual health insurance coverage.  Specifically, the proposed rule would improve the standardization, accuracy, and accessibility of public pricing disclosures in line with the goals of EO 14221, Making America Healthy Again by Empowering Patients With Clear, Accurate, and Actionable Healthcare Pricing Information. With respect to the in-network rate and out-of-network allowed amount machine-readable files, the proposed rule would achieve these goals by adding new contextual files and additional data elements like product type, network name, and enrollment counts; changing the reporting level for aggregation of data; removing in-network rates for unlikely provider-to-service mappings; increasing the reporting period and lowering the claims threshold for out-of-network historical data; and reducing the reporting cadence. The proposed rule would also improve the findability of all of the publicly disclosed machine-readable files required under the Transparency in Coverage rules, including the prescription drug file, by requiring a text file and footer with website URLs and contact information for the files. Additionally, the proposed rule would require pricing information that is made available through an online consumer tool and paper (upon request), to also be made available by phone, and establish that the satisfaction of such requirement also satisfies the requirements of section 114 of the No Surprises Act (including for grandfathered group health plans and health insurance issuers offering grandfathered group and individual health insurance coverage that are not otherwise subject to these proposed rules).

Event Notices

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

• **December 29, 2025: HRSA announced a meeting of the Advisory Commission on Childhood Vaccines. This is a virtual meeting open to the public.
• January 12-14, 2026: 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.
• **January 21, 2026: NIH announced a meeting of the National Advisory Dental and Craniofacial Research Council. This is a virtual meeting with some sessions open to the public.
• January 22, 2026: FDA announced a meeting of the Tobacco Products Scientific Advisory Committee. This is a hybrid meeting open to the public.
• January 22, 2026: NIH announced a meeting of the National Institute on Deafness and Other Communication Disorders. This is a virtual meeting open to the public.
• January 23, 2026: NIH announced a meeting of the National Center for Complementary & Integrative Health. This is a virtual meeting open to the public.
• January 26, 2026: NIH announced a meeting of the Eunice Kennedy Shriver National Institute of Child Health & Human Development. This is a virtual meeting with some sessions open to the public.
• January 27, 2026: NIH announced a meeting of the National Institute of Arthritis and Musculoskeletal and Skin Diseases. This is a virtual meeting with some sessions open to the public.
• **January 27, 2026: NIH announced a meeting of the National Advisory Council on Aging. This is a virtual meeting with some sessions open to the public.
• January 28, 2026: NIH announced a meeting of the National Diabetes and Digestive and Kidney Diseases Advisory Council. This is a virtual meeting with some sessions open to the public.
• **January 28, 2026: NIH announced a meeting of the National Institute of Biomedical Imaging and Bioengineering. This is a virtual meeting with some sessions open to the public.
• January 29, 2026: NIH announced a meeting of the National Center for Advancing Translational Sciences. This is a virtual meeting with some session open to the public.
• **January 29, 2026: NIH announced a meeting of the Office of AIDS Research Advisory Council. This is a virtual meeting open to the public.
• **January 30, 2026: NIH announced a meeting of the NIH Clinical Center Research Hospital Board. This is a hybrid meeting open to the public.
• February 8-10, 2026: NIH announced a meeting of the National Institute of Environmental Sciences. This is a hybrid meeting with some sessions open to the public.
• February 9-10, 2026: NIH announced a meeting of the Fogarty International Center Advisory Board. This is a hybrid meeting with some sessions open to the public.
• **February 9-10, 2026: NIH announced a meeting of the National Library of Medicine. This is a virtual meeting with some sessions 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.
• **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 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.
• 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.
• May 4, 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 13, 2025: 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.
• 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 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.
• 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 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.

