Health Care Week in Review | CMS Proposes New Limits on Medicaid SDPs and FFS Payments; Key House Committees Advance Several Bipartisan 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 May 18, 2026, the Department of Health and Human Services (HHS) released a rule entitled, Patient Protection and Affordable Care Act: HHS Notice of Benefit and Payment Parameters for 2027; and Basic Health Program. This final rule contains provisions to improve implementation of the Patient Protection and Affordable Care Act (ACA), 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 final 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); requirements related to defrayal for the cost of any state-required benefits in addition to the EHB; cost-sharing flexibilities for catastrophic and individual market bronze plans; establishment of catastrophic plans with plan terms of up to 10 consecutive plan years; QHP issuer quality improvement strategies (QISs); and revisions affecting which enrollees are included in Federal Basic Health Program (BHP) payment calculations to states. This final rule also includes amendments to implement certain provisions of the One, Big, Beautiful Bill Act (OBBBA).
• On May 18, 2026, HHS released a notice entitled, Requirements and Registration for 'EHIgnite Challenge'. The EHIgnite Challenge addresses data usability challenges in single patient electronic health information (EHI) exports. This challenge seeks to incentivize the development of tools, platforms, and workflows that transform single patient EHI exports into usable, readable, and actionable information that supports clinical care, patient engagement, and informed decision-making.
• On May 18, 2026, the Centers for Disease Control and Prevention (CDC) released a notice entitled, Charter Amendments, Establishments, Renewals and Terminations: Advisory Committee on Immunization Practices. Pursuant to the Public Health Service Act, as amended, and the Federal Advisory Committee Act, as amended, CDC is announcing the re-establishment of the Advisory Committee on Immunization Practices (ACIP). A notice of committee charter renewal for the ACIP, which was published in the Federal Register on April 6, 2026, is hereby withdrawn. In this document, the CDC also announces the determination that the re-establishment of the ACIP is necessary and in the public interest, in connection with the HHS’s performance of its duties.
• On May 20, 2026, the Food and Drug Administration (FDA) released guidance entitled, Assessing the Effects of Food on Drugs in INDs and NDAs – Clinical Pharmacology Considerations. This guidance provides recommendations to sponsors planning to conduct food-effect (FE) studies for orally administered drug products under investigational new drug applications (INDs) to support new drug applications (NDAs) and supplements to these applications for drugs being developed under section 505 of the Federal Food, Drug, and Cosmetic Act (FD&C Act). This guidance revises and replaces part of the 2002 FDA guidance entitled, Food-Effect Bioavailability and Fed Bioequivalence Studies.
• On May 20, 2026, the Centers for Medicare & Medicaid Services (CMS) released a proposed rule entitled, Medicaid Managed Care State Directed Payments and Medicaid Fee-for-Service Targeted Medicaid Practitioner Payments. This proposed rule describes alternatives to modify the limit on the total payment rate and other requirements for state directed payments (SDPs) in Medicaid managed care. This rule also proposes to set a limit for certain targeted Medicaid payments in Medicaid fee-for-service (FFS).
