Hardship Exemptions

Subject: Hardship Exemptions Mon Apr 13, 2009 7:05 pm

Hardship Exemptions

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 Methadone 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 Methadone 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 Methadone 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 ( 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 Methadone 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.