esMD eDoC – Evaluation Tools in Documenting Functional Assessment

1. esMDeDoC – Evaluation Tools in Documenting Functional Assessment October 30th, 2013

2. Agenda • Over View of Functional Evaluation in Completing F2F Medical Documentation • Over View of Tools in Evaluating Functionality for Medical Documentation • Examples of Levels of Functionality supporting Codification

3. Face-To-Face EvaluationHistory & ROS History relevant to mobility needs: (DME MAC LCD) • “Symptoms that limit ambulation • Diagnoses that are responsible for these symptoms • Medications or other treatment for these symptoms • Progression of ambulation difficulty over time • Other diagnoses that may relate to ambulatory problems • How far the patient can walk without stopping”

4. Face-To-Face EvaluationHistory & ROS History relevant to mobility needs: (DME MAC LCD) • “Pace of ambulation • What ambulatory assistance (cane, walker, wheelchair, caregiver) is currently used • What has changed to now require use of a power mobility device • Ability to stand up from a seated position without assistance • Description of the home setting and the ability to perform activities of daily living in the home”

5. Face-To-Face EvaluationHistory & ROS Detailed & accurate DX related to ambulatory problems; e.g., • Osteoarthritis, • Coronary artery disease, • Cardiomyopathy, • Stable angina, • Congestive heart failure, • Chronic obstructive pulmonary disease (COPD), • Reactive airway disease (ROAD), • Emphysema, • Pulmonary fibrosis, • etc.

6. Face-To-Face EvaluationHistory & ROS Key Elements: • Ambulatory assistance device (cane, walker, wheelchair, caregiver) having been tried, currently being used, & benefit or limitations of use; • Change or progression of illness that supports the need or requirement for the use of a power mobility device at this time; • Ability to accomplish positional change - stand up from a seated position without assistance; • Description of the home setting & the ability to safely perform activities of daily living in the home using MAE

7. Face-To-Face EvaluationHistory & ROS History & ROS - take prior to the Face-to-Face Evaluation • Use of a health questionnaire can identify issues such as cardiac, pulmonary, or metabolic disorders, as well as any non-compliance (e.g., medications the patient should be taking but does not).

8. Face-To-Face EvaluationPhysical Examination “Physical examination that is relevant to mobility needs” • “Weight and height” - BMI • Cardiopulmonary examination • Musculoskeletal examination • Arm and leg strength and range of motion • Neurological examination • Gait • Balance and coordination”

9. Face-To-Face EvaluationPhysical Examination • Cardiovascular (CV) Examination • CV conditions - functional limitations MRADL • Physical findings & Diagnostic (DX) testing objectively substantiating cardiac-related limitations • Diagnostic Testing: ECG, cardiac stress testing, VO2 Max, echocardiogram, X-ray findings, PET scans, Doppler vascular studies, arteriogram, etc.

10. Face-To-Face EvaluationPhysical Examination Pulmonary Examination • Pulmonary conditions - functional limitations MRADL • Physical findings & DX testing confirming pulmonary related diagnosis objectively substantiating limitations • Diagnostic Testing:Peek flow meter, PFTs – Pre and Post bronchodilators, Oxygen saturation measurements, exertionaloxymetry, blood gases, X-ray results, lung scans, CT scan, etc.

11. Face-To-Face EvaluationPhysical Examination Musculoskeletal Examination • Musculoskeletal conditions - functional limitations MRADL • Physical findings & DX testing objectively substantiating limitations • Hand, arm, and leg strength - a general assessment of movement against resistance by the examiner to actual lifting or use of strength testing equipment. • Range of motion (ROM) testing helps to establish functional limitations and capabilities, providing a basis for determining wheelchair setting and positioning requirements. • Neck, trunk and pelvic posture and flexibility • Scoliosis, atrophy, deformity, contractures, amputation, etc.

12. Face-To-Face EvaluationPhysical Examination Neurological Examination • Cerebellar testing - gait, balance & coordination • Key to understanding ambulatory limitations &capabilities • Neuropathy, paralysis, or partial paralysis or hemiparesis? • Cognitive testing & reality decision making • Essential in establishing the patient’s mental capacity to safely operate & utilize a PMD or need for a trained caregiver

13. Face-To-Face EvaluationPhysical Examination • Examination findings &objective testing can be used to calculate an impairment rating in establishing need for a PMD • (see AMA Guides for Permanent Impairment)

14. Face-To-Face EvaluationFunctional Capacity Evaluation(FCE) • Assessing Functional Capacity • Cardiac stress testing (CST), VO2 Max • Complete Pulmonary Function Tests (PFTs) • Impedance resistance to cardiac PET scan • 6 Minute Walk • Fall Risk testing

15. Face-To-Face EvaluationFCE Using Patient Self Reporting Questionnaire or “self-report” • How much work can they do? • Straight-forward questions: • “How many flights of stairs can you walk up before you have to stop?” • “How far can you walk on level ground (how many blocks) before you have to stop?”

