A Walmart/CVS Sleep Center –Coming Soon to an Area Near You!

George G. Burton, M.D.*

*Kettering Medical Center, Dayton, Ohio 2013

A Short History of Out Of Center(OOC) Home Sleep Testing(HST) and OSA

1974 – C. Guilleminault uses PSG – Stanford (Retrospectively Denied)

2000 – ACCP Consensus Paper on OSA stresses accurate diagnosis.

2002 – Cost and Access Concerns Voiced.2003 – AASM publishes 1st OOC Practice

Parameter, concludes OOC not ready for big time

Short History, continued

2007- AASM responds to Amer. Acad. of Otolaryngology request to CMS re OOC testing and publishes a new Practice Parameter suggesting that OOC could be used in patients with “HIGH PRE-TEST PROBABILITY” of OSA6

2007 – First Cochrane Review Published1

2009 – CMS Approves OOC (#00405N)12

2009 – AASM “Practice Parameters” Suggest OOC is OK in patients with “HIGH PRE-TEST PROBABILITY” Of Obstructive Sleep Apnea.14

2011- UHC covers OOC in New Jersey, Mass. –Preauthorization fury starts

2011 – Second Cochrane Review Published2

OOC Is Part of a Comprehensive Evaluation6

For the diagnosis of OSA, PM should be performed only in conjunction with a comprehensive sleep evaluation• Clinical sleep evaluations using PM must be supervised by a practitioner with board certification in sleep medicine or an individual who fulfills the eligibility criteria for the sleep medicine certification examination…(AASM Does Not Enforce)• In the absence of a comprehensive sleep evaluation, there is no indication for the use of PM

Practice Parameter Limits Use To Patients With High Pre-test Probability Of OSA6

PM may be used as an alternative to polysomnography in patients with high pre-test probability of moderate to severe OSA*

• “HST should not be used in patient groups with co-morbidities, other sleep disorders or for screening…”

False Negative Studies6

“Due to the known rate of false negative HST results*, in-laboratory PSG should be performed in cases where HST is technically inadequate or fails to establish the diagnosis of OSA in patients with a high pre-test probability…”

* A False Negative Test Suggests The Patient DOES NOT Have The Disease, When In Fact HE DOES

Follow-up Requirement6

• “A follow-up visit with a physician or other appropriately trained and Supervised health care provider should be performed on all patients Undergoing HST to discuss the results of the test.”• 75% of published “Equivalency Papers” prior to 2004 suggest HST would be of use in areas where “access to testing is limited”. HST follow-up is mandated by AASM but only required by CMS.

*JCSM 2007 Vol 3(7)

From KMC Sleep Lab’s Recent E-mail… (2012)

“Based on _______’s Sleep Apnea Guidelines a sleep test cannotbe approved at this time. Auto Positive Airway Pressure (APAP)is the first recommended treatment of individuals who are recentlydiagnosed with moderate to severe Obstructive Sleep Apnea (OSA).Moderate to severe OSA was recently diagnosed in this case, by a sleeptest. In this instance, guidelines support APAP therapy and repeatsleep testing is not required.”

Aetna/AIM Contraindications to HST Effective 7/1/12

• <18 Y.O.• Moderate to severe COPD (PFT Limits)• Moderate to severe CHF (EF Limits)• Cognitive or Neuromuscular Impairment• History of 2 previous unsuccessful or non-diagnostic HSTs• Patient on oxygen (any reason)• History of CVA in past 30 days• Any past history of V. Fibrillation or sustained V. Tachycardia

(more)

Aetna/AIM Contraindications to HST Effective 7/1/12 Continued…

• Suspicion of Sleep Disorders other than OSA:1. Central Sleep Apnea2. Narcolepsy or Idiopathic

Hypersomnolence3. PLMD/RLS4. REM-Behavioral Disorder5. Nocturnal Seizures6. Circadian Rhythm Disorders7. Parasomnias8. Insomnia?

HST – Facts or Myths?

• Recognition of “High Pre-test Probability” is easy

• HST and ILT are “Equivalent” and “Accurate”

• Interpretation of HST is straightforward

• HST Improves “Access, Patient Comfort, and Outcomes”

• HST is “Cost-Effective”

Statistics, Facts, Truths, and Rumors In The “Equivalency Literature”16

• SENSITIVITY: The probability that a patient who has the disease will test positive for it.• SPECIFICITY: The probability that a patient who has the disease will test negative for it.• ROC Curves• 95% Confidence Bands• Likelihood Ratio: (LR): Positive LR > 5% is significant – Positive LR = Sensitivity ÷ (1-Specificity)

