On the following pages you can fill out and submit to SAMHSA an on-line form SMA-162,
and supporting documents, for Provisional (initial) Certification of a new Opioid
Treatment Program (OTP).
Note: Only SMA-162s for provisional certification
of a new OTP can be submitted at this site. Existing OTPs wishing to submit
Form SMA-162 for renewal of certification, or other purposes, must
submit via their account on the SAMHSA OTP Extranet Website at
http://otp-extranet.samhsa.gov. All OTPs have an account on the site.
For help accessing your program's account, contact the SAMHSA OTP Extranet Information
Center at email@example.com,
or 866-687-2728 (866-OTP-CSAT).
The instructions below will help you prepare a complete SMA-162 submission that
can be processed expeditiously by SAMHSA. You may wish to
these instructions for use as a checklist in obtaining and preparing all required
information and supporting documents for your SMA-162 submission. When ready, click
'Continue' at the bottom of the page to begin completing your online SMA-162.
The following supporting documentation is required to be provided with an SMA-162
application for provisional certification of a new OTP. To expedite the submission
and processing of your request, SAMHSA recommends you obtain all required supporting
documents in electronic format (.TXT, .DOC, or .PDF) for attachment to your submission
prior to beginning the completion of the online SMA-162.
Required Supporting Documentation for an SMA-162 Request for Provisional
Certification of a New OTP:
A description of the current accreditation status of the OTP, including the name
and address of the accreditation body and the date of the last accreditation survey.
A copy of the application to the accreditation body to which your program has applied,
including the date on which your program 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.
A description of the organizational structure of the program. Include a chart indicating
the position and title of key personnel of the OTP, which includes the name and
complete address of any central administration or larger organizational structure
to which this program is responsible.
A diagram and description of the facilities to be used by this program. Demonstrate
how the facilities are adequate for drug dispensing and for individual and group
counseling. The description shall specify how the OTP will provide adequate medical,
counseling, vocational, educational, and assessment services at the primary facility,
unless the program sponsor has entered into a formal documented agreement with another
Name, address, and description of each hospital, institution, clinical laboratory,
or other facility used by the OTP program to provide the necessary medical and rehabilitative
Name and address of any facility other than the primary dispensing site where methadone
will be dispensed either on a regular basis or on weekends, and as a service to
the treatment program.
A copy of the Medical Director’s DEA Registration.
A copy of the Medical Director's State license.
A copy of the Medical Director's Curriculum Vitae.
If the Medical Director is also the Medical Director for another treatment program,
enclose a written justification for the feasibility of such an arrangement. This
feasibility shall address the portion of the Medical Director's time spent in the
treatment of unrelated medical patients, memberships on boards and committees that
compete for time allocated to the treatment programs.
Name and State license number of all OTP personnel (other than program physicians)
licensed by law to dispense narcotic drugs even if they are not, at present, responsible
for administering or dispensing methadone at the program. These would include pharmacists,
registered nurses, and licensed practical nurses.
A tentative schedule showing (1) dispensing hours, (2) counseling hours, and (3)
hours to be worked by physicians, nurses, and counselors. Any work to be performed
away from the primary dispensing site, should also be stated. The program must be
open for dispensing at least six days per week. Also, describe how the dispensing
hours are adequate and ensure quality of patient care per 42 CFR §8.12 (b).
A list of the program’s funding sources , including the name and address of each
governmental agency providing funds.
A description of the number of patients that will be treated by the program when
it is operating at capacity.
An affirmative statement that the treatment program will use containers having safety
closures for all take-home medication dispensed to outpatients.
Acknowledgement that the Medical Director and/or program physician must register
for an account on the SAMHSA OTP Extranet Web site to submit Federal patient exception
requests (Form SMA-168) online. Physicians may register for an Extranet account
at the following Web site: http://otp-extranet.samhsa.gov/request.
After the request is verified, the physician will receive an email with a username
and password for the Extranet Web site.
Us | Accessibility | Plain Language
FOIA | Disclaimers
| SAMHSA |
CSAT | HHS | USA.gov
Department of Health and Human Services
Substance Abuse and Mental Health Services Administration, Center for Substance
Division of Pharmacologic Therapies
5600 Fishers Lane • Rockville,
MD 20857 • 240-276-2700 • firstname.lastname@example.org