Legal

CMS Update on 2025 OPPS and PFS Proposed Rules

On July 10, the Centers for Medicare & Medicaid Services (CMS) issued its calendar year (CY) 2025 outpatient prospective payment system (OPPS) proposed rule and physician fee schedule (PFS) proposed rule.

CHA is hosting this members-only webinar to discuss key proposals in these proposed rules ahead of the comment deadline.

Extension Announced for IDR Disputes Impacted by Change Healthcare Cyberattack

What’s happening: The departments of Health & Human Services, Labor, and Treasury (departments) announced a 120-day extension for parties impacted by the Change Healthcare cyberattack to open disputes under the No Surprises Act independent dispute resolution (IDR) process.  

What else to know: Disputes must be filed by Oct. 12, and parties must attest that their ability to open a dispute was affected by the incident in February.  

Hospitals Can Require Change Healthcare to Make Breach Notifications

What’s happening: The Department of Health and Human Services (HHS) announced that hospitals and health systems can require UnitedHealth Group to notify patients if their data was stolen during the Change Healthcare cyberattack on Feb. 22.  

What else to know: CHA is urging the California Department of Public Health to make a similar clarification under state law.  

CHA Continues Work to Hold Insurers Accountable

What’s happening: CHA continues to await a response to the lawsuit filed against Anthem Blue Cross on April 23.    

What else to know: In the interim, CHA continues to collect information to support its position that many managed care plans, including Anthem Blue Cross, are violating certain provisions of the Knox-Keene Act.   

HHS Issues FAQs Extending Enforcement Discretion for Certain IDR Disputes

What’s happening: The Departments of Labor, Health and Human Services, and Treasury (the departments) issued new frequently asked questions (FAQs) related to enforcement discretion for certain disputes under the No Surprises Act.  

What else to know: The FAQs are in response to the Aug. 24, 2023, decision in Texas Medical Association et al. v. United States Department of Health and Human Services et al. (TMA III) case.  

New Process Released for Resubmitting Certain IDR Disputes

What’s happening: The Departments of Health and Human Services, Labor, and the Treasury announced the release of a new process for resubmitting independent dispute resolution (IDR) disputes that were originally improperly batched or bundled.  

What else to know: The new resubmission process is automated in the federal IDR portal. 

CMS Finalizes Skilled-Nursing Facility Staffing Standards 

What’s happening: The Centers for Medicare & Medicaid Services (CMS) issued a final rule establishing new staffing standards for long-term care facilities, including skilled-nursing facilities (SNFs) and SNFs operated as distinct-part units of acute care hospitals. 

What else to know: The regulations are effective June 21. Compliance with overall ratios is required beginning May 2026.  

Environmental Protection Agency Releases Final Rule to Reduce Ethylene Oxide Emissions by 90%

What’s happening: The U.S. Environmental Protection Agency (EPA) released a final rule limiting carcinogen ethylene oxide (EtO) emissions for commercial medical device sterilization facilities. According to EPA, the new rule is intended to lower the cancer risk in communities surrounding these facilities to below the benchmark safety threshold. 

What else to know: Hospitals and medical device suppliers have raised concerns that the updated regulations could cause a supply chain disruption for certain medical devices because many medical devices are sterilized with EtO. The new rule addresses these concerns while maintaining the goal of overall reduction of EtO emissions by 90%. 

HRSA Implements Long-Awaited Dispute Resolution Process

What’s happening: The Health Resources and Services Administration (HRSA) finalized requirements and procedures for the 340B Drug Discount Program’s administrative dispute resolution (ADR) process.  

What else to know: The regulation is effective June 18.  

CMS Revises Informed Consent Guidance for Hospitals

What’s happening: The Centers for Medicare & Medicaid Services (CMS) updated its Hospital Interpretive Guidelines for Informed Consent.  

What else to know: The guidance clarifies the need to obtain informed consent from patients to perform important surgical tasks, and sensitive or invasive procedures, as well as examinations outside of the medically necessary procedure.