Health Care Week in Review | CMS Requests Stakeholder Feedback to Guide Implementation of PBM Reforms in Medicare Part D; Senate HELP Committee Advances Several Public Health Bills

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 June 16, 2026, the Administration for Children and Families (ACF) released a final rule entitled, Reducing Bureaucracy and Burden for Human Services and Emergency Response Programs - Repatriation Program. This final rule amends the Care and Treatment of Mentally Ill Nationals of the United States, Returned from Foreign Countries regulations and the Assistance for United States Citizens Returned from Foreign Countries regulations to eliminate unnecessary or obsolete regulations.
• On June 16, 2026, the Food and Drug Administration (FDA) released a rule entitled, Medical Devices: Gastroenterology-Urology Devices; Classification of the Ingestible Gastrointestinal Blood Detection Capsule. FDA is classifying the ingestible gastrointestinal blood detection capsule into class II (special controls). The special controls that apply to the device type are identified in this rule and will be part of the codified language for classification of the ingestible gastrointestinal blood detection capsule. 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 June 16, 2026, FDA released a rule entitled, Medical Devices: Radiology Devices; Classification of the Radiological Machine Learning-Based Quantitative Imaging Software with Predetermined Change Control Plan. FDA is classifying the radiological machine learning-based quantitative imaging software with predetermined change control plan into class II. The special controls that apply to the device type are identified in this rule and will be part of the codified language for classification of the ingestible gastrointestinal blood detection capsule. 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 June 17, 2026, FDA released a notice entitled, Authorization of Emergency Use for Two Animal Drugs for the Prevention and Treatment of New World Screwworm. FDA is announcing the issuance of two Emergency Use Authorizations (EUA) under the Federal Food, Drug, and Cosmetic Act (FD&C Act) for new animal products. One EUA is for an animal product for the prevention and treatment of infestations caused by New World screwworm (Cochliomyia hominivorax) (NWS) larvae (myiasis) in cattle, horses, minor species of hoof stock, raptors and other wild birds, pet birds, and captive wild, exotic, and zoo mammals. The other EUA is for an animal product for the prevention and treatment of infestations caused by NWS larvae (myiasis) in cattle, swine, goats, sheep, horses, donkeys, domestic hybrid equids, and captive wild, exotic, and zoo mammals. The EUAs contain, among other things, conditions on the emergency use of the authorized products. The EUAs follow the August 18, 2025, determination by the Secretary of Health and Human Services (HHS) that there is significant risk for a public health emergency involving NWS that could affect national security or the health of U.S. citizens living abroad. On the basis of such determination, the HHS Secretary declared on August 18, 2025, that circumstances exist justifying the authorization of emergency use of animal drugs to treat or prevent NWS myiasis in animals. The EUAs, which include an explanation of the reasons for issuance, are reprinted in this document.
• On June 18, 2026, FDA released a rule entitled, Medical Devices: Gastroenterology-Urology Devices; Classification of the Endoscopic Light-Projecting Measuring Device. FDA is classifying the endoscopic light-projecting measuring device into class II. The special controls that apply to the device type are identified in this rule and will be part of the codified language for classification of the ingestible gastrointestinal blood detection capsule. 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 June 18, 2026, FDA released a rule entitled, Medical Devices: Gastroenterology-Urology Devices; Classification of the Endoscopic Traction Device. FDA is classifying the endoscopic traction device into class II. The special controls that apply to the device type are identified in this rule and will be part of the codified language for classification of the ingestible gastrointestinal blood detection capsule. 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 June 18, 2026, FDA released a rule entitled, Medical Devices: Immunology and Microbiology Devices; Classification of the Simple In Vitro Diagnostic Device for the Detection of Secreted Proteins From Bacillus Species (spp.) in Human Clinical Samples. FDA is classifying the simple in vitro diagnostic device for the detection of secreted proteins from Bacillus species (spp.) in human clinical samples into class II. The special controls that apply to the device type are identified in this rule and will be part of the codified language for classification of the ingestible gastrointestinal blood detection capsule. 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.

