Exception Request and Record of Justification Under 42 CFR § 8.11(h)
This form and guidance govern submission and review of patient exception requests for modified opioid treatment program (OTP) attendance or take-home medication under 42 CFR § 8.11(h), affecting OTP program staff, program physicians, State Opioid Treatment Authorities, and SAMHSA/CSAT reviewers.
No material clinical or coverage changes in this revision.
Form-based Coverage Criteria and Justification
Form-based exception criteria and workflow
Form fields capture the nature and justification for the exception, regulatory checks, and final State and Federal determinations.
ALL of the following
ALL of the following
- Temporary take-home medication
- Temporary change in protocol
- Detoxification exception
- Decrease regular attendance (specify days and schedule)
- Other (free-text)
- Patient status/characteristics (checkboxes): Homemaker, Student, Disabled, Other (specify)
- Dates of Exception: From / To and number of doses needed (specify schedule if attendance < once per week)
- Justification (select predefined reasons or specify Other): Family emergency, Incarceration, Funeral, Vacation, Transportation hardship, Step/Level change, Employment, Medical, Facility, Long-term care, Treatment, Other residential, Homebound, Split dose, Weather crisis, Holiday, etc.
ALL of the following
- For take-home medication: confirmation that the patient has been informed of dangers of children ingesting methadone (Yes/No/N/A)
- For take-home medication: physician indication that the 8-point evaluation under 42 CFR § 8.12(i)(2)(i)-(viii) was considered (Yes/No/N/A)
- For multiple detoxification admissions: physician justification and assessment per 42 CFR § 8.12(e)(4) including dates of detox episodes (Yes/No/N/A)
ALL of the following
- Printed name, signature, and date of the program physician who completed the form
- Field for physician comments or clarifying information
ALL of the following
- State response options: Approved / Denied / Decision not required (with explanation and signature/date by State Opioid Treatment Authority)
- Federal response options: Approved / Denied / Decision not required (with explanation and signature/date by Public Health Advisor, Center for Substance Abuse Treatment)
- Operational note: Exception is contingent on State Opioid Treatment Authority approval and may not be implemented until State approval is received
ALL of the following
- Preferred submission method: online via the SAMHSA OTP Extranet (http://otp-extranet.samhsa.gov) with help contact information
- Paperwork/burden statement: Form SMA-168, estimated 25 minutes per response; OMB control number and expiration provided
Submission, Approval, and Workflow Actions for Providers
Submit Form SMA-168 online and await State approval
Complete and submit the Exception Request and Record of Justification (Form SMA-168) online via the SAMHSA OTP Extranet and await State Opioid Treatment Authority approval before implementing the exception. Use the online form to provide all required fields (nature and dates of the exception, justification, physician 8‑point evaluation checks, and patient counseling items) and obtain State and Federal responses recorded on the form. The preferred submission method is the SAMHSA OTP Extranet; contact OTP Extranet support for instructions or technical help.
- Submit Form SMA-168 online at the SAMHSA OTP Extranet (http://otp-extranet.samhsa.gov).
- Include required fields: nature/dates of exception, justification, physician regulatory checks (e.g., 8-point evaluation), and counseling on dangers to children where applicable.
- Do not implement the exception until State Opioid Treatment Authority approval is received; Federal decision fields are recorded on the form.
- For technical support call 1-866-348-5741 or email OTP-Help@jbsinternational.com.
Key Definitions
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