Technology Evaluation: Challenges28,48

• Evaluating technology cannot be done in a vacuum – involves patient assessment and determination of “risk” for disease• Most studies examine patients with high “pretest probability” and in controlled settings e.g. VA Hospitals and University Medical Centers • Determination of PTP is done differently or not adequately discussed in methods

Technology Evaluation: Challenges

• What is “gold standard”?• PSG often performed with different equipment, scorers, and event definitions• Scored events are not the same (AHI/RDI Issue)• May or may not have a “sleep” measure to compare (different denominator) – Type 4 Error• Different outcome measures: -What level of AHI/RDI defines true disease? -What is good enough concordance? -What statistical methods are appropriate? – LR and Bland–Altman plots seem best16,18,36

Problems in Identifying “High Risk Probability”

• Prediction Models and Questionnaires:• High Sensitivity (76-96%) (Few false negatives) • Low Specificities (13-56% (More false positives)

• Physician Identification: • 64% Sensitive for AHI ≥/= 1521

• 63% Specific for AHI ≥/= 1523

• Research Subject Recruitment Yield – Only about 33% of cases accepted

Problems with HST Accuracy and Equivalency27,28,31

• Most validation studies have flawed study design, are underpowered, and used monitors of older design.• Test may have been interpreted by unqualified physicians.• The HST model has not been tested in community based populations with low pre-test probability. This maximizes the number of possible negative studies in symptomatic patients (false negatives).• Most studies are industry-sponsored.

In-Lab Testing : APNEA/HYPOPNEA INDEX (AHI) AHI = A+H ÷ TOTAL SLEEP TIME HST : RESPIRATORY DISTURBANCE INDEX (RDI) RDI = A+H ÷ TOTAL RECORDED TIME

•Both suffer from night-to-night variability58

“Perfect Equivalency Test” of Two Technologies (Most Were Not Done This Way)

1. Would Reflect “True Life” • ILT in LAB with Sleep Techs and Equipment

• HST in HOME with Patient and HOME Type III Equipment

• Would be done either simultaneously (Hard to do), or in randomized cross-over fashion2. Both groups Must Be “HIGH PROBABILITY TESTED” With

Instruments and Physicians as used at each site3. Full Range of appropriate referred patients must be included4. Metrics common to PSGs Only would be compared5. Test Exclusion And Failure Rates And Causes would be documented. 6. Inter- And Intra- Scorer Reliability would be reported

Equivalency Results Of Type III and In-Lab Studies2

• Mean Bias: -10 to +24 Events / Hour• • 95% Confidence Bands: -39 to +54 Events / Hour• With Cut-Off of AHI ≥ 5: - SENSITIVITY 83-87% - SPECIFICITY 48-100% - POSITIVE LIKELIHOOD RATIO 3.4

2AHRQ (2011), Table 1.13, Page D-1

Mean AHI Versus The Difference Between PSG and HRP (Bland-Altman Plot)32

Recent Outcomes-Based HST/ILT Equivalency Articles

• 5 Studies Reviewed at 2011 AASM Annual Meeting* in support of equivalency used CPAP Compliance at 3 to 6 months as metric. The idea was suggested in 2011 Cochrane Review2

• This is like comparing CXR and MRI as a guide to Lung Cancer Therapy based on equivalent patient consumption ofLuden’s cough drops!

• This is a Type III or Type IV Error33

Portable Monitor Sensitivity Itself* Depends On Site

**Compared to ILT

TYPE #PTs Percent of Pts with AHI ≥ 15

Sensitivity In Lab**

Sensitivity At Home**

Difference

TYPE III**

102 37% 95% 85% -10%7

TYPE IV 63 28% 91% 76% -15%15

AHI Correlation Coefficients Good But T-Test Values Differ

Type/NAME

# PTs Correlation Coeff.

AHI Absolute Numbers

Type IV*APNEA LINK

63 R= 0.89 *Significantly Different15

Type IV**WATCH PAT

11 R=0.92 *Significantly Different AHIAHG(PSG) = 12;AHI(HST)=21

**Arand, D: Unpublished Data (2007)

Implication Of Reduction In Sensitivity Is Incorrect Diagnosis

• If sensitivity of HST is 76% - 85% THEN Missed Diagnosis Rate = 100% - 76% = 24%

or 100% - 85% = 15%

Thus as many as 1 Out of 4 studies may result in a misdiagnosis

Interpretation Of HST Records Is Not Straightforward

• No EEG – Thus No True Sleep Time• No EKG – Thus Arrhythmias Frequently Missed• Unclear Scoring “Rules”

Some Empiric Standards• The Normal Oral Body Temperature Is 98.6°• The “55-88% Medicare Rule” Is Applicable To OSA Patients• Is there Something Magic About 4 Hours Of Sleep?52,57

Errors In Interpretation41,59

- Oximetry Example -

Decision To Treat Assessment Not Made On AHI Alone*

• Sp02 over time (e.g. ODI)• Cardiac arrhythmias or history• Neuropsychiatric status• Alertness status (e.g. ESS)• Patient preference

*Usually 5-24 Per Hour:15 – 30 or 20 – 30 Regardless of Co-morbilities: ≥ 30 increases risk for adverse outcomes2

Does HST Really Improve “Access” And “Patient Comfort”?

