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Opioid Drugs in Maintenance and Detoxification Treatment of Opiate Addiction - 42 CFR Part 8

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OMB: 0930-0206

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Page 1 of 2

Form Approved: OMB Number 0930-0206
Expiration Date: 09/30/2006

SUBSTANCE ABUSE AND MENTAL HEALTH SERVICES ADMINISTRATION
CENTER FOR SUBSTANCE ABUSE TREATMENT

See OMB Statement Statement on Reverse

Date of Submission:
3/3/2010 2:04:35 PM
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).
Exception Request and Record of Justification
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: WV10012M
(Same as FDA ID)
Program Name:
Telephone:

Patient ID No: 1795

Clarksburg Treatment Center

(304) 622-7511

Fax: (304) 622-7885

E-mail: [email protected]
Name & Title of Requestor: Lee Ann Jones Counselor
Patient's Admission Date: 10/12/2009 Patient's Current Dosage Level:

10mg

 Methadone 




 LAAM 



 Buprenorphine




 Other





Patient's program attendance schedule per week:
(Check next to all the days that the patient attends*)

S





M






T






W






T






F





S





*If current attendance is less than once per week, please enter schedule:
Patient's Status:

 Homemaker 



 Employed 





 Student 



 Disabled




 Other




Nature of Request:

 Temporary take-home medication 





 Temporary change in protocol 



 Detoxification exception



 Other:





Decrease regular attendance to
(Place an "X" next to the appropriate days*):

S 




M 



T 



W 



T 



F 




S




Beginning date: 3/12/2010

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

3/12/2010

To:

3/21/2010

# of doses needed:

9

Justification:

 Family Emergency





 Incarceration





 Funeral





 Vacation






 Transportation Hardship





 Step/Level Change





 Employment





 Medical





 Long-Term Care Facility





 Other Residential Treatment





 Homebound





 Split Dose





 Other: Pt is traveling out of town for vacation and there is no guest dosing available within 100 miles for suboxone. Pt is




counseling compliant. UDS results 12/21/09; 1/12/10; 2/16/10 - all licit.
Regulation Requirements:


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



For take-home medication: Has the program physician
 Yes 





 No 



 N/A



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)?



For multiple detoxification admissions: Did the physician
 Yes 




 No 



 N/A




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)?

 No 



 Yes 





 N/A




Comments:
Pt is traveling out of town for vacation and there is no guest dosing available within 100 miles for suboxone. Pt is counseling

https://otp-extranet.samhsa.gov/Patient/ExceptionRequest.aspx?Source=VTJGdGFITmgtZEdXOGZHQ0t...

3/3/2010

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

Page 2 of 2

compliant. UDS results 12/21/09; 1/12/10; 2/16/10 - all licit.

Submitted By:
Cindy Dugan

Electronically signed by Cindy Dugan

3/3/2010 2:04:35 PM EST

Printed Name of Physician

Signature of Physician

Date

State Response to Request:

 Approved




 Denied





State Opioid Treatment Authority

Date

 Decision not required





Federal Response to Request:

 Approved





 Denied




 Decision not required





Electronically signed by Elsworth Dory

3/3/2010 2:25:18 PM EST

Public Health Advisor, Center for Substance
Abuse Treatment

Date

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); 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.

https://otp-extranet.samhsa.gov/Patient/ExceptionRequest.aspx?Source=VTJGdGFITmgtZEdXOGZHQ0t...

3/3/2010


File Typeapplication/pdf
File Titlehttps://otp-extranet.samhsa.gov/Patient/ExceptionRequest.aspx?S
AuthorNREUTER
File Modified2010-03-03
File Created2010-03-03

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