Md. Code Regs. 10.47.02.11

Current through Register Vol. 51, No. 25, December 13, 2024

Section 10.47.02.11 - Opioid Maintenance Therapy

A. Program Description. Opioid maintenance therapy:

(1) Uses pharmacological interventions, including full and partial opiate agonist treatment medications, to provide treatment, support, and recovery to opioid-addicted patients;

(2) Is a separate service that is certified and offered by a program as described in COMAR 10.47.02.03-.11;

(3) Complies with the requirements under this regulation; and

(4) Can be provided in correctional facility based programs.

B. The program shall comply with federal regulation 42 CFR 8.

C. Staffing.

(1) The patient to alcohol and drug counselor ratio may not exceed 50 patients to one full-time counselor.

(2) Medical Director. The program shall have a medical director who is a physician and who:

(a) 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;

(b) Meets at least one of the following criteria:

(i) Has been continuously employed as the medical director for opioid maintenance therapy programs from or before August 1, 2002;

(ii) Is certified in addiction medicine by the American Society of Addiction Medicine;

(iii) Is certified in added qualifications in addiction psychiatry by the American Board of Psychiatry and Neurology, Inc.; or

(iv) Is certified in added qualifications in addiction medicine by the appropriate specialty boards of the American Osteopathic Association; and

(c) Takes an active part in interdisciplinary team meetings, not less than every 2 weeks.

(3) 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:

(a) The program shall submit a training plan for the interim medical director to the Administration for approval;

(b) 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

(c) The interim medical director shall meet the qualifications within 48 months of being hired.

D. An opioid maintenance therapy program shall:

(1) Have hours that meet the needs of the patients;

(2) 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

(3) Complete an individualized treatment plan which is described in COMAR 10.47.01.04 as follows:

(a) Completed and signed by the alcohol and drug counselor and patient within 7 working days of the comprehensive assessment;

(b) Updated every 90 days for the first year of treatment; and

(c) 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.

E. Random Drug Testing. The program shall:

(1) Conduct random drug testing on each patient at least monthly, in accordance with State law;

(2) Conduct random drug testing at a minimum for the following substances:

(a) Benzodiazepines;

(b) Marijuana;

(c) Cocaine;

(d) Opiates;

(e) Alcohol; and

(f) Methadone;

(3) Ensure that positive screens are validated using federally approved, State-certified laboratories;

(4) If appropriate, use temperature sensitive cups in place of direct observation; and

(5) Develop procedures, approved by the Administration, that mandate clinical intervention if a patient's drug test result indicates substance use.

F. Dosage. The program shall:

(1) Maintain patients with a dose adequate to alleviate all withdrawal symptoms;

(2) Employ dose increases and behavior therapy before mandatory detoxification for patients continuing to use drugs;

(3) Establish patient dosing on an individual need;

(4) Provide flexible dosage tapering at patient request; and

(5) 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.

G. Opioid maintenance programs shall arrange for transportation of medication to and from the following levels of care:

(1) Residential treatment at Levels III.3, III.5, and III.7, as described in Regulations .07-.09 of this chapter;

(2) Detoxification services at Level III.2-D and III.7-D, as described in Regulation .10 of this chapter; or

(3) 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.

H. 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.

I. Programs may administratively detoxify or transfer a patient only if the:

(1) Patient's behavior on program premises is abusive, violent, or illegal;

(2) Patient fails to pay fees and has been informed in writing and counseled as to responsibility and possible sanctions including detoxification;

(3) Patient misses 3 consecutive medication days, and the program physician after a reevaluation has determined that administrative detoxification is warranted; or

(4) Clinical staff documents therapeutic reasons for detoxification, which may include continued use of illicit drugs or an unwillingness to follow appropriate clinical interventions.

J. Criteria for Take-Home Privileges. Before the patient may take home any dose the patient shall:

(1) Meet the criteria set within 42 CFR Part 8; and

(2) Provide the program with a working lock box for the take-home medication.

K. Referral Services. Programs shall:

(1) Provide referral services as required by the level of treatment under which the program is certified; and

(2) Maintain a listing of agency referral agreements for the services.

Md. Code Regs. 10.47.02.11

Regulations .11, Specific Program Requirements, adopted effective June 10, 2002 (29:11 Md. R. 882)
Regulation .11 amended as an emergency provision effective April 1, 2008 (35:9 Md. R. 894); amended permanently effective May 5, 2008 (35:9 Md. R. 898)
Regulation .11D amended effective 40:24 Md. R. 2017, eff.12/12/2013