Health Care Week in Review | Federal Government Shutdown Continues; CMS Issues Guidance to MACs on Medicare Claims Processing and Telehealth

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 September 29, 2025, the White House released an Executive Order (EO) entitled, Continuance of Certain Federal Advisory Committees. The EO extends the operation of several advisory committees through September 30, 2027, including several advisory committees under the Department of Health and Human Services (HHS), such as the Presidential Advisory Council on HIV/AIDS, the Advisory Board on Radiation and Worker Health, the President’s Council on Sports, Fitness, and Nutrition, and the President’s Committee for People with Intellectual Disabilities.
• On September 29, 2025, the Food and Drug Administration (FDA) released a notice of availability entitled, E20 Adaptive Designs for Clinical Trials; International Council for Harmonisation; Draft Guidance for Industry. The draft guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The draft guidance is intended to provide a transparent and harmonized set of recommendations for clinical trials with an adaptive design. The draft guidance focuses on principles for the planning, conduct, analysis, and interpretation of clinical trials with an adaptive design that aims to confirm the efficacy and support the benefit-risk assessment of a treatment. The draft guidance emphasizes principles that are critical for ensuring clinical trials produce reliable and interpretable results and that involve specific considerations with use of an adaptive design.
• On September 30, 2025, the White House released an EO entitled, Unlocking Cures for Pediatric Cancer with Artificial Intelligence. The EO directs the Make America Healthy Again (MAHA) Commission to coordinate with the Secretary of HHS, the Assistant to the President for Science and Technology (APST), and the Special Advisor for Artificial Intelligence (AI) and Crypto to develop innovative ways to use advanced technologies, such as AI, to improve diagnoses, treatments, cures, and prevention strategies for pediatric cancer. Specifically, the EO directs the MAHA Commission to focus initially on identifying opportunities to accelerate the progress of AI-driven solutions at the Childhood Cancer Data Initiative (CCDI) and funding research at National Cancer Institute (NCI) designated cancer centers. It also calls on the Commission to work with the Secretary of HHS and the Directors of the Office of Management and Budget (OMB), the National Institutes of Health (NIH), and APST to prioritize the expansion of pediatric cancer research and improvements in care. Additionally, the EO directs the Secretary of HHS to consult with APST to integrate AI innovation into ongoing interoperability work. This includes maximizing the potential for electronic health record (EHR) and claims data to inform private sector and academic research and clinical trial design, while preserving patient control over personal health information.
• On September 30, 2025, the Health Resources and Services Administration (HRSA) released a notice entitled, Notice of Request for Comments on Draft Recommendations to Update the HRSA-Supported Women’s Preventive Services Guidelines Relating to Screening for Cervical Cancer. This notice seeks comment on draft recommendations for the HRSA-supported Women's Preventive Services Guidelines relating to Screening for Cervical Cancer. Under applicable law, non-grandfathered group health plans and health insurance issuers must include coverage, without cost sharing, for certain preventive services, including those provided for in the HRSA-supported Guidelines. The Departments of Labor, HHS, and Treasury have issued regulations and policy guidance which describe how group health plans and health insurance issuers apply the coverage requirements.
• On October 1, 2025, FDA released a notice of availability entitled, Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability. FDA is announcing the availability of additional draft and revised draft product-specific guidances. The draft guidances provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry entitled Bioequivalence Recommendations for Specific Products that explained the process that would be used to make product-specific guidances available to the public on FDA’s website. The draft guidances identified in this notice were developed using the process described in that guidance.
• On October 1, 2025, FDA released a notice entitled, Revocation of Emergency Use of a Biological Product; Availability. FDA is announcing the revocation of the Emergency Use Authorization (EUA) issued to Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services (ASPR/HHS) for COVID-19 convalescent plasma. FDA revoked the Authorization under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The revocation, which includes an explanation of the reasons for the revocation, is reprinted in this document.
• On October 1, 2025, FDA released a notice entitled, Revocation of Emergency Use of Three Biological Products; Availability. FDA is announcing the revocation of the Emergency Use Authorizations (EUA) issued to Pfizer, Inc. for the Pfizer-BioNTech COVID-19 Vaccine; to ModernaTX, Inc. for the Moderna COVID-19 Vaccine; and to Novavax, Inc. for the Novavax COVID-19 Vaccine, Adjuvanted. FDA revoked these Authorizations under the FD&C Act. The revocations, which include an explanation of the reasons for each revocation, are listed in the notice.

