Health Care Week in Review July 18, 2025

Health Care Week in Review | Congress Passes Recissions Package, CMS Releases CY 2026 PFS and OPPS Proposed Rules

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, Congress passed the Recissions Act of 2025, cutting nearly $8B in global aid, and CMS released CY 2026 PFS and OPPS proposed rules outlining Medicare payment rates for physicians and hospital outpatient department services for 2026.

 Regulations, Notices & Guidance

  • On July 18, 2025, FDA released draft guidance entitled, Formal Meetings Between the Food and Drug Administration and Sponsors or Applicants of Biosimilar User Fee Act Products; Guidance for Industry; Availability. This guidance provides recommendations to industry on formal meetings between FDA and sponsors or applicants relating to the development and review of proposed biosimilar, including interchangeable biosimilar, products regulated by the Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER). This guidance finalizes the draft guidance of the same title issued on August 11, 2023.
  • On July 14, 2025, the Food and Drug Administration (FDA)  released a notice entitled, Recommendations for Testing Blood Donations for Hepatitis B Surface Antigen; Draft Guidance for Industry; Availability. The draft guidance document provides blood establishments that collect blood and blood components, including Source Plasma, with FDA’s recommendations for testing blood and blood components for hepatitis B surface antigen (HBsAg) to reduce the risk of transfusion-transmitted hepatitis B virus (HBV). The recommendations contained in the guidance apply to the collection of Whole Blood and blood components, including Source Plasma. The draft guidance, when finalized, is intended to supersede the recommendations regarding testing of all blood donations for HBsAg in the guidance document entitled, Guidance for Industry: Use of Nucleic Acid Tests on Pooled and Individual Samples From Donors of Whole Blood and Blood Components, Including Source Plasma, to Reduce the Risk of Transmission of Hepatitis B Virus dated October 2012 (October 2012 Guidance). The guidance, when finalized, will also supersede information on the same topic that is in the document entitled, Recommendations for the Management of Donors and Units that are Initially Reactive for Hepatitis B Surface Antigen (HBsAg) dated December 1987 (December 1987 Memorandum).
  • On July 14, 2025, the Centers for Medicare & Medicaid Services (CMS) released a proposed rule entitled, Medicare and Medicaid Programs; CY 2026 Payment Policies under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; Medicare Shared Savings Program Requirements; and Medicare Prescription Drug Inflation Rebate Program. This major proposed rule addresses: changes to the physician fee schedule (PFS); other changes to Medicare Part B payment policies to ensure that payment systems are updated to reflect changes in medical practice, relative value of services, and changes in the statute; codification of establishment of new policies for: the Medicare Prescription Drug Inflation Rebate Program under the Inflation Reduction Act of 2022 (IRA); the Ambulatory Specialty Model (ASM); updates to the Medicare Diabetes Prevention Program (MDPP) expanded model; updates to drugs and biological products paid under Part B; Medicare Shared Savings Program (MSSP) requirements; updates to the Quality Payment Program (QPP); updates to policies for Rural Health Clinics (RHCs) and Federally Qualified Health Centers (FQHCs); updates to the Ambulance Fee Schedule (AFS) regulations; codification of the IRA and Consolidated Appropriations Act, 2023 (CAA, 2023) provisions; updates to the Medicare Promoting Interoperability Program.
