Health Care Week in Review | Energy and Commerce Health Subcommittee Reviews the Prescription Drug Supply Chain; HHS Releases Proposed Notice of Benefit and Payment Parameters for 2027

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 February 9, 2026, the Department of Health and Human Services (HHS) released a proposed rule entitled, Patient Protection and Affordable Care Act, Benefit and Payment Parameters for 2027 and Basic Health Program. This proposed rule contains provisions to improve implementation of the Patient Protection and Affordable Care Act, including payment parameters and provisions related to the HHS-operated risk adjustment and risk adjustment data validation (HHS-RADV) programs, as well as 2027 user fee rates for issuers offering qualified health plans (QHPs) through Federally facilitated Exchanges (FFEs) and State-based Exchanges on the Federal platform (SBE-FPs). This proposed rule also includes provisions related to civil money penalties (CMPs) for noncompliant issuers and other responsible entities; standards governing agents, brokers, and web-brokers; the expansion and codification of hardship exemption eligibility; implementation of the State Exchange Improper Payment Measurement (SEIPM); provider access standards and essential community provider standards for QHP certification; QHP certification of non-network plans; a prohibition on issuers from including routine non-pediatric dental services as an Essential Health Benefit (EHB); cost-sharing flexibilities for catastrophic and individual market bronze plans; establishment of catastrophic plans with plan terms of up to 10 consecutive years; QHP issuer quality improvement strategies (QISs); revisions affecting which enrollees are included in Federal Basic Health Program (BHP) payment calculations to States; and seeks comment on potential adjustments to other Federal standards, including the Federal medical loss ratio (MLR) standard in the individual market. This proposed rule also includes amendments to implement certain provisions of the Working Families Tax Cut (WFTC) legislation.
• On February 10, 2026, the Food and Drug Administration (FDA) released a notice entitled, Voluntary Quality Management Maturity Prototype Assessment Protocol Evaluation Program. FDA is announcing an opportunity for a limited number of drug manufacturing establishments to participate in the third year of the voluntary Quality Management Maturity (QMM) Prototype Assessment Protocol Evaluation Program. The Center for Drug Evaluation and Research (CDER) is implementing this voluntary program for manufacturers of CDER-regulated drug products to gain additional experience with the assessment tool and process. The continuation of this voluntary program assures that these assessments enable consistent and meaningful evaluations of establishments’ quality management practices and provide useful feedback for the establishments. This notice outlines the types of establishments FDA is seeking for participation and the process for submitting a request to participate in the program.
• On February 11, 2026, FDA released guidance entitled, Certification Process for Designated Medical Gases. This guidance explains how FDA administers the certification process and describes the annual reporting requirements for designated medical gases (DMGs). Specifically, the guidance discusses what products qualify as DMGs, who must submit a certification request, what information must be submitted, and how FDA will evaluate and act on the request. This draft guidance is being issued to reflect new and revised regulations in several areas to reduce the regulatory burden, as appropriate, for the medical gas industry. This draft guidance revises and replaces the draft guidance of the same name issued in November 2015, which was withdrawn on December 18, 2025.
• On February 12, HHS released a notice entitled, Privacy Act; Systems of Records. In accordance with the Privacy Act of 1974, as amended, HHS is partially modifying an existing system of records maintained by the Office for Civil Rights (OCR), the Program Information Management System (PIMS). The modifications include changing the system of records name to HHS Civil Rights and Health Information Privacy Program Records and affect only certain sections of the System of Records Notice (SORN), so HHS is not republishing the SORN in full. The system of records contains records about individual members of the public who submit or are named or otherwise involved in civil rights, conscience and religious freedom, and health information privacy-related complaints received by and compliance reviews conducted by OCR, and individuals who submit reports to OCR about breaches of unsecured protected health information (PHI) experienced by covered entities and business associates subject to the Health Insurance Portability and Accountability Act (HIPAA) Privacy, Security, Breach Notification, and Enforcement Rules. OCR is modifying it to include information that programs subject to 42 CFR part 2 (“Part 2”) (and, as applicable, a qualified service organization on a Part 2 program’s behalf) report to the Secretary with respect to a breach of unsecured substance use disorder (SUD) patient records maintained by a Part 2 program (“Part 2 records”) and complaints and compliance reviews involving potential violations of Part 2.
• On February 13, 2026, the Health Resources and Services Administration (HRSA) released a notice entitled, Request for Information: 340B Rebate Model Pilot Program. In this notice, HRSA explains that it is continuing to assess whether to implement another 340B Rebate Model Pilot Program and seeks input on how such a model would impact the 340B industry. HRSA invites input on all aspects of a potential 340B rebate model, but specifically seeks input on (1) costs to covered entities; (2) payment timing and potential cash flow impacts for covered entities; (3) rebate denials; (4) data collection by covered entities; (5) manufacturer efforts to avoid duplicate discounts; (6) required reporting; and (7) 340B program integrity and other potential benefits of a rebate pilot. Comments are due March 19, 2026.