Reports, Studies & Analyses

• On December 12, 2025, the Government Accountability Office (GAO) released a report entitled, Medical Device Recalls: HHS and FDA Should Address Limitations in Oversight of Recall Process. FDA oversees recalls of medical devices that may present a risk to the health of users. From fiscal years 2020 to 2024, FDA oversaw the recall of 3,934 medical devices. All were voluntarily recalled by manufacturers. FDA can mandate a recall, although it rarely does so. Insufficient staff limit FDA’s ability to conduct oversight activities, according to officials. HHS oversees FDA and is currently undergoing reforms. Conducting workforce planning to determine the staffing and skills FDA needs for oversight would help HHS keep unsafe devices from continued use. According to officials, FDA cannot require manufacturers to adopt its recommendations for how to carry out certain recalls. Some stakeholders said manufacturers and FDA communicating different information can be confusing. FDA officials said it can also result in inefficient use of resources. By working with FDA to assess if additional authorities are needed, and seeking them if beneficial, HHS may be better positioned to address current recall process inefficiencies. GAO recommended HHS work with FDA: 1) to conduct workforce planning for device recalls, and 2) assess and seek, if needed, additional authority for manufacturer-initiated recall strategies. HHS concurred with the first recommendation and is taking the second under consideration.
• On December 17, 2025, the HHS Office of Inspector General (OIG) released a report entitled, Trends in Dual-Eligible Enrollees’ Access to Drugs Under Part D, 2011-2025. For dual-eligible enrollees—that is, people enrolled in both Medicare and Medicaid—access to prescription drugs is particularly important. Overall, they have very low incomes and—because they are more likely to be in poorer health than other people enrolled in Medicare—tend to use more Medicare services. After prescription drug coverage for dual-eligible enrollees shifted from Medicaid to Medicare Part D, Congress mandated that OIG study whether Part D formularies cover prescription drugs commonly used by dual-eligible enrollees. OIG found that most Part D plan formularies have covered almost all of the drugs that dual-eligible enrollees commonly use since 2011, and coverage has been consistently high over the last decade. The number of commonly used drugs covered by all formularies steadily increased since 2011, and only a small number of commonly used drugs were not covered by most formularies. OIG concluded that over the last 15 years dual-eligible enrollees had—and continue to have—access to the drugs they most commonly use, regardless of the Part D plan in which they enroll.
• On December 19, 2025, GAO released a report entitled, Health Care Accessibility: Further Efforts Needed to Address Barriers for People with Disabilities. Millions of adults in the U.S. report having some form of a disability, such as a condition that affects vision, movement, hearing, or mental health. Federally funded programs such as Medicare pay for health services, including for people with disabilities. Although federal laws prohibit these programs from discrimination on the basis of disability, people with disabilities may face barriers to obtaining health care. GAO analyzed research literature on health care accessibility and conducted interviews with stakeholders and identified medical facilities, medical equipment, technology, communication with providers, provider training, and bias as potential barriers. GAO recommended that HHS develop plans to collect national-level data from people with disabilities on health care accessibility, share data on results of OCR’s current oversight efforts, and establish detailed plans to help ensure health care accessibility. HHS neither agreed nor disagreed with the recommendations, as discussed in the report.

Hearings & Markups

• On December 15, 2025, the House Veterans’ Affairs Subcommittee on Technology Modernization held a hearing entitled, Ready, Set, Go-Live: Assessing VA’s EHR Modernization Deployment Readiness. Witnesses included: Dr. Neil Evans, Acting Program Executive Director, Electronic Health Record Modernization (EHR) Integration Office, Department of Veterans Affairs (VA); the Honorable Seema Verma, Executive Vice President, Oracle Health and Oracle Life Sciences, Oracle Corporation; and Ms. Carol Harris, Director, Information Technology and Cybersecurity, GAO.
• On December 17, 2025, the House Energy and Commerce Oversight and Investigations Subcommittee held a hearing entitled, Examining Biosecurity at the Intersection of AI and Biology. Witnesses included: Mr. Matthew F. McKnight, MPP, MBA, General Manager, Biosecurity, Ginkgo Bioworks; Mr. James Diggans, PhD, Vice President, Policy and Biosecurity, Twist Bioscience Corporation; Dr. Jassi Pannu, MD, Assistant Professor, Department of Environmental Health and Engineering, Johns Hopkins Bloomberg School of Public Health and Senior Scholar, Johns Hopkins Center for Health Security; and Dr. Fiona Havers, MD, MHS, FIDSA, Former Lead of the Centers for Disease Control and Prevention (CDC) Respiratory Virus Hospitalization Surveillance Network Team.
• On December 17, 2025, the Senate Joint Economic Committee held a hearing entitled, Stop Paying More for Less: Realigning Healthcare Incentives to Improve Outcomes and Reduce Costs. Witnesses included: Mr. Brooks Tingle, CEO, John Hancock Financial; Ed Clarke, MD, Vice President, Chief Medical Officer of the Insurance Division; Mr. Avik Roy, Co-Founder & Chairman, The Foundation for Research on Equal Opportunity; and Mr. Matthew Fiedler, Senior Fellow, Brookings Institution Center on Health Policy.

Other Health Policy News

• On December 16, 2025, CDC adopted the recommendation of the CDC Advisory Committee on Immunization Practices (ACIP) that the vaccination of infants born to women who test negative for hepatitis B be decided on the basis of individual-based decision-making. ACIP made this recommendation by a vote of 8-3 at its December 5, 2025, meeting. Previously, the hepatitis B vaccine was recommended for all infants, regardless of the status of the mother. By adopting a recommendation for individual-based decision-making, CDC is now advising that parents discuss the benefits and risks of vaccination with their health care provider to decide the best course for each infant. If an infant does not receive a birth dose of the hepatitis B vaccine, the CDC recommends that the initial dose should not be administered before two months of age. Additionally, the recommendation does not change the coverage of the vaccine under any payment mechanisms.
  
  Of note, the CDC continues to recommend that a birth dose of hepatitis B vaccine is administered for infants born to mothers who test positive for hepatitis B or whose status is unknown. In September, ACIP had also voted to recommend that all pregnant women be tested for the hepatitis B virus, a test that is covered by all insurance programs.
  
  A press release from CDC on its adoption of the recommendation can be found here.
• December 17, 2025, House Republicans passed the Lower Health Care Premiums for All Americans Act (H.R. 6703) in a 216-211 vote. The legislation includes transparency requirements for pharmacy benefit managers (PBMs), funding for cost-sharing reductions, and language promoting other health care plan options. The bill did not include proposals to extend the ACA EPTCs, which are set to expire on December 31, 2025. While the legislation passed the House, it is unlikely to garner the 60 votes it would need to pass the Senate.
  
