§ 8.12 - Federal Opioid Use Disorder treatment standards.

§ 8.12 Federal opioid Opioid Use Disorder treatment standards.

(a) General. OTPs must provide treatment in accordance with the standards in this section and must comply with these standards as a condition of certification.

(b) Administrative and organizational structure.

(1) An OTP's organizational structure and facilities shall be adequate to ensure quality patient care and to meet the requirements of all pertinent Federal, State, and local laws and regulations. At a minimum, each OTP shall formally designate a program sponsor and medical director. The program sponsor shall agree on behalf of the OTP to adhere to all requirements set forth in this part

and any regulations regarding the use of opioid agonist treatment medications in the treatment of opioid use disorder which may be promulgated in the future.

.

(2) The medical director shall assume responsibility for

administering

all medical and behavioral health services performed by the OTP. In addition, the medical director shall be responsible for ensuring that the OTP is in compliance with all applicable Federal, State, and local laws and regulations.

(c) Continuous quality improvement.

(1) An OTP must maintain current quality assurance and quality control plans that include, among other things, annual reviews of program policies and procedures and ongoing assessment of patient outcomes.

(2) An OTP must maintain a current “Diversion Control Plan” or “DCP” as part of its quality assurance program that contains specific measures to reduce the possibility of diversion of controlled substances from legitimate treatment use dispensed MOUD, and that assigns specific responsibility to the medical OTP providers and administrative staff of the OTP for carrying out the diversion control measures and functions described in the DCP.

(d) Staff credentials. Each person engaged in the treatment of opioid use disorder OUD must have sufficient education, training, and experience, or any combination thereof, to enable that person to perform the assigned functions. All physicians, nurses, practitioners and other licensed professional /certified health care providers, including addiction counselors, must comply with the credentialing and maintenance of licensure and/or certification requirements of their respective professions.

(e) Patient admission criteria —

(1) Maintenance Comprehensive treatment. An OTP shall maintain current procedures designed to ensure that patients are admitted to maintenance treatment by qualified personnel who have determined, using accepted medical criteria such as those listed in the Diagnostic and Statistical Manual for Mental Disorders (DSM-IV), that the person is currently addicted to an opioid drug, and that the person became addicted at least 1 year before admission for treatment. In addition, a program physician : The person meets diagnostic criteria for a moderate to severe OUD; the individual has an active moderate to severe OUD, or OUD in remission, or is at high risk for recurrence or overdose. Such decisions must be appropriately documented in the patient's clinical record. In addition, a health care practitioner shall ensure that each patient voluntarily chooses maintenance treatment with MOUD and that all relevant facts concerning the use of the opioid drug MOUD are clearly and adequately explained to the patient, and that each patient provides informed written consent to treatment.

(2) Maintenance Comprehensive treatment for persons under age 18. A person Except in States where State law grants persons under 18 years of age is required to have had two documented unsuccessful attempts at short-term detoxification or drug-free treatment within a 12-month period to be eligible for maintenance treatment. No the ability to consent to OTP treatment without the consent of another, no person under 18 years of age may be admitted to maintenance OTP treatment unless a parent, legal guardian, or responsible adult designated by the relevant State authority consents in writing to such treatment.

(3) Maintenance treatment admission exceptions. If clinically appropriate, the program physician may waive the requirement of a 1-year history of addiction under paragraph (e)(1) of this section, for patients released from penal institutions (within 6 months after release), for pregnant patients (program physician must certify pregnancy), and for previously treated patients (up to 2 years after discharge).

(4) Detoxification treatment.

Withdrawal management. An OTP shall maintain current procedures that are designed to ensure that those patients

are admitted to short- or long-term detoxification treatment by qualified personnel, such as a program physician, who determines that such treatment is appropriate for the specific patient by applying established diagnostic criteria. Patients with two or more unsuccessful detoxification episodes within a 12-month period must be assessed by the OTP physician for other forms of treatment. A program shall not admit a patient for more than two detoxification treatment episodes in one year.

who choose to taper from MOUD are provided the opportunity to do so with informed consent and at a mutually agreed-upon rate that minimizes taper-related risks. Such consent must be documented in the clinical record by the treating practitioner.

