Online Form SMA-162 for Provisional Certification of a New Opioid Treatment Program

Instructions

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).

The instructions below will help you prepare a complete SMA-162 submission that can be processed expeditiously by SAMHSA. You may wish to print 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.

Who May Submit an SMA-162 Form?

An SMA-162 may only be submitted/signed by an OTP Program Sponsor. The Program Sponsor's name and contact information, including telephone number and e-mail address, are required on the form. After submitting an online SMA-162, a confirmation e-mail will be sent to the Sponsor. The Sponsor will need to click a link supplied in that e-mail withing 3 days to electronically sign the SMA-162 and complete the submission process. The submission process will not be complete until the Sponsor clicks the link in that e-mail. SAMHSA will contact the Sponsor after receipt of a completed SMA-162 if additional information is required.

Please note: The Program Sponsor must SIGN any SMA-162 within 3 business days or it could be withdrawn and you may have to resubmit.

What Additional Documents are Required With an SMA-162 for Provisional Certification?

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 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 detailed labeled floor diagram. Please label all areas of the building.
• A written 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 entity.
• 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 services.
• 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. If there is none include a statement.
• A copy of the Medical Director's State license.
• A copy of the Medical Director's DEA Registration.
• 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.