• On May 21, 2026, FDA released guidance entitled, Product-Specific Guidances. The guidance provides rationale and recommendations for implementing a harmonized digital clinical trial protocol. The template features standardized content structure and formatting, including headers and common text elements. The technical specification document contains harmonized terminologies and standardized data fields to enable electronic exchange of clinical protocol information. The intent of the guidance is to create an internationally harmonized standard for the content and exchange of clinical trial protocol information, facilitating the review and assessment by regulators, sponsors, ethical oversight bodies, investigators, and other stakeholders. This guidance finalizes the draft guidances entitled, M11 Clinical Electronic Structured Harmonised Protocol (CeSHarP) and M11 Technical Specification: Clinical Electronic Structured Harmonised Protocol.
• On May 21, 2026, FDA released guidance entitled, Protein Efficiency Ratio Rat Bioassay Studies to Demonstrate That a New Infant Formula Supports the Quality Factor of Sufficient Biological Quality of Protein. The guidance provides information for manufacturers and contract laboratories that perform protein efficiency ratio (PER) studies to assist in designing, conducting, evaluating, and reporting PER studies. The guidance explains “appropriate modifications” of the AOAC Method with the aim of supporting industry in successfully conducting PER studies that demonstrate that a new infant formula meets the quality factor of sufficient biological quality of protein when fed as the sole source of nutrition.
• On May 22, 2026, HHS released a notice entitled, Charter Amendments, Establishments, Renewals and Terminations: Renewal of the President's Council on Sports, Fitness and Nutrition's Charter. HHS is hereby giving notice that the charter for the President’s Council on Sports, Fitness & Nutrition has been renewed. The council is charged with advising the President concerning progress made in carrying out the provisions of Executive Order (EO) 14327, which aims to promote the economic, academic, and social benefits of youth sports, fitness, and nutrition. The council promotes this goal through external outreach, raising public awareness, and recommending to the President actions to accelerate such progress.
• On May 22, 2026, HHS released a rule entitled, Control of Communicable Diseases; Foreign Quarantine. This interim final rule provides a procedure for the HHS Secretary acting through the CDC Director or other delegate to suspend the introduction of persons from designated countries or places, if required, in the interest of public health.
• On May 22, 2026, HHS released a notice entitled, Notice of Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against Andes Virus. The HHS Secretary issued a Public Readiness and Emergency Preparedness Act (PREP Act) declaration finding that Andes virus poses a credible risk of a public health emergency and extending liability protections to manufacturers, providers, and other entities involved in the development, distribution, and administration of medical countermeasures. The declaration focuses on investigational use of the antiviral favipiravir for individuals potentially exposed during a recent cruise ship outbreak, provides broad immunity from legal claims (except for willful misconduct), and activates the Countermeasures Injury Compensation Program. Liability protections apply nationwide without geographic limitation and remain in effect through July 18, 2026, with additional coverage provisions for stockpiled countermeasures.