Event Notices

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

• October 7, 2025: NIH announced a meeting of the Office of the Director. This is a virtual meeting open to the public.
• October 8, 2025: FDA announced a meeting of the General Hospital and Personal Use Devices Panel of the Medical Devices Advisory Committee. This is a virtual meeting open to the public.
• October 8-9, 2025: 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.
• October 9, 2025: FDA announced a meeting of the Vaccines and Related Biological Products Advisory Committee. This is a virtual meeting open to the public.
• October 14, 2025: 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.
• October 15, 2025: NIH announced a meeting of the National Cancer Advisory Board Ad hoc Working Group on Extramural Research Concepts and Programs. This is a virtual meeting open to the public.
• October 15-16, 2025: NIH announced a meeting of the National Library of Medicine Board of Scientific Counselors. This is a hybrid meeting with some sessions open to the public.
• October 17, 2025: NIH announced a meeting of the NIH Clinical Center Research Hospital Board. This is a hybrid meeting open to the public.
• October 21-22: The Department of Veterans’ Affairs (VA) announced a meeting of the Advisory Committee on the Readjustment of Veterans. This is an in-person meeting with some sessions open to the public.
• October 27-28, 2025: 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.
• October 27-29, 2025: NIH announced a meeting of the Board of Scientific Counselors of the National Institute on Aging. This is a hybrid meeting with some sessions open to the public.
• October 29, 2025: NIH announced a meeting of the National Heart, Lung, and Blood Advisory Council. This is a hybrid meeting with some sessions open to the public.
• October 29, 2025: VA announced a meeting of the Veterans Rural Health Advisory Committee. This is a hybrid meeting open to the public.
• **October 31, 2025: NIH announced a meeting of the Muscular Dystrophy Coordinating Committee. This is a virtual meeting open to the public.
• November 6, 2025: FDA announced a meeting of the Digital Health Advisory Committee. This is a virtual meeting open to the public. 
• **November 10, 2025: NIH announced a meeting of the Council of Councils. This is a virtual meeting open to the public.
• **November 13, 2025: FDA announced a meeting of the Pediatric Advisory Committee. This is a virtual meeting open to the public.
• November 16-18, 2025: NIH announced a meeting of the National Institute of Environmental Health Sciences. This is a hybrid meeting with some sessions open to the public.
• December 1, 2025: NIH announced a peer review meeting of the draft National Toxicology Program (NTP) Developmental and Reproductive Toxicity Technical Report on 2-Hydroxy-4-methoxybenzophenone. This is a hybrid meeting open to the public.
• December 1, 2025: 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 4, 2025: 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.
• December 4-5, 2025: HRSA announced a meeting of National Advisory Council on Nurse Education and Practice. This is a hybrid meeting open to the public.
• December 5, 2025: NIH announced a meeting of the Board of Scientific 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.
• December 10, 2025: The Centers for Medicare & Medicaid Services (CMS) announced a town hall meeting on fiscal year (FY) 2027 applications for new technology add-on payments. This is a virtual meeting open to the public.
• December 10, 2025: FDA announced a workshop entitled, Advancing the Development of Pediatric Therapeutics (ADEPT) 10: Addressing Challenges in Neonatal Product Development -- Leveraging Rare Disease Frameworks. This is a hybrid meeting open to the public.
• January 23, 2026: NIH announced a meeting of the National Center for Complementary & Integrative Health. This is a virtual meeting open to the public.
• January 26-27, 2026: NIH announced a meeting of the Eunice Kennedy Shriver National Institute of Child Health & Human Development. This is a virtual meeting with some sessions open to the public.
• **February 9-10, 2026: NIH announced a meeting of the Fogarty International Center Advisory Board. This is a hybrid meeting with some sessions open to the public.
• March 30-31, 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.
• May 4, 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.
• **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 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.
• **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.

