Health Care Week in Review | CMS' Durable Medical Equipment Enrollment Moratorium Expires; DHS Proposes New H-1B Petition Fee

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 August 25, 2026, the Food and Drug Administration (FDA) released a notice entitled, International Drug Scheduling: Single Convention on Narcotic Drugs, Convention on Psychotropic Substances; Clobromazolam (phenazolam), Cychlorphine (N-propionitrile chlorphine), etc. FDA is providing interested entities with the opportunity to submit comments concerning abuse potential, actual abuse, medical usefulness, trafficking, and impact of scheduling changes on availability for medical use of eight drug substances. These comments will be considered in preparing a response from the United States to the Expert Committee on Drug Dependence (ECDD) regarding the abuse liability and diversion of these drugs. The ECDD will use this information to consider whether to recommend that certain international restrictions be placed on these drug substances. This notice requesting comments is required by the Controlled Substances Act (CSA).
• On August 27, 2026, FDA released draft guidance entitled, Compounding Animal Drugs from Bulk Drug Substances: Compounding under CGMP in Federally-Registered Facilities. This draft guidance, when finalized, will describe FDA’s current thinking regarding the circumstances under which the agency generally does not intend to take action against the compounding of animal drug products from bulk drug substances (BDS) when done in accordance with Current Good Manufacturing Practice (CGMP) at drug production facilities that are registered with FDA.
• On August 28, 2026, HHS released a notice entitled, Interest Rate on Overdue Debts. Pursuant to HHS’s claims collection regulations, HHS announced that the annual interest rate applicable to overdue debts will remain at around 11.9 percent for the quarter ending on June 30, 2026, as determined by the Secretary of the Treasury. HHS stated that the rate is based on statutory interest rates applicable to the Health Resources and Services Administration’s (HRSA’s) National Health Services Corps Scholarship Program and the National Research Service Award Program and will remain in effect until a revised rate is published in the Federal Register.

• On August 28, 2026, FDA released guidance entitled, Withdrawn CDER Product Specific Guidances. FDA updated its list of withdrawn Center for Drug Evaluation and Research (CDER) Product-Specific Guidances (PSGs). FDA withdrew PSGs associated with several reference listed drugs whose New Drug Application (NDA) approvals have been withdrawn, including products containing infigratinib phosphate, mesalamine, obeticholic acid, olaparib, panobinostat, sodium phenylbutyrate/taurursodiol, and tazemetostat hydrobromide. According to FDA, the withdrawals reflect regulatory actions taken under applicable provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and FDA regulations, including withdrawals of NDA approvals and determinations that certain products were withdrawn from sale for reasons of safety or effectiveness. FDA noted that withdrawn PSGs are no longer considered current recommendations for the development of abbreviated new drug applications (ANDAs) referencing the affected products. 

Event Notices

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

• August 31, 2026: The National Institutes of Health (NIH) announced a meeting of the National Institute on Minority Health and Health Disparities. This is a virtual meeting with some sessions open to the public.
• September 2, 2026: NIH announced a meeting of the National Cancer Institute (NCI). This is a virtual meeting with some sessions open to the public.
• **September 2, 2026: HHS announced a meeting of the Microbiome Subcommittee of the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria (PACCARB). This is a hybrid meeting open to the public.
• September 4, 2026: NIH announced a meeting of the National Deafness and Other Communication Disorders Advisory Council. This is a hybrid meeting open to the public.
• September 9, 2026: NIH announced a meeting of the National Advisory Dental and Craniofacial Research Council. This is a virtual meeting with some sessions open to the public.
• September 9-10, 2026: HHS announced a meeting of PACCARB. This is a hybrid meeting open to the public.
• September 9-10, 2026: NIH announced a meeting of the National Advisory Neurological Disorders and Stroke Council. This is a virtual meeting with some sessions open to the public.
• September 10, 2026: NIH announced a meeting of the National Advisory Environmental Health Sciences Council (NAEHSC). This is a virtual meeting with some sessions open to the public.
• September 10-11, 2026: NIH announced a meeting of the Fogarty International Center Advisory Board. This is a virtual meeting with some sessions open to the public.
• September 10-11, 2026: NIH announced a meeting of the Council of Councils. This is a hybrid meeting with some sessions open to the public.
• September 11, 2026: NIH announced a meeting of the National Advisory Council for Complementary and Integrative Health (NCCIH). This is a hybrid meeting with some sessions open to the public.
• September 14, 2026: FDA announced a hearing on the potential future therapeutic use of psychedelic drugs. This is a hybrid hearing open to the public.
• September 14-15, 2026: HHS announced a meeting of the Physician-Focused Payment Model Technical Advisory Committee (PTAC). This is a hybrid meeting open to the public.
• September 15, 2026: The Centers for Disease Control and Prevention (CDC) announced a meeting of the ICD-10 Coordination and Maintenance Committee. This is a virtual meeting open to the public.
• September 15, 2026: NIH announced a meeting of the National Arthritis and Musculoskeletal and Skin Diseases Advisory Council. This is a virtual meeting with some sessions open to the public.
• September 15, 2026: NIH announced a meeting of the National Advisory Council for Nursing Research. This is a virtual meeting with some sessions open to the public.
• September 15-16, 2026: The Centers for Medicare & Medicaid Services (CMS) announced a meeting of the Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests (CDLTs). 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 15-16, 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.
• September 16, 2026: NIH announced a meeting of the National Institute of Biomedical Imaging and Bioengineering. This is an in-person meeting with some sessions open to the public.
• September 16, 2026: The Administration for Children and Families (ACF) announced a meeting between HHS/ACF Office of Head Start (OHS) leadership and Tribal government leadership. This is a virtual meeting with some sessions open to the public.

