<?xml version='1.0' encoding='utf-8'?>
<regulation prefix="Regulation" num=".04" citation="COMAR 31.10.48.04" title_num="31" subtitle_num="10" chapter_num="48" heading="Noncompliant Contract Terms.">
  <paragraph num="A.">
    <text>A PBM may have a contract form or amendment to a contract form disapproved at any time after the contract form or amendment to a contract form has been submitted as part of an informational filing if the contract form or amendment form contains or uses any language that:</text>
    <paragraph num="(1)">
      <text>Violates Insurance Article, Title 15, Subtitle 16, Annotated Code of Maryland, or any applicable statutory provisions, including but not limited to Insurance Article, §§15-112, 15-112.2(a)—(e), 15-123(d), 15-1004, 15-1005, 15-1008(c), 15-1009, 15-1628—15-1628.3, 15-1629, 15-1631, and 15-1633—15-1639, and Health-General Article, §§19-710(s) and (t) and 19-712.2, Annotated Code of Maryland;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Does not disclose the components of the compensation program through which a reimbursement rate is set;</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Includes a definition of “multisource generic drug” that is inconsistent with COMAR 31.10.46, or “generic” or “brand name drug” that is inconsistent with Health Occupations Article, §12-504, Annotated Code of Maryland;</text>
    </paragraph>
    <paragraph num="(4)">
      <text>Allows the PBM to reimburse a covered drug in an amount that differs, including zero, based on the identity of the wholesale distributor used by a contracting pharmacy for acquisition of the covered drug;</text>
    </paragraph>
    <paragraph num="(5)">
      <text>Except for instances of error or fraud, allows the PBM to reclassify, recategorize, or recharacterize an adjudicated claim;</text>
    </paragraph>
    <paragraph num="(6)">
      <text>In any way prohibits or restricts a pharmacist or pharmacy from filing a complaint with the Commissioner; or</text>
    </paragraph>
    <paragraph num="(7)">
      <text>Fails to include the internal appeal provisions in the contract.</text>
    </paragraph>
  </paragraph>
  <paragraph num="B.">
    <text>No provisions in Insurance Article, Annotated Code of Maryland, or this chapter may be waived or modified by contract.</text>
  </paragraph>
</regulation>