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, the House Committee on Ways and Means held a hearing on health care affordability with hospital and health system CEOs, and the Department of Education (ED) released its final rule classifying certain graduate programs as “professional” programs and establishing new federal student loan caps.
Regulations, Notices & Guidance
- On April 27, 2026, the Centers for Medicare & Medicaid Services (CMS) released a notice entitled, Medicaid Program: 2028 Medicaid Home and Community-Based Services Quality Measure Set. The Home and Community-Based Services (HCBS) Quality Measure Set is a set of nationally standardized quality measures for Medicaid-funded HCBS that is intended to promote more common and consistent use within and across States of nationally standardized quality measures in HCBS programs, create opportunities for CMS and States to have comparative quality data on HCBS programs, and drive improvement in quality of care and outcomes for people receiving HCBS. The purpose of this notice with comment period is to solicit public comment on the 2028 HCBS Quality Measure Set. Specifically, it is intended to solicit public comment on: proposed mandatory and voluntary measures for the 2028 HCBS Quality Measure Set; how States collect, calculate, and report data on the measures in the proposed 2028 HCBS Quality Measure Set; the proposed measures in the 2028 HCBS Quality Measure Set for which States are required to report stratified data, including rural/urban status; the proposed stratification factors for each of the measures in the 2028 HCBS Quality Measure Set for which States are required to report stratified data; the populations for which States are proposed to report the measures in the 2028 HCBS Quality Measure Set; and the proposed reporting schedule.
- On April 28, 2026, the Health Resources and Services Administration (HRSA) released a notice entitled, Rural Hospital Provider Assistance Program. HRSA’s Federal Office of Rural Health Policy (FORHP) will administer the Rural Hospital Provider Assistance Program for fiscal year (FY) 2026, a new formula grant program authorized under the Consolidated Appropriations Act, 2026. This notice is being issued prior to the publication of the Rural Hospital Provider Assistance Program Notice of Funding Opportunity to allow eligible hospitals enough time to prepare and submit applications through www.grants.gov, and for HRSA to process applications. $25,000,000 will be available for HRSA to make payments to eligible hospitals within FY 2026.
- On April 29, 2026, the Food and Drug Administration (FDA) released a rule entitled, Cardiovascular Devices; Classification of the Laser-Powered Inferior Vena Cava Filter Retrieval Catheter. FDA is classifying the laser-powered inferior vena cava filter retrieval catheter 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 laser-powered inferior vena cava filter retrieval catheter. 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 29, 2026, FDA released a rule entitled, Neurological Devices; Classification of the Brain Temperature Measurement System. FDA is classifying the brain temperature measurement 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 brain temperature measurement 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 29, 2026, FDA released a rule entitled, Radiology Devices; Classification of the Radiation Therapy Marking Device. FDA is classifying the radiation therapy marking device 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 radiation therapy marking 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 also believes this action will enhance patients’ access to beneficial innovative devices, in part by reducing regulatory burdens.
- On April 30, 2026, FDA released a rule entitled, General and Plastic Surgery Devices; Classification of the Phototherapy Device for Reducing the Appearance of Acute Post-Surgical Incisions. FDA is classifying the phototherapy device for reducing the appearance of acute post-surgical incisions 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 phototherapy device for reducing the appearance of acute post-surgical incisions. 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 30, 2026, FDA released a notice entitled, List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act. FDA is evaluating substances that have been nominated for inclusion on a list of bulk drug substances (active pharmaceutical ingredients) for which there is a clinical need for outsourcing facilities to use in compounding (the 503B Bulks List). This notice identifies three bulk drug substances that FDA has considered and proposes not to include on the 503B Bulks List: semaglutide, tirzepatide, and liraglutide. Additional bulk drug substances nominated for inclusion on this list are under consideration and may be the subject of future notices.
- On April 30, 2026, FDA released a notice entitled, Obesity and Drug Dosing: Clinical Pharmacology Considerations. FDA is soliciting input from interested persons on assessing the effect of obesity on drug pharmacokinetics and pharmacodynamics during drug (including biological product) development. These assessments could potentially inform whether obesity impacts the safety and effectiveness of the drug and dosing recommendations for obese patients.
Event Notices
Please note that two asterisks (**) preceding the item indicate a new event.
