Section 164.307 - Additional Service Requirements for Opioid Maintenance(A)Admission of Persons Younger than 18 Years Old. Licensed and Approved Providers may not admit a person younger than 18 years old to opioid maintenance treatment, unless that person has two documented unsuccessful attempts at short-term withdrawal or drug-free treatment within a 12-month period, or is pregnant.(B)Drug Screening. The Licensed or Approved Provider shall provide for the following: (1) An initial drug-screening completed for each prospective patient as required by 105 CMR 164.305(D)(2).(2) An opioid treatment provider must conduct additional random drug screens according to federal requirements. Such drug screens shall, at a minimum, test for opioids including, but not be limited to, buprenorphine, methadone, and fentanyl; cocaine; benzodiazepines; alcohol; and any other drugs the Licensed or Approved Provider determines are clinically indicated or as approved by the Commissioner and listed in Department guidance. The Licensed or Approved Provider shall document measures taken to prevent adulteration of samples and to ensure a chain of custody.(3) Results of drug screening are to be used as a clinical tool and not as the sole factor in the diagnosis and treatment of the patient and for monitoring the patient's drug-use patterns before and during treatment. The Licensed or Approved Provider's Medical Director shall ensure that drug screen results are not used to force a patient out of treatment, but are used as an aid in making treatment decisions.(4) Drug screening may be done by one of the following: blood, oral swab, urine testing, or other method as defined by the Department.(C)Administration of Opioid Maintenance. The Licensed or Approved Provider shall provide for the following: (1) All patients who begin opioid maintenance treatment shall present themselves daily for medication so the Licensed or Approved Provider may observe the patient ingesting the prescribed dosage of opioid agonist medication on a daily basis.(2) The Medical Director may reduce the number of times patients must present themselves for observed ingestion of medication by providing take-home doses. In determining whether to provide take-home doses to a patient, the Medical Director shall ensure all decisions comply with federal take-home criteria and schedule including, but not limited to, 42 CFR Part 8.12(h)(4)(i)(1) through (5). The results of such assessment shall be documented in the patient's record.(3) The Licensed or Approved Provider shall adhere to federal limits for providing take home doses of any opioid agonist or partial agonist, including that any patient in opioid maintenance treatment may receive a single take-home dose for a day the program is closed, such as on Sundays and state and federal holidays.(4) The Licensed or Approved Provider may not exceed federally established take-home limits without written permission from the Department. Requests for such permission shall be submitted to the Department in writing in a form required by the State Opioid Treatment Authority and, where required, by the federal government.(5) Take-home doses shall be dispensed to patients in locked containers. Licensed and Approved Providers may require patients to provide their own locked container.(6) The Licensed or Approved Provider shall instruct patients receiving a take-home dose, or take-home doses, of the dangers of ingesting methadone to children, pets, and others for whom methadone is not prescribed, and of the dangers of ingesting more than the prescribed dose. Such instruction shall include information on safe storage of methadone in the home. The Licensed or Approved Provider shall document that this instruction has been provided.(7) Take-home status may be revoked or suspended if the patient does not maintain the behavior which supported approval of take-home privileges. Suspension or revocation of take-home privileges are not subject to appeal to the Department.(8) The Licensed or Approved Provider shall support patients on opioid maintenance treatment when they are admitted to to a 24-hour settings or during a time of clinical need in obtaining take-home doses in accordance with all state and federal requirements.(D)Pregnant Women.(1) Pregnant women, regardless of age, who have had a documented opioid dependency in the past and who may be in direct jeopardy of returning to opioid dependency may be placed on a maintenance regimen. For such patients, evidence of current physiological dependence on opioid drugs is not needed if an authorized staff physician certifies the pregnancy and, using reasonable clinical judgment, finds such treatment to be medically justified in accordance with best medical practices considering the health of the woman and impact on the pregnancy. Evidence of all findings shall be recorded in the patient record.(2) The Licensed or Approved Provider shall ensure that each pregnant woman is fully informed concerning the possible benefits and risks of opioid treatment to herself and to the fetus. The Licensed or Approved Provider shall document provision of this information in the patient's record.(3) The Licensed or Approved Provider shall establish a QSOA for pre-natal, obstetrical and gynecological services, unless Licensed or Approved Provider provides these services directly.(E)Blind Dosage Reduction. Patients who are undergoing medically supervised withdrawal as a planned goal in a maintenance program may request a blind dosage reduction, i.e. a gradual decrease of dosage without prior notice to the patient of the decrease. Such blind dosage reduction shall be undertaken only with written consent of the patient and Licensed or Approved Provider. Such consents shall be renewed only by mutual agreement on a regular basis.(F)Voluntary Termination. Upon request of a patient, or when deemed medically advisable and with the patient's consent, the Licensed or Approved Provider shall initiate the following services: (1) Discuss with the patient the benefits and risks of medically supervised withdrawal, including possibility of relapse;(2) Provide relapse prevention services;(3) Provide medically supervised withdrawal services directly or by referral; and(4) Make referrals as necessary to ensure a continuum of care for the patient, including continued counseling and other services, including risk reduction and outreach, as long as necessary to assure stability.(G)Medically Supervised Withdrawal Rate. The rate of medically supervised withdrawal shall be determined by a program physician to be appropriate to the patient's medical and psychiatric conditions and the dosage level at which the patient was being medicated before the decision was made to terminate. In determining the appropriate course of dosage reduction, the physician shall review the patient's record, and consider the patient's physical and mental health status, and with consent of the patient, may take into account the opinions of the patient's other practitioners and medical providers.(H)Annual Medical Exam. The Licensed or Approved Provider shall ensure that each patient has a medical examination by a Practitioner, or by a qualified health-care professional, under the supervision of a program physician once each year. The examination shall include:(1) a brief mental status exam;(2) tests for the presence of opioids, cocaine, benzodiazepines, alcohol, all FDA-approved medications for addiction treatment, and any other drugs the Licensed or Approved Provider determines are clinically indicated or as approved by the Commissioner and listed in Department guidance.(3) an assessment of pulmonary, liver, and cardiac abnormalities; dermatological and neurological sequelae of addiction; possible infectious serologies if indicated; possible concurrent surgical problems; and any other relevant laboratory studies as clinically indicated. The assessment shall include laboratory tests as needed. The Licensed or Approved Provider shall ensure that any necessary laboratory tests are completed by licensed facilities which comply with all applicable federal and state laboratory licensure and certification requirements. Any relevant laboratory findings shall be documented and reviewed with the physician and findings reviewed with the patient. Evidence of direct referrals to address findings must be properly documented.(4) Licensed or approved providers may utilize a medical examination conducted within the last 12 months, provided there are no medical issues or changes that require examination per the clinical discretion of the facility provider, and review of such a medical examination is documented in the patient's record.Amended by Mass Register Issue 1305, eff. 1/29/2016.Amended by Mass Register Issue 1482, eff. 11/11/2022.