1. (a) For purposes of this section:

   1. (1) “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, including known gene-drug interactions for medications being considered for use or already being administered. Biomarkers include gene mutations, characteristics of genes, and protein expression. A biomarker is not an assessment of how a covered person or enrollee feels, functions or survives.
   2. (2) “Biomarker testing” means the analysis of an individual’s tissue, blood, or other biospecimen for the presence of a biomarker. Biomarker testing includes single-analyte tests, multi-plex panel tests, protein expression, and whole exome, whole genome, and whole transcriptome sequencing.
   3. (3) “Investigatory and experimental biomarker tests” means biomarker tests that are subject to the United States food and drug administration’s investigational device exemption (C.F.R. Part 812).
   4. (4) “Medically necessary” means as defined in § 3581 of this title.
   5. (5) “Nationally recognized clinical practice guideline” means an evidence-based clinical practice guideline developed by independent organizations or medical professional societies using a transparent methodology and reporting structure and with a conflict-of-interest policy. A clinical practice guideline establishes a standard of care informed by a systematic review of evidence and an assessment of the benefits and risks of alternative care options and includes recommendations intended to optimize patient care.
   6. (6) “Screening” means a medical procedure or test for a covered person who has yet to display symptoms of a particular disease or condition for the purpose of determining the person’s likelihood of having the disease or condition.

2. (b) All individual health insurance policies, contracts, or certificates that are delivered, issued for delivery, renewed, extended, or modified in this State shall provide coverage for biomarker testing to guide or inform treatment decisions for the purposes of diagnosis, treatment, appropriate management, or ongoing monitoring of a covered person’s disease or condition when the test is medically necessary as demonstrated by medical and scientific evidence, including any of the following:

   1. (1) Labeled indications for an FDA-approved or FDA-cleared test.
   2. (2) Indicated tests for an FDA-approved drug.
   3. (3) Warnings and precautions on FDA-approved drug labels.
   4. (4) Centers for Medicare and Medicaid Services (CMS) national coverage determinations or Medicare administrative contractor (MAC) local coverage determinations.
   5. (5) Nationally recognized clinical practice guidelines.
3. (c) A biomarker test that meets one of the medical and scientific evidence outlined in paragraphs (b)(1) through (b)(5) of this section shall not be considered an investigational or experimental health-care service.
4. (d) Carriers must ensure that coverage for biomarker testing, as required by subsection (b) of this section, is provided in a manner that limits disruptions in care, including the need for multiple biopsies or biospecimen samples.
5. (e) Nothing in this section prevents the operation of a policy provision required by this section as a deductible, coinsurance, allowable charge limitation, coordination of benefits, or a provision restricting coverage to services by a licensed, certified, or carrier-approved provider or facility.
6. (f) Nothing in this section restricts the use of utilization management.
7. (g) Nothing in this section shall be construed to require coverage of biomarker testing for screening purposes or coverage of investigatory and experimental biomarker tests.

85 Del. Laws, c. 484, § 4