(f) Required services —

(1) General. OTPs shall provide adequate medical, counseling, vocational, educational, and other screening, assessment, and treatment services to meet patient needs, with the combination and frequency of services tailored to each individual patient based on an individualized assessment and the patient's care plan that was created after shared decision making between the patient and the clinical team. These services must be available at the primary facility, except where the program sponsor has entered into a formal, documented agreement with a private or public agency, organization, practitioner, or institution to provide these services to patients enrolled in the OTP. The program sponsor, in any event, must be able to document that these services are fully and reasonably available to patients.

(2) Initial medical examination services.

(i) OTPs shall require each patient to undergo

a complete, fully documented physical evaluation by a program physician or a primary care physician, or an authorized healthcare professional under the supervision of a program physician, before admission to the OTP. The full medical

an initial medical examination. The initial medical examination is comprised of two parts:

(A) A screening examination to ensure that the patient meets criteria for admission and that there are no contraindications to treatment with MOUD; and

(B) A full history and examination, to determine the patient's broader health status, with lab testing as determined to be required by an appropriately licensed practitioner. A patient's refusal to undergo lab testing for co-occurring physical health conditions should not preclude them from access to treatment, provided such refusal does not have potential to negatively impact treatment with medications.

(ii) Assuming no contraindications, a patient may commence treatment with MOUD after the screening examination has been completed. Both the screening examination and full examination must be completed by an appropriately licensed practitioner. If the licensed practitioner is not an OTP practitioner, the screening examination must be completed no more than seven days prior to OTP admission. Where the examination is performed outside of the OTP, the written results and narrative of the examination, as well as available lab testing results, must be transmitted, consistent with applicable privacy laws, to the OTP, and verified by an OTP practitioner.

(iii) A full in-person physical examination, including the results of serology and other tests that are considered to be clinically appropriate, must be completed within 14 calendar days following a patient's admission to the OTP. The full exam can be completed by a non-OTP practitioner, if the exam is verified by a licensed OTP practitioner as being true and accurate and transmitted in accordance with applicable privacy laws.

(iv) Serology testing and other testing as deemed medically appropriate by the licensed OTP practitioner based on the screening or full history and examination, drawn not more than 30 days prior to admission to the OTP, may form part of the full history and examination.

(v) The screening and full examination may be completed via telehealth for those patients being admitted for treatment at the OTP with either buprenorphine or methadone, if a practitioner or primary care provider, determines that an adequate evaluation of the patient can be accomplished via telehealth. When using telehealth, the following caveats apply:

(A) In evaluating patients for treatment with schedule II medications (such as Methadone), audio-visual telehealth platforms must be used, except when not available to the patient. When not available, it is acceptable to use audio-only devices, but only when the patient is in the presence of a licensed practitioner who is registered to prescribe (including dispense) controlled medications. The OTP practitioner shall review the examination results and order treatment medications as indicated.

(B) In evaluating patients for treatment with schedule III medications (such as Buprenorphine) or medications not classified as a controlled medication (such as Naltrexone), audio-visual or audio only platforms may be used. The OTP practitioner shall review the examination results and order treatment medications as indicated.

(3) Special services for pregnant patients. OTPs must maintain current policies and procedures that reflect the special needs and priority for treatment admission of patients with OUD who are pregnant. Pregnancy should be confirmed. Evidence-based treatment protocols for the pregnant patient, such as split dosing regimens, may be instituted after assessment by an OTP practitioner and documentation that confirms the clinical appropriateness of such an evidence-based treatment protocol. Prenatal care and other gender sex-specific services, including reproductive health services, for pregnant and postpartum patients must be provided and documented either by the OTP or by referral to appropriate healthcare practitioners. Specific services, including reproductive health services, for pregnant and postpartum patients must be provided and documented either by the OTP or by referral to appropriate healthcare providerspractitioners.

