Health Care Week in Review | 13 House Republicans Send Letter to Speaker of the House in Support of Enhanced Premium Tax Credits; CMS Issues Further Guidance on Claims Holds

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 22, 2025, the Food and Drug Administration (FDA) released guidance entitled, Expanded Access to Investigational Drugs for Treatment Use: Questions and Answers. This guidance provides information for industry, researchers, physicians, institutional review boards (IRBs), and patients about the implementation of FDA’s regulations on expanded access to investigational drugs for treatment use under an investigational new drug application (IND), which went into effect on October 13, 2009. After receiving numerous questions about implementing the regulatory requirements for expanded access, FDA issued industry guidance entitled Expanded Access to Investigational Drugs for Treatment Use: Questions and Answers in June 2016, later updated in October 2017. This guidance provides recommendations in a question-and-answer format, addressing the most frequently asked questions. Since 2017, FDA has received additional questions concerning implementation of the regulatory and statutory requirements of expanded access to investigational drugs, including those added by the 21st Century Cures Act and the FDA Reauthorization Act of 2017 (FDARA).
• On October 22, 2025, FDA released guidance entitled, Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments. This guidance is the third in a series of four methodological patient-focused drug development (PFDD) guidance documents that describe how stakeholders (patients, caregivers, researchers, medical product developers, and others) can collect and submit patient experience data and other relevant information from patients, caregivers, and clinicians to be used for medical product development and regulatory decision-making. This document outlines approaches to selecting, developing, modifying, and evaluating clinical outcome assessments (COAs) to measure outcomes of importance to patients in clinical trials.
• On October 24, 2025, the Department of Veterans Affairs (VA) released a notice entitled, Annual Pay Ranges for Physicians, Dentists, Podiatrists, and Optometrists of the Veterans Health Administration (VHA). This notice provides an update to annual pay ranges, which is the sum of the base pay rate and market pay for VHA physicians, dentists, podiatrists, and optometrists as prescribed by the VA Secretary for Department-wide applicability. Optometrists are now included in the annual pay ranges pursuant to the Senator Elizabeth Dole 21st Century Veterans Healthcare and Benefits Improvement Act. The pay table placement of optometrists is intended to enhance the flexibility of the VA to recruit, develop, and retain the most highly qualified optometrists to serve U.S. veterans and maintain a standard of excellence in the VA health care system.

Event Notices

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

• 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.
• 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 October 22, 2025, the RAND Corporation released a report entitled, The Unintended Consequences Of The ACA's Medical Loss Ratio Requirement. This research examines the Affordable Care Act’s (ACA) Medical Loss Ratio (MLR) requirement, designed to improve health insurance affordability by limiting insurers’ administrative costs and profits. The authors of the study found that while well-intentioned, the policy has produced unintended consequences. The report finds that the ACA’s MLR requirement discourages cost containment, advantages larger insurers, and contributes to market consolidation and vertical integration, reducing competition and consumer choice. Further, the authors note that the requirement also limits flexibility for innovation, making insurance markets more rigid and less responsive to consumer needs. Over time, these dynamics have undermined affordability and failed to address structural drivers of health care costs. The research concludes that the MLR framework distorts insurer incentives and does not effectively control premiums. The research suggests policymakers should consider targeted reforms to mitigate these impacts, including temporary relief for competitive markets, adjustments to rebate calculations, and measures to enhance transparency and consumer protections. The authors suggest that without such changes, the MLR requirement will continue to compromise affordability and competition in health insurance markets.
• On October 22, 2025, KFF released results of a survey entitled, 2025 Employer Health Benefits Survey. KFF reports that average annual family premiums for employer-sponsored health insurance reached $26,993 in 2025, a 6 percent increase from the previous year. Worker contributions averaged $6,850 toward that cost. Over the past five years, family-premium increases and worker share increases have tracked roughly alongside inflation and wage growth. Large employers report that rising prescription-drug costs, coverage of new drugs, chronic-disease prevalence, and increasing utilization are key drivers of premium growth. Meanwhile, the percentage of workers enrolled in high-deductible health plans has increased to 29 percent, with the average individual deductible now $1,886 and significantly higher in smaller firms.  

