Health Care Week in Review | Congress Passes One Big Beautiful Bill Act; CMS Releases Proposed Payment Rules for ESRD and Home Health

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.

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 Regulations, Notices & Guidance

• On June 30, 2025, the Centers for Medicare & Medicaid Services (CMS) released a notice entitled, Implementation of Prior Authorization for Select Services for the Wasteful and Inappropriate Services Reduction Model. This notice announces a 6-year model focused on reducing fraud, waste (including low-value care), and abuse in Medicare fee-for-service (FFS) via the implementation of technology-enabled prior authorization processes for select services. This notice is effective on January 1, 2026.
• On June 30, 2025, CMS released a proposed rule entitled, Medicare and Medicaid Programs; Calendar Year 2026 Home Health Prospective Payment System (HH PPS) Rate Update; Requirements for the HH Quality Reporting Program and the HH Value-Based Purchasing Expanded Model; Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Competitive Bidding Program Updates; DMEPOS Accreditation Requirements; Provider Enrollment; and Other Medicare and Medicaid Policies. This proposed rule would set forth routine updates to the Medicare home health payment rates in accordance with existing statutory and regulatory requirements. In addition, this proposed rule proposes permanent and temporary behavior adjustments and proposes to recalibrate the case-mix weights and update the functional impairment levels; comorbidity subgroups; and low-utilization payment adjustment (LUPA) thresholds for calendar year (CY) 2026. Further, this proposed rule proposes policy changes to the face-to-face encounter policy. It also proposes changes to the Home Health Quality Reporting Program (HH QRP) and the expanded Health Value-Based Purchasing (HHVBP) Model requirements. In addition, it would update the Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Competitive Bidding Program (CBP). Lastly it proposes: a technical change to the home health conditions of participation; updates to DMEPOS supplier conditions of payment; updates to provider and supplier enrollment requirements; and changes to DMEPOS accreditation requirements.
• On June 30, 2025, CMS released a proposed rule entitled,End-Stage Renal Disease Prospective Payment System, Payment for Renal Dialysis Services Furnished to Individuals with Acute Kidney Injury, End-Stage Renal Disease Quality Incentive Program, and End-Stage Renal Disease Treatment Choices Model. This proposed rule would update and revise the End-Stage Renal Disease (ESRD) Prospective Payment System for CY 2026. This proposed rule also proposes to update the payment rate for renal dialysis services furnished by an ESRD facility to individuals with acute kidney injury. In addition, this proposed rule proposes to update requirements for the ESRD Quality Incentive Program and to terminate and modify requirements for the ESRD Treatment Choices Model.
• On June 30, 2025, the Occupational Safety and Health Administration (OSHA) released a proposed rule entitled, Occupational Exposure to COVID–19 in Healthcare Settings. On June 21, 2021, OSHA adopted a Healthcare Emergency Temporary Standard (Healthcare ETS) protecting workers from COVID-19 in settings where healthcare or healthcare services are provided. On December 27, 2021, OSHA withdrew the non-recordkeeping and reporting portions of the Healthcare ETS. At that time, however, OSHA also announced that the recordkeeping and reporting requirements, which were adopted under a separate provision of the Occupational Safety and Health (OSH) Act, would remain in effect. This proposed rule would remove OSHA’s COVID-19 Emergency Temporary Standard and its associated recordkeeping and reporting provisions from the Code of Federal Regulations.
• On June 30, 2025, OSHA released a proposed rule entitled, Amending the Medical Evaluation Requirements in the Respiratory Protection Standard for Certain Types of Respirators. OSHA is proposing to remove some medical evaluation requirements in the Respiratory Protection Rule for certain types of respirators. This proposed change would only impact filtering facepiece respirators and loose-fitting powered air-purifying respirators.
• On July 1, 2025, the Food and Drug Administration (FDA) released guidance entitled, Myelodysplastic Syndromes: Developing Drug and Biological Products for Treatment. The purpose of this guidance is to assist sponsors in the clinical development of drug and biological products for the treatment of the myelodysplastic syndromes (MDS). Specifically, this guidance addresses FDA’s current thinking regarding the overall development program and clinical trial designs for the development of drug and biological products to support an indication of treatment of MDS. This guidance will focus specifically on development of drug and biological products that are considered disease-modifying and, therefore, will not cover products considered supportive only (e.g., erythropoiesis-stimulating agents). Furthermore, the guidance will not address drug development for MDS/myeloproliferative neoplasms, such as chronic myelomonocytic leukemia, which are considered a separate class of myeloid neoplasms.
• On July 2, 2025, FDA released guidance entitled, Small Volume Parenteral Drug Products and Pharmacy Bulk Packages for Parenteral Nutrition: Aluminum Content and Labeling Recommendations. FDA is announcing the availability of a draft guidance for industry entitled, Small Volume Parenteral Drug Products and Pharmacy Bulk Packages for Parenteral Nutrition: Aluminum Content and Labeling Recommendations. This draft guidance is intended to clarify the key factors in calculating the aluminum content to ensure that the total aluminum exposure in parenteral nutrition (PN) does not exceed an acceptable threshold. It also provides FDA’s recommendations regarding the aluminum concentration limits for small volume parenterals (SVPs) packaged as single doses or SVPs packaged in pharmacy bulk packages (PBPs). Additionally, this draft guidance is intended to assist sponsors and applicants in determining the appropriate placement of information on aluminum toxicity in SVP and large volume parenteral (LVP) Prescribing Information and container and carton labeling. This draft guidance revises and replaces the draft guidance for industry of the same name published on December 7, 2022.
• On July 2, 2025, FDA released guidance entitled, Drug Products not Withdrawn from Sale for Reasons of Safety or Effectiveness: Syndros (Dronabinol) Solution, 5 Milligrams/Milliliter. FDA has determined that SYNDROS (dronabinol) solution, 5 milligrams (mg)/milliliter (mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for SYNDROS (dronabinol) solution, 5 mg/mL, if all other legal and regulatory requirements are met.

