Continuous Positive Airway Pressure (CPAP) Therapy for Obstructive Sleep Apnea (OSA)

I understand that some cardiologists are supporting the use of portable monitoring in heart failure patients. I would like to resppond to two points that have been used as rationale for portable monitoring in this setting:

Cardiologists' comments:

1. Heart Failure patients have a very high prevalence of sleep disordered breathing (SDB). In fact, 40% to 60% of heart failure patients have SDB as demonstrated in multiple studies from a variety of investigators working in differing practice settings.

2. Home testing works. Testing equipment placed on patients in the clinic, and worn overnight has been shown to be safe, accurate, and economic. Recent data on cardiology patients successfully reports on sleep events, desaturations, and associated arrhythmias.

Comments:

In one large study, SDB was nearly equally distributed between central and obstructive apnea (33% central sleep apnea 37% obstructive sleep apnea)(1) which is a good argument NOT TO USE PORTABLE MONITORING because of the lack of ability or portable monitoring to accurately distinguish between CSA or OSA. This is a critical distinction because CSA substantially predicts mortality and more importantly because CSA may not be best treated with titrated CPAP the randomized controlled trial of CPAP for the treatment of CSA used a fixed, untitrated CPAP dose.(2) The issue of monitoring and treatment of SDB in heart failure should await the Canadian CPAP trial.

The substantial concerns regarding the reliability of home portable monitoring in OSAS published by AHRQ and the tri-society guidelines should promote an even more cautious attitude concerning its yet unproven use in heart failure patients.

1. Sin DD, Fitzgerald F, Parker JD, Newton G, Floras JS, Bradley TD. Risk factors for central and obstructive sleep apnea in 450 men and women with congestive heart failure. Am J Respir Crit Care Med 1999; 160(4):1101-1106.

2. Sin DD. Logan AG. Fitzgerald FS. Liu PP. Bradley TD. Effects of continuous positive airway pressure on cardiovascular outcomes in heart failure patients with and without Cheyne-Stokes respiration. Circulation. 2000;102(1):61-6.

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We are writing to you to express our strong support for a change in National CMS policy to cover unattended sleep studies, CPT code 95806, specifically for cardiology patients. We feel there are compelling medical needs and a substantial evidence base to support this change and would like to outline our position:

1. Heart Failure patients are our most sick and expensive patients. Currently, there are over 5 million patients in the U.S. and this population is expected to increase due to our aging population and increased survival rates post-MI. (1) It is also the most costly disease, consuming an estimated $27.9 billion annually for both acute and chronic care needs.(1)

2. Heart Failure patients have a very high prevalence of sleep disordered breathing (SDB). In fact, 40% to 60% of heart failure patients have SDB as demonstrated in multiple studies from a variety of investigators working in differing practice settings.(2-7)

3. Sleep Disordered Breathing (SDB) is associated with a poor prognosis in heart failure patients, including increased arrhythmias, rates of hospitalization, and total and sudden death mortality. Moreover, SDB impairs quality of life and may explain some of the functional impairment observed in heart failure patients. (8-13)

4. Heart Failure patients cannot be diagnosed for sleep disordered breathing using physical exam, questionnaire, or other risk factors due to overlapping symptomology. (6,14)

5. We estimate that less than 5% of heart failure patients nationwide are presently tested for sleep disordered breathing due to three major hurdles:

• Access – sleep labs are inconvenient, frequently require substantial travel, and have long waiting times (usually measured in months) and require an overnight stay.
• Cost – sleep lab-based polysomnography (PSG) is very expensive, many patients cannot afford them and patient co-pays can be prohibitive.
• Discomfort – many patients refuse to go, due to the complex testing process and thus the percentage of no-shows is high.

6. Home testing works. Testing equipment placed on patients in the clinic, and worn overnight has been shown to be safe, accurate, and economic. Recent data on cardiology patients successfully reports on sleep events, desaturations, and associated arrhythmias. (7,12,15-18)

7. Heart Failure patients tested and treated for sleep-disordered breathing have been shown to have significantly better outcomes as measured by: (12,15-16)

Improved quality of life
Improved blood pressure
Improved ejection fraction
( 9 LVEF units on average)
Decreased mortality (preliminary data)
Decreased arrhythmias
Decreased neuro-hormonal levels
Lower cost of healthcare

8. Home testing would result in significant overall savings and contribute to these improved outcomes. Heart Failure patients with improved outcomes cost substantially less than more severely ill patients. Home testing alone will save $1000 or more per patient, on average, for the first night of testing compared to PSG.

9. Quality healthcare is maintained. ‘Positive’ patients are sent to qualified sleep labs for treatment ensuring sleep physician / pulmonary input into patient treatment.

Our patient loads and requirements continue to increase as the number of chronically ill cardiology patients increases. Sleep apnea is a significant co-morbidity, which has been shown to dramatically affect outcomes in heart failure, hypertension, stroke, and post-MI patients. We need safe and effective tools that improve our ability to respond to this epidemic of untreated sleep apnea in cardiology patients.

Without CMS payments of home sleep testing for at- risk cardiology patients, our healthcare system will continue to dramatically under serve these patients, most of whom are Medicare / Medicaid eligible. We strongly advocate a change in policy to stem the continued loss of resources and patient welfare. Home testing is feasible and validated and may represent our only true opportunity to adequately address the problem of SDB in these patients.

