[Code of Federal Regulations]

[Title 42, Volume 1]

[Revised as of October 1, 2005]

From the U.S. Government Printing Office via GPO Access

[CITE: 42CFR8.12]



[Page 65-69]

 

                         TITLE 42--PUBLIC HEALTH

 

    CHAPTER I--PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN 

                                SERVICES

 

PART 8_CERTIFICATION OF OPIOID TREATMENT PROGRAMS--Table of Contents

 

             Subpart B_Certification and Treatment Standards

 

Sec. 8.12  Federal opioid 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. 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 

addiction which may be promulgated in the future. The medical director 

shall assume responsibility for administering all medical 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 and that assigns specific responsibility 

to the medical 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 addiction must have sufficient education, training, and 

experience, or any combination thereof, to enable that person to perform 

the assigned functions. All physicians, nurses, and other licensed 

professional care providers, including addiction counselors, must comply 

with the credentialing requirements of their respective professions.

    (e) Patient admission criteria.--(1) Maintenance 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 shall ensure that each patient voluntarily 

chooses maintenance treatment and that all relevant facts concerning the 

use of the opioid drug are clearly and adequately explained to the 

patient, and that each patient provides informed written consent to 

treatment.

    (2) Maintenance treatment for persons under age 18. A person 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 person 

under 18 years of age may be admitted to maintenance treatment unless a 

parent, legal guardian, or responsible adult designated by



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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. An OTP shall maintain current 

procedures that are designed to ensure that 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.

    (f) Required services.--(1) General. OTPs shall provide adequate 

medical, counseling, vocational, educational, and other assessment and 

treatment services. 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. 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 examination, including the 

results of serology and other tests, must be completed within 14 days 

following admission.

    (3) Special services for pregnant patients. OTPs must maintain 

current policies and procedures that reflect the special needs of 

patients who are pregnant. Prenatal care and other gender specific 

services or pregnant patients must be provided either by the OTP or by 

referral to appropriate healthcare providers.

    (4) Initial and periodic assessment services. Each patient accepted 

for treatment at 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 plan that includes the patient's short-term goals and the 

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

patient's requirements for education, vocational rehabilitation, and 

employment; and the medical, psychosocial, economic, legal, or other 

supportive services that a patient needs. The treatment plan also must 

identify the 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, social, and psychological 

services, and his or her current needs for education, vocational 

rehabilitation, and employment services.

    (5) Counseling services. (i) OTPs must provide adequate substance 

abuse counseling to each patient as clinically necessary. This 

counseling shall be provided by a program counselor, qualified by 

education, training, or experience to assess the psychological and 

sociological background of patients, to contribute to the appropriate 

treatment plan for the patient and to monitor patient progress.

    (ii) OTPs must provide counseling on preventing exposure to, and the 

transmission of, human immunodeficiency virus (HIV) disease for each 

patient admitted or readmitted to maintenance or detoxification 

treatment.

    (iii) OTPs must provide directly, or through referral to adequate 

and reasonably accessible community resources, vocational 

rehabilitation, education, and employment services for patients who 

either request such services or who have been determined by the program 

staff to be in need of such services.



[[Page 67]]



    (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, 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.

    (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 approved for use in treatment of opioid addiction. 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 whether or not the patient is enrolled any other 

OTP. A patient enrolled in an OTP shall not be permitted to obtain 

treatment in any other OTP except in exceptional circumstances. If the 

medical director or program physician 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 circumstances is 

noted in the patient's record both at the OTP in which the patient is 

enrolled and at the OTP that will provide the treatment.

    (h) Medication administration, dispensing, and use. (1) OTPs must 

ensure that opioid agonist treatment medications 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 drugs, 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 Federal and State law to administer or dispense opioid 

drugs.

