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, CMS finalized its fiscal year (FY) 2026 Medicare payment rules and the Senate Appropriations committee advanced the FY 2026 Labor-HHS appropriations act in 26-3 vote.
Regulations, Notices & Guidance
- On July 28, 2025, the Food and Drug Administration (FDA) released a notice entitled, Revocation of Emergency Use of a Drug Product During the COVID-19 Pandemic; Availability. FDA is announcing the revocation of the Emergency Use Authorizations (EUAs) (the Authorizations) issued to Regeneron Pharmaceuticals, Inc. (Regeneron) for REGEN-COV (casirivimab and imdevimab administered together), to GlaxoSmithKline LLC (GSK) for sotrovimab, to Eli Lilly and Company (Lilly) for bebtelovimab, and to AstraZeneca Pharmaceuticals LP (AstraZeneca) for EVUSHELD (tixagevimab co-packaged with cilgavimab). FDA revoked these Authorizations on December 13, 2024, under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The revocations, including an explanation of the reasons for the revocations, are reprinted in this document.
- On July 29, 2025, FDA released a notice entitled, Medical Device User Fee Rates for Fiscal Year 2026. FDA is announcing the fee rates and payment procedures for medical device user fees for FY 2026. The FD&C Act, as amended by the Medical Device User Fee Amendments of 2022 (MDUFA V), authorizes FDA to collect user fees for certain medical device submissions and annual fees both for certain periodic reports and for establishments subject to registration. This notice establishes the fee rates for FY 2026, which apply from October 1, 2025, through September 30, 2026, and provides information on how the fees for FY 2026 were determined, payment procedures, and how to qualify for reduced small business fees.
- On July 29, 2025, FDA released a notice entitled, Generic Drug User Fee Rates for Fiscal Year 2026. The FD&C Act, as amended by the Generic Drug User Fee Amendments of 2022 (GDUFA III), authorizes FDA to assess and collect fees for abbreviated new drug applications (ANDAs); drug master files (DMFs); generic drug active pharmaceutical ingredient facilities, finished dosage form (FDF) facilities, and contract manufacturing organization (CMO) facilities; and generic drug applicant program user fees. In this document, FDA is announcing FY 2026 rates for GDUFA III fees.
- On July 29, 2025, FDA released a notice entitled, Prescription Drug User Fee Rates for Fiscal Year 2026. FDA is announcing the rates for prescription drug user fees for FY 2026. The FD&C Act, as amended by the Prescription Drug User Fee Amendments of 2022 (PDUFA VII), authorizes FDA to collect application fees for certain applications for the review of human drug and biological products and prescription drug program fees for certain approved products. This notice establishes the fee rates for FY 2026.
- On July 29, 2025, FDA released a notice entitled, Outsourcing Facility Fee Rates for Fiscal Year 2026. FDA is announcing the FY 2026 rates for the establishment and reinspection fees related to entities that compound human drugs and elect to register as outsourcing facilities under the FD&C Act. The FD&C Act authorizes FDA to assess and collect an annual establishment fee from outsourcing facilities, as well as a reinspection fee for each reinspection of an outsourcing facility. This document establishes the FY 2026 rates for the small business establishment fee ($6,829), the non-small business establishment fee ($20,726), and the reinspection fee ($20,486) for outsourcing facilities; provides information on how the fees for FY 2026 were determined; and describes the payment procedures outsourcing facilities should follow.
- On July 29, 2025, FDA released a notice entitled, Food Safety Modernization Act Voluntary Qualified Importer Program User Fee Rate for Fiscal Year 2026. FDA is announcing the FY 2026 annual fee rate for importers approved to participate in the Voluntary Qualified Importer Program (VQIP) that is authorized by the FD&C Act, as amended by the FDA Food Safety Modernization Act (FSMA). This fee is effective on August 1, 2025, and will remain in effect through September 30, 2026.
- On July 29, 2025, FDA released a notice entitled, Food Safety Modernization Act Third-Party Certification Program User Fee Rate for Fiscal Year 2026. FDA is announcing the FY 2026 annual fee rate for recognized accreditation bodies and accredited certification bodies, and the initial and renewal fee rate for accreditation bodies applying to be recognized in the third-party certification program authorized by the FD&C Act, as amended by the FSMA. FDA is also announcing the fee rate for certification bodies applying for direct FDA accreditation. The fees apply from October 1, 2025, through September 30, 2026.
