California § 1367.253 - A health care service plan shall base a medical necessity determination or the ut

§ 1367.253. A health care service plan shall base a medical necessity determination or the ut

(a) A health care service plan shall base a medical necessity determination or the utilization review criteria that the plan, and an entity acting on the plan’s behalf, applies to determine the medical necessity of health care services and benefits for the treatment of symptoms resulting from menopause on current generally accepted standards of menopause care. (b) Beginning January 1, 2027, when conducting utilization review of all covered health care services and benefits for the treatment of symptoms resulting from menopause, a health care service plan shall apply criteria and guidelines developed by the Menopause Society or another nationally recognized professional association, as specified by the department. (c) In conducting utilization review involving patient care decisions that are within the scope of the sources specified in subdivision (b), a health care service plan shall not apply different, additional, conflicting, or more restrictive utilization review criteria than the criteria and guidelines set forth in those sources. This subdivision does not prohibit a plan from applying utilization review criteria to health care services and benefits for menopause care that meet either of the following criteria: (1) Are outside the scope of the criteria and guidelines set forth in the sources specified in subdivision (b), if the utilization review criteria were developed in accordance with subdivision (a). (2) Relate to advancements in technology or types of care that are not covered in the most recent versions of the sources specified in subdivision (b), if the utilization review criteria were developed in accordance with subdivision (a). (d) If a health care service plan purchases or licenses utilization review criteria pursuant to paragraph (1) or (2) of subdivision (c), the plan shall verify and document before use that the criteria were developed in accordance with subdivision (a). (e) A health care service plan shall not adopt, impose, or enforce terms in its contracts or provider agreements, in writing or in operation, that undermine, alter, or conflict with this section. (f) For purposes of this section, the following definitions apply: (1) “Generally accepted standards of menopause care” means standards of care and clinical practice that are generally recognized by health care providers practicing in relevant clinical specialties, including gynecology, endocrinology, and family practice. Valid, evidence-based sources establishing generally accepted standards of menopause care include peer reviewed scientific studies and medical literature, clinical practice guidelines and recommendations of nonprofit health care provider professional associations, specialty societies, and federal government agencies, and drug labeling approved by the United States Food and Drug Administration. (2) “Menopause” includes perimenopause, menopause, and postmenopause. (3) “Utilization review” means either of the following: (A) Prospectively, retrospectively, or concurrently reviewing and approving, modifying, delaying, or denying, based in whole or in part on medical necessity, requests by health care providers, enrollees, or their authorized representatives for coverage of health care services prior to, retrospectively, or concurrent with the provision of health care services to enrollees. (B) Evaluating the medical necessity, appropriateness, or efficacy of health care services, benefits, or procedures, under any circumstances, to determine if a health care service or benefit subject to a medical necessity coverage requirement in a health care service plan contract is covered as medically necessary for an enrollee. (4) “Utilization review criteria” means criteria, standards, protocols, or guidelines used by a health care service plan to conduct utilization review. (g) (1) This section applies to all health care services and benefits for the treatment of symptoms resulting from menopause covered by a health care service plan contract, including prescription drugs. (2) This section applies to a health care service plan that conducts utilization review and an entity or contracting provider that performs utilization review or utilization management functions on a plan’s behalf. (3) This section does not apply to a Medi-Cal managed care plan contract with the State Department of Health Care Services pursuant to Chapter 7 (commencing with Section 14000) or Chapter 8 (commencing with Section 14200) of Part 3 of Division 9 of the Welfare and Institutions Code. This section also does not apply to a Medicare supplement health care service plan contract. This section only applies to a specialized health care service plan to the extent it provides coverage for the treatment of symptoms resulting from menopause. (h) The director may assess administrative penalties for violations of this section as provided for in Section 1368.04, in addition to any other remedies permitted by law. (i) Notwithstanding Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code, the department may implement, interpret, or make specific this section and Section 1367.252 by means of all-plan letters or similar instructions, without taking regulatory action, until the department adopts regulations pursuant to the Administrative Procedure Act. The department shall consult with the Department of Insurance and interested stakeholders in developing guidance.