CPAP Adherence and the 2009 Medicare Standards. Disclaimer. What is Obstructive Sleep Apnea (OSA)? Learning Objectives

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CPAP Adherence and the 2009 Medicare Standards Disclaimer Appendix 3 Declaration of Vested Interest Form Name of presenter: Dave Henry RRT Name of employer: DeVilbiss Healthcare Definition: A

having been an employee of a company with such financial interest and/or having had substantial research support by an industry to study the product to be discussed at the presentation.

1 CPAP Adherence and the 2009 Medicare Standards Disclaimer Appendix 3 Declaration of Vested Interest Form Name of presenter: Dave Henry RRT Name of employer: DeVilbiss Healthcare Definition: A presenter may have an interest in or affiliation with an organization, which does not prevent him or her from making a presentation, however, the audience must be informed of this relationship before the presentation of the activity. For this purpose a real or apparent conflict of interest is defined as having a significant financial interest in a product to be discussed directly or indirectly during the presentation; being or having been an employee of a company with such financial interest and/or having had substantial research support by an industry to study the product to be discussed at the presentation. I recognize that I must follow all guidelines and criteria regarding vested interest. [ ] No, I have no real or perceived conflicts of interests that relate to this presentation. (If the response is no, stop here.) [ X ] Yes, I have the following real or perceived conflicts of interest that relate to this presentation: Describe real or perceived conflicts of interest that relate to this presentation By Dave Henry RRT Respiratory Clinical Specialist DeVilbiss Healthcare I am an employee of DeVilbiss Healthcare and we manufacture respiratory home care equipment. My presentations are not product specific but relate to the principles involved in best utilizing certain technologies in the home environment. 1 2 Learning Objectives What is Obstructive Sleep Apnea (OSA)? Discuss CPAP adherence and issues relating to problems with CPAP adherence Describe the Medicare guidelines for reimbursement for CPAP adherence Discuss methods and available tools that may assist patients in improving CPAP adherence 3 4

2 Who has OSA? Who has OSA? Addressed by National Sleep Foundation (NSF) Sleep in America Poll Respondents experienced (or had been observed) having pauses in their breathing during sleep at least 3 nights per week U.S. market reports reveal that only 6% of all those with OSA have been diagnosed So this means that 94% of those with OSA are yet to be diagnosed Mom Dad Uncle Sister Brother Granddad Grandmom Mailman Police Officer School Bus Driver Airline Pilot Stay-at-home mom Waiter/Waitress Teacher Taxi Driver Doctor Nurses Sleep Techs Farmer Co-Worker Neighbor Garbage man Children Chef Truck Driver Everyone else not listed 5 6 Costs to Treat OSA You Are On The Front Line! Untreated vs. Treated OSA Hospital days 2.8 times more with untreated OSA. Hospital costs $100,000 to $200,000 more with untreated OSA. Physician costs doubled in untreated OSA. Untreated OSA vs. Control group Hospital stays 2.5 days longer than control Physician costs 101 % above control subjects Annual medical costs $2720 for untreated OSA vs. $1384 for control subjects of matched age and gender. Treated OSA After 2 years physicians costs fell 33 % after treatment. Hospital days fell from 1.27 days average before treatment to 0.54 days after being treated. (Only those adherent to therapy) Cost savings between $ ,400 per quality-adjusted life year gained. (One fourth cost to diagnosis SDB compared to carotid stenosis) Patients look to you for help You are competent provider of patient care services Harness the strength of your expertise & available resources to help patients Patient s interaction & experience with you can make or break their treatment experience Especially for those first few nights wearing PAP, so you are such an integral component in the adherence equation! Cost Justification for Diagnosis and Treatment of OSA AASM Position Statement, Sleep Vol 23, No 8,

3 Common complications of PAP Claustrophobia Claustrophobia Skin Allergies Emotional Stress Fashion fears Nasal Allergies Should not be worn when severely congested Giving the patient a choice of mask helps. Desensitizing the patient will take longer on some patients. Standing at bedside with the patient is helpful. Picking a mask that does not block their vision is preferable. (like nasal pillows, for example) 9 10 Common complications of PAP Skin Allergies Claustrophobia Skin Allergies Emotional Stress Fashion fears Nasal Allergies Should not be worn when severely congested What redness, sir? 11 12