16. Face-To-Face EvaluationFCE Patient Self Reporting – Reliability & Weightiness • Historical Reliability & Challenge • Variance in ability to recall information • Overestimate or Underestimate functional capacity • Supports/directs testing - objective measurements • Objective measurements preferential to self-report

17. Face-To-Face EvaluationFCE • Assessing functionality, capabilities, & limitations • Ability to independently & safely ambulate to perform MRADLs • one room to another • Ability to perform MRADLs • Quantify current limitations

18. Face-To-Face EvaluationFCE • Functional testing – • Maximum or Submaximal exercise testing • Field tests - “shuttle walk-run tests” & “walk tests.” • Mobility limitations support need for a PMD • Limitations - performing max or sub-max exercise test • Exercise testing performed prior to the F2F evaluation • Allows comparison of past to present functional levels

19. Functional Testing CPX • Observed change in positioning, ambulation, need & use of any assist device(s) • Range of Motion (ROM) • Isometric & Isotonic strength testing • Comprehensive Neurological testing

20. Functional Testing • CPX • Maximum Exercise Testing • Submaximal Exercise Testing • Field tests

21. Functional TestingMaximum Exercise Testing • Maximum exercise testing - Treadmill Protocols (Ellestad, Bruce, Balke, or Naughton) • “MET” - Unit of measurement - energy expended • A MET = multiples of resting metabolic energy used for any given activity • One MET = 3.5 mL/(kg/min) • A 70kg man burning 1.2 kcal/min while resting in a sitting position will use 3 METs when walking 4 km/hr

22. Functional TestingMETs & Functional Class Based on protocols of several investigators: Ellestad, Bruce, Balke, and Naughton. • Functional Class I - patients who are asymptomatic, sedentary healthy &/or physically active & able to achieve MET levels from 7 – 16 • Functional Class II - patients who are symptomatic, recovered from a disease, sedentary healthy &/or physically active who can achieve MET levels from 5 – 6. • Functional Class III - patients who are symptomatic, recovered from a disease, who are not sedentary healthy &/or physically active who can achieve MET levels from 1.9 - 4 • Functional Class IV - patients who are symptomatic, who have not recovered from a disease, who are not sedentary healthy &/or physically active who can only achieve a MET level of 1.6 • American Medical Association. Guides to the Evaluation of Permanent Impairment, 4th ed. Chicago, IL: American Medical Association; 1993: 110-111,148-152,162-163, 171,178,189,198,301.

23. Functional TestingMaximal & Submaximal Exercise Tests • Useful - provides quantifiable information • Additional costs, time & scheduling • Patient may not: • Be able to perform; &/or • May not be readily available

24. Functional TestingField Tests • Fall Risk Assessment • “Shuttle walk-run tests” • “Walk Tests” - 6 Minute Walk Test (6MWT)

25. Functional TestingFall Risk Assessment Tools • Fall Risk Assessment Tool • Berg Balance Scale (BBS) • Timed-Up and-Go • Activities-Specific Balance-Confidence (ABC) Scale • Dynamic Gait Index • Tinetti Performance Oriented Mobility Assessment (POMA)

26. Tinetti Performance Oriented Mobility Assessment (POMA) • Description: The Tinetti assessment tool is an easily administered task-oriented test that measures an older adult’s gait and balance abilities. • Equipment needed: Hard armless chair • Stopwatch or wristwatch • 15 ft walkway • Completion: • Time: 10-15 minutes • Scoring: A three-point ordinal scale, ranging from 0-2. “0” indicates the highest level of impairment and “2” the individuals independence. • Total Balance Score = 16 • Total Gait Score = 12 • Total Test Score = 28 • Interpretation: 25-28 = low fall risk • 19-24 = medium fall risk • < 19 = high fall risk

27. Functional TestingFall Risk Assessment Tools Tinetti Performance Oriented Mobility Assessment (POMA) • Considered easy to administer & is capable of assessing the performance of an older patient’s gait & balance ability • Requires little equipment: • Hard armless chair, a stopwatch or wristwatch with a second hand, & 15 feet of walkway • Gait & balance are assessed by having the patient perform maneuvers representative of activities of daily living that require stability & balance

28. Functional TestingField Exercise Test • Can be performed in the outpatient office • Does not require extensive equipment or resources • Readily available field test to the evaluating physician - 6 Minute Walking Test (6MWT).

29. Functional Testing 6MWT • Guidelines for the 6MWT4 - developed by the American Thoracic Society Pulmonary Function Standards Committee

30. Functional Testing 6MWT • Indications - 6MWT • Chronic Obstructive Pulmonary Disease; • Cystic Fibrosis; • Heart Failure; • Peripheral Vascular Disease; or • Being an elderly patient.

