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<section article="ghg" article_name="Health - General" number="17-215" title_number="17" title_name="Laboratories" subtitle_number="2" subtitle_name="Medical Laboratories">
  <level label="a">
    <text>Except as provided in subsection (b) of this section, a person may not directly or indirectly advertise for or solicit business in this State for any medical laboratory, regardless of location, from anyone except a physician, hospital, medical laboratory, clinic, clinical installation, or other medical care facility.</text>
  </level>
  <level label="b">
    <level label="1">
      <level label="i">
        <text>This subsection applies only to:</text>
        <level label="1">
          <text>A diagnostic laboratory test or procedure for the purpose of screening, diagnosing, managing, or treating a physical or mental condition or disease; and</text>
        </level>
        <level label="2">
          <text>Ancestry testing using Y–chromosome mitochondrial DNA or autosomal DNA testing limited to the detection and reporting of genetic evidence of parental lineage and genetic ethnicity.</text>
        </level>
      </level>
      <level label="ii">
        <text>This subsection does not apply to germline genetic or genomic testing done in connection with the analysis, diagnosis, or prediction of human diseases.</text>
      </level>
    </level>
    <level label="2">
      <text>Subject to paragraph (3) of this subsection, a person may directly or indirectly advertise for or solicit business in the State for a diagnostic laboratory test or procedure ordered by a physician and performed by a medical laboratory certified under 42 U.S.C. § 263a.</text>
    </level>
    <level label="3">
      <text>A person that directly or indirectly advertises for or solicits business in the State for a diagnostic laboratory test or procedure under this subsection:</text>
      <level label="i">
        <text>Is a covered entity or business associate of a covered entity for purposes of the federal Health Insurance Portability and Accountability Act of 1996 and the federal Health Information Technology for Economic and Clinical Health Act;</text>
      </level>
      <level label="ii">
        <text>May not make a claim about the reliability and validity of the test or procedure that is inconsistent with the test or procedure’s performance as measured under 42 U.S.C. § 263a; and</text>
      </level>
      <level label="iii">
        <text>Shall disclose that the diagnostic laboratory test or procedure may or may not be covered by health insurance.</text>
      </level>
    </level>
    <level label="4">
      <text>The Secretary may take legal action to restrict the marketing of a diagnostic laboratory test or procedure if the Secretary determines that:</text>
      <level label="i">
        <text>There is a public health threat; or</text>
      </level>
      <level label="ii">
        <text>The diagnostic laboratory test or procedure is not in compliance with the requirements of this section.</text>
      </level>
    </level>
  </level>
</section>
