SMA-168 Exception Request and Record of Justification Under 42 C

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

Form Approved: OMB Number 0930-0206
Expiration Date: 09/30/2006
See OMB Statement on Reverse

DATE OF SUBMISSION

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

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

BACKGROUND INFORMATION

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:
(Same as FDA
ID)

–

Patient ID
No:

–
,

Program
Name:
Telephon
e:

Fax:

E-mail:

Name & Title of
Requestor:
Patient’s
current
dosage level:

Patient’s Admission
Date:
Patient’s program attendance schedule per
week
(Place an “X” next to all days that the patient
attends*):

S

Methadone
mg

M

T

LAAM

Other:

W

T

F

S

*If current attendance is less than once per week, please enter the
schedule:
Patient status:

Employed

Unemployed

Homemaker

Student

Detoxification
exception

Other
:

Disabled

Other:

REQUIREMENTS
REQUEST FOR CHANGE

Nature of
Temporary take-home
medication

Temporary change in
protocol

Decrease regular attendance to

Beginnin
g
date:

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

S

M

T

W

T

F

S

*If new attendance is less than once per week, please enter the
schedule:
Dates of
Exception:
Justificatio
n:

From

# of doses
needed:

to

Family Emergency

Incarceration

Funeral

Step/Level Change

Employment

Medical

Homebound

Split Dose

Vacation

Long Term Care
Facility

Transportation Hardship

Other Residential
Treatment

Other:

Regulation Requirements:
1. For take-home medication: Has the patient been informed of the dangers of children ingesting methadone or LAAM?

Yes

No

N/A

2. For take-home medication: Has the program physician determined that the patient meets the 8-point evaluation
criteria to determine whether the patient is responsible enough to handle methadone 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

Submitted by:

Printed Name of Physician
State response to request:

Signature of Physician

Date

Approved

Denied
State Methadone Authority

Date

Explanation:
Federal response to request:

Approved

Denied
Public Health Advisor, Center for Substance Abuse Treatment

Date

Explanation:
Please fax to CSAT/OPAT, (301) 443-3994 or Email: [email protected]
This exception is contingent upon approval by your State Methadone Authority (as applicable) and may not be implemented until you receive such
approval.

APPROVAL

FORM SMA-168 (FRONT)

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); Room 16-105, Parklawn Building; 5600 Fishers Lane, 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 (BACK)

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