CREW: Department of Veterans Affairs: Regarding PTSD Diagnosis: PTSD Dcoumentation

From:VA DIRECTOR'S OFFICE 3193397135 09/19/2008 09 16 #090 P.
001/052
~ Department of Veterans Affairs VHA FAX TRANSMITTAL

To Fax Number r FTS r Commercial Dale No. Pages
Attached
Acting VHA FOIA Officer (19F2)
(215) 823-5274 09/19/2008 51

Subject
FOIA LITIGATION: Citizens for Responsibility and Ethics in Washington, v. VA
From Telephone Number Commercial
Amber Smith, FOJA Officer Iowa City Iowa
(319) 530-7694
This transmission is intended only for the use of the person or office to whom it is addressed and may contain information
that is privileged. confidential, or protected by law.
All others lire hereby notified that receipt of this message does not waive any applicable privilege or exemption from
disclosure and that any dissemination, distribution, or copying of this communication is prohibited.
If you received this communication in error, please notify us immediately at the telephone number shown below. Thank you.
Tim,
This is the documentation given to me by our medical center manager/leadership. Please
let me know if you have any questions or need anything else. Thanks
Amber
VA FORM
SEP 1997 10-o114R
From:VA DIRECTOR'S OFFICE 3193397135 09/19/2008 09 16 #090 P.002/052
INITIAL EVALUATION FOR POST-TRAUMATIC STRESS DISORDER

EXAMINATION
Name: SSN:
Date of Exam: C-number:
Place of Exam:
A. Identifying Information:
• age
• ethnic background
• era of military service
• reason for referral (original exam to establish PTSO diagnosis and related psychosocial
impairment; re-evaluation of status of existing service-connected PTSO condition)
B. Sources of Information:
• records reviewed (C-file, 00-214, medical records, other documentation)

• review of social-industrial survey completed by social worker
• statements from collaterals
• administration of psychometric tests and questionnaires (identify here)
C. Review of Medical Records:
1. Past Medical History:
a. Previous hospitalizations and outpatient care.

b. Complete medical history is required, including history since discharge from military service.
c. Review of Claims Folder is required on initial exams to establish or rule out the diagnosis.
2. Present Medical History - over the past one year,
a. Frequency, severity and duration of medical and psychiatric symptoms.

b. Length of remissions, to include capacity for adjustment during periods of remissions.
D. Examination (Objective Findings):
Address each of the following and fully describe:
History (Subjective Complaints):
Comment on:
Premilitary History (refer to social-industrial survey if completed)
• describe family structure and environment where raised (identify constellation of family
members and quality of relationships)
• quality of peer relationships and social adjustment (e.g., activities, achievements, athletic
and/or extracurricular involvement, sexual involvements, etc.)
• education obtained and performance in school
• employment
• legal infractions
• delinquency or behavior conduct disturbances
• substance use patterns
• significant medical problems and treatments obtained
• family psychiatric history
• exposure to traumatic stressors (see CAPS trauma assessment checklist)
• summary assessment of psychosocial adjustment and progression through developmental
milestones (performance in employment or schooling, routine responsibilities of self-care,
family role functioning, physical health, social/interpersonal relationships, recreation/leisure
pursuits).
Military History
• branch of service (enlisted or drafted)

• dates of service
• dates and location of war zone duty and number of months stationed in war zone
• Military Occupational Specialty (describe nature and duration of Jobes) in war zone)
• highest rank obtained during service (rank at discharge if different)
• type of discharge from military
• substance use and consequences of substance use
• describe routine combat stressors veterans was exposed to (refer to Combat Scale)
• combat wounds sustained (describe)
• clearly describe specific stressor event(s) veteran considered particularly
traumatic,particularly, if the stressor is a type of personal assaUlt, including sexual assaUlt,
provide information, with examples, if possible.
• indicate overall level of traumatic stress exposure (high, moderate, low) based on frequency
and severity of incident exposure
• citations or medals received
• disciplinary infractions or other adjustment problems during military
From:VA DIRECTOR'S OFFICE 3193397135 09/1912008 09 17 #090 P.004/052
NOTE: Service connection for post-traumatic stress disorder (PTSD) requires medical eVidence
establishing a diagnosis of the condition that conforms to the diagnostic criteria of DSM-IV, credible
supporting evidence that the claimed in-service stressor actually occurred, and a link, established by
medical evidence, between current symptomatology and the claimed in-service stressor. It is the
responsibility of the examiner to indicate the traumatic stressor leading to PTSD, if he or she makes
the diagnosis of PTSD.
A diagnosis of PTSD cannot be adequately documented or ruled out without obtaining a detailed
military history and reviewing the claims folder. This means that initial review of the folder prior to
examination, the history and examination itself, and the dictation for an examination initially
establishing PTSD will often require more time than for examinations of other disorders. Ninety
minutes to two hours on an initial exam is normal.
Post-Military Trauma History (refer to social-industrial survey if completed)
• describe post-military traumatic events (see CAPS trauma assessment checklist)

• describe psychosocial consequences of post-military trauma exposure(s) (treatment received,
disruption to work, adverse health consequences)
Post-Military Psychosocial Adjustment (refer to social-industrial survey if completed)
• legal history (OWls, arrests, time spent in jail)

• educational accomplishmentsjail
• employment history (describe periods of employment and reasons)
• marital and family relationships (including quality of relationships with children)
• degree and quality of social relationships
• activities and leisure pursuits
• significant medical disorders (resulting pain or disability; current medications)
• treatment history for significant medical conditions, inclUding hospitalizations
• history of inpatient and/or outpatient psychiatric care (dates and conditions treated)
• history of assaultiveness
• history of suicide attempts
• summary statement of current psychosocial functional status (performance in employment or
schooling, routine responsibilities of self care, family role functioning, physical health,
social/interpersonal relationships, recreation/leisure purSUits)
E. Mental Status Examination

Conduct a mental status examination aimed at screening for DSM-IV mental disorders. Describe and
fully explain the eXistence, frequency and extent of the following signs and symptoms, or any others
present, and relate how they interfere with employment and social functioning:
• Impairment of thought process or communication.

From:VA DIRECTOR'S OFFICE 3193397135 09/19/2008 09:17 #090 P.005/052
• Delusions, hallucinations and their persistence.

• Eye Contact, interaction in session, and inappropriate behavior cited with examples.
• Suicidal or homicidal thoughts, ideations or plans or intent.
• Ability to maintain minimal personal hygiene and other basic actIvities of daily living.
• Orientation to person, place and time.
• Memory loss, or impairment (both short and long-term).
• Obsessive or ritualistic behavior which interferes with routine activities
• Rate and flow of speech (note any irrelevant, illogical, or obscure speech patterns and
whether constant or intermittent.)
• Panic attacks noting the severity, duration, frequency and effect on independent functioning
and whether clinically observed or good evidence of prior clinical or equivalent observation is
shown.
• Depression, depressed mood or anxiety.
• Impaired impulse control and its effect on motivation or mood.
• Sleep impairment and describe extent it interferes with daytime activities.
• Other disorders or symptoms and the extent they interfere with activities
F. Assessment of PTSD
• identify the primary stressor or stressors

• state whether or not the stressor meets the DSM-IV stressor critenon
• identify behavioral, cognitive, SOCial, affective, or somatic changes veteran attributes to
stress exposure
• describe specific PTSD symptoms present (symptoms of trauma re-experiencing,
avoidance/numbing, heightened physiological arousal, and associated features [e.g.,
disillusionment and demoralization])
• specify onset, duration, typical frequency, and severity of symptoms

• state whether or not the current symptoms are linked to the identified stressor or stressors
G. Psychometric Testing Results
• provide psychological testing if deemed necessary

• provide specific evaluation information required by the rating board or on a BVA Remand.
• comment on validity of psychological test results
• provide scores for PTSD psychometric assessments administered
• state whether PTSD psychometric measures are consistent or inconsistent with a diagnosis of
PTSD, based on normative data and established "cutting scores" (cutting scores that are
consistent with or supportive of a PTSD diagnosis are as follows: PCl - not less that 50;
Mississippi Scale - not less than 107; MMPI PTSD subscale a score> 28; MMPI code type: 2-8
or 2· 7-8)
• state degree of severity of PTSD symptoms based on psychometric data (mild, moderate, or
severe)
• describe findings from psychological tests measuring problems other than PTSD (MMPI, etc.)
H. Diagnosis:
1. The Diagnosis must conform to DSM-IV and be supported by the findings on the examination
report.
2. If there are multiple mental disorders, discuss their relationship with PTSD.
3. The evaluation is based on the effects of the signs and symptoms on occupational and social
functioning.
NOTE: VA is prohibited by statute, 38 U.s.c. 1110, from paying compensation for a disability that is
a result of the veteran's own ALCOHOL OR DRUG ABUSE. However, when a veteran's alcohol or drug
abuse disability is secondary to or is caused or aggravated by a primary service-connected disorder,
the veteran may be entitled to compensation, See Allen y. Principi, 237 F.3d 1368, 1381 (Fed, Cir,
2001). Therefore, it is important to determine the relationship, if any, between a service-connected
disorder and a disability resulting from the veteran's alcohol or drug abuse. Unless alcohol or drug
abuse is secondary to or is caused or aggravated by another mental disorder, you should separate, to
the extent possible, the effects of the alcohol or drug abuse from the effects of the other mental
disorder(s), If it is not possible to separate the effects in such cases, please explain why,
1. Diagnostic Status
• Axis I disorders
• Axis II disorders
• Axis III disorders
• AXis IV (psychosocial and environmental problems)
• Axis V (GAF score - current)
J. Global Assessment of Functioning (GAF):

NOTE: The complete multi-axial format as specified by DSM-IV may be required by BVA REMAND or
specifically requested by the rating specialist. If so, include the GAF score and note whether it refers
to current functioning, A BVA REMAND may also request, in addition to an overall GAF score, that a
separate GAF score be provided for each mental disorder present when there are multiple Axis I or
Axis II diagnoses and not all are service- connected. If separate GAF scores can be given, an
explanation and discussion of the rationale is needed. If it is not possible, an explanation as to why
not is needed. (See the above note pertaining to alcohol or drug abuse.)
DSM-IV is only for application from 11/7/96 on, Therefore, when applicable note whether the
diagnosis of PTSD was supportable under DSM-III-R prior to that date. The prior criteria under DSM
III-R are provided as an attachment.
K. Capacity to Manage Financial Affairs: Mental competency, for VA benefits purposes, refers
only to the ability of the veteran to manage VA benefit payments in his or her own best interest, and
not to any other subject. Mental incompetency, for VA benefits purposes, means that the veteran,
because of injury or disease, is not capable of managing benefit payments in his or her best interest.
In order to assist raters in making a legal determination as to competency, please address the
follOWing:
What is the impact of injury or disease on the veteran's ability to manage his or her financial affairs,
including consideration of such things as knowing the amount of his or her VA benefit payment,
knowing the amounts and types of bills owed monthly, and handling the payment prudently? Does
the veteran handle the money and pay the bills himself or herself?
Based on your examination, do you believe that the veteran is capable of managing his or her
financial affairs? Please provide examples to support your conclusion.
If you believe a Social Work Service assessment is needed before you can give your opinion on the
veteran's ability to manage his or her financial affairs, please explain why.
L. Other Opinion: Furnish any other specific opinion requested by the rating board or BVA remand
(furnish the complete rationale and citation of medical texts or treatise supporting opinion, if medical
literature review was undertaken). If the requested opinion is medically not ascertainable on exam or
testing please state why. If the requested opinion can not be expressed without resorting to
speculation or making improbable assumptions say so, and explain why. If the opinion asks" ... is it
at least as likely as not '" ", fully explain the clinical findings and rationale for the opinion.
M. Integrated Summary and Conclusions
• Describe changes in psychosocial functional status and quality of life fol/owing trauma
exposure (performance in employment or schooling, routine responsibilities of self care,
family role functioning, physical health, social/interpersonal relationships, recreation/leisure
pursuits)
• Describe linkage between PTSD symptoms and aforementioned changes in impairment in
functional status and quality of life. Particularly in cases where a veteran is unemployed,
specific details about the effects of PTSD and its symptoms on employment are especially
important.
• If possible, describe extent to which disorders other than PTSD (e.g., substance use
disorders) are independently responsible for impairment in psychosocial adjustment and
quality of life. If this is not possible, explain why (e.g., substance use had onset after PTSD
and clearly is a means of coping with PTSD symptoms).
• If possible, describe pre-trauma risk factors or characteristics than may have rendered the
veteran vulnerable to developing PTSD subsequent to trauma exposure.
• If possible, state prognosis for improvement of psychiatric condition and impairments in
functional status.
• Comment on whether veteran is capable of managing his or her financial affairs.
N. Effects of PTSD on Occupational and Social Functioning