(4) Initial and periodic physical and behavioral health assessment services.

(i) Each patient

accepted for treatment at

admitted to an OTP shall be

assessed initially and periodically by qualified personnel to determine the most appropriate combination of services and treatment. The initial assessment must include preparation of a treatment

given a physical and behavioral health assessment, which includes but is not limited to screening for imminent risk of harm to self or others, within 14 calendar days following admission, and periodically by appropriately licensed/credentialed personnel. These assessments must address the need for and/or response to treatment, adjust treatment interventions, including MOUD, as necessary, and provide a patient-centered plan of care. The full, initial psychosocial assessment must be completed within 14 calendar days of admission and include preparation of a care plan that includes the patient's

short-term

goals and

the tasks the patient must perform to complete the short-term goals

mutually agreed-upon actions for the patient to meet those goals, including harm reduction interventions; the patient's

requirements for

needs and goals in the areas of education, vocational

rehabilitation

training, and employment; and the medical and psychiatric, psychosocial, economic, legal,

or other supportive

housing, and other recovery support services that a patient needs and wishes to pursue. The

treatment

care plan also must identify the recommended frequency with which

these

services are to be provided. The plan must be reviewed and updated to reflect

that patient's personal history, his or her current needs for medical,

responses to treatment and recovery support services, and adjustments made that reflect changes in the context of the person's life, their current needs for and interests in medical, psychiatric, social, and psychological services, and

his or her

current needs for and interests in education, vocational

rehabilitation

training, and employment services.

(ii) The periodic physical examination should occur not less than one time each year and be conducted by an OTP practitioner. The periodic physical examination should include review of MOUD dosing, treatment response, other substance use disorder treatment needs, responses and patient-identified goals, and other relevant physical and psychiatric treatment needs and goals. The periodic physical examination should be documented in the patient's clinical record.

(5) Counseling and psychoeducational services.

(i) OTPs must provide adequate substance abuse use disorder counseling and psychoeducation to each patient as clinically necessary and mutually agreed-upon, including harm reduction education and recovery-oriented counseling. This counseling shall be provided by a program counselor, qualified by education, training, or experience to assess the psychological and sociological background of patients, and engage with patients, to contribute to the appropriate treatment care plan for the patient and to monitor and update patient progress. Patient refusal of counseling shall not preclude them from receiving MOUD.

(ii) OTPs must provide counseling on preventing exposure to, and the transmission of, human immunodeficiency virus (HIV) disease for , viral hepatitis, and sexually transmitted infections (STIs) and either directly provide services and treatments or actively link to treatment each patient admitted or readmitted to maintenance or detoxification treatmenttreatment who has received positive test results for these conditions from initial and/or periodic medical examinations.

(iii) OTPs must provide directly, or through referral to adequate and reasonably accessible community resources, vocational rehabilitationtraining, education, and employment services for patients who either request such services or who for whom these needs have been determined identified and mutually agreed-upon as beneficial by the patient and program staff to be in need of such services.

(6) Drug abuse testing services. OTPs must provide adequate testing or analysis for drugs of abuse, including at least eight random drug abuse tests per year, per patient in maintenance treatment, When conducting random drug testing, OTPs must use drug tests that have received the Food and Drug Administration's (FDA) marketing authorization for commonly used and misused substances that may impact patient safety, recovery, or otherwise complicate substance use disorder treatment, at a frequency that is in accordance with generally accepted clinical practice . For patients in short-term detoxification treatment, the OTP shall perform at least one initial drug abuse test. For patients receiving long-term detoxification treatment, the program shall perform initial and monthly random tests on each patient. and as indicated by a patient's response to and stability in treatment, but no fewer than eight random drug tests per year patient, allowing for extenuating circumstances at the individual patient level. This requirement does not preclude distribution of legal harm reduction supplies that allow an individual to test their personal drug supply for adulteration with substances that increase the risk of overdose.

