<?xml version='1.0' encoding='utf-8'?>
<regulation prefix="Regulation" num=".06" citation="COMAR 10.34.29.06" title_num="10" subtitle_num="34" chapter_num="29" heading="Therapy Management Contracts.">
  <paragraph num="A.">
    <text>A therapy management contract shall be signed by the:</text>
    <paragraph num="(1)">
      <text>Authorized prescriber or authorized prescribers involved in the management of the patient under a prescriber-pharmacist agreement;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Pharmacist or pharmacists involved in the management of the patient under a prescriber-pharmacist agreement; and</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Patient receiving care under the therapy management contract.</text>
    </paragraph>
  </paragraph>
  <paragraph num="B.">
    <text>A therapy management contract shall contain:</text>
    <paragraph num="(1)">
      <text>A list of allowable substitutions of chemically dissimilar drugs, if any;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>A statement that:</text>
      <paragraph num="(a)">
        <text>None of the parties involved in the therapy management contract have been:</text>
        <paragraph num="(i)">
          <text>Coerced into participating in the therapy management contract;</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Given economic incentives, excluding normal reimbursement for services rendered; or</text>
        </paragraph>
        <paragraph num="(iii)">
          <text>Involuntarily required to participate in the therapy management contract; and</text>
        </paragraph>
      </paragraph>
      <paragraph num="(b)">
        <text>The pharmacist shall notify the authorized prescriber under the terms of the prescriber-pharmacist agreement if the pharmacist:</text>
        <paragraph num="(i)">
          <text>Modifies the dose or agent under the therapy management contract; or</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Detects an abnormal result from an assessment activity;</text>
        </paragraph>
      </paragraph>
    </paragraph>
    <paragraph num="(3)">
      <text>Notice to the patient stating:</text>
      <paragraph num="(a)">
        <text>That the patient may terminate the therapy management contract at any time; and</text>
      </paragraph>
      <paragraph num="(b)">
        <text>The procedure by which the patient may terminate the therapy management contract;</text>
      </paragraph>
    </paragraph>
    <paragraph num="(4)">
      <text>A procedure for periodic review by the authorized prescriber of the drugs modified under the prescriber-pharmacist agreement or changed with the consent of the authorized prescriber;</text>
    </paragraph>
    <paragraph num="(5)">
      <text>A reference to the protocol or protocols under which the pharmacist shall act; and</text>
    </paragraph>
    <paragraph num="(6)">
      <text>Exceptions or limitations to the protocol or protocols for the specific patient.</text>
    </paragraph>
  </paragraph>
</regulation>