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<regulation prefix="Regulation" num=".01" citation="COMAR 14.01.05.01" title_num="14" subtitle_num="01" chapter_num="05" 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>“Driver” means a factor that causes a particular phenomenon to happen or develop.</text>
    </paragraph>
    <paragraph num="(2)">
      <text>“Eligible governmental entity” means a unit of State or local government, an organization on behalf of a unit of State or local government, or the Maryland State Medical Assistance Program, as identified in Health-General Article, §21-2C-14(a), Annotated Code of Maryland, that pays for or purchases prescription drug products.</text>
    </paragraph>
    <paragraph num="(3)">
      <text>“Eligible governmental entities upper payment limit” or “GovUPL” means upper payment limit established by the Board minus applicable patient out-of-pocket costs.</text>
    </paragraph>
    <paragraph num="(4)">
      <text>“FDA prescription drug shortage list” means the U.S. Food and Drug Administration’s Drug Shortage Database.</text>
    </paragraph>
    <paragraph num="(5)">
      <text>“Medicaid Best Price” has the meaning stated in 42 CFR §447.505.</text>
    </paragraph>
    <paragraph num="(6)">
      <text>“Medicare Maximum Fair Price” has the meaning stated in 42 USC §1320f(c)(3).</text>
    </paragraph>
    <paragraph num="(7)">
      <text>“System net ingredient cost” means the final system cost attributable to or related to the prescription drug product after accounting for all discounts and price concessions, excluding dispensing, administration and direct and indirect remuneration to pharmacies, including patient out-of-pocket costs.</text>
    </paragraph>
    <paragraph num="(8)">
      <text>“Upper payment limit” or “UPL” means the amount established by the Board and represents the system net ingredient cost.</text>
    </paragraph>
  </paragraph>
  <paragraph num="C.">
    <text>For the purpose of this chapter, “affordability challenge” refers to either (a) high out-of-pocket costs for patients or (b) an affordability challenge for the State health care system.</text>
  </paragraph>
</regulation>