Evaluation of PTSD is based on its effects on occupational and social functioning. Select the
appropriate assessment of the veteran from the choices below:
• Total occupational and social impairment due to PTSD signs and symptoms.
Provide examples and pertinent symptoms, including those already reported.
OR
• PTSD signs and symptoms result in deficiencies in most of the following areas: work, school,
family relations, judgment, thinking, and mood.
Provide examples and pertinent symptoms, including those already reported for each affected
area.
OR
• There is reduced reliability and productivity due to PTSD signs and symptoms.
OR
• There is occasional decrease in work efficiency or there are intermittent periods of inability to
perform occupational tasks due to signs and symptoms, but generally satisfactory functioning
(routine behavior, self-care, and conversation normal).
OR
• There are PTSD signs and symptoms that are transient or mild and decrease work efficiency
and ability to perform occupational tasks only during periods of significant stress.
OR
• PTSD symptoms require continuous medication
OR
• Select all that apply:

• PTSD symptoms are not severe enough to require continuous medication,
• PTSD symptoms are not severe enough to interfere with occupational and social functioning.
Include your name; your credentials (i.e., a board certified psychiatrist, a licensed psychologist, a
psychiatry resident or a psychology intern); and circumstances under which you performed the
examination, if applicable (i.e., under the close supervision of an attending psychiatrist or
psychologist); include name of supervising psychiatrist or psychologist.
Signature: Date:
From:VA DIRECTOR'S OFFICE 3193397135 09/19/2008 09:18 #090 P.0101052
Review Examination for Post-Traumatic Stress Disorder (PTSD)
# 0902 Worksheet
Name: SSN:
Date of Exam: C-nurnber:
Place of Exam:
A. Review of Medical Records.
B. Medical History since last exam:

Comment on:
1. Hospitalizations and outpatient care from the time between last rating examination to the present,
UNLESS the purpose of this examination is to ESTABLISH service connection, then the complete
medical history since discharge from military service is required,
2, significant medical disorders (resulting pain or disability; current medications)
3, frequency, severity and duration of psychiatric symptoms,
4. length of remissions from psychiatric symptoms, to include capacity for adjustment during periods
of remissions,
5. treatments including statement on effectiveness and side effects experienced,
6. subjective Complaints describe fully
C. Psychosocial Adjustment since the last exam
• legal history (OWls, arrests, time spent in jail)

• educational accomplishments
• extent of time lost from work over the past 12 month period and social impairment. If employed,
identify current occupation and length of time at this job, If unemployed. note in complaints
whether veteran contends it is due to the effects of a mental disorder Further indicate following
DIAGNOSIS what factors. and objective findings support or rebut that contention.
• marital and family relationships (inclUding quality of relationships with spouse and children)
• degree and quality of social relationships
• activities and leisure pursuits
• history of violence I assaultiveness
• history of suicide attempts
• summary statement of current psychosocial functional status (performance In employment or
schooling, routine responsibilities of self care, family role functioning, physical health,
social/interpersonal relationships, recreation/leisure pursuits)
D. Mental Status Examination

Conduct a brief mental status examination aimed at screening for DSM-IV mental disorders. Describe
and fully explain the existence, frequency and extent of the following signs and symptoms, or any others
present. and relate how they interfere with employment and social functioning:
• Impairment of thought process or communication

• Delusions, hallucinations and their persistence.
• Eye contact, interaction in session, and inappropriate behavior cited with examples.
• Suicidal or homicidal thoughts, ideations or plans or intent
• Ability to maintain minimal personal hygiene and other basic activities of daily living.
• Orientation to person, place and time.
• Memory loss, or impairment (both short and long·term),
• Obsessive or ritualistic behavior which interferes with routine activities and describe any found,
• Rate and flow of speech (note any irrelevant, illogical, or obscure speech patterns and whether
constant or intermittent.)
• Panic attacks noting the severity, duration, frequency and effect on independent functioning and
whether clinically observed or good evidence of prior clinical or equivalent observation is shown.
• Depression, depressed mood or anxiety.
• Impaired impulse control and its effect on motivation or mood.
• Sleep impairment and describe extent it interferes with daytime activities.
• Other disorders or symptoms and the extent they interfere with activities
E. Assessment of PTSD
• identify behavioral, cognitive, social, affective, or somatic symptoms veteran attributes to PTSD
• describe specific PTSD symptoms present (symptoms of trauma re-experiencing,
avoidance/numbing, heightened physiological arousal, and associated features [e.g.,
disillusionment and demoralization])
• specify typical frequency and severity of symptoms
F. Psychometric Testing Results
• provide psychological testing if deemed necessary

• provide specific evaluation information required by the rating board or on a BVA Remand.
• comment on validity of psychological test results
• provide scores for PTSD psychometric assessments administered
• state whether PTSD psychometric measures are consistent or inconsistent with a diagnosis of
PTSD, based on normative data and established "cutting scores" (cutting scores that are
consistent with or supportive of a PTSD diagnosis are as follows: PCl - not less than 50;
Mississippi Scale not less than 107; MMPI PTSD subscale a score> 28; MMPI code type 2-8 or
2-7-8)
• state degree of severity of PTSD symptoms based on psychometric data (mild, moderate, or
severe)
• describe findings from psychological tests measuring problems other than PTSD (MMPI, etc.)
G. Diagnosis:
1. The Diagnosis must conform to DSM-IV and be supported by the findings on the examination
report
2. If there are multiple mental disorders discuss the relationship with PTSD.
3. The evaluation is based on the effects of the signs and symptoms on occupational and social
functioning.
NOTE: VA is prohibited by statute, 38 U.S.C. 1110, from paying compensation for a disability that is a
result of the veteran's own ALCOHOL OR DRUG ABUSE. However, when a veteran's alcohol or drug
abuse disability is secondary to or is caused or aggravated by a primary service-connected disorder, the
veteran may be entitled to compensation. See Allen v. Principi, 237 F.3d 1368,1381 (Fed. Cir 2001)
Therefore, it is important to determine the relationship, if any, between a service-connected disorder and
a disability resulting from the veteran's alcohol or drug abuse. Unless alcohol or drug abuse is secondary
to or is caused or aggravated by another mental disorder, you should separate, to the extent possible, the
effects of the alcohol or drug abuse from the effects of the other mental disorder(s). If it is not possible to
separate the effects in such cases, please explain Why.
H. Diagnostic Status
• Axis I disorders
• Axis II disorders
• Axis III disorders
• Axis IV (psychosocial and environmental problems)
• Axis V (GAF score: current)
I. Global Assessment of Functioning (GAF):

NOTE: The complete multi-axial format as specified by DSM-IV may be required by BVA REMAND or
specifically requested by the rating specialist. If so, include the GAF score and note whether it refers to
current functioning. A eVA REMAND may also request, in addition to an overall GAF score, that a
separate GAF score be provided for each mental disorder present when there are mUltiple Axis I or Axis II
diagnoses and not all are service- connected. If separate GAF scores can be given, an explanation and
discussion of the rationale is needed. If it is not possible, an explanation as to why not is needed. (See
the above note pertaining to alcohol or drug abuse.)
J. Capacity to Manage Financial Affairs: Mental competency, for VA benefits purposes, refers only to
the ability of the veteran to manage VA benefit payments in his or her own best interest, and not to any
other subject. Mental incompetency, for VA benefits purposes, means that the veteran, because of injury
or disease, is not capable of managing benefit payments in his or her best interest. In order to assist
raters in making a legal determination as to competency, please address the following:
What is the impact of injury or disease on the veteran's ability to manage his or her financial affairs,
including consideration of such things as knowing the amount of his or her VA benefit payment, knowing
the amounts and types of bills owed monthly, and handling the payment prudently? Does the veteran
handle the money and pay the bills himself or herself?
Based on your examination, do you believe that the veteran is capable of managing his or her financial
affairs? Please provide examples to support your conclusion.
If you believe a Social Work Service assessment is needed before you can give your opinion on the
veteran's ability to manage his or her financial affairs. please explain why
K. Other Opinion: Furnish any other specific opinion requested by the rating board or eVA remand (Le.,
furnish the complete rationale and citation of medical texts or treatise supporting opinion, if medical
literature review was undertaken). If the requested opinion is medically not ascertainable on exam or
testing please state why. If the requested opinion can not be expressed without resorting to speculation or
making improbable assumptions say so, and explain why. If the opinion asks" ... is it at least as likely as
not ... ", fully explain the clinical findings and rationale for the opinion.
L. Integrated Summary and Conclusions
1. Describe changes in psychosocial functional status and quality of life since the last exam
(performance in employment or schooling, routine responsibilities of self care, family role
functioning, physical health, social/interpersonal relationships, recreation/leisure pursuits).
2. Describe linkage between PTSD symptoms and aforementioned changes in impairment in
functional status and quality of life. Particularly in cases where a veteran is unemployed, specific
details about the effects of PTSD and its symptoms on employment are especially important.
3. If possible, describe extent to which disorders other than PTSD (e.g, substance use disorders)
are independently responsible for impairment in psychosocial adjustment and quality of life. If this
is not possible, explain why (e.g., substance use had onset after PTSD and clearly is a means of
coping with PTSD symptoms).
4. If possible, state prognosis for improvement of psychiatric condition and impairments in functional
status.
5. Comment on whether veteran is capable of managing his or her financial affairs.
M. Effects of PTSD on Occupational and Social Functioning
Evaluation of PTSD is based on its effects on occupational and social functioning. Select the appropriate
assessment of the veteran from the choices below
• Total occupational and social impairment due to PTSD signs and symptoms.
OR
• PTSD signs and symptoms result in deficiencies in most of the following areas: work, school,
family relations, judgment, thinking, and mood.
Provide examples and pertinent symptoms, including those already reported for each affected
area.
OR
• There is reduced reliability and productivity due to PTSD signs and symptoms.
OR
• There is occasional decrease in work efficiency or there are intermittent periods of inability to
perform occupational tasks due to signs and symptoms, but generally satisfactory functioning
(routine behavior, self-care, and conversation normal).
Provide examples and pertment symptoms, including those already reported.
OR
• There are PTSD signs and symptoms that are transient or mild and decrease work efficiency and
ability to perform occupational tasks only during periods of significant stress.
OR
• PTSD symptoms require continuous medication
OR
• Select all that apply:

• PTSD symptoms are not severe enough to require continuous medication.
• PTSD symptoms are not severe enough to interfere with occupational and social functioning.
Include your name; your credentials, i,e" a board certified psychiatrist, a licensed psychologist, a
psychiatry resident or a psychology intern, LCSW, or NP and circumstances under which you performed
the examination, if applicable, i.e., under the close supervision of an attending psychiatrist or
psychologist; include name of supervising psychiatrist or psychologist.
Signature: Date:
Page 1 of2
Smith, Amber A. (Iowa City)