- On July 29, 2025, FDA released a notice entitled, Food Safety Modernization Act Domestic and Foreign Facility Reinspection, Recall, and Importer Reinspection Fee Rates for Fiscal Year 2026. FDA is announcing the FY 2026 fee rates for certain domestic and foreign facility reinspections, failures to comply with a recall order, and importer reinspections that are authorized by the FD&C Act, as amended by the FSMA. These fees apply to the period from October 1, 2025, and will remain in effect through September 30, 2026.
- On July 29, 2025, FDA released a notice entitled, Biosimilar User Fee Rates for Fiscal Year 2026. FDA is announcing the rates for biosimilar user fees for FY 2026. The FD&C Act, as amended by the Biosimilar User Fee Amendments of 2022 (BsUFA III), authorizes FDA to assess and collect user fees for certain activities in connection with biosimilar biological product development; review of certain applications for approval of biosimilar biological products; and each biosimilar biological product approved in a biosimilar biological product application. BsUFA III directs FDA to establish, before the beginning of each FY, the amount of initial and annual biosimilar biological product development (BPD) fees, the reactivation fee, and the biosimilar biological product application and program fees for such year.
- On July 30, 2025, FDA released guidance entitled, Medical Device User Fee Small Business Qualification and Determination Guidance Final Guidance for Industry and Food and Drug Administration Staff and Foreign Governments; Availability. FDA is announcing the availability of a final guidance for industry entitled Medical Device User Fee Small Business Qualification and Determination Guidance. This guidance updates the previous version of the guidance, entitled Medical Device User Fee Small Business Qualification and Certification Guidance, issued on August 1, 2018. The guidance includes updates which describe how FDA plans to determine if a small business is experiencing “financial hardship” which makes them eligible for a waiver of their registration fee. The guidance details what information FDA intends to review and consider in making this determination.
- On July 30, 2025, the Department of Health and Human Services (HHS) released a notice entitled, National Plan and Provider Enumeration System (NPPES) Data Changes. This notice provides information on changes to a data element collected by the National Plan and Provider Enumeration System (NPPES) when a provider applies for a National Provider Identifier (NPI), which changes are made pursuant to provisions of the January 20, 2025, Executive Order (EO), 14168 (90 FR 8615). This notice also provides an explanation of the nature and rationale for the changes, and their effect on public-facing data available in NPPES downloadable files and the query-only database on the Internet.
- On July 31, 2025, the Centers for Medicare & Medicaid (CMS) released a final rule entitled, Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities; Updates to the Quality Reporting Program for Federal Fiscal Year 2026. This final rule finalizes changes and updates to the policies and payment rates used under the Skilled Nursing Facility (SNF) Prospective Payment System (PPS) for FY 2026. This final rule also updates the requirements for the SNF Quality Reporting Program (QRP) and the SNF Value-Based Purchasing Program (SNF VBPP).
- On July 31, 2025, CMS released a final rule entitled, Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals (IPPS) and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year (FY) 2026 Rates. This final rule revises the Medicare hospital inpatient prospective payment systems (IPPS) for operating and capital-related costs of acute care hospitals; makes changes relating to Medicare graduate medical education (GME) for teaching hospitals; updates the payment policies and the annual payment rates for the Medicare PPS for inpatient hospital services provided by long-term care hospitals (LTCHs); updates and makes changes to requirements for certain quality programs; and makes other policy-related changes. CMS is also finalizing the provisions of the interim final action with comment period regarding the changes to the FY 2025 IPPS rates due to the court decision in Bridgeport Hosp. v. Becerra. Lastly, the final rule finalizes certain updates to the ONC Health Information Technology (IT) Certification Program.
