<?xml version='1.0' encoding='utf-8'?>
<regulation prefix="Regulation" num=".03" citation="COMAR 14.01.05.03" title_num="14" subtitle_num="01" chapter_num="05" heading="Policy Review and Final Action Process Overview.">
  <paragraph num="A.">
    <text>If the Board makes a preliminary determination that use of the prescription drug product has led or will lead to an affordability challenge, the Board shall commence the policy review process.</text>
  </paragraph>
  <paragraph num="B.">
    <text>The purpose of the policy review process is to:</text>
    <paragraph num="(1)">
      <text>Based on the best available information, confirm the drivers and market conditions causing the affordability challenge phenomena; and</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Identify the policies that may address those drivers and redress the affordability challenges.</text>
    </paragraph>
  </paragraph>
  <paragraph num="C.">
    <text>The policy review process includes:</text>
    <paragraph num="(1)">
      <text>Information gathering:</text>
      <paragraph num="(a)">
        <text>Informational hearings;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Stakeholder Council input;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Expert testimony hearings;</text>
      </paragraph>
      <paragraph num="(d)">
        <text>Board staff research and analysis; and</text>
      </paragraph>
      <paragraph num="(e)">
        <text>Eligible governmental entities’ information;</text>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>Preliminary policy recommendations:</text>
      <paragraph num="(a)">
        <text>Policy actions other than UPLs; and</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Policy action in the form of a UPL and the process for setting upper payment limits; and</text>
      </paragraph>
    </paragraph>
    <paragraph num="(3)">
      <text>Final actions:</text>
      <paragraph num="(a)">
        <text>Adoption of the final cost review report;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Adoption of non-UPL policy recommendations; and</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Adoption of proposed regulations setting a UPL amount.</text>
      </paragraph>
    </paragraph>
  </paragraph>
</regulation>