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Why CMS Approved Home Sleep Testing for CPAP Coverage

Alejandro D. Chediak, M.D.
President, American Academy of Sleep Medicine
On December 14, 2007 the Centers for Medicare & Medicaid Services (CMS) released its proposed decision for modification of National Coverage Determination (NCD) policy 240.41 pertaining to coverage of continuous positive airway pressure therapy (CPAP) for adult obstructive sleep apnea (OSA). The proposed modification allows for an initial 12 week period of CPAP coverage when OSA is diagnosed using both a clinical evaluation and performed in the sleep laboratory (PSG) or a clinical evaluation and unattended testing (HST) using a Type II, III or IV device. CPAP would be subsequently covered for those diagnosed with OSA who benefit from CPAP during the 12-week trial. CMS further intends to modify the criteria for a positive sleep study by removing the requirement for a minimum two hours of continuous recorded sleep (the 2-hour rule) and remove the current requirements that an individual have moderate to severe OSA and that surgery is a likely alternative to CPAP. Finally, CMS will expand Medicare coverage for CPAP for beneficiaries with a clinical diagnosis of OSA without either PSG or HST only when provided in the context of a clinical study that meets specific standards. A clinical study seeking Medicare coverage for CPAP pursuant to Coverage with Evidence Development must necessarily address specific questions as stipulated in the NCD.
Modifying the 2-hour rule as proposed is likely to be perceived favorably by all vested parties. However, allowing unattended HST to diagnose OSA has the potential to fundamentally change sleep healthcare delivery, economics and outcomes in ways that are difficult to confidently predict.
The debate over the use of HST to establish the diagnosis of OSA began long before the 2007 CMS review of NCD policy 240.4. In fact, unattended HST has been reviewed by CMS since 1989 with subsequent reviews in 1995, 2001 and 2005. The most recent prior challenge to NCD 240.4 occurred in 2004 and culminated in April of 2005 with CMS opining that “…there is not sufficient evidence to conclude that unattended portable multi-channel sleep study testing is reasonable and necessary in the diagnosis of OSA for CPAP therapy, and these tests will remain non-covered for this purpose.” I was initially surprised by the CMS decision to include unattended HST in NCD 240.4, particularly without expert oversight of HST and a mandate for a well-defined comprehensive sleep evaluation. After thoughtful reflection on the proposed changes and the CMS coverage determination policy process, I intend to offer my personal insight on the proposed modifications of NCD 240.4 and on the message that CMS is sending to the sleep community. An appreciation of the events leading up to the 2007 decision is helpful in understanding the rationale behind the CMS decision. Therefore, I will begin with a brief historical overview.
In January 2007 Dr. David R. Nielsen, Executive Vice President and Chief Executive Officer of the American Academy of Otolaryngology-Head and Neck Surgery requested that CMS revise NCD 240.4. Among the challenges to the 2005 NCD policy included the notion that the diagnosis of OSA is restricted by requirement for PSG, a test described as expensive and not widely available. Further, Dr. Nielsen argued that HST was a validated, less costly alternative to PSG and that even less expensive paradigms for diagnosis and treatment were currently being explored and that HST was an important first step in promoting and working toward these alternatives.
The American Academy of Sleep Medicine (AASM) response to CMS by then-President Dr. Michael Silber included an appraisal of the literature on the availability of PSG across the United States, a survey of PSG and sleep specialist wait times in AASM accredited facilities and a review of the clinical and economic data on HST after the 2004 challenge to NCD 240.4. The AASM April 10, 2007 letter to CMS Director of Coverage and Analysis Group, Dr. Steve Phurrough, methodically established the factual basis for the following AASM positions:
  • The most recent data indicate that PSG is widely available in the United States.
  • There is no evidence to suggest that a change in the NCD policy for HST will have a significant effect on patient access.
  • Published studies up to 2004 have not provided evidence in support of HST for the diagnosis of OSA.
  • Subsequent to 2004, two studies provide some evidence in support of HST when used in highly selected cases and managed intensively in academic sleep centers.