- On July 31, 2025, the Health Resources and Service Administration (HRSA) released a notice entitled, 340B Program Notice: Application Process for the 340B Rebate Model Pilot Program. The Office of Pharmacy Affairs (OPA), which administers the 340B Drug Pricing Program (340B Program), is issuing this notice to announce the availability of a 340B Rebate Model Pilot Program as a voluntary mechanism for qualifying drug manufacturers to effectuate the 340B ceiling price on select drugs to all covered entities, and to collect comments on the structure and application process of the 340B Rebate Model Pilot Program. OPA will consider comments received but is under no obligation to respond to or act on the comments.
- On August 1, 2025, CMS released a rule entitled, Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2026 and Updates to the IRF Quality Reporting Program. This final rule updates the prospective payment rates for inpatient rehabilitation facilities (IRFs) for FY 2026. As required by statute, this final rule includes the classification and weighting factors for the IRF PPS’s case-mix groups and a description of the methodologies and data used in computing the prospective payment rates for FY 2026. It also continues the second year of the 3-year phaseout of the rural adjustment, which began in FY 2025. Additionally, the final rule includes updates to the IRF QRP.
- On August 1, 2025, CMS released a final rule entitled, FY 2026 Inpatient Psychiatric Facilities Prospective Payment System—Rate Update. This final rule updates the prospective payment rates, the outlier threshold, and the wage index for Medicare inpatient hospital services provided by Inpatient Psychiatric Facilities (IPFs), which include psychiatric hospitals and excluded psychiatric units of an acute care hospital or critical access hospital. This final rule also revises the payment adjustment factors for teaching status and for IPFs located in rural areas. These changes will be effective for IPF discharges occurring during the FY beginning October 1, 2025, through September 30, 2026. CMS is finalizing changes to measures used in the Inpatient Psychiatric Facilities Quality Reporting (IPFQR) Program, updating and codifying the Extraordinary Circumstances Exception policy, and summarizing comments received through requests for information regarding future changes to the IPFQR Program.
- On August 1, 2025, CMS released a rule entitled, Fiscal Year 2026 Hospice Wage Index and Payment Rate Update and Hospice Quality Reporting Program Requirements. This final rule updates the hospice wage index, payment rates, and aggregate cap amount for FY 2026. This rule also finalizes changes to the admission to hospice regulations and the hospice face-to-face attestation requirements under the certification of terminal illness regulations and includes technical changes to the hospice telehealth policy and wage index. This final rule also includes a technical correction to the regulatory text and provides updates to the Hospice QRP requirements.
- On August 1, 2025, FDA released a notice entitled, Prescription Drug User Fee Act VII; Independent Assessment of Communication Through Product Quality Information Requests During Application Review; Final Report; Availability; Reopening of Comment Period. FDA is reopening the comment period for the notice of availability entitled, Prescription Drug User Fee Act VII; Independent Assessment of Communication Through Product Quality Information Requests During Application Review; Final Report; Availability; Request for Comments, which appeared in the Federal Register of May 9, 2025. In the notice of availability, FDA requested comments on the final assessment report. The agency is taking this action in response to a request to allow interested persons additional time to submit comments.
Event Notices
Please note that two asterisks (**) preceding the item indicate a new event.
- 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: 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, 2025: NIH announced a meeting of the National Deafness and Other Communication Disorders Advisory Council. This is an in-person 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 9-10, 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 10, 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.
- **September 10, 2025: FDA announced a meeting of the National Advisory Dental and Craniofacial Research 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 16, 2025: NIH announced a meeting of the National Human Genome Research Institute. This is a hybrid meeting open to the public.
- September 17-18, 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.
- 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 7, 2025: FDA announced a meeting of the Tobacco Products Scientific Advisory Committee. This is a hybrid 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 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.
- 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.
- 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.
Reports, Studies & Analyses
- On July 29, 2025, the HHS Office of Inspector General (OIG) released a report entitled, Hospitals Reported Few Captured Patient Harm Events to CMS and States. The report raises concerns that hospitals are not consistently following CMS and State reporting requirements intended to monitor patient safety. Nationwide, OIG determined that 16 percent (15 of 94) of harm events that hospitals identified and captured in their incident reporting or other surveillance systems were required to be reported externally per CMS and State requirements. Yet, in the sample, hospitals reported only 5 of 15 captured events per these requirements. The results show a significant discrepancy between the events that CMS and States expected hospitals to report and the events that hospitals actually reported. The low rate of reporting raises questions about hospital transparency and accountability for patient harm that occurs in their facilities. OIG urges CMS, States, hospitals, and others (e.g., accreditation organizations) to consider these results as they develop new strategies to improve patient safety.