Sincerely,

William T. Abraham, MD, FACP, FACC
Professor of Medicine
Chief, Division of Cardiovascular Medicine
The Ohio State University
Columbus, OH

Phillip Adamson, MD
Director of Congestive Heart Failure
University of Oklahoma
Oklahoma City, OK

Inder S. Anand, MD
VA Medical Center
Minneapolis, MN

Robert C Bourge MD
Professor and Director
Division of Cardiovascular Disease
University of Alabama at Birmingham
Birmingham, AL

Thomas G. Di Salvo, MD, M.Sci.
Medical Director, Vanderbilt Page-Campbell Heart
Institute
Vanderbilt University
Nashville, TN

Gregg C. Fonarow, MD
Professor of Medicine
Director, Ahmanson – UCLA Cardiomyopathy Center
University of California, Los Angeles
Los Angeles, CA

Edward Gilbert
Professor of Medicine
University of Utah
Salt Lake City, UT

Paul Hauptman, MD
Professor of Medicine
Saint Louis University School of Medicine
St. Louis, MO

Sharon Hunt, MD
Professor of Cardiovascular Medicine
Stanford University
Palo Alto, CA

Stuart Katz, MD
Yale School of Medicine
Associate Professor of Medicine
Dept. of Internal Medicine (Cardiology)
Heart Failure Clinic
New Haven, CT

Donald Jansen, MD
St. Joseph Hospital
Atlanta, GA

Ken Margulies, MD
Research Director
University of Pennsylvania
Philadelphia, PA

Barry Massie, MD
Chief of Cardiology
VA Hospital San Francisco
San Francisco, CA

Michael McIvor, MD
Medical Director
St. Petersburg Hospital
St. Petersburg, FL

Lyle Olson, MD
Mayo Clinic
Rochester, MN

Michael Rich, MD
Associate Professor, Cardiology
Director, Cardiac Rapid Evaluation Unit
Director, Geriatric Cardiology Program
Washington University School of Medicine
St. Louis, MO

George William, MD
Massachusetts General Hospital
Boston, MA

Randall Williams, MD
Northwestern Hospital
Evanston, IL

James B. Young, M.D.
Professor and Chairman
George and Linda Kaufman Chair
Division of Medicine
Cleveland Clinic Foundation
Cleveland, OH

Michael Zile, MS
Professor of Medicine
University of South Carolina
Columbia, SC

Reference List

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Our company, Landauer Metropolitan (LMI), is a service provider and manager of several traditional Sleep Centers, annually performing thousands of the most advanced in-lab polysomnography procedures. We also privately offer ambulatory attenuated parameter sleep studies, and in-home full-parameter polysomnography using clinical guidelines and the same acquisition equipment used in the Sleep Heart Health Study, one of the largest ongoing research projects in sleep medicine, which included thousands of in-home studies as part of the project.

LMI Sleep Diagnostics agrees the in-lab study provides a controlled environment for accurate, highly detailed studies to diagnose sleep apnea and rule out other sleep disorders as potential causes of daytime sleepiness. However, CMS should consider approving the in-home polysomnogram with the Sleep Heart Health study and related reports as evidence for clinical validity. These parameters, including the attended patient hook up and remote monitoring of the polysomnogram, should satisfy the definition of CPT 95810 (Regardless of how other non-AMA organizations have chosen to extend the definition of this code). Furthermore, the technology for the in-home polysomnogram uses the same patient data acquisition parameters as the in-lab polysomnogram, and is even reviewed (scored) using the identical software package (for example, Compumedics systems and Profusion software).

We believe attenuated parameter cardiorespiratory studies as defined by CPT 95806 should be approved for patients meeting certain defined criteria, but not be considered a first line assessment tool. Arguably, patient refusal of any type of diagnostic study and all therapies as a result provides a far worse clinical outcome than all recently proposed Sleep Apnea diagnostic and treatment modalities.

Please consider the entire continuum of care unique to Sleep Apnea treatment – and all related costs - beginning with the diagnostic study and ending with the successful use of CPAP (and many machines such as APAP have now integrated a diagnostic component with therapy).

LMI Sleep Diagnostics believes approval for in-home polysomnography should be based on accurate patient data retrieval relative to inter-laboratory accuracy of traditional polysomnography data. The report from CMS (CAG-00093R) indicates that diagnostic standards for in-lab polysomnography fall short, i.e., comparisons are being made to a standard which does not effectively exist (yet covered by CMS), and coverage for similar procedures are being denied regardless of more validation data available now than had existed when in-lab
polysomnography was first approved years ago.

If CMS chooses to approve in-home polysomnography, cost savings can still be realized as many patients could circumvent the titration study and be placed on Auto titrating CPAP following the polysomnogram (with concomitant CMS approval of APAP). Additional savings can be realized by improving access to care for elderly persons who would refuse or otherwise be unable to travel to a Sleep Center, thus receiving needed treatment before exasperation of related disease states, especially cardiovascular disease.Thank you for your attention.
Louis Rocco, CEO
Tom Saulys, Director
Landauer Metropolitan
Sleep Diagnostics Division

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Thank you for your diligence and commitment in reviewing portable diagnostic devices for the diagnosis of Obstructive Sleep Apnea (OSA). I do not agree with the conclusions in the draft document. Many of the largest managed care organizations in the US also disagree with this policy. In formulating their policies, their respective medical technology assessment committees reviewed and approved portable devices for use in diagnosing OSA on the basis of a reduction in cost in the face of growing need for recognition and treatment of this common condition. If this draft decision is implemented, it will immediately increase Medicare’s costs for sleep studies by over $123 million dollars per year (based on 2003 numbers). In addition, I believe that the current CMS policies for portable monitoring are in conflict with the stated goals for Medicare in the following ways:

1. On January 13, 2005, HHS Secretary Tommy Thompson released a report promoting solutions encouraging innovation in healthcare and to speed the development and access to new medical technologies. Secretary Thompson clearly articulated that by HHS expediting access to medical innovation, more lives would be saved and more cost efficiencies would be realized. This draft decision runs counter to Secretary Thompson’s report and vision of eliminating barriers for Medicare patients to have access innovative technologies.

2. In lab sleep studies (CPT code 95810 and 95811) are generally reimbursed by CMS at around $900 per test, while in home studies are reimbursed at $200 per test. If the current draft for portable studies is implemented, the $35MM that CMS spent in 2003 for in home studies will balloon to $157MM. During this difficult time of massive fiscal deficits, it is more economically prudent to delay such a significant and unnecessary spike in costs until more options are identified and implemented that will offset such a dramatic financial burden. This massive, immediate, and direct $123MM annual cost increase to CMS will undoubtedly lead to further service cuts in other areas of the CMS annual budget.

