Chiquita Brooks-LaSure
Administrator
Centers for Medicare & Medicaid Services
7500 Security Blvd
Baltimore, MD 21244
CHEST Response to “Long-Term Health Outcomes in Obstructive Sleep
Apnea: A Systematic Review of Comparative Studies Evaluating Positive
Airway Pressure and the Validity of Breathing Measures as Surrogate
Outcomes”
Dear Administrator Brooks-LaSure:
The American College of Chest Physicians (CHEST) appreciates the effort from
the Centers for Medicare & Medicaid Services (CMS) to commission the
Agency for Healthcare Research and Quality (AHRQ) to evaluate comparative,
long term health outcomes of Continuous Positive Airway Pressure (CPAP) in
the published report entitled, “Long-Term Health Outcomes in Obstructive
Sleep Apnea: A Systematic Review of Comparative Studies Evaluating Positive
Airway Pressure and the Validity of Breathing Measures as Surrogate
Outcomes”. CHEST supports
evidence-based medicine and research that aims to improve upon treatment
standards and guidelines; however, CHEST is concerned that the contents of
this report do not reflect current evidence-based standard of care, which is
supported by the American Academy of Sleep Medicine (AASM) guidelines.
Therefore, we urge CMS to continue its coverage of CPAP therapy in
accordance with the AASM guidelines.
CHEST is the leading professional association in innovative chest medicine.
We advance the best health outcomes for patients with lung disease through
education, advocacy, research, and philanthropy. CHEST is the professional
home for more than 21,000 pulmonary, critical care, and sleep medicine
professionals dedicated to the delivery of quality, evidence-based care for
patients. Our mission is to champion the prevention, diagnosis, and
treatment of chest diseases with a focus on ensuring and improving access
for all patients, particularly underserved patients of highest need.
OSA is a serious and potentially life-threatening public health condition.
Published studies have shown that the condition has been associated with an
increased risk of high blood pressure, heart attack, stroke, obesity,
diabetes, glaucoma, and
depression. As you know,
in December 2022, AHRQ released a Final Technology Assessment to address
this issue with the aim to “inform sleep medicine clinicians, sleep
technologists, other care providers, sleep apnea researchers, policymakers,
and other decision makers” on contextual and key questions. These questions
include, but are not limited to, inquiries regarding the following:
-
Patient-centered health outcome goals and symptom relief goals of
CPAP devices.
-
Efficacy, effectiveness, comparative effectiveness, and harms of
CPAP devices to improve long-term health outcomes.
-
Evidence that apnea and hypopnea-based measures of sleep-disordered
breathing used in current practice and research are valid surrogates
or intermediate measures for long-term health outcomes.
The AHRQ efforts to investigate these focused questions are aligned with
CHEST’s organizational mission; however, given the scope of the study, CHEST
recommends that CMS refrain from action based on the conclusions of the AHRQ
report alone and alternatively rely on the updated, comprehensive AASM
guidelines.
I.
Limitations of Systematic Review for Clinical Practice
The evidence presented in the AHRQ review excludes important
patient-important factors. The systematic review restricted eligibility to
include studies that tested a set of specified long-term clinical outcomes.
These included measures of Quality of Life, cognitive function, or mental
health. Notably absent are patient-important outcomes that were determined
to be critical outcomes in the AASM guideline, such as daytime sleepiness
and fatigue. The omission of these outcomes has significant consequence, as
the AASM guideline found significant improvement in sleepiness using CPAP
therapy with high quality evidence. Though we acknowledge this may not have
been included in the charge of the grant, these additional patient-important
outcomes provide a more comprehensive, patient-centered approach to the
treatment of OSA.
The AHRQ review also defines long-term studies by cut-offs that further
limit the inclusion of additional key studies. The minimum durations of
follow up were defined as a minimum of 1 year for most outcomes, while for
mental health conditions, cognitive function, quality of life, and sexual
function, length of duration was defined as 6 months. AHRQ states that the
choices of minimum duration of follow up were based on discussions centered
on “the concept of “long-term” and the expected minimum time required on
CPAP treatment to impact outcomes”.
As you know, Study development requires patient enrollment and
representative patient samples. Though sleep apnea affects an estimated 2-9
percent of Americans, many go undiagnosed and
untreated. The Centers
for Disease Control and Prevention (CDC) estimates that as much as 50-75
percent of adults with symptoms of sleep apnea have not been diagnosed.2 Not
only does this present a challenge in the overall treatment of the
condition, but it also is a clear barrier to research enrollment and study
development. Furthermore, once enrolled, there are ethical challenges in
randomizing patients with OSA to placebo for long periods of time.
Studies, particularly traditional randomized control trials (RCT) and
comparative studies, face additional barriers that are due to the nature of
the condition. These include the variable levels of patient compliance,
follow-up, length of time on treatment, and sleep apnea severity and
prognosis. Variable levels of patient adherence create notable challenges
for the researchers in the studies reviewed.
Well-designed studies require extensive resources, time, and funding. The
AHRQ review acknowledges insufficient evidence; however, it is important to
note that the aforementioned factors remain persisting barriers to further
evidence development.
II. AASM Guidelines
In 2019, AASM put forth updated recommendations regarding clinical practice
for CPAP treatment in adults with OSA, and these recommendations are
intended for use in the evaluation and treatment of sleep-disordered
breathing in adults, based on the current evidence available.14
AASM commissioned a task force of board-certified sleep medicine
specialists and other experts to conduct a systematic review to identify
relevant research and studies, assess the quality and strength of evidence,
and develop treatment recommendations. The meta analysis conducted by the
task force included 184 relevant studies, as outlined by the task force’s
study inclusion criteria. Specifically, the AASM guidelines recommend adult
patients use CPAP for ongoing treatment of OSA, rating this recommendation
as a strong recommendation. The establishment of the AASM guideline
recommendations followed a rigorous process that includes not only a
systematic review, but the incorporation of important other factors such as
patient values, stakeholder acceptability, equity, and cost effectiveness.
It is critical that coverage decisions incorporate not only scientific
evidence, but also these critical factors for the application of the
evidence in clinical decision-making. Consideration of these additional
factors are most critical when there are inconsistencies in the available
evidence or the strength of evidence is low, as was the conclusion in the
AHRQ review. For these reasons, these guidelines should remain the basis of
the field’s standard of care for appropriate and effective treatment of OSA.
Conclusion
CHEST appreciates the significant undertaking in capturing the long-term
effects of CPAP devices for the treatment of OSA and recognizes the
multitude of considerations in the development of a comprehensive,
systematic review. It is our view, however, that the current systematic
review does not include all of current evidence and does not highlight the
significance of patient-important outcomes. CHEST recommends that CMS
continue its coverage of CPAP therapy in accordance with the AASM
guidelines, which remain the standard of care across pulmonary and sleep
medicine.
CHEST is committed to continue engaging with key external stakeholders to
answer any questions, elaborate on CHEST policy positions, and serve as a
resource on chest medicine. CHEST is dedicated to continuing to improve the
delivery of evidence-based, patient-centered care as well as the prevention,
diagnosis, and treatment of chest diseases by supporting the publication of
treatment guidelines. We appreciate your consideration, and for additional
follow up correspondence, please contact Suzanne Sletto, at ssletto@chestnet.org.
Sincerely,
Doreen Addrizzo-Harris, MD, FCCP
CHEST President