§ 8.11 - Opioid treatment program certification.

§ 8.11 Opioid treatment program Treatment Program certification.

(a) General.

(1) An OTP must be the subject of a current, valid certification from SAMHSA the Secretary to be considered qualified by the Secretary under section 303(g)(1) of the Controlled Substances Act (21 U.S.C. 823(gh)(1)) to dispense opioid drugs MOUD in the treatment of opioid use disorderOUD. An OTP must be determined to be qualified under section 303(g)(1) of the Controlled Substances Act, and must be determined to be qualified by the Attorney General under section 303(g)(1), to be registered by the Attorney General to dispense opioid agonist treatment medications MOUD to individuals for treatment of opioid use disorderOUD.

(2) To obtain certification from SAMHSAthe Secretary, an OTP must meet the Federal opioid Opioid Use Disorder treatment standards in § 8.12, must be the subject of a current, valid accreditation by an accreditation body Accreditation Body or other entity designated by SAMHSA, the Secretary and must comply with any other conditions for certification established by SAMHSAthe Secretary.

(3) OTPs are expected to maintain certification with the Secretary and to comply with any other conditions for certification established by the Secretary. Certification shall be granted for a term not to exceed 3 years, except that certification may be extended renewed during the third final certification year if an application for accreditation is pending.

(b) Application for certification. Three copies of an application for certification must be submitted by the OTP to the address identified in § 8.3(b). SAMHSA will consider and accept the electronic submission of these materials when electronic submission systems are developed and available. The application for certification shall include

the OTP applies for certification renewal in accordance with the steps outlined in paragraph (a)(4) of this section.

(4) OTPs which satisfy the criteria for certification under this section may apply for renewal of their certification. OTPs are expected to apply for certification renewal during the final year of the OTP's certification period. OTPs should take steps to ensure that administrative tasks associated with renewal are completed before the OTP's certification expires. OTPs may apply for certification renewal in accordance with the procedures as outlined in paragraph (b) of this section. If an OTP anticipates any delays in routine certification renewal, an extension may be requested by submitting to the Secretary a statement justifying the extension in accordance with paragraph (e) of this section.

(5) OTPs that are certified and are seeking certification renewal, and who have been granted accreditation for one year by an Accreditation Body as provided under § 8.4(b)(1)(iii), may receive a conditional certification for one year unless the Secretary determines that such conditional certification would adversely affect patient health. An OTP must obtain a standard 3-year certification, as described in paragraph (a)(3) of this section, within the 1-year conditional certification period. If standard accreditation is not obtained by the OTP within the 1-year conditional certification period, the OTP's conditional certification will lapse, and the Attorney General will be notified that the OTP's registration should be revoked.

(6) OTPs whose certification has expired, and who seek re-certification, will be considered “new” programs and will be required to apply for provisional certification in accordance with paragraph (d) of this section.

(b) Application for initial or renewal certifications and re-certification. Applications for certification must be submitted by the OTP using form SMA-162. The application for initial or renewal of certification shall include, as determined by the Secretary:

(1) A description of the current accreditation status of the OTP;

(2) A description of the organizational structure of the OTP;

(3) The names of the persons responsible for the OTP;

(4) The addresses of the OTP and of each medication unit or other facility under the control of the OTP;

(5) The sources of funding for the OTP and the name and address of each governmental entity that provides such funding; and

(6) A statement that the OTP will comply with the conditions of certification set forth in paragraph (fg) of this section. ; and

(7) The application shall be signed by the program sponsor who shall certify that the information submitted in the application is truthful and accurate.

(8) Applications for re-certification shall include an explanation of why the OTP's most recent certification expired and information regarding the schedule for an accreditation survey.

(c) Action on application.

(1) Following SAMHSAthe Secretary's receipt of an application for certification of an OTP, and after consultation with the appropriate State authority regarding the qualifications of the applicant, SAMHSA the Secretary may grant the application for certification, or renew an existing certification, if SAMHSA the Secretary determines that the OTP has satisfied the requirements for certification or renewal of certification in this section.

(2) SAMHSA The Secretary may deny the application if SAMHSA the Secretary determines that:

(i) The application for certification is deficient in any respect;

(ii) The OTP will not be operated in accordance with the Federal opioid Opioid Use Disorder treatment standards established under § 8.12;

(iii) The OTP will not permit an inspection or a survey to proceed, or will not permit in a timely manner access to relevant records or information; or

(iv) The OTP has made misrepresentations in obtaining accreditation or in applying for certification.

(3) Within 5 days after it reaches a final determination that an OTP meets the requirements for certification in this section, SAMHSA the Secretary will notify the Drug Enforcement Administration (DEA) that the OTP has been determined to be qualified to provide opioid OUD treatment under section 303(g)(1) of the Controlled Substances Act.

