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<regulation prefix="Regulation" num=".02" citation="COMAR 10.25.17.02" title_num="10" subtitle_num="25" chapter_num="17" heading="Definitions.">
  <paragraph num="A.">
    <text>In this chapter, the following terms have the meanings indicated.</text>
  </paragraph>
  <paragraph num="B.">
    <text>Terms Defined.</text>
    <paragraph num="(1)">
      <text>“Commission” means the Maryland Health Care Commission.</text>
    </paragraph>
    <paragraph num="(2)">
      <text>“Executive Director” means the Executive Director of the Commission or the Executive Director’s designee.</text>
    </paragraph>
    <paragraph num="(3)">
      <text>“Health Care Service” has the meaning stated in Insurance Article, §15-10A-01, Annotated Code of Maryland.</text>
    </paragraph>
    <paragraph num="(4)">
      <text>“Payor” means one of the following State-regulated entities that require preauthorization for a health care service:</text>
      <paragraph num="(a)">
        <text>An insurer or nonprofit health service plan that provides 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;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>A health maintenance organization that provides hospital, medical, or surgical benefits to individuals or groups under contracts that are issued or delivered in the State; or</text>
      </paragraph>
      <paragraph num="(c)">
        <text>A pharmacy benefits manager that is registered with the Maryland Insurance Commissioner, except for a pharmacy benefits manager that only provides services for:</text>
        <paragraph num="(i)">
          <text>Workers’ compensation claims pursuant to Labor and Employment Article, Title 9, Annotated Code of Maryland; or</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Personal injury protection claims pursuant to Insurance Article, Title 19, Annotated Code of Maryland.</text>
        </paragraph>
      </paragraph>
    </paragraph>
    <paragraph num="(5)">
      <text>“Preauthorization” means the process of obtaining approval from a payor by meeting certain criteria before a certain health care service can be rendered by the health care provider.</text>
    </paragraph>
    <paragraph num="(6)">
      <text>“Prescriber” means a health care practitioner who has the required license and, if necessary, scope of practice or delegation agreement that permits the health care practitioner to prescribe drugs to treat medical conditions or diseases.</text>
    </paragraph>
    <paragraph num="(7)">
      <text>Step therapy or fail-first protocol" is a protocol established by an insurer, a nonprofit health service plan, a health maintenance organization, or a pharmacy benefits manager that requires a certain prescription drug or sequence of prescription drugs to be used by an insured individual or an enrollee before another specific prescription drug ordered by a prescriber is covered.</text>
    </paragraph>
    <paragraph num="(8)">
      <text>“Supporting medical information” means:</text>
      <paragraph num="(a)">
        <text>A paid claim from a payor that requires a step therapy or fail-first protocol for an insured or an enrollee;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>A pharmacy record that documents that a prescription has been filled and delivered to an insured or enrollee, or to a representative of an insured or enrollee; or</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Other information mutually agreed to that constitutes sufficient supporting medical information by an insured's or enrollee’s prescriber and a payor that requires a step therapy or fail-first protocol.</text>
      </paragraph>
    </paragraph>
  </paragraph>
</regulation>