3. This draft decision, if implemented, will not reduce healthcare cost for existing Medicare benficiaries. The draft policy does not acknowledge the significant costs of undiagnosed and untreated OSA patients. A number of evidence- based medicine published over the last five years have concluded that significant healthcare utilization reductions accrue for undiagnosed OSA patients who are then recognized, tested and treated. The AASM has published a summary for the cost justification for OSA diagnostics and therapy.1 By expanding access to diagnostics and therapy for OSA patients, CMS OSA patients will realize:

a. ~50% reduction in healthcare utilization expenditures in the 12 months following treatment (as compared to the prior 12 months) namely in lesss office visits for management of fatigue and hypertension.

b. 15% reduction in pharmaceutical utilization in the 24 months following treatment, predominantly in a reduction in blood pressure lowering drugs (as demonstrated by Dr. Terry Young’s Wisconsin Cohort Study).

c. A 16-day reduction in rehabilitation for stroke patients with OSA who are being treated.

d. $100,000 to $200,000 reduction per patient in hospitalization charges.

Consequently, I would like to offer alternative solutions and amendments to the current draft NCD:

1. Permit the potable device community to perform clinical trials based upon existing CMS guidelines. On September 15, 2004, CMS allowed PET scanner manufacturers to conduct a clinical trial with Medicare beneficiaries. Based upon this precedent, I propose that CMS allow portable sleep study device manufacturers to conduct and industry-wide clinical trial comparing multi- night PSG vs. multi-night in home sleep studies for OSA diagnosis. CMS should delay any NCD until the completion of this clinical trial. This would delay the massive $123MM annual cost increase from portable study reimbursement to in lab reimbursement until further data specific to CMS patients are published. This type of solution has been championed by Dr. Sean Tunis and Dr. Marc McClellan and is consistent with CMS’ stated public policy goal of providing quality and affordable healthcare to American senior citizens.

2. Allow those who would utilize portable sleep study devices to share the risk. Since the major concern expressed by CMS was the accuracy of unattended portable devices in the home vs. the relative and variable accuracy of the in lab PSG, CMS should require that any in home, unattended sleep study for sleep apnea that results in the need for a follow up in lab PSG for sleep apnea shall not be reimbursed by CMS. This should mitigate concerns by CMS that the portable sleep studies have a lower accuracy level than that of the PSG for the management of obstructive sleep apnea. Dr. Tunis expressed his vision that CMS will be amenable to this type of arrangement for technologies that are important to the Medicare population.

3. Recognize the current utilization of portable monitoring for which there is no or little dispute. Multiple organizations have approved in home studies in certain circumstances. CMS should allow reimbursement for in home sleep studies in these specific circumstances:

a. When a patient has already been diagnosed by in lab PSG for sleep apnea and needs to be retested for reassessment of therapeutic efficacy or need in regard to clinical management for sleep apnea.

b. If a patient is unable or unwilling to be studied in a sleep laboratory, as for instance spinal cord injury.

c. If the physician feels that the need for therapy is urgent and access to PSG cannot be accomplished in a timely and expeditious manner.

4. CMS should allow for reimbursement of in home sleep studies when the device used has an FDA approved patient monitoring function. CMS should discriminate between devices that enable “sleep technician-like” monitoring capabilities vs. completely unattended and unobserved in home studies. Currently, CMS defines attended only when a person is physically present during a test. CMS should allow reimbursement for devices that enable real-time monitoring (much like a virtual sleep technologist function).

5. Identify the clinical information needed that justify the use of portable monitoring and its interpretation. CMS should allow reimbursement for in home, virtually attended sleep studies if the device manufacturers:

a. Provide post-coverage data collection and outcomes (FOSQ, ESS, etc…)

b. Post coverage credentialing, where appropriate

c. Post coverage facility inspections This type of coverage has precedent within CMS and is consistent with other recent CMS decisions.

It is ironic that CMS policy allows for reimbursement of a minimum of 2 hours of one night of in-lab PSG recording in order to prescribe CPAP, but will not consider reimbursement of multiple night in home sleep studies. Night-to-night variability of measuring AHI in OSA patients is especially important for those with lower levels of apnea (~10.hour), positional apnea, or REM dependent events. Given this current 2 hour policy, and, since CMS publicly recognizes the significant, innate flaws of in lab PSG, it would be in the best medical and financial interests of CMS and Medicare patients to create a rational policy permitting access to in home, unattended sleep studies.

Thank you for your time and consideration.

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It seems to me that CMS has been so busy following its rigid analysis process that they are failing to recognize the simple medical appropriateness of home sleep studies – missing an entire promising avenue for improving healthcare and avoiding the cost of in-lab studies for every patient, every time.

Even if one was to accept AASM claims that there are enough sleep laboratories, they also admit that the location and actual availability of lab resources varies widely. The vast majority of sleep labs are not accredited. Meanwhile, if there isn't enough of a shortage of sleep physicians, there is certainly a shortage of polysomnographic technologists who actually perform the laboratory studies. Of this limited population of technologists, education or training has not been standardized and the inconsistency in the scoring of test results is well documented. And recent legislative actions that limit PSG testing to respiratory therapists alone (New York & North Carolina) will exclude many from the available polysomnographic technologist pool.

If the availability of laboratory facilities, qualified technicians, training standards and consistent scoring of Polysomnograms is not enough of a problem, the assumption that PSG is a "gold standard" for sleep studies – or to be used in comparison to other testing approaches – is most certainly a problem. It was useful that the MCAC discussion recognized what many have known for some time, that the PSG is no gold standard.

However, even with such knowledge of the problems with Polysomnography, CMS continued to employ an analytical approach that compared home sleep studies to this false standard. The process started with the technology assessment by RTI International where they admitted, "Specifically excluded were studies in which results from portable devices were not compared with results from PSG" (RTI p.6). From RTI's self-limiting "inclusion criteria", the comparison to PSG continued through the MCAC considerations and CMS staff analysis.

