Health Care Week in Review | OMB Initiates Significant Layoffs as Shutdown Continues; CMS Issues Updated Guidance to Temporarily Hold Claims Related to Expired Payment Provisions

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 October 14, 2025, the Food and Drug Administration (FDA) released guidance entitled, Technical Specifications for Submitting Clinical Trial Data Sets for Response Assessments for Treatments of Acute Leukemias. This document provides technical recommendations for the data sets containing the data elements for response assessments and summary level response outcomes used to evaluate efficacy in clinical trials of drugs and biological products submitted to FDA in New Drug Applications (NDAs) and Biologics License Applications (BLAs) for treatment of acute leukemias. The specifications provided complement rather than supplant the clinical development program and efficacy endpoint recommendations in disease-specific guidances. Additionally, the scope of these technical recommendations is limited to data elements specific to efficacy evaluations for acute leukemias; general recommendations on submission of standardized study data, can be found in the FDA Study Data Technical Conformance Guide.
• On October 15, 2025, FDA released guidance entitled, Dual Labeling for Fully Approved and Conditionally Approved New Animal Drugs with a New World Screwworm-Related Indication. This guidance is intended to inform new animal drug sponsors that dual labeling of a new animal drug product may include an intended use that is fully approved under section 512(b) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and an intended use that is conditionally approved under section 571 of the FD&C Act where the claim to be added to the existing product labeling is intended to treat or prevent New World screwworm myiasis.

Event Notices

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

• October 21-22, 2025: 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: The National Institutes of Health (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 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 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: The Health Resources and Services Administration (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 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.
<li">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 announceda 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 October 10, 2025, the RAND Corporation released a study entitled, Barriers to Public Health Trust-Building Using Social Media. This study aimed to examine perspectives on barriers to incorporating social media use among the public health workforce to rebuild trust in public health. Researchers performed 31 semi-structured interviews with public health practitioners and subject matter experts. They found that barriers to public health practitioner social media use included lack of training, time, and fear; limited online and offline relationships; lack of resources and supportive policies; and politicization of public health. This study identifies modifiable factors that could be leveraged to strengthen the public health workforce's social media communication and highlights existing efforts to address barriers.
• On October 14, 2025, KFF released an analysis entitled, Medicare Beneficiaries Have 32 Medicare Advantage Prescription Drug Plans Available, on Average, for 2026. KFF’s analysis of plan offerings shows that Medicare beneficiaries will have the option of 32 Medicare Advantage prescription drug (MA-PD) plans in 2026, two fewer than the 34 options available in 2025 (excluding employer plans and special needs plans). The number of MA-PD options has grown steadily since 2010, peaking in 2024 when the average Medicare beneficiary had 36 options. Despite the decline in offerings over the last two years, the number of options available for 2026 will be higher than the number available in 2022 (31) and every year before.
• On October 15, 2025, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) released a report entitled, Summary Report of Prior Office of Inspector General Penetration Tests of 10 State MMIS and E&E Systems. State Medicaid Management Information Systems (MMIS) and Eligibility & Enrollment (E&E) systems are increasingly targeted by cybercriminals because of the valuable and sensitive information they contain. Between 2020 and 2022, OIG conducted penetration tests on 10 State MMIS and E&E systems. These tests were designed to simulate cyberattacks to evaluate how effectively these systems were protected against such threats. In this report, OIG found that the 10 States implemented generally effective information technology security controls for their web-facing MMIS and E&E systems to prevent unsophisticated or limited cyberattacks, but they need to continue to improve these controls to prevent more sophisticated and persistent cyberattacks; cyber attackers would likely need a moderate to significant level of sophistication or complexity to compromise the State systems audited by the OIG; and the 10 States effectively detected and responded to some of the simulated cyberattacks but needed to improve their detection and response to other types of cyberattacks. This report does not contain recommendations to CMS but it does provide an overview of recommendations previously made to the 10 states. 

Other Health Policy News

• On October 16, 2025, the Senate failed to pass a continuing resolution (CR) for the tenth time in a 51-45 vote, ensuring the government remains shut down with few indications that it will re-open this week. The vote attracted no additional support for Democratic senators, most of whom will not agree to the CR without an extension of the expiring enhanced Affordable Care Act (ACA) premium tax credits (APTC). Senate Republicans have indicated they will continue holding votes on the bill until five more Democrats join them and reopen the government.
  
  The White House has taken steps to avoid a lapse in payments to members of the military, a significant upcoming “pressure point” that may have driven action, by reorganizing funds within the Department of Defense (DOD). In a briefing to Congressional staff, the U.S. Department of Agriculture (USDA) announced that it plans to allocate $300 million in unspent tariff revenue from the previous fiscal year (FY) to ensure the Special Supplemental Nutrition Program for Women, Infants and Children (WIC) remains funded through the end of October. The Trump Administration also announced that some federal law enforcement personnel will receive pay during the government shutdown.
  