- On July 29, 2025, the Congressional Research Service (CRS) released a report entitled, HALT Fentanyl Act Permanently Controls Fentanyl-Related Substances. The report outlines how the HALT Fentanyl Act permanently classifies fentanyl-related substances (FRS) as Schedule I drugs under the Controlled Substances Act. This classification gives law enforcement broader authority to address the trafficking and distribution of these substances, which have been a major contributor to the opioid crisis in the U.S.
- On July 31, 2025, the Government Accountability Office (GAO) released a report entitled, COVID-19: Update on Key Indicators, the Federal Response, and Implementation of GAO Recommendations. The report outlines updates to key COVID-19 indicators including public health, economic conditions, relief spending, and fraud. To provide key updates on these indicators, GAO analyzed federal data and public statements and reviewed relevant literature. GAO’s work on the pandemic has resulted in over 200 products and 484 recommendations to Congress and federal agencies. Over half of these have been closed, which has led to at least $43.9 billion in financial benefits, among other improvements. The report found that 200 GAO recommendations remain open and may continue to provide cost-saving opportunities.
Hearings & Markups
- On July 30, 2025, the Senate Health, Labor, Education, Labor, and Pensions (HELP) Committee held a full committee markup of the following legislation:
- S.2292, Over-the-Counter Monograph Drug User Fee Amendments (agreed to by a roll-call vote, 23-0);
- S. 1440, Uniformed Services Leave Parity Act (agreed to by a roll-call vote, 23-0);
- S. 2398, Kay Hagan Tick Reauthorization Act (agreed to by a roll-call vote, 23-0);
- S. 1728, Employee Ownership Representation Act of 2025 (agreed to by a roll-call vote, 23-0); and
- S. 2403, Retire Through Ownership Act (agreed to by a roll-call vote, 23-0).
- On July 31, 2025, the Senate Appropriations Committee held a full committee markup of the following legislation:
- S. 2572, Making appropriations for the Department of Defense for the fiscal year ending September 30, 2026, and for other purposes.
- S. 2587, Making appropriations for the Departments of Labor, Health and Human Services, and Education, and related agencies for the fiscal year ending September 30, 2026, and for other purposes.
- On July 31, 2025, the Senate HELP Committee held a hearing entitled, Making Health Care Affordable: Solutions to Lower Costs and Empower Patients. Witnesses included: Ms. Chris Deacon, Principal and Founder, VerSan Consulting; Dr. Benedic Ippolito, Senior Fellow, American Enterprise Institute; Dr. Brian Miller, Associate Professor of Medicine and Practicing Hospital Medicine Physician, Johns Hopkins University; Mr. Wendell Potter, President, Center for Health and Democracy; and Dr. Adam Gaffney, Assistant Professor of Medicine, Harvard Medical School.
- On July 31, 2025, the Senate Finance Committee held a hearing entitled, Hearing to Consider the Nominations Bryan Switzer, of Virginia, to be a Deputy United States Trade Representative (Asia, Textiles, Investment, Services, and Intellectual Property), with the rank of Ambassador, vice Sarah Bianchi; Gustav Chiarello III, of Virginia, to be an Assistant Secretary of Health and Human Services, vice Robert Michael Gordon; The Honorable Michael Stuart, of West Virginia, to be General Counsel of the Department of Health and Human Services, vice Samuel R. Bagenstos, resigned; and Derek Theurer, of Virginia, to be a Deputy Under Secretary of the Treasury, vice Jonathan Davidson. Witnesses included: Bryan Switzer to be a Deputy United States Trade Representative (Asia, Textiles, Investment, Services, and Intellectual Property), with the rank of Ambassador; Gustav Chiarello to be an Assistant Secretary of HHS; The Honorable Michael Stuart to be General Counsel of HHS; and Derek Theurer to be a Deputy Under Secretary of the Treasury.
