Indiana Code 27-8-14.3-10. Coverage for biomarker testing
(1) labeled indications for a test approved or cleared by the United States Food and Drug Administration;
Terms Used In Indiana Code 27-8-14.3-10
- biomarker: means a characteristic that is objectively measured and evaluated as an indicator of:
Indiana Code 27-8-14.3-3
- biomarker testing: means the analysis of a patient's tissue, blood, or other biospecimen for the presence of a biomarker. See Indiana Code 27-8-14.3-4
- covered individual: means an individual who is entitled to coverage under a health plan. See Indiana Code 27-8-14.3-6
- Evidence: Information presented in testimony or in documents that is used to persuade the fact finder (judge or jury) to decide the case for one side or the other.
- health plan: means any of the following:
Indiana Code 27-8-14.3-7
- nationally recognized clinical practice guidelines: means evidence based clinical practice guidelines that:
Indiana Code 27-8-14.3-8
- United States: includes the District of Columbia and the commonwealths, possessions, states in free association with the United States, and the territories. See Indiana Code 1-1-4-5
(3) a warning or precaution on the label of a drug approved by the United States Food and Drug Administration;
(4) a national coverage determination of the Centers for Medicare and Medicaid Services (CMS);
(5) a local coverage determination of a Medicare administrative contractor; or
(6) nationally recognized clinical practice guidelines or consensus statements.
(b) The coverage required by this section must be provided in a manner that limits disruptions in care, including the need for multiple biopsies or biospecimen samples.
(c) Nothing in this section shall be construed to require coverage of biomarker testing for screening purposes.
(d) If a prior authorization requirement applies to biomarker testing under a health plan, the health plan or a third party acting on behalf of the health plan must:
(1) approve or deny a request for prior authorization for biomarker testing; and
(2) notify the covered individual and any person requesting prior authorization of the biomarker testing on behalf of the covered individual;
in not more than five (5) business days after the request in the case of a nonurgent request or in not more than forty-eight (48) hours after the request in the case of an urgent request.
(e) A health plan shall ensure that a covered individual and the practitioner who prescribes biomarker testing for the covered individual have access to a clear, readily accessible, and convenient process for requesting an exception to:
(1) a coverage policy; or
(2) a prior authorization determination;
of the health plan that is adverse to the coverage of biomarker testing for the covered individual. The process required by this subsection shall be made readily accessible on the health plan’s website.
As added by P.L.37-2024, SEC.2.