Health Care Week in Review | House Passes Fiscal Year 2026 Spending Bills; Health Insurance CEOs Testify on Rising Costs of Healthcare

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• On January 20, 2026, the Food and Drug Administration (FDA) released draft guidance entitled, M4Q(R2) The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality. The draft guidance is intended to establish a globally harmonized framework to organizing and presenting quality data included in registration applications for medicinal products for human use. The draft guidance updates the quality section of the common technical document (CTD) to further improve registration and life cycle management efficiency, facilitate digitalization and knowledge management, and support provisions for emerging technologies.
• On January 20, 2026, FDA released draft guidance entitled, Minimal Residual Disease and Complete Response in Multiple Myeloma: Use as Endpoints to Support Accelerated Approval. This guidance provides recommendations to sponsors about using minimal residual disease (MRD) and complete response (CR) in multiple myeloma as primary endpoints in trials evaluating drug and biological products intended to treat patients with multiple myeloma (MM) to support approval under accelerated approval. For the purpose of this guidance, the MRD endpoint refers to MRD negativity rate as assessed in the bone marrow by either flow cytometry- or sequencing-based methods in patients who have achieved a CR. The definition of CR includes patients who achieved CR or stringent CR.
• On January 20, 2026, FDA released a notice entitled, Authorization of Emergency Use of Certain Medical Devices During COVID-19; Availability. FDA is announcing the issuance of Emergency Use Authorizations (EUAs) for certain medical devices related to COVID-19. FDA has issued the EUAs listed in this document under the Federal Food, Drug, and Cosmetic Act (FD&C Act). Under the FD&C Act, FDA is required to publish in the Federal Register a notice of each EUA, and each termination or revocation of an EUA, as well as an explanation of the reasons for the action. These EUAs contain, among other things, conditions on the emergency use of the authorized products. The Authorizations follow the February 4, 2020, determination by the Department of Health and Human Services (HHS) Secretary, as amended on March 15, 2023, that there is a public health emergency, or a significant potential for a public health emergency, that affects, or has a significant potential to affect, national security or the health and security of U.S. citizens living abroad and that involves the virus that causes COVID-19, and the subsequent declarations on February 4, 2020, March 2, 2020, and March 24, 2020, that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of the virus that causes COVID-19, personal respiratory protective devices, and medical devices, including alternative products used as medical devices, respectively, subject to the terms of any authorization issued under the FD&C Act.
• On January 21, 2026, FDA released draft guidance entitled, FDA Records Access Authority for Cosmetic Products. The purpose of this document is to provide guidance to industry on FDA's authority to access and copy records related to cosmetic products under sections 605, 610, and 704 of the FD&C Act. Section 605 (21 U.S.C. 364a) specifies that FDA has access to adverse event report records during an inspection under section 704. Section 610 (21 U.S.C. 364f) authorizes FDA to access and copy certain records if FDA has a reasonable belief that a cosmetic product, including an ingredient in the product, and any other cosmetic product that the FDA reasonably believes is likely to be affected in a similar manner, is likely to be adulterated such that the use or exposure to such product presents a threat of serious adverse health consequences or death to humans. Section 704(a)(1) (21 U.S.C. 374(a)(1)) extends FDA’s inspectional authority over all records and other information described in sections 605, 606, and 610 from facilities that manufacture and process cosmetic products, when the standard for records inspection under those sections applies.
• On January 22, 2026, the National Institutes of Health (NIH) released a notice entitled, Charter Amendments, Establishments, Reestablishments, Renewals, and Terminations; Sickle Cell Advisory Committee. In the notice, NIH announced the reestablishment of the Sickle Cell Disease Advisory Committee. The Director, NIH, has determined that the current activities of the Sickle Cell Disease Advisory Committee are in the public interest in connection with the performance of duties imposed on NIH by law, and that these duties can best be performed through the advice and counsel of the committee.
• On January 22, 2026, FDA released draft guidance entitled, Cuffless Non-invasive Blood Pressure Measuring Devices – Clinical Performance Testing and Evaluation. This draft guidance document provides FDA’s recommendations on clinical performance testing and evaluation to support premarket submissions for cuffless non-invasive blood pressure measuring devices. The recommendations reflect current review practices and are intended to promote consistency and facilitate efficient review of cuffless non-invasive blood pressure measuring device submissions.
• On January 23, 2026, HHS released guidance entitled, Nondiscrimination Protections under the Church Amendments; Recission. Pursuant to Section 1 of Executive Order (EO) 14182, Enforcing the Hyde Amendment, to end the forced use of Federal taxpayer dollars to fund or promote elective abortion, and the direction under EO 14219, Ensuring Lawful Governance and Implementing the President’s ‘Department Of Government Efficiency’ Deregulatory Initiative, to rescind or modify “regulations that are based on anything other than the best reading of the underlying statutory authority or prohibition,” HHS, Office for Civil Rights (OCR) hereby rescinds Guidance on Nondiscrimination Protections under the Church Amendments issued September 17, 2021.