Event Notices

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

• June 22, 2026: The National Institutes of Health (NIH) announced a meeting of the National Institute of Allergy and Infectious Diseases (NIAID). This is a virtual meeting with some sessions open to the public.
• June 22, 2026: NIH announced a meeting of the National Institute of Mental Health. This is a virtual meeting with some sessions open to the public.
• June 23, 2026: FDA announced a meeting entitled, Financial Transparency and Efficiency of the Prescription Drug User Fee Act, Biosimilar User Fee Act, and Generic Drug User Fee Amendments. This is a hybrid meeting open to the public.
• June 24, 2026: NIH announced a meeting of the Diabetes Mellitus Interagency Coordinating Committee (DMICC). This is a virtual meeting open to the public.
• June 24, 2026: NIH announced a meeting of the National Institute of Environmental Health Sciences (NIEHS). This is a virtual meeting with some sessions open to the public.
• June 25, 2026: NIH announced a meeting of the Office of AIDS Research Advisory Council. 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.
• June 29, 2026: NIH announced a meeting of the National Advisory Council for Complementary and Integrative Health. This is a virtual meeting with some sessions open to the public.
• June 29, 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.
• June 30, 2026: 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.
• July 1, 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.
• July 6-7, 2026: NIH announced a meeting of the National Cancer Institute (NCI). This is a virtual meeting with some sessions open to the public.
• July 7, 2026: FDA announced an educational conference entitled, Third Annual Animal Drug User Fee Educational Conference. This is a hybrid event 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.
• July 14-15, 2026: The Centers for Medicare & Medicaid Services (CMS) announced a meeting of the Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests. This is a hybrid meeting open to the public.
• July 15, 2026: NIH announced a meeting of the NCI Clinical Trials and Translational Research Advisory Committee. This is a virtual meeting open to the public.
• July 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.
• July 23-24, 2026: FDA announced a meeting of the Pharmacy Compounding Advisory Committee. This is a hybrid meeting open to the public.
• August 6, 2026: NIH announced a meeting of the National Heart, Lung, and Blood Institute. This is a hybrid 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.
• September 2, 2026: NIH announced a meeting of the NCI. 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 hybrid meeting with some sessions 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 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 15-16, 2026: CMS announced a meeting of the Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests. 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 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.
• 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.
• November 5, 2026: ONC announced a meeting of the Health Information Technology Advisory Committee. This is a virtual meeting open to the public.
• December 1, 2026: NIH announced a meeting of the 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 the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria. This is a virtual meeting open to the public.

Reports, Studies & Analyses

• On June 15, 2026, KFF released an analysis entitled, Spending on Medicaid State Directed Payments Before New Limits Take Effect. KFF analyzed baseline levels of Medicaid spending on state-directed payments (SDPs) prior to the implementation of new federal limits under the One Big Beautiful Bill Act (OBBBA), using data from publicly available state preprint submissions to CMS. KFF estimated that SDPs currently account for approximately $137 billion in total annual Medicaid spending, including about $93 billion in federal spending, with participation spanning 41 states and significant variation in the number, structure, and financial scale of these arrangements. KFF found that SDPs are predominantly used to increase payments in Medicaid managed care—most notably for hospital services, which account for roughly 84 percent of SDP spending—and that most payments are benchmarked to commercial rates rather than Medicare or Medicaid fee-for-service (FFS) rates. KFF also highlighted that SDP financing is often complex and frequently relies on mechanisms such as provider taxes and intergovernmental transfers, making it difficult to determine how much funding represents new revenue for providers. While SDPs were originally intended to improve access to care and provider participation, the analysis emphasized limitations in available data, including reliance on projected rather than actual spending and gaps in reporting, which complicate evaluation of their effects.
• On June 15, 2026, the Medicare Payment Advisory Commission (MedPAC) released its June 2026 report to Congress entitled, Medicare and the Health Care Delivery System. In the report, MedPAC highlights several policy recommendations and proposed approaches across Medicare payment and delivery topics. MedPAC’s discussion of payment incentives emphasizes prior recommendations to refine fee-for-service pricing and adopt site-neutral payment rates for certain services that can be safely furnished in multiple ambulatory settings, including clinician offices, ambulatory surgical centers, and hospital outpatient departments. The report also describes prior recommendations to revise Medicare Advantage (MA) payment policy, including changes to benchmarks, risk adjustment, coding-intensity adjustments, quality bonuses, and encounter-data reporting, intended to improve payment accuracy and reduce incentives that can inflate plan payments. Regarding beneficiary enrollment, the report identifies potential policy directions, including additional updates to Plan Finder, greater support for the State Health Insurance Assistance Program, and expanded use of technology to help beneficiaries navigate coverage choices. The hospice chapter briefly outlines options to address access to certain complex palliative services, including enhanced data collection, targeted payment approaches, or a transitional concurrent-care model. The report’s only formal recommendation appears in the ground ambulance chapter, where MedPAC recommends that Congress direct the HHS Secretary to continue collecting cost and revenue data from ground ambulance providers and suppliers, while focusing the effort on information necessary to assess payment accuracy and beneficiary access and streamlining the process to reduce reporting burden.

