Health Care Week in Review | FDA and CMS Announce New Program to Accelerate Medicare Coverage of Breakthrough Medical Devices; CMS Administrator Oz Asks All 50 States to Revalidate High-Risk Medicaid Providers | Alston & Bird

Highlight of the Week

This week, FDA and CMS unveiled the “RAPID” coverage pathway to speed up access to certain breakthrough medical devices for Medicare beneficiaries and CMS Administrator Mehmet Oz issued letters to all 50 governors and state Medicaid directors directing states to undertake a swift revalidation of high risk Medicaid providers.

Regulations, Notices & Guidance

• On April 21, 2026, the Food and Drug Administration (FDA) released a rule entitled, Medical Devices: Anesthesiology Devices; Classification of the Device for Sleep Apnea Testing Based on Mandibular Movement. FDA is classifying the device for sleep apnea testing based on mandibular movement 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 for sleep apnea testing based on mandibular movement. 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 also believes this action will enhance patients’ access to beneficial innovative devices, in part by reducing regulatory burdens.
• On April 21, 2026, FDA released a rule entitled, Medical Devices: Clinical Chemistry and Clinical Toxicology Devices; Classification of the Setmelanotide Eligibility Gene Variant Detection System. FDA is classifying the setmelanotide eligibility gene variant detection system into class II. 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 setmelanotide eligibility gene variant detection system. FDA is taking this action because the agency has determined that classifying the device into class II will provide a reasonable assurance of safety and effectiveness of the device. FDA also believes this action will enhance patients’ access to beneficial innovative devices, in part by reducing regulatory burdens.
• On April 21, 2026, FDA released a rule entitled, Medical Devices: Immunology and Microbiology Devices; Classification of the Alzheimer’s Disease Pathology Assessment Test. FDA is classifying the Alzheimer’s disease pathology assessment test into class II. 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 Alzheimer’s disease pathology assessment test. 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 also believes this action will enhance patients’ access to beneficial innovative devices, in part by reducing regulatory burdens.
• On April 21, 2026, FDA released a rule entitled, Medical Devices: Ophthalmic Devices; Classification of the Digital Therapy Device for Amblyopia. FDA is classifying the digital therapy device for amblyopia into class II. 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 digital therapy device for amblyopia. 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 also believes this action will enhance patients’ access to beneficial innovative devices, in part by reducing regulatory burdens.
• On April 22, 2026, the Agency for Health Research and Quality (AHRQ) released a notice entitled, Requests for Nominations: U.S. Preventive Services Task Force. AHRQ invites nominations of individuals qualified to serve as members of the U.S. Preventive Services Task Force (USPSTF).
• On April 23, 2026, FDA released a notice entitled, Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements and Commitments. FDA is announcing the availability of the Agency’s annual report entitled, Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements and Commitments. Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), FDA is required to report annually on the status of postmarketing requirements (PMRs) and postmarketing commitments (PMCs) required of, or agreed upon by, application holders of approved drug and biological products.
• On April 24, 2026, FDA released a notice entitled, Advisory Committee; Anesthetic and Analgesic Drug Products Advisory Committee; Renewal. FDA is announcing the renewal of the Anesthetic and Analgesic Drug Products Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Anesthetic and Analgesic Drug Products Advisory Committee for an additional two years beyond the charter expiration date. The new charter will be in effect until the May 1, 2028, expiration date.

