(a)By July 1, 2024, biomarker testing, as specified in this section, is a covered benefit, subject to utilization controls and medical necessity requirements, as described in Section 14059.5. Biomarker testing shall be covered for the purposes of diagnosis, treatment, appropriate management, or ongoing monitoring of a Medi-Cal beneficiary’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, to the extent allowed under the Medicaid program.
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(a)
By July 1, 2024, biomarker testing, as specified in this section, is a covered benefit, subject to utilization controls and medical necessity requirements, as described in Section 14059.5. Biomarker testing shall be covered for the purposes of diagnosis, treatment, appropriate management, or ongoing monitoring of a Medi-Cal beneficiary’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, to the extent allowed under the Medicaid program.
(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)
(1)
This section does not preclude any obligation on a Medi-Cal managed care plan subject to Chapter 2.2 (commencing with Section 1340) of Division 2 of the Health and Safety Code, including any obligations under Section 1363.5 of the Health and Safety Code.
(2)
This section does not require coverage of biomarker testing for screening purposes unless otherwise required by this chapter.
(3)
The department shall direct, by means of all-county letters, plan letters, plan or provider bulletins, or similar
instructions, that biomarker testing is to be provided in a manner that limits disruptions in care.
(c)
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.
(d)
This section shall be implemented only to the extent that federal financial participation is available and not otherwise jeopardized, and any necessary federal approvals have been obtained.
(e)
(1)
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, and make specific this section by means of all-county letters, plan letters, plan or provider bulletins, or similar instructions, without taking any further regulatory action.
(2)
An all-county letter, plan letter, plan or provider bulletin, or similar instructions promulgated pursuant to paragraph (1) shall be based at a minimum on
evidence-based clinical practice guidelines.
(f)
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 pharmacologic responses to a specific therapeutic intervention. A biomarker includes, but is not limited to, gene mutations or protein expression.
(2)
“Biomarker testing” is 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.
(g)
This section is subject to the provisions of Section 1367.665 of the Health and Safety Code as amended by Chapter 605 of the Statutes of 2021 for a Medi-Cal beneficiary with advanced or metastatic stage III or IV cancer covered by a Medi-Cal managed care plan.