  • On July 15, 2025, CMS released a proposed rule entitled, Medicare and Medicaid Programs: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems; Quality Reporting Programs; Overall Hospital Quality Star Ratings; and Hospital Price Transparency. This proposed rule would revise the Medicare Hospital Outpatient Prospective Payment System (OPPS) and the Medicare Ambulatory Surgical Center (ASC) payment system for calendar year (CY) 2026 based on CMS’s continuing experience with these systems. CMS also describes the changes to the amounts and factors used to determine the payment rates for Medicare services paid under the OPPS and those paid under the ASC payment systems. This proposed rule would also update and refine the requirements for the Hospital Outpatient Quality Reporting Program (QQR), Rural Emergency Hospital Quality Reporting Program (REHQR), ASC Quality Reporting Program (ASCQR), Overall Hospital Quality Star Rating, and hospitals to make public their standard charge information and enforcement of hospital price transparency. This proposed rule also contains requests for information on measure concepts regarding Well-Being and Nutrition for consideration in future years for all three programs (Hospital OQR, REHQR, and ASCQR); expanding the method to control for unnecessary increases in the volume of covered OPD services to on- campus clinic visits; software as a service (SaaS); and adjusting payment under the OPPS for services predominately performed in the ASC or physician office settings.
  • On July 16, 2025, FDA released guidance entitled, Development of Cancer Drugs for Use in Novel Combination - Determining the Contribution of the Individual Drugs' Effects. This draft guidance is intended for sponsors developing drugs for use in combination for the treatment of cancer and provides recommendations for characterizing the safety and effectiveness of individual drugs for use in a novel combination regimen in oncology (i.e., demonstrating the contribution of each drug to the overall effect that is observed for the population). This guidance expands on the recommendations in the 2013 guidance for industry entitled, Codevelopment of Two or More New Investigational Drugs for Use in Combination. This guidance does not address contribution of effect in settings where an investigational drug is being developed in combination with a drug approved for the same indication for the purposes of comparing the approved drug to the combination or to fixed combinations of previously approved drugs for the approved indication(s).
  • On July 16, 2025, the FDA released a proposed rule entitled, Proposal to Revoke 23 Standards of Identity for Foods. FDA is proposing to revoke 23 standards of identity for food. FDA is taking this action because it tentatively concluded that these standards are no longer necessary to promote honesty and fair dealing in the interest of consumers. This proposed action would reduce redundant regulatory requirements.
  • On July 16, 2025, FDA released a proposed rule entitled, Proposal to Revoke 18 Standards of Identity for Dairy Products. FDA is proposing to revoke 18 standards of identity for dairy products. FDA is taking this action as it tentatively concluded that these standards are no longer necessary to promote honesty and fair dealing in the interest of consumers. This proposed action would reduce redundant regulatory requirements.
  • On July 16, 2025, FDA released a rule entitled, Revocation of Food Standards for 11 Products Not Currently Sold. In this rule, FDA revokes 11 food standards for foods that are no longer sold in the United States. FDA is taking this action as these standards are no longer necessary to promote honesty and fair dealing in the interest of consumers. This action will remove obsolete rules to reduce unnecessary regulatory requirements.
  • On July 18, 2025, FDA released draft guidance entitled, E21 Inclusion of Pregnant and Breastfeeding Women in Clinical Trials; International Council for Harmonisation; Draft Guidance for Industry; Availability. The draft guidance is intended to provide general principles on the conduct of clinical trials that include pregnant and breastfeeding women to inform evidence-based decisions on safe and effective use of medicinal products by these populations. The draft guidance includes approaches to generating data that support informed decision-making on the safety, dosing, and efficacy of medicinal products during pregnancy and breastfeeding. Additionally, the draft guidance includes recommendations for recruiting and retaining pregnant and breastfeeding women in clinical trials, while reducing burden and harm on these participants.