Event Notices

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

• 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 Advisory Council for Nursing Research. This is a virtual meeting 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: The Centers for Disease Control and Prevention (CDC) announced a meeting of the Subcommittee on Procedures Reviews of the Advisory Board on Radiation and Worker Health. This is a virtual meeting 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 sessions 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 29, 2026: NIH announced a meeting of the Council of Councils. 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 3, 2026: NIH announced a meeting of the National Institute on Drug Abuse. This is a hybrid meeting with some sessions open to the public.
• **February 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.
• February 6, 2026: NIH announced a meeting of the National Advisory Council on Minority Health and Health Disparities. This is a virtual meeting open to the public.
• February 6, 2026: NIH announced a meeting of the National Cancer Advisory Board Ad hoc Working Group on Extramural Research Concepts and Programs. This is a hybrid meeting open to the public.
• February 6, 2026: HHS announced a Tribal consultation on the proposed rule entitled, Modifications to the HIPAA Privacy Rule to Support, and Remove Barriers to, Coordinated Care and Individual Engagement. This is a virtual 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, 2026: HHS announced a meeting of the Advisory Council on Alzheimer’s Research, Care, and Services. This is a hybrid meeting 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.
• February 10, 2026: FDA announced a roundtable discussion with small tobacco product manufacturers to solicit input on premarket tobacco product application (PMTA) submissions for electronic nicotine delivery systems (ENDS) products. This is a hybrid meeting open to the public.
• February 11, 2026: NIH announced a meeting of the National Advisory Neurological Disorders and Stroke Council. This is a virtual meeting open to the public.
• February 13, 2026: NIH announced a meeting of the National Advisory Eye Council. This is a virtual meeting open to the public.
• February 19, 2026: CDC announced a meeting of the Advisory Board on Radiation and Worker Health (ABRWH). This is a hybrid meeting open to the public.
• **February 19, 2026: The Assistant Secretary for Technology Policy (ASTP) announced a meeting of the Health Information Technology Advisory Committee. This is a virtual meeting open to the public.
• **February 23-24, 2026: HHS announced a meeting of the Physician-Focused Payment Model Technical Advisory Committee (PTAC). This is a hybrid 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 16, 2026: NIH announced a meeting of the National Cancer Advisory Board. This is a hybrid 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.
• 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 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.
• 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 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: ASTP announced a meeting of the Health Information Technology Advisory Committee. This is a hybrid meeting 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.
• 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.
• **June 15-16, 2026: HHS announced a meeting of PTAC. This is a hybrid meeting 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: 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.
• **October 29, 2026: NIH announced a meeting of the National Heart, Lung, and Blood Advisory Council. This is a hybrid 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: HHS announced a meeting of PTAC. This is a hybrid meeting open to the public.

