Regulations

HHS Finalizes Privacy Rule to Protect Reproductive Health Information

What’s happening: The Department of Health and Human Services’ (HHS) Office for Civil Rights (OCR) issued a final rule prohibiting entities regulated by the Health Insurance Portability and Accountability Act Privacy Rule from using or disclosing protected health information (PHI) to investigate or prosecute patients, providers, or others involved in providing legal reproductive health services. 

What else to know: The final rule is effective June 25, and covered entities are required to comply within 240 days. Hospitals will need to update their policies and procedures to comply with these new rules. 

HHS Issues Rules on Nondiscrimination in Health Care

What’s happening: The Department of Health and Human Service (HHS) issued two final rules to strengthen nondiscrimination protections in health care.  

What else to know: These rules also aim to ensure equitable access to health care. Hospitals will need to update their policies and procedures to comply with the new rules. 

CHA Issues Summaries of IPPS, LTCH PPS Proposed Rules

What’s happening: CHA has issued summaries of the federal fiscal year 2025 inpatient prospective payment system (IPPS) and long-term care hospital (LTCH) PPS proposed rules. 

What else to know: CHA will host a complimentary, members-only webinar on the IPPS provisions on May 15. Comments on the proposed rules are due by 2 p.m. (PT) on June 10.  

FDA Finalizes Rule on Laboratory-Developed Tests

What’s happening: The Food and Drug Administration (FDA) finalized a regulation of laboratory-developed tests (LDTs), effective July 5. 

What else to know: The final rule amends FDA regulations to make explicit that in vitro diagnostic (IVD) products, which include LDTs, are devices under the Federal Food, Drug, and Cosmetic Act.  

CMS Finalizes Rule on Access to Medicaid Services

What’s happening: The Centers for Medicare & Medicaid Services (CMS) finalized a rule meant to improve access to care and services for the people enrolled in the Medicaid program. 

What else to know: The rule is effective July 9.  

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.