Health Care Week in Review | Senate Bipartisan 340B Working Group Introduces Legislation; Senate Advances FY 2027 CR

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 August 4, 2026, the Centers for Medicare & Medicaid Services (CMS) released a notice entitled, Privacy Act; Matching Program. In accordance with the Privacy Act of 1974, as amended, CMS is providing notice of the re-establishment of a matching program between CMS and the Department of War for “Verification of Eligibility for Minimum Essential Coverage Under the Patient Protection and Affordable Care Act through a Department of War Health Benefits Plan.”
• On August 5, 2026, the Food and Drug Administration (FDA) released an order entitled, Medical Devices: Radiology Devices; Classification of the Fludeoxyglucose F18-Guided Radiation Therapy System. FDA is classifying the fludeoxyglucose F18-guided radiation therapy system 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 classification of the fludeoxyglucose F18-guided radiation therapy system. FDA is taking this action because the agency has determined that classifying the device into class II will provide a reasonable assurance of safety and effectiveness of the device. FDA believes this action will also enhance patients’ access to beneficial innovative devices, in part by reducing regulatory burdens.
• On August 5, 2026, FDA released a notice entitled, Authorization of Emergency Use of an In Vitro Diagnostic Device in Response to an Outbreak of Mpox. FDA announced the issuance of an Emergency Use Authorization (EUA) for Seegene USA’s Allplex HSV-1&2/VZV/MPXV Assay, an in vitro diagnostic test designed to simultaneously detect and differentiate monkeypox virus (MPXV) clades I and II, herpes simplex virus type 1 (HSV-1), herpes simplex virus type 2 (HSV-2), and varicella-zoster virus (VZV). The EUA, effective July 9, 2026, was issued under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) in response to the ongoing public health emergency (PHE) related to mpox. FDA determined that the test met the statutory criteria for emergency authorization, including the potential to effectively diagnose infections associated with the declared PHE and the absence of adequate, approved, and available alternatives. The agency noted that the EUA builds on the Department of Health and Human Services’ (HHS) 2022 declaration that circumstances justified the emergency use of diagnostic tests for monkeypox virus detection. According to FDA, the assay is intended to support clinicians by improving diagnostic capabilities for mpox and other viral infections that may present with similar symptoms, helping inform timely patient management and public health responses.
• On August 5, 2026, FDA released guidance entitled, Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to their Microbiological Effects on Bacteria of Human Health Concern. This guidance updates FDA’s qualitative risk assessment framework for assessing whether antimicrobial drugs administered to food-producing animals could contribute to antimicrobial resistance. In particular, the guidance revises and clarifies FDA’s ranking of medically important antimicrobial drugs based on their importance to human medicine and emphasizes that these rankings should be used as one component of a broader risk assessment process rather than as standalone risk management tools. FDA stated that the revisions reflect advances in scientific understanding, changes in human and veterinary medicine since the guidance was first issued in 2003, and feedback received from stakeholders during multiple public comment periods. According to the agency, the updated guidance is intended to support the review of new animal drug applications while helping preserve the effectiveness of antimicrobial drugs that are important for treating human disease.
• On August 6, 2026, the Administration for Children and Families (ACF) released a notice of proposed rulemaking (NPRM) entitled, Reducing Federal Burden for Head Start Programs. According to the NPRM, ACF would comprehensively revise the Head Start Program Performance Standards by rescinding most existing regulations and replacing them with a streamlined framework intended to reduce federal requirements, eliminate regulatory duplication, and increase state and local flexibility. The proposal would shift authority over areas such as classroom group size, staff-to-child ratios, transportation practices, and background check requirements to states, while reducing federal oversight of curriculum implementation, family engagement processes, and other operational requirements. At the same time, the proposal would maintain statutory requirements established under the Head Start Act, including provisions related to governance, eligibility, school readiness, services for children with disabilities, fiscal accountability, and child safety. The NPRM would also strengthen certain health-focused requirements by encouraging nutrient-dense meals and requiring at least 30 minutes of physical activity for every three and a half hours a child participates in the program. According to ACF, the proposed changes are intended to reduce administrative burden, improve operational efficiency, and allow programs to devote more resources to direct services, with the agency estimating significant cost savings and the potential expansion of Head Start and Early Head Start enrollment capacity if the NPRM is finalized.
• On August 7, 2026, FDA released a proposed rule entitled, Radiology Devices; Reclassification of Digital Breast Tomosynthesis System. FDA is proposing to reclassify digital breast tomosynthesis (DBT) systems, product code OTE, which are postamendments class III devices, from class III (premarket approval) into class II (special controls), subject to premarket notification. FDA is also proposing a new device classification regulation with the name “Digital Breast Tomosynthesis System,” to identify these devices along with special controls that FDA believes are necessary to provide a reasonable assurance of the safety and effectiveness of these devices.
• On August 7, 2026, CMS released a notice entitled, Medicare Program; Regulatory Alignment for Predictable and Immediate Device (RAPID) Coverage Pathway. This notice with comment period provides information to the public on the process CMS will use to provide accelerated Medicare coverage through the Regulatory Alignment for Predictable and Immediate Device (RAPID) coverage pathway for new innovative technologies. The RAPID coverage pathway leverages existing processes to provide expedited national Medicare coverage for eligible technologies. This notice with comment period solicits public comment on the proposed RAPID coverage pathway.

