Exception Requests
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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