One might have expected that RTI would have taken note that the vast weight of peer-reviewed papers clearly identifies the engineering success and clinical value of home diagnostic studies. Instead, RTI and CMS analysts came to the conclusion that none of the universities, medical centers and researchers seem to know how to design a quality study. If such a suggestion is true, I fear for the quality of all medical device research.

In spite of CMS's stated claim to support the introduction of new technology, the proposed CPAP decision rejects the successful medical practice of thousands of physicians and major organizations across the country that have employed formal technology-review procedures to adopt home sleep studies. It appears that national private payors, HMO's and PPO's, Veterans Administration medical centers, Military Hospitals, and Professional Associations representing the thoughtful expertise of thousands of medical specialists are all wrong and CMS is right.

If the only thing CMS proposed to do was to remain with it's current policy of not accepting home sleep studies for Medicare reimbursement of CPAP devices, that would be a disappointing enough failure to recognize at-home innovations that have accurately, and cost-effectively, diagnosed patients across America. But, simply limiting the diagnostic options for CPAP therapy is not what the proposed CMS decision says. What the decision states is a wholesale rejection of home sleep studies. Such a broad assertion by CMS is breathtaking.

I would go so far as to compare the stance of CMS regarding PSG's with the FDA's strident defense of its policies and methodology regarding Vioxx. Up to the very day Vioxx was pulled off the market by Merck, the FDA kept right on insisting that it was behaving correctly – while continuing to miss the fundamental point that their focus and decision process was flawed. Now CMS demonstrates that, it too, can follow a perfectly laid-out path that leads to patients not receiving the quality healthcare they require.

Continuing with such an expensive high bar for delayed diagnosis and CPAP reimbursement represents an astounding failure of CMS to meet its public policy responsibility to advance the cause of healthcare improvement.

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Summary

Diagnosis of obstructive sleep apnea syndrome (OSAS) by ambulatory systems is a growing practice in view of the large number of patients awaiting correct diagnosis. New technology is important in advancing and changing the practice of medicine and home diagnostics offers a solution that can help to reduce delays beneficiaries experience and reduce costs associated with facility based PSG. Home diagnostics may offer an accurate, robust and reliable ambulatory method for the detection of OSAS with minimal patient discomfort, no risks or harms to patients and the approach can be used in a stepwise manner in the diagnostic process. Much like cancer screening guidelines that escalate the diagnostic tests from less to greater, home diagnostics provides an accurate means for screening and diagnosis to expedite patients with moderate to severe signs and symptoms of OSAS to the management and treatment phase. Home sleep studies are a viable form of diagnosing OSAS and are less expensive than polysomnography.

Patients with a suspected sleep apnea/hypopnea syndrome should initially be studied in a home setting with a portable monitor of respiratory parameters since it is a reliable method with an acceptable cost-effective profile. The patients that are difficult to diagnose are those that should be evaluated in a tertiary facility using fully attended polysomnography. Use of home sleep studies has benefits in time and cost. Home sleep studies adds to the armamentarium of diagnostics for OSAS, saves the Medicare program money and decreases the delays in access to diagnostics that beneficiaries experience. Waiting times for hospital-based monitoring are rising and results in patients not receiving treatment timely that could lead to an increase in the incidence of co-morbid disease. Additionally, improved sleep at home raises the question whether laboratory-based polysomnography is always required or whether less obtrusive monitoring of sleep duration at home would sometimes suffice. These comments provide an approach that must be considered in order to reduce the increase in expenditures afforded for diagnostics and provide a cost neutral environment in which dollars are shifted to the most important aspects of treatment management to assure adherence with prescribed therapy once the diagnosis is established.

CMS Draft Recommendation:

The evidence is not adequate to conclude that the use of unattended portable multi-channel sleep testing with a minimum of 7 monitored channels including EEG, EOG, EMG, ECG or heart rate, airflow, respiratory effort, and oxygen saturation (Type II Devices based on the 1994 ASDA classification) is reasonable and necessary in the diagnosis of OSA and these tests will remain non-covered for this purpose

Practice policies must address the need for choice of a particular health practice for a disease, for example, preventive activity, diagnostic test and treatment. (1) Physicians must be afforded the choice to utilize home diagnostics as a screening method for their patients who are suspected of having moderate to severe OSAS. In the case of diagnostic tests and in particular polysomnography there exists no evidence that shows that health outcomes in Medicare beneficiaries diagnosed with OSA are improved.

The health outcomes of paramount importance in a patient diagnosed with OSA centers around adherence to prescribed therapy and ultimately elimination of symptoms with improved Epworth Sleepiness Scale scores post-treatment with Continuous Positive Airway Pressure (CPAP). There exists no evidence from the medical literature that suggests that diagnostics performed with polysomnography improves patient adherence to prescribed treatment with CPAP and no evidence that shows that patients experience elimination of symptoms as a result of diagnostics with polysomnography. In fact health outcomes from diagnostics are not adequately ascertained in the absence of a specific intervention. As with all diseases practice policies must employ a stepwise approach to diagnostics. The approach must encompass standards that allow the most cost effective screening to be performed first, followed by subsequent and inherently more expensive approaches as a last resort once it has been determined that the test is inconclusive or the intervention following the test is unsuccessful in improving health outcomes.

Many experts believe that a polysomnography to screen for obstructive sleep apnea should be performed on every patient who has a history of loud snoring and sleepiness. However this is not the case with other diseases. A careful history and physical examination along with home diagnostics allows you to confirm the diagnosis of OSAS thus there is no need to study all such patients, at least not until fully attended polysomnography becomes as convenient and economical as home diagnostics. (2) For policies that address health practice, the target can be divided into specific sections: 1) Patient management problems, 2) Diagnostic problems, 3) Screening problems in which the patient might have a disease but has no signs or symptoms – in this case home diagnostics is appropriate. (3)

The common practice of reading diagnostic tests with clinical information seems justified and future studies should be designed to investigate the best way of providing clinical information in an expedient and cost efficient manner. These studies should also give an estimate of the accuracy of clinical information used; display ROC curves with identified data points, and include a wider range of diagnostic tests. (4) Rapidly accumulating evidence shows that sleep apnea is a major factor influencing personal health and public safety. Diagnosis and treatment of this syndrome may well result in significant preventive medicine outcomes. The prevalence of sleep apnea is so high that evaluation and treatment must become the province of the primary care physician and home diagnostics with appropriate practice guideline to aid in the rapid screening of patients in the primary care setting. (5) Accurate and appropriate history, physical assessment and clinical management are the mainstays of care, with the judicial application of technology.