(g) Recordkeeping and patient confidentiality.

(1) OTPs shall establish and maintain a recordkeeping system that is adequate to document and monitor patient care. This system is required to comply with all Federal and State reporting requirements relevant to opioid drugs MOUD approved for use in treatment of opioid use disorderOUD. All records are required to be kept confidential in accordance with all applicable Federal and State requirements.

(2) OTPs shall include, as an essential part of the recordkeeping system, documentation in each patient's record that the OTP made a good faith effort to review determine whether or not the patient is enrolled in any other OTP. A patient enrolled in an OTP shall not be permitted to obtain treatment in any other OTP except in exceptional circumstances. circumstances involving an inability to access care at the patient's OTP of record. Such circumstances include, but are not limited to, travel for work or family events, temporary relocation, or an OTP's temporary closure. If the medical director or program physician practitioner of the OTP in which the patient is enrolled determines that such exceptional circumstances exist, the patient may be granted permission to seek treatment at another OTP, provided the justification for finding exceptional the particular circumstances is are noted in the patient's record both at the OTP in which the patient is enrolled and at the OTP that will provide the treatmentMOUD.

(h) Medication administration, dispensing, and use.

(1) OTPs must ensure that opioid agonist treatment medications MOUD are administered or dispensed only by a practitioner licensed under the appropriate State law and registered under the appropriate State and Federal laws to administer or dispense opioid drugsMOUD, or by an agent of such a practitioner, supervised by and under the order of the licensed practitioner . This agent is required to be a pharmacist, registered nurse, or licensed practical nurse, or any other healthcare professional authorized by and if consistent with Federal and State law to administer or dispense opioid drugs.

(2) OTPs shall use only those opioid agonist treatment medications MOUD that are approved by the Food and Drug Administration under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) for use in the treatment of opioid use disorderOUD. In addition, OTPs who are fully compliant with the protocol of an investigational use of a drug and other conditions set forth in the application may administer a drug that has been authorized by the Food and Drug Administration under an investigational new drug application under section 505(i) of the Federal Food, Drug, and Cosmetic Act for investigational use in the treatment of opioid use disorderOUD. Currently the following opioid agonist treatment medications MOUD will be considered to be approved by the Food and Drug Administration for use in the treatment of opioid use disorderOUD:

(i) Methadone;

(ii) Levomethadyl acetate (LAAM); and

(iii)

Buprenorphine and buprenorphine combination products that have been approved for use in the treatment of

opioid use disorder

OUD; and

(iii) Naltrexone.

(3) OTPs shall maintain current procedures that are adequate to ensure that the following dosage form and initial dosing requirements are met:

(i) Methadone shall be administered or dispensed only in oral form and shall be formulated in such a way as to reduce its potential for parenteral abusemisuse.

(ii) For each new patient enrolled in a programan OTP, the initial dose of methadone shall not exceed 30 milligrams and the be individually determined and shall include consideration of the type(s) of opioid(s) involved in the patient's opioid use disorder, other medications or substances being taken, medical history, and severity of opioid withdrawal. The total dose for the first day shall should not exceed 40 50 milligrams , unless the program physician unless the OTP practitioner, licensed under the appropriate State law and registered under the appropriate State and Federal laws to administer or dispense MOUD, finds sufficient medical rationale, including but not limited to if the patient is transferring from another OTP on a higher dose that has been verified, and documents in the patient's record that 40 milligrams did not suppress opioid abstinence symptomsa higher dose was clinically indicated.

(4) OTPs shall maintain current procedures adequate to ensure that each opioid agonist treatment medication MOUD used by the program is administered and dispensed in accordance with its FDA approved product labeling. Dosing and administration decisions shall be made by a program physician familiar with the most up-to-date product labeling. These procedures The program must ensure that any significant deviations from the approved labeling, including deviations with regard to dose, frequency, or the conditions of use described in the approved labeling, are specifically documented in the patient's record.

