(f) “Opioid treatment program” has the meaning given in Code of Federal Regulations, title 42, section 8.12, and includes programs licensed under Minnesota Rules, part 9530.6500. (g) “Program” means an entity that is licensed under Minnesota Rules, part 9530.6500. (h) “Unsupervised use” means the use of a medication for the treatment of opioid addiction dispensed for use by a client outside of the program setting. This is also referred to as a “take-home” dose. (i) “Placing authority” has the meaning given in Minnesota Rules, part 9530.6605, subpart 21a. (j) “Minnesota health care programs” has the meaning given in section 256B.0636. Subd. 3. Medication orders. Prior to the program administering or dispensing a medication used for the treatment of opioid addiction: (1) a client-specific order must be received from an appropriately credentialed physician who is enrolled as a Minnesota health care programs provider and meets all applicable provider standards; (2) the signed order must be documented in the client’s record; and (3) if the physician that issued the order is not able to sign the order when issued, the unsigned order must be entered in the client record at the time it was received, and the physician must review the documentation and sign the order in the client’s record within 72 hours of the medication being ordered. The license holder must report to the commissioner any medication error that endangers a patient’s health, as determined by the medical director. Subd. 3a. High dose requirements. A client being administered or dispensed a dose beyond that set forth in subdivision 5, paragraph (a), clause (1), that exceeds 150 milligrams of methadone or 24 milligrams of buprenorphine daily, and for each subsequent increase, must meet face-to-face with a prescribing physician. The meeting must occur before the administering or dispensing of the increased dose. Subd. 4. Drug testing. Each client enrolled in the program must receive a minimum of eight random drug abuse tests per 12 months of treatment. These tests must be reasonably disbursed over the 12-month period. A license holder may elect to conduct more drug abuse tests. Subd. 5. Criteria for unsupervised use. (a) To limit the potential for diversion of medication used for the treatment of opioid addiction to the illicit market, any such medications dispensed to patients for unsupervised use shall be subject to the following requirements: (1) any patient in an opioid treatment program may receive a single take-home dose for a day that the clinic is closed for business, including Sundays and state and federal holidays; and (2) treatment program decisions on dispensing medications used to treat opioid addiction to patients for unsupervised use beyond that set forth in clause (1) shall be determined by the medical director. 201
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