Medication and Care Plan Medication and Care Plan Adherence Technologies Adherence Technologies

That Improve Patient That Improve Patient OutcomesOutcomes

Bruce A. Kehr, M.D.Chairman and CEO

InforMedix, IncTel: 301-984-1566 ext. 101

E-mail: bruce.kehr@informedix.com

� Understand the costs of poor medication adherence, and the savings opportunities through proper medication adherence, to help solve our nation’s escalating healthcare cost crisis

� Review a variety of technologies that facilitate patients adhering to their medications and care plans

� Explore a case study whereby a comprehensive medication and care plan was delivered to senior citizens, and review the outcomes Confidential and Proprietary

� What are the costs to our nation’s healthcare system related to poor medication adherence?

� Can I describe differing technologies available today to assist patients in following their care plans?

� What types of monitors are available to track and report patients’ health status in the home?

� What are examples of a comprehensive medication adherence solutions?

� Can I now envision a spectrum of technology services across the wellness/chronic disease continuum, that are available and affordable today?

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• Too many medications at home• Old medications not destroyed• New prescriptions received: new dose,

different medication, generic vs brand labeling

• Inconsistent communication between multiple providers: pharmacies, PCP, Hospitalist, Specialist

• Which pill is which?

?

??

� “What medication do I take?”� “What did the doctor say?”� “What is the correct dose?”� “What is the correct time?”� “What do each of these medications do?”� “Why are they important?”� “Why do I need them, I feel better”?”

Source: Manhattan Research 2004 data

Dis

ease

Pre

vale

nce

Reported rate of non-compliance

Failure to take medication as prescribed:� Causes 10% - 28% of total hospital

admissions� Causes 33% of CHF hospital admissions� Causes 75% of Schizophrenia admissions� Causes 68% of NNRTI resistant/mutated

HIV virus � Results in $100 billion/year in

unnecessary hospital costs� Causes 40% of nursing home admissions� Costs the U.S. economy $300 billion/year

(N Engl. J Med 8/4/05, National Pharmaceutical Council, Archives of Internal Medicine, NCPIE, American Public Health Association, AIDS 2006 20:223-232)

Senior Citizens with DiabetesSenior Citizens with Diabetes

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Disease State

Est. U.S. Prevalence

Annual Total Health Care Costs @ $16,500 Per Patient (1),(2)

Est. Annual Cost with 25% Improved Adherence (1),(2)

Annual Net Savings

Diabetics over age 65

10,000,000 $165 Billion total

$16,500 per patient

$87 Billion total

$8,700 per patient

$78 Billion

$7,800 per patient

(2)American Association of Clinical Endocrinologists (AACE)

(1) Predictors of medication adherence and associated health care costs in an older population with type 2 diabetes mellitus; a longitudinal cohort study; Balkrishnan R, et. al. Department of Public Health and Sciences, Wake Forest

University School of Medicine, Winstons Salem North Carolina, USA

Congestive Heart Failure – The #1 Cost to Medicare

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Disease State

Est. U.S. Prevalence

Number of Non-Adherent Heart Failure Patients = 50%

Annual Hospital Costs of Non-Adherent Patients (1),(2)

Annual Hospital Costs of Adherent Patients (1),(2)

Annual Savings

Congestive Heart Failure

7,500,000 3,750,000 $46 Billion total

$12,270 per patient

$11.5 Billiontotal

$3,068 per patient

$34.5 Billion total

$9,202 per patient

(1)Outpatient Management program of patients with chronic heart failure; Cacciatare, G. et. al; Servizio Centrale di Cardiolgia

(2) Cost of hospitalizations for heart failure: sodium retention versus other decompensating factors; Bennett SJ, et. al.; Indiana University, Indianapolis, USA; PubMed index for MEDLINE 10076109

� The challenge is to simultaneously improve the efficiency and effectiveness of medication adherence and care management programs…..

