Laws & Regulations

About Laws & Regulations

Navigating the vast network of health care laws and regulations is difficult. To help hospitals, CHA produces manuals and guidebooks, including the Consent Manual, a one-stop resource for all legal requirements related to patient consent for medical treatment, release of medical information, reporting requirements and more; the Model Medical Staff Bylaws and Rules, which outline the framework for working relationships among medical staff, hospital administrators and governing bodies; and the California Hospital Compliance Manual, which covers high-risk compliance issues. CHA also represents California hospitals’ interests in court on issues, including reimbursement, labor and employment, and more.

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 Emergency Services Forum Discussed Patient Volume, Regulations, and Innovation

What’s happening: CHA hosted the 2024 Emergency Services Forum on May 6 in Newport Beach, California. The forum covered an array of topics, including compliance with legislation, regulating ambulance patient offload time, the impact of recent changes in the behavioral health system on emergency departments (EDs), and a keynote address by RaDonda Vaught, a nurse who was convicted of negligent homicide after accidentally giving a patient the wrong medication.   

What else to know: The forum saw a record attendance of 156 attendees this year, a capacity crowd of professionals and providers from around the state. The gathering provided clarity on laws that affect EDs, previewed upcoming regulations, and provided ED personnel the opportunity to discuss prehospital challenges. Those in attendance said it was a reminder there is a resilient community to lean on.  

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.  

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.  

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. 

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.