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.
Highlight of the Week
This week, HHS announced a new “MAHA Action Plan” to promote appropriate psychiatric prescribing, particularly for children and adolescents, and HHS’s Office for Civil Rights issued an interim final rule extending the timeframe for covered entities to bring websites, mobile apps, and other digital tools into compliance with federal accessibility standards.
Regulations, Notices & Guidance
- On May 5, 2026, the Food and Drug Administration (FDA) released a proposed rule entitled, Modification of Certain Terminology in Title 21. FDA is issuing a proposed rule to modify certain terminology in Title 21 of the Code of Federal Regulations (CFR) to comply with Executive Order (EO) 14168, Defending Women From Gender Ideology Extremism and Restoring Biological Truth to the Federal Government, issued on January 20, 2025. Specifically, this proposed rule, if finalized, would remove the term “gender” wherever it appears and either replace it with the term “sex,” or delete the reference to gender, as applicable, along with other editorial changes to improve readability.
- On May 5, 2026, FDA released a rule entitled, Immunology and Microbiology Devices; Classification of the Circulating Tumor Cell Enrichment Device. FDA is classifying the circulating tumor cell enrichment device 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 circulating tumor cell enrichment device. 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 5, 2026, FDA released a rule entitled, Immunology and Microbiology Devices; Classification of the Device to Preserve and Stabilize Relative Abundances of Microbial Nucleic Acids in Clinical Samples. FDA is classifying the device to preserve and stabilize relative abundances of microbial nucleic acids in 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 device to preserve and stabilize relative abundances of microbial nucleic acids in clinical samples. 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 5, 2026, FDA released a rule entitled, Ophthalmic Devices; Classification of the Corneal Storage Medium With Preservatives Including Antifungals. FDA is classifying the corneal storage medium with preservatives including antifungals 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 corneal storage medium with preservatives including antifungals. 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 5, 2026, the Health Resources and Services Administration (HRSA) released a notice entitled, Criteria for Determining Maternity Care Health Professional Target Areas. HRSA published a 30-day public notice in the Federal Register on February 3, 2026 (91 Fed. Reg. 4927-4931), soliciting feedback on updated criteria for determining maternity care target areas (MCTA). In particular, HRSA requested feedback on proposed changes to the criteria and point scales for MCTAs by removing the criterion for Social Vulnerability Index (SVI) and reallocating its two points as follows: one point to the population-to-full-time equivalent maternity care health professional ratio and one point to the score for travel time/distance to the nearest source of accessible care outside of the MCTA. This notice responds to the comments received during the 30-day public notice period and sets forth updated MCTA scoring criteria.
- On May 6, 2026, FDA released guidance entitled, Patient-Matched Guides for Orthopedic Implants; Guidance for Industry and Food and Drug Administration Staff. FDA is announcing the availability of a final guidance entitled, Patient-Matched Guides for Orthopedic Implants. This guidance document provides recommendations regarding information that should be included in regulatory submissions for patient-matched guides for orthopedic implants. This guidance also provides recommendations that manufacturers should consider when developing their design process for these device types. This guidance is intended to promote clarity and transparency for expectations regarding submission recommendations for orthopedic patient-matched guides. Following such recommendations may increase efficiency and consistency in review.
- On May 7, 2026, the Department of Health and Human Services (HHS) released an interim final rule entitled, Extension of Compliance Dates for Nondiscrimination on the Basis of Disability; Accessibility of Web Content and Mobile Applications of Recipients of Departmental. In this interim final rule (IFR), HHS is revising the Department’s regulations implementing section 504 of the Rehabilitation Act (section 504) to extend the compliance dates for the requirements for web content and mobile application accessibility that were adopted on May 9, 2024. The compliance date for recipients with 15 or more employees is extended from May 11, 2026, to May 11, 2027. The compliance date for recipients with fewer than 15 employees is extended from May 10, 2027, to May 10, 2028.
- On May 7, 2026, FDA released a notice entitled, Medical Devices; Obstetrical and Gynecological Devices; Classification of the External Condom for Anal Intercourse or Vaginal Intercourse. FDA is classifying the external condom for anal intercourse or vaginal intercourse 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 external condom for anal intercourse or vaginal intercourse. 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 8, 2026, FDA released guidance entitled, Enforcement Priorities for Certain New Tobacco Products Marketed Without Premarket Authorization; Guidance for Industry. This guidance document describes certain enforcement policies with regard to the marketing of certain electronic nicotine delivery systems and oral nicotine pouch products that do not have premarket authorization.
