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“Diseases of the brain commonly produce changes in behavior, including impairment of cognitive abilities and production of neuropsychiatric symptoms. Knowledge of the presence and characteristics of these changes can aid in the evaluation, management, and longitudinal care of patients with neurologic and psychiatric diseases.” Adapted from: Neurology 1996;47:592-599.

Healthy Aging / Memory Care Guide

Contents

Introduction ………………………………………………………………………………………………………Measure & Monitor Cognitive Function… WHY?………………………………………………….Step One: Evaluate Cognitive Function… HOW?…………………………………………………………Step Two: Assess Comorbidities and Functional Status ………………………………………………Step Three: Manage Neurocognitive Health… HOW?………………………………………………Annual Wellness Visit Algorithm for Assessment of Cognition ………………………………Procedure Reimbursement ……………………………………………………..……………………Benefits: Help Your Patients and Your Practice …………………………………………………………Cognitrax Sensitivity and Specificity ……………………………………………………………..

Disclaimer & CopyrightsTHE USER OF THIS SOFTWARE UNDERSTANDS AND AGREES THAT CNS VITAL SIGNS LLC. IS NOT ACTING AS A QUALIFIED HEALTH PROFESSIONAL OR MEDICAL PROVIDER (“Provider”), AND THAT THE SOFTWARE IS AN INFORMATION PROCESSING TOOL ONLY. The Software is not intended to replace the professional skills and judgments of Provider and its employees and contractors. Provider alone shall be responsible for the accuracy and adequacy of information and data furnished for processing and any use made by Provider of the output of the Software or any reliance thereon. Provider represents and warrants that it is a properly licensed healthcare provider and that all individual employees or contractors of Provider using the Licensed Product have sufficient credentials, training, and qualifications in order to understand and interpret the Licensed Product and its results. Provider further represents and warrants that it shall consider the results of use of the Licensed Product only in conjunction with a variety of other information in connection with relevant diagnostic and treatment decisions.

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Promotion using CNS Vital Signs® name or logos in any form or by any means without the written permission of CNS Vital Signs® is prohibited. No part of the contents of this book may be reproduced or transmitted in any form or by any means without the written permission of CNS Vital Signs®. All rights reserved.

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IntroductionPopulation aging raises many fundamental questions for clinicians and policy-makers. How do we help people remain independent and active as they age? How can we strengthen health promotion and prevention policies, especially those directed to older people? As people are living longer, how can the quality of life in old age be improved? Will large numbers of older people bankrupt our health care and social security systems?

ability to plan and carry out tasks), judgment, attention, perception, remembered skills such as driving, and the ability to live a purposeful life. Much like physical health, neurocognitive health can be viewed as a journey —from optimal, healthy functioning to mild cognitive impairment to severe dementia. Mental decline may not be an inevitable part of aging. Normal aging is a gradual process that comes with certain changes in mental function. It is important to measure and monitor brain function under challenge with a non-painful procedure called neurocognitive testing. It is important to note that some causes of cognitive impairment are related to treatable health issues (e.g., medication side effects, Folic Acid and vitamin B12 deficiency, and depression).

Cognitrax can be a partner in helping you support the goals of the Alzheimer’s Association and the Centers for Disease Control and Prevention’s (CDC) Healthy Aging Program Healthy Brain Initiative.

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“Health” refers to physical, mental and social well being. Successful ageing is characterized by high neurocognitive and physical functioning, a positive engagement with life, and the ability to avoid disease and disability.

What is cognition?Cognition can be viewed along a continuum—from optimal functioning to mild cognitive impairment to Alzheimer’s disease and severe dementia—and may include tasks involved with cognitive function such as: language, thought, memory, executive function (the

“Productivity, independence, and quality of life for millions of Americans depend on the nation’s collective ability to prevent and treat cognitive impairment and dementia, and to promote cognitive functioning for individuals living in our communities. To accelerate efforts to meet these goals and help incorporate cognitive health in the plans and initiatives of states, territories, and communities in the U.S., we look forward to working with our partners to implement the actions identified in The Healthy Brain Initiative: The Public Health Road Map for State and National Partnerships, 2013–2018.” Lynda A. Anderson, PhD, and Robert Egge Co-chairs of Leadership Committee

Monitor & ManageMeasure, Early Identification & Manage

Start AD brain

changes

MCI

“Healthy” Aging

Clinically diagnosed

AD

Loss of Functional Independence

Normal Aging

60 DeathLife Course40Birth

Behavioral Problems

Cognitive Symptoms

Nursing Home Placements

High

LowAD

ZONE OF IMPACT

Measure & Monitor Cognitive Function… WHY?

