On the following pages you will be able to fill out and submit an SMA-163 form,
and additional required documents, online to the Substance Abuse and Mental Health
Services Administration (SAMHSA). The instructions below will help you prepare a
complete SMA-163 submission that can be processed expeditiously by SAMHSA. You may
these instructions for use as a checklist in obtaining and preparing all required
information and documents for your SMA-163 submission.
Although the additional documents you need to provide (e.g., the accreditation body’s
nonprofit status) to SAMHSA are not required at the same time you submit your online
SMA-163 (you may submit them separately by ground mail or fax), doing so will expedite
the processing of your form. SAMHSA will not begin processing an SMA-163 until all
required additional documentation is received. We recommend that you obtain and
prepare all required documents in electronic format (e.g., Word, PDF) for attachment
with your online SMA-163.
After reading these instructions, and preparing all required additional documents
for upload, click 'Continue' at the bottom of the page to begin completing your
When Should an Accreditation Body Submit an SMA-163 Form to SAMHSA?
An accreditation body should submit an SMA-163 form to SAMHSA for any of the following
- To apply to SAMHSA for approval to serve as an accreditation body
- To apply for renewal of SAMHSA approval as an accreditation body (required every
Who May Submit an SMA-163 Form?
An SMA-163 may only be submitted/signed by a responsible official from the accreditation
body. The responsible official’s name and contact information, including telephone
number and e-mail address, are required on the form. After submitting an online
SMA-163, a confirmation e-mail will be sent to the responsible official. The responsible
official will need to click a link supplied in that e-mail in order to sign the
SMA-163 electronically and complete the submission process. The submission process
will not be complete until the responsible official clicks the link in that e-mail.
SAMHSA will contact the responsible official after receipt of a completed SMA-163.
What Information Is Required on the SMA-163 Form?
The following information is required on all SMA-163 forms submitted online:
- Accreditation body name
- Accreditation body address and contact information
- Responsible official name
- Responsible official address and contact information
- Purpose of the application (New, Renewal)
What Additional Documents Are Required To Be Sent With an SMA-163 Form?
After filling out the online SMA-163 form, you will be presented with a page that
shows the additional required documents. On that page you may attach the additional
documents in electronic format (e.g., Word, PDF), and they will be submitted to
SAMHSA with your SMA-163.
The following sections detail the additional documents that are required with the
online SMA-163 form.
- A description of evidence of the accreditation body’s nonprofit status (i.e., of
fulfilling Internal Revenue Service requirements as a nonprofit organization) if
the accreditation body is not a State governmental entity or political subdivision.
- A description of accreditation elements and a detailed discussion showing how the
proposed accreditation elements will ensure that each OTP surveyed by the accreditation
body is qualified to meet or is meeting each of the Federal opioid treatment standards
set forth under 42 CFR § 8.12.
- A detailed description of the accreditation body’s decision making process, including:
procedures for initiating and performing onsite accreditation surveys of OTPs, procedures
for assessing OTP personnel qualifications; copies of an application for accreditation,
guidelines, instructions, and other materials that the accreditation body will send
to OTPs during the accreditation process; policies and procedures for notifying
OTPs of deficiencies and for suspending or revoking an OTP’s accreditation; policies
and procedures for ensuring the timely processing of accreditation applications,
and a description of the accreditation body’s appeals process to allow OTPs to contest
adverse accreditation decisions.
- A description of the policies and procedures established by the accreditation body
to avoid conflicts of interest, or the appearance of conflicts of interest, by the
accreditation body’s board members, commissioners, professional personnel, consultants,
administrative personnel, and other representatives.
- A description of the education, experience, and training requirements for the accreditation
body’s professional staff, accreditation survey team membership, and the identification
of at least one licensed physician on the accreditation body’s staff, along with
a description of the accreditation body’s training policies and survey fee schedules
with supporting cost data.
- Assurance that the accreditation body will comply with the accreditation body responsibilities
set forth under 42 CFR §8.4, including a contingency plan for investigating complaints
under 42 CFR §8.4 (e).
- A description of the policies and procedures that the accreditation body has established
to protect confidential information that the accreditation body will collect or
receive in its role as an accreditation body.