1 the evidence for nasal cpap nicholas j. macmillan is the national clinical director for rotech...

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The Evidence for Nasal CPAP

Nicholas J. Macmillan is the National Clinical Director for Rotech Healthcare Inc. and owns and operates Outside the Box Consulting, a health care consulting firm. Nick has been involved in health care for over twenty five years as a registered respiratory therapist (RRT), manager and executive. He has worked in acute care, emergency care, intensive care, neonatal intensive care, cardiopulmonary diagnostics and rehabilitation, sub-acute care, home care, manufacturing and respiratory, nursing and community education. Over the last fifteen years Nick’s home care positions have included Global Sleep Product Director, Director of Respiratory Care and New Business Development, Vice President of HME Operations and Corporate Compliance Officer. He has held several state and national appointments and elected positions, including the President of the Indiana Society for Respiratory Care, Chairperson for the Home Care Section of the American Association for Respiratory Care and member of AAHomecare’s HME/RT Council. Nick was inducted as a Fellow of the American Association for Respiratory Care in 2003. Nick has been invited to present on a variety of topics at state, regional and national conferences. In addition, he has been published in several trade and related journals.

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Review the available clinical evidence supporting nasal CPAP treatment

HistorySupporting research

Provide an update on recent strategies to enhance compliance

Compliance todayFuture strategies

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The Evidence for Nasal CPAP:History

Obstructive Sleep Apnea Syndrome 1st recognized ~30 years ago 1981 Sullivan publishes small study in Lancet¹ Late 80s, early 90s population based studies

suggest high prevalence of OSA in adults² Abundance of quality research supporting the

clinical effectiveness of CPAP in the management of OSA

Numerous studies in US and worldwide1 Sullivan CE, et al. Reversal of obstructive sleep apnoea by continuous positive airway pressure applies through the nares. Lancet 1981 Apr 18;1(8225):862-5

2 Young T, et al. Epidemiology of Obstructive Sleep Apnea: A population health perspective. Am J Respir Crit Care Med 2002. Vol 165:1217-1239

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The Evidence for Nasal CPAP:Supporting Research

18MM Americans have sleep apnea 24% middle aged men 9% middle aged women

“Sleep apnea is a chronic condition, and an estimated 80% to 90% of persons with obstructive sleep apnea have not received a clinical diagnosis.” (1)

Annual market growth mirroring that of obesity (>20%)

(1) Pack A. Economic implications of the diagnosis of obstructive sleep apnea. Anals of Internal Medicine, 16 March 1999. 130:533-534

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Obesity/Overweight

13 14.5 1523

3145 47 47

5664.5

0

20

40

60

80

100

1960 1971 1976 1988 1999

YearAdults 20-74

Overweight=10-30 pounds over idealObese = 30 pounds over ideal

PercentObese

Overweight

Source: National Health and Nutrition Examination Survey

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25%25% 18%

22% 14%

34% 10%10%

9%

26%

0

100

200

300

400

500

1995 1996 1997 1998 1999 2000 2001 2002 2003 2004

# of sleep studies (000s)

U. S. Growth in Sleep StudiesCMS data represents 15% of US market


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Reduced hospitalization with cardiovascular and pulmonary disease in

obstructive sleep apnea patients on nasal CPAP treatment. Peker Y; Hedner J; Johansson A; Bende M

Department of Pulmonary Medicine, Sahlgrenska University Hospital, Goteborg, Sweden.Sleep (UNITED STATES) Aug 1997, 20 (8) p645-53

Economic and medical significance of sleep-related breathing disorders.

Fischer J; Raschke FInstitut fur Rehabilitationsforschung, Norderney, Deutschland.Respiration (SWITZERLAND) 1997, 64 Suppl 1 p39-44

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Utilization of health care services in patients with severe obstructive sleep

apnea.

Kryger MH; Roos L; Delaive K; Walld R; Horrocks JSleep Disorders Center, St. Boniface General Hospital, Winnipeg, Manitoba, Canada.Sleep (UNITED STATES) Nov 1996, 19 (9 Suppl) pS111-6

Health care utilization in the 10 years prior to diagnosis in obstructive sleep apnea syndrome patients.

Ronald J, Delaive K, Roos L, Manfreda J, Bahammam A, Kryger MH. Sleep 1999; 22: 225-229.


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Recent Strategies to Enhance Compliance: Compliance Today

Compliance and Pandora’s Box The original contributing factors of OSA Co-morbidities

Diabetes CHF Stroke Etc.

