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
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
Objectives
1. Take the mystery and fear out of HSAT
2. Improve your understanding about HSAT on an
intellectual level and on a practical level
3. 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 Breathing
Report of a Workshop From the National Center on Sleep Disorders
Research and the National Heart, Lung, and Blood Institute
Basic Science
Cellular / molecular
studies
Mouse models
Pathway studies
for humans
Clinical Epidemiology
Develop new tools for
Sleep
Disordered
Breathing
&
Cardiovascular
Disease
population screening
Prospective cohort
studies
Incorporation of
SDB / Sleep Deprivation
in ongoing CV cohort
studies
Clinical Therapeutic Studies
• High – risk patient subsets
• Development of new
treatment approaches
Circulation 2004
109:951-957
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
Single site studies; small samples
Homogenous cohorts – middleaged male snorers
Variable rigor of study design;
frequently focused on highest
risk subjects
All focused on “new portable
monitor” vs. PSG approach
2006
Expand awareness through
education and training.
Develop and diagnostic and
therapeutic technologies
2007-Present
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
Neg LR < 0.1
Pos LR >10
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
N = 106
Berry et al, Sleep, 2008
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
VSATT goals
2. Compare the differences in cost and qualityadjusted 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 – Equipment
• Diagnostic HSAT – Embletta by Embla
• AutoCPAP – Respironics REMstar auto
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
VSATT study design
Baseline Assessment and
Randomization (n=296)
Home sleep study
(n=139)
In-lab PSG
(n=35)
Home autoCPAP
titration (n=119)
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)
In-lab PSG
(n=141)
AHI < 15
(n=23)
Clinic F/U
Non-OSA
(n=9)
Dx’ic PSG
(n=99)
Split PSG
(n=42)
CPAP PSG
(n=84)
VSATT endpoints and covariates
General outcome
Cost-effectiveness
•
•
•
•
•
•
•
•
•
• HUI 2
• EuroQol 5D
• Healthcare costs – VA and
non-VA
FOSQ
Adherence - smart cards
ESS
PVT
SF-12
CESD
MAP
Meds
Comorbidities
Baseline characteristics in all subjects
initiated on CPAP
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
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
ESS score
* n=111; † n=109
FOS
Mean (SD) of FOSQ total score by treatment group
5
from baseline to month 3Figure
in all1a
subjects initiated on CPAP
FOSQ Total Score Mean and SD
by Treatment
Group in the mITT Efficacy Evaluable Cohorts
0
Before and
After the Three Month
Treatment
Period
Baseline
Month
3
Time
25
Home (N=105)
In-Lab (N=96)
Mean (SD)
FOSQ Total Score
20
15
10
5
0
Baseline
Time
Month 3
Mean CPAP adherence from baseline to month 3
in all subjects initiated on CPAP
Endpoint
Mean CPAP
(hours/day)
Home
adjusted
mean
change1
(n=113)
In-Lab
adjusted
mean
change1
(n=110)
3.42
2.99
Adjusted
P-value2
difference in
mean
changes (SE)1
0.42 (0.32)
0.180
Lower bound of
90% CI for
difference in
mean changes
- 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
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
• Reimbursement
• Vested interest in the
status quo
• Lack of training
HOME
OSA
TESTING
Evidence
HOME
OSA
TESTING
Practice
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 1015%
• 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 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, 3 channels
95810
$694.14
95811
$749.18
95800
$205.56
95806
$182.11
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?