(a) General. (1) An OTP must be the subject of a current, valid certification from the Secretary to be considered qualified by the Secretary under section 303(g)(1) of the Controlled Substances Act (21 U.S.C. 823(h)(1)) to dispense MOUD in the treatment of OUD. 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 MOUD to individuals for treatment of OUD.

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

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

(6) A statement that the OTP will comply with the conditions of certification set forth in paragraph (g) 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 the 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, the Secretary may grant the application for certification, or renew an existing certification, if the Secretary determines that the OTP has satisfied the requirements for certification or renewal of certification in this section.

(2) The Secretary may deny the application if 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 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, the Secretary will notify the Drug Enforcement Administration (DEA) that the OTP has been determined to be qualified to provide OUD treatment under section 303(g)(1) of the Controlled Substances Act.

(d) Provisional certification. New OTPs that have not received the Secretary's certification previously, except as provided in paragraph (a)(6) of this section, who are applying for certification from the Secretary, and who have applied for accreditation with an Accreditation Body, are eligible to receive provisional certification for up to 1 year. To receive provisional certification, an OTP shall submit the information required by paragraph (b) of this section to the Secretary along with a statement identifying the 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. Provisional certification for up to 1 year will be granted, following receipt of the information described in this paragraph (d), unless the Secretary determines that patient health would be adversely affected by the granting of provisional 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 MOUD in the treatment of 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.

(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, by the Drug Enforcement Administration (DEA), and by authorized employees of any 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 these regulations, as applicable. Records on the receipt, storage, and distribution of 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) 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 MOUD in accordance with the provisions of 42 CFR part 2 and 45 CFR parts 160 and 164.

(5) OTPs shall notify 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 MOUD.

(7) OTPs must operate in accordance with Federal Opioid Use Disorder treatment standards and approved accreditation elements.

(f) Conditions for interim treatment program approval. (1) Before an OTP may provide interim treatment, the OTP must receive the approval of both the Secretary and the SOTA of the State in which the OTP operates.

(2) Before the Secretary may grant such approval, the OTP must provide the Secretary with documentation from the SOTA of the State in which the OTP operates demonstrating that:

(i) Such officer does not object to the providing of interim treatment in the State;

(ii) The OTP seeking to provide such treatment is unable to provide access for patients in a comprehensive treatment program within a reasonable geographic area within 14 days of the time patients seek treatment for OUD;

(iii) The authorization of the OTP to provide interim treatment will not otherwise reduce the capacity of comprehensive treatment programs in the State to admit individuals (relative to the date on which such officer so certifies); and

(iv) OTPs providing interim treatment will arrange for each individual's transfer to a comprehensive treatment program no later than 180 days from the date on which each individual first requested treatment. 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 treatment. The OTP shall not provide such treatment until it has received such notice from the Secretary.

(g) Exemptions. An OTP may, at the time of application for certification or any time thereafter, request from 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 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. The Secretary will approve or deny such exemptions at the time of application, or any time thereafter, if appropriate. The Secretary shall consult with the appropriate State authority prior to taking action on an exemption request.

(h) Medication units, long-term care facilities and hospitals. (1) Certified OTPs may establish medication units that are authorized to dispense MOUD. Before establishing a medication unit, a certified OTP must notify 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 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 is not required for the initiation or continuity of medication treatment or withdrawal management of a patient who is admitted to a hospital, 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 OUD, and who requires treatment of OUD with methadone during their stay, when such treatment is permitted under applicable Federal law.

(i) The term “long-term care facility” is defined in § 8.2. Nothing in this section is intended to relieve hospitals, or long-term care facilities 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, under section 303(g) of the Controlled Substances Act. Treatment provided under this section should always comply with applicable Federal laws.

(ii) [Reserved]