Event Notices

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

• February 19, 2026: The Centers for Disease Control and Prevention (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 6, 2026: The National Institutes of Health (NIH) announced a meeting of the National Advisory Mental Health Council. This is a virtual meeting with some sessions open to the public.
• March 11-13, 2026: 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 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 24, 2026: The Department of Veterans’ Affairs (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.
• 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: 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.
• 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 15-16, 2026: HHS announced a meeting of 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

• On February 10, 2026, the Congressional Research Service (CRS) released a report entitled, An Analysis of No Surprises Act (NSA) Independent Dispute Resolution (IDR) Emergency Service Outcomes Relative to In-Network Rates. The No Surprises Act (NSA) established various consumer protections related to surprise billing, specifically related to circumstances in which individuals receive large, unexpected medical bills when they are unknowingly, and potentially unavoidably, treated by out-of-network (OON) providers. The NSA also specifies a methodology to be used to determine how much insurers must pay OON providers for care in specified situations. Under the federal payment methodology, when an insurer and an OON provider cannot agree on the relevant payment amount, either party may initiate an independent dispute resolution (IDR) process before a private arbitrator. The median prevailing offers for emergency service disputes ranged from two and a half to three times the qualifying payment amount (QPA) in 2023 and 2024.
  
  CRS analyzed IDR process emergency service outcomes in 14 states against the in-network rates of IDR-participating providers to compare QPAs, insurer and provider offers, and prevailing offers. For IDR emergency service disputes determined in the first half of 2024, over 95 percent of disputes had a prevailing offer that was above the 2025 median in-network rate among IDR-participating providers, and the median prevailing offer in the IDR process for emergency service was over three times the 2025 median in-network rate among IDR-participating providers. In addition, the median QPA was slightly higher than the 2025 median in-network rate of IDR-participating providers. CRS also highlighted that in all 14 states assessed, the median prevailing offer for emergency service disputes determined in the first half of 2024 was greater than the 2025 median in-network rate of IDR-participating providers; however, the degree to which the median prevailing offer exceeded the median in-network rate of IDR-participating providers varied by state. In Nevada and California, the median prevailing offer was slightly higher than the median in-network rate, whereas Colorado saw a median prevailing offer that was over six times the median in-network rate of Colorado IDR-participating providers. In total, nine states had a median prevailing offer that was more than three times the median in-network rate. Additionally, the relationship between the QPA and median in-network rates varied across states. In six states, the median QPA was less than the median in-network rate; in eight states, it was greater than the median in-network rate.
• On February 10, 2026, the Government Accountability Office (GAO) released a report entitled, Biosafety and Biosecurity: Comparing the U.S. and Selected G20 Members. The Coronavirus Aid, Relief, and economic Security Act (CARES Act) includes a provision for GAO to monitor federal efforts in response to the COVID-19 pandemic. GAO was also asked to compare the biosafety and biosecurity standards of G20 members with U.S. standards. This report examines the extent to which selected G20 members’ publicly available guidance documents reflect (1) selected key components of U.S. biosafety and biosecurity for all biological agents and research and (2) additional precautions of the U.S. biosafety and biosecurity key components specific to high-risk biological agents and research. GAO identified 10 key components that describe steps a U.S. lab should take to mitigate the risks of biological agent research. The U.S. key components include additional precautions for specified high-risk agents—such as Ebola virus—and research. Nine of the 10 selected G20 members in GAO’s review had documents that were comparable to one or more of the U.S key components for all biological agents and research. Guidance documents from Australia, Canada, and China included comparable language to most of the additional precautions GAO identified for U.S. key components of biosafety and biosecurity. GAO reported that national guidance documents addressing biosafety and biosecurity are important, but other factors might also influence a G20 member’s biosafety and biosecurity. For example, Australian officials told GAO that state and territory governments play a role in managing biosecurity, such as responding to animal disease outbreaks.