� Efficiency can be significantly improved by deploying better new technologies…

� Effectiveness is improved by deploying better clinical pharmaceutical and care management knowledge… that is embedded in a technology

� The “end-to-end solution” combines knowledge embedded in technology with the knowledge embedded in the clinically trained mind

• Processes that improve patient adherence are of high value to DM programs, payors, healthcare professionals, patients and their loved ones

• Technologies exist TODAY that leverage pharmacists, nursing personnel, and physicians and deploy and monitor medication and care management knowledge

• These technologies enable rapid, targeted patient interventions to improve health outcomes and reduce ER visits, hospitalizations, and nursing home admissions

• For Seniors and their loved ones – “Aging Gracefully in Place”

Implementing Medication and Care Plan Implementing Medication and Care Plan

Adherence TechnologiesAdherence Technologies

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Identify Poor Adherence

Emphasize value of regimen and effect of adherence

Provide simple, clear instructions

Simplify regimen as much as possible

Encourage use of medication-taking system

Listen to patient, and customize regimen in accordance with patient wishesElicit patient’s feelings about ability to follow regimen, and if necessary, design supports to promote adherenceReinforce desirable behavior and results

Consider more “forgiving” medications when adherence appears unlikely

“Adherence to Medication,” Table 3 - Strategies for Improving Adherence to a Medication Regimen –

N Engl J Med 2005;353:487-97

� Monitor chronically ill patients’adherence to medication and care plans

� Monitor physiologic functioning

� Prevent hospital admissions

� Data transmitted via phone line

� Cost decreasing ($35 - $150/month)

� Gaining acceptance by Homecare agencies to reduce traditional visits

� Used selectively by DM firms and Veterans Administration programs

� Barriers:� Cost per patient (falling)� Patient selection� Ease of Use for patients� Ease of Use for Care

Managers� What gets reported? Data

analytics? Trend analysis? Predictive Modeling?

• Integrated Diary/Physiologic Monitoring Systems

• Web-based Solutions• IVRS Telehealth Systems

• Medication Adherence Tools and Systems• Monitoring Systems combined with Web-

based solutions and professionally staffed call centers

iMetrikus MediCompass: Biometric Device Interfaces

Blood Glucose Monitors :•Accu-Chek ™ Active

•Accu-Chek™ Advantage•Accu-Chek ™ Compact •Accu-Chek ™ Complete

•Ascensia® Breeze™•Ascensia® Contour™

•Ascensia Elite XL®•Bayer Glucometer ® DEX

•Bayer Glucometer ® DEX2•Bayer Glucometer ® Elite XL

•BD Logic ™•BD Paradigm Link ™

•In Duo ™•One Touch® Basic

•One Touch ® II•One Touch ® Profile

•One Touch ® Ultra•One Touch ® UltraSmart•One Touch ® Sure Step

•Precision Q-I-D ®•Precision XTRA™

•Prestige Smart System™•TrueTrack Smart System ™

•TheraSense FreeStyle ®

Diabetes Management

Cardiac Management

Respiratory Management

Insulin Pumps:

D-TRON PlusBlood Pressure Cuffs:

A&D LifeSource UA-767PC (Arm)OMRON HEM-637 (Wrist)

OMRON HEM-705CP (Arm)

Digital Scales:A&D LifeSource UC-321PL*

Digital Spirometry:

AirWatch Lipid Testing:

CardioChek PA*(cholesterol, triglycerides, glucose, & ketones)

� 1027 home health care Medicare patients in 6month study

� Results:� 5.56 fewer skilled nursing visits, with visit decrease of over

50% in several agencies� Skilled nursing caseload increased by 8 on average� Decreased ER visits and hospitalizations� Revenue increase of $128,000 per nurse per year� Cost savings of $64,800 per year� ROI of 6.14 at composite of 32 sites (Assumptions: skilled

nursing visit fully burdened @$100, skilled nurse visits dropped from 15.76 to 13.18, caseloads increased from 19 to 27, HHRG of $2000, LOS = 8 episodes/year, equipment cost of $75/month for 30 monitors per nurse)

*National Telehealth Value Study, Remington Report May/June, July/August 2006

� Many vendors – the technologies are becoming a commodity, though still relatively expensive

� Key barrier to broader usage is cost and ROI for diseases other than severe heart failure

� Differentiators will be in the “software” that creates behavioral change in patients and displays the data for care managers, and in the trend analysis and predictive modeling algorithms

Product Category Product Category –– WebWeb--based Solutions based Solutions --WorldDocWorldDoc

� Phone-based speech enabled outreach designed to inspire behavior change

� Understands what you say and responds accordingly – over the phone

� Provides focused and actionable feedback� Senior programs include

� Welcome outreach� Health Risk Assessments� Quality of Life surveys� Age-appropriate reminders- colon cancer screening,

mammograms, flu…� Excellent tool for the visually impaired patient� Seniors just might be the most receptive of all!

