Section 9. Eligibility For Approval To Operate An Opioid Treatment Program

Only applicants who possess all of the following shall be eligible to receive approval to operate from the New Mexico health care authority (HCA): A. drug enforcement agency (DEA) approval to operate an OTP; B. SAMHSA/CSAT approval to operate an OTP; C. accreditation by a SAMHSA/CSAT-approved nationally recognized accreditation body, such as JCAHO or CARF, to operate an OTP: (1) if the applicant is a start-up program unable to obtain such accreditation prior to beginning operation because the accreditation body requires a period of program operation, typically six months, before it will grant accreditation: (a) the HCA shall grant provisional approval to operate pending accreditation, provided that all other requirements of these regulations are met; and (b) the program demonstrates in its application to the HCA that it is taking the steps necessary to become accredited as quickly as possible, and provides a timeline for the anticipated accreditation; (2) during this interim period, the provisional approval to operate is contingent on the ongoing progress of the program, as determined by the HCA, to obtain accreditation within the timeline contained in the application; the program shall immediately inform the HCA of anything that will delay or prevent accreditation according to that timeline; (3) the HCA shall withdraw its provisional approval if it concludes that accreditation will not be forthcoming; in any event, the program shall obtain accreditation within 12 months of beginning operation, or the provisional approval shall be withdrawn, unless the HCA elects to extend the provisional approval period after consultation with the appropriate federal and accrediting entities. D. a license from the New Mexico state board of pharmacy to operate an OTP; E. other permits and licenses such as a business license from the applicant’s local governmental entity, as required by local ordinances; F. evidence of appropriate liability insurance coverage for the program and its employees sional approval period after consultation with the appropriate federal and accrediting entities. D. a license from the New Mexico state board of pharmacy to operate an OTP; E. other permits and licenses such as a business license from the applicant’s local governmental entity, as required by local ordinances; F. evidence of appropriate liability insurance coverage for the program and its employees. [8.321.10.9 NMAC - N, 7/1/2024] 8.321.10.10 APPLICATION FOR APPROVAL TO OPERATE AN OPIOID TREATMENT PROGRAM: A. Each OTP sponsor applicant shall submit to the HCA an application for approval to operate an opioid treatment program application using the form provided by the HCA. This application shall be in addition to the application to drug enforcement agency, SAMHSA/CSAT, the NM board of pharmacy, local government, etc. B. The HCA shall approve or deny the application within 45 working days of submission, unless the HCA and applicant mutually agree to extend the application review period. C. The HCA may require the applicant to provide additional written or verbal information in order to reach its decision to grant or deny approval. Such further information shall be considered an integral part of the application. D. Approval shall be for a duration of three years, except as otherwise provided below for initial grandfathered approvals. E. The HCA shall not grant approval to operate an OTP to any program sponsor who has been convicted of any crime related to controlled substances laws or any felony within the last five years. No person who 8.321.10 NMAC 4 has been convicted of any felony in the last five years shall be employed by the OTP in any capacity that gives that person access to controlled medications. F thered approvals. E. The HCA shall not grant approval to operate an OTP to any program sponsor who has been convicted of any crime related to controlled substances laws or any felony within the last five years. No person who 8.321.10 NMAC 4 has been convicted of any felony in the last five years shall be employed by the OTP in any capacity that gives that person access to controlled medications. F. The HCA shall not grant approval to any entity that poses a risk to the health and safety of the public based on a history of noncompliance with state and federal regulations as verified by the DEA, New Mexico state board of pharmacy, FDA, SAMSHA approved accreditation bodies, or the state licensure agency in any state in which the program sponsor currently operates. G. The HCA may deny approval if there is a documented history of repeated and serious negative neighborhood impact with respect to other OTP programs currently operated by the program sponsor or by any corporation, LLC or partnership with whom the program sponsor has been associated in the past five years. H. As a condition of approval to operate an OTP, the OTP must maintain or obtain accreditation with a SAMHSA/CSAT-approved nationally recognized accreditation body, (e.g. CARF or JCAHO.) In the event that such accreditation lapses, or approval of an application for accreditation becomes doubtful, or continued accreditation is subject to any formal or informal finding of need for improvement, the OTP program will notify the HCA within two business days of such event. The OTP program will furnish the HCA with all information related to its accreditation status, or the status of its application for accreditation, upon request. I. The application for approval shall be accompanied by a needs assessment, specifying the proposed geographical area to be served, estimated number of patients anticipated, and such other information as may assist the HCA in review of the application ram will furnish the HCA with all information related to its accreditation status, or the status of its application for accreditation, upon request. I. The application for approval shall be accompanied by a needs assessment, specifying the proposed geographical area to be served, estimated number of patients anticipated, and such other information as may assist the HCA in review of the application. The HCA shall take into consideration in making its decision the need for an OTP in a given geographic area and the impact on the community. J. The HCA shall perform on-site inspection of the proposed OTP facility as part of the review and approval process. K. In the event of change of ownership of an approved opioid treatment program, the HCA approval is not transferable; the new ownership must institute an application for approval as a new program, in accordance with these regulations. [8.321.10.10 NMAC - N, 7/1/2024] 8.321.10.11 DENIAL OF HCA APPROVAL TO OPERATE; APPEAL OF DENIAL: A. The HCA shall not deny approval to operate until the applicant has been notified in writing of the deficiency in the application resulting in the contemplated denial, and given opportunity to remedy the application deficiency within a specified time period. B. The HCA shall provide a written explanation for any denied application. Denial may be appealed to the secretary of the HCA, whose decision shall be final. C. An applicant who is denied approval may re-apply by submitting a new application 90 days or more after notification of denial. D. Failure to complete the application form in its entirety, including requests for additional information as specified above, shall be grounds for denial of approval.