Medicare Encourages Medically Necessary Cognitive AssessmentEffective January 1, 2011 Medicare now provides an Annual Wellness Visit benefit, in addition to the “Welcome to Medicare” physical exam that occurs only in the first year of joining Medicare. The new Annual Wellness Visit benefit includes several preventive health services, including “detection of any cognitive impairment”. This is a new medical exam that has some important implications for both patients and physicians.

Early Detection can save the Health Care System Money“Early detection, diagnosis, and care of individuals with newly diagnosed cognitive impairment and dementia can significantly reduce outpatient healthcare costs new research suggests… multicenter pilot program… show healthcare costs for 1 year before and after diagnosis decreased by $1741 in the year after diagnosis of cognitive impairment compared with the year before diagnosis.” Source: WSJ July 20th 2010

The Zone of Impact: Catch MCI as early as possible… Shifting the Mean

"If we could keep people who are still functioning from having any further decline for five years--then they would probably die from something else… The impact would be immeasurable.” Source: Forbes 4-08; Todd Golde, neuroscientist at the Mayo Clinic, in Jacksonville, Fla.

Source: http://mybraintest.org/dl/Cognitive_Screening_Tests_for_Medicare_Annual_Wellness_Visit.pdf

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Adapted From:  NIA; Feldman and Gracon. In Gauthier S (Ed.) Clinical Diagnosis and Management of Alzheimer’s Disease. Martin Dunitz, London, 1996, 241.

Step One:Evaluate Cognitive Function… HOW?

education matched peers on culturally appropriate normative data (i.e., forthe impaired domain(s), when available). It is emphasized that these ranges are guidelines and not cutoff scores.

2.2.1. Cognitive assessment…impairment in episodic memory (i.e., the ability to learn and retain new information) is most commonly seen in MCI patients who subsequently progress to a diagnosis of AD dementia… These tests share the characteristic that they assess both immediate and delayed recall, so that it is possible to determine retention over a delay… Because other cognitive domains can be impaired among individuals with MCI, it is important to examine domains in addition to memory. These include: executive functions, language, visuospatial skills, and attentional control. Many validated clinical neuropsychological measures are available to assess these cognitive domains…

2.2.3. Longitudinal cognitive evaluationEvidence of progressive decline in cognition provides additional evidence that the individual has “MCI due to AD,” as noted earlier in the text. Thus, it is important to obtain longitudinal assessments of cognition, whenever possible. It is recognized that a diagnosis will likely need to be given without the benefit of this information; however, obtaining objective evidence of progressive declines in cognition over time is important for establishing the accuracy of the diagnosis, as well as for assessing any potential treatment response.

2.1. MCI—Criteria for the clinical and cognitive syndrome Concern regarding a change in cognition Impairment in one or more cognitive domains Preservation of independence in functional abilities Not demented

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2.2 Cognitive characteristics of MCIIt is important to determine whether there is objective evidence of cognitive decline, and if so, the degree of this decline in the reports by the individual and/or an informant. Cognitive testing is optimal for objectively assessing the degree of cognitive impairment for an individual. Scores on cognitive tests for individuals with MCI are typically 1 to 1.5 standard deviations below the mean for their age and

Step One: Continued

Evaluate Cognitive Function…

How should MEMORY IMPAIRMENT be measured and assessed? “The objective memory impairment that is part of the criteria is determined by a combination of the history from the subject and an informant, supplemented with neuropsychological testing. The degree of impairment is assessed neuropsychologically , but the result of the impairment is determined by the clinician through the exam and interview. Consequently, no single cutoff score determines the memory impairment. Rather the degree of memory impairment is gauged relative to appropriate normative data.” Source: Mild Cognitive Impairment; Ronald C. Petersen

