Medical and behavioral health standards

1. a. A physician or other health care professional for the opioid treatment program must diagnose opioid use disorder for an individual to be admitted for opioid treatment. The physician or other health care professional shall document or cosign the diagnosis, and admit each patient to maintenance treatment or detoxification treatment, as medically necessary. If pharmacological treatment is medically appropriate and prior to prescribing methadone, the physician or other health care professional shall assess whether it is appropriate to treat the patient with buprenorphine. b. An individual must have a one-year history of addiction to be admitted to a maintenance treatment program. An individual with less than a one-year history of dependence may be admitted to undergo detoxification treatment. The absence of current physiological dependence is not an exclusion criterion; admission is acceptable when clinically justified. An opioid treatment program may accept arrest and medical records, information from significant others and relatives, and other information as documentation of the one-year history of addiction. c. An opioid treatment program may waive the requirement that the individual have a one-year history of active addiction for an individual with a history of narcotic dependence who does not have current or active use, as a result of being released from a penal institution or having been previously treated. d. A physician or other health care professional shall assess and review assessment results with each patient before the patient is approved for treatment with an opioid agonist treatment medication. If the physician or other health care professional determines admission of an individual is an emergency, the physician or other health care professional may review a medical examination performed by another qualified health care professional to make the required diagnosis that would allow admission of the individual, provided the physician or other health care professional reviews and countersigns the patient record within seventy-two hours of the patient's admission. The physician or other health care professional would subsequently review the assessment with the patient and discuss the medical services to be provided. e. An opioid treatment program shall make an intravenous drug injecting individual or a pregnant woman a priority when prioritizing individuals for admission. 2. At a minimum, an opioid treatment program shall provide each patient with the following: a. A comprehensive physical examination of the patient, including a review of health history, identification of other chronic or acute health conditions, current objective measures of health, pregnancy status of female patients, and laboratory work determined to be medically appropriate by a physician or other health care professional. b. Based on the individual's history and physical examination, an evaluation of the possibility of infectious disease, liver or pulmonary conditions, cardiac abnormalities, psychiatric problems, dermatologic sequelae of addiction, and possible concurrent surgical and other problems. 3. An opioid treatment program shall: a. Obtain voluntary, written, program-specific informed consent to treatment from each patient at admission, and written releases of information for all ancillary providers. b. Inform each patient about all relevant treatment procedures and services and about other policies and regulations throughout the course of the patient's treatment. c. Obtain, before medicating a patient, voluntary, written, informed consent from the patient to the specific pharmacotherapy ordered by the physician or other health care professional. d. Inform each patient that: (1) The goal of medication-assisted treatment is stabilizing of the patient's functioning. (2) At periodic intervals of the patient's present level of functioning, course of treatment, and future goals, without placing pressure on the patient to withdraw from opioid agonist treatment medication or to remain on maintenance treatment unless the physician or other health care professional determines the proposed action to be medically indicated. e. Inform each patient, at admission, about specific requirements and program policies regarding the report of suspected child abuse and neglect, danger of harm to self or others or both, abuse or neglect of a vulnerable individual, and other behaviors having negative impact on the patient or others. f. Adhere to all requirements of federal confidentiality regulations, including the Health Insurance Portability and Accountability Act (Public Law 104-191; 110 Stat. 1936). 4. a. The medical director or other health care professional of an opioid treatment program shall refer a patient for medical or psychiatric treatment when the medical director or other health care professional determines it to be appropriate. b. An opioid treatment program shall retain a patient in opioid treatment as long as treatment is clinically appropriate, medically necessary, acceptable to the patient, and the patient is considered to be adherent with the established rules of the program. c. (1) When a patient relocates, transfers to another treatment program, or needs temporary care at another program, the original opioid treatment program shall ensure the patient makes as smooth a transition as is feasible, and when possible shall avoid interruptions in treatment that could lead to relapse. (2) The original opioid treatment program shall forward relevant records to the receiving opioid treatment program, with patient consent in accordance with the privacy standards of title 42, Code of Federal Regulations, part 2. d. The opioid treatment program shall continue to provide psychosocial treatment for a patient who elects to discontinue pharmacotherapy. The opioid treatment program may continue to offer treatment, or referrals for continued psychosocial supports to patients as needed. 