31. Functional Testing6MWT - Patient Safety Considerations Variables Measured: • Primary: total distance walked • Secondary: fatigue and dyspnea – modified Borg or visual analog scale • Optional: oxygen saturation – pre- and post-test (O2 saturation during testing may be unreliable)

32. Functional Testing6MWT - Interpreting the Results • Normal range from 400 to 700 meters • Predicting distances may vary as much as 30% • A predictive 6MWD in healthy elderly is 631 + 93 m51

33. Functional Testing6MWT - Interpreting the Results • Calculating Predictive Value • (Published study - two 6MWTs performed & the best result recorded) • Predicted six-minute walk distance in healthy elderly = 631 + 93 meters • Predictive equation: 6MWDpred = 218 + (5.14 x height cm – 5.32 x age) – 1.80 x weight kg + 51.31 x gender • Note: Gender is factored into the equation by: male = 1, female = 0

34. Functional Testing6MWT - Interpreting the Results • Low 6MWD may not be specific or diagnostic • Understand underlying condition &/or co-morbidities contributing to capacity limitation • COPD, arthritis, cardiovascular disease, &neuromuscular disorders reduce the 6MWD

35. Functional Testing6MWT - Study Results • Mortality rate - significantly higher in HF patients with 6MWD of < 300m compared to patients having a 6MWD > 300m • Risk of death higher in patients with left ventricular ejection fraction < 0.30 Bautmans I, Lambert M, Mets T. The six-minute walk test in community dwelling elderly: influence of health status. BMC Geriatr. 2004;4(6). doi:10.1186/1471-2318-4-6

36. Functional Testing6MWT - Study Results • The New York Heart Association (NYHA) Class III • Denotes marked limitations of activity due to symptoms of chest pain or shortness of breath during activity that is less than ordinary, e.g., walking 20 – 100 m • Anticipated that a patient will demonstrate a very low 6MWT - may not be able to complete the full 6 minutes due to development of symptoms secondary to marked limitations in functional capacity Bautmans I, Lambert M, Mets T. The six-minute walk test in community dwelling elderly: influence of health status. BMC Geriatr. 2004;4(6). doi:10.1186/1471-2318-4-6

37. NYHA ClassSymptoms • l Cardiac disease, but no symptoms and no limitation in ordinary physical activity, e.g. shortness of breath when walking, climbing stairs etc. • II Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity. • III Marked limitation in activity due to symptoms, even during less-than-ordinary activity, e.g. walking short distances (20–100 m).Comfortable only at rest. • IV Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients.

38. Classes of Heart Failure • ClassFunctional Capacity: How a patient with cardiac disease feels during physical activity • I Patients with cardiac disease but resulting in no limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea or anginal pain. • II Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea or anginal pain. • III Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary activity causes fatigue, palpitation, dyspnea or anginal pain. • IV Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of heart failure or the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort increases.

39. COPDSeverity - Breathlessness • Modified Medical Research Council – mMRD Grading • Grade 0 – breathless with strenuous exercise • Grade 1 – short of breath (SOB) when hurrying on the level or walking up slight hill • Grade 2 – walk slower than people of same age on level plane 2nd breathlessness, or having to stop to catch breath when walking on regular pace on level plane • Grade 3 – 100 meters capacity or only a few minutes tolerance • Grade 4 – too breathless to leave house or breathless when dressing or undressing Proprietary and Confidential

40. COPD - Severity - Airflow Limitation in COPD – Post-Bronchodilator FEV1 - Spirometry DX – COPD – FEV1/FVC < .70 &/or FEV1 <80% Grade Predicted FEV1 • GOLD 1 – Mild FEV1 > 80% • GOLD 2 – Moderate 50% < FEV1 < 80% • GOLD 3 – Severe 30% < FEV1 < 50% • GOLD 4 – Very Severe FEV1 < 30% Proprietary and Confidential

43. Coverage and Documentation Requirements • Complete coverage and documentation requirements are outlined in the following policies: • National Coverage Determination (NCD) for PMD • LCDs for PMD • Jurisdiction A LCD (including NY) • Jurisdiction B LCD (including IL, MI) • Jurisdiction C LCD (including FL, NC, TX) • Jurisdiction D LCD (including CA) • CMS MLN Matters Article(SE1112) provides further guidance and clarification about documentation for physicians and treating practitioners when ordering PMDs 43

44. Structured Information for PMD • Based on clinical template developed by CMS • Available at http://www.cms.gov/Research-Statistics-Data-and-Systems/Computer-Data-and-Systems/ESMD/Downloads/Suggested-PMD-Electronic-Clinical-Template-v98-posted-11-02-12.pdf • Supports • Data collection by providers during face-to-face evaluation • Reporting of clinical information for coverage determination • Clinical decision support and automated determination of coverage 44

45. References/Contact Information • Links • esMDInitiative: http://wiki.siframework.org/esMD+Initiative • esMD Program: http://www.cms.gov/esmd • Contact Information • Robert Dieterle – esMD Initiative Coordinator (rdieterle@enablecare.us) • Sweta Ladwa – ESAC (sweta.ladwa@esacinc.com ) • Dan Kalwa – CMS (Daniel.Kalwa@cms.hhs.gov) • Mark Pilley – Co Lead (m.pilley@strategichs.com) • Dr. Viet Nguyen – Co Lead (viet.nguyen@systemsmadesimple.com ) 45