Event Notices

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

• May 26, 2026: The National Institutes of Health (NIH) announced a meeting of the Sickle Cell Advisory Committee (SCDAC). This is a virtual meeting open to the public.
• May 28, 2026: FDA announced a meeting of the Vaccines and Related Biological Products Advisory Committee. This is a virtual meeting open to the public.
• May 29, 2026: NIH announced a meeting of the Board of Scientific Counselors of the Eunice Shriver National Institute of Child Health & Human Development (NICHD). 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 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 2, 2026: CMS announced the first biannual Healthcare Common Procedure Coding System (HCPCS) Level II public meeting of 2026. This is a hybrid meeting open to the public.
• June 4, 2026: FDA announced that a public hearing related to the Commissioner’s National Priority Voucher (CNPV) Pilot Program will be rescheduled to June 4, 2026. This is a hybrid meeting open to the public.
• June 5, 2026: NIH announced a meeting of NICHD. This is a hybrid meeting with some sessions open to the public.
• June 5, 2026: NIH announced a meeting of the National Advisory Eye Council. This is a virtual meeting with some sessions open to the public.
• June 5, 2026: CDC announced a meeting of the Subcommittee on Procedure Reviews of the Advisory Board on Radiation and Worker Health. This is a virtual meeting open to the public.
• **June 8, 2026: NIH announced a meeting of the President’s Cancer Panel. This is an in-person meeting open to the public.
• June 8-9, 2026: FDA announced a public workshop entitled, Fiscal Year 2026 Generic Drug Science and Research Initiatives Workshop. This is a hybrid meeting open to the public.
• June 9, 2026: NIH announced a meeting of the National Heart, Lung, and Blood Institute. This is an in-person meeting open to the public. 
• June 10, 2026: CMS announced a public meeting regarding new and reconsidered clinical diagnostic laboratory test codes for the Clinical Laboratory Fee Schedule for calendar year (CY) 2027. 
• June 10-11, 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.
• June 12, 2026: NIH announced a meeting of the NIH Clinical Center Research Hospital Board. This is a hybrid meeting open to the public.
• June 15, 2026: NIH announced a meeting of the National Institute of Environmental Health Sciences Board of Scientific Counselors. This is a hybrid meeting with some sessions open to the public.
• June 15-16, 2026: HHS announced a meeting of the Physician-Focused Payment Model Technical Advisory Committee (PTAC). This is a hybrid meeting open to the public.
• June 15-16, 2026: NIH announced a meeting of the National Institute of Biomedical Imaging and Bioengineering Board of Scientific Counselors. This is an in-person meeting with some sessions open to the public.
• June 16, 2026: NIH announced a meeting of the Interagency Pain Research Coordinating Committee. This is a virtual meeting open to the public.
• June 18, 2026: CMS announced a meeting of the Advisory Board on Radiation and Worker Health (ABRWH). This is a virtual meeting open to the public.
• **June 18, 2026: FDA announced a meeting of the Vaccines and Related Biological Products Advisory Committee. This is a virtual meeting open to the public.
• June 22, 2026: 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 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. 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 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 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: 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 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.
• 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: 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.
• November 5, 2026: ONC announced a meeting of the Health Information Technology Advisory Committee. This is a virtual meeting 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 May 19, 2026, the HHS Office of Inspector General (OIG) released a report entitled, Impacts of Vertical Integration in Medicare Part D on Sponsors’ Drug Costs, Pharmacy Reimbursement, and Enrollee Cost Sharing. OIG found that vertical integration in Medicare Part D—where sponsors, pharmacy benefit managers (PBMs), and sometimes pharmacies are owned by the same parent company—has led to similar overall drug costs compared to non-integrated sponsors, but through different payment dynamics. OIG reported that vertically integrated sponsors tend to pay pharmacies more upfront and then recoup more through rebates and fees, and they receive a disproportionate share of total price concessions. In addition, OIG stated that the market is highly concentrated, with a small number of integrated firms accounting for the majority of enrollment and spending. OIG noted that, for beneficiaries, these arrangements are associated with lower monthly premiums but higher out-of-pocket costs for many drugs. While the data suggest modest differences in how pharmacies are reimbursed, including slightly lower payments to affiliated pharmacies, OIG noted that limitations, particularly around incomplete DIR data and recent policy changes, prevent definitive conclusions about the full impact on pharmacy payments and competition.
• On May 19, 2026, KFF released a report entitled, What We Know So Far About 2026 ACA Marketplace Enrollment, Premiums, and Deductibles. According to KFF, following the expiration of enhanced premium tax credits at the end of 2025, ACA Marketplace enrollment is projected to fall sharply from 22.3 million to approximately 17.5 million people in 2026. KFF reported that those most affected were enrollees with incomes just above the 400 percent federal poverty level “subsidy cliff,” who accounted for 27 percent of sign-up drops despite representing only three percent of 2025 enrollees. To manage rising costs, KFF noted that many remaining enrollees shifted to lower-premium bronze plans, driving average deductibles up 37 percent to a record high of $3,786 – the steepest single-year increase since the Marketplaces launched in 2014. KFF also reported that average monthly premium payments rose 58 percent, from $113 to $178 per month.