Reports, Studies & Analyses

• On January 22, 2026, the Government Accountability Office (GAO) released a report entitled, Organ Transplantation: HHS Action Needed to Improve Lifesaving Program. GAO reported that HHS has overseen organ allocation services since 1984, using the same contractor to do so, until recently. In 2024, HHS entered into contracts to assess weaknesses in organ allocation services, as part of a modernization initiative. According to GAO the assessments target issues, including inequitable organ allocation and insufficient investigation of serious events, such as beginning to recover organs before patient death. However, GAO found that HHS has not yet developed detailed plans for the next initiative phase, including how it will make reforms to address identified weaknesses. GAO also reported that HHS has not assessed the risks associated with its contractor providing supplementary services outside of its HHS contract, and charging a related monthly fee to transplant programs. GAO stated that these supplementary services and fees raise several concerns, including whether the services should be provided as part of the contractor’s agreement with HHS and that transplant programs may be paying the fee without realizing it is optional. GAO concluded that assessing the risks associated with this contractor activity, and making changes as appropriate, would better position HHS to ensure it is effectively overseeing its contractor, which has a crucial role in ensuring lifesaving organs are provided to patients effectively and safely. In 2021, HHS formed a coordination group to improve the organ transplantation system, but GAO found that the group’s action plan does not include specific, actionable steps with milestone completion dates and measures to gauge success of actions taken. GAO recommended that HHS develop detailed plans for the next phase of the modernization initiative, assesses risks associated with its contractor’s supplementary services and fee, and that HHS’s coordination group include in its action plan actionable steps with milestones to gauge success of actions taken. HHS agreed with these recommendations.

Hearings & Markups

• On January 21, 2026, the House of Representatives Judiciary Committee, Subcommittee on Crime and Federal Government Surveillance, held a hearing entitled, When Public Funds Are Abused: Addressing Fraud and the Theft of Taxpayer Dollars. Witnesses included: Ms. Jennifer Larson, Founder and CEO, Holland Autism Center and Clinic; Mr. Nick Shirley, YouTuber and content creator; Mr. Scott Dexter, Former Wyoming, Minnesota police officer and former fraud investigator, Minnesota Department of Human Services; and Mr. Dylan Hedtler-Gaudette, Acting Vice President, Policy and Government Affairs, Project on Government Oversight.
• On January 21, 2026, the House Committee on the Budget held a hearing entitled, Reverse the Curse: Skyrocketing Health Care Costs and America's Fiscal Future. Witnesses included: Dr. Benedic Ippolito, Senior Fellow, American Enterprise Institute; Mr. Avik Roy, Co‑Founder and Chairman, Foundation for Research on Equal Opportunity; Mr. Joel White, President, Council for Affordable Health Coverage; and Ms. Rena Bumbray-Graves, home care worker.
• On January 21, 2026, the House Committee on Veterans’ Affairs Subcommittee on Economic Opportunity held a legislative hearing on 14 bills, including:
• H.R. 982, the Warriors to Workforce Act;
• H.R. 2878, the Daniel J. Harvey, Jr. and Adam Lambert Improving Servicemember Transition to Reduce Veteran Suicide Act;
• H.R. 4105, the VET Act of 2025;
• H.R. 5634, the Veterans Flight Training Responsibility Act of 2025;
• Discussion Draft: the CRUISE Act;
• Discussion Draft: the Improving Mental Health Care and Coordination for Homeless Veterans Act;
• Discussion Draft: the Improving Emerging Tech Opportunities for Veterans Act;
• Discussion Draft: the Affordable Housing Guarantee Act;
• H.R. 3159, the Improving SCRA Benefit Utilization Act;
• H.R. 5436, To amend title 38, United States Code, to prohibit an educational institution from withholding a transcript from an individual who pursued a course or program of education at such institution using Post-9/11 educational assistance;
• Discussion Draft: To amend title 38, United States Code, to require the Secretary of Veterans Affairs to submit to Congress a quarterly report on housing loans insured, guaranteed, or under laws administered by the Secretary, and for other purposes; and
• Discussion Draft: the Veteran Housing Promise Act.
• On January 22, 2026, the House Energy and Commerce Committee, Subcommittee on Health, held a hearing entitled, Lowering Health Care Costs for All Americans: An Examination of Health Insurance Affordability. Witnesses included: Mr. Stephen Hemsley, Chief Executive Officer, UnitedHealth Group; Mr. David Joyner, Chairman and Chief Executive Officer, CVS Health; Ms. Gail Boudreaux, President and Chief Executive Officer, Elevance Health; Mr. David Cordani, President, Chief Executive Officer, and Chairman of the Board, The Cigna Group; Mr. Paul Markovich, President and Chief Executive Officer, Ascendiun; and Ms. Ellen Allen, Executive Director, West Virginians for Affordable Health Care.
• On January 22, 2026, the House Ways and Means Committee held a hearing entitled, Full Committee Hearing with Health Insurance CEOs. Witnesses included: Mr. Stephen Hemsley, Chief Executive Officer, UnitedHealth Group; Mr. David Joyner, Chief Executive Officer, CVS Health; Ms. Gail Boudreaux, President and Chief Executive Officer, Elevance Health; Mr. David Cordani, Chief Executive Officer, The Cigna Group; Mr. Paul Markovich President and Chief Executive Officer, Ascendiun; and Ms. ReShonda Young, Owner, TnK Health and Nutrition.

