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medication-assisted treatment for substance use disorders

Exception Requests

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Overview

Section 8.12 of Federal Regulation 42 CFR sets forth Federal standards for the administration and management of opioid treatment. Included in the standards are a schedule of maximum allowable unsupervised use (i.e., take-home medications), and standards for the provision of detoxification treatment.

On occasion, patients may need exceptions from the Federal opioid treatment standards due to transportation hardships, employment, vacation, medical disabilities, etc. In these instances, the physician must submit to SAMHSA and (where applicable) the State Opioid Treatment Authority an "exception request" for approval to change the patient care regimen from the requirements specified in Regulation 42 CFR part 8.

Any deviation from the opioid treatment standards set forth in Regulation 42 CFR part 8 requires the submission and approval of an SMA-168 exception request. Failure to submit an SMA-168 exception request and obtain approval from SAMHSA and (where applicable) the State Opioid Treatment Authority prior to providing care that deviates from the federal opioid treatment standards constitutes a serious regulatory violation which may threaten a program's federal and state compliance, accreditation and certification.

Exception requests are submitted to SAMHSA and the applicable State Opioid Treatment Authority using form SMA-168 Exception Request and Record of Justification under 42 CFR 8.12. SMA-168 exception requests may be submitted on-line, by fax or by mail. For fastest processing, SAMHSA strongly recommends on-line submission. SAMHSA's decision on on-line exception requests is typically viewable by the submitting OTP within one hour of submission.

When Should an Exception Request be Submitted?

An SMA-168 exception request must be submitted (and approved) whenever a physician wishes to vary from the opioid treatment standards set forth in Federal Regulation 42 CFR 8.12 in the treatment of an individual patients.

The most common reasons for submitting exception requests are to request:

  • A temporary increase in the number of take-home doses permitted for unsupervised use.
  • An exception to the detoxification standards outlined in the regulation

Exception Request for Temporary Increase in Take Home Medications

Table 1 displays the allowable schedule defined in Regulation 42 CFR Section 8.12 for the provision of take-home medications. To be eligible for take-home medications according to this schedule a patient must meet the following eight conditions (unchanged from the previous rule): (1) no recent drug use, (2) attends clinic regularly, (3) no serious behavioral problems, (4) no criminal activity, (5) stable home environment and good social relationships, (6) length of time in treatment (see below), (7) assurance that take-home medication will be safely stored, and (8) judgment that the rehabilitative benefit to the patient will outweigh the risk of diversion (42 CFR Part 8.12.i (2) (i-viii)).

Eligible patients may be provided take-home medication according to this schedule with no exception request required. However, if a treating physician believes it would be in the best interest of an individual patient to receive a temporary increase in the number of take-home medications, such as because of a family or health emergency, approval of an SMA-168 exception request by SAMHSA and (where applicable) the State Opioid Treatment Authority is required.

It should be noted that the take-home schedule defined in 42 CFR Section 8.12(i)(3) represents a minimum standard. States and treatment programs may choose a more stringent standard, e.g., require longer time periods of stability, or provide fewer total take-home doses.

In addition, it is important to recognize that simply because an individual patient meets the time-in-treatment criteria for take-home doses according to the schedule, the patient is not automatically eligible to receive those take-home medications. The decision as to whether or not an individual patient should receive take-home medication is a medical decision that is made by the medical director (physician) of the program. The physician must assess each patients progress and determine whether the rehabilitative benefit derived from decreasing the frequency of attendance outweighs any potential risks. While programs are being encouraged to individualize treatment and utilize the SAMHSA take-home schedule, this does not mean that they are required to do so.

Table 1. Schedule of Maximal Take-Home Medications per Federal Opioid Treatment Regulation 42 CFR 8.12

Patient Time in Treatment Maximum Take-Home Medication Permissible (not automatic)
1-90 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.
91-180 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.
181-270 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.
271-365 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).

“Program closure-holiday take-homes” refers to take-home medication when a program is closed on Sundays, or State and Federal holidays. “Time in treatment take-homes” refers to 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).

Exception Request for Variation from Detoxification Standards

Section 8.12 of Federal Regulation 42 CFR specifies that 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 best interest of an individual patient to receive a third (or greater) detoxification treatment episodes in one year, approval of an SMA-168 exception request by SAMHSA and (where applicable) the State Opioid Treatment Authority is required. On the SMA-168 submission, the physician must justify the reason for requesting more than two detoxification episodes per year and attest that the patient has been assessed for other forms of treatment.

Exception Request for Other Reasons

Programs should submit an SMA-168 exception request for approval of any other treatment that differs from the Federal opioid treatment standards set forth under 42 CFR Section 8.12(i)(3).

When is an SMA-168 Exception Request Not Required?

Programs do not need to submit SMA-168 exception requests to SAMHSA for the provision of care that is in compliance with the treatment standards set forth in Regulation 42 CFR part 8. For example, a common misperception is that a program must obtain approval from SAMHSA when treating a patient with methadone at doses greater than 100mg. However, 42 CFR part 8 places no such limit on the maximal allowed dose of methadone for a patient in treatment. Thus no SMA-168 exception request is required by SAMHSA in this case (State rules may vary).

Regulation 42 CFR part 8 does specify a limit of 30mg of methadone for the initial dose, and 40mg for the total daily dose, for new a patient on the first day of treatment. Thus, treatment on the first day with methadone doses greater than these amounts would require approval from SAMHSA and (where applicable) the State Opioid Treatment Authority of an SMA-168 exception request.

When in doubt, submit. If a program has consulted the text of the federal opioid treatment standards in 42 CFR part 8 and is unsure if the care it intends to provide for a patient is in compliance with the standards, then the program should submit an SMA-168 exception request. There are no penalties for submitting an exception request when one is not required, but failure to submit and obtain approval from SAMHSA and (where applicable) the State Opioid Treatment Authority prior to providing care that deviates from the federal opioid treatment standards constitutes a serious regulatory violation which may threaten a program's federal and state compliance, accreditation and certification.

Submit an SMA-168 Exception Request

SMA-168 exception requests may be submitted on-line, by fax or by mail. For fastest processing, SAMHSA strongly recommends on-line submission. SAMHSAs decision on on-line exception requests is typically viewable by the submitting OTP within one hour of submission.

On-line

SMA-168 exception requests can be submitted on-line at the SAMHSA OTP Exception Request Web site. For help getting started with on-line exception requests, and to request a physician account on the OTP Exception Request Web site, call or email the

The log-in page for the SAMHSA OTP Extranet Web site is http://otp-extranet.samhsa.gov

Fax or Mail

SMA-168 exception request forms can completed in paper form and faxed or mailed to SAMHSA and (where applicable) the State Opioid Treatment Authority. SAMHSAs fax number and mailing address are located on the form.

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