Safety Insurance Liability

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Recent Strategies to Enhance Compliance: Compliance Today “Use of inhaled anti-asthma therapy is suboptimal in 43-52% of

patients.” (1) “The use of oral anti-hypertensive therapy has been shown to be sub-

optimal in at least 44% of patients.” (2) Of 415 US hemodialysis patients, 147 missed 699 treatments over a 6-

month period. During a 3-month period, there were 0 missed treatments from Japan and 0 missed treatments from Sweden: 64.5% compliance to therapy (3)

(1) Mawhinney H, Spector SL, Kinsman RA, et al. Compliance and clinical trials of two non bronchodilator anti-asthma medications. Ann Allergy 1991; 66:294-299

(2) Rudd P. Clinicians and patients with hypertension: unsettled issues about compliance. Am Heart J 1995;130:572-579.

(3) Bleyer A, Hylander B, Sudo H et al. An international study of patient compliance with hemodialysis. JAMA. Vol.. 281, No. 13, April 7, 1999.

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Recent Strategies to Enhance Compliance: Compliance Today“Compliance can also be compared with long-term oxygen therapy, another form of lifelong home treatment with a machine. Long-term domiciliary oxygen therapy has been demonstrated to improve survival in patients with chronic obstructive pulmonary disease provided that it is given for at least 15h a day. In a group of a thousand patients, only 45% used oxygen for at least 15h per day on average.”

Barjhoux C, Pepin JL, Deschaux-Blanc C et al. Oxygenotherapie au long cours a domicile: respect de la prescription medicale et observance d’une duree quotidiennne d’au moins 15 heures. Rev Mal Respir 1994; 11: 37-45.

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Compliance Widely variable rates 50-70% overall Probably need >4 hrs. nightly for response 1

Pattern 1: 6.2 hrs./nt., 90% of nights (50% pts)

Pattern 2: 3.5 hrs./nt., 2-79% of nights

Compliance determined early on 2

1) Kribbs NB. Am Rev Respir Dis 1993; 147:887-895

2) Weaver TE. Sleep 1997;20(4):278-83

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Self Reported vs. MeasuredCPAP Compliance

“As predominantly patients with poor compliance misestimated daily use time, we conclude that self-reports are unable to distinguish between compliant and non-compliant 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, 1675-1680.

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No consistent predictive factors across several studies aid in determining patient compliance with CPAP therapy

Patients with subjective complaints of excessive daytime sleepiness however show greater hours of CPAP use vs. those with minimal daytime complaints

Reeves-Hoche MK. AJRCCM 1994;149(1):149-54Reeves-Hoche MK. AJRCCM 1994;149(1):149-54


AAHOMECARE FINANCIAL PERFORMANCE SURVEY: Sleep Disordered Breathing

Survey Objectives: Provide industry information

I.e. What is the rest of the world doing?

Provide performance and financial benchmarks

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Market SpecialtyPercent of Firms in

Survey


Respiratory 42%HME 6%Re/hab 4%Home Infusion 3%Mixed-Market Firms 45%Total 100%

Number of SDB Patients in 2002

256

Average length of compliance monitoring

4 months

Where initial set-up is performed:Patient’s home

50%Office

44%Sleep lab

4%Other

2%TOTAL

100%Labor cost to visit the home of an SDB patient

$35(hourly rte of the visiting personnel only, not benefits or vehicle costs)

IndustryAverage


Number of SDB Patients in 2002

108/680

Average length of compliance monitoring

3/6 months

Where initial set-up is performed:Patient’s home

10/90%Office

5/90%Sleep lab

0/5%Other

0/3%

Labor cost to visit the home of an SDB patient

$25/50(hourly rte of the visiting personnel only, not benefits or vehicle costs)

Low/High


Low/High

For a 12-Month Period…

What is the average number of visits per patient forpatient therapy? 0/3

What is the average number of visits per patient forequipment/compliance data retrieval? 0/2

What is the average number of visits per patient for the exchangeof equipment (i.e., the exchange of non-compliance recording equipment for compliance recording equipment)? 0/1


Low/High

What is your protocol for the number of phone calls madeto each SDB patient over a 12 month period of time?(per patient) 2/5

What is the average number of phone calls actually madeto each SDB patient over a 12 month period of timeincludes no answer, busy, etc.)? (per patient) 3/10

What is your estimate of the average cost to phonea patient, including both labor and long distance costs? $3/10


Monitoring compliance is driven by two factors: Insurance utilization verification and referral source demand.

It is common for payors to verify utilization between 30 – 60 days, while Medicare requires verification between the 61st and 90th day.

Therefore, it apparent by these results that the referral sources may still be driving compliance monitoring or that the compliance monitoring frequency of companies need revision.

Furthermore, a sleep disordered breathing program’s cost are primarily compliance monitoring related, i.e. home visits, telephone calls, gathering, processing and distribution of data, etc.