• September 16, 2026: FDA announced a meeting to discuss proposed recommendations for the reauthorization of the Prescription Drug User Fee Act (PDUFA) for fiscal years (FYs) 2028 through 2032. This is a hybrid meeting open to the public.

• September 17, 2026: FDA announced a meeting to discuss proposed recommendations for the reauthorization of the Generic Drug User Fee Amendments (GDUFA) for FYs 2028 to 2032. This is a hybrid meeting open to the public.
• September 17, 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.
• September 17, 2026: FDA announced a meeting of the Office of Women’s Health and the Center for Drug Evaluation and Research. This is a hybrid meeting open to the public.
• September 18, 2026: NIH announced a meeting of the Diabetes Mellitus Interagency Coordinating Committee (DMICC). This is a hybrid meeting open to the public.
• September 18, 2026: NIH announced a meeting of the National Center for Advancing Translational Sciences Advisory Council. This is a virtual meeting with some sessions open to the public.
• September 23, 2026: NIH announced a meeting of the National Advisory Allergy and Infectious Diseases Council. This is a virtual meeting with some sessions open to the public.
• September 23, 2026: NIH announced a meeting of the AIDS Research Advisory Committee. This is a virtual meeting 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 (HITAC). This is a virtual meeting open to the public.
• September 25, 2026: NIH announced a meeting of the National Advisory Eye Council. This is a hybrid meeting with some sessions open to the public.
• September 28-29, 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.
• October 8, 2026: CDC announced a meeting of the Advisory Board on Radiation and Worker Health (ABRWH). This is a virtual meeting open to the public.
• October 14, 2026: NIH announced a meeting of the Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD) National Advisory Child Health and Human Development Council. This is an in-person meeting with some sessions open to the public.
• October 16, 2026: NIH announced a meeting of the NIH Clinical Center Research Hospital Board. This is a hybrid meeting open to the public.
• October 20, 2026: NIH announced a meeting of the Advisory Committee on Research on Women’s Health. This is a virtual meeting open to the public.
• **October 20, 2026: NIH announced a meeting of the Office of AIDS Research Advisory Council. This is a hybrid meeting open to the public. 
• October 28, 2026: NIH announced a meeting of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). This is a virtual meeting with some sessions open to the public.
• October 28, 2026: CDC announced a meeting of the Subcommittee on Procedures Reviews (SPR) of the ABRWH. This is a virtual meeting open to the public.
• **October 28, 2026: NIH announced a meeting of the National Heart, Lung, and Blood Advisory Council. This is a hybrid meeting open to the public.
• November 5, 2026: ONC announced a meeting of HITAC. This is a virtual meeting open to the public.
• **November 20, 2026: NIH announced a meeting of the Board of Scientific Counselors, National Institute of Diabetes and Digestive and Kidney Diseases. This is a virtual meeting with some sessions open to the public.  
• December 1, 2026: NIH announced a meeting of NCI. This is an in-person meeting with some sessions 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 August 27, 2026, the Congressional Research Service (CRS) released a report entitled, The No Surprises Act Independent Dispute Resolution (IDR) Process. The report provides an overview of the federal IDR process established under the No Surprises Act to resolve payment disputes between providers, facilities, air ambulance services, and health plans for certain out-of-network services. In the report, CRS describes the eligibility requirements, procedural steps, and timelines governing the IDR process, as well as the role of certified IDR entities in determining payment amounts. The report also highlights ongoing implementation and operational challenges, including the volume of disputes submitted, administrative backlogs, litigation related to payment determinations, and policy questions regarding the long-term effectiveness of the federal dispute resolution framework.