--------------- ._--
From: Lynch, Debra
Sent: Thursday, September 18,20081139 AM
To: Mills, Pamela; Cook, Brian L.; Sadler, Anne G; Surom, Clay M.; Jensen, Cory J.; Thomas, Karl W,
Crosby, Matthew J.; Szot, Joseph F
Cc: Smith, Amber A (Iowa City)
Subject: RE: Urgent FOIA Request. Need response immediatelyl
From: Lynch, Debra
Sent: Monday, July 21, 2008 9:37 AM
To: VHAIOW PC&CBOCs Providers
Subject: FW: Additional resource for information about psychotherapy and PTSD is available on National
Center's for PTSD's new Intranet Site
FYI
From: Thomas, Karl W.
Sent: Friday, July 18, 2008 8:34 AM
To: Lynch, Debra; Szot, Joseph F
Can we make sue that the Primary Care providers are informed of this resource? Thanks, Karl
From: Frohn, Sally M.
Sent: Friday, July 18, 2008 8:20 AM
To: VISN 23 Prim&SM MD Leaders; VISN 23 Prim&SM Nurse Leaders
Forwarding FYI
Sally Frohn, RN, BSN, CPHQ
Administrative Officer
VISN 23 Primary & Specialty Medicine Service Line
Phone: 402-484-3247/8-865-3247
Fax: 402-484-3237
For those who want additional infonnation about Cognitive Processing Therapy (CPT) and
Prolonged Exposure (PE) Therapy, visit the National Center for PTSD's Intranet site at:
http://vaww.ptsd.va.gov
This site was recently launched and is specifically for VA clinicians and employees and includes:
• Immediate access to assessment instruments such as the Clinician-Administered PTSD Scale

(CAPS)
9/18/2008
From:VA DIRECTOR'S OFFICE 3193397135 09/19/2008 09'19 #090 P.015/052
Page 20f2
• Information on training programs for effective PTSD treatments such as Cognitive Processing
Therapy and Prolonged Exposure Therapy.
• Information fOT clinicians and PTSD program administrators on the PTSD Mentoring Program.
This new Intranet site does not duplicate any information on our main Website for the public
(www.nc.Qtsd.va.gov) but does provide links to important NCPTSD products such as the Iraq War
Clinician Guide and the CTU-Online newsletter.
9/18/2008
From:VA DIRECTOR'S OFFICE 3193397135 09/19/2008 09,19 #090 P.016/052

Page 1 of2
From: Rinehart, Kathy J.

Sent: Thursday, September 18, 2008 1:28 PM
To: Smith, Amber A. (Iowa City)
Subject: FW PTSD Polypharmacy and Varenicline Review
Attachments: PTSD Dosing Sheet.doc; PTSD DDI Criticallist,xls
VISN 23 pharmacist, Bruce Alexander, sent this email to mental health providers regarding the VA's mandated
PTSD survey ...
From: Alexander Bruce

l
sent: Friday, July 18, 2008 11:07 AM

To: Smith, Robert E.; Halloran, Vivien J.; Westlake, Jennifer M; Rinehart, Richard H.; Satisky, Kevin F.; Miller,
Anthony C. (lOW); Shanks l Connie S.; Swayze, Victor; Calderwood l Laura V.; Soukup, Beverly; Behrendtsen, Ole
Cc: Rinehart, Kathy J.; Cook, Brian L.; Alexanderl Bruce; Hensley, Carl E.; Havens, Oliver A; Cowdery, John 5.;
RossI Phillip T.; RossI Debra (V23)
Subject: PTSD Polypharmacy and Varenicline Review
Dear all,
Dr. Cook has asked me to communicate the Central Office (CO) mandated review dated July 7, 2008 of all PTSD
patients receiving varenicline and PTSD patients receiving at least one agent in 5 or more of the following
medication classes or medications:
1. SSRls
2, Atypical Antipsychotics
3. Typical Antipsychotics
4. Tricyclic Antidepressants
5. Second-generation Antidepressants
6. Monoamine Oxidase Inhibitors
7. Benzodiazepines
8. Non-benzodiazpine sedative/hypnotics
9. Anticonvulsants
10. Sympatholytics (e,g. prazosin)
11. Opioids
VISN23 PBM supplied Iowa City with the names of 115 patients that met the above criteria, Pharmacy Service
was required as the first step to review each of these patients to determine if the patients currently met review
criteria. They completed their review yesterday. Pharmacy Service was able to reduce the list to 35 patients.
The 2nd step is for the each responsible provider (or designated MH reviewer if the patient is only seen in primary
care) to complete the CO-issued review template. I am forwarding to each provider of record the review template
completed by pharmacy service and the current list of medications. Attached are supporting documents that were
also supplied by CO to be used in the review. I have no additional information on the use of the templates than
what you will receive; however, if you have questions of clarification, please call me and I will try to help interpret
the criteria. If you have received a patient that you are not the primary MH provider, please let me know.
Dr. Cook has established a deadline of August 7 for return of the reviews so the results can be complied,
reviewed by Dr. Cowdery, and forwarded to VISN23 MH leadership. These results will then be forwarded to the
VA Secretary's office,
Please return all the documents via secure packet according to VA guidelines to Bruce Alexander, Psychiatry
Service (116A) prior to August 7.
Thank you.
9/18/2008
Page 2 0[2
Bruce Alexander PharmD BCPP I Clinical Pharmacy Specialist I Department of Psychiatry I Iowa City
VAMC 1319.338.0581 ext. 51181 bruce.alexander@va..9-~'l
9/18/2008
VA/DoD PTSD Medication Dosing Guidelines
f--=-0.::...ru::J:L. ~ f--O-R:.:ec::.co:::.:m=m:.:eC""n.._.de_"'d::....:::D..::o:::.:se:..__~
Fluoxetine 20 _ 60 m Id
I-P'--a_r-'-ox_e_tl:.:.;·n-'-e ~ _+-'2=-0'----- 60 m~~_ ... _J
Sertraline 50 - 200 m d I
Fluvoxamine 50 - 150 m bid
Citalo ram 20 - 60 m Id
Duloxetine 60 - 120 m Id
f-==-==='-------------------j---'----'--"'--'-------j
Escitalo 10- 20 m Id
Nortri t line
Protri line
Clomi
Target 6 .. 10 mg/d Start

with 1 mg at bedtime
and increase as blood
ressure allows.
Recommended Dose
150 -450 m d
300-600 m d
300 - 600 m d
ISO-375m d
Recommended Dose
Tar et 400 - 1600 m d
Tar et 300 - 3600 m d
Target 25 - 500 mg/d
Start 25 mg qod x 2
weeks, then 25 mg qd x
2 weeks, then 25 . 50
mg qd q 1-2 weeks to
400 mgld or as
Lamotri ine tolerated.
List has been updated to include newer agents not included in the 2003 version of the VA/DoD
PTSD Practice Guideline.
VA/DoD PTSD Medication Dosing Guidelines
Dru
Start - 0.25 mg bid,
increase by 0.25 mg q
1-2 days; maximum 20
mg/d
1.S-6m d
10·40 m Id
Recommended Dose
5-lOm d
5-lOm d
20 - 60 mg/d
- I [-3 mgld --------:J
L...:...:=,;.;..:..:..:...c:. _ I 8 mg/d =:J
List has been updated to include newer agents not included in the 2003 version of the VA/DoD
PTSD Practice Guideline.
From:VA DIRECTOR'S OFFICE 3193397135
09/19/2008 09 20 #090 P.020/052
Alprazolam Amitriptyline Bupropion

Critical 001 Critical 001 Critical 001
DELAVIRDINE MESYLATE CISAPRIDE PHENELZINE
EFAVIRENZ CLONIDINE RITONAVIR
INDINAVIR SULFATE FLUCONAZOLE SELEGILINE
VORICONAZOLE ISOCARBOXAZID TRANYLCYPROMINE
ITRACONAZOLE
KETOCONAZOLE
Buspirone LlNEZOLlD Carbamazepine
Critical DOl PARGYLINE Critical 001
PHENELZINE PHENELZINE ANISINDIONE
SELEGILINE CYCLOSPORINE
TRANYLCYPROMINE DESOGESTREL
Chlorpromazine DICUMAROL
DIETHYLSTILBESTROL
CISAPRIDE Citalopram ESTRADIOL
ZIPRASIDONE Critical DOl ESTROGENS
CLOZAPINE ESTRONE
ISOCARBOXAZID ESTROPIPATE
Clomipramine PARGYLINE ETHYNODIOL DIACETATE
Critical 001 PHENELZINE ISONIAZID
CISAPRIDE PIMOZIDE LAPATINIB
CLONIDINE SELEGILINE LEVOMETHADYL
ISOCARBOXAZID TRANYLCYPROMINE MEDROXYPROGESTERONE
PARGYLINE MESTRANOL
PHENELZINE NORETHINDRONE
PROCARBAZINE Clonazepam NORETHYNODREL
TRANYLCYPROMINE Critical 001 NORGESTIMATE
FLUOXETINE NORGESTREL
PHENPROCOUMON
Desipramine QUINESTROL
Critical 001 Duloxetine RITONAVIR

CISAPRIDE Critical 001 WARFARIN
CLONIDINE ISOCARBOXAZI D
FLUCONAZOLE MESORIDAZINE
ISOCARBOXAZID PHENELZINE Fluoxetine
ITRACONAZOLE RASAGILINE Critical 001
KETOCONAZOLE THIORI DAZI NE CLONAZEPAM
PARGYLINE TRANYLCYPROMINE CLOZAPINE
PHENELZINE ISOCARBOXAZID
PIMOZIDE PARGYLINE
PROCARBAZINE PHENELZINE
TRANYLCYPROMINE PIMOZIDE
ZIPRASIDONE RITONAVIR
SELEGILINE
THIORIDAZINE
TRANYLCYPROMINE
Fluvoxamine Haloperidol Imipramine

ALOSETRON CISAPRIDE CISAPRIDE
ASTEMIZOLE RANOLAZINE CLONIDINE
C1SAPRIDE FLUCONAZOLE
ISOCARBOXAZID ISOCARBOXAZID
PARGYLINE ITRACONAZOLE
PHENELZINE KETOCONAZOLE
RASAG1LlNE PARGYLINE
SELEGILINE PHENELZINE
TERFENADINE PIMOZIDE
THIORIDAZINE PROCARBAZINE
TIZANIDINE TRANYLCYPROMINE
TRANYLCYPROMINE ZIPRASIDONE
Nefazodone Nortriptyline Olanzapine

ASTEMIZOLE CISAPRIDE CISAPRIDE
ATORVASTATIN CALCIUM CLONIDINE
CISAPRIDE FLUCONAZOLE
ELETRIPTAN
ISOCARBOXAZID Oxcarbazepine
EPLEREN ONE
ITRACONAZOLE Critical 001
ERGOT
KETOCONAZOLE LEVONORGESTREL
FENTANYL
PARGYLINE
LOVASTATIN
PHENELZINE
PIMOZIDE PIMOZIDE Propranolol
RANOLAZINE PROCARBAZINE Critical 001
RITONAVIR TRANYLCYPROMINE ERGOT
SIMVASTATIN ZIPRASIDONE ERGOTAMINE TARTRATE
TACROLIMUS MESORIDAZINE
TERFENADINE VERAPAMIL
Phenelzine
Critical 001
Paroxetine PHENYLEPHRINE Protriptyline
Critical 001 PHENYLPROPANOLAMINE Critical 001
CLOZAPINE PROTRIPTYLINE CISAPRIDE
ISOCARBOXAZID PSEUDOEPHEDRINE CLONIDINE
PARGYLINE RASAGILINE ISOCARBOXAZI D
PHENELZINE SERTRALINE PARGYLINE
PIMOZIDE SIBUTRAMINE HYDROCHLORIDE PHENELZINE
SELEGILINE TRIMIPRAMINE PIMOZIDE
THIORIDAZINE PROCARBAZINE
TRANYLCYPROMINE
Quetiapine
Critical 001
CISAPRIDE
MESORIDAZINE
Sertraline Tranylcypromine Ziprasidone

