(a)A health insurance policy that is issued, amended, delivered, or renewed on or after July 1, 2024, shall include coverage for medically necessary biomarker testing, subject to utilization review management, pursuant to this section. Biomarker testing shall be covered for the purposes of diagnosis, treatment, appropriate management, or ongoing monitoring of an insured’s disease or condition to guide treatment decisions. Coverage shall include biomarker tests that meet any of the following:
(1)A
labeled indication for a test that has been approved or cleared by the United States Food and Drug Administration (FDA) or is an indicated test for an FDA-approved drug.
(2)A national coverage determination made by the federal Centers for Medicare and Medicaid Services.
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(a)
A health insurance policy that is issued, amended, delivered, or renewed on or after July 1, 2024, shall include coverage for medically necessary biomarker testing, subject to utilization review management, pursuant to this section. Biomarker testing shall be covered for the purposes of diagnosis, treatment, appropriate management, or ongoing monitoring of an insured’s disease or condition to guide treatment decisions. Coverage shall include biomarker tests that meet any of the following:
(1)
A
labeled indication for a test that has been approved or cleared by the United States Food and Drug Administration (FDA) or is an indicated test for an FDA-approved drug.
(2)
A national coverage determination made by the federal Centers for Medicare and Medicaid Services.
(3)
A local coverage determination made by a Medicare Administrative Contractor for California.
(4)
Evidence-based clinical practice guidelines, supported by peer-reviewed literature and peer-reviewed scientific studies published in or accepted for publication by medical journals that meet nationally recognized requirements for scientific manuscripts and that submit most of their published articles for review by experts who are not part of the editorial staff.
(5)
Standards set by the National Academy of Medicine.
(b)
A health insurer shall use the process described in subdivision (f) of Section 10123.135 to determine whether biomarker testing is medically necessary for purposes of this section.
(c)
A health insurance policy that is subject to this
section shall ensure that biomarker testing is provided in a manner that limits disruptions in care, including the need for multiple biopsies or biospecimen samples. This section shall not be construed to require coverage of biomarker testing for screening purposes unless otherwise required by this part.
(d)
Restricted or denied use of biomarker testing for the purpose of diagnosis, treatment, or ongoing monitoring of any medical condition is subject to grievance and appeal processes under state and federal law, including Section 2719 of the federal Public Health Service Act (42 U.S.C. Sec. 300gg-19) and any regulations subsequently adopted thereunder, and the Independent Medical Review System under Article 3.5 (commencing with Section 10169).
(e)
For purposes of this
section, the following definitions apply:
(1)
“Biomarker” means a characteristic that is objectively measured and evaluated as an indicator of normal biological processes, pathogenic processes, or pharmacological responses to a specific therapeutic intervention. A biomarker includes, but is not limited to, gene mutations or protein expression.
(2)
“Biomarker testing” means the analysis of an individual’s tissue, blood, or other biospecimen for the presence of a biomarker. Biomarker testing includes, but is not limited to, single-analyte tests, multiplex panel tests, and whole genome sequencing.
(f)
This section is subject to the provisions of Section 10123.20 as amended by Chapter 605 of the Statutes of 2021 for an insured with
advanced or metastatic stage III or IV cancer.