Hearings & Markups

• On May 20, 2026, the Senate Committee on Education and Workforce Subcommittee on Health, Employment, Labor, and Pensions held a hearing entitled, Bad Medicine: Politics, Unions, and Antisemitism in Health Care. Witnesses present included: Ms. Deena Margolies, Litigation Staff Attorney, Louis D. Brandeis Center for Human Rights Under Law; Dr. Jacob Agronin, Cardiology Fellow; Ms. Jamie Beran, Chief Executive Officer, Bend the Arc; and Ms. Eveline Shekhman, Chief Executive Officer, American Jewish Medical Association.
• On May 20, 2026, the House Committee on Energy and Commerce Subcommittee on Health held a hearing entitled, Examining the Medicare Physician Fee Schedule, MACRA, and Opportunities for Payment Reforms. Witnesses present included: Dr. William Fox, Chair Emeritus, American College of Physicians Board of Regents, Fox & Brantley Internal Medicine; Dr. Steven Furr, Family Medicine Physician; Dr. Dana Smetherman, Chief Executive Officer, American College of Radiology; Dr. Rick Snyder, President, HeartPlace; and Dr. Farzad Mostashari, Chief Executive Officer and Co-Founder, Aledade.
• On May 20, 2026, the Senate Special Committee on Aging held a hearing entitled, Preventing Falls, Preserving Independence: Technology, Community Programs, and Innovation in Senior Safety. Witnesses present included: Ms. Christine Didion, Director of Programs, Area Agency on Aging Pasco-Pinellas; Ms. Laura Mitchell, Co-Founder and CEO, GrandCare Systems; and Ms. Martha Petteys, Director of Grant Management and Health Strategies, Alliance of New York State YMCAs.
• On May 21, 2026, the Senate Committee on Appropriations held a hearing entitled, A Review of the President’s Fiscal Year 2027 Budget Request for the National Institutes of Health. Witnesses present included: The Honorable Jay Bhattacharya, Director, NIH; Dr. Richard Hodes, Director, National Institute on Aging; Dr. Anthony Letai, Director, NCI; Dr. Griffin Rodgers, Director, National Institute of Diabetes and Digestive and Kidney Diseases; Dr. Joni Rutter, Director, National Center for Advancing Translational Sciences; and Dr. Nora Volkow, Director, National Institute on Drug Abuse.
• On May 21, 2026, the House Committee on Ways and Means held a markup of several bills including: H.R. 3164, the Ensuring Community Access to Pharmacist Services Act; H.R. 8163, the Provider Reimbursement Stability Act of 2026; H.R. 8875, the Improving Home Dialysis Act of 2026; H.R. 8883, the Protecting Seniors and Stopping Fraudsters Act; H.R. 8871, the DME Scammer Prevention Act of 2026; H.R. 8884, the  Removing Barriers to Work for Disabled Americans Act; H.R. 8873, the Recover COVID Unemployment Fraud in Banks Act; and H.R. 8872, the Preventing Waste, Fraud, and Abuse in TANF Act.

Other Health Policy News

• On May 20, 2026, CMS released a proposed rule entitled, Medicaid Managed Care State Directed Payments and Medicaid Fee-for-Service Targeted Medicaid Practitioner Payments, implementing Section 71116 of the OBBBA. The rule establishes new limits on certain Medicaid managed care SDPs; specifically, total payment rates are capped at 100 percent of Medicare in expansion states and 110 percent in non-expansion states, with Medicaid state plan rates used where a Medicare benchmark is unavailable. These limits apply to rating periods beginning after enactment of the rule, with limited grandfathering for qualifying SDPs already in place, which will be subject to a 10 percentage-point annual phase-down beginning in the 2028 rating period.
  
  The proposed rule also includes several significant policy proposals that go beyond the statutory requirements and prior CMS SDP guidance. Of note, CMS proposes to extend the Medicare-based payment cap beyond the four statutorily specified service categories to all SDPs, regardless of service type, beginning January 1, 2029.
  
  The rule establishes new claims-level compliance and reporting requirements, including submission of provider-specific data, identification of applicable benchmark rates, and documentation of controls to ensure that each individual service payment does not exceed the cap.
  