- May 4-5, 2026: The National Institutes of Health (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 Office of the National Coordinator for Health Information Technology (ONC) 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 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 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: 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: The Centers for Disease Control and Prevention (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, 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: The Department of Health and Human Services (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 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 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: 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 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 28, 2026, the Congressional Research Service (CRS) released a report entitled, Changes to CDC Vaccine Recommendations in 2025 and 2026. In this report, CRS summarizes changes to federal vaccine recommendations made by HHS in 2025 and 2026 following the appointment of a new HHS Secretary Robert F. Kennedy Jr. February 2025. For decades, vaccine recommendations were developed primarily through the Advisory Committee on Immunization Practices (ACIP), whose evidence‑based recommendations were typically adopted by the CDC and incorporated into annual immunization schedules referenced in federal and state law. Beginning in 2025, HHS altered long‑standing processes for vaccine policymaking, including removing all sitting ACIP members, appointing a new committee, and changing certain vaccine recommendations without ACIP consultation. During 2025, ACIP meetings resulted in revised recommendations for COVID‑19, RSV, influenza, hepatitis B, and other vaccines, and CDC announced a revised childhood immunization schedule in January 2026 reflecting several of these changes. In March 2026, a federal district court stayed implementation of vaccine recommendation changes adopted after June 11, 2025, including portions of the 2026 childhood and adult immunization schedules. As a result, CDC is currently unable to implement most of the recent changes, and immunization schedules have largely reverted to their 2025 versions. The stay has created uncertainty regarding the status of some newer vaccine recommendations, particularly with respect to coverage implications. The report notes that HHS retains authority to issue future vaccine recommendations consistent with the court order. In April 2026, CDC renewed and revised ACIP’s charter, expanding the scope of committee expertise and signaling potential future appointments and additional vaccine policy activity.
- On April 29, 2026, the Government Accountability Office (GAO) released a report entitled, Federal Employees Health Benefits Program: Additional Actions Needed to Address Significant Risks in Verifying Provider Eligibility. GAO found that weaknesses in control activities allowed potentially ineligible health care providers to participate in the Federal Employees Health Benefits (FEHB) program, creating risks of fraud and improper payments. GAO identified FEHB claims submitted by roughly 400 deceased providers and more than 2,000 claims from providers excluded from other federal programs, indicating that existing screening mechanisms used by the Office of Personnel Management (OPM) and its Office of the Inspector General (OIG) have limitations. While these claims represented a small share of overall FEHB spending, GAO concluded the risks could be mitigated through stronger data matching, such as comparing claims with death and exclusion data. GAO also found that selected FEHB carriers did not consistently comply with requirements to identify, exclude, or notify patients about suspended or debarred providers, nor did they always notify OPM OIG when such providers warranted further action. GAO issued 15 recommendations to strengthen provider oversight and clarify requirements, all of which OPM and OPM OIG agreed with.
Hearings & Markups
- On April 28, 2026, the House Committee on Ways and Means held a hearing entitled, Full Committee Hearing with Health System CEOs. Witnesses present included: Mr. Sam N. Hazen, Chief Executive Officer, HCA Healthcare; Mr. Wright Lassiter III, President and Chief Executive Officer, CommonSpirit Health; Dr. Brian G. Donley; President and Chief Executive Officer, New York-Presbyterian; Dr. Michael Waldrum, Chief Executive Officer, ECU Health; and Mr. Brad Woodhouse, President, Protect Our Care.
- On April 29, 2026, the House Committee on Energy and Commerce Health Subcommittee held a hearing entitled, Healthier America: Legislative Proposals on the Regulation and Oversight of Food. Witnesses present included: Mr. Steven Mandernach, Executive Director, Association of Food and Drug Officials; Mr. Joseph Colalillo, President, ShopRite of Hunterdon County, Inc.; Mr. Chad Hamilton, Board Member, Cheese Board, International Dairy Foods Association; and Mr. Scott Faber, Senior Vice President, Government Affairs, Environmental Working Group.
- On April 29, 2026, the Senate Committee on Homeland Security & Governmental Affairs held a hearing entitled, Unmasked: How Biden Health Officials Purposely Turned a Blind Eye Toward COVID-19 Vaccine Safety Signals. Witnesses present included: Dr. David Wiseman, President, Synechion, Inc.; Dr. Karl Jablonowski, Director of Science and Research, Children's Health Defense; and Ms. Maria Young, COVID-19 survivor.