Event Notices

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

• August 10, 2026: The National Institutes of Health (NIH) announced a meeting of the National Institute of Neurological Disorders and Stroke. This is a hybrid meeting with some sessions open to the public.
• August 24, 2026: NIH announced a meeting of the Advisory Council on Parkinson's Research, Care, and Services (ACPRCS). This is a virtual meeting open to the public.
• August 24, 2026: CMS announced a meeting of the Advisory Panel on Hospital Outpatient Payment. This is a virtual meeting open to the public.
• August 25, 2026: FDA announced a meeting entitled, Patient-Focused Drug Development for Nonhealing Chronic Wounds. This is a hybrid meeting open to the public.
• August 26, 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.
• August 26, 2026: NIH announced a meeting of the Muscular Dystrophy Coordinating Committee (MDCC). This is a virtual meeting open to the public.
• August 31, 2026: NIH announced a meeting of the National Institute on Minority Health and Health Disparities. This is a virtual meeting with some sessions open to the public.
• September 2, 2026: NIH announced a meeting of the National Cancer Institute (NCI). This is a virtual meeting with some sessions open to the public.
• **September 4, 2026: NIH announced a meeting of the National Deafness and Other Communication Disorders Advisory Council. This is a hybrid meeting open to the public.
• **September 9, 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.
• September 9-10, 2026: HHS announced a meeting of the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria (PACCARB). This is a hybrid meeting open to the public.
• September 10, 2026: NIH announced a meeting of the National Advisory Environmental Health Sciences Council (NAEHSC). This is a virtual 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 virtual meeting with some sessions open to the public.
• September 10-11, 2026: NIH announced a meeting of the Council of Councils. This is a hybrid meeting with some sessions open to the public.
• September 11, 2026: NIH announced a meeting of the National Advisory Council for Complementary and Integrative Health (NCCIH). This is a hybrid meeting with some sessions open to the public.
• September 14, 2026: FDA announced a meeting on the potential future therapeutic use of psychedelic drugs. This is a hybrid hearing open to the public.
• September 14-15, 2026: HHS announced a meeting of the Physician-Focused Payment Model Technical Advisory Committee (PTAC). This is a hybrid meeting open to the public.
• September 15, 2026: CDC announced a meeting of the ICD-10 Coordination and Maintenance Committee. This is a virtual meeting open to the public.
• September 15, 2026: NIH announced a meeting of the National Arthritis and Musculoskeletal and Skin Diseases Advisory Council. This is a virtual meeting with some sessions open to the public.
• September 15, 2026: NIH announced a meeting of the National Advisory Council for Nursing Research. This is a virtual meeting with some sessions open to the public.
• September 15-16, 2026: CMS announced a meeting of the Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests (CDLTs). This is a virtual 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 15-16, 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.
• September 16, 2026: NIH announced a meeting of the National Institute of Biomedical Imaging and Bioengineering. This is an in-person meeting with some sessions open to the public.
• September 18, 2026: NIH announced a meeting of the Diabetes Mellitus Interagency Coordinating Committee (DMICC). This is a hybrid meeting open to the public.
• September 18, 2026: NIH announced a meeting of the National Center for Advancing Translational Sciences Advisory Council. This is a virtual meeting with some sessions open to the public.
• September 23, 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.
• September 23, 2026: NIH announced a meeting of the AIDS Research Advisory Committee. This is a virtual meeting open to the public.
• September 24, 2026: The Office of the National Coordinator for Health IT (ONC) announced a meeting of the Health Information Technology Advisory Committee. This is a virtual meeting open to the public.
• September 28-29, 2026: NIH announced a meeting of the National Advisory Council for Human Genome Research. This is a hybrid meeting with some sessions open to the public.
• October 8, 2026: CDC announced a meeting of the Advisory Board on Radiation and Worker Health (ABRWH). This is a virtual meeting open to the public.
• October 14, 2026: NIH announced a meeting of the Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD) National Advisory Child Health and Human Development Council. This is an in-person meeting with some sessions open to the public.
• October 16, 2026: NIH announced a meeting of the NIH Clinical Center Research Hospital Board. This is a hybrid meeting open to the public.
• October 20, 2026: NIH announced a meeting of the Advisory Committee on Research on Women’s Health. This is a virtual meeting open to the public.
• October 28, 2026: NIH announced a meeting of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). This is a virtual meeting with some sessions open to the public.
• October 28, 2026: CDC announced a meeting of the Subcommittee on Procedures Reviews (SPR) of the ABRWH. This is a virtual meeting open to the public.
• November 5, 2026: ONC announced a meeting of the Health Information Technology Advisory Committee (HITAC). This is a virtual meeting open to the public.
• December 1, 2026: NIH announced a meeting of NCI. This is an in-person meeting with some sessions open to the public.
• December 7-8, 2026: NIH announced a meeting of NICHD. This is a hybrid meeting open to the public.
• December 8-9, 2026: HHS announced a meeting of PTAC. This is a hybrid meeting open to the public.
• January 16, 2027: HHS announced a meeting of PACCARB. This is a virtual meeting open to the public.