4 Skin Allergies Common complications of PAP Latex-free vs. Silicone All silicones are not created equal. Medical grade silicone masks are available, but some patients may be allergic to that as well. (Rare) Marks on the patient s face may come from the mask being over-tightened. Nasal Pillows Interface may be useful because of it s design providing less contact with the face. Claustrophobia Skin Allergies Emotional Stress Fashion fears Nasal Allergies Should not be worn when severely congested Emotional Stress Common complications of PAP Wondering if a lack of support by spouse will be a problem. Sleep apnea can affect the patient wanting to try something new. CPAP equipment seems too complicated. Claustrophobia Skin Allergies Emotional Stress Fashion fears Nasal Allergies Should not be worn when severely congested 15 16

5 Fashion Fears Common complications of PAP What will it do to my hair? Will I look like I am ready to go trick or treating? I don t like wearing masks! Can t they make an invisible mask? Claustrophobia Skin Allergies Emotional Stress Fashion fears Nasal Allergies Should not be worn when severely congested Nasal Allergies Potential OSA Social/ Family Issues Seasonal allergies will make PAP therapy very difficult, if not impossible. Lab air filter must be checked regularly. CPAP filter must be checked regularly. A heated humidifier will also help. Patient may require allergy medication. Decreased interest in intimacy Impotence Sounds of OSA: Gasping and Snoring Thought of as Lazy or Out there by family and co-workers Forgetfulness Fatigue and daytime sleepiness Impedes participation in family events, increases relationship stresses, decreases work productivity 19 20

6 Positive Impact CPAP Utilization Effects: increased energy levels, more likely to improve work performance, daily tasks Increased oxygenation and proper sleep architecture improves cognition, memory Improved sleep architecture and how you now progress properly through the normal stages of sleep Renewed energy allows desire for participation in familial events Renewed interest in intimacy NEW CMS Guidelines Criteria for CPAP Device for treatment of OSA Face to face clinical evaluation by treating physician prior to sleep test. Meets following criteria: AHI or RDI of 15 events/hour OR greater than 30 events OR AHI or RDI greater than 5 and less than 14 events per hour with minimum of 10 events AND documentation of Excessive Daytime Sleepiness, impaired cognition, mood disorders or insomnia OR Hypertension, ischemic heart disease, or history of stroke. LCD for Positive Airway Pressure (PAP) Devices for the Treatment of Obstructive Sleep Apnea (L171) pg NEW CMS Guidelines Clinical Evaluation for CPAP OSA diagnosed using: PSG used in a sleep lab OR Unattended home sleep monitoring device of Type II (Minimum 7 channels EEG, EOG, EMG, ECG or heart rate, airflow, respiratory effort/movement, Oxygen saturation) Type III (Minimum 4 channels respiratory movement/effort, airflow, ECG/heart rate, oxygen saturation) Type IV (Minimum 3 channels allowing direct calculation of AHI or RDI or substantive equivalent) NEW CMS Guidelines Re-evaluation by Treating Physician No sooner than 31 st day and no later than 91 st day after initiating therapy, the physician must conduct a clinical re-evaluation and document that the beneficiary is benefiting from PAP therapy. LCD for Positive Airway Pressure (PAP) Devices for the Treatment of Obstructive Sleep Apnea (L171) pg 7. LCD for Positive Airway Pressure (PAP) Devices for the Treatment of Obstructive Sleep Apnea (L171) pg