  Democrats may next be looking to the Open Enrollment period of the ACA Marketplace, which begins on November 1, as a possible pressure point to drive Republican action on an extension of APTCs, which are set to expire on December 31, 2025, because of projected significant increases in premiums and losses of coverage for ACA Marketplace enrollees.
  
  Ahead of the government shutdown, the White House Office of Management and Budget (OMB) issued guidance encouraging agencies to consider reduction in force (RIF) notices for employees in programs that lack discretionary funding or are not aligned with current administration priorities. A Department of Justice (DOJ) court filing on October 10, 2025, estimated that between 1,100 and 1,200 HHS employees have received RIF notices so far. However, recent reports indicate that over half of those initially fired at the Centers for Disease Control and Prevention (CDC) had already been reinstated by the Trump Administration, which stated that some notices of termination were sent in error.
  
  The CR passed by the House of Representatives can be found here. A summary of the bill can be found here. The CR released by the Democratic leadership of the Senate and House Appropriations Committees can be found here. A summary of the bill can be found here.
  
  On October 10, 2025, President Trump announced that AstraZeneca committed to selling new drugs at Most-Favored-Nation (MFN) pricing and selling all drugs to state Medicaid programs at MFN prices. AstraZeneca will receive a three-year delay in Section 232 tariffs in exchange for a $50 billion commitment in U.S. research and development (R&D) and manufacturing by 2030. The deal, which comes after the announcement of the Trump Administration’s agreement with Pfizer on September 30, 2025, commits AstraZeneca to offer certain primary care medicines at discounts through direct-to-consumer (DTC) sales. Details of the agreement remain confidential. A fact sheet on MFN pricing activity can be found here.
  
  Additionally, on October 16, 2025, President Trump announced that EMD Serono, a U.S. subsidiary of German drug manufacturer Merck KGaAell, has agreed to sell commonly used fertility medications at reduced prices through a new federal platform called TrumpRx beginning January 2026. Individuals with incomes below 550 percent of the federal poverty level (FPL) will receive an additional discount when purchasing these drugs through the platform. Like previous agreements made with Pfizer and AstraZeneca, EMD Serono has committed to selling new drugs at MFN prices and providing state Medicaid programs with MFN pricing on its products. Additionally, EMD Serono’s pharmaceutical products and ingredients will be exempt from Section 232 tariffs in exchange for investments in U.S.-based manufacturing and research.
  
  The Trump Administration also announced that the Food and Drug Administration (FDA) will include a lower cost fertility drug in the Commissioner’s National Priority Review Voucher program to expedite its review timeline. Furthermore, the White House announced efforts to expand access to in vitro fertilization (IVF) coverage through the creation of a New Benefit Option, under which employers may offer fertility benefits directly to employees. A fact sheet on expanded access to IVF can be found here.

• On October 15, 2025, CMS provided an update on its October 1 guidance in which the agency instructed all Medicare Administrative Contractors (MACs) to implement a temporary hold on claims processing due to the scheduled expiration of certain legislative payment provisions known as “extenders.” CMS stated that it will “continue to process and pay held claims in a timely manner with the exception of select claims for services impacted by the expired provisions.” The agency clarified that, “to date, no payments have been delayed as statute already requires all claims to be held for a minimum of fourteen days,” and that the hold is consistent with statutory requirements. CMS noted that “providers may continue to submit claims accordingly.”
  
  The updated guidance can be found here.
  
  Additionally, on October 10, 2025, CMS issued a reminder to Medicare Advantage (MA) organizations regarding telehealth claims during the federal government shutdown. CMS stated that MA organizations “may temporarily hold telehealth claims, so long as the applicable prompt payment requirements are met.” MA organizations must pay 95 percent of “clean claims” for services “furnished by non-contracted providers or submitted by, or on behalf of, an enrollee of an MA private fee-for-service plan” within 30 days. Within 60 days, MA organizations must pay or deny all other claims from non-contracted providers.

• On October 15, 2025, the Trump Administration issued an Executive Order (EO) entitled, Ensuring Continued Accountability in Federal Hiring, which establishes new policies and procedures for federal hiring. The EO states that “no Federal civilian position that is vacant may be filled, and no new position may be created, except as provided for in [the EO] or required by applicable law.” It calls for federal agencies to submit annual staffing plans to ensure that new career appointments are in the highest-need areas and aligned with the Trump Administration’s priorities. Agencies are also instructed to create “strategic hiring committees,” which include the deputy agency head and the chief of staff to the agency head, to approve hiring decisions and ensure they align with the “national interest,” agency needs, and the Trump Administration’s priorities. The EO further requires federal hiring to be consistent with the Merit Hiring Plan issued by the Office of Personnel Management on May 29, 2025. The EO also includes exceptions for certain positions, including political appointees and positions related to immigration enforcement, national security, or public safety. The EO can be found here.

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