Notifying SAMHSA of Changes to an Existing Opioid Treatment Program

What Changes to an Existing OTP Require Notification of SAMHSA?

• Change of Program Sponsor
• Change of Medical Director

In addition, existing OTPs must apply to SAMHSA to receive approval for:

• Relocation
• Addition of new medical units (satellite clinics or mobile units)

What supporting documentation is required when notifying/applying to SAMHSA for program changes?

Each notification/application purpose requires different supporting documentation, listed below.  This documentation can be attached in electronic format on page 2 of the online SMA-162. The attached file(s) may be in any of the following formats: .txt, .doc, .docx, .tiff, or .pdf.

For each notification/application purpose the required supporting documentation is/are:

New Medical Director

• A copy of the Medical Director’s State license
• A copy of the Medical Director’s Curriculum Vitae
• A copy of the Medical Director’s DEA number
• 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.

New Program Sponsor

• No supporting documentation required

Relocation of Primary Dispensing Unit or Medication Unit

• 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.

Addition of a new Medication Unit

• A description of how the medication unit receives the medication supply from the primary facility
• 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
• An affirmative statement that the sponsor agrees to retain responsibility for patient care

How does an OTP Notify SAMHSA of these Changes?

OTPs notify/apply for these changes by submitting an online Form SMA-162 at the SAMHSA OTP Extranet Web site (http://otp-extranet.samhsa.gov).

All OTPs have an account on the SAMHSA OTP Extranet Web site. For instructions on accessing your program's account, contact the SAMHSA OTP Extranet Information Center at:

1-866-687-2728 (OTP-CSAT)
or
otp-extranet@opioid.samhsa.gov.

Who may submit Form SMA-162?

Form 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 to electronically sign the SMA-162 and complete the submission process. The notification/application 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.

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For More Information

For more information about OTP certification and opening a treatment program

In states beginning in A - I and OH-TN, contact

• Mary Lou Ojeda
  Division of Pharmacologic Therapies
  SAMHSA Center for Substance Abuse Treatment
  mary.ojeda@samhsa.hhs.gov
  Voice: 240.276.2894
  Fax: 240.276.2710

In states beginning in K-N and TX-WY, contact

• Sara Azimi-Bolourian
  Public Health Advisor
  Division of Pharmacologic Therapies
  SAMHSA Center for Substance Abuse Treatment
  sara.azimi-bolourian@samhsa.hhs.gov
  Voice: 240.276.2708
  Fax: 240.276.2710

The mailing address for the above listed personnel is:

• Division of Pharmacologic Therapies
  Center for Substance Abuse Treatment
  SAMHSA
  1 Choke Cherry Rd.
  Rockville, MD 20857
  (Overnight: 20850)

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