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<section article="gin" article_name="Insurance" number="15-859" title_number="15" title_name="Health Insurance" subtitle_number="8" subtitle_name="Required Health Insurance Benefits">
  <level label="a">
    <level label="1">
      <text>In this section the following words have the meanings indicated.</text>
    </level>
    <level label="2">
      <level label="i">
        <text>“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.</text>
      </level>
      <level label="ii">
        <text>“Biomarker” includes gene mutations, characteristics of genes, or protein expression.</text>
      </level>
    </level>
    <level label="3">
      <level label="i">
        <text>“Biomarker testing” is the analysis of a patient’s tissue, blood, or other biospecimen for the presence of a biomarker, the results of which:</text>
        <level label="1">
          <text>provide information that may be used in the formulation of a treatment or monitoring strategy that informs a patient’s outcome and impacts the clinical decision; and</text>
        </level>
        <level label="2">
          <text>include both information that is actionable and some information that cannot be immediately used in the formulation of a clinical decision.</text>
        </level>
      </level>
      <level label="ii">
        <text>“Biomarker testing” includes single–analyte tests, multi–plex panel tests, protein expression, and whole exome, whole genome, and whole transcriptome sequencing.</text>
      </level>
    </level>
  </level>
  <level label="b">
    <text>This section applies to:</text>
    <level label="1">
      <text>insurers and nonprofit health service plans that provide hospital, medical, or surgical benefits to individuals or groups on an expense–incurred basis under health insurance policies or contracts that are issued or delivered in the State; and</text>
    </level>
    <level label="2">
      <text>health maintenance organizations that provide hospital, medical, or surgical benefits to individuals or groups under contracts that are issued or delivered in the State.</text>
    </level>
  </level>
  <level label="c">
    <text>An entity subject to this section shall provide coverage for biomarker testing for the purpose of diagnosis, treatment, appropriate management, or ongoing monitoring of a disease or condition that is supported by medical and scientific evidence, including testing:</text>
    <level label="1">
      <text>cleared or approved by the U.S. Food and Drug Administration;</text>
    </level>
    <level label="2">
      <text>required or recommended for a drug approved by the U.S. Food and Drug Administration to ensure an insured or enrollee is a good candidate for the drug treatment;</text>
    </level>
    <level label="3">
      <text>required or recommended through a warning or precaution for a drug approved by the U.S. Food and Drug Administration to identify whether an insured or enrollee will have an adverse reaction to the drug treatment or dosage;</text>
    </level>
    <level label="4">
      <text>covered under a Centers for Medicare and Medicaid Services National Coverage Determination or Medicare Administrative Contractor Local Coverage Determination; or</text>
    </level>
    <level label="5">
      <text>supported by nationally recognized clinical practice guidelines that are:</text>
      <level label="i">
        <text>developed by independent organizations or medical professional societies using a transparent methodology and reporting structure and that have a conflict of interest policy; and</text>
      </level>
      <level label="ii">
        <text>established standards of care informed by a systematic review of evidence and an assessment of the benefits and risks of alternative care options and include recommendations intended to optimize patient care.</text>
      </level>
    </level>
  </level>
  <level label="d">
    <text>An entity subject to this section shall ensure that the coverage required under subsection (c) of this section is provided in a manner that limits disruptions in care including the need for multiple biopsies or biospecimen samples.</text>
  </level>
  <level label="e">
    <level label="1">
      <text>Subject to paragraph (2) of this subsection, the coverage required under this section may be subject to the annual deductibles, copayments, or coinsurance requirements imposed by an entity subject to this section for similar coverages under the same health insurance policy or contract.</text>
    </level>
    <level label="2">
      <text>The annual deductibles, copayments, or coinsurance requirements imposed under paragraph (1) of this subsection for the coverage required under this section may not be greater than the annual deductibles, copayments, or coinsurance requirements imposed by the entity for similar coverages.</text>
    </level>
  </level>
</section>
