Instructions for Submitting an Online SMA-162 Form
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On the following pages you will be able to fill out and submit to SAMHSA an online SMA-162 form and additional required documents. 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 documents for your SMA-162 submission. When ready, click 'Continue' at the bottom of the page to begin completing your online SMA-162.

 

When Should an Opioid Treatment Program (OTP) Submit an SMA-162 form to SAMHSA?
 

An OTP should submit an SMA-162 form to SAMHSA for any of the following purposes:
    1. To apply to SAMHSA for provisional (initial) certification of an OTP
    2. To apply to SAMHSA for renewal of certification of an OTP
    3. To notify SAMHSA of change of Program Sponsor
    4. To notify SAMHSA of change of Medical Director
    5. To apply to SAMHSA for relocation
    6. To apply to SAMHSA for addition of new medical unit (satellite clinic or mobile unit)
 
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 in order 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.
 
What Additional Documents are Required With an SMA-162 Form?

Depending on the Purpose(s) of Request you select in block 14 of the SMA-162 form, you will need to provide SAMHSA with certain additional documentation (e.g., description of program accreditation status). You will be able to attach these additional required documents in electronic format to your online SMA-162 for submission to SAMHSA.

Although the additional documents are required by SAMHSA to process your SMA-162 form, it is not required that they be submitted as attachments with you online form. You may, if necessary, submit them to SAMHSA later by ground mail or fax. However, we recommend you do submit them electronically with your online SMA-162, as doing so will expedite the processing of your form. SAMHSA will not begin processing an SMA-162 until all required additional documentation is received.

Required documents may be attached to the online SMA-162 form in .TXT, .DOC, or .PDF formats.

The following sections detail the additional documents that are required for each purpose selected on the SMA-162 form.

For Notification of New Program Sponsor:

  • No additional documents required

For Notification of New Medical Director:

  1. A copy of the Medical Director's State license

  2. A copy of the Medical Director's Curriculum Vitae.

  3. 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.

For Relocation of Program Primary Dispensing Address:

  1. 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 entity.

For New Medication Unit:

  1. A description of how the medication unit receives the medication supply from the primary facility

  2. An affirmative statement that the medication unit is limited to administering and dispensing the narcotic treatment drug and collecting samples for drug testing or analysis

  3. An affirmative statement that the sponsor agrees to retain responsibility for patient care

For Renewal/Re-certification:

  1. 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.

For Provisional (initial) Certification:

  1. 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 status.

  2. 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.

  3. 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.

  4. 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 entity.

  5. 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.

  6. Name and address of any facility other than the primary dispensing site where methadone or LAAM will be dispensed either on a regular basis or on weekends, and as a service to the treatment program.

  7. A copy of the Medical Director's State license.

  8. A copy of the Medical Director's Curriculum Vitae.

  9. 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.

  10. 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 or LAAM at the program. These would include pharmacists, registered nurses, and licensed practical nurses.

  11. 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.

  12. A list of the sources of funding, including the name and address of each governmental agency providing funds.

  13. A description of the number of patients that will be treated by the program when it is operating at capacity.

  14. An affirmative statement that the treatment program will use containers having safety closures for all take-home medication dispensed to outpatients.

  15. 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.

 
Note to users of screen readers and other assistive technologies: Please report your problems
to us at otp-extranet@opioid.samhsa.gov.
link to the Substance Abuse & Mental Health Services Administration