• On June 18, 2026, the White House Council of Economic Advisors published a report entitled, Effects of Banning Hospitals’ Anti-Steering, Anti-Tiering, and All-or-Nothing Contracts. The report examines how certain contract provisions between hospitals and insurers may affect prices in employer-sponsored insurance markets. The report’s analysis found that banning these provisions could reduce hospital and affiliated-physician prices by an estimated 18 percent in directly affected markets, resulting in about $4,100 less per inpatient admission. The report further estimates that, if savings were passed through to premiums, employer-sponsored insurance premiums in affected markets could decline by 6.5 percent, or about $1,800 per family and $600 per individual annually. Nationally, the report estimates that such a policy could reduce employer-sponsored insurance premiums by about $45 billion per year.

• On June 18, 2026, RAND released a report entitled, State-Level Impacts of Key Medicaid Provisions in the One Big Beautiful Bill Act. The report provides a state-level analysis of the Medicaid-related provisions in the OBBBA using a combination of state-specific data, federal datasets, and modeling assumptions. The study estimates the fiscal and enrollment impacts of 12 key provisions—such as work requirements, more frequent eligibility redeterminations, restrictions on provider taxes and state-directed payments, limits on immigrant eligibility, and reductions in federal matching funds—through 2034. Overall, the report found that these provisions are expected to significantly reduce Medicaid funding and enrollment, projecting a $679 billion decline in state Medicaid funds, $82 billion in reduced state general fund spending, and approximately $724 billion in federal savings, alongside an estimated loss of 7.6 million Medicaid enrollees by 2034. The report found that impacts vary widely across states depending on factors such as Medicaid expansion status, reliance on provider taxes and state-directed payments, and population size, with some states experiencing substantial funding reductions while a few smaller or rural states may see net gains due to new federal funding streams like the Rural Health Transformation Program (RHTP). The report also highlights that while some provisions directly reduce enrollment and spending, others primarily reduce federal contributions, requiring states to either increase their own spending or make programmatic cuts, with broader implications for access to care and uncompensated care. The report notes that all estimates are subject to uncertainty based on assumptions about state responses and future economic and demographic trends.

Hearings & Markups

• On June 17, 2026, the Senate Health, Education, Labor, and Pensions (HELP) Committee held an executive session for the following legislation: S. 1782, the Charlotte Woodward Organ Transplant Discrimination Protection Act; S. 3799, the Healthy Start Reauthorization Act of 2026; S. 4109, the Stem Cell Therapeutic and Research Reauthorization Act; S. 2339, the EARLY Act Reauthorization of 2025; S. 4472, the Accelerating Access to Critical Therapies for ALS Act of 2026; S. 2658, the Medication Affordability and Patent Integrity Act; S. 3014, the Ensuring Timely Access to Generics Act of 2025; and S. 1954, the Biosimilar Red Tape Elimination Act.

   

• On June 17, 2026, the Senate Special Committee on Aging held a hearing entitled, Counting the Cost: Communist China's Toll on Older Americans' Health, Finances, and Security. Witnesses present included: Mr. Joshua Hodges, Commissioner, U.S.-China Economic and Security Review Commission; Mr. Leland R. Miller, Commissioner, U.S.-China Economic and Security Review Commission; Ms. Reva Price, Commissioner, Chair Emeritus, U.S.-China Economic and Security Review Commission; and Mr. Chris Slevin, Commissioner, U.S.-China Economic and Security Review Commission.

