Health Care Week in Review | CMS Announces Six-Month Moratoria on Hospice and Home Health Agency Medicare Enrollment; FDA Commissioner Marty Makary Resigns

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 11, 2026, ACF released a proposed rule entitled, Restoring Flexibility to Support Head Start Program Access. In this notice of proposed rulemaking (NPRM), ACF proposes to remove requirements from the Head Start Program Performance Standards (Performance Standards) to restore local flexibility to Head Start programs and improve access to quality services. Specifically, this NPRM proposes to remove requirements related to wages and benefits that the Administration believes are not in line with the plain language of the Head Start Act and are costly and overly prescriptive for Head Start programs and staff. ACF estimates these proposed changes, if finalized, will result in over $2 billion in future cost savings for Head Start programs. The proposed rescissions in this NPRM, if finalized, would impact the costliest parts of the final rule published by the Office of Head Start (OHS) in 2024, Supporting the Head Start Workforce and Consistent Quality Programming.
• On May 11, 2026, the Food and Drug Administration (FDA) released a rule entitled, Medical Devices; Immunology and Microbiology Devices; Classification of the Device to Detect and Identify Microorganism Nucleic Acids and Resistance Markers From Patients With Suspected Orthopedic Infection. FDA is classifying the device to detect and identify microorganism nucleic acids and resistance markers from patients with suspected orthopedic infection 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 device to detect and identify microorganism nucleic acids and resistance markers from patients with suspected orthopedic infection. 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 May 11, 2026, FDA released a notice entitled, 21st Century Cures Act: Annual Compilation of Notices of Updates From the Susceptibility Test Interpretive Criteria Web Page. FDA is announcing the availability of the agency’s annual compilation of notices of updates to the FDA’s Susceptibility Test Interpretive Criteria web page. FDA established the Susceptibility Test Interpretive Criteria web page on December 13, 2017, and since establishment has provided updates to both the format of the web pages and the susceptibility test interpretive criteria identified and recognized by FDA on the web pages. FDA is publishing this notice in accordance with procedures established by the 21st Century Cures Act (Cures Act).
• On May 11, 2026, FDA released a notice entitled, Drug Repurposing for Unmet Medical Needs; Request for Information. FDA is opening a public docket to solicit input and comments on FDA’s efforts with respect to drug repurposing to address unmet medical needs. FDA is requesting information on potential priority disease areas and potential candidates for drug repurposing, with a focus on FDA-approved drugs for which there appears to be no commercial interest in adding a new use through a supplement to a new drug application (supplemental application). Information provided through this public docket will help FDA refine its efforts toward considering and evaluating candidates for drug repurposing.
• On May 12, 2026, the Department of Health and Human Services (HHS) released a proposed rule entitled, Excepted Fertility Benefits. The proposed rule would amend the regulations regarding excepted benefits under the Employee Retirement Income Security Act of 1974 (ERISA), the Internal Revenue Code (IRC), and the Public Health Service Act (PHS Act) to establish certain fertility benefits as a new category of limited excepted benefits. Excepted benefits are generally exempt from the market requirements that were added to those laws by the Health Insurance Portability and Accountability Act (HIPAA), the Patient Protection and Affordable Care Act (ACA), the No Surprises Act (NSA), and certain other Federal laws specifically related to group health plans and group and individual health insurance coverage.
• On May 12, 2026, FDA released a notice entitled, Biomarker Incubator: Urinary Kidney Safety Biomarkers; Request for Information. The Center for Drug Evaluation and Research (CDER) within the FDA is announcing a request for information regarding a regulatory science initiative. The aims of the initiative are to advance biomarker validation through the compilation of data from multiple sources and through a specific pilot project focused on aggregating data for biomarkers of drug-induced kidney injury. The purpose of this notice is to inform the public of the aims of this initiative, to encourage human data submission and sharing, and to identify opportunities to enhance interactions between relevant stakeholders and FDA. The agency intends to use the information submitted to inform future activities related to data sharing, biomarker development, and broader translation of biomarkers of drug-induced kidney injury.
• On May 13, 2026, the Centers for Medicare & Medicaid Services (CMS) released a notice entitled, Medicare and Medicaid Programs; Quarterly Listing of Program Issuances—January through March 2026. This quarterly notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published in the 3-month period, relating to the Medicare and Medicaid programs and other programs administered by CMS.
• On May 13, 2026, CMS released a notice entitled, Medicare, Medicaid, and Children's Health Insurance Programs: Announcement of Nationwide Temporary Moratoria on Enrollment of Home Health Agencies (HHAs). This notice announces the imposition of a 6-month nationwide moratorium on the Medicare enrollment of home health agencies (HHAs).
• On May 13, 2026, CMS released a notice entitled, Medicare, Medicaid, and Children's Health Insurance Programs: Announcement of Nationwide Temporary Moratorium on Enrollment of Hospices. This notice announces the imposition of a 6-month nationwide moratorium on the Medicare enrollment of hospices.
• On May 14, 2026, the National Institutes of Health (NIH) released a notice entitled, Government Owned Inventions Available for License: Synergistic Interactions for Improved Cancer Treatment. The National Cancer Institute (NCI) seeks research co-development partners and/or licensees to develop hetIL-15 in combination with other agents, such as PPARa agonists (Fenofibrate), FLT3 inhibitors (quizartinib), IL-12, or chemotherapy into a therapeutic for cancer.
• On May 15, 2026, HHS released a notice entitled, Delegation of Authority: Agency for Healthcare Research and Quality. HHS Secretary Robert F. Kennedy, Jr. is delegating to the Director, Agency for Healthcare Research and Quality (AHRQ), the authorities vested in the HHS Secretary to administer and implement HHS’s supervisory framework governing support for, and oversight of, the U.S. Preventive Services Task Force (USPSTF or Task Force).