  • Available data do not indicate that HST is more cost effective than PSG, especially taking into account technical failures, as well as false negative and false positive results.
  • Wide spread use of HST by physicians lacking training and/or experience in sleep disorders will likely result in adverse patient outcomes.
  • There is credible evidence that patients managed for OSA at AASM accredited sleep centers have better outcomes.
  • If HST is demonstrated in the future to be of utility in the management of some patients suspected of having OSA, it will be necessary that such procedures be restricted to use in accredited sleep centers in order to ensure optimal patient care.
CMS used several sources of evidence in its decision to modify NCD 240.4. In addition to receiving commentary from professional societies, industry and individuals, CMS prepared for the decision by commissioning an external technology assessment from the Agency for Healthcare Research and Quality (AHRQ) to review published clinical evidence on the use of HST in the diagnosis of OSA,2 reviewed relevant published evidence based guidelines since 2003 and held a Medical Coverage Advisory Committee (MedCAC) meeting on September 12, 2007. Collectively, the evidence largely aimed to answer three fundamental questions regarding OSA and CPAP coverage. Firstly, CMS inquired if there is sufficient evidence to determine that diagnostic strategies other that facility based PSG accurately identify patients with OSA who will benefit from CPAP treatment. Secondly, they questioned the notion that at least two hours of continuous recorded sleep is necessary for the accurate diagnosis of OSA. Thirdly, CMS queried if a diagnosis of OSA by clinical criteria alone is sufficient for the use of CPAP.
The AASM testimony that I delivered to the MedCAC panel largely mirrored the April 10, 2007 AASM letter to CMS. Other professional societies providing testimony included the American Academy of Otolaryngology-Head and Neck Surgery (in favor of HST), American Association of Respiratory Care (spoke to the 2-hour rule), the American College of Chest Physicians (ACCP), and the American Thoracic Society (ATS). While there was variance in the degree of conviction, in general the AASM, ACCP and ATS testified against the indiscriminate use of HST. AASM member Dr. David Kuhlmann testified as a private individual and was supportive the AASM position. The sleep device and healthcare delivery industry representatives such as Ion Healthcare, Apria Healthcare, Freudman Healthcare Consulting, Advanced Brain Monitoring, SNAP Laboratories, and others countered with their opinion that HST identified sleep-related breathing events similarly to PSG and that outcomes of patients diagnosed with OSA and treated with CPAP based on HST derived data was not worse than that when the diagnosis was based on data derived by PSG. The notion that PSG is the gold standard for diagnosing OSA was challenged along the lines that information derived from PSG (AHI, arousals, sleep and desaturation variables) correlate only weakly with symptom severity, response to CPAP therapy, utilization of CPAP and prognosis. Among the industry consultants and/or executives testifying in support of HST were AASM members Dr. Mark Goetting and AASM Past Presidents Drs. William Dement and Philip Westbrook. In essence, the MedCAC panel members were exposed to widely divergent opinions regarding the value of PSG and HST in the diagnosis of OSA and as a predictor of outcomes after treatment with CPAP. The panel expressed moderate to high confidence on the evidence used to determine if clinical evaluation and PSG can accurately diagnose OSA, moderate confidence on the evidence for clinical evaluation and HST and less confidence on the evidence for clinical evaluation alone. In regards to the accuracy of strategies used to diagnose OSA, the MedCAC panel expressed strong moderate to high confidence for a clinical evaluation combined with PSG, strong to moderate confidence for a clinical evaluation with a Type II HST, moderate confidence for a clinical evaluation with a Type III HST and less than moderate confidence for both a clinical evaluation with a Type IV HST and a clinical evaluation alone. Considering the value of a clinical evaluation alone or combined with either PSG or HST to predict CPAP use, the panel expressed moderately high confidence when combined with PSG, moderate confidence when combined with HST and low confidence in a clinical evaluation alone. Finally, the panel expressed low to moderate confidence that a trial of CPAP without prior PSG or HST would not produce clinically meaningful harm.
