Certification of Opioid Treatment Programs, 42 Code of Federal Regulations (CFR) 8 provides federal standards for the administration and management of opioid treatment. Any deviation from the opioid treatment standards in 42 CFR 8 requires the submission and approval of the Form SMA-168 exception request.
Failure to submit the Form SMA-168 exception request and obtain approval from the state opioid treatment authority and SAMHSA prior to providing care that deviates from the federal opioid treatment standards constitutes a serious regulatory violation. This type of violation may threaten an OTP’s accreditation and certification and bring it out of compliance with state and federal regulations.
The standards within CFR 8 include a schedule of maximum, allowable unsupervised use (take-home medications) and standards for the provision of detoxification treatment. On occasion, patients in opioid treatment programs (OTPs) may need exceptions from the federal opioid treatment standards. Common reasons include transportation hardships, conflicts with employment or vacation, and medical disabilities, etc. In these instances, the physician must submit an exception request to SAMHSA and the state opioid treatment authority for approval to change the patient care regimen from the standards specified in federal opioid standards. The time-in-treatment requirements are not applicable for patients receiving buprenorphine products, if an OTP practitioner determines the patient is suitable for unsupervised use (take home).
When is an Exception Request Not Required?
The 2015 modification of 42 CFR 8.12 waives OTPs from the time in treatment requirements for patients receiving buprenorphine products, if an OTP practitioner determines the patient is suitable for unsupervised use (take-home supplies).
Programs do not need to submit exception requests to SAMHSA if the care complies with treatment standards in 42 CFR 8. When in doubt, submit. If a program has consulted the text of the federal opioid treatment standards in 42 CFR 8 and is unsure if the care it intends to provide for a patient is in compliance, then the program should submit a Form SMA-168 exception request on the SAMHSA OTP Extranet website.
There are no penalties for submitting an exception request when one is not required. However, failure to submit and obtain approval from SAMHSA and (where applicable) the state opioid treatment authority before providing care that deviates from the federal opioid treatment standards constitutes a serious regulatory violation. That violation may threaten a program’s federal and state compliance, accreditation, and certification.
|Patient Time in Treatment||Maximum Take-Home Medication Permissible (not automatic)|
|x1 to 90 days||1 time in treatment take-home a week, and 1 program closure-holiday take-home if the program is closed for business Sundays, including state and federal holidays|
|91 to 180 days||2 time in treatment take-homes a week, and 1 program closure-holiday take-home if the program is closed for business Sundays, including state and federal holidays|
|181 to 270 days||3 time in treatment take-homes a week, and 1 program closure-holiday take-home if the program is closed for business Sundays, including state and federal holidays.|
|271 to 365 days||6 time in treatment take-homes a week (reporting once a week).|
|After 1 year||Up to 14 days’ time in treatment take-homes (reporting up to twice a month).|
|After 2 years||Up to 31 days’ time in treatment take-homes (reporting up to once a month).|
- “Time in treatment take-homes” refers to a single dose of take-home medications when the patient has met the minimum stabilized time-in-treatment schedule set forth under 42 CFR Section 8.12(i)(3).
- “Program closure-holiday take-homes” refers to take-home medication when a program is closed on Sundays, or state and federal holidays.
- If a patient meets the time-in-treatment criteria for take-home doses, the patient is not automatically eligible to receive those take-home medications. The OTP medical director decides whether or not an individual patient should receive take-home medication.
- The take-home schedule defined in 42 CFR 8.12(i)(3) represents a minimum standard. States and treatment programs may choose a more stringent standard.
Practitioners shall consider the following take-home criteria (8 take-home criteria) as defined in 42 CFR 8 and outlined in t determining whether a patient is responsible in handling any take-home medications for unsupervised use:
- Exhibit no recent drug use
- Attend a clinic regularly
- Exhibit no serious behavioral problems
- Engage in no criminal activity
- Demonstrate a stable home environment and good social relationships
- Meet length of time in treatment requirements (outlined in the Table: Schedule of Maximal Take-Home Medications per 42 CFR 8.12)
- Provide assurance that take-home medication will be safely stored
- Show that the rehabilitative benefit outweighs the risk of diversion
Additional guidance on the take-home criteria is available in the Federal Guidelines for Opioid Treatment Programs – 2015.
The most common reasons for submitting exception requests include:
- A temporary increase in the number of take-home doses permitted for unsupervised use
- An exception to the detoxification standards in the regulation
Per 42 CFR 8.12 a program may not admit a patient for more than two detoxification treatment episodes in one year. Patients with two or more unsuccessful detoxification episodes within a 12-month period must be assessed by the OTP physician for other forms of treatment.
If, after this assessment, a physician believes it would be in the patient’s best interest to receive a third (or greater) detoxification treatment episode in one year, the physician can submit an exception request to SAMHSA and (where applicable) the state opioid treatment authority. The physician must:
- Use form SMA-168 for the request
- Justify the reason for requesting more than two detoxification episodes per year
- Attest that the patient has been assessed for other forms of treatment
Exception Request for Other Reasons
Programs should submit an exception request for approval of any deviation from the federal opioid treatment standards in 42 CFR 8.
How to Submit an Exception Request
Exception requests must be made using Form SMA-168: Exception Request and Record of Justification. Login to the Extranet website to access Form SMA-168. This form must be submitted via the SAMHSA OTP Extranet website for review by both the state opioid treatment authority and SAMHSA.
All OTPs have an account on the SAMHSA OTP Extranet website. Exceptions can only be submitted by an OTP’s qualifying practitioner(s) who have submitting and approval authority.
For instructions on accessing your program’s account, contact the SAMHSA OTP Extranet Information Center at: