Sma-168

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: xx/xx/xxxx See OMB Statement on Reverse

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

DATE OF SUBMISSION:

Note: 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 provided at http://www.samhsa.gov/medication-assisted-treatment/opioid-treatment-programs/submit-exception-request. PLEASE complete ALL applicable items on this form and submit online* for a prompt reply. Thank you.

Program OTP No: (e.g., AL-10001-M) BACKGROUND INFORMATION

–

–

Patient ID No:

Program Name: ________________________________________________________________________________________________________

Telephone: _____________________________

E-mail:

_________________________________

Name & Title of Requestor: ______________________________________________________________________________________________

Patient’s Admission Date:____________________ Patient’s applicable drug(s) and dosage (check all that apply): ___ Methadone ___ Buprenorphine ___ Other ___ mg ___ mg ___mg

Most recent urinalysis result (check all that apply): ___ Methadone ___ Buprenorphine ___Other  positive  negative  positive  negative  positive  negative

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

___

S

___

M

___ T

___

W

___

T ___ F

___

S

*If current attendance is less than once per week, please enter the schedule _________________________________________________________

Patient status:

___

Employed

___ Caregiver ___

Student

___

Disabled

___

Other:

_______________________________________________________________________________________

N REQUEST FOR CHANGE ature of Request:

___

Temporary take-home medication

___

Temporary change in protocol ___ Medically Supervised Withdrawal exception _____

___ Other: _____

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

___

S

___ M

___

T

___

W

___

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

Weather Crisis

__

__

Other:

________________________________________________________________

R REQUIREMENTS egulation Requirements:

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 practitioner considered factors that indicate the therapeutic benefits of unsupervised doses outweigh the risks to determine whether the patient is suitable for dispensed methadone or buprenorphine as outlined in 42 CFR § 8.12(i)(2)(i)-(vi)?

___ Yes

___ No

___ N/A

Comments: _____________________________________________________________________________________________________________

Submitted by: ____________________________________		___________________________________________	__________________
	Printed Name of Physician	Signature of Practitioner	Date

FORM SMA-168 (revised 2024) (FRONT)

State response to request:

__ Approved

__ Denied

___________________________________________

__________________

State Opioid Treatment Authority

Date

__

Decision not required

Explanation:

________________________________________________________________________________________________________

Federal response to request:

__ Approved

_

Denied

____________________________________________

__________________

Public Health Advisor, Center for Substance Abuse Treatment

Date

__

Decision not required

Explanation:

________________________________________________________________________________________________________

* APPROVAL 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 1-866-348-5741 or [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.

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); 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 (revised 2024) (BACK)