<?xml version='1.0' encoding='utf-8'?>
<regulation prefix="Regulation" num=".07" citation="COMAR 14.01.05.07" title_num="14" subtitle_num="01" chapter_num="05" heading="Policy Review—Final Policy Action.">
  <paragraph num="A.">
    <text>Final Determination Concerning Affordability Challenge.</text>
    <paragraph num="(1)">
      <text>Prior to taking an action with respect to policy, the Board shall:</text>
      <paragraph num="(a)">
        <text>Make a final determination of whether the prescription drug has or will create an affordability challenge; and</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Adopt as final a cost review study report under COMAR 14.01.04.05G.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>The Board’s determination of whether a prescription drug has or will create an affordability challenge is not final until the final cost review study report is adopted by the Board.</text>
    </paragraph>
    <paragraph num="(3)">
      <text>The public may provide oral and written comments concerning any agenda item of the Board or any decision pending before the Board in accordance with the procedures and timelines in COMAR 14.01.01.05A and B(2).</text>
    </paragraph>
  </paragraph>
  <paragraph num="B.">
    <text>Final Policy Action: Policy Recommendations and Proposed Regulations.</text>
    <paragraph num="(1)">
      <text>If the Board makes a final determination that the prescription drug has or will create an affordability challenge, the Board may adopt:</text>
      <paragraph num="(a)">
        <text>Non-UPL policy recommendations in accordance with Regulation .05 of this chapter;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Proposed regulations setting the UPL at the specified amount in accordance with Regulation .08 of this chapter; or</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Both.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>The public may provide oral and written comments concerning any agenda item of the Board or any decision pending before the Board in accordance with the procedures and timelines in COMAR 14.01.01.05A and B(2).</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Where applicable, the adoption of the final cost review study report, non-UPL policy recommendations, and proposed regulations setting a UPL amount:</text>
      <paragraph num="(a)">
        <text>Shall be performed sequentially; and</text>
      </paragraph>
      <paragraph num="(b)">
        <text>May be taken at the same Board meeting.</text>
      </paragraph>
    </paragraph>
  </paragraph>
</regulation>