Authority to Operate an Opioid Treatment Program

(A) Compliance with Other Laws, Rules, Regulations and Standards. In addition to 105 CMR 164.000, the Licensed or Approved Provider shall comply with the following: (1) M.G.L. c. 94C governing controlled substances and 105 CMR 700.00: Implementation of M.G.L. c. 94C governing controlled substance registration; and (2) 21 CFR Parts 1300 through 1399 of the U.S. Department of Justice, Drug Enforcement Administration (DEA) regulations requiring registration under the Controlled Substances Act. (B) Current Certification. The Licensed or Approved Provider shall have a current valid certificate from the Substance Abuse and Mental Health Services Administration of the U.S. Department of Health and Human Services, in compliance with 42 CFR Part 8. (C) Accreditation. The Licensed or Approved Provider shall be accredited by an accrediting organization approved by the Substance Abuse and Mental Health Service Administration. If the Licensed or Approved Provider has operated an opioid treatment program for less than one year, the Licensed or Approved Provider shall obtain accreditation by the end of the first year of operation. (D) State Opioid Treatment Authority Approval. No one may operate an opioid treatment program in the Commonwealth of Massachusetts without Department and State Opioid Treatment Authority Approval, except for opioid treatment programs operated by the Veterans Administration or programs directly operated by the federal government. Persons who hold a current Department-issued License or Approval and State Opioid Treatment Authority Approval to operate an opioid treatment program may not open a new or relocated facility, or transfer ownership, without applying for and receiving a new License or Approval and State Opioid Treatment Authority Approval. (1) Upon receipt of the Request for State Opioid Treatment Authority to Operate an Opioid Treatment Program, the Department shall review and make a determination as to whether the applicant has met all state and federal standards and the interests of public health would be served by the establishment of the opioid treatment program. Should the Department determine the applicant meets all such requirements, the Department will approve the Request and shall forward the State Opioid Treatment Authority Approval to the SAMHSA. (2) Upon State Authority Approval, the Department shall issue a Provisional License valid for six months and shall sign and forward it to the SAMHSA. (3) The Department may review the program's operations during the provisional licensing period. Following the provisional period, the Department shall make a recommendation regarding the issuance of a two-year license. (4) If the Department determines that the applicant has not met the requirements of state and federal regulations and/or the interests of public health are not served by the establishment of the opioid treatment program at the proposed site, the Department shall deny State Authority Approval of the application in writing, citing specific reasons for denial, and forward its denial to the SAMHSA. If denied, the applicant may request an adjudicatory hearing, pursuant to M.G.L. c. 30A and 801 CMR 1.01(7): Motions. (5) The State Authority may make a request to SAMHSA to revoke SAMHSA approval of a opioid treatment program for cause. (E) Deemed Status. (1) License Renewal Based on Accreditation. In considering an application for renewal of a license to operate an opioid treatment program pursuant to 105 CMR 164.008, the Department may in its complete discretion accept accreditation as evidence of compliance with one or more requirements of 105 CMR 164.000, and grant deemed status to the Licensed or Approved Provider, provided that: (a) The Licensed or Approved Provider's accreditation is not provisional; (b) The Licensed or Approved Provider meets all requirements of 105 CMR 164.000; (c) The Licensed or Approved Provider submits documentation to the Department as follows: 1. the accreditation letter; 2. the accrediting body's explanation of its survey findings; and 3. the Licensed or Approved Provider's response to the accrediting body's explanation, submitted to the Department at the same time it is submitted to the accrediting body. (d) The Licensed or Approved Provider provides written consent to permit the Department to observe the accrediting body's summation conference(s); and (e) The Licensed or Approved Provider agrees in writing to release to the Department any other accreditation information requested. Licensed or Approved Providers requesting renewal based on accreditation shall submit this request on an approved form obtained from the Department, in a manner prescribed by the Department. (2) Department's Decision. The Department's decision to deny a request for deemed status is not subject to review or hearing pursuant to 105 CMR 164.020. If the Department denies the request for deemed status, the Licensed or Approved Provider shall provide full evidence of compliance by submitting an application for renewal as required by 105 CMR 164.008. (3) Required Notifications. Licensed or Approved Providers granted deemed status shall, during the term of the license: (a) provide the Department with the following documentation within ten business calendar days of receipt of such documentation by the Licensed or Approved Provider: 1. accreditation renewal letter(s); 2. accrediting body's explanation(s) of survey findings related to accreditation renewal; the Licensed or Approved Provider shall submit its response(s) to the accrediting body's explanation(s) to the Department at the same time it is submitted to the accrediting body; and 3. notice(s) of any changes to the Licensed or Approved Provider's accreditation status. (b) notify the Department immediately upon loss of accreditation. (4) Department's Authority. In granting deemed status, the Department retains all authority described in 105 CMR 164.000, including authority to evaluate applications; to conduct inspections; and to suspend, deny, refuse to renew, restrict, limit or revoke a license. (5) Additional Grounds for Suspension, Denial, Refusal to Renew, Restriction, Limitation or Revocation of License: In addition to the grounds for such action specified in 105 CMR 164.018 and 105 CMR 164.019, the Department may suspend, deny, refuse to renew, restrict, limit or revoke any license granted by deemed status if: (a) the Licensed or Approved Provider loses its accreditation status; (b) the Licensed or Approved Provider fails to comply with one or more conditions of accreditation; or (c) the Licensed or Approved Provider's accreditation is made provisional.