Other Health Policy News

• On June 12, 2026, CMS issued a proposed rule to establish a permanent framework for the Medicare Drug Price Negotiation Program (Negotiation Program), as required by the Inflation Reduction Act of 2022. As required by law, CMS will select up to 20 additional negotiation-eligible drugs covered under Part D and/or payable under Part B for this fourth cycle of negotiations and subsequent cycles of the Negotiation Program. As required by law, the Negotiation Program must transition from being implemented through guidance to being codified in regulations as a durable, long-term framework. This proposed rule would create certain new policies for the Negotiation Program and the Medicare Prescription Drug Benefit Program (“Part D”). The proposed rule also proposes a narrow modification of the policy used to identify qualifying single source drugs to address potential program integrity concerns posed by certain new formulations. 

  Further, CMS proposes to implement the Temporary Floor for Small Biotech Drugs, as required by law, which would limit CMS from offering or agreeing to a counteroffer for a maximum fair price (MFP) for Small Biotech Drugs below the floor for certain eligible drugs during initial price applicability years 2029 and 2030. The proposed rule also proposes to codify policies related to formulary inclusion of selected drugs and the definition of “negotiated price.” These policies ensure that Part D plans include selected drugs with an MFP in effect on their formularies and that the negotiated prices paid to dispensing entities by Part D plans do not exceed the MFP plus any dispensing fees.

  The proposed rule as published in the Federal Register is available here. The CMS press release is available here. Comments are due at 5:00 PM ET on August 17, 2026.

• On June 16, 2026, CMS issued a request for information (RFI) entitled, Pharmacy Benefit Manager Compensation and Data Collection. CMS is seeking input on the current state of pharmacy benefit manager (PBM) business practices as it begins planning for implementation of PBM reforms in Medicare Part D, as required under the Consolidated Appropriations Act (CAA) of 2026, enacted earlier this year. CMS is seeking information to help determine how to ensure that compensation PBMs receive based on Part D drug utilization is limited to bona fide service fees. The agency is also examining how to collect the data PBMs are newly required to provide annually to plan sponsors and HHS.

   

  The RFI outlines several areas where CMS is requesting stakeholder input. CMS is asking what types of entities—such as group purchasing organizations, data vendors, and mail-order pharmacies—should be considered affiliates of PBMs under the CAA of 2026’s definition of “affiliate,” and the rationale for those determinations.

  CMS is also seeking feedback on what additional data elements, beyond those already required under the CAA of 2026, would help inform its implementation and oversight of PBM reforms and ensure compliance with the law.

  In addition, the agency is requesting information on the types of remuneration between Part D plan sponsors and PBMs or their affiliates that currently create incentives influencing PBM performance, and how those arrangements differ from the statutory definition of a “bona fide service fee.”

  The RFI as published in the Federal Register is available here. Comments on the RFI are due at 5:00 PM ET on July 17, 2026.

• On June 17, 2026, the Senate HELP Committee voted to advance seven health bills during a committee markup. Lawmakers voted unanimously to favorably report bills that would reauthorize programs to reduce infant mortality rates, connect patients with bone marrow transplant donors, boost education about breast health and breast cancer risks, and maintain grants to increase research of neurodegenerative diseases. Committee members also unanimously voted to advance legislation to ban physical and mental disability discrimination within the organ transplant system and to automatically deem biosimilars as interchangeable upon arrival, thus permitting pharmacies to make substitutions without prescriber involvement. The Committee also voted 16-6 to advance a bill that would clarify information that drugmakers must provide to FDA and to the U.S. Patent and Trademark Office (PTO).

The Committee ultimately did not vote on S. 3014, Ensuring Timely Access to Generics Act of 2025, after nine amendments were offered by Senator Bernie Sanders (I-VT). This bill would allow FDA to deny a citizen petition if the agency determined that the primary reason it was filed was to delay generic or biosimilar competition.

The hearing announcement, legislation considered, and amendments offered are available here.

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