Event Notices

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

• July 7, 2025: The National Institutes of Health (NIH) announced a meeting of the Board of Scientific Counselors, National Cancer Institute. This is a virtual meeting with some sessions open to the public.
• July 9, 2025: FDA announced a meeting of the Pediatric Advisory Committee. This is a virtual meeting open to the public.
• July 10, 2025: CMS announced a meeting of the Air Ambulance Quality & Patient Safety Advisory Committee. This is a virtual meeting open to the public.
• 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 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: 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.
• 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 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.
• 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 June 30, 2025, the General Accountability Office (GAO)released a report entitled, Highlights of a Forum: Reducing Spending and Enhancing Value in the U.S. Health Care System. This report provides a summary of GAO’s October 2024 forum on reducing health care spending and enhancing value in the U.S. health system. With federal health expenditures projected to reach 8.5 percent of GDP in 30 years, GAO convened 30 experts from government, academia, and industry to explore solutions. Participants identified five key areas for reform: strengthening primary care through hybrid payment models; expanding the health care workforce to address shortages and reduce reliance on costly institutional care; reforming pricing to align costs with clinical value; revising Medicare physician payments to reduce incentives for unnecessary specialty services; and implementing site-neutral payments to curb provider consolidation. Most proposals would require legislative action or federal investment to implement, reflecting the scale and complexity of the challenge.
• On June 30, 2025, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) released a report entitled, 2025 National Health Care Fraud Takedown. OIG participated with key federal and state law enforcement partners in the 2025 National Health Care Fraud Takedown. The action resulted in criminal charges against 324 defendants, with intended losses exceeding $14.6 billion—making it the largest health care fraud Takedown in U.S. Department of Justice history and doubling the previous record of $6 billion. 324 defendants—including 96 doctors, nurse practitioners, pharmacists, and other licensed medical professionals—across 50 federal districts and 12 State Attorneys General’s Offices were charged for their alleged roles in health care fraud schemes that exploited patients and taxpayers and resulted in over $14.6 billion in fraudulent activity.
• On July 1, 2025, OIG released a report entitled, CMS Should Improve Its Methodology for Collecting Medicare Postoperative Visit Data on Global Surgeries.  The report outlined audit estimates showing that Medicare’s global surgery payments may be overvalued, with practitioners providing fewer postoperative visits than CMS assumes in its bundled payment rates. The audit estimated that Medicare overpaid by $5.7 million and beneficiaries by $1.7 million. Additionally, data CMS collected to improve payment accuracy was found to be inaccurate for 45 of 105 sampled procedures. OIG recommended that CMS improve education, documentation, reporting, data collection, and fee valuation practices related to postoperative visits in global surgery billing to reflect actual care provided.