ISOCARBOXAZID AMITRIPTYLINE AMIODARONE
PARGYLINE AMOXAPINE ARSENIC TRIOXIDE
PHENELZINE AMPHETAMINE CHLORPROMAZINE
PIMOZIDE ATOMOXETINE HCL CIPROFLOXACIN
SELEGILINE BENZPHETAMINE CISAPRIDE
TRANYLCYPROMINE BRIMONIDINE TARTRATE CLARITHROMYCIN
BUPROPION DESIPRAMINE
Thioridazine CITALOPRAM DISOPYRAMIDE
Critical 001 CLOMIPRAMINE DOFETILIDE
ALATROFLOXACIN MESYLATE DESIPRAMINE DOLASETRON MESYLATE
AMIODARONE DEXTROAMPHETAMINE DROPERIDOL
CIPROFLOXACIN DEXTROMETHORPHAN ERYTHROMYCIN
CISAPRIDE DIETHYLPROPION GATIFLOXACIN
DULOXETINE DOPAMINE IBUTILIDE FUMARATE
ERYTHROMYCIN DOXEPIN IMIPRAMINE
FLUOXETINE DULOXETINE LEVOFLOXACIN
FLUVOXAMINE MALEATE EPHEDRA MEFLOQUINE
LEVOFLOXACIN EPHEDRINE MESORIDAZINE
MOXIFLOXACIN FENFLURAMINE MOXI FLOXACIN
PAROXETINE FLUOXETINE NORTRIPTYLINE
RANOLAZINE FLUVOXAMINE MALEATE PENTAMIDINE
ZIPRASIDONE IMIPRAMINE PIMOZIDE
MEPERIDINE PROCAINAMIDE
MEPHENTERMINE QUINIDINE
METHAMPHETAMINE RANOLAZINE
METHYLPHENIDATE SOTALOL
Valproate MIRTAZAPINE SPARFLOXACIN
Critical 001 NORTRIPTYLINE TACROLIMUS
MEROPENEM PAROXETINE THIORIDAZINE
PHENYLEPHRINE
PHENYLPROPANOLAMINE
Venlafaxine PSEUDOEPHEDRINE
Critical 001 RIZATRIPTAN
L1NEZOLID SERTRALINE
SIBUTRAMINE HYDROCHLORIDE
SUMATRIPTAN
TRIMIPRAMINE
ZOLMITRIPTAN
Page 1 of2

--_. __._-------------- ~-- ~"--'--

Sent: Thursday, September 1S, 2008 1:28 PM
To: Smith. Amber A. (Iowa City)
Subject: FW: PTSD Polypharmacy and Varenicline Review - Updated Information July 23, 2008
More email communication from Bruce Alexander, Pharm.D., pertaining to PTSD review .. (again, sent to mental
health providers)
-----------
From: Alexander, Bruce
sent: Thursday, july 24,20082:11 PM
To: Smith, Robert E.; Halloran, Vivien J.; Westlake, Jennifer M; Rinehart, Richard H.; Satisky, Kevin F.; Miller,
Anthony C. (lOW); Shanks, Connie S.; Swayze, Vidor; Calderwood, Laura V.; Soukup, Beverly; Behrendtsen, Ole
Cc: Rinehart, Kathy l; Cook, Brian L.; Alexander, Bruce; Hensley, Carl E.; Havens, Oliver A; Cowdery, John S.;
Ross, Phillip T.; Ross, Debra (V23)
Subject: PTSD Polypharmacy and Varenicline Review - Updated Information July 23, 2008
Dear all,
Below is the updated directive and time-line for the PTSD review that I received yesterday.
To briefly review my original email, Iowa City had 115 names of patients with PTSD that met the original criteria.
Pharmacy's review according to the initial guidelines eliminated 80 patients from provider review, leaving 35 sent
to providers on Friday, July 18 However, with the updated email as noted below, those 80 patients now must all
be reviewed.
I am in the process of identifying the MH provider for each of the 80 patients. When this is complete I will fOlWard
patient review forms to the individual providers.
The original deadline for submitting your reviews to me was 8/7/2008; however, with the new workload I am
moving the date to August 12. I am responsible for entering the review information for the 115 patients on the
Sharepolnt site, so if you can get me your reviews earlier than the 12th I would appreciate it.
I will send an email when the patient assignments are distributed.
Bruce
Bruce Alexander PharmD BCPP I Clinical Pharmacy Specialist I Department of Psychiatry I Iowa City
VAMC 1319.338.0581 ext. 51181 bruc_e.alexander@va.gov
From: Hensley, Carl E.
sent: Wednesday, July 23, 20088:51 AM
To: VlSN 23 Pharmacy Advisory Group; VISN 23 Formulary Committee; Alexander, Bruce; Graham, Barry A.
Cc: VISN 23 Directors Secretary; VISN 23 Suspense Group
Subject: RE: SUSPENSE lON23CY08-317 --PTSD Polypharmacy and Varenicline Review
Further details regarding requirements and milestone dates:
August 20, 2008 - All patient reviews must be completed and the data entered into the facility
specific spreadsheets on Sharepoint
September .3....2.OM - The facility should then complete a summary report, The facility
summary report should report the percent of patient reviews completed. It should also
9118/2008
From:VA DIRECTOR'S OFFICE 3193397135 09/1912008 09:21 #090 P.024/052
Page 20f2
summarize any action plans. It may include other findings, based on review by the COS or
designee.
~1.e..IlJ.herJh2008 - The summary report with action plans and any findings should remain at
the local medical center. Only a confirmation that all patient reviews are completed needs to
be submitted to the V1SN by September 8, 2008
~p-tember 8,2008 - VISN Directors will be asked by VHA to certify that all patient
reviews have been completed on September 8, 2008. There is no longer a requirement to
prepare a VISN summary report. There is only a requirement to confirm that all patient
reviews are completed.
Octobe.r 8, 200~ - VISN Director will direct the VISN Mental Health Liaison and VISN
Formulary Leader to review the findings with each medical center by Octob~I 8, 2008.
There is nQ need to "fQII ~ the data tQ VAC~ PBM will do another database review of
the same patients (using the same SSNs) in a few months to see if there has been a sustained
reduction in the number of prescriptions for these patients. This review will be of aggregate
data by facility and not by provider.
Please contact me jf you have questions.
Carl Hensley
612-467-3380
A memo will be issued soon from VACO regarding the polypharmacy review of patients on 5 or
more medications. My understanding is that this review now requires that ALL PTSD patients
be reviewed for appropriateness, interactions, and dose regardless of the number of
medications. BQttQm line is that you haye tQ as!te~s ALL patienl~Qathe list provided by
the PBM·SHG - you can't stQP' witl:uluestiQn 2A - YQU,JJlust proceed with the~
~~
You must also have a Mental Health Physician do the provider portion of the review. Work
with facility Mental Health and/or the facility Director/COS who should appoint a MH Physician
to review those patients who are not currently assigned to a MH provider.
Carl E. Hensley" RPh MBA
VISN 23 Pharmacy Benefits Manager
Phone: 612-467-3380
Fax 612-629-7719
9/18/2008

From: Havens, Oliver A
Sent: Thursday, September 18, 2008 1:58 PM
To: Smith, Amber A (Iowa City)
Subject: FW: Final Varenicline Preliminary Prescribing Guidance
Attachments: Varenicline Patient Letter_053008.pdf; FinalVarenichne Preliminary Guidance.doc
sent: Sunday, June 15, 2008 5:49 PM
To: Zeman, Christine L.; Havens, Oliver A; Szot, Joseph F; Lynch, Debra; Surom, Clay M.
Cc: cantrell, Matthew A.; Desloover Koeh, Yvonne D.; Egge, Jason A.; Geraets, Douglas R.; Janney, Laurel M.; Johnson,
Sheila R.; Waterbury, Nancee V
SUbject: FW: Final Varenlcline Preliminary Prescribing Guidance
AI and Chris,
Can you please update me regarding where we are at regarding the VA's new prescribing limits on varenicline (Chantix)
-m
Varenicline Patient
Letter_OS3...
(i.e., change Rx's to 28 day limit on all fills; patient must be contacted by a "health care provider" every 28 days, in order to
get future refills)? For pharmacy to refill the drug, we can only verify that contact took place if the provider enters some
sort of note. Do we want to search for that documentation versus develop some sort of varenicline template? It also
appears that ·criteria for use" of this drug has become much more stringent and will reduce the number of veterans eligible
to receive this drug in the first place (Varenicline "preliminary prescribing guidance" link is at the bottom of this email
string - Word document). Also, per PBM request, I plan to move forward with mailing out the varenicline patient letter in
the upcoming week, unless there are objections. (See "varenicline patient letter" PDF file).
Kathy J. Rinehart, Phann.D.

Chief, Pharmacy Service
From: Korchik, William P

Sent: Friday, May 3D, 2008 3:32 PM
To: VISN 23 Formulary Committee; VISN 23 Pharmacy Advisory Group
Subject: FW: Final Varenicline Preliminary Prescribing Guidance
It would appear that his will be posted on the PBM website and hence become official next week. You all need to figure
out how to implement this.
From: Geraci, Mark

Sent: Friday, May 30, 2008 10:59 AM
To: VHAPBH VrSN Formulary Leaders; VHAPBH MAP Committee
Subject: Final Varenidine Preliminary Prescnbing Guidance
FinalVarenicline
Preliminary G...
Attached is the Final Varenlcline Preliminary Prescribing Guidance. Thanks to everyone for voting electronically. These
will not be posted to the website until the middle of next week as I am at 5 day oncology conference
Thanks,
Mark
Mark C. Geraci, Pharm.D.• SCOP

VHA Pharmacy Benefits Management Services (119D)
1st Avenue-1 Block North of Cermak (Bldg 37, Room 139)
Hines,IL 60141
Phone: 708-786-7866
Fax: 708-786-7989
2
DEPARTMENT OF VETERANS AFFAIRS

VETERANS HEALTH ADMINISTRATION
MEDICATION SAEETY INFORMATION:
V ARENICLINE (CHANTIXTM)
May 30, 2008

Dear Veteran,
The Department of Veterans Affairs would like to infonn you of safety concerns with your
medication called varenicline, also known as Chantix™, which you may be taking to help you
stop smoking.
Earlier this year, the Food and Drug Administration (FDA) issued a Public Health Advisory
after receiving reports of changes in behavior, agitation, depressed mood, and thoughts of
suicide in patients taking varenicline (ChantixTM).
On May 22, 2008, the Federal Aviation Administration (FAA) banned the use of varenicline
(Chantix™) in airline pilots and air traffic controllers due to reports to the FDA of patients
experiencing the following symptoms while taking varenic1ine (Chantix™):
• loss of consciousness,
• seizures,
• uncontrolled muscle movements,
• vision disturbances,
• hearing or seeing imaginary things,
• feelings of fear, mistrust, or suspicion, and
• other severe disruptions in thought and behavior.
Use of varenicline (Chantix™) in persons operating motor vehicles or heavy machinery can
lead to serious injury. We recommend that you use caution when driving or operating vehicles
andlor machinery until you know how varenicline (Chantix™) affects you. We also
recommend that you contact your health care provider as soon as possible if you notice any
changes in mood or behavior while you are taking varenic1ine (Chantix™).
Thank you.
Sincerely,
Varenicline Preliminary Criteria for Prescribing

