A.The administration and its contractors shall provide biomarker testing for the purposes of diagnosis, treatment, appropriate management or ongoing monitoring of a member's disease or condition to guide treatment decisions when the test provides clinical utility as demonstrated by medical and scientific evidence, including any of the following:
1.Labeled indications for tests that are approved or cleared by the United States food and drug administration or indicated tests for a drug that is approved by the United States food and drug administration.
2.Centers for medicare and medicaid services national coverage determinations or medicare administrative contractor local coverage determinations.
3.Nationally recognized clinical practice guidelines and consensus statements.
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A. The administration and its contractors shall provide biomarker testing for the purposes of diagnosis, treatment, appropriate management or ongoing monitoring of a member's disease or condition to guide treatment decisions when the test provides clinical utility as demonstrated by medical and scientific evidence, including any of the following:
1. Labeled indications for tests that are approved or cleared by the United States food and drug administration or indicated tests for a drug that is approved by the United States food and drug administration.
2. Centers for medicare and medicaid services national coverage determinations or medicare administrative contractor local coverage determinations.
3. Nationally recognized clinical practice guidelines and consensus statements.
B. The administration and its contractors shall provide biomarker testing with the same scope, duration and frequency as the system otherwise provides to members pursuant to this article.
C. The member and prescribing practitioner must have access to a clear, readily accessible and convenient online process to request an exception to a coverage policy of the system. This subsection does not require a separate process if the administration's and its contractor's existing process complies with this subsection. Any request for a coverage exception shall be submitted electronically by the prescribing practitioner.
D. For the purposes of this section:
1. "Biomarker":
(a) 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.
(b) Includes gene mutations or protein expression.
2. "Biomarker testing":
(a) Means the analysis of a patient's tissue, blood or other biospecimen for the presence of a biomarker.
(b) Includes single-analyte tests, multiplex panel tests and whole genome sequencing.
3. "Clinical utility" means the test result provides information that is used in the formulation of a treatment or monitoring strategy that informs a patient’s outcome and impacts the clinical decision. The most appropriate test may include both information that is actionable and some information that cannot be immediately used in the formulation of a clinical decision.
4. "Consensus statements" means statements that:
(a) Are developed by an independent, multidisciplinary panel of experts using a transparent methodology and reporting structure that includes a conflict of interest policy.
(b) Are aimed at specific clinical circumstances.
(c) Are based on the best available evidence for the purpose of optimizing clinical care outcomes.
5. "Nationally recognized clinical practice guidelines" means evidence-based clinical practice guidelines that both:
(a) Are developed by independent organizations or medical professional societies using a transparent methodology and reporting structure and a conflict of interest policy.
(b) Establish standards of care that are informed by a systematic review of evidence and an assessment of the benefits and costs of alternative care options that includes recommendations intended to optimize patient care.