Other Health Policy News

• On July 3, 2025, the House of Representatives passed the budget reconciliation bill, the One Big Beautiful Bill Act (H.R. 1), by a vote of 218-214. All but two Republicans voted in favor – Representative Fitzpatrick and Thomas Massie (R-KY) – while all Democrats opposed. This version of the legislation was originally passed by the Senate on July 1, 2025, by a vote of 51-50, with Vice President JD Vance casting the tie-breaking vote. All Democrats voted against the bill, joined by Republican Senators Rand Paul (KY), Thom Tillis (NC), and Susan Collins (ME).
• The bill directs nearly a trillion dollars in reduced federal spending in Medicaid over ten years, primarily achieved through the implementation of work requirements and reforming how states finance their cost-sharing mechanisms. While provider tax rates for states that did not expand Medicaid eligibility under the Affordable Care Act (ACA) are grandfathered and frozen, the bill includes a phase down of the “safe harbor” from 6 percent to 3.5 percent of net patient revenue in expansion states from FY 2028 through 2032 through annual 0.5 percent reductions. This provision exempts provider taxes on nursing and intermediate care facilities.
• The text includes limits on Medicaid state directed payments (SDPs)—100 percent of the Medicare rate for expansion states and 110 percent for non-expansion states—but narrows grandfathering provisions. Only SDPs approved by May 1, 2025, or those for rural hospitals with prior approval or a submitted preprint before enactment, are exempt. Beginning in 2028, grandfathered SDPs not in compliance must reduce rates by 10 percentage points annually until they meet the new limits.
• The text also provides a 2.5 payment increase to the Medicare Physician Fee Schedule (PFS) conversion factor for calendar year 2026. This is different from the text the House passed in May, which would have updated the conversion factor to 75 percent of the Medicare Economic Index (MEI) for 2026 and provided for an increase of 10 percent of MEI in each subsequent year.
• Further, the bill creates a rural stabilization fund, the Rural Health Transformation Program, to offset the initial impact from the Medicaid proposals, largely targeted for rural hospitals and community health centers. The $50 billion fund would allow the Centers for Medicare & Medicaid Services (CMS) to distribute $10 billion annually from FY 2026 through FY 2030.
• The legislation now heads to President Trump’s desk, meeting the July 4 deadline he had set for its passage. The latest H.R. 1 bill text is available here.
• On July 2, 2025, Representative Buddy Carter (R-GA) announced he is stepping down as Chair of the House Energy and Commerce Health Subcommittee. He shared that he plans to remain an active member of the Subcommittee, but is stepping down to give his “undivided attention” to his district in Georgia. This announcement comes as the congressman is making a bid for the Senate. Representative Morgan Griffith (R-VA) has been appointed to Chairman of the Subcommittee on Health following Representative Carter’s departure. Additionally, Representative Diana Harshbarger (TN-01) has been appointed to Vice Chair of the Subcommittee. The full E&C Committee updates announcement is available here.

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