A history of snoring, particularly when it is intermittent, interrupted by snorts, and accompanied by restless sleep or daytime sleepiness suggests the need for further evaluation. When co-morbid conditions such as hypertension, cardiovascular disease or type 2 diabetes are present, formal evaluation and consideration of treatment are needed. If initial evaluation reveals severe obstructive sleep apnea with observed apneas, together with excessive daytime sleepiness, clinical management with empirical application of continuous positive airway pressure (CPAP) may suffice in experienced hands. (6) Primary care physicians play a key role in the identification, management and follow- up of patients with sleep apnea. (7) Obstructive sleep apnea syndrome is a major public health hazard affecting 2-4% of the adult population in the U.S. and in the last decade the number of referrals for polysomnography increased threefold compared to 12-fold worldwide and is expected to increase even more in the coming years. This constant demand for PSG studies is beyond the current capacity of sleep laboratories thus preventing diagnosis for most patients with suspected OSAS. (8) Patients with OSAS have higher incidences of hypertension, coronary artery disease, congestive heart failure, and arrhythmia’s. (9) Limited availability of PSG poses ultimate access to care issues for patients with a high suspicion for OSAS who could be effectively diagnosed and treated more expediently with the use of unattended home diagnostics.

A full night polysomnography, conducted by a technologist in a sleep laboratory, is the gold standard for the diagnosis of suspected OSAS, but the capacity for performing polysomnography is limited. On the basis of the high incidence and prevalence of OSAS, of the limited number of sleep laboratories, long waiting times; recommendations have been formulated for the use of unattended portable systems in the assessment of OSAS. (10) Substantial evidence shows that patients with OSA have an increased incidence of hypertension compared with individuals without OSA and that OSA is a risk factor for the development of hypertension. Recent studies show that OSA may be implicated in stroke and transient ischemic attacks. Obstructive sleep apnea appears to be associated with coronary heart disease, heart failure, and cardiac arrhythmias. Pulmonary hypertension may be associated with OSA, especially with preexisting pulmonary disease. Although the exact cause that links OSA with cardiovascular disease is unknown, there is evidence that OSA is associated with a group of proinflammatory and prothrombotic factors that have been identified to be important in the development of atherosclerosis. (11)

Median sleep duration is greater in the home than in the sleep lab as is sleep efficiency thus home testing is exceptionally reasonable for the immediate diagnosis of OSAS and can lead to quicker treatment. (12) Quicker treatment can reduce the continued negative effects of untreated patients with co-morbid disease due to limited access to sleep laboratories. Undiagnosed OSAS leads to a roughly two-fold increase in medical expenses in the years preceding the diagnosis and that treating the disease (once it is diagnosed) results in a decrease in these excess costs. It seems clear that OSAS increase the actual number of road traffic accidents, which will carry a definite, but unmeasured up to now economic cost consequence. (13) The initial evaluation and management of OSA should be with Home Studies. As with traditional sleep studies, the number of split-night study patients treated per night is still limited to a lab's bed space. Advances in portable recording technology have given sleep specialists yet another option by studying patients in their own homes. Not only does this eliminate limited bed space and backlogs it allows patients to sleep in their own beds, reducing the sleeplessness caused by unfamiliar surroundings.

Although portable devices record fewer channels than a laboratory PSG, research shows them to be effective screening tools to effectively diagnose patients with high symptom severity indexes in addition to High ESS scores. This serves to eliminate issues with beneficiary access to care that they experience due to long wait times for PSG. In this case PSG access can be effectively improved through the use of home diagnostics. Patients diagnosed in a sleep lab also experience a First Night Effect (FNE) with PSG-abnormalities and night-to-night-variability in sleep parameters, but not in respiratory parameters. An adaptation night is, therefore, necessary when sleep architecture is to be studied, but not when only the nocturnal respiratory pattern is investigated. Sleep parameters, HR and arousal indices are all age-dependent and in Medicare beneficiaries night-to-night variability is greater thus home diagnostics can aid in efficiently diagnosing OSAS and identify the most beneficial treatment parameters that serve to enhance adherence to treatment following diagnosis.

CMS Draft Recommendation:

The evidence is not adequate to conclude that the use of unattended portable multi-channel sleep testing with a minimum of 4 monitored channels including ventilation or airflow, heart rate or ECG, and oxygen saturation (Type III Devices based on the 1994 ASDA classification system) is reasonable and necessary in the diagnosis of OSA and these tests will remain non-covered for this purpose

The studies evaluated do not show results that suggest harm; the clinical trials are definitive well-conducted and free of major bias; the results have clear implications for clinical practice and the strength and direction of underlying secular trends prior to publication of new evidence are addressed. Currently 95% of patients with sleep disorders remain undiagnosed. (14) Over 40 million Americans are chronically ill with various sleep disorders and an additional 20 to 30 million experience intermittent sleep-related problems. The consequences of sleep disorders are diverse, serious, and often catastrophic and delay in diagnosis leads to greater socioeconomic issues particularly in Medicare beneficiaries. Falling asleep at the wheel is the most costly and devastating problem on American highways. Every component of society is seriously impaired by sleep deprivation. Access to PSG is a staggering problem and home based diagnostics can mitigate the issues with access to PSG in patients who are clearly suspected of OSAS.

