On January 7, 2026, the Arizona Department of Insurance and Financial Institutions (DIFI) published Regulatory Bulletin 2026-01. The bulletin provides guidance to ensure uniform adherence among Arizona health plans regarding mandatory coverage of biomarker testing. The bulletin was issued, in part, to respond to observed noncompliance, especially denials based on outdated utilization review criteria.
Since January 1, 2023, Arizona law has required insurers to cover biomarker testing if it provides clinical utility as shown by medical and scientific evidence for diagnosis, treatment, appropriate management, or ongoing monitoring of a person’s disease or condition. Clinical utility is shown through credible scientific and medical evidence, including:
- FDA-labeled indications for approved or cleared tests or tests indicated for an FDA‑approved drug.
- Centers for Medicare and Medicaid Services (CMS) national or Medicare administrative contractor local coverage determinations.
- Nationally recognized clinical practice guidelines and consensus statements.
The bulletin reiterates that insurers may not deny coverage based on criteria or guidelines that conflict with Arizona law or that have not been updated to reflect current standards. The bulletin also reiterates that insurers should provide sufficient evidence regarding elements of Arizona’s law and explain how relevant evidence supports when denying coverage. For example, through the healthcare appeals process, DIFI identified instances where insurers failed to do so. The bulletin also encourages insurers to update their internal guidelines to avoid improper denials and to refrain from using any terms or standards that differ from those in Arizona law.
The bulletin applies to all Arizona-regulated health insurers, including hospital or medical service corporations, healthcare services organizations, disability insurers, and group/blanket disability insurers.
To view the official text of the bulletin, see Regulatory Bulletin 2026-01 Coverage for Biomarker Testing.