Event Notices

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

• April 27, 2026: The Department of Health and Human Services (HHS) announced a meeting of the Advisory Council on Alzheimer’s Research, Care, and Services. This is a hybrid meeting open to the public.
• April 28, 2026: The National Institutes of Health (NIH) announced a meeting of the Office of the Secretary. This is a hybrid meeting open to the public.
• April 29, 2026: The Centers for Disease Control and Prevention (CDC) announced a meeting of the Advisory Board on Radiation and Worker Health. This is a virtual meeting open to the public.
• April 30, 2026: FDA announced a meeting of the Oncologic Drugs Advisory Committee. This is a hybrid meeting open to the public.
• May 4-5, 2026: NIH announced a meeting of the Eunice Kennedy Shriver National Institute of Child Health & Human Development. This is a hybrid meeting open to the public.
• May 5, 2026: NIH announced a meeting of the National Advisory Council on Alcohol Abuse and Alcoholism. This is a hybrid meeting with some sessions open to the public.
• **May 5, 2026: NIH announced a meeting of the National Institute on Drug Abuse. This is a hybrid meeting with some sessions open to the public.
• May 7, 2026: The Assistant Secretary for Technology Policy (ASTP) announced a meeting of the Health Information Technology Advisory Committee. This is a hybrid meeting open to the public.
• 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 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 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 to discuss and make recommendations on the selection of the 2026-2027 Formula for COVID-19 vaccines for use in the United States. This is a virtual meeting open to the public.
• **May 29, 2026: NIH announced a meeting of the Board of Scientific Counselors Eunice Kennedy Shriver National Institute of Child Health and 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: The Centers for Medicare & Medicaid Services (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 the Eunice Kennedy Shriver National Institute of Child Health & Human Development. This is a hybrid meeting with some sessions open to the public.
• June 5, 2026: CDC announced a meeting of the Subcommittee on Procedures 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 10-11, 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 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 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 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 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: 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: ASTP announced a meeting of the Health Information Technology Advisory Committee. This is a virtual meeting open to the public.
• November 5, 2026: ASTP 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 the Eunice Kennedy Shriver National Institute of Child Health & Human Development. 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 April 20, 2026, the HHS Office of Inspector General (OIG) released a report entitled, CMS Has Limited Oversight of Selected Compounded Drugs Prescribed to Medicare Part D Enrollees. OIG conducted an audit examining CMS’ oversight of compounded drugs prescribed to Medicare Part D enrollees and found significant limitations driven largely by incomplete reporting data. OIG reported that because Prescription Drug Event (PDE) records capture only a single National Drug Code (NDC) and do not list all compound ingredients, CMS lacks routine visibility into the full composition of compounded drugs, constraining its ability to effectively oversee sponsor quality assurance efforts. The audit identified instances in which FDA‑approved reconstituted injectable drugs were incorrectly reported as compounded drugs, potentially increasing the risk of medication errors, as well as cases where enrollees received compounded drugs containing gabapentin or controlled substances such as ketamine that were not reflected on PDE records and, in some cases, overlapped with separate prescriptions for gabapentin and opioids. These gaps limit CMS’s capacity to detect potential overutilization, misuse, and patient safety risks. OIG recommended that CMS improve the accuracy of compounded drug reporting, strengthen sponsor oversight of compounds containing controlled substances and gabapentin, and provide guidance on monitoring bulk drug ingredients; CMS concurred with all recommendations and committed to issuing additional guidance to sponsors.
• On April 21, 2026, the Government Accountability Office (GAO) publicly released a report that it sent to the Senate Special Committee on Aging entitled, Medicare: CMS’s Use of Data Analytics to Identify and Prevent Fraud. The report examines CMS’s use of claims‑based data analytics in traditional Medicare to identify anomalous billing patterns associated with common fraud schemes, particularly those involving misuse of provider billing privileges and beneficiary identifiers, and to generate leads for investigations and administrative actions. GAO reports that CMS relies on these analytics to support actions such as payment suspensions, revocations, and prepayment reviews, and that CMS estimates these actions prevented approximately $11.9 billion in potentially fraudulent Medicare payments during fiscal years 2022–2024, noting these figures reflect CMS estimates rather than adjudicated fraud. The report highlights a large urinary catheter billing scheme as an example in which early analytic detection enabled CMS to suspend payments and avoid most of the billed amounts. GAO also found that until late 2025 CMS did not routinely share payment suspension information with supplemental payers, contributing to continued cost‑sharing payments on potentially fraudulent claims, and notes CMS has since begun sharing this information.

Hearings & Markups

• On April 21, 2026, the House Committee on Energy and Commerce Subcommittee on Health held a hearing entitled, The FY2027 Department of Health and Human Services Budget. HHS Secretary Robert F. Kennedy Jr. served as the sole witness.
• On April 21, 2026, the Senate Committee on Appropriations – Labor, Health and Human Services, Education and Related Agencies Subcommittee held a hearing entitled, A Review of the President’s FY2027 Budget Request for the Department of Health and Human Services. HHS Secretary Robert F. Kennedy Jr. served as the sole witness.
• On April 22, 2026, the Senate Committee on Finance held a hearing entitled,The President’s Fiscal Year 2027 Department of Health and Human Services Budget. HHS Secretary Robert F. Kennedy Jr. served as the sole witness.
• On April 22, 2026, the House Committee on Education and the Workforce – Health, Employment, Labor, and Pensions Subcommittee: Profits Over Patients: The PBM (Pharmacy Benefit Managers) Business Model Under Scrutiny. Witnesses present included: Mr. James Gelfand, President and CEO, The ERISA Industry Committee (ERIC); Mrs. Chris Deacon, Principal and Founder, VerSan Consulting; Ms. Mariana Socal, Associate Professor, Johns Hopkins Bloomberg School of Public Health; and Ms. Hannah Anderson, Director, Healthy America Policy and Senior Director of Policy.
• On April 22, 2026, the SenateCommittee on Health, Education, Labor and Pensions (HELP) held a hearing entitled, FY2027DepartmentofHealthandHumanServicesBudget. HHS Secretary Robert F. Kennedy Jr. served as the sole witness.

Other Health Policy News

Regulatory Alignment for Predictable and Immediate Device (RAPID) Coverage Pathway

On April 23, 2026, FDA and CMS jointly announced the Regulatory Alignment for Predictable and Immediate Device (RAPID) coverage pathway. This pathway is intended to provide more rapid Medicare coverage of certain Class II and Class III Breakthrough Devices which address unmet medical needs within the Medicare population. This coordinated approach allows CMS and FDA to rely on premarket evidence to inform both FDA premarket review and Medicare coverage processes and establish a predictable timeline and process that can safely expedite national Medicare coverage for eligible devices. Under the RAPID coverage pathway, CMS will issue a proposed National Coverage Determination (NCD) the same day an eligible device participating in this pathway receives FDA market authorization.