The National Commission on Sleep Disorders Research stated that it is imperative that policy makers clearly understand both the magnitudes of the problems and the strategy behind the recommendations that will provide solutions. Most Americans are not fully aware of the magnitude and seriousness of the major sleep disorders such as sleep apnea. The relationship of sleep- deprivation to accidents has been recognized and based on the Commission’s findings, it is imperative that a strong national commitment be directed to sleep and sleep disorders and clearly that a commitment be made to address the need to diagnose beneficiaries with OSAS quicker. The site of recording (home versus hospital) has no influence on polysomnographic indexes. (15) Sleep apnea is common among older people and its effects can be more severe than in younger people. The added impact is because of a physiological decline in sleep quality with age in most people and the increasing frequency of other co-morbidities with increasing years that affect both sleep and daytime function. It is important to expedite diagnosis, bearing in mind these other influences on sleep quality. (16) The diagnosis is generally straightforward once appropriate tests are performed and home diagnostics provide a valuable tool to eliminate issues with poor access to quick diagnostics with facility based PSG.

In a recent study conducted by Whitelaw et al (2005) it was concluded that for practical purposes polysomnography could be replaced by home monitoring using oximetry for assessment of many patients suspected of having sleep apnea. Although this will not suffice for all patients, it deserves serious consideration as the first step in a scheme where patients with positive tests go directly to trials of treatment and are not further tested if they improve satisfactorily. (17) Polysomnography should be reserved for those in whom the clinical suspicion of symptomatic sleep apnea is strong but portable monitoring is negative. Additionally, for those who improve only partially or not at all on treatment, for those in whom compliance is a problem, and for those for whom it is a very urgent matter to make a diagnosis and begin optimal treatment. Home diagnostics plays an important role in urgent screening for highly suspected moderate-to-severe OSA and must be available in the armamentarium of diagnostics tests. Home-based monitoring provides reasonable negative predictive values in the diagnosis of OSA syndrome in symptomatic patients. It therefore qualifies as a screening method. Combined with clinical features and questionnaires it provides high positive predictive values and may therefore prove useful in simplifying diagnostic procedures and reducing costs associated with diagnosing beneficiaries using facility based PSG.

(1) Eddy, DM – Assessing Health Practices & Designing Practice Policies – The Explicit Approach 1992 Page 8, Paragraph 1

(2) Ear Nose Throat J. 1999 Sep; 78(9): 710, 714- 5. Who needs a sleep test? The value of the history in the diagnosis of obstructive sleep apnea Goode RL Division of Otolaryngology-Head and Neck Surgery, Stanford, Calif., University Medical Center 94305-5328, USA. goode@leland.stanford.gov

(3) Eddy, DM – Assessing Health Practices & Designing Practice Policies – The Explicit Approach 1992 Page 8, Paragraph 2

(4) JAMA 2004 Oct 6; 292 13): 1602-9. Accuracy of diagnostic tests read with and without clinical information: a systematic review. Loy CT, Irwig L. Screening and Test Evaluation Program, School of Public Health, University of Sydney, Sydney, Australia.

(5) WMJ 2003; 102(1): 25-7, 46. Diagnosis of sleep apnea Stevenson JE

(6) WMJ 2003; 102(1): 25-7, 46. Diagnosis of sleep apnea Stevenson JE

(7) Am Fam Physician. 1996 Jan; 53 (1): 247-53. Comment in: Am Fam Physician. 1996 Jan; 53 (1): 50, 53. Sleep apnea: is your patient at risk? National Heart, Lung, and Blood Institute Working Group on Sleep Apnea

(8) Isr Med Assoc J. 2004 Nov; 6 (11): 686-90. Comment in: Isr Med Assoc J. 2004 Nov; 6 (11): 699-700. Obstructive sleep apnea syndrome: the diagnostic strategy dilemma. Tarasiuk A, Reuveni H. Sleep-Wake Disorders Center, Soroka Medical Center, Israel tarasiuk@bgu.ac.il

(9) J Long Term Eff Med Implants. 2004; 14 (3): 167-76. Obstructive sleep apnea: Part I. Pathophysiology, diagnosis, and medical management. Carswell JJ, Koenig SM. Division of Pulmonary Medicine, University of Virginia Health

System, Charlottesville, Virginia, USA.

(11) Mayo Clin Proc. 2004 Aug; 79 (8): 1036-46. Obstructive sleep apnea and cardiovascular disease Parish JM, Somers VK Sleep Disorders Center and Division of Pulmonary Medicine and Internal Medicine, Mayo Clinic College of Medicine, Scottsdale, Ariz 85259, USA.

(12) Sleep. 2004 May 1; 27(3): 536-40. Polysomnography performed in the unattended home versus the attended laboratory setting--Sleep Heart Health Study methodology. Iber C, Redline S, Kaplan Gilpin AM, Quan SF, Zhang L, Gottlieb DJ, Rapoport D, Resnick HE, Sanders M, Smith P. Department of Medicine, University of Minnesota, Minneapolis, MN, USA. iberx001@tc.umn

(13) Health care costs and the sleep apnea syndrome. Wittmann Valerie; Rodenstein Daniel O Department of Internal Medicine, Cliniques universitaires Saint-Luc, Universite catholique de Louvain, Brussels, Belgium. Sleep medicine reviews (England) Aug 2004, 8 (4) p269-79 Comment in Sleep Med Rev. 2004 Aug;8(4) 253-5

(14) OVERVIEW OF THE FINDINGS OF THE NATIONAL COMMISSION ON SLEEP DISORDERS RESEARCH (1992) Updated July 22, 1998

(15) Chest 2002 Mar; 121(3): 753-8. Home unattended v hospital telemonitored polysomnography in suspected obstructive sleep apnea syndrome: a randomized crossover trial. Gagnadoux F, Pelletier-Fleury N, Philippe C, Rakotonanahary D, Fleury B. Service de Pneumologie, Hopital de Versailles, le Chesnay, France. gagnadoux@sat.ap-hop-paris.fr

(16) Drugs Aging. 2004; 21(5): 307-22. Obstructive sleep apnoea in the elderly: recognition and management considerations. Quinnell TG, Smith IE Respiratory Support and Sleep Centre, Papworth Hospital, Papworth Everard, Cambridge CB3 8RE, UK.

