- 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.
Sleep Solutions 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 home sleep 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 home sleep 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 diagnostic evaluation of adults with possible sleep apnea. 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 sleep labs use to diagnose OSA: respiratory effort, oxygen saturation, 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 sleep lab 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 primary care physicians (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 Food and Drug Administration.
- Claman D, et al; Otolaryng Head Neck Surg 2001; 125: 227–230.
- Reichert JA, et al; Sleep Med 2003; 4: 213–218.
Richard Hassett, MD CEO NovaSom, Inc. http://www.novasom.com.
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 Neurosciences Institute, the Voltmer Sleep Center is seamlessly integrated within the continuum of care. Sleep is not an afterthought. Neurologists, ENTs, pulmonologists, endocrinologists, and primary care physicians 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 pulmonologist 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 cardiologists. “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.” Cardiologists 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 CPAP machine, Selecky and Stiger work closely with trusted durable medical equipment (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.
Unlike the 1980s, Selecky says it seems as though these days there is a sleep lab on every corner. Favorable demographic trends suggest that won’t change, despite the furor caused last year when Medicare approved home sleep studies—much to the chagrin of lab owners. “People said that might be the end of all sleep centers,” says Selecky. “But as time has gone on, that has not occurred at all. Part of it is that reimbursement for home sleep studies is low. However, it has made every lab consider whether it should be involved in home sleep 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 American Academy of Sleep Medicine, 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.”
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 polysomnography, 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 home sleep 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.
The Somté home sleep 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 home sleep testing has exploded from all sectors of medicine. Combining home sleep 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.”
HOME TESTING: WHAT’S DRIVING THE MARKET?
Sleep Diagnosis & Therapy spoke with Kuznia about a wide-ranging discussion on the future of home sleep 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?
ARE RESEARCHERS CLOSER TO DETERMINING A FIRM LINK BETWEEN SDB AND CARDIOVASCULAR PROBLEMS?
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.
THERE IS A LOT OF COMPETITION IN HOME TESTING. WHAT MAKES THE SOMTE STAND OUT?
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.
WHAT ARE PATIENTS SAYING ABOUT THE PRODUCT?
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.
IS THE BATTLE FOR CLINICAL ACCEPTANCE OF HOME SLEEP TESTING OVER?
The vast majority of sleep professionals believe that home sleep 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 home sleep 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 home sleep testing is done in larger numbers.
If more people are doing home sleep 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.
DO YOU BELIEVE THE POTENTIAL OF THE HOME SLEEP MARKET IS A REALITY?
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 home sleep 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 home sleep testing services in a manner that you can more than cover your costs is still a challenge for a lot of practitioners.
WHERE DO YOU SEE HOME SLEEP TESTING IN THE FUTURE?
There is definitely a role for home sleep 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 sleep apnea 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.
CAN HOME SLEEP TESTING EXPAND INTO OTHER AREAS SUCH AS THE REALM OF TRUCKING?
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 home sleep 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 sleep apnea 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. Home sleep testing is an ideal way to do cost-effective follow-up.
Jeff Kuznia, RRT, RPFT
Compumedics USA Inc
Somté Software Package Includes:
• full waveform review;
• automatic respiratory event detection and statistics (central apnea, obstructive apnea, mixed apnea, hypopnea, • SpO2 desaturation events and artifacts);
• oximetry analysis;
• full manual event editing capabilities (deletion, reclassification, marking new);
• event searching;
• ability to view patient information; and
• comprehensive report generation with user definable template
• full disclosure printing
• Optional ECG Analysis with arrhythmia detection, classification, heart rate variability and ST-Segment measurements and statistics.