VA Center for Medication Safety, Tobacco Use Cessation Technical Advisory Group, Public
Health Strategic Healthcare Group, V A Pharmacy Benefits Management Service, and Medical
Advisory Panel
May 2008
Thefollowing recommendations are l>ased on ClIrrenl medical eVidence and expert opinionjrom clinicians The content oj/he
document is dynamic and will be revised as nell' clinical data becomes available. The purpose oJehis document IS 10 assist
practitioners in climcal decision-making, to standardi:e and improve the quality ofpatient care. and to promote cose-effective drug
prescribing. The c1imcian should IItili:e thiS guidance and interpret II In lhe clinical contexe of individual patient situations.
Exclusion
0 Patients whose smoking cessation monitoring is via non-VA telephone counseling (e.g. a state
telephone quit-line)
0 Patients who wish to receive varenicline based on a prescription wrinen by a non· VA prescriber (i.e.
not directly monitored for smoking cessation by a VA provider while on varenicline)
0 Patients with a history of suicidal, homicidal, or assaultive behavior within the previous 12 weeks
0 Patients with current, persistent suicidal or homicidal ideation or an active plan or intent to harm self
or others
0 Patients with an untreated or unstable mental disorder such as, but not limited to, psychotic disorder,
bipolar disorder, major depressive disorder, and PTSD
Inclusion -
0 Patients without an active mental health disorder are included if they have had:
A) more than I relapse on nicotine replacement therapy, bupropion , or combination therapy)
or
B) a medical contraindication to these medications.
OR
0 Patients with a mental health disorder are included if they meet the following criteria:
A) More than J relapses on nicotine replacement therapy andlor bupropion (andlor combination
therapy) OR have a medical contraindication to these medications.
B) The mental disorder is clinically stable.
C) The clinician prescribing varenicline should obtain concurrence for varenicline treatment from
the patient's mental health provider if the patient is under mental health care; OR, if the patient is not
under mental health care, the prescribing clinician should consult with a mental health provider as
clinicallv indicated.
Prescription Limits
0 Prescriptions quantity limits of28 days or less with no refills. Requires monitoring by a Health Care
Provider at least every 28 days in person or by telephone
Monitoring
0 Health care providers should educate veterans and families, if available, prior to starting varenicline
about the possibility of changes in behavior or mood and particularly any thoughts of suicide,
homicide, assault, self harm, or harm to others. The veteran or family member should immediately
report such changes or thoughts to the provider, stop the varenicline, andlor seek urgent or emergent
evaluation and care. (See appendix)
0 Health care providers should monitor veterans taking varenicline at least monthly for changes in
behavior and mood and document any of these changes in the medical record.
May 2008
Updated versions may be found at hltp:llwww.pbm.va.gov or http://vawwDbmva.gov
Background Information
Varenicline is a partial agonist at the a4p2 neuronal nicotinic acetylcholine receptor and has an FDA
indication as an aid to smoking cessation treatment. The u4p2 neuronal nicotinic acetylcholine receptor
releases dopamine in the central nervous system, and activation is thought to mediate dependence,
including reinforcement, tolerance, and sensitization of the receptor. As a panial agonist, varenicline binds
to the receptor and produces low to moderate levels of dopamine release that reduces craving and
withdrawal symptoms. At the same time, varenicline acts as an antagonist, blocking the binding and
positive reinforcement effects of smoked nicotine.
Varenicline efficacy and safety were evaluated in a drug development program that included 4 trials of 12
weeks durationI,2.3.4 and a maintenance trial that allowed for an additional 12 weeks of therapy. S In these
trials, patients with any serious or unstable disease in the past 6 months were excluded, as were patients
with a history of depression, psychosis, substance abuse other than nicotine, bipolar disease, panic disorder,
or eating disorder. Serious neuropsychiatric adverse events reported in the 12 week studies included vivid
dreaming, nightmares, insomnia, emotional lability (n=l)and acute psychosis (n=I). Atrial fibrillation and
other cardiovascular events were also reponed as serious adverse events. An additional trial evaluating 52
weeks of therapy with varenicline versus placebo was performed in the United States and Australia.
Patients with any clinically significant medical condition or taking antidepressants, antipsychotics, or
naltrexone were eXCluded. The most common serious adverse events were cardiovascular; no
neuropsychiatric serious adverse events were reported. 6 ln August of 2007 there were 2 case reports of
neuropsychiatric adverse events with varenicline: one case of exacerbation of schizophrenia 7 and one case
of mania in a bipolar patient. 8
In November of2007, the FDA released an early communication about an ongoing safety review of
varenicline regarding reports of suicidal thoughts and aggressive and erratic behavior in patients who have
taken the medication. FDA was reviewing postmarketing cases submitted by Pfizer, Inc, varenicline's
manufacturer, describing suicidal ideation and suicidal behavior. FDA's preliminary assessment indicated
that many cases presented with new-onset of depressed mood, suicidal ideation, and behavior and
emotional changes within days to weeks of starting varenicline. Not all cases had a pre-existing
psychiatric illness or had stopped smoking. The role ofvarenicline is uncertain.
In February 0[2008, the FDA issued a Public Health Advisory on varenicline to alert health professionals
and patients about new warnings related to changes in behavior, agitation, depressed mood, suicidal
ideation, and actual suicidal behavior. Following a review of post-marketing adverse events, FDA
requested that Pfizer elevate the prominence of this safety information to the warnings and precautions
section of the prescribing information of the labeling.
In the VA, the VA Center for Medication Safety Wldertook a pharmacovigilance effort with varenicline
beginning in September of 2006, caHecling and analyzing spontaneous reports of adverse events.
Following the first FDA communication in November of2007, the Center's efforts progressed with an
intensive monitoring effort to evaluate events not in the spontaneous reporting system. This included an
integrated database monitoring program to pick up events not otherwise captured in the spontaneous
reporting database. The initial evaluation of these data was used to fommlate the CWTent criteria.
May 2008 2
Updated versions may be found al http://www.pbm.vagov or http://vaww.Dbm.va.gov
From:VA DIRECTOR'S OFFICE 3193397135 09/19/2008 09:23 #090 P.0301052
Appendix: Patient Information
The following Patient Infonnation should be provided to all patients and family members (if available)
when initiating therapy with varenicline:
Please watch for side effects when taking this drug. Contact your health care provider if
these occur. It is especially important to seek help if you have a change in your thoughts,
behavior or mood. Stop taking the drug and seek help immediately if you have thoughts
of harming yourself or others.
References
1 Nides M, Oncken C, Gonzalez 0, Rennard S, Watsky El, Anziano R, reeves KR. Smoking cessation with
varenicline, a selective a4~2 nicotinic receptor partial agonist: results from a 7-week, randomized, placebo
and bupropion-controlled trial with a I -year follow-up. Arch Intern Med 2006; 166: 156 I-68.
2 Oncken C, Gonzales DE, Nides M, Rennard S, Watsky E, Billing CB, et a1. Efficacy and safety of the
novel selective nicotinic acetylcholine receptor partial agonist, varenicline, for smoking cessation. Arch
Intern Med 2006; 166: 1571-77.
) Gonzales 0, Rennard S, Nides M, Oncken C, Azoulay S, Billing CS, et a1. Varenicline, an u4P2 nicotinic
acetylcholine receptor partial agonist, vs sustained-release bupropion and placebo for smoking cessation: a
randomized controlled trial. lAMA 2006; 296:47·55.
4 10renby DE, Hays lR, Rigotti NA, Azoulay S, Watsky El, Williams KE, et al. Efficacy of varenicline, an
a~2 nicotinic acetylcholine receptor partial agonist, vs placebo or sustained-release bupropion for smoking
cessation: a randomized controlled tria. lAMA 2006; 296:56-63.
S Tonstad S, T01mesen P, Hajek P, Williams KE, Billing CB, Reeves, KR. Effect of maintenance therapy
with varenicline on smoking cessation: a randomized controlled trial. lAMA 2006; 296:64-71.
6 Williams KE, Reeves KR, Billing CO, Pennington AM, Gong l. A double-blind study evaluating the
long-term safety of varenicline for smoking cessation. Current Med Res Opin 2007;23 :793-80 1.
7 Freedman, R. Exacerbation of schizophrenia by varenicline (letter). Am 1 Psychiatry 2007; 164: 1269.
8 Kohen I, Kremen N. Varenicline-induced manic episode in a patient with bipolar disorder (letter). Am 1
Psychiatry 2007; 164:1269-70.
May 2008 3
Updated versions may be found at http://~ or http://yaww.pbm.va.gov
From:VA DIRECTOR'S OFFICE 3193397135 09/19/2008 09.23 #090 P.031/052
NOTE: These Quality Indicators for Exams 1-10 will be used for the FY 2005 VISN Performance Standards
KEY ELEMENTS (QUALITY INDICATORS) FOR THE
10 MOST FREQUENTL Y REQUESTED C&P EXAMINATIONS
(Exams 1 through 10)
The CPEP Office is using these key elements to establish a baseline qualify level
for C&P examination reports
CPEP Office
Nashville, Tennessee
October 1, 2004 Version 2.4
Quality Indicators for Exams 1-10

TABLE OF CONTENTS
Audio _
Eye _
Feet _
General Medical _
Initial PTSD _
Joints _
Mental Disorders (Except Initial PTSD and Eating Disorders) _

Review PTSD _
Skin (not scars) _
Spine _
Exam Core Questions _
October 2004 ii Version 2.4

AUDIO
Key Element AMIE Reviewer Instructions

Ref.
1. Describes noise exposure during military? 84 For original service connection for hearing disorder:
38 CFR Answer NA if veteran is already service connected for
3.303 hearing loss or tinnitus OR if claim is for NSC
3.304 pension.
3.385 Answer YES if report indicates presence OR absence
of noise exposure during military service.
Answer NO if report does not address military noise
exposure.
2. Describes non-military noise exposure? 84 For original service connection for hearing disorder:
38 CFR Answer NA if veteran is already service connected for
3.303 hearing loss or tinnitus OR if claim is for NSC
3304 pension.
Answer YES if report indicates presence OR absence

I of non-military occupational and recreational noise
exposure.
Answer NO if report does not address non-military
noise exposure.
3. Does report address whether tinnitus is S5c
Do not use NA.
recurrent? DC 6260
Answer YES if report indicates no tinnitus was found
OR (if tinnitus is present but not constant) indicates
how frequently tinnitus episodes occur.
Otherwise, answer NO.
4. Findings of pure tone thresholds for both ears? C1
Do not use NA.
38 CFR
Answer YES if report provides separate thresholds for
4.85
each ear at the frequencies specified in the AMIE
3.385
worksheet.
DC 6100
5. Average of pure tone thresholds recorded C1
Do not use NA.
properly? 38 CFR
Answer YES if report contains average pure tone
3.385 threshold calculated using thresholds at 1000, 2000,
4.85 3000, and 4000 Hz for each ear.
Answer NO if report does not contain average
threshold OR if threshold average is not properly
calculated.
6. Findings of speech recognition for both ears? C2
Do not use NA.
38 CFR
Answer YES if report includes results of the Maryland
3385
CNC word list speech recognition test for each ear
485
OR examiner explains why the test could not be
DC 6100
administered (for example, language difficulties).
[NOTE: The exam report need not explicitly state that
the Maryland CNC word recognition test was used in
order to score a "YES" for this question.]
7. Diagnosis reports type of hearing loss7 E1
Do not use NA.
38CFR
Answer YES if report indicates there is no hearing
3.303
loss OR (if hearing loss is present) identifies the type
3.385
of loss (normal, conductive, sensorineural, central, or
3.304
mixed)
BACK TO TABLE OF CONTENTS
October 2004 -1 Version 2.4

From:VA DIRECTOR'S OFFICE 3193397135 09/19/2008 0923 #090 P.034/052
EVE
Key Element AMIE Ref.

