<?xml version='1.0' encoding='utf-8'?>
<regulation prefix="Regulation" num=".09" citation="COMAR 14.01.05.09" title_num="14" subtitle_num="01" chapter_num="05" heading="Reconsideration.">
  <paragraph num="A.">
    <text>Authority to Reconsider UPL.</text>
    <paragraph num="(1)">
      <text>The Board may reconsider a UPL for any reason.</text>
    </paragraph>
    <paragraph num="(2)">
      <text>If the Board becomes aware of a shortage of a prescription drug product in the State, for a drug that is subject to a UPL, the Board shall reconsider the UPL.</text>
    </paragraph>
    <paragraph num="(3)">
      <text>The Board may suspend a UPL at any time and may suspend the UPL for the duration of the reconsideration process by proposing an amended regulation.</text>
    </paragraph>
    <paragraph num="(4)">
      <text>Following completion of the reconsideration process the Board may:</text>
      <paragraph num="(a)">
        <text>Take no action and allow the UPL to stand;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Modify the UPL amount and propose amendment of the UPL regulation setting the new modified UPL amount;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Suspend the UPL for a specified period and propose amendment of the regulation to proscribe the suspension; and</text>
      </paragraph>
      <paragraph num="(d)">
        <text>Repeal the UPL and propose repealing the regulation setting the UPL amount.</text>
      </paragraph>
    </paragraph>
  </paragraph>
  <paragraph num="B.">
    <text>Reconsideration Process.</text>
    <paragraph num="(1)">
      <text>General Procedures.</text>
      <paragraph num="(a)">
        <text>Board staff shall post notice of the reconsideration of the UPL on the Board’s website.</text>
      </paragraph>
      <paragraph num="(b)">
        <text>The Board may solicit patient and stakeholder feedback through written comments submitted in accordance with COMAR 14.01.01.05B(4) and informational hearings held under COMAR 14.01.01.06C.</text>
      </paragraph>
      <paragraph num="(c)">
        <text>The Board may use the information gathering process under Regulation .04 of this chapter to obtain information for the reconsideration process.</text>
      </paragraph>
      <paragraph num="(d)">
        <text>Board staff shall present to the Board:</text>
        <paragraph num="(i)">
          <text>The basis for reconsideration;</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>A summary of the feedback obtained through written comments, informational hearings and the information gathering process, as applicable;</text>
        </paragraph>
        <paragraph num="(iii)">
          <text>A summary of the information generated through the UPL monitoring program, as applicable;</text>
        </paragraph>
        <paragraph num="(iv)">
          <text>Estimated impact of the UPL to date such as savings estimates, and estimated impact on access to the drug; and</text>
        </paragraph>
        <paragraph num="(v)">
          <text>Staff recommendations for Board action.</text>
        </paragraph>
      </paragraph>
      <paragraph num="(e)">
        <text>The Board may take any action specified under §A(4) of this regulation.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>Modifying a UPL.</text>
      <paragraph num="(a)">
        <text>If Board staff recommends further study to support modification of the UPL, the Board shall use the procedures in Regulations .06D-F and .07B(1)(b) of this chapter to develop a new UPL amount and receive public comment.</text>
      </paragraph>
      <paragraph num="(b)">
        <text>The Board may modify the UPL amount and propose amendment of the UPL regulation setting the modified UPL amount under § A(4)(b) of this regulation.</text>
      </paragraph>
    </paragraph>
  </paragraph>
  <paragraph num="C.">
    <text>Action on Drug where UPL was Repealed.</text>
    <paragraph num="(1)">
      <text>For any prescription drug product previously subject to a UPL that was later repealed, the Board may:</text>
      <paragraph num="(a)">
        <text>Select the prescription drug product for cost review study if the drug product meets the eligibility requirements set forth in COMAR 14.01.04.02;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Conduct a cost review study in accordance with COMAR 14.01.04.05; and</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Make a preliminary determination in accordance with COMAR 14.01.04.05.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>If the Board makes a preliminary determination that the prescription drug product has or will create an affordability challenge the Board may:</text>
      <paragraph num="(a)">
        <text>Consider any element or analysis from the original cost review study report;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>If available, consider information from the UPL monitoring program;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Consider information obtained through the reconsideration process under §B of this regulation; and</text>
      </paragraph>
      <paragraph num="(d)">
        <text>Set a UPL or make other policy recommendations in accordance with Regulations .07—.08 of this chapter.</text>
      </paragraph>
    </paragraph>
  </paragraph>
</regulation>