7 NEW CMS Guidelines Documentation of Clinical Benefit NEW CMS Guidelines Definition of Adherence Face to face clinical re-evaluation by treating physician with documentation that symptoms of OSA or improved AND Objective evidence of adherence to use of the PAP device reviewed by the treating physician. Use of PAP greater than or equal to 4 hours per night on 70% of nights during a consecutive 30 day period anytime during the first 3 months of initial usage. LCD for Positive Airway Pressure (PAP) Devices for the Treatment of Obstructive Sleep Apnea (L171) pg 7. LCD for Positive Airway Pressure (PAP) Devices for the Treatment of Obstructive Sleep Apnea (L171) pg CPAP Compliance CPAP Compliance Methods In new CPAP users, prospectively studied during their first 3 months of home therapy, 46 % of the patients were considered as regular users (defined by at least 4h of effective CPAP on 70% of the days. CPAP Hour meter Techniques Power on (? Accuracy) Back pressure (? Accuracy) Kribbs NB, Pack AI, Kline LR et al. Objective measurement of patterns of nasal CPAP use by patients with obstructive sleep apnea. Am Rev Respir Dis 1993; 174: While breathing (Most accurate) 27 28

8 CPAP Compliance Models Self Reported vs. Measured Compliance Telephone Interviews Personal (face to face) Interviews Embedded memory data card As predominantly patients with poor compliance misestimated daily use time, we conclude that self-reports are unable to distinguish between compliant and noncompliant patients. Mean measured use time was 4.9 +/- 0.3 h per night, whereas reported daily use time calculated from reported nights a week and hours a night was 6.1 +/- 0.3 h per night. (1.2 h difference) Rauscher H, Formanek D. Poop W, Zwick H. Self-reported vs measured compliance with ncpap for obstructive sleep apnea. CHEST, Vol 103, Internal Memory Chip - Direct Download Modem Technology Automatic download/transfer of data CPAP Compliance Models Adherence Data Retrieval How Does it Work? Telephone Interviews Advantages Interactive with patient Direct communication (no third party story) Good customer service Disadvantages Accuracy of information Multiple attempts for communication Off hours for providing service As soon as IntelliPAP is plugged in, it begins to collect usage data (even non-usage data) and to store that data as a set of codes. Each SmartCode is displayed on the IntelliPAP LCD screen To retrieve the SmartCodes and generate reports, the provider simply needs to call the patient and have them read the code over the phone. A SmartCode report can be generated using our online Report Generator 31 32

9 How does all of that information fit into a code? With the right system, a lot of information can be stored in a code. A retail bar code can store information about price, item number, lot, inventory type, date manufactured, etc. in a numerical code SmartCode uses both numbers and letters to store specific values that relate to usage and/or therapy data it s like a patient therapy data bar code (without the bars) This code: 16J-TCXM-T76, tells us 33 Standard (DV51) Smart Code When the SmartCode is collected from the IntelliPAP Standard, it looks like this: 16J-TCXM-T76 (10 digits) The online Report Generator converts that code into some key data points: Day Count, Days At Least 4 hours, and Consecutive Days at Least 4 Hours Each of these measurements are recorded for each of the 4 time frames The Report Generator uses these key data points to calculate important metrics about the patient s usage 34 AutoAdjust (DV54) SmartCode Adherence Score Metrics Provided for Each Time Frame % Days at least 4 hours Days used at least 4 hours 95 th percentile pressure 90 th percentile pressure AHI Pressure plateau time % Leak Non-responding event index (NRI) Exhalation puff index (EPI) Adherence Score Medicare Requires use of PAP greater than or equal to 4 hours per night on 70% of nights during a consecutive 30 day period during the first 3 months of initial usage. Translation, the patient must use their CPAP for at least 4 hours per night for at least 21 nights in a 30-day period in the first 90days of therapy. We call this an Adherence Score. 90-Days 70% At least 21 nights > 4hrs continuous use Adherence Score (21/30) 30-Day Window 35 36

Suggested Patient Management Protocol DeVilbiss Intellipap Main Screen - Smartcode Patient Set-up Education Patient views the IntelliPAP video and training is documented to patient file Fitting and

Obtain best time to call. 3-6 Day Follow-up Call patient to see how it s going and retrieve the 7-day SmartCode. Generate report and discuss results with patient.

