Form SMA-168

Form Approved: OMB Number 0930-0206
Expiration Date: 03/31/2013
See OMB Statement on Reverse

DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBSTANCE ABUSE AND MENTAL HEALTH SERVICES ADMINISTRATION
CENTER FOR SUBSTANCE ABUSE TREATMENT

Exception Request and Record of Justification
Under 42 CFR § 8.11(h)
Note:

DATE OF SUBMISSION:

This form was created to assist in the interagency review of patient exceptions in opioid treatment programs (OTPs) under 42 CFR § 8.11(h).

Detailed INSTRUCTIONS are on the cover page of this form. PLEASE complete ALL applicable items on this form. Your cooperation will result in
a speedy reply. Thank you.
Program OTP No:

-

BACKGROUND INFORMATION

(e.g., AL-10001-M)

Program
Name:

-

Patient ID No:

_______________________________________________________________________________________________________________

Telephone: _______________________________
Name & Title of
Requestor:

Fax: ______________________

E-mail: _________________________________

___________________________________________________________________________________________________________

Patient’s Admission
Date:

Patient’s current
dosage level:
____ mg

_________________________

Patient’s program attendance schedule per week

___ S

(Place an “X” next to all days that the patient attends*):

___ M

___ T

___ Methadone
___ Other:

___ W

___ T

___ Buprenorphine
_________________________________

___ F

___ S

*If current attendance is less than once per week, please enter the schedule: ____________________________________________________________
___ Employed

Patient status:

REQUEST FOR CHANGE

___ Other:
Nature of Request:
Temporary
take-home
___ medication

___ Homemaker

___ Student

___ Disabled

__________________________________________________________________________________________

Temporary change in
___ protocol

Decrease regular attendance to

(Place an “X” next to appropriate days*):

___ S

Detoxification
___ exception

___ M

___ T

___ W

___ Other:
___ T

___ F

_______________________________________
___ S

Beginning date: _________________

*If new attendance is less than once per week, please enter the schedule: ______________________________________________________________
Dates of
Exception:
From ________________ to ________________
# of doses needed: __________
Justification:

__ Family Emergency

__ Incarceration

__ Funeral

__ Vacation

__ Transportation Hardship

__ Step/Level Change

__ Employment

__ Medical

__ Long-Term Care Facility

__ Other Residential Treatment

__ Homebound

__ Split Dose

__ Other: ____________________________________________________________________
1. For take-home medication: Has the patient been informed of the dangers of children ingesting methadone?

___ Yes

___ No

___ N/A

2. For take-home medication: Has the program physician considered the 8-point evaluation criteria to determine whether the
patient is suitable for dispensed methadone or buprenorphine as outlined in 42 CFR § 8.12(i)(2)(i)-(viii)?

___ Yes

___ No

___ N/A

3. For multiple detoxification admissions: Did the physician justify more than 2 detoxification episodes per year and
assess the patient for other forms of treatment (include dates of detoxification episodes) as required by 42 CFR § 8.12(e)(4)?

___ Yes

___ No

___ N/A

Comments: _______________________________________________________________________________________________________________
(e.g., information from State PDMP, drug screen results, if applicable.)
Submitted by: ____________________________________
___________________________________________
__________________
Printed Name of Physician
Signature of Physician
Date

APPROVAL

State response to request:

__ Approved

__ Denied

__ Decision not required
Explanation:

___________________________________________
State Methadone Authority

__________________
Date

____________________________________________________________________________________________________________

Federal response to request: __ Approved

__ Denied

___________________________________________
Public Health Advisor, Center for Substance Abuse Treatment

__________________
Date

__ Decision not required
Explanation:

____________________________________________________________________________________________________________

The preferred method for submitting this form to CSAT/DPT is online at the SAMHSA OTP Extranet Web site, http://otp-extranet.samhsa.gov. For instructions or
technical support, contact the OTP Extranet Information Center at 1-866-OTP-CSAT (1-866-687-2728) or [email protected]. If you are unable to
submit online, the form may be faxed to (240) 276-1630 or e-mailed as an attachment to [email protected].
This exception is contingent upon approval by your State Opioid Treatment Authority (as applicable) and may not be implemented until you receive such approval.

FORM SMA-168 (revised 2010) (FRONT)

REQUIREMENTS

Regulation Requirements:

Purpose of Form: This form was created to facilitate the submission and review of patient exceptions under
42 CFR § 8.11(h). This does not preclude other forms of notification.
Paperwork Reduction Act Statement
Public reporting burden for this collection of information is estimated to average 25 minutes per response, including the time
for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and
reviewing the collection of information. Send comments regarding this burden estimate or any other aspect of this collection
of information, including suggestions for reducing this burden to SAMHSA Reports Clearance Officer; Paperwork
Reduction Project (0930-0206); Suite 7-1043, 1 Choke Cherry Road, Rockville, MD 20857. An agency
may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a
currently valid OMB control number. The OMB control number for this project is 0930-0206.
FORM SMA-168 (revised 2010) (BACK)