<?xml version='1.0' encoding='utf-8'?>
<regulation prefix="Regulation" num=".05" citation="COMAR 14.01.05.05" title_num="14" subtitle_num="01" chapter_num="05" heading="Policy Review—Preliminary Policy Recommendations.">
  <paragraph num="A.">
    <text>When developing preliminary policy recommendations for the Board, Board staff may use information gathered or obtained through the:</text>
    <paragraph num="(1)">
      <text>Cost review study process under COMAR 14.01.04; and</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Information gathering process under Regulation .04 of this chapter.</text>
    </paragraph>
  </paragraph>
  <paragraph num="B.">
    <text>Policy Action Other than UPL.</text>
    <paragraph num="(1)">
      <text>Board staff may recommend policy options to redress the affordability challenge.</text>
    </paragraph>
    <paragraph num="(2)">
      <text>When recommending policy options, Board staff may analyze the:</text>
      <paragraph num="(a)">
        <text>Drivers of the affordability challenge;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>How the policy addresses a driver;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Strengths and weaknesses of the policy;</text>
      </paragraph>
      <paragraph num="(d)">
        <text>Possible implementation of the policy through legislation, regulation, or enforcement; and</text>
      </paragraph>
      <paragraph num="(e)">
        <text>Potential impacts of the policy.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(3)">
      <text>The Board may:</text>
      <paragraph num="(a)">
        <text>Adopt none of the non-UPL policy recommendations;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Adopt one or more policy recommendations; or</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Adopt and modify one or more policy recommendations.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(4)">
      <text>The Board may adopt a final policy recommendation only after the Board has:</text>
      <paragraph num="(a)">
        <text>Made a final affordability challenge determination; and</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Adopted the final cost review study report under COMAR 14.01.04.05G.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(5)">
      <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="C.">
    <text>Policy Action in the Form of an Upper Payment Limit.</text>
    <paragraph num="(1)">
      <text>Board staff may recommend a UPL as a policy option to redress an affordability challenge.</text>
    </paragraph>
    <paragraph num="(2)">
      <text>When recommending a UPL as a policy option, Board staff may analyze the:</text>
      <paragraph num="(a)">
        <text>The drivers and market conditions causing the affordability challenge phenomena;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Ability of a UPL to address these issues;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Strengths and weaknesses of the UPL policy;</text>
      </paragraph>
      <paragraph num="(d)">
        <text>Potential impacts of the UPL policy;</text>
      </paragraph>
      <paragraph num="(e)">
        <text>Possible implementation of the policy through legislation, regulation or enforcement;</text>
      </paragraph>
      <paragraph num="(f)">
        <text>Relevant regulatory criteria under Regulation .02 of this chapter; and</text>
      </paragraph>
      <paragraph num="(g)">
        <text>Use of the drug by eligible governmental entities.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(3)">
      <text>Board staff may provide recommendations related to establishing a UPL including:</text>
      <paragraph num="(a)">
        <text>An assessment of the drivers of the affordability challenge; and</text>
      </paragraph>
      <paragraph num="(b)">
        <text>The extent to which a UPL may address the drivers.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(4)">
      <text>The Board may pursue development of a UPL as a policy option and direct Board staff to provide recommendations concerning the frameworks and contextual information that may be used to set a UPL in accordance with the UPL process set forth in Regulation .06 of this chapter.</text>
    </paragraph>
    <paragraph num="(5)">
      <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>
</regulation>