- On April 29, 2026, the Senate Committee on Veterans’ Affairs held a hearing to examine the following legislation: S.1127, Dennis and Lois Krisfalusy Act; S.3000, FRAUD in VA Disability Exams Act of 2025; S.3098, Presumptive CLARITY Act of 2025; S.3170, Stuck On Hold Act; S.3286, Veterans Appeals Improvement and Modernization Act 2.0; S.3311, Veterans Affairs Peer Review Neutrality Act of 2025; S.3395, Mammography Access for Veterans Act of 2025; S.3591, Thomas M. Conway Veterans Access to Resources in the Workplace Act; S.3647, Disabled Veterans Dignity Act of 2026; S.3653, Veterans’ Bill of Rights Act of 2026; S.3706, Produce Prescriptions for Veterans Act; S.3726, National Veterans Strategy Act of 2026; S.3988, Veterans STAND Act; S.3992, Joint Medical Facilities Fund Act of 2026; S.3993, Reducing Arbitrary Barriers to Apprenticeship Act of 2026; S.3999, Women Veterans Specialty Care Access Act; S.4043, Health Care for Homeless Veterans Act; S.4108, Veteran Burial Benefit Correction Act; S.4140, Carlton H. Ingram Veterans’ Benefits Protection Act; S.4197, Veterans Outdoor Rehabilitation Act; S.4220, Veterans Health Administration Novel Therapeutics Preparedness Act; and S.749, Justice for ALS Veterans Act of 2025.
- On April 30, 2026, the House Committee on Appropriations Subcommittee on Commerce, Justice, Science, and Related Agencies held a markup of the Fiscal Year 2027 Commerce, Justice, Science, and Related Agencies Bill.
- On April 30, 2026, the House Committee on Appropriations Interior, Environment, and Related Agencies Subcommittee held a hearing entitled, Budget Hearing – Indian Health Service. Witnesses present included: Mr. Clayton Fulton, Chief of Staff, Indian Health Service (IHS); and Ms. Jillian Curtis, Director, Office of Finance and Accounting, IHS.
Other Health Policy News
- On April 28, 2026, the House Committee on Ways and Means held a full committee hearing entitled, Hearing with Health System CEOs. The Committee heard testimony from witnesses representing a for-profit hospital system; a non-profit, faith-based hospital system; a large, urban, academic hospital; and a regional, academic hospital system; as well as the leader of a health care advocacy group. The hearing was the next in a series examining health care affordability, which has also included a hearing with health insurance CEOs and a hearing focused on Medicare fraud.
During the hearing, Republican members argued that high hospital prices—driven by market consolidation, misuse of government programs such as rural classifications and site‑neutral payment policies, and a lack of transparency—are the primary contributors to rising health care costs. Republican members defended H.R. 1 (the One Big Beautiful Bill Act) as a measure intended to eliminate waste, fraud, and abuse in Medicaid, while criticizing hospitals for opposing reforms they said would increase competition.
Conversely, Democratic members contended that H.R. 1 itself is the root of the problem, asserting it cut a trillion dollars from Medicaid and the Affordable Care Act (ACA), which they claim will strip coverage from 15 million Americans and push hospitals, particularly in rural areas, to the brink of closure. They framed the hearing as a Republican attempt to deflect blame from their policies and argued for strengthening affordable coverage through the ACA and Medicaid, while also pointing to other cost drivers like pharmaceutical prices and the practices of Medicare Advantage (MA) plans.
More information on this hearing can be found here.
- On April 30, 2026, the Department of Education (ED) issued a final rule implementing new student loan borrowing limits established by H.R. 1. ED is finalizing its proposal to exclude advanced practice nurses, physician assistants, anesthesia assistants, and other allied health professionals from the category of “professional degree students,” and instead categorize them as “graduate degree students.” This means that the borrowing limit under the Direct Unsubsidized Loan Program for these students will be $20,500 per academic year, with an aggregate cap of $100,000. Professional degree students, including those pursuing degrees in medicine, dentistry, pharmacy, and clinical psychology, among others, are permitted to borrow up to $50,000 per academic year and are subject to a $200,000 aggregate limit.
The rule will go into effect for enrollment periods beginning on or after July 1, 2026. The full rule can be found here.
- On April 30, 2026, President Donald Trump withdrew the nomination of Dr. Casey Means to be U.S. surgeon general and instead nominated Dr. Nicole Saphier. Dr. Saphier is a radiologist and Director of Breast Imaging at Memorial Sloan Kettering Cancer Center's facility in Monmouth County, New Jersey, as well as a regular medical contributor on Fox News. Dr. Saphier is President Trump’s third nominee for the Surgeon General position, after her predecessors have faced considerable scrutiny from the Senate over their medical credentials and stances on vaccines.
If confirmed by the Senate, Dr. Saphier would become the nation’s top doctor, with the power to issue health advisories for the country.
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