Reports, Studies & Analyses

• On August 5, 2026, the HHS Office of Inspector General (OIG) released a report entitled, Department of Health and Human Services Met Many Requirements, but It Did Not Fully Comply With the Payment Integrity Information Act of 2019 for Fiscal Year 2025. OIG found that HHS met many of the reporting requirements under the Payment Integrity Information Act of 2019 (PIIA) for fiscal year (FY) 2025 but did not fully comply with all statutory and Office of Management and Budget (OMB) requirements. As part of its review, OIG evaluated HHS’s reporting on improper payments across several programs identified as susceptible to significant improper payments, including Medicare Fee-for-Service (FFS), Medicare Advantage (Part C), Medicare Prescription Drug Benefit (Part D), Medicaid, the Children’s Health Insurance Program (CHIP), Advance Premium Tax Credits (APTC), Temporary Assistance for Needy Families (TANF), Foster Care, the Child Care and Development Fund (CCDF), and Head Start. The audit also assessed HHS’s internal controls and methodologies for estimating improper payments, with particular focus on Medicare FFS and CCDF. OIG’s audit found that while HHS generally satisfied many PIIA requirements related to improper payment reporting and oversight, HHS did not achieve full compliance for FY 2025, highlighting ongoing challenges in accurately measuring, reporting, and reducing improper payments across major federal health and human services programs.
• On August 6, 2026, the Government Accountability Office (GAO) released a report entitled, Wearable Technologies: Potential Benefits and Challenges in Clinical Decision-Making. GAO examined the potential role of wearable devices with health-related features, such as continuous glucose monitors and smartwatches, in clinical decision-making and found that these technologies may help clinicians diagnose and treat patients more effectively by providing continuous health data, supporting more personalized care, and expanding opportunities for remote patient monitoring. The report also explored how artificial intelligence (AI) could enhance wearables by improving data analysis and decision-making capabilities, while noting that significant questions remain regarding the extent to which AI-enabled wearables can autonomously support clinical care. At the same time, GAO identified challenges related to device accuracy and reliability, integration into clinical workflows, data privacy, liability concerns, and the complexity of the health technology market. To address these issues, GAO outlined three policy options: (1) continuing current digital health initiatives; (2) improving the integration of wearable data into clinical workflows and health care infrastructure; and (3) encouraging stronger device performance through independent certification and public reporting mechanisms. Overall, GAO’s report concluded that while wearables have the potential to improve patient care and access to services, particularly for underserved populations, policymakers will need to balance these benefits against implementation, regulatory, and patient safety considerations.

Hearings & Markups

• On August 4, 2026, the Senate Committee on Finance, Subcommittee on Health Care, held a hearing entitled, Building a Resilient Health Care Future with Biotechnology. Witnesses present included: Dr. Alan D. Palkowitz, President and Chief Executive Officer (CEO), Indiana Biosciences Research Institute (IBRI); Dr. Michelle Rozo, Vice Chair, National Security Commission on Emerging Biotechnology; Dr. Vera P. Luther, Section Chief of Infectious Disease and International Health, Dartmouth Hitchcock Medical Center, Dartmouth Health; and Mr. Kevin Outterson, Austin B. Fletcher Professor of Law, and Executive Director and Principal Investigator of Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X), Boston University.
• On August 4, 2026, the Senate Committee on the Budget held a hearing entitled, Medicaid: The Reality. Witnesses present included: Dr. Brian Blase, President, Paragon Health Institute; Mr. Jonathan Ingram, Vice President of Policy and Research, Foundation for Government Accountability; and Mr. Andy Schneider, Research Professor of the Practice, Center for Children and Families McCourt School of Public Policy, Georgetown University.

