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<chapter num="36" heading="Pharmacy Benefit Managers — Approval of an Accrediting Organization" title_num="31" subtitle_num="10">
  <regulation prefix="Regulation" num=".01" heading="Purpose.">
    <text>The purpose of this chapter is to establish the factors the Commissioner shall consider when approving an accrediting organization for the purposes of Insurance Article, §15-1618, Annotated Code of Maryland.</text>
  </regulation>
  <regulation prefix="Regulation" num=".02" heading="Definitions.">
    <paragraph num="A.">
      <text>In this chapter, the following terms have the meanings indicated.</text>
    </paragraph>
    <paragraph num="B.">
      <text>Terms Defined.</text>
      <paragraph num="(1)">
        <text>“Accrediting organization” means an entity that accredits a pharmacy benefits manager.</text>
      </paragraph>
      <paragraph num="(2)">
        <text>“Applicant” means a pharmacy benefits manager that is applying for a registration from the Commissioner to act as a pharmacy benefits manager in Maryland.</text>
      </paragraph>
      <paragraph num="(3)">
        <text>“Commissioner” means the Maryland Insurance Commissioner.</text>
      </paragraph>
      <paragraph num="(4)">
        <text>“Pharmacy and therapeutics committee” has the meaning stated in Insurance Article, §15-1601, Annotated Code of Maryland.</text>
      </paragraph>
      <paragraph num="(5)">
        <text>“Pharmacy benefits manager” has the meaning stated in Insurance Article, §15-1601, Annotated Code of Maryland.</text>
      </paragraph>
    </paragraph>
  </regulation>
  <regulation prefix="Regulation" num=".03" heading="Determination of Approved Accrediting Organization.">
    <paragraph num="A.">
      <text>An accrediting organization is not an approved accrediting organization for the purposes of Insurance Article, §15-601, Annotated Code of Maryland, until the Commissioner issues a letter of approval to the accrediting organization.</text>
    </paragraph>
    <paragraph num="B.">
      <text>For the purpose of determining which entities are approved accrediting organizations, the Commissioner shall consider whether:</text>
      <paragraph num="(1)">
        <text>The accreditation standards required to be met for accreditation by the accrediting organization meet or exceed the requirements of Insurance Article, §§15-1614 and 15-1617, Annotated Code of Maryland;</text>
      </paragraph>
      <paragraph num="(2)">
        <text>The accrediting organization measures an applicant's pharmacy and therapeutics committee's ability to meet each standard; and</text>
      </paragraph>
      <paragraph num="(3)">
        <text>The accrediting organization agrees to notify the Commissioner at least 30 days in advance if it revises its accreditation standards that pertain to a pharmacy and therapeutics committee or changes the method in which it reviews a pharmacy and therapeutics committee of an applicant.</text>
      </paragraph>
    </paragraph>
    <paragraph num="C.">
      <text>An accrediting organization continues to be approved by the Commissioner until notified in writing by the Commissioner that its approval has been withdrawn.</text>
    </paragraph>
  </regulation>
  <annotations>
    <annotation type="Authority">Insurance Article, §§2-109, 15-1618, and 15-1619, Annotated Code of Maryland</annotation>
    <annotation type="History" subtype="Administrative History">Effective date: May 4, 2009 (36:9 Md. R. 654)</annotation>
  </annotations>
</chapter>