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<regulation prefix="Regulation" num=".11" citation="COMAR 10.47.02.11" title_num="10" subtitle_num="47" chapter_num="02" heading="Opioid Maintenance Therapy.">
  <paragraph num="A.">
    <text>Program Description. Opioid maintenance therapy:</text>
    <paragraph num="(1)">
      <text>Uses pharmacological interventions, including full and partial opiate agonist treatment medications, to provide treatment, support, and recovery to opioid-addicted patients;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Is a separate service that is certified and offered by a program as described in COMAR 10.47.02.03 — .11;</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Complies with the requirements under this regulation; and</text>
    </paragraph>
    <paragraph num="(4)">
      <text>Can be provided in correctional facility based programs.</text>
    </paragraph>
  </paragraph>
  <paragraph num="B.">
    <text>The program shall comply with federal regulation 42 CFR 8.</text>
  </paragraph>
  <paragraph num="C.">
    <text>Staffing.</text>
    <paragraph num="(1)">
      <text>The patient to alcohol and drug counselor ratio may not exceed 50 patients to one full-time counselor.</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Medical Director. The program shall have a medical director who is a physician and who:</text>
      <paragraph num="(a)">
        <text>Has 3 years documented experience providing services to persons who are addicted to alcohol or other drugs, including at least 1 year of experience in the treatment of opioid addiction with opioid maintenance therapy;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Meets at least one of the following criteria:</text>
        <paragraph num="(i)">
          <text>Has been continuously employed as the medical director for opioid maintenance therapy programs from or before August 1, 2002;</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Is certified in addiction medicine by the American Society of Addiction Medicine;</text>
        </paragraph>
        <paragraph num="(iii)">
          <text>Is certified in added qualifications in addiction psychiatry by the American Board of Psychiatry and Neurology, Inc.; or</text>
        </paragraph>
        <paragraph num="(iv)">
          <text>Is certified in added qualifications in addiction medicine by the appropriate specialty boards of the American Osteopathic Association; and</text>
        </paragraph>
      </paragraph>
      <paragraph num="(c)">
        <text>Takes an active part in interdisciplinary team meetings, not less than every 2 weeks.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(3)">
      <text>A program unable to hire a medical director who meets the criteria set forth in §C(2) of this chapter may hire an interim medical director under the following conditions:</text>
      <paragraph num="(a)">
        <text>The program shall submit a training plan for the interim medical director to the Administration for approval;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>The plan shall address a means for achieving minimal competencies and proficiencies until the interim medical director meets qualifications set forth in §C(1) of this chapter; and</text>
      </paragraph>
      <paragraph num="(c)">
        <text>The interim medical director shall meet the qualifications within 48 months of being hired.</text>
      </paragraph>
    </paragraph>
  </paragraph>
  <paragraph num="D.">
    <text>An opioid maintenance therapy program shall:</text>
    <paragraph num="(1)">
      <text>Have hours that meet the needs of the patients;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Establish an answering system when the program is closed which provides direct contact or call back by a staff member capable of addressing emergency patient issues; and</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Complete an individualized treatment plan which is described in COMAR 10.47.01.04 as follows:</text>
      <paragraph num="(a)">
        <text>Completed and signed by the alcohol and drug counselor and patient within 7 working days of the comprehensive assessment;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Updated every 90 days for the first year of treatment; and</text>
      </paragraph>
      <paragraph num="(c)">
        <text>After completion of 1 year of continuous treatment and if the patient meets the requirements for unsupervised or take home use set forth in CFR 42 §8.12(i), the individualized treatment plan may be updated every 180 days and signed by the alcohol and drug counselor and patient.</text>
      </paragraph>
    </paragraph>
  </paragraph>
  <paragraph num="E.">
    <text>Random Drug Testing. The program shall:</text>
    <paragraph num="(1)">
      <text>Conduct random drug testing on each patient at least monthly, in accordance with State law;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Conduct random drug testing at a minimum for the following substances:</text>
      <paragraph num="(a)">
        <text>Benzodiazepines;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Marijuana;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Cocaine;</text>
      </paragraph>
      <paragraph num="(d)">
        <text>Opiates;</text>
      </paragraph>
      <paragraph num="(e)">
        <text>Alcohol; and</text>
      </paragraph>
      <paragraph num="(f)">
        <text>Methadone;</text>
      </paragraph>
    </paragraph>
    <paragraph num="(3)">
      <text>Ensure that positive screens are validated using federally approved, State-certified laboratories;</text>
    </paragraph>
    <paragraph num="(4)">
      <text>If appropriate, use temperature sensitive cups in place of direct observation; and</text>
    </paragraph>
    <paragraph num="(5)">
      <text>Develop procedures, approved by the Administration, that mandate clinical intervention if a patient's drug test result indicates substance use.</text>
    </paragraph>
  </paragraph>
  <paragraph num="F.">
    <text>Dosage. The program shall:</text>
    <paragraph num="(1)">
      <text>Maintain patients with a dose adequate to alleviate all withdrawal symptoms;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Employ dose increases and behavior therapy before mandatory detoxification for patients continuing to use drugs;</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Establish patient dosing on an individual need;</text>
    </paragraph>
    <paragraph num="(4)">
      <text>Provide flexible dosage tapering at patient request; and</text>
    </paragraph>
    <paragraph num="(5)">
      <text>Develop a detoxification schedule at least 21 days long with daily dosage reductions less than 5 percent of the original total dose, regardless of the patient's ability to pay.</text>
    </paragraph>
  </paragraph>
  <paragraph num="G.">
    <text>Opioid maintenance programs shall arrange for transportation of medication to and from the following levels of care:</text>
    <paragraph num="(1)">
      <text>Residential treatment at Levels III.3, III.5, and III.7, as described in Regulations .07 — .09 of this chapter;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Detoxification services at Level III.2-D and III.7-D, as described in Regulation .10 of this chapter; or</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Residential treatment at Level III.1, when the patient cannot obtain or transport his or her own take-home opioid maintenance medication because of developmental or physical disabilities or because the patient does not have access to transportation.</text>
    </paragraph>
  </paragraph>
  <paragraph num="H.">
    <text>Opioid maintenance programs may transfer care of a patient to a closer opioid maintenance program when the patient is also being treated at a residential program or for detoxification services in a different county or jurisdiction.</text>
  </paragraph>
  <paragraph num="I.">
    <text>Programs may administratively detoxify or transfer a patient only if the:</text>
    <paragraph num="(1)">
      <text>Patient's behavior on program premises is abusive, violent, or illegal;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Patient fails to pay fees and has been informed in writing and counseled as to responsibility and possible sanctions including detoxification;</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Patient misses 3 consecutive medication days, and the program physician after a reevaluation has determined that administrative detoxification is warranted; or</text>
    </paragraph>
    <paragraph num="(4)">
      <text>Clinical staff documents therapeutic reasons for detoxification, which may include continued use of illicit drugs or an unwillingness to follow appropriate clinical interventions.</text>
    </paragraph>
  </paragraph>
  <paragraph num="J.">
    <text>Criteria for Take-Home Privileges. Before the patient may take home any dose the patient shall:</text>
    <paragraph num="(1)">
      <text>Meet the criteria set within 42 CFR Part 8; and</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Provide the program with a working lock box for the take-home medication.</text>
    </paragraph>
  </paragraph>
  <paragraph num="K.">
    <text>Referral Services. Programs shall:</text>
    <paragraph num="(1)">
      <text>Provide referral services as required by the level of treatment under which the program is certified; and</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Maintain a listing of agency referral agreements for the services.</text>
    </paragraph>
  </paragraph>
</regulation>