Integrating into Clinical Practice

“…Assuming that screening is positive or that clinical suspicion is strong, full in-office computerized c assessment is warranted. …requires the use of a validated system that is objective andstandardized …with an assessment of a patient’s cognitive function that gives a cognitive profile of performance across multiple cognitive domains. …In difficult cases in which clinical interpretation of in-office computerized assessment results is not apparent, referral to a neuropsychologist might be warranted, as in some cases of MCI or frontotemporal dementia… The scheme is driven by the availability of tools that are valid and easy to use, particularly in-office computerized cognitive assessment, as well as by medicoeconomic realities. Adapted from: Practicality of a computerized system for cognitive assessment in the elderly; Alzheimer's & Dementia; November 4 (2008) 14–21

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Step One: Cognitrax Testing Report

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The Cognitrax Neurocognitive Assessment Report is designed to present the testing

results in a SUMMARY DASHBOARD and a DETAILED

REPORT format immediately following the testing session.

The Cognitrax reports are logical and intuitive making the reports interpretation by a qualified health professional relatively straightforward. All assessment results should be

considered with other relevant clinical information such as history, physical examination, other psychological or neuropsychological tests, lab results, imaging

studies, etc., in accordance with good clinical practice standards.

Cognitrax serial administered neurocognitive tests can also be

presented in a LONGITUDINAL REPORT format to track disease

progression, outcomes, or treatment effects.

Step Two:Assess Comorbidities and Functional Status

Identification of comorbidities, psychological (e.g. depression, other neuropsychiatric symptoms) and daily functioning (MOS SF-36) can affect, influence and help clinicians better identify evaluate their patients.

Patient Health Questionnaire (PHQ-9)Major Depressive Syndrome: If 5 more responses are shaded ("More than half the days" or "Nearly every day") and at least one the shaded questions is #1 or #2.Other Depressive Syndrome: If 2 to 4 responses are shaded ("More than half the days" or "Nearly every day") and at least one the shaded questions is #1 or #2.Note: the diagnoses of Major Depressive Disorder and Other Depressive Disorder requires ruling out normal bereavement (mild symptoms, duration less than 2 months), a history of a manic episode (Bipolar Disorder) and a physical disorder, medication or other drug as the biological cause of the depressive symptoms.PHQ-9 Depression Severity: This is calculated by assigning scores of 0, 1, 2, and 3, to the response categories of "Not at all", "Several days", "More than half the days", and "Nearly every day" respectively. PHQ-9 total score for the nine items ranges from 0 to 27.Interpretation of Total Score:1-4 Minimal depression5-9 Mild depression10-14 Moderate depression

10. How difficult have the problems you reported made it for you to do your work, take care of things at home, or get along with other people? Developed by Drs. Robert L. Spitzer, Janet B.W. Williams, Kurt Kroenke and colleagues, with an educational grant from Pfizer Inc. No permission required to reproduce, translate, display or distribute.

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Step Three:Manage Neurocognitive Health… HOW?

Aggressive Evaluation, Management and Monitoring of MCI/Dementia SyndromesAdapted from: Don Schmechel et,al. ICAD Paris 2011

1. Most cases of MCI/dementia have multiple factors, particularly vascular.2. Factors that can be identified include sleep disorders, vasculopathic factors including diabetes,

dyslipidemias, MTHFR alleles (homocysteine metabolism), nutritional.3. Aggressive evaluation will often include genetic testing to help in differential diagnosis and

treatment selection4. Treatment will then involve multiple therapies and interventions5. Staging and monitoring can be assisted by cognitive testing at relatively frequent intervals,

including short screens such as MMSE, MOCA, or Hachinski Ischemic forms.6. Finer detail (“granularity”) can be revealed using computer cognitively testing such as here

illustrated by Cognitrax - CNS Vital Signs battery. Test can be administered by support personnel, takes 30-40 minutes, and has alternate forms. Most patients with high school education and reasonable exposure to computers can handle testing. Familiarity and practice effects can be dealt with by leading in with two baselines prior to monitoring.

7. MCI and dementia are treatable disorders, involving complex interactions of genes-environment including behavioral responses and life practices of patient and caregiver.