Event Notices

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

  • July 14, 2025: 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.
  • July 14, 2025: 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.
  • July 15, 2025: FDA announced a meeting entitled, Second Annual Animal Drug User Fee Educational Conference. This is a hybrid meeting open to the public.
  • July 17, 2025: FDA announced a meeting of the Oncologic Drugs Advisory Committee. This is an in-person meeting open to the public.
  • July 18, 2025: FDA announced a meeting of the Psychopharmacologic Drugs Advisory Committee. This is an in-person meeting open to the public.
  • July 23, 2025: FDA announced a meeting entitled, Use of Orally Ingestible Unapproved Prescription Drug Products Containing Fluoride in the Pediatric Population. This is a hybrid meeting open to the public.
  • July 23-24, 2025: CMS announced a meeting of the Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests. This is a hybrid meeting open to the public.
  • August 4, 2025: FDA announced a meeting entitled, Medical Device User Fee Amendments. This is a hybrid meeting open to the public.
  • August 5, 2025: The Department of Veterans Affairs (VA) announced a meeting of the Special Medical Advisory Group. This is a virtual meeting open to the public.
  • August 6-7, 2025: The Health Resources and Services Administration (HRSA) announced a meeting of National Advisory Council on Nurse Education and Practice (NACNEP). This is a hybrid meeting open to the public.
  • August 7, 2025: The National Institutes of Health (NIH) announced a meeting of the National Institute of Neurological Disorders and Stroke. This is a hybrid meeting open to the public.
  • August 7-8, 2025: NIH announced a meeting of the National Heart, Lung, And Blood Institute. This is a hybrid meeting open to the public.
  • August 8, 2025: HRSA announced a meeting of the Advisory Committee on Training in Primary Care Medicine and Dentistry. This is a hybrid meeting open to the public.
  • August 13, 2025: FDA announced a meeting of the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee. This is a virtual meeting open to the public.
  • August 20, 2025: VA announced a meeting of the Rehabilitation Research and Development Service Scientific Merit Review Board. This is a virtual meeting with some sessions open to the public.
  • **August 26-27, 2025: VA announced a meeting of the Veterans’ Advisory Committee on Rehabilitation. This is a virtual meeting open to the public.
  • **August 27, 2025: VA announced a meeting of the Health Systems Research Scientific Merit Review Board. This is a virtual meeting with some sessions open to the public.
  • September 4-5, 2025: NIH announced a meeting of the Fogarty International Center Advisory Board. This is a hybrid meeting with some sessions open to the public.
  • **September 5, 2025: NIH announced a meeting of the National Advisory Council on Minority Health and Health Disparities. This is a hybrid meeting with some sessions open to the public.
  • September 9, 2025: 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.
  • September 11, 2025: NIH announced a meeting of the National Advisory General Medical Sciences Council. This is a virtual meeting with some sessions open to the public.
  • September 11-12, 2025: HRSA announced a meeting of the Council on Graduate Medical Education. This is a hybrid meeting open to the public.
  • September 11-12, 2025: NIH announced a meeting of the National Institute of Environmental Health Sciences. This is a hybrid meeting open to the public.
  • September 17-18, 2025: NIH announced a meeting of the National Institute on Aging. This is a virtual meeting with some sessions open to the public.
  • September 25, 2025: NIH announced a meeting of the National Institute of Allergy and Infectious Diseases. 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 virtual meeting with some sessions open to the public.
  • December 1-2, 2025: NIH announced a meeting of the Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD). This is a hybrid meeting open to the public.
  • December 4-5, 2025: HRSA announced a meeting of NACNEP. This is a hybrid meeting open to the public.
  • December 5, 2025: NIH announced a meeting of the Board of Scientific Counselors Eunice Kennedy Shriver NICHD. This is a hybrid meeting with some sessions open to the public.