A proposed procedural notice outlining the RAPID coverage pathway will soon be published in the Federal Register. The public will have 60 days to provide comments on the procedural notice. CMS will respond to public comments in a subsequent final notice. The effective date of the new pathway is expected to occur upon publication of the final notice in the Federal Register.

A press release with more information is available here.

CMS Calls for “Swift Review and Revalidation” of Medicaid Providers

On April 23, 2026, CMS Administrator Dr. Mehmet Oz issued letters to all 50 state Medicaid programs and all 50 governors directing each state and program to submit proposals on carrying out a “swift review and revalidation of high-risk providers.” CMS specifies that states may make their own determination of what constitutes a high-risk provider but must include “any provider without a National Provider Identifier.” While the Medicaid programs have been provided 30 days to respond to CMS with a strategy on how they will engage in provider revalidation, CMS is asking that governors respond to the letter within 10 business days (May 7, 2026) on whether the state intends to carry out a “swift revalidation” of high-risk providers, along with a proposed timetable. CMS also indicates that failure for the state to do so “will be considered as [CMS] evaluate[s] the likelihood of fraud in each state moving forward,” which may be in reference to recent stoppages in federal Medicaid funds for states that CMS alleges experience large amounts of Medicaid fraud.

An example of the full letter sent to governors can be found here.

HHS Secretary Kennedy Attends Hearings on FY 2027, Program Oversight, & More

This week, HHS Secretary Kennedy appeared before multiple House and Senate committees, including the Senate Committee on Finance, the Senate HELP Committee, the Senate Committee on Appropriations – Subcommittee on Labor, Health and Human Services, Education and Related Agencies, and the House Committee on Energy and Commerce – Health Subcommittee. The hearings focused on the Administration’s FY 2027 budget request, oversight of HHS programs, and policy decisions made during Secretary Kennedy’s first 15 months in his role. Across the hearings, Secretary Kennedy emphasized the Administration’s health priorities, including efforts to address chronic disease, expand nutrition education, negotiate drug prices, accelerate FDA clearances/approvals, and direct new resources to rural healthcare. Secretary Kennedy also highlighted the release of updated dietary guidelines, efforts to increase price transparency in healthcare, and changes intended to shift federal health policy toward prevention. Republican members largely focused their questions on these priorities, particularly nutrition policy and Medicaid oversight.

Democratic members questioned proposed reductions in federal health spending and the potential effects on public health and medical research. The President’s FY 2027 budget proposes an overall reduction in HHS funding, including decreases for agencies such as NIH and CDC, while increasing federal defense spending. As a reminder, the HHS Budget-in-Brief proposes $111.1 billion in discretionary budget authority for FY 2027, a decrease of $15.8 billion, or 12.5 percent. The FY 2027 HHS budget proposal reflects an overall reduction in discretionary spending across the Department, consistent with the Administration’s broader effort to reduce non-defense spending. Lawmakers raised concerns about the impact of these proposals on research grants, public health staffing, maternal health programs, disability‑focused resources, and safety‑net programs. Secretary Kennedy described the budget as a reallocation intended to address longstanding inefficiencies and refocus federal efforts on chronic disease prevention and argued that prior funding levels had not produced commensurate improvements in health outcomes.

Across committees, Members questioned changes to vaccine advisory processes, the federal response to recent measles outbreaks, delayed international vaccine funding, and Secretary Kennedy’s prior public statements on vaccines. Secretary Kennedy claimed that HHS continues to promote vaccination, including measles immunization, and reiterated that vaccines are effective at preventing disease. At the same time, he emphasized that declining public trust and global trends, rather than recent policy changes alone, have contributed to lower vaccination rates. He also pointed to ongoing federal investments in vaccine research.

Members also raised healthcare affordability and coverage, rural hospital closures, and the expiration of enhanced Affordable Care Act (ACA) Marketplace subsidies. Secretary Kennedy defended the Administration’s approach by citing proposed rural health investments and long‑term increases in Medicaid spending projections, while acknowledging that Congress would ultimately determine funding levels. Lawmakers also questioned the Administration’s TrumpRx drug pricing platform, environmental and agricultural policy decisions affecting pesticide regulation, consolidation of health agencies, grant terminations that were later reversed, and the use of HHS resources for public communications.

In several instances, members from both parties identified areas of potential agreement, including interest in prescription drug pricing reforms, consumer food labeling, and nutrition policy.

More information on the President’s Budget Proposal can be found here.[A1] More information on the Senate Finance Committee hearing can be found here. More information on the Senate HELP hearing can be found here. More information on the Senate Appropriations hearing can be found here. More information on the House Energy and Commerce hearing can be found here.