    (2) OTPs shall use only those opioid agonist treatment medications 

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 addiction. 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 addiction. Currently the following opioid agonist treatment 

medications will be considered to be approved by the Food and Drug 

Administration for use in the treatment of opioid addiction:

    (i) Methadone;

    (ii) Levomethadyl acetate (LAAM); and

    (iii) Buprenorphine and buprenorphine combination products that have 

been approved for use in the treatment of opioid addiction.

    (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 abuse.

    (ii) For each new patient enrolled in a program, the initial dose of 

methadone shall not exceed 30 milligrams and the total dose for the 

first day shall not exceed 40 milligrams, unless the program physician 

documents in the patient's record that 40 milligrams did not suppress 

opiate abstinence symptoms.

    (4) OTPs shall maintain current procedures adequate to ensure that 

each opioid agonist treatment medication used by the program is 

administered and dispensed in accordance with its approved product 

labeling. Dosing and administration decisions shall be made by a program 

physician familiar with



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the most up-to-date product labeling. These procedures 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.

    (1) Any patient in comprehensive maintenance treatment may receive a 

single take-home dose for a day that the clinic is closed for business, 

including Sundays and State and Federal holidays.

    (2) Treatment program decisions on dispensing opioid treatment 

medications to patients for unsupervised use beyond that set forth in 

paragraph (i)(1) of this section, shall be determined by the medical 

director. In determining which patients may be permitted unsupervised 

use, the medical director shall consider the following take-home 

criteria in determining whether a patient is responsible in handling 

opioid drugs for unsupervised use.

    (i) Absence of recent abuse of drugs (opioid or nonnarcotic), 

including alcohol;

    (ii) Regularity of clinic attendance;

    (iii) Absence of serious behavioral problems at the clinic;

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

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

relationships;

    (vi) Length of time in comprehensive maintenance treatment;

    (vii) Assurance that take-home medication can be safely stored 

within the patient's home; and

    (viii) Whether the rehabilitative benefit the patient derived from 

decreasing the frequency of clinic attendance outweighs the potential 

risks of diversion.

    (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 drugs, the 

following restrictions apply:

    (i) During the first 90 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 days of treatment, the take-home supply 

(beyond that of paragraph (i)(1) of this section) is two doses per week.

    (iii) In the third 90 days of treatment, the take-home supply 

(beyond that of paragraph (i)(1) of this section) is 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) 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 take-home supplies are 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 91-601 

(15 U.S.C. 1471 et seq.)).

    (j) Interim maintenance treatment. (1) The program sponsor of a 

public or nonprofit private OTP may place an individual, who is eligible 

for admission to comprehensive maintenance treatment, in interim 

maintenance treatment if the individual cannot be placed in a public or 

nonprofit private comprehensive program within a reasonable geographic 

area and within 14 days



[[Page 69]]



of the individual's application for admission to comprehensive 

maintenance treatment. An initial and at least two other urine screens 

shall be taken from interim patients during the maximum of 120 days 

permitted for such treatment. A program shall establish and follow 

reasonable criteria for establishing priorities for transferring 

patients from interim maintenance to comprehensive maintenance 

treatment. These transfer criteria shall be in writing and shall 

include, at a minimum, a preference for pregnant women in admitting 

patients to interim maintenance and in transferring patients from 

interim maintenance to comprehensive maintenance treatment. Interim 

maintenance 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 when a patient 

begins interim maintenance treatment, when a patient leaves interim 

maintenance treatment, and before the date of mandatory transfer to a 

comprehensive program, and shall document such notifications.

    (3) SAMHSA may revoke the interim maintenance authorization for 

programs that fail to comply with the provisions of this paragraph (j). 

Likewise, SAMHSA 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 Sec. 8.11(g).

    (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;

    (v) Interim maintenance cannot be provided for longer than 120 days 

in any 12-month period; and

    (vi) Rehabilitative, education, and other counseling services 

described in paragraphs (f)(4), (f)(5)(i), and (f)(5)(iii) of this 

section are not required to be provided to the patient.



[66 FR 4090, Jan. 17, 2001, as amended at 68 FR 27939, May 22, 2003]