Other Health Policy News

Bipartisan Senate Group Introduces 340B Reform Legislation

On August 5, 2026, the Senate 340B Bipartisan Working Group, made up of three Republican and three Democratic senators, introduced a bill to reform the 340B program, the SUSTAIN 340B Act. This legislation would largely preserve the point-of-purchase discount model, sunsetting the proposed 340B Rebate Model Pilot Program within one year and instead creating an independent data clearinghouse to oversee the prevention of diversion and duplicate discounts. The bill would also codify the ability for covered entities to use contract pharmacies while establishing certain registration and audit requirements for these relationships. However, the SUSTAIN 340B Act greatly increases compliance requirements for covered entities, including placing limitations on eligible patients and the use of child sites and establishing greater reporting, auditing, and transparency obligations.

The full text of the bill is available here. A press release from the Senate 340B Bipartisan Working Group is available here.

Senate CR Delays OMB Grantmaking Rule, Extends Government Funding

On August 7, 2026, the Senate advanced a CR that would extend government funding at current levels until December 11, 2026. Notably, the Senate’s CR contains language delaying finalization of OMB’s proposed Uniform Guidance for federal grantmaking for the duration of the CR. This delay was supported by a bipartisan group of senators responding to concerns from the larger scientific research community that OMB’s proposed Uniform Guidance provided political appointees with too much influence over the grantmaking review process and introduced greater uncertainty into the duration and availability of grant opportunities. The Senate’s CR also reallocates $21.4 million from the Medicare Improvement Fund for disaster relief in the Northern Mariana Islands.

The House passed its own CR legislation on July 21, 2026. The House CR would extend funding levels only to December 4, 2026, and does not include language delaying finalization of the Uniform Guidance. Congress will need to reconcile the differences between the two CRs by September 30, 2026, if it is to avoid a government shutdown.

The full text of the Senate’s CR and a section-by-section summary can be found here. The full text of the House’s CR and a section-by-section summary can be found here.

Senate Budget Committee Examines Medicaid Spending and Program Integrity

On August 4, 2026, the Senate Budget Committee held a hearing entitled, Medicaid: The Reality. Chairman Ron Johnson (R-WI) and some witnesses argued that Medicaid spending and enrollment have grown dramatically, even outpacing initial projections from the expansion of Medicaid by the Affordable Care Act (ACA), and pointed to concerns about improper enrollment, fraud, and abuse of provider taxes and state directed payment (SDP) arrangements. Witnesses Dr. Brian Blase and Mr. Jonathan Ingram contended that federal financing incentives encourage states to prioritize expansion populations and maximize federal reimbursement, while several Republican members called for stronger eligibility verification, more frequent redeterminations, and increased program integrity efforts. Discussions also focused heavily on the role of Medicaid managed care organizations (MCOs), provider reimbursement structures, and state financing arrangements that influence the flow of Medicaid dollars throughout the health care system.

Democratic members countered that Medicaid remains a critical source of coverage for children, low-income families, seniors, and people with disabilities, and warned that recent legislative and regulatory changes could reduce coverage and strain health care providers. Much of the discussion centered on the potential impact on hospitals, clinics, and other providers serving large Medicaid populations, particularly in rural communities where senators cited concerns about service reductions and facility closures. Witness Mr. Andy Schneider argued that Medicaid supports access to preventive care, long-term services, and financial protection for beneficiaries, while Democratic senators highlighted concerns that increased reporting requirements and coverage losses could lead to higher uncompensated care costs and additional pressure on providers. Throughout the hearing, members from both parties expressed support for reducing fraud, but differed sharply on whether recent Medicaid reforms represent necessary program integrity measures or policies that could undermine access to care and provider sustainability.

More information on this hearing is available here.

White House Fraud Task Force Targets Medicaid and Benefits Fraud

On August 5, 2026, Vice President J.D. Vance hosted a roundtable as part of the White House Fraud Task Force. At the roundtable, administration officials pressed Congress to back the task force with legislation aimed at strengthening data sharing, increasing penalties for fraud, and expanding resources for enforcement efforts. Vice President Vance said the task force has identified roughly $230 billion in suspected fraud and prevented an estimated $56 billion in improper payments, framing fraud as both a taxpayer issue and a threat to the sustainability of public benefit programs.

Much of the discussion focused on federal health and human services spending, including Medicaid, where administration officials argued that improved federal-state data sharing could help detect ineligible participation and improper payments. Participants also cited examples of fraud in the Medicare and Medicaid Home Health programs and the Supplemental Nutrition Assistance Program (SNAP) and highlighted the growing use of AI and cross-agency analytics to identify fraud before funds are disbursed.

More information on the roundtable can be found here.

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