Reports, Studies & Analyses

• On September 30, 2025, KFF released a report entitled, ACA Marketplace Premium Payments Would More than Double on Average Next Year if Enhanced Premium Tax Credits Expire. Enhanced premium tax credits (EPTCs), which were introduced in 2021 and extended in the Inflation Reduction Act, are set to expire on December 31, 2025. Since the introduction of EPTCs, enrollment in the Affordable Care Act (ACA) Marketplace has increased from approximately 11 million to over 24 million people. The vast majority of ACA Marketplace enrollees receive an EPTC. KFF estimates that annual premium payments in 2026 would increase by an average of 114 percent for subsidized enrollees if EPTCs expire. Trump Administration changes to tax credit calculations and insurers’ proposals to raise rates by a median of 18 percent in 2026 are expected to compound the impact of the expiration of EPTCs, resulting in the largest premium increases since 2018.
• On September 29, 2025, HHS OIG released a report entitled, HRSA Rural Communities Opioid Response Program Award Recipients Generally Met All Core Activities and Benchmarks. The Rural Communities Opioid Response Program (RCORP), administered by HRSA, is an initiative aimed at reducing the barriers to treatment for substance and opioid use disorder. Through the RCORP Medication-Assisted Treatment (MAT) Expansion initiative, HRSA awarded $8.3 million to 12 rural hospitals, clinics, and Tribal organizations in 2019 to establish or expand MAT programs in rural areas. OIG evaluated whether the award recipients met the five required core activities and three proposed benchmarks within the grant period. The review found that ten recipients implemented all five core activities, while two completed four out of the five core activities. Ten recipients met two of the three benchmarks, and two met only one benchmark. However, it could not be determined whether any recipient achieved the benchmark of increasing the number of unique patients served. Award recipients reported challenges in implementing or expanding MAT programs in rural areas, including lack of transportation, difficulties hiring and retaining staff, disruptions caused by the COVID-19 pandemic, and lack of recovery housing.

Other Health Policy News

• On September 25, 2025, President Trump announced that a 100 percent tariff will be imposed on imported pharmaceutical products beginning October 1, 2025. In a post on Truth Social, President Trump stated that the tariff will apply to “any branded or patented Pharmaceutical Product, unless a Company IS BUILDING their Pharmaceutical Manufacturing Plant in America.” He further clarified that “IS BUILDING” will be defined as “‘breaking ground’ and/or ‘under construction,’” and that products will be exempt from the tariff if construction has started. However, to date, the Trump Administration has not taken any action to effectuate the tariff as described in the aforementioned Truth Social post.

  The announcement comes amid an ongoing Section 232 investigation initiated by the Department of Commerce in April 2025 into the “effects on the national security of imports of pharmaceuticals and pharmaceutical ingredients, including finished drug products, medical countermeasures, critical inputs such as active pharmaceutical ingredients, and key starting materials, and derivative products of those items.” President Trump’s announcement suggests the Administration is preparing to impose tariffs on a wide range of products, though generic drugs may be excluded.

  The tariff announcement also comes as HHS and CMS submitted the Global Benchmark for Efficient Drug Pricing (GLOBE) Model, a new drug pricing pilot program, for review by OMB on September 25, 2025. Additional details on the model are expected in the coming weeks, but the release of this drug pricing model may be in response to the Trump Administration July 31, 2025 letter to 17 pharmaceutical company CEOs, calling on manufacturers to guarantee most favored nation (MFN) pricing for new drugs, participate in direct purchasing at MFN pricing, and return increased revenues to U.S. patients and taxpayers.

  In the meantime, on September 29, 2025, the Pharmaceutical Research and Manufacturers of America (PhRMA) announced the launch of a new website that will allow manufacturers to list direct purchase programs beginning January, 2026. The announcement coincided with President Trump’s deadline for manufacturers to respond to his July 31 letters and likely was issued in response to the Administration’s push for MFN pricing and expanded direct-to-patient purchasing.

  Also, on September 30, 2025, President Trump announced that major pharmaceutical company, Pfizer, has agreed to provide state Medicaid programs with MFN price on its products and offer discounts on select top-selling drugs through a new federal platform called TrumpRx. The confidential agreement also commits Pfizer to launch future drugs in the U.S. at prices matching those in other developed countries and to reinvest revenue from foreign drug sales into domestic research and development, as well as further price reductions. The Trump Administration has indicated it is actively negotiating similar deals with other major pharmaceutical companies.

  Furthermore, it appears that the Administration is exploring policy changes in the medical device space.  On September 24, 2025, the Trump Administration announced the opening of two additional Section 232 investigations, including one into personal protective equipment (PPE) and other medical items. A Federal Register notice outlining the investigation stated that medical devices include any instrument, apparatus, or machine used in the diagnosis, monitoring, or treatment of medical conditions.

