1. (a) If nonprofit professional association clinical criteria that determine the medical necessity of a health care benefit or an advancement in a technology or type or level of care for a mental health condition or substance use disorder do not exist, then an insurer may use other clinical criteria to conduct utilization review, provided that:

   1. (1) The gap-filling utilization review criteria are based on current generally accepted standards of mental health and substance use disorder care. An insurer shall document the sources, and evidence supporting the clinical appropriateness, of each of the gap-filling utilization review criteria in a clinical policy.

   2. (2) An insurer develops and maintains, and provides upon request, the following records:

      1. (A) To any requestor, the clinical policy containing the gap-filling utilization review criteria that the insurer uses to perform utilization review of the health care benefit.
      2. (B) To an insured or an insured's authorized representative, and the insured's health care provider, a comparative analysis and all underlying supporting documentation demonstrating that the gap-filling utilization review criteria were designed, and in practice are applied, in compliance with the Mental Health Parity and Addiction Equity Act rule on nonquantitative treatment limitations set forth in subdivision (c)(4) of Section 146.136 of Title 45 of the Code of Federal Regulations.

      3. (C) To an insured or an insured's authorized representative, and the insured's health care provider, a written justification prepared by appropriately qualified health care professionals that includes the following:

         1. 1. A description of the nonprofit professional association sources the insurer examined and the process the insurer followed to make its finding that nonprofit professional association clinical criteria that determine the medical necessity of a health care benefit or an advancement in a technology or type or level of care for a mental health condition or substance use disorder do not exist.
         2. 2. An explanation of the clinical rationale and evidence supporting the insurer's determination that the gap-filling utilization review criteria are based on current generally accepted standards of mental health and substance use disorder care for determining the medical necessity of a health care benefit or an advancement in a technology or type or level of care for a mental health condition or substance use disorder.
2. (b) If nonprofit professional association clinical criteria that determine the medical necessity of an existing technology or type or level of care of care exist, those criteria shall be used exclusively to make a utilization review coverage determination unless the specific coverage determination at issue is whether a novel or different application of an existing technology or type or level of care is medically necessary.

3. (c) An insurer shall perform, and document completion of, each of the following at least annually:

   1. (1) Survey sources of nonprofit professional association clinical criteria for new or revised clinical criteria that determine the medical necessity of a health care benefit or an advancement in a technology or type or level of care that is the subject of each of the insurer's gap-filling clinical criteria and clinical policies.
   2. (2) If new or revised nonprofit professional association clinical criteria do not exist, evaluate whether the gap-filling utilization review criteria are based on current generally accepted standards of mental health and substance use disorder care and update the clinical policy as necessary.
   3. (3) Review the records maintained pursuant to subdivision (a)(2) of this section for contemporaneity and continued accuracy and update the records as necessary.

Note: Authority cited: Sections 10144.4, 10144.5, 10144.52 and 10144.57, Insurance Code. Reference: Sections 10123.135, 10123.191, 10123.193, 10123.195, 10123.197, 10123.201, 10144.4, 10144.5, 10144.51, 10144.52, 10144.53 and 10144.57, Insurance Code.

History

1. New section filed 6-26-2025; operative 6-26-2025 pursuant to Government Code section 11343.4(b)(3) (Register 2025, No. 26).