Legal

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.  

CDPH’s Centralized Application Evolution

The Center for Health Care Quality (CHCQ) licenses and certifies over 14,000 health care facilities and agencies in California in 30 different licensure and certification categories. Keeping licensing and certification practices consistent throughout California can be challenging. The Centralized Program Flex Unit (CPFU), a division of CHCQ, has a mission to ensure standardization and consistency […]

CHA Unveils Appellate Advocacy Tracker

What’s happening: CHA has released an appellate advocacy tracker that reports CHA’s amicus efforts to provide courts with important factual context and legal analysis, highlighting the ramifications of legal issues for hospitals.  

What else to know: The tracker contains both the links to the amicus documents that CHA files and the outcome of these efforts.