<?xml version='1.0' encoding='utf-8'?>
<regulation prefix="Regulation" num=".04" citation="COMAR 14.01.05.04" title_num="14" subtitle_num="01" chapter_num="05" heading="Policy Review—Information Gathering.">
  <paragraph num="A.">
    <text>In studying the drivers, market conditions and policy options, the Board and staff may consider the information collected through the cost review study process pursuant to Health-General Article, §21-2C-09, Annotated Code of Maryland and COMAR 14.01.04.05, including all information, analyses, and public input collected and considered during the selection of drug for the cost review study and the cost review study process.</text>
  </paragraph>
  <paragraph num="B.">
    <text>If additional information is needed, the Board and staff may gather additional information through the tools outlined in §D of this regulation.</text>
  </paragraph>
  <paragraph num="C.">
    <text>If additional information is needed, the Board may utilize the information-gathering tools outlined in §D of this regulation at any point in the policy review process, including the consideration and setting of a UPL.</text>
  </paragraph>
  <paragraph num="D.">
    <text>Information Gathering Tools.</text>
    <paragraph num="(1)">
      <text>Public Informational Hearings.</text>
      <paragraph num="(a)">
        <text>The Board may, through Board staff, convene a hearing to receive input, information, and opinions from the public and stakeholders to inform the consideration and development of policy options including upper payment limits to redress an affordability challenge.</text>
      </paragraph>
      <paragraph num="(b)">
        <text>The public informational hearing shall be conducted in accordance with COMAR 14.01.01.06.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>Stakeholder Council Input.</text>
      <paragraph num="(a)">
        <text>The Board may request input from the Stakeholder Council. This input can be a request for general input and ideas on policies or more specific requests for specific information.</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Board staff may provide the Board with summaries of input from the Stakeholder Council.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(3)">
      <text>Technical Hearings.</text>
      <paragraph num="(a)">
        <text>The Board may convene a hearing for the purpose of receiving technical input, technical information or expert testimony.</text>
      </paragraph>
      <paragraph num="(b)">
        <text>The technical hearing shall be conducted in accordance with COMAR 14.01.01.06.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(4)">
      <text>Board Staff Research and Analysis.</text>
      <paragraph num="(a)">
        <text>Board staff may provide the Board with policy research and analyses related to the drivers of the potential affordability and potential options.</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Research may include a literature review of available literature and original quantitative or qualitative research conducted by staff.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(5)">
      <text>Eligible Governmental Entities’ Information.</text>
      <paragraph num="(a)">
        <text>Board staff may collect information concerning the prescription drug product and therapeutic alternatives from eligible governmental entities.</text>
      </paragraph>
      <paragraph num="(b)">
        <text>The information collected may include utilization, spending, costs, benefit design, formulary placement, rebates, discounts, price concessions and other relevant information.</text>
      </paragraph>
    </paragraph>
  </paragraph>
</regulation>