Reports, Studies & Analyses

  • On July 14, 2025, the Government Accountability Office (GAO) released a report entitled, Comparative Effectiveness Research: HHS Should Evaluate Its Performance of Related Activities. The report reviewed the Department of Health and Human Services’ (HHS’s) efforts to disseminate and implement findings from comparative clinical effectiveness research, which evaluate the outcomes of different medical treatments to inform evidence-based decision-making.  Since 2010, the Patient-Centered Outcomes Research Institute (PCORI) and HHS have collectively obligated $3.1 billion for comparative clinical effectiveness research activities. From 2016 to March 2025, HHS disseminated findings from 16 PCORI-funded studies and implemented the findings of one study through its dissemination and implementation programs. While PCORI has established performance measures to assess its dissemination and implementation efforts, it is unclear whether HHS has completed a planned evaluation of its own dissemination and implementation portfolio. The report highlights that this delay has hindered HHS’s ability to determine whether its efforts are effectively promoting evidence-based, patient-centered care and improving health outcomes. GAO recommended that HHS complete the planned evaluation and establish near-term goals and performance measures to better assess the impact of its activities. HHS neither agreed nor disagreed with the recommendation.
  • On July 17, 2025, GAO released a report entitled, Federal Employees Health Benefits Program: OPM Should Take Timely Action to Mitigate Persistent Fraud Risks. In this report, GAO reviewed the Office of Personnel Management’s (OPM’s) efforts to manage fraud risk in the Federal Employees Health Benefits (FEHB) program, which serves over 8.2 million individuals and cost $70 billion in FY 2024. GAO found that while OPM has taken some steps—such as designating a lead entity and conducting fraud risk assessments—its efforts do not fully align with leading practices. The designated lead, the Risk Management Council, may not continue in that role, and OPM’s fraud risk assessments failed to capture the full range of inherent risks. Officials could not explain these omissions. GAO made six recommendations, including clarifying leadership for fraud risk management, conducting a more comprehensive fraud risk assessment, and involving key stakeholders. OPM concurred with all recommendations and plans to implement them.
  • On July 18, 2025, the Congressional Budget Office (CBO) released a report entitled, How Changes to Funding for the NIH and Changes in the FDA’s Review Times Would Affect the Development of New Drugs. This report assesses how changes to funding for NIH and changes in FDA’s review times would affect the development of new drugs. In particular, CBO assessed two hypothetical scenarios: (1) a permanent 10 percent reduction in the amount of funding that the government provides to the NIH, and (2) a nine-month increase in the time it takes FDA to review new drug applications (NDAs). CBO estimated that a reduction in NIH’s funding of external preclinical research would ultimately decrease the number of new drugs coming to market by roughly 4.5 percent, or about two drugs per year. That result would not be immediate; rather, the impact of the reduction in funding would grow over a 30-year period and would take full effect in the third decade after the reduction began. A reduction in other components of the NIH’s budget would further decrease the number of new drugs coming to market; CBO has not assessed the magnitude of that effect. CBO also found that a nine-month increase in FDA review times for NDAs would reduce the number of FDA-approved drugs in the first year following the increase because all but three months’ worth of drug approvals would shift to the next year. In addition to that initial delay, CBO found the increase in review times would reduce the number of such approvals by raising the cost to develop new drugs. The number of drug approvals deterred by the increase in development costs would grow over time and would reach its full effect of a two percent reduction—amounting to about one less new drug—each year in the second decade after the increase in review times began.