• The federal government shut down on Wednesday, October 1, 2025, following unresolved disagreements between Republicans and Democrats over a short-term funding bill. The government had been operating under a continuing resolution (CR) passed in March 2025, which expired on September 30, 2025. The House-passed Republican CR would extend current funding levels through November 21, 2025, and includes the extension of several expiring health provisions, including Medicare telehealth flexibilities and funding for community health centers, the National Health Service Corps, and the Teaching Health Center Graduate Medical Education (THCGME) program.

   

  Democrats continue to push for the inclusion of additional health care provisions in a CR, most notably a permanent extension of EPTCs for Marketplace plans. Senate Majority Leader John Thune (R-SD) held multiple votes this week to advance the House Republican proposal, but each failed to meet the 60-vote threshold required to proceed. So far, three Democratic Senators have voted in favor of the measure, but at least seven are needed for passage. While the impasse remains, lawmakers from both parties are reportedly engaged in discussions to explore potential compromise language.

• On October 1, 2025, CMS issued guidance to all MACs to implement a temporary hold on claims processing due to the scheduled expiration of certain legislative payment provisions known as extenders. The hold, which typically lasts up to 10 business days, is a standard precautionary measure designed to ensure that Medicare payments remain consistent with statutory requirements. It is intended to minimize disruption by preventing the need to reprocess claims should Congress act after the expiration date. Providers may continue submitting claims during this period, but payments will not be released until the hold is lifted. Due to the existing 14-day payment floor during which Medicare claims are to be held before processing, CMS anticipates minimal impact on providers.

  CMS also confirmed that absent Congressional intervention, many pre-pandemic statutory limitations on Medicare telehealth services have resumed as of October 1, 2025. These reinstated restrictions apply to services outside of behavioral and mental health services, and include prohibitions on telehealth services delivered to beneficiaries in their homes or outside designated rural areas. Additionally, hospice recertifications now require face-to-face encounters. These changes may affect eligibility for other Medicare benefits, and CMS advises practitioners to consider issuing Advance Beneficiary Notices of Noncoverage when providing services that are no longer reimbursable. Practitioners are also encouraged to monitor legislative developments and may choose to hold claims for telehealth services that are not currently payable.

  Additionally, clinicians participating in applicable Medicare Shared Savings Program Accountable Care Organizations (ACOs) retain the ability to provide and bill for covered telehealth services without geographic restrictions, including services delivered in the beneficiary’s home. This provision remains in effect throughout calendar year 2025 and does not require a special application or approval process.

  Finally, CMS notes in the guidance that MACs will continue to perform all functions related to Medicare Fee-for-Service (FFS) claims processing and payment during the government shutdown.

  The CMS guidance can be found here.

• On September 29, 2025, HHS released its updated FY 2026 shutdown contingency plan outlining operational impacts in the event of a government shutdown. HHS estimates that 47,257 employees will be retained while 32,460 will be furloughed, meaning approximately 59 percent of staff will remain on duty. Within the department, CMS and HRSA are each expected to retain 53 percent of their respective workforces. Recent guidance from OMB encourages agencies to consider reduction in force (RIF) notices for employees in programs that lack discretionary funding or are not aligned with current administration priorities. This marks a departure from previous shutdown protocols, which typically involved temporary furloughs with reinstatement upon the resumption of funding. The final staffing impact of the shutdown may vary depending on further actions by OMB.

  According to the plan, CMS will continue essential functions such as administering Medicare and Medicaid, conducting fraud and abuse-related activities, operating the Center for Medicare & Medicaid Innovation (CMMI), and managing Federal Marketplace activities including eligibility verification. Federal funds are sufficient to cover Medicaid for the first quarter of FY 2026, and CMS will retain staff to ensure Children’s Health Insurance Program (CHIP) payments to states. However, certain activities will be paused, including oversight of MACs, operation of the Medicare call center, policymaking, rulemaking, and beneficiary casework.

  HRSA programs supported by carryover funding, mandatory appropriations, or user fees will continue, including the THCGME, Medical Student Education, and Family to Family Health Information Systems. Activities including the Vaccine Injury Program and administrative contracts will be delayed.

  HHS contingency staffing plan can be found here.

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