(a) A health care service plan contract, except for a specialized health care service plan contract, that is issued, amended, delivered, or renewed on or after July 1, 2024, shall cover 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 enrollee‘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.

Terms Used In California Health and Safety Code 1367.667

  • Appeal: A request made after a trial, asking another court (usually the court of appeals) to decide whether the trial was conducted properly. To make such a request is "to appeal" or "to take an appeal." One who appeals is called the appellant.
  • Contract: A legal written agreement that becomes binding when signed.
  • department: means State Department of Health Services. See California Health and Safety Code 20
  • Enrollee: means a person who is enrolled in a plan and who is a recipient of services from the plan. See California Health and Safety Code 1345
  • licensed: refers to , a license as a plan pursuant to Section 1353. See California Health and Safety Code 1345
  • Obligation: An order placed, contract awarded, service received, or similar transaction during a given period that will require payments during the same or a future period.
  • plan: refers to health care service plans and specialized health care service plans. See California Health and Safety Code 1345
  • Plan contract: means a contract between a plan and its subscribers or enrollees or a person contracting on their behalf pursuant to which health care services, including basic health care services, are furnished. See California Health and Safety Code 1345
  • specialized health care service plan: means either of the following:

    California Health and Safety Code 1345

  • State: means the State of California, unless applied to the different parts of the United States. See California Health and Safety Code 23

(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 care service plan shall use the process described in Section 1363.5 to determine whether biomarker testing is medically necessary for purposes of this section.

(c) A health care service plan 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 does not require coverage of biomarker testing for screening purposes unless otherwise required by this chapter.

(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.

(e) (1) This section shall not apply to any 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. For these plans, the biomarker testing coverage pursuant to § 14132.09 of the Welfare and Institutions Code shall apply.

(2) This subdivision shall not be construed to remove any obligation that is otherwise applicable to Medi-Cal managed care plans licensed under this chapter.

(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 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.

(g) This section is subject to the provisions of Section 1367.665 as amended by Chapter 605 of the Statutes of 2021 for an enrollee with advanced or metastatic stage III or IV cancer.

(Added by Stats. 2023, Ch. 401, Sec. 1. (SB 496) Effective January 1, 2024.)

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