- On May 8, 2026, FDA released guidance entitled, Clostridioides difficile Infection: Developing Drugs for Treatment, Reduction of Recurrence, or Prevention; Guidance for Industry. The purpose of this guidance is to assist sponsors in the clinical development of drugs to support an indication of treatment, reduction of recurrence, or prevention of Clostridioides difficile infection (CDI). This guidance finalizes the draft guidance titled “Clostridioides difficile Infection: Developing Drugs for Treatment, Reduction of Recurrence, and Prevention” issued on October 28, 2022.
- On May 8, 2026, FDA released guidance entitled, Postapproval Pregnancy Safety Studies; Guidance for Industry. FDA is announcing the availability of a final guidance for industry entitled, Postapproval Pregnancy Safety Studies. The purpose of this guidance is to provide sponsors and investigators with recommendations on how to design investigations to assess the outcomes in pregnant women exposed to drug and biological products regulated by FDA (i.e., pregnancy safety studies) in the postapproval setting. This guidance finalizes the draft guidance of the same name issued on May 9, 2019.
- On May 8, 2026, FDA released guidance entitled, Pulmonary Tuberculosis: Developing Drugs for Treatment; Guidance for Industry. FDA is announcing the availability of a final guidance for industry entitled, Pulmonary Tuberculosis: Developing Drugs for Treatment. The purpose of this guidance is to assist sponsors in the clinical development of new antibacterial drugs for the treatment of pulmonary tuberculosis (TB). This guidance finalizes the draft guidance of the same title issued on December 15, 2022.
- On May 8, 2026, the National Institutes of Health (NIH) released a notice entitled, Government Owned Inventions Available for License: Enhanced Tumor Reactivity of T Cells Lacking SIT1, LAX1 or TRAT1. The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) is actively seeking potential licensees interested in further developing these inhibitory transmembrane adapter proteins as targets for T-cell immunotherapy for the treatment of cancer, infectious diseases, and autoimmune diseases.
Event Notices
Please note that two asterisks (**) preceding the item indicate a new event.
- May 12, 2026: NIH announced a meeting of the Board of Regents of the National Library of Medicine. This is a virtual meeting with some sessions open to the public.
- May 13, 2026: NIH announced a meeting of the National Institute on Aging. This is an in-person meeting with some sessions open to the public.
- May 13, 2026: NIH announced a meeting of the National Diabetes and Digestive and Kidney Diseases Advisory Council. This is a hybrid meeting with some sessions open to the public.
- May 14-15, 2026: NIH announced a meeting of the Office of the Director. This is a hybrid meeting with some sessions open to the public.
- May 14, 2026: NIH announced a meeting of the National Deafness and Other Communication Disorders Advisory Council. This is a hybrid meeting with some sessions open to the public.
- 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: The Centers for Medicare & Medicaid Services (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 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 a public hearing related to the Commissioner’s National Priority Voucher (CNPV) Pilot Program will be rescheduled to June 4. 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 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.
- 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 6, 2026, the Government Accountability Office (GAO) released a report entitled, High-Tech Medical Equipment: VA Has Opportunities to Improve Its Acquisition of Maintenance Services. GAO found that the Department of Veterans Affairs (VA) spends hundreds of millions of dollars each year to purchase and maintain high-tech medical equipment, such as MRI machines, but does not consistently use agency-wide contracts designed to reduce administrative burden and secure the best pricing for maintenance services. GAO determined that unclear and inconsistent procurement guidance, along with insufficient national contracting resources, led some VA officials to award duplicative or stand-alone contracts that did not yield better prices and, in some cases, resulted in higher costs. While selected medical centers generally reported satisfactory maintenance and comparable pricing, GAO identified instances of weak documentation, inefficient purchasing practices, and overpayments. GAO recommended that VA clarify whether agency-wide contracts are mandatory, update and standardize procurement guidance, and improve training and resources for contracting officials. VA agreed with the recommendations and indicated it plans to review and revise its approach.
Hearings & Markups
- On May 5, 2026, the Senate Committee on Health, Education, Labor, and Pensions (HELP) held a hearing entitled, Making Health Care Affordable Again Part 2: Perspectives from Employers, Patients, and Providers. Witnesses present included: Ms. Ronnell Nolan, President and Chief Executive Officer, Health Agents for America; Ms. Debbie Rowell, Owner, Coffee Connection, Acadian Coffee Roasters; Ms. Kathy Oubre, Chief Executive Officer, Pontchartrain Cancer Center; and TJ Woodard, Co-Owner, Prescriptions to Geaux.
