OUT OF CENTER TESTING FOR OSA: TIME TO GET SERIOUS! Charles Atwood, MD, FCCP, FAASM University of Pittsburgh and VA Pittsburgh Healthcare System Indiana.

OUT OF CENTER TESTING FOR OSA: TIME TO GET SERIOUS!

Charles Atwood, MD, FCCP, FAASMUniversity of Pittsburgh and VA Pittsburgh Healthcare System

Indiana Sleep Society, 2012

Indiana Sleep Society, 2012

DISCLOSURES

• Commercial research support– Philips-Respironics, Resmed, Embla, Vapotherm

• Federal support– VA HSR&D, NIH

• Consultant– Care Core national

Presentation

• Overview of home sleep apnea testing (HSAT)– Classification – Types of monitors– Data supporting its use

• Practical lessons about how to make this work– Equipment– Reimbursement– Pittfalls to avoid

Objectives1. Take the mystery and fear out of HSAT2. Improve your understanding about HSAT on an

intellectual level and on a practical level3. Equip you with the tools you need to successfully

add this to your practice

The Present

The current state of HSAT

“May you live in interesting times”

-Ancient Chinese curse

Home Sleep Apnea Testing

Talking about…what?

• Portable monitoring – conventional term• Ambulatory monitoring – conventional • Home sleep testing (HST) – CMS term• Home sleep apnea testing (HSAT) – my

preferred term• Out of center testing (OCT) – AASM term

Why is HSAT so controversial?

• Threat to polysomnography• Sleep medicine is quite young as an organized

field and vulnerable – Need significant clinical $$ to support it– PSAT threatens PSG revenue

• Many are satisfied with status quo

Some current controversies/opportunities in Sleep Apnea Medicine

• Integrating HSAT into clinical practice• Integrating adherence-usage data into clinical

practice• Developing a chronic disease mindset about

sleep apnea• DME in the sleep lab

Who wants HSAT?

• CMS (medicare/medicaid)• CPAP manufacturers• Capitated health plans• Homecare• Some physicians• Other Insurers• Patients and patient advocacy groups

Who is opposed to HSAT?

• Some sleep lab owners• Physicians who read a lot of PSGs• Sleep laboratory technologists?

Cardiovascular Consequences of Sleep-Disordered BreathingReport of a Workshop From the National Center on Sleep Disorders

Research and the National Heart, Lung, and Blood Institute

Circulation 2004109:951-957

Basic Science Clinical Epidemiology

Clinical Therapeutic Studies

SleepDisordered Breathing

&Cardiovascular

Disease

Cellular / molecularstudies

Mouse models

Pathway studiesfor humans

• High – risk patient subsets• Development of new treatment approaches

Develop new tools for

population screening

Prospective cohort studies

Incorporation of SDB / Sleep Deprivationin ongoing CV cohort studies

Institute of Medicine Report, 2006

What is needed?• Expand awareness among

health care professionals through education and training.

• Develop and validate new and existing diagnostic and therapeutic technologies.

Why is HSAT Important?

• Need for “mainstreaming” of sleep medicine – lack of options for tools hinders this

• Variable access to care• Fosters chronic disease model approach to

care• May save money

Current Coverage of HSAT

• CMS Medicare Administrative Carriers (MACS) define HSAT in the context of CPAP therapy…

• CPAP can be prescribed if… OSA is diagnosed based on a clinical evaluation and one of the following– Full PSG– HSAT level II, III, IV with 3 channels

Classification of HSAT Equipment

• Level 1 – Full in lab PSG

• Level 2 – Miniaturized full PSG in a non-lab setting

• Level 3– Cardiopulmonary studies

• Oximetry, airflow, effort, HR

• Level 4– 1, 2 or 3 channels

Type 4 with 3 channels

• One channel must be airflow• Other channels typically are pulse-ox and

EKG/HR

The Past

How we got to this current state

Summary of Literature

1990-2006 2006 2007-PresentSingle site studies; small samples

Homogenous cohorts – middle-aged male snorers

Variable rigor of study design; frequently focused on highest risk subjects

All focused on “new portable monitor” vs. PSG approach

Expand awareness through education and training.