• On August 27, 2026, CRS released a report entitled, Senate Committee Considers a Farm Bill Draft that Would Change the Upcoming State Sharing of SNAP Benefit Costs. The report examines a draft farm bill proposal under consideration by the Senate Agriculture Committee that would modify the funding structure of the Supplemental Nutrition Assistance Program (SNAP) by requiring states to share a portion of benefit costs. According to CRS, the proposal would represent a significant change from the current financing framework, under which the federal government generally bears the full cost of SNAP benefits while states share administrative expenses. CRS notes that the draft bill could have varying fiscal impacts across states depending on enrollment levels, benefit expenditures, and state budget conditions. 

Other Health Policy News

• On August 24, 2026, the Department of Homeland Security (DHS) released a proposed rule to establish a new $103,265 fee for all H-1B cap-subject petitions, including visa-seekers eligible for the advanced degree exemption. This fee would be in addition to current filing costs and would apply regardless of company size, annual revenue, industry, or nonprofit status. If finalized, the additional fee would apply to petitions filed under both the annual 65,000 regular H-1B cap and the 20,000 advanced degree exemption (master’s cap). Under the proposed rule, the additional fee would not apply to H-1B petitions that are not subject to the cap, including those of qualifying institutions of higher education, certain nonprofit entities and nonprofit research organizations, and governmental research organizations. The fee also would not apply to H-1B extension petitions or change-of-employer filings for workers who have already been counted against the H-1B cap. 

  The proposal could lead to an increase in employers’ cost of recruiting and retaining foreign talent to fill specialized positions, specifically impacting industries such as health care where employers often face shortages of specialized workers.

  The proposed rule as published in the Federal Register is available here. A press release is available here.

• On August 26, 2026, CMS released additional guidance and technical materials for the Medicare Part D Claims Data 340B Repository, which is intended to help implement the exclusion of 340B units from Medicare Part D inflation rebate calculations.

  CMS plans to open the repository on October 1, 2026, for voluntary submissions from 340B covered entities. Covered entities may submit claims information directly or through third-party administrators or other partners. CMS is requesting quarterly submissions, with data for Part D 340B claims with dates of service from January through September 2026 expected by December 31, 2026.

  A fact sheet is available here.

• On August 26, 2026, HHS announced a new $32.5 million initiative entitled, Developing Evidence for Programs to Ensure Nutrition for Development (DEPEND), to support efforts to improve the nutritional quality of school meals and evaluate innovative approaches to school food programs. The initiative, led by the Agency for Healthcare Research and Quality (AHRQ) and NIH, will provide funding to schools and school districts to test strategies designed to increase access to nutrient-dense foods while reducing reliance on highly processed foods. According to HHS, DEPEND will fund projects focused on food purchasing and supply chains, workforce development and food production, student demand and meal economics, and operational and infrastructure improvements. Award amounts are expected to range from $75,000 to $2.5 million, with the first round of funding anticipated later this year. The initiative is intended to identify scalable and financially sustainable school nutrition models while strengthening the evidence base for future school meal policy decisions.
• On August 27, 2026, CMS allowed its six-month moratorium on new Medicare enrollment applications from certain durable medical equipment (DME) suppliers to expire without extension. Following the expiration of the moratorium, CMS announced that National Provider Enrollment Contractors would resume accepting initial enrollment applications from DME suppliers seeking to participate in Medicare, including suppliers preparing for Round 2028 of the Competitive Bidding Program. The agency’s decision follows ongoing efforts to address fraudulent billing by DME suppliers while balancing access to the Medicare program for legitimate providers. Several states that imposed similar Medicaid enrollment moratoria during the federal freeze are now evaluating whether to maintain or lift those restrictions.

More information on the moratorium is available here. A press release is available here.

• On August 28, 2026, CMS announced that it has prevented more than $1.6 billion in potentially fraudulent Medicare laboratory payments since the beginning of the Trump Administration through a series of program integrity and enforcement actions. According to CMS, these efforts included the revocation of 157 laboratory providers from the Medicare program, resulting in approximately $732 million in savings, as well as more than $500 million in suspended payments tied to investigations of hundreds of laboratories suspected of improper billing practices. CMS reported that the enforcement actions were supported by advanced analytics, including artificial intelligence (AI) and machine learning tools, which were used to identify unusual billing patterns and other indicators of potential fraud. The agency stated that the initiative is part of a broader effort to strengthen Medicare program integrity and prevent improper payments related to laboratory testing, durable medical equipment, hospice services, and other high-risk areas.

A press release is available here.

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