- On May 6, 2026, the Senate HELP Committee held a hearing entitled, From Crisis to Care: Mental Health and Substance Use Treatment Across the Continuum of Care. Witnesses present included: Dr. Arthur Kleinschmidt, Former Principal Deputy Assistant Secretary for Mental Health and Substance Use, Substance Abuse and Mental Health Services Administration (SAMHSA); Mr. Nick Richard, Executive Director, National Alliance on Mental Illness Southeast Louisiana; Stuart Archer, Chief Executive Officer, Oceans Healthcare; and Tonja R. Myles, Chief Executive Officer, Set Free Indeed Ministry.
Other Health Policy News
- On May 4, 2026, HHS announced a new departmental action plan aimed at addressing the perceived overuse of psychiatric medications, particularly among children, during a summit hosted by the Make America Healthy Again (MAHA) Institute focused on mental health and overmedicalization. The initiative was outlined by HHS Secretary Robert F. Kennedy, Jr. in closing remarks and is intended to promote more deliberate use of psychiatric medications, emphasize informed consent and shared decision-making, and encourage deprescribing when patients do not experience clinical benefit. HHS framed the effort as part of a broader response to ongoing mental health challenges, with an emphasis on evaluating prescribing patterns, improving transparency around risks and benefits, and increasing the use of nonmedication interventions when appropriate.
As part of the action plan, HHS agencies will coordinate their work to assess the effects and utilization of psychiatric medications while elevating evidence-based alternatives such as psychotherapy, family support, nutrition, and physical activity. The Department described a multipronged strategy that includes education and outreach, programmatic and policy changes, and research-to-practice initiatives designed to prevent unnecessary initiation of psychiatric medications and to support safe tapering or discontinuation. HHS also released a Dear Colleague Letter encouraging clinicians to routinely review treatment risks and benefits with patients and outlining available billing codes for delivering nonmedication care.
CMS issued accompanying guidance clarifying how physicians and other practitioners can be reimbursed under Medicare for deprescribing-related care. The guidance also directs clinicians to established resources, including professional society recommendations, peer-reviewed protocols, and FDA tapering instructions. Across the coming months, SAMHSA will release a report on prescribing trends and host educational webinars for clinicians, while SAMHSA and HRSA are planning joint outreach to Federally Qualified Health Centers (FQHCs) on holistic care and medication tapering. HHS also intends to convene a Technical Expert Panel in July to inform the development of formal clinical guidance.
In parallel, HHS plans to support changes in clinical practice through grant-funded training for frontline prescribers, with a focus on pediatric assessment, treatment planning, and access to specialist consultation. CMS will pursue policy changes to expand access to evidence-based nonmedication services and psychotherapy, particularly for children and adolescents. On the research side, NIH and FDA are expediting studies of new mental health treatments. HHS described the action plan as a coordinated effort to standardize evidence-based care and ensure that patients and families have the information and support needed to make informed mental health treatment decisions.
A press release can be found here.
- On May 4, 2026, the Department of Homeland Security (DHS) confirmed to reporters that it had resumed processing visa applications for foreign medical physicians from a group of 39 restricted countries. This is a modification of a December 16, 2025 presidential proclamation which restricted the entry of all foreign nationals from countries that the Trump Administration identified as posing a heightened national security risk. While the travel ban from these 39 countries remains in place, the modification allows for physician visa petitions and applications to be processed, including J-1, H-1B, O-1, and EAD visas.
This proclamation was one of several steps the Administration has taken to restrict the use of visas by foreign nationals. Previously, in September 2025, DHS implemented a $100,000 fee for all new H-1B visa applications. These restrictions are impacting work visas for health care workers. Health care providers have sought exemptions for health care workers from these restrictive visa fees and policies, noting their reliance on foreign workers to address workforce shortages, particularly in rural areas. Monday’s change in policy was one such modification urged by providers and Members of Congress from both parties.
The December 2025 presidential proclamation can be found here.
- On May 5, 2026, the Senate HELP Committee held a field hearing entitled, Making Health Care Affordable Again Part 2, which examined the drivers of rising health care costs from the perspectives of employers, patients, and providers. Members and witnesses focused on affordability challenges facing American families and potential legislative approaches to addressing high costs across the health care system. Key policy themes included the No Surprises Act, pharmacy benefit manager (PBM) oversight, the 340B drug pricing program (340B program), and the role of price transparency. Chairman Bill Cassidy (R‑LA) noted that the No Surprises Act was intended to prevent patients from facing unexpected medical bills, though witnesses suggested that awareness and implementation gaps may remain.