  A Democrat-led bill to extend the expiring ACA tax credits for three years is set for a House vote in early January, according to Speaker Mike Johnson (R-LA). This move came after moderate House Republicans Brian Fitzpatrick (R-PA), Mike Lawler (R-NY), Rob Bresnahan (R-PA), and Ryan Mackenzie (R-PA) joined all 214 House Democrats in signing a discharge petition in support of a January vote on a three-year extension of the ACA EPTCs.
  
  Further, while the three-year extension is now expected to pass in the House, it will then move to the Senate, where it must overcome a 60-vote threshold. A three-year extension (S. 3385) has already failed a vote in the Senate by a 51-48 margin, making it unlikely that the House’s bill will be successful.
  
  The House-passed health care bill can be accessed here.
• On December 18, 2025, CMS and HHS OCR released three different proposed rules that would restrict federal funding and protections for gender-affirming care (GAC).
  
  The first rule from CMS would prohibit state Medicaid plans from using federal funds to make payments for “sex-rejecting procedures” for children under 18, as well as prohibit state CHIP from using federal funding to make payments for such procedures for children under the age of 19. The proposed rule defines “sex-rejecting procedures” as any pharmaceutical or surgical intervention attempting to align a child’s physical appearance or body with an identity that differs from the child’s sex by intentionally disrupting or suppressing normal development of biological functions or altering a child’s physical appearance or body. The definition exempts treatments for “medically verifiable disorder[s] of sexual development,” “purposes other than attempting to align a child’s physical appearance or body with a [different sexual identity],” or to treat complications from prior sex-rejecting procedures. The proposed rule also defines sex as an immutable biological classification of male or female and defines both male and female. The full proposed rule can be viewed here.
  
  The second proposed rule from CMS would incorporate a prohibition on sex-rejecting procedures into the Medicare Conditions of Participation (CoPs) for hospitals. If enacted, hospitals that continue to perform these procedures could be prohibited from participating in the Medicare program. The full proposed rule can be found here.
  
  Finally, the proposed rule from OCR clarifies that the definitions of “disability” and “individual with a disability” specifically exclude “gender dysphoria not resulting from physical impairments.” OCR states that this clarification is necessary to resolve ambiguity introduced in the preamble to the 2024 Final Rule and to ensure compliance with the best reading of the plain language of the governing statute.
  
  As a result, OCR is proposing that individuals with gender dysphoria not be afforded the protections provided by law to individuals with disabilities. The full proposed rule can be found here.
  
  Both CMS proposed rules will have open public comment periods until February 17, 2026. The OCR proposed rule will have an open public comment period until January 20, 2026.
  
  The HHS press release that includes these proposed rules can be accessed here.
• On December 19, 2025, the Trump Administration signed deals with nine pharmaceutical companies to lower drug prices for some Americans in exchange for a three-year reprieve from threatened tariffs on their products. The companies are Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Genentech, Gilead, GSK, Merck, Novartis and Sanofi. The agreements require the nine companies to offer medicines at a deep discount off the list price when selling directly to American patients through TrumpRx. Additionally, the agreements will provide that every State Medicaid program in the country can access MFN drug prices on products made by the nine companies.
  
  These pledges mean that 14 of 17 drugmakers targeted by the Administration this summer have agreed to lower prices for the Medicaid program for low-income and disabled people, sell discounted drugs directly to consumers, and launch medicines for the same prices in the U.S. as they do abroad, also known as Most Favored Nation (MFN) pricing. The companies that signed the deals earlier are Pfizer, AstraZeneca, EMD Serono, Eli Lilly and Novo Nordisk. Additionally,  the nine newly-pledged companies will also contribute to the Strategic Active Pharmaceutical Ingredients Reserve (SAPIR), donating six-month supplies of Active Pharmaceutical Ingredients (APIs) and committing to manufacture those APIs into finished medicines during emergencies.
  
  A fact sheet can be found here.
• On December 19, 2025, the HHS Office of the Deputy Secretary and Assistant Secretary for Technology Policy (ASTP) and Office of the National Coordinator for Health Information Technology (ONC) (collectively, ASTP/ONC) announced the release of a Request for Information (RFI) seeking broad public input on how HHS can accelerate the adoption and use of artificial intelligence (AI) as part of clinical care. This RFI builds on the recently published HHS AI Strategy and the administration’s overall AI policy framework. HHS is especially interested in comments from those building AI tools for clinical settings, those buying or implementing AI tools for clinical settings, and those who want to use AI in clinical care but face barriers. Comments will inform how HHS uses regulation, reimbursement, and research and development.
  
  Responses are also encouraged to address long-term health care challenges, such as managing conditions like frailty and dementia, and to consider trends that will shape future care delivery. Feedback will inform coordinated efforts across HHS divisions as part of its broader AI strategy.
  
  The RFI can be found here. A press release can be found here. The HHS AI Strategy can be found here. The Administration’s overall AI policy framework can be found here.

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