<?xml version='1.0' encoding='utf-8'?>
<regulation prefix="Regulation" num=".02" citation="COMAR 31.10.49.02" title_num="31" subtitle_num="10" chapter_num="49" 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>“Appeal decision” means a written or electronic notice in response to an appeal under this chapter provided to a contracted pharmacy that includes a reason for the appeal denial.</text>
    </paragraph>
    <paragraph num="(2)">
      <text>“Contracted pharmacy” means an independent pharmacy in a pharmacy services administrative contract.</text>
    </paragraph>
    <paragraph num="(3)">
      <text>“Delivered by electronic means” includes:</text>
      <paragraph num="(a)">
        <text>Delivery to an electronic mail address at which an independent pharmacy or contracted pharmacy has consented to receive notice; and</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Posting on an electronic network, together with separate notice to an independent pharmacy or contracted pharmacy directed to the electronic mail address at which the independent pharmacy or contracted pharmacy has consented to receive notice of the posting.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(4)">
      <text>“Independent pharmacy” has the meaning stated in Insurance Article, §15-2001(b), Annotated Code of Maryland.</text>
    </paragraph>
    <paragraph num="(5)">
      <text>“Material change” means a change in control or business operations of a pharmacy services administrative organization after a purchase, merger, or acquisition of a parent company, subsidiary, or other organization.</text>
    </paragraph>
    <paragraph num="(6)">
      <text>Medical Device.</text>
      <paragraph num="(a)">
        <text>“Medical device” means a device used in the diagnosis, treatment, or prevention of disease.</text>
      </paragraph>
      <paragraph num="(b)">
        <text>“Medical device” does not include:</text>
        <paragraph num="(i)">
          <text>Any surgical or dental instrument;</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Physical therapy equipment;</text>
        </paragraph>
        <paragraph num="(iii)">
          <text>Any x-ray apparatus; or</text>
        </paragraph>
        <paragraph num="(iv)">
          <text>Any component or accessory of any of these items.</text>
        </paragraph>
      </paragraph>
    </paragraph>
    <paragraph num="(7)">
      <text>“Pharmacy benefits manager (PBM)” has the meaning stated in Insurance Article, §15-1601, Annotated Code of Maryland.</text>
    </paragraph>
    <paragraph num="(8)">
      <text>“Pharmacy services administrative contract” has the meaning stated in Insurance Article, §15-2001(d), Annotated Code of Maryland.</text>
    </paragraph>
    <paragraph num="(9)">
      <text>“Pharmacy services administrative organization” or “PSAO” has the meaning stated in Insurance Article, §15-2001(e), Annotated Code of Maryland.</text>
    </paragraph>
    <paragraph num="(10)">
      <text>“Purchaser” has the meaning stated in Insurance Article, §15-2001(f), Annotated Code of Maryland.</text>
    </paragraph>
    <paragraph num="(11)">
      <text>“Working days” means any day that the Maryland Insurance Administration is open for business.</text>
    </paragraph>
  </paragraph>
</regulation>