Considering that in general the MedCAC panel and AHRQ technology assessment review expressed greater diagnostic confidence in PSG than in HST (particularly in Type IV HST devices), what prompted CMS to allow HST in the diagnostic paradigm for CPAP coverage determination? Simply stated, CMS approached the 2007 decision on NCD 240.4 in a manner fundamentally distinct from earlier reviews. In contrast to the 2005 CMS decision where diagnostic accuracy was the primary determinant of CPAP coverage, in 2007 CMS deemphasized diagnostic accuracy in lieu of strategies more apt to predict favorable outcomes for treatment of OSA with CPAP. Since the available evidence does not confidently establish that indices derived from either PSG or HST can be used to reliably predict treatment outcomes in OSA patients treated with CPAP, neither could be specifically excluded from the coverage determination policy. The relative value of treatment outcome over diagnostic accuracy as the primary determinant of CPAP coverage is consistent with the CMS proposal to link long-term coverage for CPAP to demonstrable benefit after a 12-week trial of CPAP. Finally, the language of the proposed decision suggests that CMS is seeking evidence to add benefit from CPAP among the reasonable and necessary prerequisites to a diagnosis of OSA for CPAP coverage determination purposes.
CMS has not excluded PSG as reasonable and necessary for the diagnosis of OSA and makes no provision on the mechanism of CPAP titration. The proposed modification of NCD 240.4 does not specifically address management strategies after a failed home CPAP trial in patients diagnosed with OSA by clinical evaluation and HST. In this regard, PSG remains necessary in the diagnosis and management of OSA. However, in mandating benefit from CPAP as reasonable and necessary for continued coverage of therapy, is CMS encouraging the medical community in general and sleep medicine in particular towards a chronic care approach to OSA? Many patients with OSA have coexisting sleep disorders such as insomnia and residual sleepiness despite appropriate CPAP therapy, conditions that increase the likelihood of a CPAP trial failure if the combined sleep disorder is not simultaneously addressed.3 Postgraduate medical education in disciplines other than a dedicated sleep medicine fellowship affords little opportunity to gain proficiency at managing sleep disorders including complicated OSA. Physicians lacking experience in sleep medicine and unaccustomed to the nuances of modern positive pressure devices and interfaces are not likely to provide the longitudinal care mandated by NCD 240.4. This provision of the proposed decision can serve to raise the value of sleep specialists working in AASM accredited sleep facilities whom, by virtue of specialty training, experience and facility infrastructure, are best equipped to provide chronic care for patients with OSA. The past decade has seen explosive growth in our field. If sleep medicine is to continue its unprecedented growth we need be prepared to develop and embrace disease management paradigms with greater focus on chronic care and less emphasis on facility based testing.
Recognizing the potential for gains in healthcare outcomes and economics afforded by chronic care management paradigms,4,5 in January 2007 I proposed a meeting of AASM leadership with aims to enhance our understanding of chronic care models, consider the feasibility of chronic care models in sleep practices and to define the role of the AASM in developing chronic care models specific to sleep medicine. The meeting, scheduled to coincide with the April 2008 meeting of the AASM Board of Directors, fortuitously falls shortly after the final CMS decision on NCD 240.4 allowing AASM leadership to focus the discussion in light of the final ruling. I am optimistic that this conference will serve as a catalyst to promote sleep healthcare strategies that emphasize chronic care of our patients.
This editorial purposely avoids comment on inconsistencies and inaccuracies apparent in the proposed decision by CMS. A number of critical omissions including the failure of CMS to define terms crucial for coverage determination such as “clinical evaluation” and “benefit from CPAP” are similarly excluded as the official AASM response to the proposed modification of NCD 240.4 will elucidate on these and other salient issues. In sharing my experience and perspective it is hoped that this editorial helps prepare the individual sleep specialist and the field of sleep medicine for the challenges ahead.