♦ Reminds participants Reminds participants to take their medications and records/monitors adherence to take their medications and records/monitors adherence

over mobile phones, PDA/cellphones and landlinesover mobile phones, PDA/cellphones and landlines

♦♦ Prompt/record answers to Prompt/record answers to simple health status queriessimple health status queries

♦♦ Branching logic allows a participant to Branching logic allows a participant to identify reasons that they do not take theiridentify reasons that they do not take their

medicationsmedications

♦♦ Simple web enrollment Simple web enrollment provides adherence data via Medprovides adherence data via Med--eXpert eXpert –– sends esends e--mailsmails

and text messages if meds missed or health declinesand text messages if meds missed or health declines

♦♦ MedMed--eXpert also provides eXpert also provides detailed reports detailed reports via the Webvia the Web

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Call Result Occurance over last 30 daysTaken 26No Answer 3Answering Machine 4Missed - Doctor's Order 2Missed - Ran Out 0Missed - Side Effects 1Missed - Other 1

� Audio Reminders� Voice Reminders� Medication and Care Plan

Tracking Devices� Integrated Dispensing

Systems� RFID-enabled� Landline/Wireless

♦Monitored Automatic Medication Dispenser

♦Alerts caregivers if medications are not dispensed or if MD.2 is running low on medications

♦About the size of a large coffeemaker

♦Holds 60 medication cups, dispenses up to 6 cups per day (re-usable cups included)

♦Stores 3-4 weeks of medications for most patients

♦3-Way Reminders: VOICE, TEXT, BLINKING LIGHT

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Care GiversCare Givers

Monitoring Center(s)Monitoring Center(s)

PatientPatientss

Nurses and DoctorsNurses and Doctors

PharmacistsPharmacists

Family MembersFamily Members

MedMed--eXperteXpert ™™ Information Information RepositoryRepository

Patient Interface DevicesPatient Interface Devices

MedMed--eMonitoreMonitor ™™

MedMed--ePhoneePhone ™™

Third Third Party Party

33

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♦Med-eMonitor reminds the patient to take their medications from the exact bin or bottle as required (e.g. “Sunday PM,” “ Bin 17,” “Specific

number code or color of blister card,” “Specific Pre scription Vial”)

♦Med-ePhone prompts medication use at specific times, assesses reasons for non-adherence, asks simple health status questions

♦The patient will confirm that they have taken these medications so that adherence can be monitored and reported

♦Important notifications sent out to Care Givers and /or the health care team

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InforMedix

Repository

Patient/ Appliance Interaction

Data

Urgent Alerts

Monthly Reports by Individual, Population

Population Data

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Urgent alerts provided if medications missed or health declines, to enable rapid, targeted interventions by care managers, pharmacists, or family members

Monthly trend analysis reports available on the Web, using graphics to present medication adherence and other health information; to be used by physicians, and incorporated into online patient-accessible personal health record

Managed outcomes information to evaluate program effectiveness; used by health insurers, disease management companies, Medicare, Medicaid, and pharmaceutical manufacturerscrolevel health

Patient interacts with appliance of choice to receive and record medication and care plan adherence information

Additional Repositories Storing: Disease-Specific Information; Health Claims/Cost, Physician Encounter, Hospital/ER, Laboratory, Radiographic Data

1

2

3

4

Med-eXpert™

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Population LevelPopulation Level Participant LevelParticipant Level

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Tennessee Medicare ProgramTennessee Medicare Program

InforMedixInforMedix teamed with teamed with XLHealthXLHealth and and ADTADT to use InforMedixto use InforMedix’’s Meds Med--eXpert System and MedeXpert System and Med--eMonitor eMonitor ““smart pillboxsmart pillbox”” for monitoring medication adherence of participants with diabetfor monitoring medication adherence of participants with diabetes and heart failure in a es and heart failure in a Medicare program in Tennessee. Medicare program in Tennessee.

InforMedix/XLHealth/ADT InforMedix/XLHealth/ADT ParadigmParadigm

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Tennessee Medicare Program Tennessee Medicare Program (continued)(continued)

Care Plan for Diabetics with CHFCare Plan for Diabetics with CHF

♦♦ Prompt and record adherence to medications using SeniorsPrompt and record adherence to medications using Seniors’’existing medication storage containers (e.g. plastic pillboxes, existing medication storage containers (e.g. plastic pillboxes, blister cards, standard prescription vials)blister cards, standard prescription vials)

♦♦ Prompt and record glucose levelsPrompt and record glucose levels

♦♦ Prompt and record systolic, diastolic BP, daily weightsPrompt and record systolic, diastolic BP, daily weights

♦♦ Reminders about proper care per ADA guidelinesReminders about proper care per ADA guidelines

♦♦ Meal planMeal plan

♦♦ Schedule annual eye examSchedule annual eye exam

♦♦ Check feet for cracks or sores and use temperature probeCheck feet for cracks or sores and use temperature probe

♦♦ Check Lipid levelsCheck Lipid levels

♦♦ Schedule quarterly doctor visit for HbA1C blood testSchedule quarterly doctor visit for HbA1C blood test

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Reminder to wear protective shoes.Reminder to wear protective shoes.

