Regulations

Expanded Hospital Supplier Diversity Reports Due July 1

What’s happening: The first round of expanded Hospital Supplier Diversity Reports required under Assembly Bill (AB) 1392 (2023) are due to the Department of Health Care Access and Information (HCAI) on July 1.  

What else to know: In 2024, the Office of Administrative Law approved HCAI’s regulations to implement AB 1392. This year, the new reporting requirements are fully in effect — and HCAI has developed a new template to support and inform this updated reporting. 

CMS Finalizes Medicare Advantage, Part D Rule for 2026

What’s happening: In its finalized changes to the Medicare Advantage (MA) and Part D prescription drug programs for contract year 2026, the Centers for Medicare & Medicaid Services (CMS) struck most of the Biden-era proposals and declined to finalize additional insurer accountability provisions.  

What else to know: The rule, which did not address several other proposals (detailed below), is effective Jan. 1, 2026.  

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.