10 Suggested Patient Management Protocol DeVilbiss Intellipap Main Screen - Smartcode Patient Set-up Education Patient views the IntelliPAP video and training is documented to patient file Fitting and orientation Fit interface and set up IntelliPAP AutoAdjust Show patient how to retrieve SmartCode and Adherence Score and explain what to expect in terms of follow-up by phone. Obtain best time to call. 3-6 Day Follow-up Call patient to see how it s going and retrieve the 7-day SmartCode. Generate report and discuss results with patient. If required, help patient resolve any issues they may be having. If necessary, schedule an additional follow-up 45 Day Follow-up Call patient to see how it s going and ask them to relay their Adherence Score to you If Adherence Score is over 70%, retrieve the 90-day SmartCode from the PAP. If patient does not show qualifying usage, then work with them to resolve any issues and encourage adherence. Schedule follow-up for 1-2 weeks. Tell patient to contact their physician to schedule their re-evaluation appointment. Send report to referring Physician and request for them to schedule reevaluation appointment. Wrap up patient file with documentation of re-evaluation Accessing Smartcode from Main Screen Smartcode Characters Smartcode Patient Information Access: SmartCode Entering Codes 39 40

11 SmartCode Report Standard CPAP SmartCode Report AutoAdjust DeVilbiss SmartLink SmartLink Report Case

SmartLink Report Case 2 Hey, I know how to beat this thing!

Patients appear to establish their patterns of use by the FIRST MONTH (as early as 4 days) Adherence at 1 month

should be considered in non-adherent patients Sanders M.

12 SmartLink Report Case 2 Hey, I know how to beat this thing! CPAP Adherence Patient Education: Education and Follow up Early use patterns predict long-term adherence Patients appear to establish their patterns of use by the FIRST MONTH (as early as 4 days) Adherence at 1 month appears to predict adherence at 3 months Since adherence is established by 3 months, alternative forms of therapy should be considered in non-adherent patients Sanders M. Can intensive support improve continuous positive airway pressure use in patients with sleep apnea/hypopnea syndrome? SLEEP MEDICINE (2000) 1: n = 80 Weaver et al. Sleep 1997; 20: 278 Kribbs et al. Am Rev Respir Dis 1993; 147:

Standard Support ESS: 13 +/- 1 / AHI: 58 +/- 5 Intensive Support ESS: 13 / AHI: 59 +/- 5 Standard Support: Education regarding the nature of SAHS and need for CPAP therapy and viewing a video;

13 Standard Support ESS: 13 +/- 1 / AHI: 58 +/- 5 Intensive Support ESS: 13 / AHI: 59 +/- 5 Standard Support: Education regarding the nature of SAHS and need for CPAP therapy and viewing a video; daytime acclimatization to CPAP followed by nocturnal CPAP titration. Patients counseled to report side effects and telephone contact between sleep nurses and patients was made on the 2nd and 21st day following initiation of therapy. The sleep nurse and physician saw patients at 1, 3 and 6 months after titration Intensive Support: Consisted of the elements associated with standard support plus initial educational activities to the patients and partner conducted in the patients home: two additional nights of CPAP titration and home visits at 1, 2 and 4 weeks as well as after 4 months after initiation of CPAP Results: Conclusion: Patients receiving Intensive Support had greater CPAP usage than standard support patients 5.4+/- 0.3 vs 3.8 +/- 0.4 (1.6 hr greater use) Patients who were self referred had greater CPAP usage than those whose referral was partner initiated. The later group also had a greater decline in usage over the study period. The authors concluded that intensive education and support of SAHS and their partner facilitates better compliance with CPAP therapy and improved patient outcome. Furthermore, partner referral identifies patients who are less likely to sustain daily usage of CPAP over time and may be useful in focusing intensive support efforts