8. Clinical stability and improvement should be sought for assiduously by dealing with all reasonable treatable factors impacting behavior and cognition.

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First Visit

Second Visit

4-6 Weeks

2 Month Visit

3 Month Depending on Intervention

History & Physical ……………………………………………………….…

Neurocognitive Exam ………………………………………………….……

MMSE Screen …………………………………………………………………

Social Work Consultation & Overview …………………………………..

Review/Order Neuroimaging, Sleep Studies, etc. ……………………..

Blood Work ……………………………………………………………………

Genetic Testing ……………………………………………………………….

Other Blood Work (homocysteine, inflammatory indices, etc.) …………………….…

Establish Primary, Secondary, Medical Diagnosis ………………………

Computerized Neurocognitive Testing (Cognitrax) …………………………………..……………

Review of Clinical Status …………………………………………………………………………………………

Review of Genetics, Blood Work, Imaging ………………………………………………………

Revision of Diagnosis …………………………………………………………….……………….

Selection of Interventions (Nx-Nutrition, Rx-Pharmacologic, Ex-Exercise, etc.) ………………………………………..

Medicare Annual Wellness Visit Algorithm for Assessment of

Cognition**

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Adapted from: **Alzheimer’s Association Medicare Annual Wellness Visit Algorithm for Assessment of Cognition; Alzheimer's & Dement. 2013 Mar;9(2):141-50; ***Practicality of a computerized system for cognitive assessment in the elderly; Alzheimer's & Dementia; November 4 (2008) 14–21

A: **The following questions may be suitable for the AWV HRA and have been tested and evaluated in the general population through the Behavioral Risk Factor Surveillance System or presented as HRA example questions: (1) During the past 12 months, have you experienced confusion or memory loss that is happening more often or is getting worse ? (2) During the past 7 days, did you need help with others to perform everyday activities such as eating, getting dressed, grooming, bathing, walking, or using the toilet ? Or (3) During the past 7 days, did you need help from others to take care of things such as laundry and housekeeping, banking, shopping, using the telephone, food preparation, transportation, or taking your own medications?* No one tool is recognized as the best brief assessment to determine if a full dementia evaluation is needed. Some providers repeat patient assessment with an alternate tool to confirm initial findings before referral or initiation of full dementia evaluation.

NO

Informant available to

confirm Signs/Symptoms Present

Follow-up during

subsequent AWV

A

B

C

* Conduct brief structured assessment: Patient Assessment, Informant

assessment of patient

Cognitrax In-Office Neurocognitive Assessment, Conduct full Dementia

Evaluation, or Refer

Review HRA (Health Risk Assessment), clinician observation, self-reported

concerns, responses to queries

***Serial Assessment to Track Progression or Outcome according to Current Guidelines

YES NO

YES

NOBrief Assessment Triggers Concern

Procedure Reimbursement

Additional Billing information is available in the Cognitrax billing & coding guide.

Coping With Mild Cognitive Impairment; NYT; Adapted from: JUDITH GRAHAM

“About 10 to 15 percent of adults age 65 and older are believed to have mild cognitive impairment — a condition commonly characterized by memory problems, well beyond those associated with normal aging. Alarmingly, mild cognitive impairment, or M.C.I., can signal serious problems ahead:… Why is this important? We don’t have any medications at this point to prevent or treat M.C.I. or dementia. Yet we can engage in activities that will help reduce the impact of the disease and maintain our level of functioning. “

Medicare Annual Wellness ExampleG0438 Annual Wellness Visit, Initial (AWV) $172.18 National AVG.

Annual wellness visit, including a personalized prevention plan of service (PPPS), first visit.G0439 Annual Wellness Visit, Subsequent (AWV) $111.35 National AVG.

Positive Cognitive Screen

96120Testing & 

Interpretation

Neuropsychological testing (e.g. Wisconsin Card Sorting Test, CNS Vital Signs), administered by a computer, with qualified health care professional interpretation and report.