Chairman Cassidy framed health care affordability as a central concern for households nationwide, citing high deductibles as a significant barrier to care. He used the hearing to outline his Money and Value for Patients (MVP) agenda, which aims to give consumers greater control over health care spending through pre‑funded health savings accounts and enhanced price transparency. Chairman Cassidy argued that empowering patients to see prices and manage their health care dollars directly would increase competition, lower premiums, and reduce administrative costs.
Witnesses echoed concerns about structural cost drivers across the system. Ms. Ronnell Nolan, President of Health Agents of America, highlighted systemic issues, including a "huge hole" in the federal marketplace that allows for fraud, and called for CMS to implement two-factor authentication to prevent unauthorized plan changes. Ms. Nolan emphasized the continued importance of agents in helping consumers navigate coverage options. Ms. Kathy Oubre, CEO of the Pontchartrain Cancer Center, pointed to provider consolidation as a major cost driver and called for site‑neutral payment reforms, stronger oversight of the 340B program, and continued scrutiny of PBM practices. Mr. T.J. Woodard, an independent pharmacist, criticized PBMs as a key source of dysfunction in the prescription drug supply chain and urged Congress to address conflicts of interest stemming from vertical integration.
More information on this hearing can be found here. More information on Chairman Cassidy’s MVP agenda can be found here.
- On May 6, 2026, the Senate HELP Committee held a field hearing entitled, From Crisis to Care: Mental Health and Substance Use Treatment Across the Continuum of Care, which featured behavioral health executives, policy advocates, and peer support specialists to discuss strategies for addressing the nation’s mental health and addiction crises. The discussion focused on modernizing outdated federal regulations, expanding the behavioral health workforce, and integrating supportive housing into the health care continuum.
Throughout the hearing, witnesses discussed the regulatory and statutory barriers that limit access to long‑term behavioral health care. Of note, Mr. Stuart Archer, CEO of Oceans Healthcare, urged Congress to eliminate Medicare’s 190‑day lifetime limit on inpatient psychiatric care, arguing that such limits are inconsistent with how chronic illness is treated elsewhere in the health care system. He also highlighted restrictions that prevent private behavioral health providers from directly accessing SAMHSA mental health block grants, noting that similar restrictions have already been lifted for substance use treatment providers.
Witnesses and members also debated the Medicaid Institutions for Mental Diseases (IMD) exclusion, which limits inpatient psychiatric treatment duration and facility size. Chairman Cassidy raised concerns about how to extend access to care while preventing abuse of the system, while former SAMHSA Acting Assistant Secretary Arthur Kleinschmidt suggested modifying the IMD exclusion for individuals with severe mental illness or substance use disorders to reduce repeated emergency department use and homelessness.
Multiple witnesses emphasized that clinical care must be paired with wraparound services to support long‑term recovery. Mr. Nick Richard of NAMI Southeast Louisiana underscored that discharging patients without stable housing increases the likelihood of relapse and asserted that supportive housing should be viewed as a core health care service. Additionally, Ms. Lonnie Granier of Odyssey House Louisiana described integrated care models that combine behavioral health treatment, primary care, and medication‑assisted treatment, emphasizing that recovery is a process rather than a single intervention.
Chairman Cassidy noted that effective, scalable models already exist, but federal alignment, particularly through Medicare and Medicaid payment policy, is necessary to expand access and sustain long‑term behavioral health recovery.
More information on this hearing can be found here.
- On May 7, 2026, HHS released an IFR to announce that it was delaying the compliance deadline for digital accessibility requirements established by the May 2024 final rule entitled, Nondiscrimination on the Basis of Disability in Programs or Activities Receiving Federal Financial Assistance. The compliance deadline originally set by the May 2024 rule for covered entities with 15 or more employees was May 11, 2026. The new compliance deadline is May 11, 2027. Additionally, the original compliance deadline for covered entities with fewer than 15 employees was May 10, 2027. This deadline is now May 10, 2028.
The May 2024 rule requires that all health care entities which receive Medicare Part A, Part B, or Medicaid/ Children’s Health Insurance Program (CHIP) payments ensure that any programs or activities provided through a kiosk, all web-based content, and any mobile applications meet Web Content Accessibility Guidelines (WCAG) 2.1 Level A and Level AA, depending on whether the entity has more or fewer than 15 employees. There are a number of exceptions to these requirements, including content that is archived, entities that would experience undue financial hardship, and content that does not impede an individual with disabilities’ access to the same information, programs, and transactions as an individual without disabilities.
The IFR, which provides the reasoning for the delay, can be found here. The May 2024 final rule can be found here.
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