14 Equipment Reduce Side Effects: Mask-Related Issues Choosing the right equipment Type of positive pressure (CPAP vs. AutoAdjust vs. BiLevel) Patient Interface: Fit and Comfort Nasal masks Nasal pillows Full-Face (oronasal) mask Dual Airway PROBLEM Skin breakdown/irritation Eye irritation Mouth leaks SOLUTIONS Refit mask Try nasal pillows Refit mask Saline eye drops Eye mask Chinstrap Switch masks Accessories Humidifiers Pressure ramp Altitude compensation 53 Mask leaks/discomfort 54 Refit or switch masks Reduce Side Effects Nasal Issues Reduce Side Effects Flow/Pressure Issues PROBLEM Nasal congestion Epistaxis (Nosebleeds) Rhinorrhea (Runny nose) SOLUTIONS Heated humidification Nasal saline sprays Nasal steroids ± decongestants ± antihistamines Correct any anatomic obstruction Heated humidifiers and saline Heated humidifier, nasal saline ± antihistamines PROBLEM Aerophagia (Spasmodic swallowing of air, common cause of flatulence, belching) Claustrophobia Difficulty exhaling SOLUTIONS Reduce CPAP pressure Consider APAP, BiLevel Switch to nasal pillows or prongs Desensitization Ramp feature Consider switch to APAP, BiLevel, flexible PAP Consider re-titration 55 56

15 PROBLEM Noise Tube condensation Partner intolerance Portability Reduce Side Effects Other Common Issues SOLUTIONS Move unit away (under bed, in closet)- may need extra hose Change machines One of Newest unit on the market and is only 26 dba compared to leading brands that are 31 dba Insulated sleeve for hose Heated wire Move machine away Education/bring to follow-up visits Bed Partner Support Group Online Smaller units Letters of necessity Improving CPAP Adherence A General Approach Identify and treat source(s) of adverse effects: Mask Nasal Flow-related Other First-line technological interventions Assess mask fit and consider alternative interfaces Heated humidifiers Ramp feature Instead of just a linear ramp, choose a unit that uses a constant delay *then* a ramp to prescribed pressure Auto-CPAP, BiLevel Patient education Consider alternative behavioral interventions if necessary NEW CMS Guidelines CMS Replacement Policy CPAP Adherence Take Home Message! Number Device Frequency A4604 Tubing with Integrated Heating Element 1 per 3 months A7027 Combination Oral/Nasal Mask 1 per 3 months A7028 Oral Cushion for Combination Oral/Nasal Mask (Replacement) 2 per 1 month A7029 Nasal Pillows for Combination Oral/Nasal Mask (Replacement) 2 per 1 month A7030 Full Face Mask 1 per 3 months A7031 Face Mask Interface (Replacement) 1 per 1 month A7032 Cushion for Nasal Mask Interface (Replacement) 2 per 1 month A7033 Pillow for Nasal Cannula Type Interface (Replacement) 2 per 1 month Identify possible problems early on in PAP therapy 4 hours per day, 70% of time within a 30 day time within a 90 day trial. It behooves us to get the patient adherent with the PAP therapy both clinically and economically. A7034 Nasal Interface (Mask or Cannula Type) 1 per 3 months A7035 Headgear 1 per 6 months A7036 Chinstrap 1 per 6 months A7037 Tubing 1 per 3 months A7038 Filter (Disposable) 2 per 1 month A7039 Filter (Non-Disposable) 1 per 6 months A7046 Water chamber for Humidfier (Replacement) 1 per 6 months LCD for Positive Airway Pressure (PAP) Devices for the Treatment of Obstructive Sleep Apnea (L171) pg

16 And My Thanks to YOU! You will receive an Evaluation Form Complete and back to address listed. We will send your CEU certificate via . Thanks for attending! DAVE For more information concerning products mentioned in this presentation, go to For On Demand Programs Take the Quiz Complete the Quiz. If you have a passing score, it will prompt you to automatically print off your CEU certificate. If you have problems, follow prompts in for assistance. Thanks for Attending! DAVE 61 62

Patient Interface Fitting. Dave Henry RRT Respiratory Clinical Specialist

Patient Interface Fitting. Dave Henry RRT Respiratory Clinical Specialist Patient Interface Fitting Dave Henry RRT Respiratory Clinical Specialist 1 Objectives Assist the patient to pick the best interface to make the therapy work. Instruct the patient to the concept of interfaces