(d) Transitional Provisional certification. New OTPs that before May 18, 2001 were the subject of a current, valid approval by FDA under 21 CFR, part 291 (contained in the 21 CFR parts 200 to 299 edition, revised as of July 1, 2000), are deemed to be the subject of a current valid certification for purposes of have not received the Secretary's certification previously, except as provided in paragraph (a)(116) of this section. Such “transitional certification” will expire on August 17, 2001 unless the OTP submits the information required by paragraph (b) of this section to SAMHSA on or before August 17, 2001. In addition to this application, OTPs must certify with a written statement signed by the program sponsor, that they will apply for accreditation within 90 days of the date SAMHSA approves the second accreditation body. Transitional certification, in that case, will expire on May 19, 2003. SAMHSA may extend the transitional certification of an OTP for up to one additional year provided the OTP demonstrates that it has applied for accreditation, that an accreditation survey has taken place or is scheduled to take place, and that an accreditation decision is expected within a reasonable period of time (e.g., within 90 days from the date of survey). Transitional certification under this section may be suspended or revoked in accordance with § 8.14.

(e) Provisional certification.

(1) OTPs that have no current certification from SAMHSA, but have

, who are applying for certification from the Secretary, and who have applied for accreditation with an

accreditation body

Accreditation Body, are eligible to receive

a

provisional certification for up to 1 year. To receive

a

provisional certification, an OTP shall submit the information required by paragraph (b) of this section to

SAMHSA

the Secretary along with a statement identifying the

accreditation body

Accreditation Body to which the OTP has applied for accreditation, the date on which the OTP applied for accreditation, the dates of any accreditation surveys that have taken place or are expected to take place, and the expected schedule for completing the accreditation process.

A provisional

Provisional certification for up to 1 year will be granted, following receipt of the information described in this paragraph (d), unless

SAMHSA

the Secretary determines that patient health would be adversely affected by the granting of provisional certification.

(

(

2) An extension of provisional certification may be granted in extraordinary circumstances or otherwise to protect public health. To apply for a 90-day extension of provisional certification, an OTP shall submit to SAMHSA a statement explaining its efforts to obtain accreditation and a schedule for obtaining accreditation as expeditiously as possible.

(f) Conditions for certification.

e) Requirements for certification.

(1) OTPs shall comply with all pertinent Federal and State laws and regulations. Nothing in this part is intended to limit the authority of State and, as appropriate, local governmental entities to regulate the use of

opioid drugs

MOUD in the treatment of

opioid use disorder

OUD. The provisions of this section requiring compliance with requirements imposed by State law, or the submission of applications or reports required by the State authority, do not apply to OTPs operated directly by the Department of Veterans Affairs, the Indian Health Service, or any other department or agency of the United States.

Federal agencies operating OTPs have agreed to cooperate voluntarily with State agencies by granting permission on an informal basis for designated State representatives to visit Federal OTPs and by furnishing a copy of Federal reports to the State authority, including the reports required under this section.

(2) OTPs shall allow, in accordance with Federal controlled substances laws and Federal confidentiality laws, inspections and surveys by duly authorized employees of the Department of Health and Human Services (HHS) or Substance Abuse and Mental Health Services Administration (SAMHSA), by

accreditation bodies

Accreditation Bodies, by the Drug Enforcement Administration (DEA), and by authorized employees of any

relevant State or

other Federal governmental entity with legal authority to conduct inspections or surveys on an OTP's premises.

(3) Disclosure of patient records maintained by an OTP is governed by the provisions of 42 CFR part 2 and 45 CFR parts 160 and 164, and every program must comply with

that part

these regulations, as applicable. Records on the receipt, storage, and distribution of

opioid agonist treatment medications

MOUD are also subject to inspection under Federal controlled substances laws and under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321 et seq.). Federally

-

sponsored treatment programs are subject to applicable Federal confidentiality statutes.

(4)

A treatment program

An OTP or medication unit or any part thereof, including any facility or any individual, shall permit a duly authorized employee of the Department of Health and Human Services or SAMHSA to have access to and to copy all records on the use of

opioid drugs

MOUD in accordance with the provisions of 42 CFR part 2 and 45 CFR parts 160 and 164.

(5) OTPs shall notify

SAMHSA

the Secretary in writing within 3 weeks of any replacement or other change in the status of the program sponsor or medical director.

(6) OTPs shall comply with all regulations enforced by the DEA under 21 CFR chapter II

,

and must be registered by the DEA before administering or dispensing

opioid agonist treatment medications

MOUD.

