<?xml version='1.0' encoding='utf-8'?>
<regulation prefix="Regulation" num=".05" citation="COMAR 31.10.47.05" title_num="31" subtitle_num="10" chapter_num="47" heading="Complaint Process.">
  <paragraph num="A.">
    <text>Prior to filing a complaint with the Commissioner, a contracted pharmacy or its designee shall exhaust the internal appeal process established in the participating pharmacy contract.</text>
  </paragraph>
  <paragraph num="B.">
    <text>A contracted pharmacy or its designee may file a complaint with the Commissioner to dispute a PBM’s appeal decision for the following reasons:</text>
    <paragraph num="(1)">
      <text>The PBM’s cost pricing did not comply with Insurance Article, Title 15, Subtitle 16, Annotated Code of Maryland; or</text>
    </paragraph>
    <paragraph num="(2)">
      <text>The PBM’s cost pricing or reimbursement amount determination did not meet the terms of the applicable participating pharmacy contract.</text>
    </paragraph>
  </paragraph>
  <paragraph num="C.">
    <text>A complaint is properly completed and may be filed if a contracted pharmacy or its designee:</text>
    <paragraph num="(1)">
      <text>Completes all applicable portions of the Commissioner’s complaint form;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Provides a copy of the relevant contract or the provisions that are related to the appeal, including but not limited to establishing a drug pricing or pharmacy reimbursement amount, sources, pricing information, and the compensation program of the applicable participating pharmacy contract; and</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Provides a copy of the appeal decision.</text>
    </paragraph>
  </paragraph>
  <paragraph num="D.">
    <text>A complaint may not include more than ten appeal decisions using a single complaint form.</text>
  </paragraph>
  <paragraph num="E.">
    <text>Notification of the Complaint to the PBM.</text>
    <paragraph num="(1)">
      <text>Upon receipt of a completed complaint form, the Commissioner shall provide a copy of the submitted complaint form to the PBM.</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Within 5 working days of receiving the Commissioner’s notice, the PBM shall provide the Commissioner:</text>
      <paragraph num="(a)">
        <text>A complete, unredacted copy of the applicable portion of the participating pharmacy contract relating to the compensation program and the complaint filed with the Commissioner, including any other contract under which the pricing or reimbursement amount is determined;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>A copy of the applicable source and pricing information used to calculate the pharmacy reimbursement amount;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>A mathematical calculation that demonstrates how the reimbursement amount was determined;</text>
      </paragraph>
      <paragraph num="(d)">
        <text>All information required to complete the response portion of the complaint form; and</text>
      </paragraph>
      <paragraph num="(e)">
        <text>Any other information the Commissioner may require for the purposes of determining a PBM’s compliance with:</text>
        <paragraph num="(i)">
          <text>Insurance Article, Annotated Code of Maryland;</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>This chapter;</text>
        </paragraph>
        <paragraph num="(iii)">
          <text>The compensation program; or</text>
        </paragraph>
        <paragraph num="(iv)">
          <text>The applicable terms of the participating pharmacy contract.</text>
        </paragraph>
      </paragraph>
    </paragraph>
  </paragraph>
</regulation>