N.M. Admin. Code § 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 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. 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.
Notes
State regulations are updated quarterly; we currently have two versions available. Below is a comparison between our most recent version and the prior quarterly release. More comparison features will be added as we have more versions to compare.
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 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. 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.