Hearings & Markups

• On October 22, 2025, the Senate Health, Education, Labor, and Pensions (HELP) Committee held a hearing entitled, Labor Law Reform Part 2: New Solutions for Finding a Pro-Worker Way Forward. Witnesses included: Hon. Thomas Beck, Senior Advisor, Littler Mendelson Workplace Policy Institute; Mr. F. Vincent Vernuccio, President and Co-Founder, Institute for the American Worker; Mr. Jonathan Hartley, PHD Candidate and Teaching Assistant, Stanford University; and Mr. Joshua Arnold, Shop Steward, IAM Union Local 837B, Boeing; and Ms. Mary Turner, RN, President, National Nurses United.
• On October 22, 2025, the Senate Special Committee on Aging held a hearing entitled, Modernizing Health Care: How Shoppable Services Improve Outcomes and Lower Costs. Witnesses included: Mr. Mark Cuban, Co-Founder and Entrepreneur, Cost Plus Drugs; Dr. G. Keith Smith, MD, Co-Founder, Surgery Center of Oklahoma; Dr. Don Moulds, PhD, Chief Health Director, California Public Employees’ Retirement System (CalPERS); and Dr. Jeanne Lambrew, PhD, Director of Healthcare Reform and Senior Fellow, The Century Foundation.
• On October 23, 2025, the Senate HELP Committee held a hearing entitled, The 340B Program: Examining Its Growth and Impact on Patients. Witnesses included: Ms. Michelle Rosenberg, Director, Health Care, U.S. Government Accountability Office (GAO); Dr. Aditi Sen, PhD, Chief, Health Policy Studies Unit, Congressional Budget Office (CBO); and Dr. William B. Feldman, MD, DPhil, MPH, Physician and Health Policy Researcher, University of California, Los Angeles.

Other Health Policy News

• >On October 21, 2025, thirteen House Republicans sent a letter to Speaker of the House Mike Johnson (R-LA) in support of preventing the lapse of enhanced premium tax credits (EPTCs) for plans purchased on the ACA Marketplace. The members stated that they were not necessarily supportive of EPTCs as a long-term solution to health care affordability, but that the imminent premium increases that a lapse in the EPTCs would cause warranted a short-term extension. Notably, the signatories emphasized that this not be done as part of ending the government shutdown, but instead take place after the shutdown has ended. All but one of the signatories are cosponsors of a bipartisan bill that would extend the EPTCs for one year. A press release containing the full letter can be found here.
• On October 21, 2025, CMS posted further guidance on holding Medicare claims. This guidance instructs all Medicare Administrative Contractors (MACs) to lift the claims hold and process claims with dates of service on or after October 1, 2025, for services impacted by expired payment provisions under the Full-Year Continuing Appropriations and Extension Act of 2025 (Public Law 119-4). However, CMS instructed MACs to continue to hold claims for telehealth services (other than those definitively confirmed to be for behavioral and mental health services) and for Acute Hospital Care at Home services.  The full CMS claims hold update can be found here. Alston & Bird’s Healthy Byte, which includes discussion of the current state of telehealth reimbursement, highlighting practical advice from Medicare during the government shutdown, can be viewed here.
• On October 22, 2025, the Senate Special Committee on Aging held a hearing entitled, Modernizing Health Care: How Shoppable Services Improve Outcomes and Lower Costs. The hearing examined strategies to curb escalating healthcare costs, with a particular focus on price transparency, consumer choice, and market competition as tools to improve outcomes and reduce financial burdens, especially for older Americans. Witnesses shared innovative approaches to price transparency, including upfront pricing models for surgical procedures, reference-based pricing by large purchasers, and direct-to-consumer drug pricing. Discussions also addressed the role of pharmacy benefit managers (PBMs) in driving prescription costs and the importance of ACA EPTCs in maintaining coverage affordability. While there was general agreement on the urgency of lowering costs, the hearing revealed sharp differences over whether reforms should rely primarily on free-market solutions or government intervention and subsidies. More information on this hearing can be found here.
• On October 22, 2025, the Senate failed to pass a continuing resolution (CR) for the twelfth time in a 54-46 vote, falling short of the 60 votes required to proceed, with Senators John Fetterman (D-PA), Catherine Cortez Masto (D-NV), and Angus King (I-ME) voting alongside Republicans in favor of the bill. Some Democrats believe the beginning of ACA Open Enrollment on November 1, 2025, will put pressure on the White House as significant increases in premiums will become more apparent. Until then, the Trump Administration has threatened further reductions-in-force (RIFs) at federal agencies. However, these continue to run into legal challenges. On October 15, 2025, a federal judge in California issued a temporary restraining order against the Administration, halting the RIFs initiated at the Department of Health and Human Services (HHS). Therefore, the permanency of any RIFs being conducted right now is currently unclear. 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.
  