Develop and diagnostic and therapeutic technologies

Realization that home testing is here to stay and evidence is neither perfect nor dismal

Outcomes-oriented studies replace “comparison-of-device” studies

To get your own copy, go to www.arhq.gov and search under completed technology assessments, 2007

Ability of type III monitors in the home setting to identify AHI suggestive of OSAHS in laboratory-based polysomnography

Pos LR >10

Neg LR < 0.1

Trikalinos et al, AHRQ, 07

Recent Research Update

Review of recent HSAT studies

Recent studies in HSAT

• N = 65• Highly selected group

high risk for OSA• Compared autocpap

after home test vs. sleep lab approach

Mulgrew et al, Ann Int Med, 2007

Recent studies in HSAT

Berry et al, Sleep, 2008

N = 106

Recent Studies of HSAT• Single site study from Saskatchewan• Randomized order of testing but all subjects had full PSG and home testing• N=89• Home APAP for 1 week• 4 week follow-up• Found no difference in outcomes for home vs. lab therapy

Skomro et al, Chest, 2010

Veterans Sleep Apnea Treatment Trial (VSATT)

• OSA is common in VA• VA is ill-equipped to manage OSA in the conventional

way– Few labs relative to numbers of patients– Geographic disparities for access

• Necessary to think creatively to solve this problem• Believed that home dx and treatment MUST be a

part of this

Kuna et al, AJRCCM, May, 2011

VSATT goals

1. Determine if home diagnosis of OSA followed by autoCPAP for OSA positive patients has no worse an outcome compared to patients who are diagnosed and have CPAP started in the sleep laboratory

We predicted equivalent outcomes

2. Compare the differences in cost and quality-adjusted life years saved (QALYS) between home and in-lab testing by estimation of the ratio of the cost per QALYS saved.

We predict lower costs with equivalent outcomes

VSATT goals

VSATT – Equipment

• Diagnostic HSAT – Embletta by Embla• AutoCPAP – Respironics REMstar auto

Inclusion criteria:• Patients referred for a sleep evaluation for suspected sleep apnea• Age 18 years• Living within 90 miles of the sleep center

Exclusion criteria:• Unable or unwilling to provide informed written consent• Inability to complete the Assessment Battery• Lack of telephone access or inability to return for follow-up testing.• Prior sleep evaluations, OSA treatment, or other sleep disorder • A clinically unstable chronic medical condition as defined by a new diagnosis

or change in medical management in the previous 3 months of cardiac disease, thyroid disease, diabetes, depression or psychosis, cirrhosis, or recently diagnosed cancer

• Individuals on long term oxygen therapy or requiring BIPAP• Rotating shift work or irregular work schedules over the last 6 months• Suspected or confirmed to be pregnant

Inclusion and Exclusion Criteria

Clinic F/U

In-lab PSG(n=35)

AHI < 15 (n=23)

CPAP PSG (n=84)

Home autoCPAP titration (n=119)

In-lab PSG (n=141)

Home sleep study (n=139)

CPAP set-up (n=110)

One month FU (n=92)

Baseline Assessment and Randomization (n=296)

CPAP set-up (n=113)

Dx’ic PSG (n=99)

Split PSG (n=42)

In-lab PSG(n=18)

Non-OSA(n=9)

Non-OSA(n=9)

One month FU (n=103)

Three month FU (n=86)

Three month FU (n=96)

VSATT study design

VSATT endpoints and covariates

General outcome• FOSQ• Adherence - smart cards• ESS• PVT• SF-12• CESD• MAP• Meds• Comorbidities

Cost-effectiveness • HUI 2• EuroQol 5D• Healthcare costs – VA and

non-VA

Home Testing (n=113)

In-Lab Testing (n=110)

Factor Mean ± SD Mean ± SD P-value

Age (yrs) 55.1 ± 10.3 51.8 ± 10.4 0.02

Height (in) 69.3 ± 3.5 69.9 ± 3.3 0.30

Weight (lb) 238.9 ± 53.1 237.7 ± 42.4 0.85

BMI (kg/m2) 35.0 ± 7.5 34.2 ± 5.2 0.34

FOSQ total score 15.0 ± 3.2 14.7 ± 2.9 0.55

ESS score 12 ± 5 13 ± 5 0.21

PVT (transformed lapses) 3.8 ± 2.6* 4.3 ± 3,7 0.83

CES-D 23.3 ± 7.8 25.0 ± 8.8 0.13

SF-12 physical score† 36.7 ± 10.9 38.2 ± 10.2 0.29

SF-12 mental health score 44.4 ± 10.8 41.1 ± 10.7 0.02

* n=111; † n=109

Baseline characteristics in all subjects initiated on CPAP

Mean (SD) of FOSQ total score by treatment group from baseline to month 3 in all subjects initiated on CPAP

