Regulations

Court Rules FDA Cannot Regulate Laboratory-Developed Tests

What’s happening: In a final judgment filed March 31, the U.S. District Court for Eastern Texas ruled that the Food & Drug Administration (FDA) does not have the authority to regulate laboratory-developed tests, rendering a final rule issued May 6, 2024, null and void.  

What else to know: This final rule phased out the FDA’s general enforcement discretion approach for most laboratory-developed tests to instead provide greater oversight.  

Summary on Affordable Care Act Marketplace Integrity Proposed Rule Now Available 

What’s happening: A summary of the Patient Protection and Affordable Care Act; Marketplace Integrity and Affordability proposed rule for health insurance marketplaces — including issuers, agents, and brokers who assist marketplace enrollees — is available for CHA members.  

What else to know: Comments on the proposed rule, which alters several policies, are due to the Centers for Medicare & Medicaid Services (CMS) by April 11.  

CHA Comments on Proposed Changes to HIPAA Rule

What’s happening: On March 7, CHA submitted comments on proposed modifications to the Health Insurance Portability and Accountability Act (HIPAA) security rule.  

What else to know: CHA urged the Office of Civil Rights to rescind the proposed rule and instead focus policymaking on coordinated federal efforts to prevent and deter cyberattacks in the broader health care sector.   

Comments on Proposed EMSA Critical, Specialty Care Program Regulations Due April 3

What’s happening: The Emergency Medical Services Authority (EMSA) is proposing to update a chapter of the California Code of Regulations (CCR) that covers critical and specialty care programs, including as trauma, ST-elevation myocardial infarction (STEMI), stroke, and emergency medical services for children (EMSC) systems. Written comments on the proposed regulations are due April 3. 

What else to know: The proposed revisions — to CCR Title 22, Division 9, Chapter 6 on Specialty Programs — were developed in collaboration with the California state technical advisory committees for trauma, STEMI, stroke, and EMSC. Each committee included CHA representatives.  

Medicare Patient Reclassification Notices Now in Effect

What’s happening: Effective Feb. 14, providers are required to issue a Medicare Change of Status Notice (MCSN) to eligible patients who were admitted as hospital inpatients, but the hospital subsequently reclassified them as outpatients who are receiving observation services.

What else to know: This requirement only applies to patients with traditional Medicare as the primary payer. The form and its instructions are available to download.   

HCAI Issues Advisory Guide for Building, Remodeling Acute Psychiatric Facilities

What’s happening: The Department of Health Care Access and Information (HCAI) recently released an advisory guide for new construction of acute psychiatric hospitals, psychiatric nursing units provided within general acute care hospitals, and special treatment programs within skilled-nursing facilities — and remodeling or alterations to existing structures of this kind. 

What else to know: The advisory guide includes new structural requirements; basic and supplemental services; and mechanical, engineering, and plumbing requirements. 

CHA Presentation Details Hospitals’ Role in Health Care Ecosystem

What’s happening: As part of CHA’s efforts to educate new and existing lawmakers on hospitals’ role in the health care ecosystem, Kathryn Austin Scott, senior vice president, state relations and advocacy, and vice presidents of advocacy Kalyn Dean, Mark Farouk, and Vanessa Gonzalez hosted a “Hospital 101” legislative staff briefing on Jan. 14.   What else […]