  CMS also introduces new reconciliation requirements for value-based payment SDPs, requiring states to demonstrate post-period compliance with the cap at the service level. The proposed rule specifies that payments exceeding the cap constitute Medicaid overpayments subject to recovery and reporting requirements, explicitly linking SDP limits to existing overpayment regulations. Additionally, CMS proposes to extend the payment cap framework to U.S. territories beginning in 2029, which goes beyond the scope of Section 71116 that only applies to the 50 states and the District of Columbia. The proposed rule adds more detailed and prescriptive criteria for grandfathered SDPs, including interpretation of the 180-business-day window, “good faith effort” standard, and required documentation, and codifies these operational definitions and threshold requirements into regulation.
  
  The proposed rule also includes targeted FFS proposals including a proposal to establish Medicare-aligned limits on certain targeted Medicaid practitioner payments in FFS delivery systems, extending payment caps beyond managed care SDPs to analogous FFS supplemental and enhanced payment arrangements. CMS indicates that these FFS limits would apply where payments are not already constrained by existing upper payment limit (UPL) frameworks or other statutory caps, effectively limiting states’ ability to structure payments outside of SDP arrangements.
  
  Taken together, these proposals reflect CMS’s broader efforts to standardize Medicaid payment ceilings across both managed care and FFS delivery systems and reduce reliance on supplemental and targeted payment mechanisms that result in payment levels above Medicare.
  
  The proposed rule can be found here. A press release is available here. A fact sheet is available here.
• On May 20, 2026, the House Committee on Energy and Commerce Subcommittee on Health held a hearing entitled, Examining the Medicare Physician Fee Schedule, MACRA, and Opportunities for Payment Reforms. The hearing examined reforms that can be made to Medicare physician payment and policies enacted in the Medicare Access and CHIP Reauthorization Act (MACRA) to incentivize the shift to value-based care. The discussion builds on the Committee’s broader affordability series conducted throughout the year.
  
  The hearing focused on the structure and performance of the Medicare Physician Fee Schedule (PFS) and opportunities for reform. Members and witnesses highlighted ongoing bipartisan concerns regarding physician payment instability, administrative burden, declining reimbursement rates, and barriers to participation in value-based care models. Additional issues discussed included the adequacy of inflationary updates, complexity associated with the Merit-Based Incentive Payment System (MIPS), and continued provider consolidation. The hearing also explored opportunities to strengthen alternative payment models (APMs), enhance support for primary care, and ensure that Medicare payment policy promotes affordability, provider sustainability, and patient access to care.
  
  More information on this hearing can be found here.
• On May 21, 2026, the House Committee on Ways and Means held a markup of several health bills including: H.R. 3164, the Ensuring Community Access to Pharmacist Services Act; H.R. 8163, the Provider Reimbursement Stability Act of 2026; H.R. 8875, the Improving Home Dialysis Act of 2026; H.R. 8883, the Protecting Seniors and Stopping Fraudsters Act; H.R. 8871, the DME Scammer Prevention Act of 2026; H.R. 8884, the Removing Barriers to Work for Disabled Americans Act; H.R. 8873, the Recover COVID Unemployment Fraud in Banks Act; and H.R. 8872, the Preventing Waste, Fraud, and Abuse in TANF Act.
  
  Overall, the markup centered on two primary priorities: expanding access to health care, particularly in rural areas, and strengthening program integrity across federal benefits. The Committee advanced eight bills, addressing these goals, including stabilizing physician payments, and enhancing coverage for home dialysis patients, alongside legislation aimed at combating fraud in Medicare, unemployment insurance, and Temporary Assistance for Needy Families (TANF). While the Committee found unanimous bipartisan consensus to stabilize Medicare physician payments, they disagreed over TANF reforms that Republicans argued would stop states from misusing welfare funds but that Democrats warned would be weaponized to freeze aid to vulnerable families. Members also clashed over the broader definition of fraud, with Republicans emphasizing programmatic abuse and Democrats pointing to systemic and administrative concerns. Despite these tensions, the Committee ultimately reported all eight bills, along with its FY 2027 budget views and estimates, favorably to the House.
  
  More information on this markup can be found here.

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