1. OUT OF CENTER TESTING FOR OSA: TIME TO GET SERIOUS!
Indiana Sleep Society, 2012
OUT OF CENTER TESTING FOR OSA: TIME TO GET SERIOUS!
Charles Atwood, MD, FCCP, FAASM
University of Pittsburgh and
VA Pittsburgh Healthcare System

2. DISCLOSURES Commercial research support Federal support Consultant
Philips-Respironics, Resmed, Embla, Vapotherm
Federal support
VA HSR&D, NIH
Consultant
Care Core national

3. 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

4. Objectives Take the mystery and fear out of HSAT
Improve your understanding about HSAT on an intellectual level and on a practical level
Equip you with the tools you need to successfully add this to your practice

5. The current state of HSAT
The Present
The current state of HSAT

6. “May you live in interesting times”
-Ancient Chinese curse

7. Home Sleep Apnea Testing

8. 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

9. 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

10. 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

11. Who wants HSAT? CMS (medicare/medicaid) CPAP manufacturers
Capitated health plans
Homecare
Some physicians
Other Insurers
Patients and patient advocacy groups

12. Who is opposed to HSAT? Some sleep lab owners
Physicians who read a lot of PSGs
Sleep laboratory technologists?

13. Cardiovascular Consequences of Sleep-Disordered Breathing
Report of a Workshop From the National Center on Sleep Disorders
Research and the National Heart, Lung, and Blood Institute
Basic Science
Clinical Epidemiology
Develop new tools for
population screening
Cellular / molecular
studies
Sleep
Disordered
Breathing
&
Cardiovascular
Disease
Prospective cohort
studies
Mouse models
Incorporation of
SDB / Sleep Deprivation
in ongoing CV cohort
studies
Pathway studies
for humans
Clinical Therapeutic Studies
High – risk patient subsets
Development of new
treatment approaches
Circulation 2004
109:

14. 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.

15. 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

16. 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

17. 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

18. Type 4 with 3 channels One channel must be airflow
Other channels typically are pulse-ox and EKG/HR

19. How we got to this current state
The Past
How we got to this current state

20. Summary of Literature 1990-2006 2006 2007-Present
Single 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

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

22. Ability of type III monitors in the home setting to identify AHI suggestive of OSAHS in laboratory-based polysomnography
Neg LR < 0.1
Pos LR >10
Trikalinos et al, AHRQ, 07

23. Recent Research Update
Review of recent HSAT studies

24. 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

25. Recent studies in HSAT
N = 106
Berry et al, Sleep, 2008

26. 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

27. 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

28. VSATT goals
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

29. VSATT goals
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

30. VSATT – Equipment Diagnostic HSAT – Embletta by Embla
AutoCPAP – Respironics REMstar auto

31. Inclusion and Exclusion Criteria
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

32. VSATT study design Baseline Assessment and Randomization (n=296)
In-lab PSG (n=141)
Home sleep study (n=139)
In-lab PSG
(n=35)
AHI < 15 (n=23)
Dx’ic PSG (n=99)
Split PSG (n=42)
Home autoCPAP titration (n=119)
Non-OSA
(n=9)
CPAP PSG (n=84)
Clinic F/U
Non-OSA
(n=9)
CPAP set-up (n=110)
CPAP set-up (n=113)
In-lab PSG
(n=18)
One month FU (n=92)
One month FU (n=103)
Three month FU (n=86)
Three month FU (n=96) 32

33. 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

34. Baseline characteristics in all subjects initiated on CPAP
Home Testing (n=113)
In-Lab Testing (n=110)
Factor
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
* n=111; † n=109

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

36. Mean CPAP adherence 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.
Kuna et al, AJRCCM, May, 2011

37. Conclusion Implication
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

38. Practical applications of HSAT
The future
Practical applications of HSAT

39. “Gap” Between Evidence and Practice
Reimbursement
Vested interest in the status quo
Lack of training
HOME OSA TESTING
Evidence
Home
OSA
Testing Practice

40. 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?

41. 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

42. 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

43. 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

44. Estimated reimbursements for various sleep studies
Level 1
Full in lab PSG
95810
$694.14
95811
$749.18
Level 2
Miniaturized full PSG in a non-lab setting
95800
$205.56
Level 3
Cardiopulmonary studies
Oximetry, airflow, effort, HR
95806
$182.11
Level 4
1, 2, 3 channels
95801
$96.83

45. Is there a viable practice model for HSAT?

46. 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?

47. 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!!!

48. Polysomnography?

49. Philosophical reasons
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

50. 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

51. 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

52. 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…

53. Thank you
Questions?