<?xml version='1.0' encoding='utf-8'?>
<regulation prefix="Regulation" num=".02" citation="COMAR 14.01.05.02" title_num="14" subtitle_num="01" chapter_num="05" heading="Criteria for Setting an Upper Payment Limit.">
  <paragraph num="A.">
    <text>When determining whether to set an upper payment limit and when setting an upper payment limit amount, the Board shall apply the criteria set forth in this regulation.</text>
  </paragraph>
  <paragraph num="B.">
    <text>The Board shall:</text>
    <paragraph num="(1)">
      <text>Consider the cost of administering the drug and delivering the drug to consumers, as well as other relevant administrative costs;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Determine whether an upper payment limit is an appropriate tool to address the drivers of the affordability challenge identified for the prescription drug product;</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Set an upper payment limit in a way to minimize adverse outcomes and minimize the risk of unintended consequences; and</text>
    </paragraph>
    <paragraph num="(4)">
      <text>Prioritize drugs that have a high proportion of out-of-pocket costs compared to the system net cost of the drug.</text>
    </paragraph>
  </paragraph>
  <paragraph num="C.">
    <text>The Board shall not set an upper payment limit if:</text>
    <paragraph num="(1)">
      <text>Spending on the prescription drug product by the eligible governmental entities is less than the administrative cost to implement an upper payment limit; or</text>
    </paragraph>
    <paragraph num="(2)">
      <text>The prescription drug product is a generic and there are nine or more marketed therapeutic equivalents for the product.</text>
    </paragraph>
  </paragraph>
  <paragraph num="D.">
    <text>The Board shall not set an upper payment limit at an amount that:</text>
    <paragraph num="(1)">
      <text>Impacts statutory or regulatory amounts, such as Medicaid Best Price; or</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Is lower than the Medicare Maximum Fair Price.</text>
    </paragraph>
  </paragraph>
</regulation>