J Clin Sleep Med. 2008 February 15; 4(1): 16–18.

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  3. Home Testing for the Sleep Centers

Brand Takes Center Stage – Sleep Solutions Becomes NovaSom

slepp1 Brand Takes Center Stage   Sleep Solutions Becomes NovaSom may have changed its name to NovaSom and moved the company from California to Delaware, but the company’s intense focus remains the same.

More than a year after taking the reins at the largest national service provider of tests, Richard Hassett, MD, believes the time is ripe for a change. Specifically, the CEO of Sleep Solutions has decided to switch the company’s name to NovaSom®, a move designed to build on the familiar testing brand.

Changing a well-known moniker is no small decision, but Hassett believes the new name better reflects the company’s commitment to providing accurate and cost effective home tests. Factoring in some annoying name similarities to competitors and the change became a no-brainer. “Other entities had the name ‘Sleep Solutions’ as some part of their name, and that could potentially be confusing,” says Hassett. “If we were ever going to make a change, now was the time. At the same time, we reincorporated the company from California to Delaware.”

Recent years have seen a steady climb for the NovaSom® brand in its role as a full-service model for home sleep testing. The actual unit is a small device used in the home and typically shipped to patients via overnight carrier. After that, it is returned to the company when the patient completes testing, ideally for three nights. Upon return of the device the data are downloaded and the results are interpreted by a qualified or board-certified sleep physician. Results are provided to the prescribing physician within 48 hours.

The NovaSom Home Sleep Test is a Type III portable cardio-respiratory monitor with FDA clearance for of adults with possible . Predictive accuracy of the test, night for night, has been established in two peer-reviewed publications comparing the device to PSG.¹,²

Three sensors record the same five physiological parameters that use to diagnose OSA: , , heart rate, airflow (oral & nasal), and snoring. The first sensor is a belt that goes around the chest to determine respiratory excursions. The second is an oxygen sensor on the finger, and finally a sensor beneath the nose detects the snoring sound and air flow. This acoustic airflow sensor is a patented device utilizing noise cancellation technology, which has demonstrated a highly linear relationship to the Hans Rudolph pneumotachograph – a standard of airflow measurement used by pulmonologists.

Clinicians appreciate the unit’s capacity to store data for three nights, and users benefit from the device’s ability to literally speak via mechanical voice. “Similarly to a GPS, the NovaSom device talks patients through the procedure,” explains Hassett. “Even if patients have not had access to the Web site or seen the instruction materials that come with the test, the device will actually talk them through the set up and operation.” The company also provides technical and clinical services 24⁄7 by credentialed sleep technologist.

The consumer friendly nature of the test can mean the difference between diagnosis and failure. After all, says Hassett, potential patients often shy away from sleep labs, preferring the comfort and privacy of their own home. Factor in NovaSom’s lower price and it all points to more patients with proper diagnoses.

“Clinicians are starting to realize that we have a massive public health epidemic on our hands with OSA, and the community can’t handle all the patients,” says Hassett. “The fact that the device has the capacity for three nights of data eliminates the high false negative rate which is a problem with any one-night test, whether it is home or lab based. This turns out to be an advantage for providers and patients.”

Hassett and NovaSom’s customers believe the secret lies in the product’s ability to overcome the inevitable night-to-night variability that can hamper sleep testing results. “It’s been known for a long time that there was a burden of false negatives with one-night tests, perhaps even more so with labs than at home because of how daunting, unfamiliar, and uncomfortable it is to achieve natural sleep in the lab environment,” says Hassett. “With the 3-night test, we pick up a significant number of patients after the first night that would have been missed. With the high false negatives after one night tests, it just makes more sense.”

Provider education teams from NovaSom are dedicating time and energy to increasing awareness among (PCPs), ENTs, and pulmonologists. Since there are so many more PCPs out there, they have so far naturally benefitted a bit more from these educational efforts.

Particularly for uncomplicated patients at the primary level, PCPs are the main portal for a variety of patients with many different apnea severities. “We read statistics that say 7 out of 8 people with OSA are undiagnosed and unaware,” says Hassett. “Most providers in America do not have the level of vigilance for this condition that its public health implications would warrant.”

By now the statistics are familiar, but no less staggering. The costs and co-morbidities seem to multiply every year, and Hassett believes medical research will continue to confirm these findings. “We provide the resources that primary care physicians need to identify people at risk for OSA and determine appropriate candidates for both in-home and laboratory tests,” says Hassett. “We have a field-based medical education force and have made significant investments in CME and non-CME educational programs, aimed at primary care.”

The NovaSom home sleep test is offered as a turnkey service. There is no capital investment required of physicians. NovaSom provides rigorous infection controls, biomedical inspection, testing and calibration for each device in between patient uses, ensuring that every test sent to a patient will function accurately. Physicians view detailed study results through the online MediTrack® system.

“NovaSom has a large client care team and offers live clinical/technical support, 24 hours a day, 7 days a week, to patients undergoing the home sleep test,” adds Roger Richardson, vice president, Operations, for NovaSom. “We try to make testing as easy as possible, and are committed to raising consumer awareness of OSA through http://www.apnea.com.”