Other Health Policy News
- On July 28, 2025, HHS announced a $100 million pilot funding opportunity aimed at eliminating Hepatitis C (HCV) among individuals with substance use disorder (SUD) or serious mental illness (SMI). The program will focus on communities heavily impacted by homelessness and is designed to improve prevention, testing, treatment, and cure rates for HCV. The initiative will be administered by the Substance Abuse and Mental Health Services Administration (SAMHSA) and is part of a broader federal effort to reduce chronic disease burden and healthcare costs. Eligible applicants include state and community-based organizations. The pilot will also serve to develop best practices and scalable models for future implementation. An HHS press release announcing the project can be found here.
- On July 30, 2025, the Trump Administration announced a new digital health initiative during a White House “Make Health Tech Great Again” event. More than 60 companies, including Google, Amazon, UnitedHealth Group, and CVS Health, signed a voluntary interoperability pledge in coordination with CMS. Twenty-one data networks pledged to meet the CMS Interoperability Framework criteria to become “CMS Aligned Networks.” Also, eleven health systems and providers committed to support patient use of digital tools, and seven Electronic Health Record (EHR) vendors pledged to facilitate data exchange and reduce reliance on paper intake forms. Moreover, participating developers of conversational AI assistants, chronic disease management apps, and digital check-in tools committed to connect to CMS Aligned Networks or personal health record apps, with patient consent. A CMS press release on the announcement can be found here.
- Additionally, CMS provided updates to its foundational efforts aimed at supporting a new digital health ecosystem and enhancing the beneficiary experience, which were first announced at a public meeting on June 3, 2025:
- National Provider Directory: CMS has begun building a Fast Healthcare Interoperability Resources (FHIR)-based Application Programming Interface (API) to enable apps to locate provider networks, participants, and relevant endpoints, with plans to launch initial functionality later this year.
- Digital Identity for Medicare.gov: CMS is working to implement modern digital identity features on Medicare.gov to enhance security while maintaining access to existing services.
- Blue Button Data Access: CMS is developing infrastructure to reduce the time between receipt and availability of Medicare claims data through the Blue Button API.
- Data at the Point of Care: CMS is integrating digital identity and provider directory validation into its Data at the Point of Care pilot as development continues.
- Trusted Data Exchange: CMS plans to participate in trusted data exchange by responding to patient and provider queries and sharing Blue Button claims data through CMS Aligned Networks beginning in early 2026.
- On July 31, 2025, the Senate Committee on Finance held a hearing to consider nominations for several officials including the Honorable Michael Stuart to be the General Counsel of HHS. During the hearing, Mr. Stuart emphasized his commitment to public service, rural health care, and legal integrity. Drawing on his experience as a U.S. Attorney and West Virginia State Senator, Mr. Stuart highlighted his work on opioid enforcement, Medicaid fraud, and child welfare reform. He pledged to prioritize fraud prevention, build collaborative legal teams, and support effective service delivery for programs like Medicaid and the Supplemental Nutrition Assistance Program (SNAP). Notably, Senator Ron Wyden (D-OR) questioned Mr. Stuart on the Trump Administration’s interpretations regarding entities’ compliance with Emergency Medical Treatment and Labor Act (EMTALA) and criticized past efforts to roll back guidance on EMTALA following the Supreme Court’s decision to overturn Roe v. Wade, citing cases where women were denied timely care. Mr. Stuart’s full opening statement is available here.
- On July 31, 2025, President Donald Trump’s nominee for Centers for Disease Control and Prevention (CDC) Director, Dr. Susan Monarez, was sworn in by HHS Secretary Robert F. Kennedy, Jr. The Senate confirmed her nomination on July 29, 2025, by a vote of 51-47. The Senate HELP Committee previously approved her nomination by a vote of 12-11 on July 25, 2025. During her confirmation hearing, Dr. Monarez, a microbiologist and former deputy director at the Advanced Research Projects Agency for Health (ARPA-H), emphasized the importance of science-based public health communication and vaccination. An HHS press release on Dr. Monarez’s confirmation can be found here.