Reducing the compliance monitoring period or the method that compliance information is gathered can significantly reduce costs.

AAHOMECARE FINANCIAL PERFORMANCE SURVEY: Discussion of Results


The costs for a home visit appear understated when compared to what was reported for home oxygen visits when this information was gathered during the BBA (Balanced Budget Act) of 1997 deliberation.

These lower figures however could be due to the utilization of non-professional personnel for these visits, shorter visit duration or simply an underestimate.

It is interesting that 50% of the visits are not in a patient’s home. This appears to be the due to the acute recognition of the costs associated with home visits.The purpose of question 92 and 93 (phone calls) were to determine to what degree this compliance monitoring methodology was utilized, subsequent efficiency and costs. The apparent inefficiency could be due in large part to phone calls being made during “normal business hours”, when most sufferers of SDB are working.


AAHOMECARE FINANCIAL PERFORMANCE SURVEY: Discussion of Results

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Past studies blunted results due to mixing all patientsUse of “compliant” patients only - 90 % of the time or moreAdherent mean = 5.9 hours/nightDemonstrated subjective improvementDecreased PVT (Psychomotor Vigilance Task) lapses

Chansens ER, Weaver TE, Maislin G et al. Sleepiness and Adherence to CPAP Treatment in Adults with OSA. APSS - 2003 Poster 0642.J, Page A256


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Significant relationship between nightly duration and subjective sleepiness resolution

Estimated that > 6 hours every night to restore normal functioning in OSA patients

Weaver TE, Maislin G, Dinges D et al. CPAP Dose Duration for Effective Outcome Response. ATS - 2003 Poster 702, Page A324


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Patients receiving Intensive Support had greater CPAP usage than standard support patients

5.4 +/- 0.3 vs 3.8 +/- 0.4

(1.6 h 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.”

Sanders M. Can intensive support improve continuous positive airway pressure use in patients with sleep apnea/hypopnea syndrome? SLEEP MEDICINE (2000) 1:65-66.


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The precise prescription: Monitoring

Objective Early on

Minimum nocturnal duration that produce positive outcomes 6+ hours Subjective improvement

Frequency of use 90%

Education Before After - Intervention

Recent Strategies to Enhance Compliance: Future Strategies

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Definitions and Nomenclature Compliance: following orders

Clinician is in control Adherence: sticking to a plan

Patient is partially in control Concordance: agreement between equals

Patient and clinician working together toward mutual goals and outcomes


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Research gaps: Patient involvement research

What if you could see your data Data collection device research Interface research and compliance


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Compliance (Adherence) and Pandora’s Box The original contributing factors of OSA Co-morbidities

Diabetes CHF Stroke Etc.

Safety Insurance Liability

Is there a role for Disease State Management (DSM)

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Payor - Health Insurance How much? I’m kind of listening...

The difference in physician claims between patients and controls differed significantly two years after diagnosis and treatment. 1

Hospital stays decreased from 1.25 days to .53 days after treatment. 1 [significant]

1) Health Care Utilization In Males With Obstructive Sleep Apnea Syndrome Two Years After Diagnosis And Treatment. Bahammam, A. et al, Sleep 22:06: 740-747


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Payor - Automobile Insurance Drowsy Driving 1

More than 100,000 police-reported accidents 71,000 injuries 1,550 deaths per year

Reducing Motor-Vehicle Collisions, Costs, and Fatalities by Treating Obstructive Sleep Apnea Syndrome 2

OSA-related car crashes cost $15.9 billion in 2000 If 70% of those drivers had adhered to their CPAP therapy

– at a cost of $3.18 billion annually the authors conclude that would save $11 billion annually

(1) National Sleep Foundation(2) Alex Sassani, MD; Larry J. Findley, MD; Meir Kryger, MD, FRCPC; Eric Goldlust, PhD; Charles George, MD, FRCPC; Terence M. Davidson, MD


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What are your intentions? Effectiveness

Set-up Outcome

Efficiency (profitability) Satisfaction

Patient Clinical Community Payor


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Building your adherence model WIIFM, I.e. “A better program.” Base program on anticipated challenges, I.e.

compliance Collaboration Patient Choice

Missing Ingredients Costs

Services are critical Outcomes/DSM Technology


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Share the facts and the data Payors Employers Medical Community

Make your case Stratify accordingly

You get what you pay for Monitor the results


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Sleep is growing Sleep is changing Medicare historically has not led change The bottle neck is diagnostics Costs ultimately drive change and profitability The answer is right in front of you Get in or get out Innovators win


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Thank You!

Nick Macmillan

1 the evidence for nasal cpap nicholas j. macmillan is the national clinical director for rotech...

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