(17) Am J Respir Crit Care Med Vol 171. pp 188– 193, 2005 Clinical Usefulness of Home Oximetry Compared with Polysomnography for Assessment of Sleep Apnea William A. Whitelaw, Rollin F. Brant, and W. Ward Flemons Departments of Medicine and Community Health Sciences, University of Calgary, Calgary, Alberta, Canada

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Along with leading cardiologist around the nation, I am writing to you to express our strong support for a change in National CMS policy to cover unattended sleep studies, CPT code 95806, specifically for cardiology patients. We feel there are compelling medical needs and a substantial evidence base to support this change and would like to outline our position:

1. Heart Failure patients are our most sick and expensive patients. Currently, there are over 5 million patients in the U.S. and this population is expected to increase due to our aging population and increased survival rates post-MI. (1) It is also the most costly disease, consuming an estimated $27.9 billion annually for both acute and chronic care needs.(1)

2. Heart Failure patients have a very high prevalence of sleep disordered breathing (SDB). In fact, 40% to 60% of heart failure patients have SDB as demonstrated in multiple studies from a variety of investigators working in differing practice settings.(2-7)

3. Sleep Disordered Breathing (SDB) is associated with a poor prognosis in heart failure patients, including increased arrhythmias, rates of hospitalization, and total and sudden death mortality. Moreover, SDB impairs quality of life and may explain some of the functional impairment observed in heart failure patients. (8-13)

4. Heart Failure patients cannot be diagnosed for sleep disordered breathing using physical exam, questionnaire, or other risk factors due to overlapping symptomology. (6,14)

5. We estimate that less than 5% of heart failure patients nationwide are presently tested for sleep disordered breathing due to three major hurdles:

• Access – sleep labs are inconvenient, frequently require substantial travel, and have long waiting times (usually measured in months) and require an overnight stay.
• Cost – sleep lab-based polysomnography (PSG) is very expensive, many patients cannot afford them and patient co-pays can be prohibitive.
• Discomfort – many patients refuse to go, due to the complex testing process and thus the percentage of no-shows is high.

6. Home testing works. Testing equipment placed on patients in the clinic, and worn overnight has been shown to be safe, accurate, and economic. Recent data on cardiology patients successfully reports on sleep events, desaturations, and associated arrhythmias. (7,12,15-18)

7. Heart Failure patients tested and treated for sleep-disordered breathing have been shown to have significantly better outcomes as measured by: (12,15-16)

8. Home testing would result in significant overall savings and contribute to these improved outcomes. Heart Failure patients with improved outcomes cost substantially less than more severely ill patients. Home testing alone will save $1000 or more per patient, on average, for the first night of testing compared to PSG.

9. Quality healthcare is maintained. ‘Positive’ patients are sent to qualified sleep labs for treatment ensuring sleep physician / pulmonary input into patient treatment.

Our patient loads and requirements continue to increase as the number of chronically ill cardiology patients increases. Sleep apnea is a significant co-morbidity, which has been shown to dramatically affect outcomes in heart failure, hypertension, stroke, and post-MI patients. We need safe and effective tools that improve our ability to respond to this epidemic of untreated sleep apnea in cardiology patients.

Without CMS payments of home sleep testing for at-risk cardiology patients, our healthcare system will continue to dramatically under serve these patients, most of whom are Medicare / Medicaid eligible. We strongly advocate a change in policy to stem the continued loss of resources and patient welfare. Home testing is feasible and validated and may represent our only true opportunity to adequately address the problem of SDB in these patients.

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What is considered to be an unattended sleep study? In our area there is a company doing in home sleep studies and it is my understanding they are billing for attended studies (95810 and 95811). I have spoken with patients that have had studies there and they said that all the company did was leave a cell phone to call with any problems. I have recently found out that this company dials into the sleep diagnostic equipment via modem over the internet a few times during the study. My question is: What is Medicare's definition of an unattended sleep study? I have always understood it to be in the presence of a technician throughout the entire study. This company is billing you and you have been paying them for these in home studies. If what they are doing is wrong I will be glad to give you their name.

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as a conscientious pulmonologist with 13 years experience performing in-home over night sleep studies..(>2200) along with clinical correlation and response to therapy, there is simply NO DOUBT that this method of dealing with OSA is more then adequate and certainly cost effective..the journal CHEST has printed more then one article documenting this, and unless one has a financial interest in a full sleep lab, there is no reason not to cover in-home studies..hope you will put the patient pocket book ahead of other concerns, i assure you patient care will not suffer at all..the few times when attended studies come up with other Diagnoses, does not justify forcing all patients being screened for OSA to suffer the delay and nuisance of going to a sleep lab.. also, we send a trained Resp Therapist to the home to set up the equipment and monitor the first hour..rarely do we need to repeat a study..

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Portable unattended sleep studies have a place in the arena of sleep medicine for those that cannot take part in an attended study and for those who need screening for detection of possible OSA.

For the purpose of definitive diagnosis of sleep apnea, however, they remain inadequate due in part to limitations of current technology and to the potential for abuse by those who would use the result of the studies for profit.

Polysomnograms performed by experienced technologists incorporate a checks and balance system to insure that false positives are minimized and that positive findings are acted on with immediate dispatch when necessary.

Sleep Apnea is a growing concern for all as a cause of hypertension, heart failure and hypersomnia among many other sequellae. It is for this reason that definitive diagnosis is necessary in every case. The posibility of treating hypersomnia inappropriately, for instance, must, in every case, be eliminated.

Portable sleep systems (at this stage) are not evolved enough and do not produce rigorous enough data to clearly identify all possible disorders of sleep and breathing and, therefore, should serve as an adjunctive diagnostic tool only.