Event Notices

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

• May 18, 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.
• May 18, 2026: CMS announced a meeting of the Healthcare Advisory Committee. This is a virtual meeting 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.
• May 19, 2026: NIH announced a meeting of the Interagency Autism Coordinating Committee. This is a hybrid meeting open to the public.
• May 19, 2026: NIH announced a meeting of the National Advisory Council on Minority Health and Health Disparities. This is a virtual meeting open to the public.
• May 19-20, 2026: NIH announced a meeting of the National Institute of Dental & Craniofacial Research. This is a hybrid meeting with some sessions open to the public.
• May 20, 2026: NIH announced a meeting of the National Institute of Neurological Disorders and Stroke. This is a virtual meeting open to the public.
• May 20, 2026: NIH announced a meeting of the National Advisory Council for Biomedical Imaging and Bioengineering. This is a hybrid meeting with some sessions open to the public.
• May 21, 2026: NIH announced a meeting of the National Advisory General Medical Sciences Council. This is a virtual meeting open to the public.
• May 21-22, 2026: NIH announced a meeting of the National Center for Advancing Translational Sciences. This is a virtual meeting with some sessions open to the public.
• May 26, 2026: 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 National Institute of Child Health & Human Development. 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 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: The Centers for Disease Control and Prevention (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 8-9, 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 22, 2026: NIH announced a meeting of the National Institute of Allergy and Infectious Diseases. 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 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. 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 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.