Questionnaires:Questionnaires:

�� Prodromal signs of strokeProdromal signs of stroke

�� Change in medicationsChange in medications

�� HospitalizationsHospitalizations

�� ER VisitsER Visits

�� Depression inventoryDepression inventory

�� Patient Satisfaction SurveyPatient Satisfaction Survey

Tennessee Medicare Program Tennessee Medicare Program (continued)(continued)

Care Plan for Diabetics with CHFCare Plan for Diabetics with CHF

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Tennessee Medicare Program Tennessee Medicare Program (continued)(continued)

Medication Adherence Rates and Health Status Monitoring Medication Adherence Rates and Health Status Monitoring Results Using MedResults Using Med--eXpert Information System:eXpert Information System:

♦ 153 seniors 153 seniors with heart failure and diabetes were enrolled into the twelve with heart failure and diabetes were enrolled into the twelve month month program, program, many with fifth and sixth grade education many with fifth and sixth grade education levelslevels

♦♦ 97%97% retention rate once participant began using the Medretention rate once participant began using the Med--eMonitoreMonitor

♦♦ 90%90% rate of medication adherencerate of medication adherence

♦♦ 93% 93% response rate to answering health status questionnairesresponse rate to answering health status questionnaires

♦♦ 90%90% response rate to reminders about selfresponse rate to reminders about self--care checks and healthy care checks and healthy behaviorsbehaviors

♦♦ Program terminated after 12 months on 7/31/08 due to end of MHSProgram terminated after 12 months on 7/31/08 due to end of MHSProgramProgram

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Tennessee Medicare Program Tennessee Medicare Program (continued)(continued)

1480 Real1480 Real--time, actionable alerts provided the opportunity for time, actionable alerts provided the opportunity for rapid, targeted interventions by ADT and XLHealth staff:rapid, targeted interventions by ADT and XLHealth staff:

Description of Alerts to XLHealth Number of AlertsHospitalized this month 52ER this month 48

Blisters, redness, cracks or cuts on feet new this week 63New, severe pain in your legs that is so bad you can't bear it, even when resting? 2Lack of Device Acceptance 7Blood sugar > 299 37

PHQ#1: During the past month, have you often been bothered by feeling down, depressed or hopeless? 41

PHQ#2: During the past month, have you experienced a loss of interest or pleasure in daily activities? 39

Not using temperature probe (for feet) provided 14

Overall Medication Compliance Low (<85%) 223Single Medication Compliance Low (<85%) 90

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Tennessee Medicare Program Tennessee Medicare Program (continued)(continued)

1480 Real1480 Real--time, actionable alerts provided the opportunity for time, actionable alerts provided the opportunity for rapid, targeted interventions by ADT and XLHealth staff:rapid, targeted interventions by ADT and XLHealth staff:

Alerts to ADT and XLHealth

MS1: Missed Medication due to Side Effects 308

MS2:Glucose too high (> 299) 36

MS3: Blood pressure too high (Sys> 130, Dias>80) 44

MS4: Warning Symptoms 43Sudden numbness, or w eakness of the face, arms or legs, especially on one side of the body? 23

Sudden confusion, trouble speaking or understanding? 6Sudden trouble w alking, dizziness, loss of balance or coordination? 14

Chest Pain 1

MS5: Foot Changes 20

MS6: Medication Change 109

Nonactivity 42

Noncommunication 262

Total 1,480

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Government Funded Research ProgramsGovernment Funded Research ProgramsDisease State

Academic Center

Funding Source

Number of Programs

Number of Patients

Duration of Research Program

Medication Adherence Results

Care Plan Adherence Results

Presentations and Publications

HIV+ with drug abuse and severe mental illness

University of California, San Francisco

SBIR/STTR 1 76 Six months 89.5% N/A 2008 International Association of Physicians in AIDS Care (IAPAC) , and submitted for publication

Stroke prevention using Coumadin (Warfarin)

University of Pennsylvania

PA Tobacco Settlement, then Aetna Foundation

Phase 1Phase 2

89 of 120 enrolled

Six months In first 20 patients, adherence increased from 78% to 97.7%

Out of range INRs decreased from 35% to 12%

Multiple lay publications and insurance company publications

Schizophrenia in “Wounded Warriors”

Baltimore Veterans Hospital

SBIR/STTR 1 22 Three months The Med-eMonitor System provided for compliance enhancement with medications and protocols.