5. An opioid treatment program shall retain all records required by title 42, Code of Federal Regulations, part 8.12 for a minimum of seven years from the last date of service. a. An opioid treatment program is required under title 42, Code of Federal Regulations, part 8.11(f)(3) to comply with confidentiality requirements set forth under title 42, Code of Federal Regulations, part 2. b. A physician or other appropriate health care professional with the opioid treatment program shall write each medication order and dosage change on an acceptable order sheet and shall sign the sheet. (1) Appropriate staff of the opioid treatment program shall make a record of each dosage the opioid treatment program dispenses, prepares, or receives and shall sign each entry to ensure a perpetual and accurate inventory of all medications and prescriptions, including controlled substances in stock at all times. (2) Appropriate staff of the opioid treatment program shall document clearly the patient's individual medication dose history, the time that each dose is administered or dispensed, and the identification of who administered or dispensed the medication. 6. a. A physician or other health care professional: (1) Who is with the opioid treatment program must be trained in the use of medication-assisted treatment to determine the individual dose of opioid medication for a patient. (2) Who is with the opioid treatment program shall provide opioid agonist treatment medication as clinically indicated, and shall assess the patient's ability to tolerate the medication and whether the patient suffers negative effects. (3) Who is with the opioid treatment program may not prescribe methadone on the first day it is administered to a patient in excess of thirty milligrams unless the physician documents a treatment need to prescribe an initial dose of forty milligrams. (4) As clinically appropriate, may prescribe the admission of a patient to an opioid treatment program for detoxification treatment. Detoxification treatment is conducted as a voluntary and therapeutic process, agreed on between physician or health care professional and patient using current best practices. b. An opioid treatment program shall have a procedure for calibrating medication-dispensing instruments, consistent with manufacturers' recommendations, to ensure accurate patient dosing and substance tracking. c. An opioid treatment program may not adjust medication doses to reinforce positive behavior or to punish negative behavior, unless the patient is noncompliant with programmatic expectations and the taper constitutes the start of a detoxification treatment or a dosage increase needed to address the patient's symptoms. d. The opioid treatment program should have the capability to obtain serum methadone levels when clinically indicated or urine-based buprenorphine or nor-buprenorphine levels. 7. An opioid treatment program shall take reasonable measures to prevent its patients from enrolling in treatment from more than one opioid treatment program. 8. a. If an opioid treatment program administratively discharges a patient from treatment using an opioid agonist treatment medication, the opioid treatment program shall offer a humane schedule of detoxification treatment, if clinically appropriate, provided doing so does not compromise the safety of staff or patients of the opioid treatment program. b. An opioid treatment provider may determine during the process of ongoing assessment that a patient is not appropriate for treatment through the opioid treatment program and may be better served by other treatment modalities. Specifically, if a patient continues to use substances, engages in medication diversion, or fails to respond to the treatment plan, the opioid treatment program may find the patient is not appropriate for treatment through its programming and may administratively discharge the patient. c. An opioid treatment program shall work with a patient to develop a plan of continuing care that includes discharge and recovery planning. An opioid treatment program shall ensure the discharge planning process includes procedures that address the patient's physical and mental health problems following detoxification treatment. The opioid treatment program shall include in the discharge plan, a plan for continuing care following the last dose of medication, including making a referral for continuing outpatient care as needed, and planning for reentry to maintenance treatment if relapse occurs and resumption of care continues to be appropriate. 9. Each opioid treatment program shall: a. Use drug and alcohol screening and testing as aids in monitoring and evaluating patient's progress in treatment. b. Ensure that treatment personnel in a medication-assisted treatment program understand the benefits and limitations of toxicological testing procedures. c. Address results of toxicology testing with patients promptly. d. Document in the patient record the results of toxicology tests and shall follow therapeutic interventions. e. Ensure compliance with all federal regulations related to urine toxicology results, title 42, Code of Federal Regulations, part 8.12(f). An opioid treatment program must provide adequate testing of or analysis for drugs of abuse according to best practices. f. For patients in short-term detoxification treatment, the opioid treatment program shall perform at least one initial drug abuse test.