Hearings & Markups

Other Health Policy News

  • On July 14 and 15, 2025 CMS released its CY 2026 proposed rules for the Medicare PFS and Medicare Hospital OPPS, respectively.
  • In the CY 2026 PFS proposed rule, CMS proposes increasing the physician payment conversion factor by 3.8 percent, raising it to $33.42 for most physicians and $33.59 for those participating in qualifying Alternative Payment Models (APMs). This is in part a result of the required increase of 2.5 percent included in the budget reconciliation package, the One Big Beautiful Bill Act (OBBBA) (H.R. 1), signed into law on July 4, 2025. The rule also proposes policy changes, including significant reimbursement changes for skin substitutes, updating practice expense calculations, introducing new billing codes to strengthen behavioral health and chronic disease care, and announcing a new Center for Medicare and Medicaid Innovation (CMMI) mandatory payment model designed to strengthen behavioral health and chronic disease care.
  • In the OPPS proposed rule, CMS proposes updating the OPPS rate by a net 2.4 percent in CY 2026, based upon a 3.2 percent Market Basket Index (MBI) increase with a downward productivity adjustment of 0.8 percent. In addition, CMS proposes implementing site-neutral reimbursement policies by paying for drug administration services in certain off-campus provider-based departments at the PFS rate. The agency also includes proposals impacting hospital price transparency requirements and enforcement.
  • The PFS proposed rule can be viewed here and the OPPS proposed rule can be viewed here. The CMS press release for the PFS proposed rule can be viewed here and the press release for the OPPS proposed rule can be viewed here.
  • On July 15, 2025, the Center for Medicare and Medicaid Innovation (CMMI) announced that 33 states, along with the District of Columbia and Puerto Rico, will participate in the Cell and Gene Therapy (CGT) Access Model—an initiative aimed at improving access to high-cost, high-impact gene therapies for Medicaid beneficiaries with sickle cell disease. These participants represent approximately 84 percent of Medicaid enrollees living with the condition. The CGT Access Model tests the use of outcomes-based agreements between CMS and pharmaceutical manufacturers to promote more affordable and accountable access to transformative treatments. Participation is voluntary, with flexible start dates between January 2025 and January 2026. Under the model, CMS has negotiated guaranteed discounts and rebates if therapies fail to deliver expected clinical outcomes. States may also receive up to $9.55 million in optional federal support to assist with implementation, outreach, and data tracking.
  • A CMS press release on the CGT Access Model can be found here.
  • On July 18, 2025, the House voted 216-213 to pass H.R. 4, the Recissions Act of 2025. This comes after the Senate passed the bill by a vote of 51–48. The bill now goes to the President’s desk for final approval.
  • The legislation will rescind approximately $9 billion in discretionary funding previously allocated through the Full-Year 2025 Continuing Resolution. Targeted agencies include the U.S. Agency for International Development (USAID), the Corporation for Public Broadcasting, the United States Institute of Peace, and other international assistance programs.
  • Ahead of the vote, the Senate removed a proposed $400 million cut to the President’s Emergency Plan for AIDS Relief (PEPFAR), the only change between the House and Senate’s initial versions of the bill. This came after numerous Senate Republicans, most notably Senate Appropriations Committee Chairwoman Susan Collins (R-ME), expressed concern over cuts to this program in addition to a lack of information on how the proposed cuts would be implemented.
  • Full bill text is available here.
  • On July 16, 2025, Representative Morgan Griffith (R-VA-09) held his first hearing as Chairman of the House Committee on Energy and Commerce Subcommittee on Health, entitled Legislative Proposals to Maintain and Improve the Public Health Workforce, Rural Health, and Over-the-Counter Medicines. A central focus of the hearing was H.R. 4273, the Over-the-Counter Monograph Drug User Fee Amendments. This bill would reauthorize a user fee program created under the 2020 Coronavirus Aid, Relief, and Economic Security (CARES) Act to support FDA’s updated framework for regulating over-the-counter (OTC) drugs. The new system allows the FDA to issue administrative orders rather than using the previous, more burdensome rulemaking process. Lawmakers discussed the program’s early successes and the need to ensure it continues to reduce regulatory burdens, support innovation, and improve access to safe OTC products.
  • The subcommittee also examined H.R. 3686, the SAFE Sunscreen Standards Act, which would require FDA to consider real-world evidence and non-animal testing methods when evaluating new sunscreen ingredients. Members noted that the U.S. trails other countries in approving innovative sunscreens and discussed how the bill could help close that gap.
  • Another bill under review was H.R. 2821, FDA Modernization Act 3.0, which would require FDA to update its regulations to allow for non-animal testing alternatives, such as artificial intelligence (AI) modeling and organ-on-chip technologies. This follows the enactment of the FDA Modernization Act 2.0 in 2022, which granted the agency authority to adopt such methods. The bill does not mandate non-animal testing but would make it a viable option for companies seeking cost-effective alternatives.
  • In addition to FDA-related legislation, the subcommittee considered the reauthorization of Title VII and Title VIII programs, which provide scholarships and educational assistance to students from underserved and rural backgrounds pursuing careers in health care. Lawmakers emphasized the importance of these programs in addressing workforce shortages and improving access to care in medically underserved areas.
  • More information on this hearing is available here. 

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