Sec. 356z.46. Biomarker testing.

398 words·~2 min read·/il/chapter-215/act-5/356z-46

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(a)As used in this Section:

"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. "Biomarker" includes, but is not limited to, gene mutations or protein expression.

"Biomarker testing" means the analysis of a patient's tissue, blood, or fluid biospecimen for the presence of a biomarker. "Biomarker testing" includes, but is not limited to, single-analyte tests, multi-plex panel tests, and partial or whole genome sequencing.

(b)A group or individual policy of accident and health insurance or managed care plan amended, delivered, issued, or renewed on or after January 1, 2022 shall include coverage for biomarker testing as defined in this Section pursuant to criteria established under subsection (d).

(c)Biomarker testing shall be covered and conducted in an efficient manner to provide the most complete range of results to the patient's health care provider without requiring multiple biopsies, biospecimen samples, or other delays or disruptions in patient care.

(d)Biomarker testing must be covered for the purposes of diagnosis, treatment, appropriate management, or ongoing monitoring of an enrollee's disease or condition when the test is supported by medical and scientific evidence, including, but not limited to:

(1)labeled indications for an FDA-approved test or indicated tests for an

FDA-approved drug;

(2)federal Centers for Medicare and Medicaid Services National Coverage

Determinations;

(3)nationally recognized clinical practice guidelines;

(4)consensus statements;

(5)professional society recommendations;

(6)peer-reviewed literature, biomedical compendia, and other medical literature that

meet the criteria of the National Institutes of Health's National Library of Medicine for indexing in Index Medicus, Excerpta Medicus, Medline, and MEDLARS database of Health Services Technology Assessment Research; and

(7)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.

(e)When coverage of biomarker testing for the purpose of diagnosis, treatment, or ongoing monitoring of any medical condition is restricted for use by a group or individual policy of accident and health insurance or managed care plan, the patient and prescribing practitioner shall have access to a clear, readily accessible, and convenient processes to request an exception. The process shall be made readily accessible on the insurer's website.