Reports, Studies & Analyses

• On May 12, 2026, the Congressional Research Service (CRS) released a report entitled, Overview of the Medicare Wasteful and Inappropriate Service Reduction (WISeR) Model. CRS described CMS’ new WISeR initiative, a large-scale expansion of prior authorization (PA) in traditional Medicare to be tested in six states from 2026 through 2031, and provided background on existing Medicare PA practices and utilization management policies. While the report does not make formal recommendations, CRS noted that health providers may see more PA denials, increased time responding to PA requests, and potential revenue losses from services that are denied or that providers choose not to furnish. Medicare beneficiaries may experience delays or barriers to accessing the selected services. By reducing the use of low-value or unnecessary care, CMS states that WISeR would decrease Medicare spending and potentially reduce patient safety risks. This decreased spending could modestly decrease Part B beneficiary premiums and the federal deficit.
• On May 14, 2026, the Office of Inspector General (OIG) released a report entitled, Unclear Medicare Requirements Led to Differing Interpretations of Inpatient Rehabilitation Facility Documentation, Coverage, and Billing Requirements. OIG found that unclear Medicare requirements led to differing interpretations between OIG, inpatient rehabilitation facility (IRF) stakeholders, and CMS related to documentation, coverage, and billing requirements. Since these requirements are unclear, OIG, IRF stakeholders, and CMS had differing opinions on the allowability of the sampled claims, which raises concerns about increased risk of financial loss to the program, compromised program integrity, and operational inefficiency in the Medicare program. OIG made four recommendations to CMS:
1. Revise or clarify IRF documentation requirements related to developing and individualizing a plan of care, leadership of interdisciplinary team (IDT) meetings and the review of enrollee progress at such meetings, and the functional status of enrollees during the preadmission screening;
2. Revise or clarify IRF coverage requirements related to reasonable expectations for rehabilitation physician supervision, the definition of active and ongoing therapeutic intervention from multiple disciplines, and what it means to be sufficiently stable to actively participate in an intensive rehabilitation therapy program;
3. Revise or clarify Inpatient Rehabilitation Facility Patient Assessment Instrument (IRF-PAI) signature requirements; and
4. Offer training and learning sessions to IRFs to assist in complying with regulations.

CMS only concurred with the fourth recommendation to offer education on Medicare requirements, stating that the remaining recommendations were addressed at issues too infrequent to warrant action beyond increased education.

Hearings & Markups

• On May 13, 2026, the Senate Homeland Security and Governmental Affairs Committee held a hearing entitled, Whistleblower Testimony on the COVID Coverup. Mr. James E. Erdman III, Senior Operations Officer, Central Intelligence Agency, served as the sole witness
• On May 13, 2026, the House Appropriations Committee held a markup entitled, Full Committee Markup of the Fiscal Year 2027 Commerce, Justice, Science, and Related Agencies Bill. The Committee met to consider the Fiscal Year 2027 Commerce, Justice, Science, and Related Agencies Appropriations Act. The measure was approved by the Committee with a vote of 32 to 28. 
• On May 13, 2026, the House Committee on Energy and Commerce Subcommittee on Health held a markup entitled, Subcommittee on Health Markup on Various Public Health Reauthorizations and Policies to Improve the Medicare Program. The Committee examined the following legislation:
  • H.R. 4348, To reauthorize the Kay Hagan Tick Act, and for other purposes
  • H.R. 4541, EARLY Act Reauthorization of 2025
  • H.R. 3747, Accelerating Access to Dementia and Alzheimer’s Provider Training (AADAPT) Act
  • H.R. 8209, School-Based Health Centers Reauthorization Act of 2026
  • H.R. 5160, Stem Cell Therapeutic and Research Reauthorization Act of 2025
  • H.R. 8205, Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026
  • H.R. 2715, Destruction of Hazardous Imports Act
  • H.R. 2821, FDA Modernization Act 3.0
  • H.R. 5347, Health Care Efficiency Through Flexibility Act
  • H.R. 1703, Choices for Increased Mobility Act of 2025
• On May 14, 2026, the House Education and Workforce Committee held a hearing entitled, Examining the Policies and Priorities of the Department of Education. The Honorable Linda McMahon, Secretary of the U.S. Department of Education, served as the sole witness.

Other Health Policy News

• On May 10, 2026, HHS launched Moms.gov, a website for new and expecting mothers that offers guidance and information to support the health and well-being of mothers and their families. Moms.gov also supports expecting parents who are navigating difficult or unexpected pregnancies. It features information about pregnancy centers, Federally Qualified Health Centers (FQHCs), nutritional guidance, Trump Accounts, and other resources that allow maternal and infant health to thrive.
  
  A press release can be found here.
• On May 12, 2026, the Trump Administration announced that FDA Commissioner Martin Makary would be resigning from his role after 13 months leading the agency. In a social media post, President Donald Trump confirmed that Kyle Diamantas, who previously worked as the top food official at FDA, will lead FDA in an acting capacity.
  