Reviewer Instructions
1. Subjective complaints of visual symptoms? 83
Do not use NA.
38 CFR
This item refers to complaints of watering; swelling,
4.10
blurred vision; distorted or enlarged images: etc.
4.40
Answer YES if report includes any statement
identifying visual symptoms or noting absence of
symptoms.
2. Description of ophthalmologic treatment? 84, 85 Do not use NA.
38 CFR Answer YES if the report indicates the veteran has
4.1 received no ophthalmologic treatment OR (if
4.2 treated) describes the type and last date of
treatment.
3. Findings prOVide the best corrected visual acuity C1
Answer NA if veteran's visual acuity is worse than
for each eye? 38 CFR
5/200 in both eyes.
4.83
Answer YES if report indicates best corrected near
475
AND far visual acuity for each eye in which visual
DC 6061
acuity is at least 5/200.
to 6079
Answer NO if best corrected visual acuity
information (both near AND far for each eye) is
absent or incomplete.
4 Findings on reading chart, counting fingers. hand C1e
This item applies ONL V if the veteran's visual acuity
motion andlor light perception when visual acuity 38 CFR
is worse than 5/200 in either or both eyes.
is worse than 5/200? 4.75
Answer NA if visual acuity is 5/200 or BETTER in
4.83
both eyes.
DC 6061
Answer YES if the report states the distance at
to 6079
which veteran is able to read chart, count fingers, or
detect hand motion OR (if unable to detect hand
motion) whether or not veteran has light perception.
Answer NO if distance and detection information is
absent or incomplete.
5. If diplopia, constant or intermittent? C2b
Answer NA if diplopia is not diagnosed.
38 CFR
Answer YES if report indicates whether diplopia is
4.77
constant or intermittent.
DC 6090
to 6092
6. For diplopia and/or visual field deficit. does the C2, C3

Answer NA jf veteran does not have diplopia and/or
report include the Goldmann Perimeter Chart? 38 CFR
visual field deficit
4.27
Answer YES if the report includes a Goldmann
4.77
Perimeter Chart Illustrating the size and location of
DC 6080
each condition present (that is. diplopia and/or field
to 6081;
of vision defect).
6090 to
6092
7 Does the report address eye disease or injury? C4

Do not use NA
DC 6000
This item refers to details of eye disease or injury
to 6035
(including eyebrows. eyelashes, and eyelids)
OTHER THAN loss of visual acuity, diplopia. or
visual field defect.
Answer YES if report comments on presence or
absence of eye disease or injury,
[NOTE: It is not necessary that the report explicitly
mention eyebrows, eyelashes, and eyelids, as long
as, in the reviewer's judgment, the examiner
considered their condition.]
Otherwise answer NO.

FEET

Ref.
1. Subjective complaints of pain, weakness, or 81 Answer NA if not addressed AND veteran is not
fatigability? 38 CFR ambulatory (that is, in a wheelchair).
4.10 Answer YES if the report indicates presence or
4.59 absence of pain, weakness, or fatigability, etc, at rest
, or on standing or walking.
Answer NO if report does not address effects in at
least one of these activities.
2. Description of treatment (other than corrective 82 Do not use NA.
devices) and response? 38 CFR Answer YES if the report indicates that veteran is not
4.1 treated for the condition OR (if veteran is treated)
4.2 describes the treatment and effects.
3. Effectiveness of corrective devices described? 86 Answer NA if veteran is not ambulatory (that is, in a
DC 5276, wheelchair).
5278 Answer YES if report indicates the veteran does not
use corrective devices OR describes the effectiveness
of corrective shoes, shoe inserts, braces, or other
corrective devices.
Answer NO if the report is silent on use of these items
OR does not describe their effectiveness.
4. Effects of condition on usual occupation? B7 Answer NA if veteran is retired.
38 CFR Answer YES if report includes any comment on what
4.10 effect, if any, the foot condition has on the veteran's
4.40 ability to function in his/her usual occupation.
3.321 Otherwise, answer NO.
5 Findings describe each foot? C1 Answer NA if veteran does not have two feet OR any
38 CFR other circumstance makes the item irrelevant (for
4.26 example, exam is for unilateral neuroma, gunshot
DC wound, infection, malignancy, etc.).
5276 Answer YES if report describes each foot.
5277 [NOTE: Each foot must be described separately if the
5279 condition of each is not the same.)
5280 Otherwise, answer NO.
I 5281
5284
6. Evidence of painful motion, edema, weakness, C5 Do not use NA.
instability, or tenderness? 38 CFR Answer YES if report indicates there is no objective
4.6 evidence that veteran has painful motion, edema,
4.10 weakness, instability, or tenderness OR (if any of
4.59 these is present) describes objective evidence.
DC 5276 Otherwise, answer NO.
7. Functional limitations on standing and walking? C6 Do not use NA.
38CFR Answer YES if report states veteran is not ambulatory
4 10 OR describes functional limitations on standing or
4.40 walking.
DC Otherwise, answer NO.
5276
5283
5284
October 2004 -3- Version 2.4

FEET (Continued)
8. Evidence of abnormal weight bearing? C7 Do not use NA.

38 CFR Answer YES if the report indicates any of the
4.10 following:
4.40 1) Veteran is not ambulatory OR
DC 5276, 2) There is no evidence of abnormal weight bearing
5278 OR
3) Objective signs of abnormal weight bearing (for
example. callosities, breakdown, unusual shoe wear).
Otherwise, answer NQ
9. Describes alignment of Achilles tendon for flat C11a Answer NA jf veteran does not have flat foot
foot condition? DC 5276 Answer YES if report describes alignment of the
Achilles tendon.
10. Pain on manipulation is addressed for flat foot C11b Answer NA if veteran does not have fiat foot.
condition? 38 CFR Answer YES if the report indicates whether or not the
I 4.59 foot or Achilles tendon is painful on manipulation.
i DC 5276 Answer NO if pain on manipulation is not addressed.

GENERAL MEDICAL

Ref.
1. Report notes complaints and time of onset in 81 Answer NA if claim is NOT for original service
relation to service? 38 CFR connection.
3.303 Answer YES if report indicates when, according to the
3304 veteran, each identified injury or disease occurred
I 3306 (before. during, or after active service).
442 Answer NO if report does not address time of onset in
,elal;on 10 Ihe veleran's acllve service :~
2. Current treatment and effects are described? 83 Do not use NA.
38 CFR Answer YES if report describes current treatments
4.1 and effects OR states that there are no current
4.2 treatments.
4.10 Answer NO if one or both elements are absent.
3. Indicates dominant hand? C2 Answer NA in the event of bilateral upper extremity
38 CFR amputations.
4.71A Answer YES if the dominant hand is noted.
4.241a
4. Gait described? C3, C19 Answer NA if veteran is not ambulatory.
38 CFR Answer YES if the report notes gait to be normal OR
4.45 (if the gait is abnormal) describes the abnormality.
4.10
5. Does report include Eye exam worksheet C7 and Do not use NA.
information, if indicated? Narrative Answer YES if report states no vision problem was
38 CFR noted OR eye exam information is included.
475 Otherwise, answer NO
6. Does report include Audio exam worksheet C8 and Do not use NA.
information, if indicated? Narrative Answer YES if report states no hearing problem was
38 CFR noted OR (if hearing problem noted) audio exam
4.85 information is included.
I
7. If hypertension is not claimed AND was not C13.c.iv Answer NA if veteran has been diagnosed with, or is
previously diagnosed, at least three blood 38CFR claiming, hypertension.
pressure measurements reported? 4.104 Answer YES if at least three blood pressure
measurements are recorded.
Answer NO if fewer than three measurements are
recorded
8. Does report include Joint exam worksheet C17 and Do not use NA.
information, if indicated? Narrative Answer YES if the report indicates no joint pathology
38CFR was noted OR (if joint pathology noted) includes joint
4.40 exam worksheet information OR if absence of the
4.59 information is explained (for example, veteran
4.71a refused).
I 4.61

GENERAL MEDICAL (Continued)
9. Does report include Spine exam worksheet C17 and

Do not use NA.
information, if indicated? Narrative
Answer YES if the report indicates no spine pathology
38CFR
was noted OR (if spine pathology noted) includes
4.40
spine exam worksheet information OR if absence of
4.59
the information is explained (for example, veteran
4.61
refused).
4.66
4.71a
10. Does report include Mental exam worksheet C20 and

Do not use NA.
information, if indicated? Narrative
Answer YES if report states no mental disorder was
38 CFR
noted or suspected OR (if noted or suspected)
4.125
includes mental or PTSD exam worksheet information
4.130
OR if absence of the information is explained (for
example, veteran refused).
_Otherwise, answer NO.
11. Were all other worksheets followed as Narrative
Do not use NA.
appropriate? 38 CFR
Answer YES if the appropriate worksheet information
4.42
for every condition that was either claimed or noted is
38 USC
included in the report OR if absence of the information
DC 5103.
is explained (for example. veteran refused).
5107

NOTE: These Quality Indicators for Exams 1-10 will be used for the FY 2005 VIS N Performance Standards
INITIAL PTSD
Key Element AM IE Reviewer Instructions

I
Ref.
1 C-file reviewed? 81, C1(c) Do not use NA.
M21-1 Answer YES if report definitively states that C-file was
Part VI reviewed OR states that C-file was not provided
2. Frequency, severity, and duration of C2 Do not use NA.
symptoms? 38 CFR Answer YES if report states that no psychiatric
4.126 symptoms appeared in the past year OR (if symptoms
4.130 appeared) addresses their frequency, severity, and
duration.
Symptoms may include: persistent re-experiencing of
traumatic events; persistent avoidance of stimuli
associated with trauma; numbing of general
responsiveness; persistent symptoms of increased
arousal (startle); distressing dreams during which the
traumatic event is replayed.
3. Specific stressors during service and link to D (Mil) 9 Do not use NA
current condition? and NOTE This item refers to specific stressors experienced
38 CFR during service and their relationship to the current
3.304(f) condition.
M21-1 Answer YES if the report clearly describes stressor(s)
Part VI with details and the relationship to current symptoms
11.38 OR explains why these cannot be described.
4. Post-military stressors and description of o (Post- This item refers to post-military stressors (for example,
psychosocial consequences? Mil) 2 accidents, natural disasters, assault, rape, etc.) AND
38 CFR any psychosocial consequences (such as treatment
3.303(d) received, disruption to work, or adverse health
M21-1 consequences).
Part VI Answer NA if PTSD is diagnosed on a pre-discharge
11.38 exam.
Answer YES if report indicates no post-military
stressors OR (if present) describes psychosocial
consequences
5. Does the report address problematic alcohol o (Post- Do not use NA.
or substance abuse? Mil) 8 Answer YES if report indicates presence or absence
38 CFR of substance abuse AND (if present) makes any
4130 reference to presence or absence of associated
3.301 problems (for example, legal problems related to
FL01-35 substance use, interference with employment,
domestic abuse, etc.).
6. Effects on employment functioning? E Answer NA if PTSD is not diagnosed in the report.
38 CFR Answer YES if report contains any comment on how
4.130 PTSD signs, symptoms, or impairment interfere with
4.16 employment.
7. Is impairment of thought process or E1 Do not use NA.
communication addressed and described? 38 CFR Answer YES if report states there is no impairment of
4.130 thought process or communication OR (if impairment
is found) indicates frequency and extent of impairment
and how it interferes with employment or social
functioning.
Otherwise. answer NO.