(i) Unsupervised or “take-home” use. To limit the potential for diversion of opioid agonist treatment medications to the illicit market, opioid agonist treatment medications dispensed to patients for unsupervised use shall be subject to the following requirements. medication doses. Unsupervised or “take-home” medication doses may be provided under the following circumstances:

(1) Any patient in comprehensive maintenance treatment may receive a single their individualized take-home dose for a day doses as ordered for days that the clinic is closed for business, including Sundays one weekend day (e.g., Sunday) and State and Federal holidays, no matter their length of time in treatment.

(2) Treatment program OTP decisions on dispensing opioid treatment medications MOUD to patients for unsupervised use beyond that set forth in paragraph (i)(1) of this section , shall be determined by an appropriately licensed OTP medical practitioner or the medical director. In determining which patients may be permitted receive unsupervised usemedication doses, the medical director or program medical practitioner shall consider, among other pertinent factors that indicate that the following take-home criteria in determining whether a patient is responsible in handling opioid drugs for unsupervised use. therapeutic benefits of unsupervised doses outweigh the risks, the following criteria:

(i) Absence of recent abuse of drugs (opioid or nonnarcotic), including alcoholactive substance use disorders, other physical or behavioral health conditions that increase the risk of patient harm as it relates to the potential for overdose, or the ability to function safely;

(ii) Regularity of clinic attendance for supervised medication administration;

(iii) Absence of serious behavioral problems at the clinicthat endanger the patient, the public or others;

(iv) Absence of known recent criminal activity, e.g., drug dealingdiversion activity;

(v) Stability of the patient's home environment and social relationships;

(vi) Length of time in comprehensive maintenance treatment;

(vii) Assurance that

Whether take-home medication can be safely

stored within the patient's home

transported and stored; and

(

viii) Whether the rehabilitative benefit the patient derived from decreasing the frequency of clinic attendance outweighs the potential risks of diversion

vi) Any other criteria that the medical director or medical practitioner considers relevant to the patient's safety and the public's health.

(3) Such determinations and the basis for such determinations consistent with the criteria outlined in paragraph (i)(2) of this section shall be documented in the patient's medical record. If it is determined that a patient is responsible in handling opioid drugssafely able to manage unsupervised doses of MOUD, the dispensing restrictions set forth in paragraphs (i)(3)(i) through (viiii) of this section apply. The dispensing restrictions set forth in paragraphs (i)(3)(i) through (viiii) of this section do not apply to buprenorphine and buprenorphine products listed under paragraph (h)(2)(iiiii) of this section.

(i) During the first 90 14 days of treatment, the take-home supply (beyond that of paragraph (i)(1) of this section) is limited to a single dose each week and the patient shall ingest all other doses under appropriate supervision as provided for under the regulations in this subpart.

(ii) In the second 90

7 days. It remains within the OTP practitioner's discretion to determine the number of take-home doses up to 7 days, but decisions must be based on the criteria listed in paragraph (i)(2) of this section. The rationale underlying the decision to provide unsupervised doses of methadone must be documented in the patient's clinical record, consistent with paragraph (g)(2) of this section.

(ii) From 15 days of treatment, the take-home supply (beyond that of paragraph (i)(1) of this section) are two doses per week.

(iii) In the third 90

is limited to 14 days. It remains within the OTP practitioner's discretion to determine the number of take-home doses up to 14 days, but this determination must be based on the criteria listed in paragraph (i)(2) of this section. The rationale underlying the decision to provide unsupervised doses of methadone must be documented in the patient's clinical record, consistent with paragraph (g)(2) of this section.

(iii) From 31 days of treatment, the take-home supply (beyond that of paragraph (i)(1) of this section) are three doses per week.

(iv) In the remaining months of the first year, a patient may be given a maximum 6-day supply of take-home medication.

(v) After 1 year of continuous treatment, a patient may be given a maximum 2-week supply of take-home medication.

(vi) After 2 years of continuous treatment, a patient may be given a maximum one-month supply of take-home medication, but must make monthly visits.