NovaSom, Inc. is fully accredited by The Joint Commission‘s Ambulatory Care Program, is a Medicare-approved Independent Diagnostic Testing Facility (IDTF), and is registered with the .


  1. Claman D, et al; Otolaryng Head Neck Surg 2001; 125: 227–230.
  2. Reichert JA, et al; Sleep Med 2003; 4: 213–218.

Richard Hassett, MD CEO NovaSom, Inc. http://www.novasom.com.

ScreenShot070 Brand Takes Center Stage   Sleep Solutions Becomes NovaSom

California Dreaming

bed California DreamingOfficials at the Orange County, Calif-based Judy & Richard Voltmer Sleep Center make sleep health a priority throughout the many specialties at Hoag Memorial Hospital.

Even in the population-dense region of Southern California, sleep labs used to be rare. When compared to 2011, sleep apnea awareness in the 1980s significantly trailed other conditions.

Officials at Hoag Memorial Hospital Presbyterian in Orange County, Calif, recognized early on that there was a need for a specialized center to evaluate and treat sleep disorders. The Judy & Richard Voltmer Sleep Center, backed by the resources at Hoag, filled this void back in 1987 in Newport Beach, Calif. More recently, the center moved to gleaming new quarters in an effort to modernize and accommodate more patients.

With considerable resources, expertise, and referrals flowing from Hoag, the state-of-the-art 8-bed facility never lacks for patients. Paul Selecky, MD, FACP, FCCP, FAASM, long-time medical director of the Voltmer Sleep Center, has tirelessly spread the message of sleep health among his colleagues. The result is that clinicians from diverse specialties appreciate the value of healthy sleep, and they don’t hesitate to ask for help when they need it.

Under the umbrella of Hoag , the Voltmer Sleep Center is seamlessly integrated within the continuum of care. Sleep is not an afterthought. Neurologists, ENTs, pulmonologists, endocrinologists, and all readily send patients to the center.

Colleagues on Board

The evidence for the sleep/health connection seems to build each year, with ever-more co-morbidities related to poor sleep. The more apt question these days is what is not affected by sleep.

When the American Society of Anesthesiology (ASA) came out with its 2006 guidelines on peri-operative management of patients with known or suspected sleep apnea, clinicians at Voltmer Sleep Center were ready. “Our anesthesiologists asked if we could help them develop a program to screen patients who were coming in for elective surgery,” says Selecky. “That protocol has now grown, and nearly every admission coming into Hoag is evaluated for the risk factors of sleep apnea.”

Hoag has taken a proactive approach, and patients who come in for other ailments benefit from the extra attention. “About 70% of stroke patients have sleep apnea,” says Selecky. “It’s a chicken-egg type of thing, but at least they get sent here to lower that risk. Others who come in for total knee, hip, chest pain—we ask them about sleep and the patient is educated about serious breathing problems.”

Not surprisingly, about 90% of all referrals to Voltmer Sleep Center come from Hoag, but outside referrals are growing. If a patient is referred by a Hoag neurologist for sleep problems related to that neurologic problem, a neurologist working on staff at Voltmer Sleep Center is the one to see that patient.

If COPD was the primary problem, a would visit with the patient. “This is not just an independent sleep center,” explains Trish Stiger, BBA, RPSGT, CRT, manager of the Voltmer Sleep Center. “It is part of Hoag, and they refer from the Diabetes Center, the Cardiovascular Institute, and more. Even obstetricians are reminded that a snoring pregnant woman should not be ignored as if she merely has nasal congestion, as this can lead to complications of pregnancy.”

In line with the large body of evidence linking sleep apnea and congestive heart failure, Voltmer Sleep Center clinicians provide information and education to all Hoag . “A lot of them have gotten the message,” says Selecky. “They ask every congestive heart patient, ‘Do you snore?’ If the patient snores, and has other features of sleep apnea,  he comes to us.” will also send patients whom they are treating for resistant hypertension, as is recommended by the American College of Cardiology and American Heart Association because of the link with untreated obstructive sleep apnea.

Much the same can be said for diabetes management. Endocrinologists who prescribe several different medications for diabetes have referred their patients to the Center, again because of the link between diabetes management and sleep apnea  . “The first thing that should be done is to rule out sleep apnea,” says Selecky.

