Leslie V. Norwalk, Esq.
Acting Administrator
Centers for Medicare & Medicaid Services
U.S. Department of Health and Human Services
Room 445-G, Hubert H. Humphrey Building
200 Independence Avenue, SW
Washington, DC 20201


RE: NCA for Continuous Positive Airway
Pressure (CPAP) Therapy for Obstructive
Sleep Apnea (OSA) (CAG-00093R2)


Dear Ms. Norwalk,

On behalf of DeVilbiss®, a division of Sunrise
Medical and a global manufacturer of home
respiratory devices, we appreciate the
opportunity to comment on the National Coverage
Determination (NCD) for Continuous Positive
Airway Pressure (CPAP) devices. Our comments
will focus on three aspects of the diagnosis and
treatment of obstructive sleep apnea (OSA) –
diagnostic testing, compliance and use of
autoadjust technology.


Introduction
The medical literature has well-established that
if untreated or undertreated, sleep disordered
breathing (SDB) has significant impacts on a
variety of conditions including heart disease,
hypertension, stroke and diabetes. Moreover,
there is increasingly recognition that daytime
sleepiness is a major contributor to work-related
injuries and traffic accidents. As a result,
SDB awareness has improved dramatically in both
the general population and treatment
practitioners. In 2006, there was an estimated
200 million impressions of SDB in the media.
While the increased awareness is important step
in addressing this complex issue, it has also
created problems for healthcare professionals in
terms of timely access to diagnosis and treatment.


Home Diagnostic Testing
In 2004, the Centers for Medicare & Medicaid
Services (CMS) convened a Medicare Coverage
Advisory Committee (MCAC) panel to examine the
issue of home diagnostic testing. After much
debate, the final decision was continuation of a
national non-coverage position for home
diagnostic testing. This unfortunate decision
has further compounded the access issues
prevalent under a policy requiring facility-based
polysomnographic (PSG) studies. In some
locations and settings, estimated waiting times
can range from a few weeks to several months for
bed availability. While some may argue that the
delay is not critical since SDB develops over a
period of time and the sequelae also have a long
timeline, there is growing medico-legal
justification that diagnostic delays constitute
negligence and medical malpractice.

Since the MCAC evaluated the medical literature
in 2004, several studies have been published
supporting the use of autotitrating CPAP
(autoCPAP) in combination with various
physiologic parameters to support SDB diagnosis
and treatment initiation in the home setting.
For example, Ryan et al reported results from 68
patients initiated on CPAP without prior PSG.
In this study, patients with a high pre-test
probably of SDB were identified with a
combination of the Epworth Sleepiness Scale (ESS)
score, Sleep Apnea Clinical Score, and overnight
oximetry. Patients were randomly assigned to PSG
or ambulatory titration using a combination of
autoCPAP and overnight oximetry. The results
demonstrated that in patients with a high
probability of SDB, PSG conferred no advantage
over the ambulatory approach. Moreover, the
study also suggested that ambulatory diagnosis
and initiation of treatment may improve adherence
to therapy.

A portable monitoring classification system was
developed by the American Academy of Sleep
Medicine (AASM) to categorize the types of
monitoring systems and to standardize the
parameters (channels) measured. Note that Type I
devices are not listed on the table as these are
used for facility-based, attended overnight PSG).

Type of Portable Monitoring Device
Parameters Measured
Type 2
Comprehensive Portable
Polysomnography minimum of 7 channels, including
electroencephalogram, electrooculogram, chin
electromyogram, electrocardiogram or heart rate,
airflow, respiratory effort, and oxygen saturation
Type 3
Modified Portable Sleep Apnea Testing
Minimum of 4 channels monitored, including
ventilation or airflow (at least 2 channels of
respiratory movement, or respiratory movement and
airflow), heart rate or electrocardiogram, and
oxygen saturation
Type 4
Continuous Single or Dual Bioparameters
One or 2 channels, typically including oxygen
saturation or airflow

Sunrise Medical supports the expansion of home
diagnostic testing to include both Type 2 and
Type 3 devices. These devices, in combination
with objective and subjective clinical data such
as body mass index (BMI), neck circumference and
a validated sleepiness scale, have consistently
demonstrated comparable predictive value to that
obtained by facility-based, attended PSG. ,

At the MCAC panel, one of the concerns with some
portable sleep testing monitors is the limited
ability to monitor sleep staging, or whether the
patient is actually sleeping, since
electroencephalography (EEG) and electromyography
(EMG) are the metrics used to determine sleep
staging. Moreover, there was concern that
unattended Type 2 studies would have issues
related to difficulties positioning electrodes or
electrodes losing adherence to the patient during
the night. Both of these concerns are
essentially eliminated with current systems. For
example, although Type 3 devices do not provide
EEG and/or EMG channels, in most routine OSA
diagnostic situations, sleep staging is not
necessary. Furthermore, the concern with
electrodes and their application for a Type 2
device study is also virtually eliminated by
technology available today using wireless
communication that avoids patient entanglement.


AutoCPAP Technology
Historically, CMS and the Healthcare Common
Procedure Coding System (HCPCS) workgroup have
failed to recognize the difference between
standard CPAP and autoCPAP technology. AutoCPAP,
used either as an adjunct to home diagnosis and
pressure titration (autotitration) or as a
treatment modality following standard PSG,
confers several advantages over standard CPAP.
First, conducting SDB diagnostic testing in the
home in conjunction with autoCPAP affords the
clinician the opportunity to study the patient’s
sleep and breathing pattern in a more “natural”
environment. This is likely to be more conducive
to their regular sleep pattern and, therefore,
provide a more accurate reflection of their
disease state.