(4) No medications shall be dispensed to patients in short-term detoxification treatment or interim maintenance treatment for unsupervised or take-home use.

(5)

provided to a patient is not to exceed 28 days. It remains within the OTP practitioner's discretion to determine the number of take-home doses up to 28 days, but this determination must be based on the criteria listed in paragraph (i)(2) of this section. The rationale underlying the decision to provide unsupervised doses of methadone must be documented in the patient's clinical record, consistent with paragraph (g)(2) of this section.

(4) OTPs must maintain current procedures adequate to identify the theft or diversion of take-home medications, including labeling containers with the OTP's name, address, and telephone number. Programs also must ensure that each individual take-home

supplies are

dose is packaged in a manner that is designed to reduce the risk of accidental ingestion, including child-proof containers (see Poison Prevention Packaging Act,

Public Law

Pub. L. 91-601 (15 U.S.C. 1471 et seq.)). Programs must provide education to each patient on: Safely transporting medication from the OTP to their place of residence; and the safe storage of take-home doses at the individual's place of residence, including child and household safety precautions. The provision of this education should be documented in the patient's clinical record.

(j) Interim maintenance treatment.

(1) The program sponsor of a public or nonprofit private an OTP may place admit an individual, who is eligible for admission to comprehensive maintenance treatment, in into interim maintenance treatment if the individual cannot be placed in a public or nonprofit private comprehensive program comprehensive services are not readily available within a reasonable geographic area and within 14 days of the individual's application for admission to comprehensive maintenance seeking treatment. An initial and at At least two other urine screens drug tests shall be taken obtained from interim patients during the maximum of 120 180 days permitted for such interim treatment. A program shall establish and follow reasonable criteria for establishing priorities for transferring moving patients from interim maintenance to comprehensive maintenance treatment. These transfer transition criteria shall be in writing and shall include, at a minimum, a preference for pregnant women prioritization of pregnant patients in admitting patients to interim maintenance treatment and in transferring patients from interim maintenance to comprehensive maintenance treatment. Interim maintenance treatment shall be provided in a manner consistent with all applicable Federal and State laws, including sections 1923, 1927(a), and 1976 of the Public Health Service Act (21 U.S.C. 300x-23, 300x-27(a), and 300y-11).

(2) The program shall notify the State health officer SOTA when a patient begins interim maintenance treatment, when a patient leaves interim maintenance treatment, and before the date of mandatory transfer to a comprehensive programservices, and shall document such notifications.

(3) SAMHSA The Secretary may revoke the interim maintenance authorization for programs that fail to comply with the provisions of this paragraph (j). Likewise, SAMHSA the Secretary will consider revoking the interim maintenance authorization of a program if the State in which the program operates is not in compliance with the provisions of § 8.11(gh).

(4) All requirements for comprehensive maintenance treatment apply to interim maintenance treatment with the following exceptions:

(i) The opioid agonist treatment medication is required to be administered daily under observation;

(ii) Unsupervised or “take-home” use is not allowed;

(iii) An initial treatment plan and periodic treatment plan evaluations are not required;

(iv)

A primary counselor is not required to be assigned to the patient, but crisis services, including shelter support, should be available;

(

v

ii) Interim

maintenance

treatment cannot be provided for longer than

120

180 days in any 12-month period;

(iii) By day 120, a plan for continuing treatment beyond 180 days must be created, and

(vi) Rehabilitative, education, and other counseling

documented in the patient's clinical record; and

(iv) Formal counseling, vocational training, employment, economic, legal, educational, and other recovery support services described in paragraphs (f)(4)

,

and (f)(5)(i)

,

and (

f)(5)(

iii) of this section are not required to be

provided

offered to the patient.

[66 FR 4090, Jan. 17, 2001, as amended at 68 FR 27939, May 22, 2003; 77 FR 72761, Dec. 6, 2012; 80 FR 34838, June 18, 2015]

However, information pertaining to locally available, community-based resources for ancillary services should be made available to individual patients in interim treatment.