Education and Follow-up

Every physician takes patients to the lab bedrooms to explain the diagnostic tests and procedures, and these in-person consultations provide vital information. Despite all the media attention on sleep, Selecky admits that some convincing is often part of the job. “Sometimes there is too much negative information out there,” laments Selecky. “People come in and say, ‘I don’t want that breathing machine. I know somebody that hated it.’ It gets a bad rap, so we must provide a lot of education.”

When it comes time to dispensing the actual machine, Selecky and Stiger work closely with trusted (DME) providers who are known for their good service. “If they don’t provide good service, we don’t refer to them—it’s that simple,” says Selecky. “That means excellent follow-up, because if patients don’t have a positive experience in the first few weeks of CPAP use, they are more likely  to abandon it. Nationally, the average for CPAP users is that 50% drop it by the end of the first year. We have several of the DME RTs spend time in the Center so patients can try a dozen different masks. It’s like buying a pair of shoes. If it doesn’t fit well, you are not going to use it.”

In addition to the familiar sleep apnea/CPAP combination, officials at Voltmer are keen to address all sleep disorders and treatments. “Insomnia is not a huge percentage of our patient population at this point, but it’s significant enough and our physicians treat it,” says Stiger. “Patients may need extensive cognitive behavioral therapy, sometimes with the aid of  psychologists.

In addition to CPAP for apnea, we embrace dental sleep medicine as a valid option.  “Oral corrective devices have been used throughout our history with the help of local dentists who started treating some of our milder patients, or those who could not tolerate CPAP,” adds Selecky.

The Future

Unlike the 1980s, Selecky says it seems as though these days there is a on every corner. Favorable demographic trends suggest that won’t change, despite the furor caused last year when Medicare approved studies—much to the chagrin of lab owners. “People said that might be the end of all ,” says Selecky. “But as time has gone on, that has not occurred at all. Part of it is that reimbursement for studies is low. However, it has made every lab consider whether it should be involved in studies. The answer is yes for certain populations.”

In 2011, Selecky believes the keys to success looks a lot like the keys of the past. Education, clinical excellence, follow-up, and compliance must be the driving forces. As understanding of sleep medicine grows and physicians know more about it, they will inevitably order more sleep studies.

Those who have worked to be a full service center will remain in the black as they gain the trust of physicians and patients alike. “There is a difference between establishing yourself as a sleep center vs a sleep lab,” adds Stiger. “A center deals with everything. You educate, go out and teach the community, and work with all the other specialties to care for patients—which should always be the number one goal.”

Tradition of Excellence
Hoag Memorial Hospital Presbyterian is accredited by the Joint Commission on Accreditations of Healthcare Organizations (JCAHO), and home to Centers of Excellence in cancer, heart, orthopedics and women’s health services. Orange County residents named Hoag the “Hospital of Choice” in a National Research Corporation poll, as well as the county’s top hospital in a a local newspaper survey.

The Voltmer Sleep Center is an accredited member of the , and features a Web site (http://www.hoag.org/services/neurosciences-institute/voltmer-sleep-center) where potential patients can view online sleep assessments, photos of the sleep center, and information about the physicians. “Many people simply don’t realize that an adequate night’s sleep is needed to maintain good health and stay fully alert throughout the day,” says Selecky. “We are excited about the opportunity to use the Internet to educate the public and to let them know there is help nearby.”

Home Testing for the Sleep Centers

Written by Chris Vu, Dec 20th 2010:

Sleep medicine in the Home and the Lab

With each passing month, sleep professionals continue to ponder the best way to use in-lab sleep testing in conjunction with proper home testing. Economic pressures are driving the evolution, which began in earnest 18 months ago when Medicare allowed the diagnosis of apnea, in certain patients, with home testing. “Medicare again has announced in certain areas they are reducing the reimbursement for full PSG, and this has been the trigger for some to try to be smarter about sleep testing. The financial pressures on labs have made many people more willing to accept home testing.

Specifically, the Centers for Medicare and Medicaid Services (CMS) targeted a local coverage area for reimbursement reduction on full , a trend that is likely to continue. In a separate local coverage determination (LCD), CMS stated that starting in January you must be AASM-accredited, JCAHO accredited, or have a board-certified doctor as your medical director to bill Medicare for studies. Most hospital facilities already have that, but it will have a dramatic effect on the alternate care sites—the off-hospital sleep labs. A greater percentage of those are not AASM accredited. These rules may improve labs, but will probably limit the number of people who can get care because fewer labs will be available.