INITIAL PTSD (Continued)
I
8. Is the diagnosis consistent with DSM-IV and H1
Do not use NA.
supported by the exam findings? 38 CFR

Answer YES if the diagnosis of PTSD (or non-
4.125
diagnosis of PTSD) is consistent with DSM-IV criteria
4.126
AND the diagnosis is supported by exam findings.
4,130
9. Does report describe multiple mental H2 and

When more than one mental disorder is present,
disorders and symptoms? NOTE

examiner should delineate, to the extent possible,
38 CFR
symptoms associated with each disorder and discuss
4.14
their relationship to PTSD, if diagnosed.
Answer NA if PTSD was not diagnosed in the report.
Answer YES if report states other mental disorders
were not found OR delineates symptoms associated
with each disorder (or explains why delineation is not
possible) and discusses the relationship of other
mental disorders to PTSD.
10. Does report address veteran's ability to K

Do not use NA
manage VA benefits? 38 CFR

Answer YES if report states veteran is, or is not, able
3.353
(competent) to manage VA benefits.

JOINTS
Key Element AM IE Reviewer Instructions

I Ref.
1. Does report note subjective complaints? 81 Do not use NA.
38 CFR Answer YES if the report comments on presence or
4.1 absence of any subjective complaints (for example,

4.10 pain, weakness, swelling, stiffness, instability, etc.).
4.59
2. Does report describe need for assistive 82 Do not use NA.
devices? 38CFR Answer YES if the report indicates that veteran does
4.1 not need assistive devices (for example, crutches,

4.2 brace, cane, corrective shoes, etc.) OR describes
veteran's need for such devices.
3. Does the report describe the effects of the 88 Answer NA jf veteran is retired.
condition on the veteran's usual occupation? 38 CFR Answer YES if any comment appears about what
4.1 effect, if any, the joint condition has on the veteran's

3321/b){1)
4. Does report describe effects of the condition on 88 Do not use NA.
the veteran's routine daily activities? 38 CFR Answer YES if any comment appears about what
4.10 effect, if any, the joint condition has on the veteran's

ability to perform daily activities associated with his or
. her ordinary routine.
5. Does report provide the active range of motion C1 Do not use NA.
in degrees? 38 CFR Answer YES if the report states active range of
440 motion (ROM) in degrees OR explains why these
445 measurements could not be done.
459 [NOTE: An indication in the report that a joint's ROM
is normal is acceptable for a YES answer.]
6. Does the report state whether the joint is C2 Do not use NA.
painful on motion? 38 CFR Answer YES if the report notes presence or absence
4.59 of pain on motion AND (if painful motion is present)

indicates at what point in the range of motion pain
begins (or explains why this measurement could not
be done).
I
7. Does the report address additional limitation C3 Do not use NA.
following repetitive use? 38 CFR Answer YES if report indicates to what extent (if any)
4.40 and in which degrees (if possible - or reason this
4.45 could not be determined) the range of motion or joint
4.59 function is additionally limited by pain, fatigue,
(DeLuca) weakness, or lack of endurance following repetitive
use.
[NOTE: The additional functional loss may be
expressed in terms of either degrees of loss of motion
OR in terms of an additional percentage of loss. If
the additional loss is expressed in either way, answer
YES.)
I
l.--

JOINTS (Continued)
8. Does the report describe flare-ups? 83

Do not use NA.
38 CFR
Answer YES if the report states there are no flare-ups
445
OR provides a description of the flare-ups.
4.59
(DeLuca)
9 Does report address instability of knee? D2b
Answer NA if the knee is not an issue in the exam.
38 CFR
Answer YES if report notes the knee is stable OR (if
410
instability is present) describes knee instability.
4.14
Otherwise, answer NO
DC
5257
5260
5261
GC
I
Precedent
I
Opinion
97-23
10. Does the report include results of all conducted E2

Do not use NA.
diagnostic and clinical tests? 38CFR

Answer YES if no tests were conducted OR results of
4.10
all conducted tests are included in the report.

From:VA DIRECTOR'S OFFICE 3193397135 09/19/2008 0925 #090 P.043/052
MENTAL DISORDERS (Except Initial PTSD and Eating Disorders)

I Ref.
1. Frequency, severity, and duration of symptoms? 82a Do not use NA.
38 CFR Answer YES if report states no mental disorders or
3.309 psychiatric symptoms appeared in the past year OR
3.304 addresses frequency, severity, and duration of
4.41 documented symptoms.
2. Report addresses unemployment or time lost
82c Answer NA if veteran is retired.
from work?
38 CFR Answer YES jf report indicates veteran has been
4.126 unemployed over the last 12 months OR indicates
4.16 current occupation and extent of time lost from work
DC 9440 over that period.
Otherwise, answer NO
3. Examiner reports effects of symptoms on
C2 Answer NA if no mental disorder is found on exam.
employment functioning?
410 signs, symptoms, or impairment associated with
4.126 veteran's mental disorder (if diagnosed) interfere with
4.16 employment functioning.
DC 9440
4. Effects on social functioning? C2 Answer NA if no mental disorder is found on exam.
4.126 signs, symptoms, or impairment associated with
DC 9440 I veteran's mental disorder (if diagnosed) interfere with
social functioning.
5. Thought process or communication impairment C2a

Do not use NA.
described? 38 CFR
Answer YES if report states there is no impairment of
4.10
thought process or communication OR (if found)
4.126
indicates how it interferes with employment or social
I
DC 9440
functioning.
6 Does report address veteran's behavior? C2c

Do not use NA.
38 CFR
Answer YES if report indicates presence or absence
4.126
of inappropriate behavior AND (if present) provides
examples.
7. Describes activities of daily living? C2e

Do not use NA
38 CFR
Answer YES if report describes veteran's ability to
4.130
maintain any basic activities of daily living in addition
DC 9440
to personal hygiene (for example, eating, dressing,
toileting, etc.).
8. Does the report address veteran's ability to

D3a
Do not use NA.
manage VA benefits?
38CFR
3.353
(competent) to manage VA benefits.
3.354
DC 9440

MENTAL DISORDERS (Continued)
9. MUltiple mental disorders and symptoms E3 Do not use NA.

discussed? DC 9440 When more than one mental disorder is present,
their relationship
possible) and discusses their relationship.
10. Effects of drug or alcohol abuse addressed, Eand Do not use NA.
when appropriate? NOTE Answer YES if report states drug and/or alcohol abuse
38 CFR are not factors in the veteran's condition OR
3.301 separates drug/alcohol abuse effects from other
4.130 mental disorders (or explains why the effects cannot
DC 9440 be separated).
FL01·35 Otherwise, answer NO.

From:VA DIRECTOR'S OFFICE 3193397135 09/1912008 09'26 #090 P.045/052
REVIEWPTSD
Key Element AMIE

Reviewer Instructions
Ref.
1. Frequency, severity, and duration of symptoms 82

Do not use NA.
since last exam reported? 38 CFR
Answer YES if report states there are no psychiatric
4.126
symptoms since last exam OR (if symptoms are
DC 9411
noted) addresses frequency, severity, and duration.
2. Does report comment on remissions and 83
Do not use NA.
capacity for adjustment? 38 CFR
This item refers to the duration of remissions (if any)
3.327(a)
from psychiatric symptoms, including some indication
4.1
of veteran's ability to adjust during periods of
4.2
remission.
Answer YES if report states there are no periods of
remission OR (if remissions occur). indicates the
veteran's capacity for adjustment during remission
[NOTE: This Key Element should be answered in
view of the entire exam report. If it is clear that there
has been no remission since last exam, answer YES.]
Answer NO if report does not address remissions OR
(if remissions occur) does not discuss capacity for
adjustment
3. Does the report comment on type of treatment? 84
Do not use NA.
38CFR
Answer YES if the report indicates that veteran is not
4.1
treated for the condition OR (if veteran is treated)
4.2 describes the treatment and its effects.
Answer NO if the report does not indicate whether or
not veteran receives treatment OR (if treated) does
not describe the treatment and effects.
4. Does the report describe veteran's current C3
Answer NA if the veteran is retired.
occupation and time lost from work? 38 CFR
Answer YES if veteran is employed and report
3.321
identifies current occupation, length of time at job, and
DC 9411
time lost from work during last 12 months OR (if
unemployed) states whether veteran attributes
unemployment to mental disorder and examiner notes
factors and objective findings that support or rebut the
veteran's contention.
5. Does the report describe social functioning C5
Do not use NA.
since the last exam? 38 CFR
Answer YES if the report comments on social
3.327(a)
relationships or social functioning.
6. Does the report address problematic alcohol or C7
Do not use NA.
substance abuse? 38 CFR
Answer YES if report indicates presence or absence
3301
of substance abuse AND (if present) makes any
4.130
reference to presence or absence of associated
FL 01-35
problems (for example, legal problems related to
substance use, interference with employment,
domestic abuse, etc.).

REVIEW PTSD (Continued)
7. Is impairment of thought process or D1

Do not use NA.
communication addressed and described? 38 CFR

This item refers to social or work effects of impaired
4.130
thought process or communication:
DC 9411
Answer YES if report states there is no impairment of
thought process or communication OR (if found)
indicates frequency and extent of impairment and how
it interferes with employment or social functioning.
8. Describes activities of daily living? 05

Do not use NA.
3B CFR
Answer YES if report describes veteran's ability to
4,130
maintain any basic activities of daily living in addition
DC 9411
to personal hygiene (for example, eating, dressing,
toileting, etc,).
9. Does report describe multiple mental disorders G2

When more than one mental disorder is present,
and symptoms? 38 CFR

4.14
their relationship to PTSD, if diagnosed.
Answer NA if PTSD was not diagnosed
possible) and discusses the relationship of other
mental disorders to PTSD,
Otherwise, an?wer NO,
10. Does the report address veteran's ability to J

Do not use NA.
manage VA benefits? 38 CFR

3.852
(competent) to manage VA benefits,
3.853

SKIN

Ref.
1 Report comments on onset of the skin B1 Answer NA if skin condition is already service-
condition? 38 CFR connected OR claim is for NSC pension only.
3.303 Answer YES if report Indicates veteran denies
3304 symptoms OR report describes disease onset.
3306 Answer NO if service connection is at issue and report
4.118 does not comment on disease onset.
2. Report describes the course of the skin 81 Do not use NA.
condition (that is, the variation of symptoms 38 CFR Answer YES if report describes the variation of the
over time)? 4118 disease/symptoms over time, to include whether it is
intermittent, constant, or progressive.
3. Does report describe treatment type(s) and 82 Do not use NA.
dosage(s)? 38 CFR Answer YES if the report indicates that the veteran is
4.118 not treated OR describes the type(s) of treatment (that
is, systemic treatments such as corticosteroids or
other immunosuppressive drugs; topical treatments;
or light/beam therapy) AND (for systemic treatment
only) dosage of treatment. I
4. Does report note frequency and duration of 83 Answer NA if report indicates that the veteran is not
each treatment during past twelve months? 38 CFR treated for the skin condition.
4.118 Answer YES if the report addresses the frequency of
use and duration of each treatment over the past
twelve months.
5. Report states the percentage of exposed areas C1 NOTE: This item applies only if one or more of the
affected? DC 7800, following conditions is diagnosed:
7806 to • Dermatitis
7817 • Eczema
• Leishmaniasis
• Lupus
• Dermatophytosis
• Bullous disorders
• Psoriasis
• Infections of the skin
• Cutaneous manifestations of collagen
vascular diseases
• Papulosquamous disorders
Answer NA if exposed skin areas (head, face, neck, or
hands) are not at issue OR if no listed condition is
diagnosed.
Answer YES if report notes the percentage of
exposed skin area involved.
Answer NO if exposed skin is affected AND the report
does not indicate the percentage of exposed skin
affected. _.. I

SKIN (Continued)
6 Does report state percentage of entire body C1 NOTE: This item applies only if one or more of the
affected? 38CFR following conditions is diagnosed:
4,118 • Dermatitis
• Eczema
• Leishmaniasis
• Lupus
• Dermatophytosis
• Bullous disorders
• Psoriasis
• Infections of the skin
• Cutaneous manifestations of collagen
vascular diseases
• Papulosquamous disorders
Answer NA jf only fingernails andlor toenails are
affected OR if no listed condition is diagnosed.
Answer YES if condition does not involve (or is not
limited to) fingernails and/or toenails AND report
indicates percentage of entire body affected.
7. If scarring andlor disfigurement are involved, C2
Answer NA if scarring andlor disfigurement are not
does report provide the Scars worksheet 38 CFR
present.
information? 4.118
Answer YES if scarring andlor disfigurement are
present and Scars worksheet information is provided,
Answer NO if scarring andlor disfigurement are
present and Scars worksheet information is not
provided.
8. If acne or chloracne, report describes whether C3
Answer NA if acne or chloracne is not at issue,
condition is superficial or deep? 38 CFR
Answer YES if report indicates whether disease is
4,118
superficial (comedones, papules, superficial cysts) or
deep (deep inflamed nodules and pus filled cysts) OR
states acne is not currently active.
Otheryvise, answer NO.
9. Does the report include results of all conducted D2
Do not use NA.
diagnostic and clinical tests? 38 CFR
4,118
all conducted tests are included in the report,
OthelWise. answer NO,
10, Does report include color photos? D3
Do not use NA.
38CFR
Answer YES if there is no indication of disfiguring skin
4.118
condition or disfiguring scars of the head, face, or
DC 7800
neck OR (if report indicates disfiguring condition of the
head, face, or neck) color photos accompany the
exam report.
OthelWise, answer NO.

