20-1057.19. Biomarker testing; coverage; definitions
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/az/title-20/20-1057-19A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
A. A health care services organization that issues, amends, delivers or renews an evidence of coverage on or after January 1, 2023 shall provide coverage for biomarker testing.
B. An evidence of coverage shall cover biomarker testing for the purposes of diagnosis, treatment, appropriate management or ongoing monitoring of an enrollee'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.
C. A health care services organization must ensure that coverage is provided in a manner that limits disruptions in care, including the need for multiple biopsies or biospecimen samples.
D. The enrollee and prescribing practitioner must have access to a clear, readily accessible and convenient process to request an exception to a coverage policy of a health care services organization. The process shall be readily accessible on the health care services organization's website. This subsection does not require a separate process if the health care services organization's existing process complies with this subsection.
E. 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)Include 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 both:
(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 based on the best available evidence for the purpose of optimizing clinical care outcomes.
(c)Are aimed at specific clinical circumstances.
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.