At least for uncomplicated patients, the medical community has come to accept testing is clinically effective in appropriate patients. Full PSG will likely never go away, at least in the foreseeable future, because home studies are simply not indicated for everybody.

Experts acknowledge that many in the sleep community are still struggling to reconcile the high clinical standards achieved in sleep labs with the home environment. Right now, the opportunity for manufacturers who have a device that can comply with the high standards of the AASM. Those who can, will be successful. The tradeoff is that those high-standard devices can often be more difficult and more cumbersome to use.

On the other side of the Atlantic, these important questions have largely been answered, with greater acceptance of home testing found in much of Europe. We believe that outside the U.S. the number one opportunity is full PSG unattended, which is a Type 2 device. Reimbursement outside the U.S. also continues to decline. The full sleep labs must figure out a way to stay in business, and the next step for them is to do unattended full PSGs. In Japan, they have a rule this year where you get the same reimbursement whether the test is attended or not. The big incentive is to do unattended studies, because the reimbursement in Japan is the highest in the world.

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The Heart of the Matter: with Home Sleep Testing

The Somté testing (HST) device by Compumedics addresses the technological challenges of home studies while its sophisticated ECG capabilities help set the device apart from its peers.

When engineers from Australia-based Compumedics developed the Somté, they knew cardiology was likely to play a growing role within sleep medicine. With this in mind, they developed a Holter-type sleep system that earned a 2006 Frost & Sullivan award for Technology Leadership.

Since that time, interest in sleep disorders and testing has exploded from all sectors of medicine. Combining diagnostics with the optional capability for Holter ECG monitoring and pulse transit time results, is one way to recognize this new reality. Most other HST units do not have the option, because they don’t record electrocardiography (ECG) signals.

Jeff Kuznia, Vice-President of North American Sales and Marketing for Compumedics
, says the unit’s ability to record reliable data means that the equipment fits well into the Type 3 recorder market. Holter ECG monitoring exists as a stand-alone product, but the software development required to combine it with sleep makes it difficult for other companies to make a similar device.

Compumedics’ involvement in the Sleep-Heart Health Study sparked the original Holter idea, and there are no regrets—but still some work to do. “ Most cardiologists are aware of the connection between sleep disordered breathing and cardiovascular disease. However I do not believe that many have firsthand experience with managing sleep disorders, and may not appreciate the impact that sleep disorders have on cardiovascular disease, but also the effect of treating Sleep Disordered Breathing ‘SDB’ when it comes to managing many patients who suffer from complex hypertension or cardiac arrhythmias.”

Sleep Diagnosis & Therapy spoke with Kuznia about a wide-ranging discussion on the future of testing. Topics such as reimbursement and clinical efficacy are driving the market, but what shape will these changes make, and how will new discoveries alter diagnostic testing?
somte units The Heart of the Matter: with Home Sleep Testing

Data is out there, but from a scientific standpoint, the issue is still one of determining causality. There definitely is clear interaction between these processes, and a lot of people with cardiovascular disease have OSA or develop CSA. However, the evidence is inconclusive in showing SDB actually leads to cardiovascular disease. If you have cardiovascular disease, chances are increased that you have SDB, which should be treated. In many patients, treating SDB improves the status of their cardiovascular disease, or improves the ability to manage that disease, but what caused the other has not been determined. With respect to “hard science” this question may be viewed as rhetorical as hopefully either diagnosis warrants treatment.

One of the advantages of the Somté is it has some flexibility and capabilities that a lot of the other products don’t have that are in that class. It is one of the few units that has a built-in display that allows the technician to verify the quality of the recording prior to sending the patient away, avoiding a wasted recording night. It’s easy for the patient to set it up in most cases, the Somté uses the best methods of measuring respiratory data, with built-in RIP technology.  It’s also one of the few units that provide additional inputs to record limb movement.

You’ve got the ability to look at body position with the Somté if you so desire, and you can add in these high frequency channels. There are two of them, and the original concept was they would be used for ECG, but when we released the product we made it flexible enough so they could be used for a channel of EEG or EMG, and we’ve got people that are looking at this and saying this would be a very good thing to monitor Bruxism for instance.

