[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: 42CFR8.14]



[Page 70]

 

                         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. 8.14  Suspension or revocation of certification.



    (a) Revocation. Except as provided in paragraph (b) of this section, 

SAMHSA may revoke the certification of an OTP if SAMHSA finds, after 

providing the program sponsor with notice and an opportunity for a 

hearing in accordance with subpart C of this part, that the program 

sponsor, or any employee of the OTP:

    (1) Has been found guilty of misrepresentation in obtaining the 

certification;

    (2) Has failed to comply with the Federal opioid treatment standards 

in any respect;

    (3) Has failed to comply with reasonable requests from SAMHSA or 

from an accreditation body for records, information, reports, or 

materials that are necessary to determine the continued eligibility of 

the OTP for certification or continued compliance with the Federal 

opioid treatment standards; or

    (4) Has refused a reasonable request of a duly designated SAMHSA 

inspector, Drug Enforcement Administration (DEA) Inspector, State 

Inspector, or accreditation body representative for permission to 

inspect the program or the program's operations or its records.

    (b) Suspension. Whenever SAMHSA has reason to believe that 

revocation may be required and that immediate action is necessary to 

protect public health or safety, SAMHSA may immediately suspend the 

certification of an OTP before holding a hearing under subpart C of this 

part. SAMHSA may immediately suspend as well as propose revocation of 

the certification of an OTP before holding a hearing under subpart C of 

this part if SAMHSA makes a finding described in paragraph (a) of this 

section and also determines that:

    (1) The failure to comply with the Federal opioid treatment 

standards presents an imminent danger to the public health or safety;

    (2) The refusal to permit inspection makes immediate suspension 

necessary; or

    (3) There is reason to believe that the failure to comply with the 

Federal opioid treatment standards was intentional or was associated 

with fraud.

    (c) Written notification. In the event that SAMHSA suspends the 

certification of an OTP in accordance with paragraph (b) of this section 

or proposes to revoke the certification of an OTP in accordance with 

paragraph (a) of this section, SAMHSA shall promptly provide the sponsor 

of the OTP with written notice of the suspension or proposed revocation 

by facsimile transmission, personal service, commercial overnight 

delivery service, or certified mail, return receipt requested. Such 

notice shall state the reasons for the action and shall state that the 

OTP may seek review of the action in accordance with the procedures in 

subpart C of this part.

    (d)(1) If SAMHSA suspends certification in accordance with paragraph 

(b) of this section:

    (i) SAMHSA will immediately notify DEA that the OTP's registration 

should be suspended under 21 U.S.C. 824(d); and

    (ii) SAMHSA will provide an opportunity for a hearing under subpart 

C of this part.

    (2) Suspension of certification under paragraph (b) of this section 

shall remain in effect until the agency determines that:

    (i) The basis for the suspension cannot be substantiated;

    (ii) Violations of required standards have been corrected to the 

agency's satisfaction; or

    (iii) The OTP's certification shall be revoked.