  In recent months, Acting Commissioner Diamantas had garnered support from multiple corners of the Trump Administration and HHS Secretary Kennedy’s Make America Healthy Again (MAHA) movement to serve as acting commissioner. Acting Commissioner Diamantas joined FDA to lead the agency’s food division in February 2025 after working as a corporate lawyer at Jones Day and Baker Donelson. He does not have a medical degree, typically a credential expected for FDA leaders.
• On May 12, 2026, HHS, through the Office on Women’s Health (OWH), announced a new Memorandum of Understanding (MOU) with Heartland Forward to advance maternal health outcomes and improve care for women and families across the U.S. Through this partnership, HHS and Heartland Forward will exchange information, align strategies, and collaborate on evidence-based initiatives to reduce maternal morbidity and mortality and strengthen care across the lifespan, including before, during, and after pregnancy. The collaboration will support the expansion of the HHS Perinatal Improvement Collaborative (HHS PIC), a nationwide network of hospitals and healthcare teams working to improve maternal and infant health outcomes through measurable, evidence-based practices. Currently spanning more than 220 hospitals, the initiative will broaden its reach to address the full continuum of maternal and child health.
  
  As part of the MOU, HHS and Heartland Forward will:
  • Expand the HHS Perinatal Improvement Collaborative to assess care and outcomes across the full maternal and child health continuum.
  • Leverage hospital networks and data systems to identify pregnancy-related risks and improve outcomes.
  • Collect and analyze linked data on maternal and infant morbidity and mortality to inform quality improvement efforts.
  • Convene national and regional leaders to share best practices and advance policy solutions.

  HHS notes this collaboration reflects its broader commitment to improving maternal health through innovation, partnerships, and evidence-based care.

  A press release can be found here.

• On May 12, 2026, HHS and CMS announced the first meeting of the Healthcare Advisory Committee. The public meeting will be held on May 18 at 2 PM EST and will focus on introducing committee members, outlining the vision of the committee and establishing committee bylaws.
  
  The Healthcare Advisory Committee, was established earlier this year as a federal advisory body comprised of leaders from across the healthcare system to provide expert advice on improving, strengthening and modernizing U.S. healthcare. The Healthcare Advisory Committee will advise HHS Secretary Kennedy and CMS Administrator Dr. Mehmet Oz on ways to improve how care is financed and delivered across Medicare, Medicaid, the Children’s Health Insurance Program (CHIP), and the Health Insurance Marketplace.
  
  The meeting will be held via a virtual webinar only and pre-registration is not required. Webinar details and full agenda can be found here.
  
  A press release can be found here.
• On May 13, 2026, CMS announced a six-month, nationwide moratoria on new Medicare enrollment for hospices and home health agencies (HHAs) in coordination with Vice President JD Vance’s Anti-Fraud Task Force. The moratoria will allow CMS to temporarily halt the influx of new providers into these categories.
  
  During the six-month moratoria, CMS will intensify targeted investigations, deploy advanced data analytics, and accelerate the removal of hospice and HHA providers from the Medicare program that are suspected of committing fraud. This nationwide approach will also eliminate the ability of bad actor operators to evade detection by simply shifting across state lines. In addition, the moratoria will apply to all applications for initial Medicare enrollment and certain changes in majority ownership. The moratoria will not impact current enrollments, and existing providers can continue to deliver services to Medicare beneficiaries.
  
  CMS’ announcement today follows the agency’s declaration earlier this year of a similar moratorium to prevent fraudulent Medicare billing by certain durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) companies.
  
  A press release can be found here.
• On May 13, 2026, CMS announced that through its Health Tech Ecosystem, it will be advancing its electronic prior authorization efforts through a newly established Electronic Prior Authorization Acceleration initiative to address key challenges and drive solutions ahead of 2027 requirements. 29 healthcare organizations—including health systems, electronic health record developers, physician practices, networks, and digital health developers—have signed on as early adopters in this cross-sector effort. They join many of the nation’s largest payers that have already committed to working with CMS to identify and address workflow, technical, and operational barriers that have slowed adoption of electronic prior authorization across the healthcare system.
  
  A press release can be found here.

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