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We believe all sleep evaluation testing regardless of preceived diagnosis should be done in an accredited sleep disorders center. There are too many variables and considerations for diagnotic testing and further evaluation and follow-up to make this beneficial to patients. We believe in a holistic approach to make treatment successful. national averages for cpap compliance are around 45-50% our sleep center boasts a greater than 75% compliance rate with CPAP. The point is without an in-based sleep center doing the testing. The patient loses all potential mechanisms to get proper treatment. We are a total support and follow-up system. This greatly benefits our patients. This could not be achieved in a home based arena.

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I believe that CPAP for OSA is the most effectivew treatment for OSA. I also believe that it is imperative to use at least 4 channel study to determine the severity of their condition whatever it is. By using respiratory effort, heart rate, EKG tracing and oximetry, you can determine to what degree of trouble the patient may be getting into and where to put him or her to wait in line for a complete poly at the nearest sleep lab. Also this would be very helpful to do as a follow up when it has been determined the patient does have OSA to see if the patient needs any adjustments and that the therapy is truly effective and we are not paying for equipment needlessly. Thank you for reading this. Donna Southworth

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I am sending this email in response to CMS' request for comments regarding a draft policy on home sleep testing.

In my sleep disorders center we attempted, as a part of a study we conducted, to determine the sensitivity and specificity of unattended sleep studies in the home.

We found that, when testing the same patient 1-2 days apart, one test at home and one test in the sleep disorders center, the specificity and selectivity of the home test was not sufficient to use the home study for diagnostic purposes. We found that the home studies were certainly not reliable enough to use for recommending treatment of sleep disorders.

Our center opposes home sleep studies for this reason and many other reasons ranging from insufficient home electrical systems to unsafe working conditions for our staff!

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I agree with the general consensus that portable sleep studies are not adequate for the proper evaluation and diagnosis of SDB in the general population. IF these studies were allowed re- imbursement, then there would a large push by less scrupulous individuals to OVERDIAGNOSE this condition and push patients for surgery, without giving the patient an adequate chance for proper evaluation and provision of the various treatment options. Billing would in fact increase due to the overwhelming increase in these studies, and overall healthcare costs would skyrocket despite the resulting inadequate evaluation and treatment of patients. Sleep medicine is a highly complicated science and to simply leave the interpretation of studies to monitoring systems with faulty algorithms would be a big mistake. We have to be very careful in making any significant changes that would take the science out of the hands of the clinicians, who are ultimately dedicated to our patients' well-being.

the author of this proposal suggests that SDB is underdiagnosed and that by allowing reimbursement for home studies, we will be better able to treat the patient population. Though he is right that SDB is underdiagnosed, increasing the amount of home studies is not the answer. That would just increase the number of patients who are misdiagnosed and inappropriately treated by the misguided and underinformed individuals in the sleep community. Does it really make sense to increase the number of studies of inferior quality, to be interpreted by individuals with little or no formal training in the field of sleep medicine?

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Please let it be known that I believe accredited Sleep Centers across America do the best job using professional polysomnographists and that a mere device used in the home by the patient himself can not and should not replace these qualified technologists.

Although some people feel they do not get a representative night's sleep in a strange place, Sleep Centers get qualitative and quantitative information to supply knowledgeable doctors and any insurance company the proof of any sleep disturbance that they require.

Sleep techs maintain the quality of the "PSG" test (make sure that it is true and readable, and that it is indeed the correct patient). At home, if any electrodes or sensors 'fall off,' the test will be invalid and must be repeated either at home or in the 'lab' anyway. Also 'home' tests require the patients to go to the Sleep Center at least twice for just one test; and this is an inconvenience for many people (rural, older, or with limited [dependent] transportation).

Indeed, there are times when a 'home PSG' is just the ticket (i.e. for a re-titration after regular testing); when an auto titration won't do. But for a diagnostic PSG, the 'Gold Standard' of Sleep Center "PSG" testing should be maintained.

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My career in healthcare has spanned almost 30 years and during that time I have had quite a diverse array of positions. These include RT Department Manager, Sleep Laboratory Manager, and Clinical Manager at a Home Medical Equipment Company. While in this latter position I developed a successful program for performing comprehensive home-based sleep testing. In this program, medical direction was provided by a board-certified pulmonologist and patient setup was performed in the patients home by a registered technologist. If these requirements are followed, we found this type of testing just as accurate as a full laboratory polysomnography when performed on patients with OSA symptoms. While admittedly the home-based test has it's limitations, if it is used only on patients with clear OSA symptoms, (which comprise around 80% of those tested) it would reduce costs significantly. Other factors that also support home testing are: Elimination of "First Night Effect", (altered sleep architecture when a patient is required to sleep in a strange place), home sleep environment evaluation, conditions contributing to the sleep problem ie. multiple pillows, pre-bedtime routine, noises, etc. Often, if these conditions are corrected, restorative sleep can be restored without the cost of hospital testing or CPAP device. Another point in favor of alternate site testing is that many nationally accredited sleep centers have begun to investigate how home and laboratory testing methods could compliment one another.

Essentially, I believe there is room for both types of testing in the field of sleep diagnostics. Not only will the selective use of these two techniques reduce overall costs significantly, alternate site testing offers benefits that laboratory testing cannot. Therefore I strongly urge that Medicare coverage be extended to include home testing, but require that it be performed by credentialed personnel such as a Registered Respiratory Therapist, or Registered Polysomnographic Technologist, and the results interpreted by a qualified physician.
Thank you for your kind consideration.

Sincerely,
Harold E. Just

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Certainly the gold standard in Sleep Medicine is the in-lab, attended PSG. However, there are manysituations where home or portable studies (ie skilled nursing facilities) would be appropriate. The patients would benefit from testing and subsequent treatment (positive pressure) but they may very well not receive testing or treatment if Medicare does not reimburse for studies performed outside of the traditional setting.

There should be guidelines that clearly state who may receive in-home or facility testing. For example, the severely disabled, non-ambulatory individuals, individuals who need 24 hour nursing care, etc.

Out of lab testing should not be performed for profit of the company providing the service or theconvenience of the patient who would rather stay at home.

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