Hearings & Markups

• On February 11, 2026, the House Veterans' Affairs Committee held a hearing entitled, Opportunities with VHA Reorganization. Witnesses present: The Honorable Douglas A. Collins, Secretary, VA; The Honorable John Bartrum, Under Secretary for Health, VA; Mr. Mark Englebaum Assistant Secretary for Human Resources and Administration, VA; and Mr. Gregory Goins, Acting Chief Operating Officer, Veterans Health Administration, VA.
• On February 11, 2026, the House Energy and Commerce Committee Health Subcommittee held a hearing entitled, Lowering Health Care Costs for All Americans: An Examination of the Prescription Drug Supply Chain. Witnesses present: Ms. Lori M. Reilly, Esq., Chief Operating Officer, PhRMA; Mr. John F. Crowley,President and CEO, Biotechnology Innovation Organization; Mr. John Murphy, President and CEO, Association for Accessible Medicines; Mr. David Marin, President and CEO, Pharmaceutical Care Management Association; Ms. Angie Boliver, President and CEO, Healthcare Supply Chain Association; Mr. Chester “Chip” Davis, Jr., President and CEO, Healthcare Distribution Alliance; Mr. James Gelfand, President and CEO, The ERISA Industry Committee; Mr. Douglas Hoey, Chief Executive Officer, National Community Pharmacists Association; and Ms. Rachel E. Sachs, Professor of Law, Washington University in St. Louis.
• On February 11, 2026, the Senate Veterans’ Affairs Committee held a hearing entitled, Building a 21st Century VA Health Care System: Assessing the Next Generation of VA’s Community Care Network. Witnesses present: The Honorable Richard F. Topping, Assistant Secretary for Management and Chief Financial Officer, Office of the Secretary, VA;   Ms.  Alicia Skolrood,  Executive Director, Integrated External Networks, Office of Integrated Veteran Care, Veterans Health Administration, VA; and Ms.  Leigh Ann Searight, Deputy Assistant Inspector General for Audits and Evaluations, Office of the Inspector General, VA.
• On February 11, 2026, the Senate Special Committee on Aging held a hearing entitled, The Doctor Is Out: How Washington’s Rules Drove Physicians Out of Medicine. Witnesses present: Dr. Alma Littles M.D., Dean & Chief Academic Officer, Florida State University College of Medicine; Mr. Lee Gross M.D., Founder, Epiphany Health Direct Primary Care, Mr. Jeffrey Smith CPA, MBA, FACMPE, CGMA, Incoming Board Chair of Medical Group Management Association (MGMA) and Chief Executive Officer, Piedmont HealthCare; and Mr. Corey Feist JD, MBA, Co-Founder and Chief Executive Officer, Lorna Breen Heroes’ Foundation.

Other Health Policy News

• On February 11, 2026, the House Energy and Commerce Subcommittee on Health held a hearing entitled, Lowering Health Care Costs for All Americans: An Examination of the Prescription Drug Supply Chain. The hearing examined the cost drivers and structural complexities within the U.S. prescription drug supply chain. The panel featured nine witnesses representing brand‑name and generic drug manufacturers, pharmacy benefit managers (PBMs), drug distributors, pharmacists, and employer purchasers. Over the course of the hearing, witnesses defended their roles in the system while frequently attributing rising prescription drug costs to other sectors.
  
  A central tension throughout the witnesses’ testimony involved balancing incentives for U.S. biomedical innovation with efforts to improve patient affordability. Lawmakers from both parties focused particular attention on the market power and opaque business practices of PBMs, as well as the effects of vertical and horizontal consolidation across the health care industry. This included discussion of arrangements in which large insurers own PBMs and pharmacies, raising questions about competition and potential conflicts of interest.
  
  There was clear policy divide over the impact of the Inflation Reduction Act (IRA) compared with recent Trump Administration proposals such as “Trump Rx” and allegations of undisclosed pricing arrangements. Despite these disagreements, lawmakers from both parties expressed interest in increasing pricing transparency, strengthening competition for generic and biosimilar drugs, and addressing the pressures faced by independent community pharmacies.
  
  More information on this hearing can be found here.
• On February 11, 2026, Senators Josh Hawley (R-MO) and Elizabeth Warren (D-MA) introduced the Break Up Big Medicine Act. The bill’s sponsors argue that breaking up these common ownerships would reduce conflicts of interests and enhance market competition, particularly for independent pharmacies and physicians.
  
  The bill would prohibit a parent company from owning a medical provider or management services organization and a PBM or an insurer. Additionally, it would prohibit parent companies of a prescription or medical device wholesaler from owning a medical provider or management services organization. Lawmakers say these restrictions are designed to prevent companies from holding conflicting positions on both the purchasing and pricing sides of the healthcare market. The legislation also outlines a compliance framework requiring companies found in violation to separate conflicting business units within one year.
  
  Per the bill, the Federal Trade Commission, the Department of Justice, HHS, state attorneys general, and private parties would be empowered to bring legal action against violators. Regulators would additionally be authorized to block future mergers or transactions that could recreate the types of conflicts the bill seeks to eliminate.
  
  A press release on the bill’s introduction, which included the bill text and a one-pager, can be found here.

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