  Meanwhile, the Senate is considering a bill from Senator Josh Hawley (R-MO), entitled the Keep SNAP Funded Act of 2025, to extend funding for Supplemental Nutrition Assistance Program (SNAP) benefits through the remainder of the government shutdown. SNAP benefits are set to expire on November 1, 2025, in at least 25 states if the government shutdown continues, which could impact an estimated 40 million people who rely on the program. The full bill text can be found here.
• On October 23, 2025, the Senate rejected a proposal to continue paying active-duty military personnel and certain exempt government employees during the ongoing federal funding lapse. The measure failed in a 54–45 vote. Three Democratic senators—Jon Ossoff (D-GA), Raphael Warnock (D-GA), and John Fetterman (D-PA)—broke ranks to support the bill. Opponents warned that passage could set a precedent allowing the president to selectively decide which employees receive pay and which remain furloughed. The full bill text can be found here.
• On October 23, 2025, the Senate HELP Committee held a hearing entitled, The 340B Program: Examining Its Growth and Impact on Patients. The hearing explored the complexities of the 340B Drug Pricing Program, weighing its original intent against concerns about rapid growth, oversight, and potential contributions to rising healthcare costs. Members and witnesses repeatedly emphasized the program’s role as a lifeline for safety net providers, including rural hospitals and community health centers. Several senators warned that looming Medicaid cuts and the expiration of ACA EPTCs would intensify financial strain.
  
  Strong defenders of the program included Senators Tammy Baldwin (D-WI), Tommy Tuberville (R-AL), Patty Murray (D-WA), Susan Collins (R-ME), and Lisa Murkowski (R-AK), who highlighted 340B’s role in keeping providers afloat and ensuring access in underserved areas. Other members voiced support but called for reforms to improve transparency and ensure patient benefit. Senators Jon Husted (R-OH), Roger Marshall (R-KS), Tim Kaine (D-VA), Maggie Hassan (D-NH), Andy Kim (D-NJ), and John Hickenlooper (D-CO) advocated for bipartisan efforts to preserve the program while addressing misuse and inefficiencies.
  
  Conversely, Chairman Bill Cassidy (R-LA) opened with sharp criticism, arguing that 340B’s growth drives higher costs, incentivizes consolidation, and often benefits “middlemen” rather than patients. He concluded the program “has lost its way.” Senator Jim Banks (R-IN) echoed these concerns, questioning whether 340B increases drug spending and pressing for stricter revenue-use requirements. More information on this hearing can be found here.

Executive Order, Action & Proclamation Task Force

Alston & Bird's multidisciplinary Executive Order, Action & Proclamation Task Force advises clients on the business and legal implications of President Trump's Executive Orders.

Learn more about administrative actions on our tracker.

AlstonHealth State Law Hub

Alston & Bird's Health Care team highlights state legislation and regulatory actions with direct implications for operations, reimbursements, privacy, and enforcement risk. Designed for in-house counsel, the tracker supports legal teams in proactively managing risk and aligning business strategy with a rapidly evolving state regulatory environment.

Learn more on the AlstonHealth State Law Hub.

View our Health Care Legislative & Public Policy team.

Did you miss a week? Browse our Health Care Week in Review archive.