Secondly, home diagnostic testing in conjunction
with autoCPAP titration allows the clinician the
opportunity to study the patient over multiple
nights. The current paradigm in a facility-based
PSG lab is to have the patient studied for a
short period of time, typically around 2 hours
(according to current CMS national policy, this
is the minimum time allowed for a proper study to
be reimbursed), and then placed on CPAP. In this
scenario, one is making a diagnostic
determination that will potentially impact the
patient for decades. Moreover, with the
prescription of standard CPAP, the clinician is
also required to make a determination of the
optimal pressure necessary to ameliorate the SDB
pattern. In all with current practice, the
clinician is making a treatment decision with
long-term consequences based on a few short hours
of observation in a simulated “sleep”
environment. As one can see, use of home
diagnosis and autoCPAP would eliminate the
necessity for the accelerated diagnostic routine
by allowing studies to be performed over several
nights, in the patient’s own home and bed, and
with a device that can assist in determining the
optimal pressure necessary to eliminate symptoms.

Finally, multiple studies have shown that
patients using autoCPAP demonstrate improved
adherence to therapy. , , Compliance with
CPAP therapy is notoriously low. Despite the
documented efficacy of CPAP treatment, it is
estimated that over 50% of those started on CPAP
will not be using it 1 year later. Although
multiple factors have been cited for failure to
adhere to treatment, it is clear from the medical
literature that the patient’s experience in the
first few nights of therapy is critical to
continued long-term adherence. Given that the
current scheme of diagnosis and titration occur
over a compressed timeframe in a sleep
laboratory, it is not surprising that a
significant number of failures are the result of
inaccurate estimates of nasal CPAP pressure
needed to eliminate symptoms. Excessive pressure
can result in mask leakage, sinus congestion, dry
nasal and ocular mucosa, and feelings of
suffocation.

While one could argue that CMS provides coverage
for autoCPAP technology, the reality is that
reimbursement does not support its use.
Requestors, both from the clinical and the
manufacturing community, have attempted to obtain
a HCPCS code for this technology for the past
several years. Each year, the HCPCS national
panel has declined to recognize the unique
characteristics of autoCPAP and its documented
advantages over standard CPAP in terms of
adherence to therapy. By continuing to code
autoCPAP as E0601 (the HCPCS code for standard
CPAP), CMS is continuing a defacto non-coverage
position.


Compliance Monitoring
Intimately linked to the use of autoCPAP is the
issue of compliance monitoring. As noted above,
CMS has declined to award a unique HCPCS code for
autoCPAP citing the improvement in adherence as
a “convenience” and therefore non-covered by
statute. In 2006, an S code was created for
electronic compliance monitoring; however, the
code was not eligible for Medicare
reimbursement.

Multiple health plans cover compliance monitoring
and make compliance monitoring a requirement for
new CPAP patients. For example, Health Insurance
Plan of New York (HIP New York) demonstrated that
their use of compliance monitoring technology
resulted in savings of over $62,000 in 2004 by
identifying patients who were prescribed CPAP but
failed to adhere to therapy. And while CMS
recognizes, through its Medicare contractor local
coverage determination (LCD), the importance of
compliance by requiring an adherence statement at
60 days post-initiation of treatment, there is no
mechanism for reimbursement associated with this
activity.


Summary and Recommendation

An analysis of the medical literature
demonstrates that home testing for SDB in
conjunction with autoCPAP titration represents a
cost-effective, efficacious, and clinically
sensitive mechanism for a large population of
patients at risk for SDB. Moreover, use of
autoCPAP improves compliance with SDB therapy.
DeVilbiss requests that CMS consider the
following recommendations for incorporation into
the national coverage determination for CPAP:

1. Expand coverage for home diagnostic
systems as an alternative to facility-based PSG.
The system should include, at a minimum:
airflow, oximetry, heart rate, and respiratory
effort (Type 2 and Type 3 devices). Criteria for
coverage should include a screening mechanism
that improves the pre-test likelihood that SDB is
present (e.g., Epworth Sleepiness Scale, Sleep
Apnea Clinical Score).
2. Recognize the advantages of autoPAP,
either as an adjunct to home testing or long-term
therapeutic use, through an explicit coverage
statement in the NCD. CMS’ Coverage and Analysis
Group should work with the Alpha-numeric
Workgroup and HCPCS national panel to assign a
new HCPCS code to autoCPAP. Assignment of a
unique code to autoCPAP technology will allow
tracking of utilization and provide a
reimbursement mechanism. Reimbursement will be
critical to appropriate adoption of this
technology.
3. Recognize the importance of adherence
monitoring as a critical component in both the
short- and long-term treatment strategy for SDB
by elimination of Medicare non-coverage for
compliance monitoring. Reimbursement for
compliance monitoring could be limited to the
first 60-90 days of therapy – the time when
therapy adjustments and follow-up are critical to
adherence to therapy.
4. Given the impact of untreated SDB on
multiple disease process and the complexity of
factors impacting adherence, CMS should consider
creation of a SDB Management Service, similar to
Diabetes Self-Management Training Services
(DMST). The DMST benefit was created by the
Balanced Budget Act of 1997. DMST is intended to
teach patients with diabetes the importance of
diet and nutrition, glucose self-monitoring,
treatment plan education and motivation for use
of skills learned. This is an ideal model for
training new patients initiating CPAP therapy for
SDB.


DeVilbiss appreciates the opportunity to comment
on the national coverage reconsideration of the
continuous positive airway pressure (CPAP)
devices. We look forward to the expansion of
coverage for home testing, autoCPAP and adherence
monitoring. Should you have any questions about
the information presented or would like copies of
the articles cited, please do not hesitate to
contact me.

Respectfully submitted,

Robert D. Hoover, Jr., MD, MPH, FACP


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