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<section article="gin" article_name="Insurance" number="15-847.2" title_number="15" title_name="Health Insurance" subtitle_number="8" subtitle_name="Required Health Insurance Benefits">
  <level label="a">
    <text>In this section, “specialty drug” has the meaning stated in § 15–847 of this subtitle.</text>
  </level>
  <level label="b">
    <level label="1">
      <text>This section applies to:</text>
      <level label="i">
        <text>insurers and nonprofit health service plans that provide coverage for prescription drugs under individual, group, or blanket health insurance policies or contracts that are issued or delivered in the State; and</text>
      </level>
      <level label="ii">
        <text>health maintenance organizations that provide coverage for prescription drugs under individual or group contracts that are issued or delivered in the State.</text>
      </level>
    </level>
    <level label="2">
      <text>An insurer, a nonprofit health service plan, or a health maintenance organization that provides coverage for prescription drugs through a pharmacy benefits manager is subject to the requirements of this section.</text>
    </level>
  </level>
  <level label="c">
    <text>An entity subject to this section may not exclude coverage for a covered specialty drug administered or dispensed by a provider under § 12–102 of the Health Occupations Article if the entity determines that:</text>
    <level label="1">
      <text>the provider that administers or dispenses the covered specialty drug:</text>
      <level label="i">
        <text>is an in–network provider of covered oncology services; and</text>
      </level>
      <level label="ii">
        <text>complies with State regulations for the administering and dispensing of specialty drugs; and</text>
      </level>
    </level>
    <level label="2">
      <text>the covered specialty drug is:</text>
      <level label="i">
        <text>auto–injected or an oral targeted immune modulator; or</text>
      </level>
      <level label="ii">
        <text>an oral medication that:</text>
        <level label="1">
          <text>requires complex dosing based on clinical presentation; or</text>
        </level>
        <level label="2">
          <text>is used concomitantly with other infusion or radiation therapies.</text>
        </level>
      </level>
    </level>
  </level>
  <level label="d">
    <level label="1">
      <text>Subject to subsection (f) of this section, the reimbursement rate for specialty drugs covered under this section shall be:</text>
      <level label="i">
        <text>agreed to by the covered, in–network provider and the entity subject to this section; and</text>
      </level>
      <level label="ii">
        <text>billed at a nonhospital level of care or place of service.</text>
      </level>
    </level>
    <level label="2">
      <text>Unless otherwise agreed to by the covered, in–network provider and the entity subject to this section, the reimbursement rate for specialty drugs covered under this section may not exceed the rate applicable to a designated specialty pharmacy for dispensing the covered specialty drugs.</text>
    </level>
  </level>
  <level label="e">
    <text>This section does not prohibit an entity subject to this section from refusing to authorize or approve or from denying coverage for a covered specialty drug administered or dispensed by a provider if administering or dispensing the drug fails to satisfy medical necessity criteria.</text>
  </level>
  <level label="f">
    <text>This section may not be construed to supersede the authority of the Health Services Cost Review Commission to set rates for specialty drugs administered to patients in a setting regulated by the Health Services Cost Review Commission.</text>
  </level>
</section>