Endpoint Home adjusted mean change1 (n=113)

In-Lab adjusted mean change1 (n=110)

Adjusted difference in mean changes (SE)1

P-value2 Lower bound of 90% CI for difference in mean changes

Mean CPAP (hours/day)

3.42 2.99 0.42 (0.32) 0.180 - 0.10

1 Adjusted mean changes and adjusted differences in mean changes were estimated as site-total-sample-size weighted values controlling.2 P-value from Type II sum of squares estimated by way of analysis of covariance. To produce site weighted comparisons the ANCOVA model included main effects for type of study (home vs in-lab) and site.

Mean CPAP adherence from baseline to month 3 in all subjects initiated on CPAP

Kuna et al, AJRCCM, May, 2011

Conclusion

Functional improvement with CPAP for OSA is not worse when treated in the home setting vs. the sleep laboratory

Implication

Home based OSA diagnosis and initiation of CPAP is effective in treating OSA

The future

Practical applications of HSAT

“Gap” Between Evidence and Practice

HOME HOME OSA OSA

TESTING TESTING EvidenceEvidence

HOME HOME OSA OSA

TESTING TESTING EvidenceEvidence

HOMEHOMEOSAOSA

TESTING TESTING PracticePractice

• Reimbursement

• Vested interest in thestatus quo

• Lack of training

Practical Application of HSAT

• Pick one system and get to know it well• Patient selection – pre-select or all comers?• Considerations

– Who will teach patients how to use it?– How will patients return it?– Who will score it?

Practical Considerations

• Lost equipment• Turn around time – want it short• Technically inadequate studies – expect 10-

15%• What to do with negative studies• Contracting with private insurance companies

A few recommendations…

• Consider using mailers– UPS or Fedex; tracking codes– May not be a reimburseable expense but you can

get your monitor back quickly

• Purchase or develop video to explain hook up for patient –can be time saving

Home treatment trends

• Autocpap – AASM does NOT recommend home based

autocpap titration as a standard– Yet there are 4 studies in the past 4 years

demonstrating it is equivalent to lab studies for clinical outcomes

– That is likely to change

Estimated reimbursements for various sleep studies

Level 1Full in lab PSG

95810 $694.14

95811 $749.18

Level 2Miniaturized full PSG in a non-lab setting 95800 $205.56

Level 3Cardiopulmonary studiesOximetry, airflow, effort, HR 95806 $182.11

Level 41, 2, 3 channels 95801 $96.83

Is there a viable practice model for HSAT?

? ?

Answer is unknown…Too many variables

• No clear cut model yet for commercial insurance markets

• Model for capitated plans – Yes!• Probably works best in a high volume lab but

what the critical volume is is unknown• Local competition• National companies – the biggest threat?

Making it work for you

• If you have a viable lab, start small and get comfortable with it

• External pressure – gear up lab or office staff to do this

• External pressure – network with Primary care and other referral base like crazy!!!

Polysomnography?

Why HSAT is a good idea

Philosophical reasons Sleep medicine cannot survive if we have only

1 test for most every disorder What other field has this limitation? Applying simpler/less expensive tests to more

straightforward patients and saving more sophisticated testing for more difficult patients is how medicine is practiced

Why HSAT is a good idea

Practical reasons More patients will be tested More patients will have unclear studies,

requiring services of specialists Fosters a more mainstream approach to

OSA management

Is HSAT the future of diagnostic testing for OSA?

• Unlikely to be the whole future• Predict a de-emphasis on diagnosis and

increased emphasis on therapy– 12 week reassessment mandated by CMS for

medicare/medicaid beneficiaries– Minimal acceptable usage of PAP

Sleep Medicine Practice of the Future

• Integrate HSAT with full PSG in a clinically rational way

• Those who adapt to changing climates will survive.

• Those who cannot adapt…

Thank you

Questions?