$48

Neurocognitive Assessment

*AWV reimbursement rate is from http://www.acponline.org/running_practice/payment_coding/wellness_q9.htmProcedure reimbursement is from https://ocm.ama‐assn.org/OCM/CPTRelativeValueSearch.do

96103Testing & 

Interpretation

Psychological testing (includes psych assessment of emotionality, intellectual abilities, personality and psychopathology, administered by a computer, with qualified health care professional interpretation and report.

$28

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Neuropsychological testing

Psychological testing

* 2014 Physician Fee Schedule

National Average Payments

Billing Code

96120

96103

Annual Wellness Visit G0438

$48

$28

$172

Total $248

Testing 2 Patients Per Day - Annual

Reimbursement**

$119,040**Estimates based on 2 patients per day, 48 weeks per year, needing both AWV and Cognitive testing

* 2014 Physician Fee Schedule

National Average Payments

Benefits: Help Your Patients and Your Practice

As you map the future strategic direction of your practice… Consider the CNS Vital Signs Advantages:As the Affordable Care Act takes effect in the next few years, there will be an increased emphasis on outcomes rather than procedures. How will your practice navigate and to respond to the challenge of optimizing care by efficiently providing the necessary in-office procedures while preparing your practice for collecting and documenting outcomes?

Cognitrax / CNS Vital Signs is a world leader in the assessment of Neurocognition and collecting additional important clinical PRO endpoints such as symptoms, behaviors, quality-of-life, and comorbidities. The Cognitrax assessment platform is easy to implement and intuitive to use making for simple adoption into your clinical practice operations.

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Improve Patient Care Enhance the Practice

Cognitive function is an important biomarker for many conditions e.g., Neurocognitive disorders due to aging, etc.

Neurocognitive function can now be measured with valid millisecond precision

A Broad spectrum assessment of cognitive domains is available to support and inform your healthy aging and care management activities

Cognitrax is designed for the assessment of the more cognitively impaired

Normative comparison from ages 8 to 90

Many evidence-based medical and health PRO rating scales to complement the cognitive testing

HIPAA and 21 CFR 11 Compliant

Generate increased revenue with commonly used Cognitive testing procedure billing codes

Automate the collection of important quality and outcome measures e.g., PQRS Dementia

Easy to administer, scientifically valid, reliable, and affordable,‘research quality’ assessment platform

Easy-to-interpret, Immediately auto-scored Report (seconds) & systematically documented

No contracts, just a per-patient assessment fee. No special equipment purchase required, works with any Windows OS or computer with a browser. Complimentary live support during normal business hours

Sensitivity and Specificity

Computerized tests are an efficient way to assess large numbers of people who may have mild cognitive disorders, including MCI and early dementia. The CNS Vital Signs battery was administered to 322 patients age 55-94 at the NC Neuropsychiatry Clinics in Chapel Hill & Charlotte; to 102 elderly people at the New England Cognitive Center in Hartford, CT ; and to 92 elderly subjects at the University of Colorado in Denver. The patients were clinically diagnosed as normal, MCI or early dementia. The different components of the CNS Vital Signs battery were evaluated for receiver operating characteristics. Memory tests were the most sensitive and specific for the purpose of differentiating between normals and patients with MCI, followed by the composite Neurocognition Index, and then measures of executive function , processing speed and attention. A BRIEF-CORE assessment battery, therefore, would appropriately consist of tests of verbal and visual memory, executive function, processing speed, and complex attention.

We compared the sensitivity & specificity of all the relevant domains generated by the CNS Vital Signs battery. The area under the ROC curve is the best single representation of the sensitivity & specificity of a mental test. The various memory domains were the best indicators of MCI. All of the memory domains were significantly different when normals were compared to patients with MCI and early dementia, but the composite memory domain was the best of all the memory scores.

Specificity

ROC Curve

Sen

siti

vity

0.0

0.2

0.4

0.6

0.8

1.0

0.0 0.2 0.4 0.6 0.8 1.0

Cognitive Domain AUC

Immediate Memory 0.88

Verbal Memory 0.85

Delayed Memory 0.85

Psychomotor Speed 0.79

Processing Speed 0.73

Adapted from: ICAD 2008 – Chicago, IL C THOMAS GUALTIERI North Carolina Neuropsychiatry Chapel Hill ALAN F BOYD CNS Vital Signs Chapel Hill

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