Ease of central evaluation by treating professionals, additional education, and reduced on-site evaluation

Feasibility of Using the Med-eMonitor System in Monitoring and Enhancing Research Protocol Compliance and Health Status in Schizophrenia,”Drug Information Journal, 37 (281-289), 2003

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Government Funded Research ProgramsGovernment Funded Research Programs

Disease State

Academic Center

Funding Source

Number of Programs

Number of Patients

Duration of Research Program

Medication Adherence Percentage

Care Plan Adherence Percentage

Presentations and Publications

Schizophrenia

University of Texas Health Science Center San Antonio

NIMH Phase 1Phase 2

68 of 230 enrolled

One Year 94% Phase 1

N/A “The Med-eMonitor™for improving adherence to oral medication in schizophrenia”, Bendle S, Velligan DI, et.al:

Schizophrenia Bulletin, 31(2): 519, 2005;

International Congress of Schizophrenia Research 2005; “Intervention to Improve Adherence to Anti-psychotic Medication”, Velligan, DI, Weiden, PJ:

Psychiatric Times, August 2006, Vol XXIII, No. 9 ;

The Clinical Handbook of Schizophrenia

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Government Funded Research ProgramsGovernment Funded Research ProgramsDisease State

Academic Center

Funding Source

Number of Programs

Number of Patients

Duration of Research Program

Medication Adherence Percentage

Care Plan Adherence Percentage

Presentations and Publications

Congestive Heart Failure in a Veterans Population

Wayne State University, Detroit Veterans Hospital

NIH 1 18 Three Months

94% 96%, improved physical quality of life

“Pilot Study of a Web-Based Compliance Monitoring Device For Patients with Congestive Heart Failure,”Artinian,N, Harden,J,et.al., Heart & Lung, 2003: 32, 226-233;

“Telehealth as a Tool for Enhancing Care for Patients with Cardiovascular Disease”Artinian, N, Journal of Cardiovascular Nursing, Vol. 22, No.1, pp 25-31, 2007

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Additional Government Funded Research ProgramsAdditional Government Funded Research Programs

Disease State

Academic Center

Funding Source

Number of Programs

Number of Patients

Duration of Research Program

Medication Adherence Percentage

Care Plan Adherence Percentage

Presentations and Publications

Diabetes St.Vincent/ University of Pennsylvania

Center for Healthy Aging/Federal

1 20 Three Months

92% HbA1c dropped 18.7% (p<.002)

Remote Monitoring and Management of Rural Diabetic Patients Using a Web-based Medication Adherence/ePRO Monitoring Device”Farberow, B, Disease Management Congress, 2005

Interventions across the populationInterventions across the population

-to-face

,

IntelligentRPM +

Call Center

Web Only

TeleWeb(Call Center Linked

with Web)

Net PotentialSavings

Net Savings

Wellness At Risk Critical Episode High AcuityChronically ill

Population – Breakdown by Presence of Chronic Diseas e

Seamless integration ofCall center, Internet, smart

devices, person to person,-deployed according to

severity

TargetedDevices(RPM)

Baseline Medical Costs

Recurrence

Technology and Disease Management

� What are the costs to our nation’s healthcare system related to poor medication adherence?

� Can I describe differing technologies available today to assist patients in following their care plans?

� What types of monitors are available to track and report patients’ health status in the home?

� What are examples of a comprehensive medication adherence solutions?

� Can I now envision a spectrum of technology services across the wellness/chronic disease continuum, that are available and affordable today?

Confidential and Proprietary

INFORMEDIX, INC.INFORMEDIX, INC.

Georgetowne ParkGeorgetowne Park5880 Hubbard Drive5880 Hubbard DriveRockville, MD 20852Rockville, MD 20852

Telephone: Telephone: 301301--984984--15661566Website: Website: www.informedix.comwww.informedix.com

Confidential and Proprietary 49

Med-eXpert™ SystemMed-ePhone™

Med-eMonitor™