• Good current data is lacking17,45,56,60

• Experience says “NO”• Almost all early papers refer to use of HST in “underserved areas”• Pre-authorization now lengthens the process

Population – Development of Sleep Medicine In The United States24,47,54

• 5% of US population have sleep apnea• 5 million people over 45 have apnea• 93% of women, 82% of men with moderate to severe OSA still undiagnosed• 2.0 million in 2007• 1292 Sleep Labs in 2001• More than 2500 Sleep Labs in 2012

Wait Time For HST17

2005 22.3 Days*

2007 14.0 Days**

2012 6.5 Days***

In Canada Wait Time is 11 Months45

*Flemons WW: AJRCCM 169(6) 2004**Kuhlman D www.sleepmed.com 7/17/08***Burton G (Dayton, Ohio) 2012

HST Is Not Cost Effective

• Provider Costs Are High• Reimbursement is Poor• Misdiagnosis Rate Is High• Exclusion Rate Is High (Particularly In Older Population)

ROI Is Poor

Medicare Spent $235 Million On Sleep Testing in 2009(Office Of Inspector General 2010)37

In-Lab Testing and HST CMS Reimbursement for Polysomnography

DAYTON PHILIDELPHIA

LEVENDOWSKI31

In-Lab $900 $800 $625

Home $154 $99 $146

Estimated Direct Costs Of HST*

Per Study:

Equipment (Rental Amortized) $15.00Disposable Supplies $15.00Non-Disposable Supplies $10.00Technician Set-Up Time $18.00Technician Scoring and Report $18.00

Sub Total = $76.00+ 30% Overhead $23.00Total = $99.00

*KMC Data**Sleep Review (2012) 13: Page 20-22

Average Cost Of HST Monitor Is $3600**

Downstream Costs Of HST40

• Cardiovascular events• No show problem at home at in-lab hookup• Missed patients not at home• Delayed equipment return• Accidents to personnel• Medicolegal costs?

Outcomes Focus29,39

• “What is the future of sleep medicine?”• “Have we run the ship on to the rocks?”• “How do we right the ship?”• “Sleep disorders medicine is a Chronic Care Management Field”

OUTCOMES FOCUS: The New Kid On The Block “Integrated Sleep Care Programs” (“A Slippery Slope”)

• Institute of medicine emphasis on outcomes9,22,24,39,48,50

• Physician quality reporting system (PQRS) focus - Sleep medicine is a target group for 2013 with penalties

• Patient Protection and Affordable Care Act – ACO’s - Sleep medicine is not yet targeted

• AASM proposal for integrated sleep management delivery model 2011 turned downed by OIG as Anti-Stark37

• DME competitive bidding nationwide 2014

Conclusions Regarding HST

From the AHRQ Systematic Review Protocol: Diagnosis and Treatment of OSA in Adults (Cochran Review), 20112

• “Severe OSA Is Associated With An All Cause Mortality Risk Ratio of 1.5-3.0”• “Portable Monitors Can Predict A Diagnosis Of OSA, But Additional Studies Are Needed to Prove Their value Compared To (In Laboratory) Polysomnography”• “Type III HST Monitors…Cannot Estimate Exact AHI As Measured By In Laboratory Testing

A Criminal Paradox?

• Sleep apnea is the most serious of the clinical sleep disorders• Existing “Exclusions” (Co-Morbitities) and the suspicion of other sleep disorders protects these patients while…• Leaving the most seriously ill sleep apnea patients to rely on still unproven and not particularly accurate technology• Is this good medicine in 2013?

“One-stop Shopping”

All of this off the Internet, through the mail or off the shelf?

Conclusions

• Expertise in sleep medicine should be valued in the diagnosis of sleep apnea, with an emphasis on clinical skills• Speed should not sacrifice accuracy of diagnosis• The Less Information You Have The More Expertise That You Need• Be prepared for “Total Patient Care”. Start a careful clinical register in your department including all CPAP compliance data

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Conclusions

The Government, Third Party Payers, Our Professional Medical And Technical Associations, Scientific Researchers And Equipment Manufacturers Are NOT The Enemy.

IF The “Ship Of Sleep Medicine Is Steering For The Rocks” It Is OUR Job To Right Its Course And Send It On Its Way.

Thank You!