<?xml version='1.0' encoding='utf-8'?>
<regulation prefix="Regulation" num=".19" citation="COMAR 10.63.03.19" title_num="10" subtitle_num="63" chapter_num="03" heading="Opioid Treatment Service.">
  <text>An opioid treatment service is one that:</text>
  <paragraph num="A.">
    <text>Complies with the requirements of 42 CFR §8;</text>
  </paragraph>
  <paragraph num="B.">
    <text>Is under the direction of a medical director who is a physician and:</text>
    <paragraph num="(1)">
      <text>Has at least 3 years of documented experience providing services to persons with substance-related disorders and opioid use disorders, including at least 1 year of experience in the treatment of opioid use disorder with opioid maintenance therapy and is board-certified in addiction medicine or addiction psychiatry; or</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Is certified in added qualifications in addiction psychiatry by the American Board of Psychiatry and Neurology, Inc.;</text>
    </paragraph>
  </paragraph>
  <paragraph num="C.">
    <text>Uses pharmacological interventions, including dispensing of full and partial opiate agonist treatment medications as part of treatment, support, and recovery services to an individual with an opioid addiction;</text>
  </paragraph>
  <paragraph num="D.">
    <text>Provides clinical services to each patient at a frequency based on the patient’s clinical stability level, not to exceed an overall program average of 50:1 patient-to-counselor ratio;</text>
  </paragraph>
  <paragraph num="E.">
    <text>Arranges for any opioid maintenance medication dispensed to a patient to be transported to the following service sites:</text>
    <paragraph num="(1)">
      <text>Residential programs at Levels 3.3, 3.5, and 3.7, as described in Regulations .12—.14 of this chapter;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Withdrawal management services at ASAM levels 3.2-WM and 3.7-WM as described in Regulation .18 of this chapter; or</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Residential programs at levels 3.1, when the patient, because of a developmental or physical disability, or lack of access to transportation, cannot obtain or transport the patient’s take-home opioid maintenance medication;</text>
    </paragraph>
  </paragraph>
  <paragraph num="F.">
    <text>In accordance with 21 CFR §1300, et seq., arranges transportation of opioid maintenance medication from the program sites identified in §E of this regulation or confirms the disposal of such medication when a patient leaves residential levels of care;</text>
  </paragraph>
  <paragraph num="G.">
    <text>Conducts random drug testing on each patient at least monthly, according to the provisions of COMAR 10.10.03.02;</text>
  </paragraph>
  <paragraph num="H.">
    <text>Conducts random drug testing, at a minimum, for the following substances:</text>
    <paragraph num="(1)">
      <text>Benzodiazepines;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Marijuana;</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Cocaine;</text>
    </paragraph>
    <paragraph num="(4)">
      <text>Opiates;</text>
    </paragraph>
    <paragraph num="(5)">
      <text>Alcohol;</text>
    </paragraph>
    <paragraph num="(6)">
      <text>Methadone or buprenorphine, whichever is appropriate; and</text>
    </paragraph>
    <paragraph num="(7)">
      <text>Oxycodone;</text>
    </paragraph>
  </paragraph>
  <paragraph num="I.">
    <text>Develops a taper 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 num="J.">
    <text>Nonvoluntarily tapers or transfers 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 taper;</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Patient misses 3 consecutive medication days, and the program physician, after reevaluation, has determined that nonvoluntary taper is warranted; or</text>
    </paragraph>
    <paragraph num="(4)">
      <text>Clinical staff documents therapeutic reasons for taper, which may include continued use of illicit drugs or an unwillingness to follow appropriate clinical interventions;</text>
    </paragraph>
  </paragraph>
  <paragraph num="K.">
    <text>Requires that a patient show evidence of the availability of locked storage before a patient may take home any dose of medication; and</text>
  </paragraph>
  <paragraph num="L.">
    <text>Provides clinical services addressing any substance-use disorders to each patient.</text>
  </paragraph>
</regulation>