An operational advantage of the system is that you can preconfigure the unit for the recording. The patient can put it on themselves, and does not have to interact with the unit because it will turn on automatically, record the data, and then turn off. A lot of the people that send the units out to patients will preprogram the unit to turn on at night and shut off in the morning. All patients have to do is hook themselves up, and they do not have to worry about touching the unit and turning it on and off. So in some cases patients may come to the sleep clinic or the physician’s office, get wired up, and then they can test to make sure that everything looks good before they go home.

It’s small, lightweight, and it’s easy to wear. Some of the units out there for home studies are still fairly large and bulky. There is a comfort factor to this that comes into play, and I think we’ve addressed that effectively.

The vast majority of sleep professionals believe that testing is valid and appropriate in certain populations, and that it can be done reliably. There are concerns still amongst some that if everybody was evaluated with a test that we would be missing other factors and other issues involved with their symptoms, such as co-existing sleep disorders. That being said, if you go to your primary care physician complaining of stomach pain and are treated and he/she missed the fact that you had an ear infection, does this constitute “bad medicine”? It is one of these things where there are still questions in the mind of the marketplace that would only be answered when testing is done in larger numbers.

If more people are doing testing, and have a larger volume of experience, the general consensus of the marketplace may shift because they would might experience more success, or they would be able to determine when it would not be successful and be able to more clearly state which set of patients need to be done in the lab.

We have been telling ourselves for the last 20-plus years that the number of people in the population with undiagnosed sleep disorders is large. If we are claiming that 80% of the people with sleep disorders are currently not diagnosed and treated, than there is this population of people not being cared for in our health care system. The thought was that if we had more testing being done, we would reach more patients with sleep disordered breathing and treat them, and that would be a cost effective way of managing this particular part of the health care challenge.
We don’t have a good handle on whether that is true or not. The economics are driven from the reimbursement end, whether it is Medicare or other third party payers. They look at the growth of sleep diagnostics and the cost of ongoing treatment, and are concerned at the cost and not necessarily the benefit. Anytime a diagnostic procedure or a treatment procedure has rapid growth, it puts a spotlight on it and payors look and say we maybe need to manage this more aggressively.

The issue is that if, or maybe when, reimbursement drops in the clinical lab, will it necessarily push people to doing more sleep studies in the home? This is unclear because the reimbursement at the home level is also relatively low, and so, from a business operations standpoint, to provide testing services in a manner that you can more than cover your costs is still a challenge for a lot of practitioners.

There is definitely a role for testing in the whole milieu of sleep medicine, and clearly there are a lot of people, including physicians, insurers, and patients, that are very strong advocates for that approach. The concern in the minds of many sleep professionals is that sleep medicine and managing patients with obstructive is not within the general training of most internal medicine physicians and most family practitioners. You are going to have family practitioners and internists with no sleep medicine training, caring for patients who may require more complex management than just prescribing a CPAP pressure. That is precisely the reason that sleep centers should be looking at expanding into it [home testing] because it keeps the profession in the sleep home testing market.

I think you can expand trucking industry to transportation in general. The airline industry is definitely another example and here you’ve got other complicating issues. You’ve got shift work compounded with potentially a pilot that may have OSA.  Clearly anything involving hazardous waste material or in the broad category of transportation is certainly a legitimate testing population.

It is still unclear what role testing plays in that arena. For instance, the truck drivers: one of the concerns is that if you would give a recorder to a truck driver and say, “put this on and bring it back in the morning after you have slept all night,” is that the truck driver is going to take that unit home and place it on his kid and not necessarily on himself. This is one situation where it may need to be a monitored study, since you need to verify whom the recording was actually done on.

One other population is those patients who are already diagnosed, that are already on treatment but have not been reevaluated for a while. Once a patient is diagnosed with and we have put them on treatment, we often don’t know how effective the treatment is long term, or if it needs to be adjusted. This has been one of the issues with tracking compliance in the usage of CPAP over time; in many cases those patients are not retested to see if their treatment is still valid, or if it is effective from an objective standpoint. testing is an ideal way to do cost-effective follow-up.

Jeff Kuznia, RRT, RPFT
Compumedics USA Inc
Charlotte, NC

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