Other Health Policy News

• On January 22, 2026, the House of Representatives advanced the last four fiscal year (FY) 2026 spending bills. Of note, the funding bill for HHS passed in a bipartisan 341 to 88 vote.  The bill includes a total of $116 billion of discretionary spending for HHS. Of note, the bill allocates $8.9 billion for the Health Resources and Services Administration (HRSA), $9.2 billion for CDC, $48.7 billion for NIH, and $4.1 billion for the Centers for Medicare & Medicaid Services (CMS).
  
  The spending bill also includes bipartisan, bicameral healthcare legislation which would extend several public health programs through the December 31, 2027. It also extends the Acute Hospital Care at Home waiver for five years. The extension preserves a physician-led model that delivers hospital-level care in the home. The bill also includes Medicare telehealth extension through December 31, 2027, including continuation of geographic and originating-site flexibilities, suspension of the in-person requirement for telemental health services, expanded telehealth use at federally qualified health centers (FQHCs) and rural health clinics (RHCs), and authorization of telehealth for hospice recertification. The bill also includes a number of bipartisan health care policies, including reforms for pharmacy benefit managers (PBMs) and a directive to state Medicaid programs to streamline out-of-state provider enrollment for pediatric providers. The bill would also require separate unique health identifiers for services furnished by an off-campus outpatient department of a provider. Other notable provisions include a boost in funding for community health centers to $4.6 billion for FY 2026 and another that would allow Medicare coverage for multi-cancer early detection screening tests.
  
  The full bill text and summaries can be found here.
• On January 22, 2026, several health insurance executives testified before the House Energy and Commerce and Ways and Means committees in back-to-back hearings to address rising health-care costs. One of the executives, Mr. Paul Markovich, president and CEO of Ascendiun, wrote in his opening testimony that lawmakers should revive the Affordable Care Act (ACA) enhanced premium tax credits (EPTCs) that expired at the end of 2025.
  
  Of note, the other four CEOs did not mention the ACA EPTCs in their opening testimonies and instead suggested other solutions focused on improving health outcomes, targeting hospital costs, and reducing drug prices. UnitedHealth Group CEO, Mr. Stephen Hemsley, promised to return any profits it makes in the ACA marketplace to consumers in 2026.
  
  Throughout the hearings, lawmakers from both parties presented differing views on the primary drivers of unaffordability, with Republicans often citing the ACA and insurer consolidation, while Democrats focused on the expiration of ACA EPTCs and high insurer profits. CEOs offered their perspectives on the root causes of rising costs, frequently attributing them to underlying medical and pharmaceutical expenses, and proposed solutions centered on value-based care, transparency, and competition.
• On January 22, 2026, the U.S. formally completed its withdrawal from the World Health Organization (WHO), one year after President Trump signed an executive order initiating the process. The Administration cited what it described as WHO’s mishandling of the early COVID‑19 response—including delays in declaring a public health emergency—and argued that the organization unfairly criticized U.S. actions such as early travel restrictions. Under a 1948 joint resolution governing U.S. participation in WHO, withdrawal requires a one‑year notice and the payment of outstanding dues. Although the U.S. had roughly $260 million in unpaid assessments, HHS officials claimed there is no requirement in statute to settle the debt before exiting the agency. Public health experts have criticized the departure, warning that it may disadvantage the U.S. in responding to future domestic and global health emergencies. WHO leaders also expressed concern, calling the withdrawal harmful both to the U.S. and to global health security.

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