(7) OTPs must operate in accordance with Federal

opioid

Opioid Use Disorder treatment standards and approved accreditation elements.

(

g

f)Conditions for interim

maintenance

treatment program approval.

(1) Before

a public or nonprofit private

an OTP may provide interim

maintenance

treatment, the

program

OTP must receive the approval of both

SAMHSA

the Secretary and the

chief public health officer

SOTA of the State in which the OTP operates.

(2) Before

SAMHSA

the Secretary may grant such approval, the OTP must provide

SAMHSA

the Secretary with documentation from the

chief public health officer

SOTA of the State in which the OTP operates demonstrating that:

(i) Such officer does not object to the providing of interim

maintenance

treatment in the State;

(ii) The OTP seeking to provide such treatment is unable to

place

provide access for patients in a

public or nonprofit private

comprehensive treatment program within a reasonable geographic area within 14 days of the time patients seek

admission to such programs

treatment for OUD;

(iii) The authorization of the OTP to provide interim

maintenance

treatment will not otherwise reduce the capacity of comprehensive

maintenance

treatment programs in the State to admit individuals (relative to the date on which such officer so certifies); and

(iv)

The State certifies that each individual enrolled in interim maintenance treatment will be transferred

OTPs providing interim treatment will arrange for each individual's transfer to a comprehensive

maintenance

treatment program no later than

120

180 days from the date on which each individual first requested treatment

, as provided in section 1923 of the Public Health Service Act (21 U.S.C. 300x-23). (3) SAMHSA

. Individuals enrolled in interim treatment shall not be discharged without the approval of an OTP practitioner, who shall consider on-going and patient-centered treatment needs, which are to be documented in the patient record, while awaiting transfer to a comprehensive treatment program.

(3) The Secretary will provide notice to the OTP denying or approving the request to provide interim

maintenance

treatment. The OTP shall not provide such treatment until it has received such notice from

SAMHSA

the Secretary.

(

h

g) Exemptions. An OTP may, at the time of application for certification or any time thereafter, request from

SAMHSA

the Secretary exemption from the regulatory requirements set forth under this section and § 8.12. An example of a case in which an exemption might be granted would be for a private practitioner who wishes to treat a limited number of patients in a non-metropolitan area with few physicians and no

rehabilitative

OUD treatment services geographically accessible, and requests exemption from some of the staffing and service standards. The OTP shall support the rationale for the exemption with thorough documentation, to be supplied in an appendix to the initial application for certification or in a separate submission.

SAMHSA

The Secretary will approve or deny such exemptions at the time of application, or any time thereafter, if appropriate.

SAMHSA

The Secretary shall consult with the appropriate State authority prior to taking action on an exemption request.

(

i

h) Medication units, long-term care facilities and hospitals.

(1) Certified OTPs may establish medication units that are authorized to dispense

opioid agonist treatment medications for observed ingestion

MOUD. Before establishing a medication unit, a certified OTP must notify

SAMHSA

the Secretary by submitting form SMA-162. The OTP must also comply with the provisions of 21 CFR part 1300 before establishing a medication unit. Medication units shall comply with all pertinent

state

State laws and regulations. Medication units include both mobile and brick and mortar facilities.

(2) Specifically, any services that are provided in an OTP may be provided in the medication unit, assuming compliance with all applicable Federal, State, and local law, and the use of units that provide appropriate privacy and have adequate space.

(3) Certification as an OTP under this part

will

is not

be

required for the

maintenance

initiation or

detoxification treatment

continuity of medication treatment or withdrawal management of a patient who is admitted to a hospital

or

, long-term care facility, or correctional facility, that is registered with the Drug Enforcement Administration as a hospital/clinic, for the treatment of medical conditions other than

opioid use disorder

OUD, and who requires

maintenance or detoxification treatment during the period of his or her stay in that hospital or long-term care facility. The terms “hospital” and

treatment of OUD with methadone during their stay, when such treatment is permitted under applicable Federal law.

(i) The term “long-term care facility”

as used in this section are to have the meaning that is assigned under the law of the State in which the treatment is being provided.

is defined in § 8.2. Nothing in this section is intended to relieve hospitals

and

, or long-term care facilities

from the obligation to obtain

and correctional facilities that are registered with the Drug Enforcement Administration as a hospital/clinic, from their obligations to obtain appropriate registration from the Attorney General,

as appropriate,

under section 303(g) of the Controlled Substances Act.

[66 FR 4090, Jan. 17, 2001, as amended at 66 FR 15347, Mar. 19, 2001

Treatment provided under this section should always comply with applicable Federal laws.

(ii) [Reserved]