SPINE

Ref.
1. Does report note veteran's complaints/ 81 Do not use NA.
symptoms? 38 CFR Answer YES if the report indicates veteran denies
4.1 symptoms OR describes veteran's
I
4.2 complaints/symptoms (for example, pain, weakness,
4.10 stiffness, fatigability, lack of endurance, etc.),
I 4.40 including duration and characteristics.
2. Report notes location and distribution of pain B1b Answer NA if veteran denies pain.
(including any radiation)? 38 CFR Answer YES if report identifies the location and
42 distribution of pain, to include any radiation of pain to
4.41 extremities. {NOTE: If pain does not radiate to
4.71a extremities, report should so indicate.]
3. Report describes veteran's ability to walk. 85 Do not use NA.
including the use of assistive devices? 38 CFR Answer YES if report describes the veteran's ability to
4.1 walk, including whether or not the veteran uses a
4.10 cane, crutches, walker, orthosis, etc
4.71a Otherwise, answer NO.
4. Does report describe effects of the condition on 88 Answer NA if veteran is retired.
the veteran's usual occupation? 38 CFR Answer YES if report includes any comment on what
4.10 effect, if any, the spine condition has on the veteran's
5. Does report provide each range of motion in C2.a, Do not use NA.
degrees? C2.b.38 Each measured range of motion (ROM) is to be
CFR reported in degrees.
4.40 Answer YES if the report indicates ROM in degrees
4.45 OR explains why measurement could not be done.
4.46 The report must include each of the following ROM:
4.59
461 Forward flexion
4.71 Extension
Left lateral flexion
Right lateral flexion
Left lateral rotation
Right lateral rotation
[NOTE 1: Indication that a ROM (or all ROMs) is/are

normal is acceptable for a YES answer]
{NOTE 2: The updated AMIE worksheet (effective 9
26-03) treats the thoracolumbar spine as a single unit
for purposes of ROM measurement. If both cervical
and thoracolumbar ROM are appropriate to the
condition being examined, these are to be measured
and reported separately.]

From:VA DIRECTOR'S OFFICE 3193397135 09/19/2008 09.27 #090 P.0501052
SPINE (Continued)
6. Does the report address additional limitation C2.aiii, This item refers to functional status with repetitive use
following repetitive use? C2b.iii of spine.
38 CFR Do not use NA.
440 Answer YES if report indicates to what extent (if any)
4.45 and in which degrees (if possible - or reason this
could not be determined) the range of motion or joint
function is additionally limited by pain, fatigue,
weakness, or lack of endurance following repetitive
use.
[NOTE: The additional functional loss may be
expressed In terms of either degrees of loss of motion
OR in terms of an additional percentage of loss of
motion. If the additional loss is expressed in either of
these ways, answer YES.]
7. Does the report describe flare-ups? 83

Do not use NA.
38 CFR
Answer YES if the report states there are no flare-ups
4.1
OR provides a description of the flare-ups.
4.45
4.71
8. Does report address objective evidence of C2.a.iv,

Do not use NA.
painful motion, spasm, weakness, and/or C2.b.iv

Answer YES if report addresses presence or absence
tenderness? 38 CFR
of objective evidence of any of the following:
4.10
• Painful motion
4.45
• Spasm
4.59
• Weakness, and/or
4.71a
• Tenderness, etc.
9. Report describes neurological findings, to C3
Do not use NA.
include sensory and motor examination? 38 CFR
Answer YES if report describes neurological findings,
4.1
inclUding sensory and motor examination (including
4.2
atrophy, tone, and strength) AND (if necessary)
4.66
follows appropriate exam worksheet for affected body
4.71a
system(s).
[NOTE: Also answer NO if atrophy is noted but
circumferential measurements are not included.l
10. Does report describe the duration of each 04
Answer NA if intervertebral disc syndrome is not
incapacitating episode during the past 12-month 38 CFR
diagnosed and not at issue
period? 4.71a
Answer YES if report specifies the duration of each
DC 5243
incapacitating episode during the past 12·month
period.
[NOTE: An incapacitating episode, for disability
evaluation purposes, is a period of acute signs and
symptoms due to intervertebral disc syndrome that
requires bed rest prescribed by a physician and
treatment by a physician.]
11. Does the report include results of all conducted E
Do not use NA.
diagnostic and clinical tests? 38 CFR
4.10
all conducted tests are included in the report.

EXAM CORE QUESTIONS
Exam Core Question Reviewer Instructions

1. Is each diagnosis stated precisely? [NOTE 1: This Core Question applies only to the
diagnosis statement(s) that actually appear(s) in the
Ref: 38 CFR 3.4b/4.2/4.13 exam report Core Question 2 applies to reports in
which at least one condition relevant to the exam is
not addressed by a diagnosis.]
Answer NA if the examiner explains why a clear,
specific diagnosis could not be provided in each
instance where an unclear and/or non-specific
diagnosis appears for a condition at issue.
Answer YES if each statement that is supposed to be
a diagnosis actually is a crear and specific diagnosis
(as opposed to a sign, symptom, rule-out, only
historical. etc.).
[NOTE 2: In cases involving multiple conditions. an
exam report might adequately explain some. but not
all, non-specific diagnoses. In that event, answer
Core Question 1 NO.
2. Was the lack of a diagnosis justified? Answer NA if each condition that is relevant to the
exam being reviewed and/or is identified on the
Ref: 38 CFR 4.2/4.13 exam request was addressed by a diagnosis
statement
Answer YES if the report indicates why a diagnosis
was not provided for each condition at issue (for
example, "tn spite of sUbjective complaints. there
was no evidence to support a diagnosis," veteran
interrupted exam, undiagnosed illness, etc.).
3. Was functional impairment information Do not use NA.
provided?' Answer YES if the report paints a picture of the
effect, if any. of the disability on the veteran's normal
Ref: 38 CFR 4.10/4.40 daily activities, including general employment
capacity (without regard to whether or not the
veteran is currently employed).
4. Did the examiner address all issues in the Do not use NA.
remarks section of the AMIE exam request? Answer YES if the examiner addressed the issue at
all, without regard to completeness.
Ref: 38 CFR 4.2 Otherwise, answer NO.
M21-1, Part VI, Para. 1.07
\ Core Question #3 does nOl apply to Audio and Eye exams. Accordingly, CPEP scores this item NfA on reviews of
Audio and Eye exam reports.

EXAM CORE QUESTIONS (Continued)
5. Was the requested medical opinion properlyAnswer NA if a medical opinion was NOT requested
stated? in the remarks section of the exam request OR if the
requested medical opinion was not provided (that is,
Ref: 38 CFR 3328/4.13 if you answer Core Question 4 NO because a
medical opinion was not provided, you would
generally answer Core Question 5 NA).
For each REQUESTED medical opinion:
Answer YES if the opinion is expressed using the
proper medico-legal threshold of assurance.
[NOTE 1:
Proper phrases include:
As likely as not
Not as likely as not
More likely than not
At least as likely as not
Etc.
Improper words include:
Maybe
Could be
Might be
Etc]
[NOTE 2: In cases involving multiple medical opinion
requests, the exam report might provide some, but
not all, requested opinions. In that event, answer
Core Question 4 NO (for the missing opinion{s», and
answer Core Question 5 as appropriate for the
provided opinion(s)1
Comments (for clarification and/or points not covered by the Instrument):

CREW: Department of Veterans Affairs: Regarding PTSD Diagnosis: PTSD Dcoumentation

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CREW: Department of Veterans Affairs: Regarding PTSD Diagnosis: PTSD Dcoumentation

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From:VA DIRECTOR'S OFFICE 3193397135 09/19/2008 09 16 #090 P.

~ Department of Veterans Affairs VHA FAX TRANSMITTAL

(215) 823-5274 09/19/2008 51

This is the documentation given to me by our medical center manager/leadership. Please

INITIAL EVALUATION FOR POST-TRAUMATIC STRESS DISORDER

Date of Exam: C-number:

• records reviewed (C-file, 00-214, medical records, other documentation)

C. Review of Medical Records:

1. Past Medical History:

a. Previous hospitalizations and outpatient care.

2. Present Medical History - over the past one year,

a. Frequency, severity and duration of medical and psychiatric symptoms.

D. Examination (Objective Findings):

Address each of the following and fully describe:

History (Subjective Complaints):

Premilitary History (refer to social-industrial survey if completed)

• branch of service (enlisted or drafted)

• describe post-military traumatic events (see CAPS trauma assessment checklist)

Post-Military Psychosocial Adjustment (refer to social-industrial survey if completed)

• legal history (OWls, arrests, time spent in jail)

E. Mental Status Examination

• Impairment of thought process or communication.

• Delusions, hallucinations and their persistence.

whether constant or intermittent.)

• identify the primary stressor or stressors

avoidance/numbing, heightened physiological arousal, and associated features [e.g.,

disillusionment and demoralization])

• specify onset, duration, typical frequency, and severity of symptoms

G. Psychometric Testing Results

• provide psychological testing if deemed necessary

J. Global Assessment of Functioning (GAF):

M. Integrated Summary and Conclusions

N. Effects of PTSD on Occupational and Social Functioning

appropriate assessment of the veteran from the choices below:

Provide examples and pertinent symptoms, including those already reported.

Provide examples and pertinent symptoms, including those already reported.

Provide examples and pertinent symptoms, including those already reported.

Provide examples and pertinent symptoms, including those already reported.

• PTSD symptoms require continuous medication

• Select all that apply:

Review Examination for Post-Traumatic Stress Disorder (PTSD)

A. Review of Medical Records.

B. Medical History since last exam:

3, frequency, severity and duration of psychiatric symptoms,

C. Psychosocial Adjustment since the last exam

• legal history (OWls, arrests, time spent in jail)

D. Mental Status Examination

• Impairment of thought process or communication

avoidance/numbing, heightened physiological arousal, and associated features [e.g.,

disillusionment and demoralization])

• specify typical frequency and severity of symptoms

F. Psychometric Testing Results

• provide psychological testing if deemed necessary

I. Global Assessment of Functioning (GAF):

L. Integrated Summary and Conclusions

M. Effects of PTSD on Occupational and Social Functioning

Provide examples and pertinent symptoms, including those already reported.

Provide examples and pertinent symptoms, including those already reported.

Provide examples and pertment symptoms, including those already reported.

Provide examples and pertinent symptoms, including those already reported.

• PTSD symptoms require continuous medication

• Select all that apply:

Smith, Amber A. (Iowa City)

From: Lynch, Debra