- On July 31, 2025, the Senate Committee on Appropriations held a full committee markup of its Labor, Health and Human Services, and Education (Labor-HHS) appropriations bill for FY 2026, which includes investments in public health, education, and workforce development. The bill rejects the Trump Administration’s proposed cuts to programs addressing substance use, HIV, and pandemic preparedness, and restores funding for women’s health initiatives like Title X and the Teen Pregnancy Prevention Program. It allocates $487 billion for biomedical investments to support research on Alzheimer’s, cancer, diabetes, rare diseases, and women’s health. The bill also boosts resources for caregiving, rural health and education, and mental health. Additional provisions aim to safeguard education programs from administrative restructuring and increase transparency in federal spending. The full committee advanced the bill by a vote of 26-3. The full bill text is available here. The Labor-HHS Senate report is available here.
- On July 31, 2025, CMS finalized annual updates to Medicare payment policies for inpatient services under the IPPS and the LTCH PPS. Acute care hospitals participating in quality and interoperability programs will receive a 2.6 percent increase in operating payment rates under the IPPS, contributing to an estimated $5 billion overall increase in hospital payments. LTCHs will see a 2.7 percent increase in their standard payment rate, totaling approximately $72 million in additional payments. In addition, the IPPS final rule includes the Assistant Secretary for Technology Policy/Office of the National Coordinator (ASTP/ONC) Electronic Prescribing, Real-Time Prescription Benefit and Electronic Prior Authorization (HTI-4) final rule, which finalizes updates to the ONC Health IT Certification Program that advance health care providers’ ability to engage in electronic prescribing, real-time prescription benefit checks, and electronic prior authorization. The text of the final rule is available here.
- On July 31, 2025, CMS issued a final rule updating Medicare payment policies for SNFs for FY 2026. Specifically, CMS finalized a 3.2 percent increase, totaling an estimated 1.6 billion. The final rule includes a 3.2 percent rate increase in SNF payment rates, amounting to a $1.16 billion increase over FY 2025. The final rule also includes updates to the Patient-Driven Payment Model (PDPM), revising ICD-10 code mappings to improve diagnostic accuracy. Changes to the SNF Value-Based Purchasing (VBP) Program include new performance standards, removal of the Health Equity Adjustment, and a new reconsideration process. Additionally, CMS is modifying the SNF QRP by removing certain social determinant data elements from assessments and updating the reconsideration policy. The text of the rule is available here.
- On August 1, 2025, CMS issued a final rule updating Medicare payment policies and quality reporting requirements for IPFs for FY 2026. Under the IPF PPS, CMS is increasing payment rates by 2.5 percent, reflecting a market basket update of 3.2 percent offset by a 0.7 percent productivity adjustment. These changes are expected to result in a $70 million increase in total payments. CMS is also updating the outlier threshold and revising facility-level adjustment factors for teaching status and rural location, based on more recent data and statutory requirements. In the IPF QRP, CMS is finalizing the removal of four quality measures and modifying the reporting period for one emergency department visit measure to align with related programs. The agency is also updating the Extraordinary Circumstances Exception policy, shortening the request window from 90 to 60 days, and codifying the process for requesting relief. Additionally, CMS summarized public feedback on potential future changes to the IPF QRP, including the development of a star rating system for IPFs, new measure concepts related to well-being and nutrition, and the use of FHIR standards for digital quality measurement. The text of the final rule is available here.
- On August 1, 2025, CMS issued a final rule updating Medicare payment rates and policies for IRFs for FY 2026. Under the IRF PPS, CMS is implementing a 2.6 percent increase in payment rates, reflecting a 3.3 percent market basket update offset by a 0.7 percent productivity adjustment. These changes, along with technical updates to payment rates and case-mix classifications, are expected to result in a $340 million increase in aggregate IRF payments. CMS also finalized updates to the IRF QRP, a pay-for-reporting initiative. Key changes include the removal of two COVID-19 vaccination measures and four social determinant of health (SDOH) data elements from the IRF patient assessment instrument to reduce reporting burden. Additionally, CMS is amending the reconsideration policy to allow IRFs more flexibility in appealing non-compliance determinations, particularly in cases of extraordinary circumstances. The final rule also summarizes stakeholder feedback on future quality measures, data submission timelines, and the adoption of health IT standards, including FHIR. The text of the final rule is available 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.