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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Worth the Weight

The ultra light SleepView type 3 home sleep monitor from CleveMed is designed to be simple for patients, and cost effective for sleep labs.

Just shy of a year on the market, the SleepView from CleveMed has managed to carve a growing niche in the highly competitive world of home sleep monitoring. Sarah Weimer, director of Sleep Products at the Cleveland-based manufacturer, touts the device as the smallest and lightest home sleep monitor within the AASM-recommended Type 3 channel-set guidelines.

At a weight of approximately 2 ounces, the equipment is ergonomically designed for patients to perform a self test at home, while also working hand in hand with CleveMed’s eCrystal PSG Web Portal. The Web site is a place where sleep studies are uploaded for review and scoring by sleep technologists, then interpreted by board certified sleep physicians.

Easy for Patients
While Medicare approved home sleep testing last year, reimbursement still stands at just over $200. At that rate, Weimer points out that it is not cost effective for sleep labs, especially if sleep professionals must be involved with the setup every step of the way. “With that in mind, the goal with the SleepView was to make a device that fulfilled the channel set asked for by AASM, with the types of sensors that they like to see as well,” says Weimer. “At the same time, we wanted it to be very easy for patients to do a self hook up with minimal instruction.”

Clevemed was uniquely suited to do an incredibly small Type III device due to the company’s long history of producing wireless electrophysiology monitors. Working within the diminutive design parameters, engineers sought to avoid the more complex harness systems used by competitors. “We wanted it to be small and light enough that it could be supported by a traditional respiratory effort belt,” reveals Weimer. “It is easier for patients to hook themselves up. They don’t have to worry about extra mounting straps or the discomfort of having the device worn elsewhere on the body.”

Not surprisingly, patients appreciate how easy it is to put on the SleepView. For patients who think it may be too easy and question the procedure, engineers went an additional step with LED light indicators on the front that let patients know if they have hooked themselves up properly. “If they turn the device on, but they don’t have sensors on, there is a little light on the front of the device by each channel name that will light up red to let them know that they are not hooked up properly,” explains Weimer. “As they get each channel hooked up correctly, those lights will turn green to indicate that it is collecting a good signal. When the patient first turns the device on, those lights will stay on for 90 seconds, and then anytime during the night the patient can hit the ‘on’ button again to get another 30 seconds of feedback about whether the device is collecting good signals or not.”

Feedback on usability and success rates tabulated from sponsored tests have consistently shown that patients come back with valid data. “Other customers have been using our other product, the Sleep Scout, which is a little bit more traditional and a little bit more complicated for the patient to put on,” says Weimer. “It [the Scout] does not have the feedback, and we would have an increased number of unsuccessful studies with that product compared to this product. The immediate patient feedback on the SleepView lets patients know that they may not have a sensor in place properly, and they can fix it right away.”

Expanding the Market
Weimer agrees that the SleepView, and home testing in general, will likely expand the market for sleep labs by increasing access and awareness to potential patients. The undiagnosed masses will get into the treatment cycle, benefitting all parties throughout the continuum of care.

As more clinicians learn about the importance of sleep, referrals will also increase the flow of patients. “Patients are typically seeing their or primary care physicians, and if those health care professionals are asking the right questions about sleep, it is just going to increase the number of people who are aware and getting tested,” says Weimer. “There is also the idea that home testing could harm the sleep lab by reducing the number of patients they are able to see, but I think that is a misconception.”

SleepView handhold Worth the Weight

SleepView At a Glance
Hardware Dimensions: 3” x 2.6” x 0.7” (7.6 cm x 6.6 cm x 1.8 cm)

Weight: 2 oz (57 g) (approx.) with batteries
Power: 1 AAA battery
Memory: 1G internal memory
7 Dedicated Channels
1) Heart Rate
2) Pulse Oximetry
3) Airflow (pressure based)
4) Airflow (thermistor)
5) Snore (derived from airflow)
6) Respiratory Effort Belt (RIP)
7) Body Position

SleepView works with the eCrystal PSG Web Portal, allowing treating physicians to initiate home sleep tests directly from their practices. Data from the SleepView is uploaded through the web portal to a network of professional technologists and sleep physicians for timely scoring and study interpretation. Later reports with recommended treatment or follow-up are retrieved by the treating physician. This patient monitoring system allows physicians to provide a continuum of care.

For more information: http://www.clevemed.com/SleepView/overview.shtml

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Investigational Implantable Sleep Apnea Device to be Tested in U.S.

Inspire Medical Systems Inc has been given the go-ahead from regulators to sell the device in Europe and test it in the United States.

The U.S. Food and Drug Administration has given its approval to begin testing the device for safety and efficacy among patients with moderate or severe obstructive sleep apnea at several medical centers in the U. S. and Europe. Patients in the U.S. enrolled in its Stimulation Therapy for Apnea Reduction, STAR, pivotal trial are expected to begin being implanted early next year.

The device delivers a gentle electrical pulse during sleep to restore tone to the muscles that hold the tongue in place. More than 15 million adults in the United States are believed to suffer from obstructive sleep apnea.

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Man v Machine: Automatic scoring exists to assist technologists, not replace them

Giving Automatic Scoring a Second Thought

Changes in technology have been exponential over the last two decades. The sleep medicine industry has advanced significantly by software innovation. In our enthusiasm to wholeheartedly welcome these enhancements to our processes, we sometimes forget that technology in the form of automation is meant to assist, not replace, our skilled technologists.

To automate or not to automate the scoring of sleep studies remains an ongoing debate in our industry and with software giants looking for ways to expand service offerings, the discussion is unlikely to end any time soon. While the notion of computerized analysis holds the promise of decreased staffing costs and increased efficiency, the reality of this premise is far less simplistic. One would no doubt question the rationale behind the insistence that a plane does not require a pilot in light of autopilot technology. Yet there exists a movement that would apply such logic, resulting in the ultimate redundancy of scoring technologists.

Whether as a primary or secondary resource, a registered technologist is essential for an accurate analysis of a patient study—period.

Sleep medicine is still very much a human-centered industry. With over 80 different sleep disorders currently documented, nothing comes close to replicating the nuance and contextually-reliant assessments made possible by intensive, real-life training and experience.

Any sleep facility or homecare company that are uses automatic scoring as a one-for-one alternative to human analysis is neglecting the clinical aspect of patient care. What begins as a well-intentioned, cost-cutting measure emerges as a practice that risks undermining the credibility of an entire industry.

Like every industry, efforts to streamline business and make processes leaner are present in sleep medicine. What we are seeing, however, are moves to market such software as a turnkey solution—completely undermining the specialized nature of sleep scoring and the skills, knowledge and training that go into delivering this process. Laboratories that wish to remain reputable should take a critical look at automated scoring and question whether the absence of registered technologists involved in this process is putting patient care in jeopardy.

The Reality of No Regulations

None of this is to say that automated scoring is without value. On the contrary, it can prove to help the technologist become a more effective clinician—especially as automation matures and is improved.

Early detection, identification of irregularities, cost-efficiency and timely performance  are just some of the benefits that automated systems bring to the table. To ignore these benefits would be denying progress for the sake of it. However,  as the sleep industry is itself still coming of age, it remains vulnerable to unscrupulous business models that risk tarnishing an entire sector by making patient care an after thought.

Discount scoring services have gained significant traction with unsustainably low price points underwritten by unregistered and clinically inexperienced scoring staff.  What such practices fail to respect is that scoring is far more than an objective matter of computation. There are qualitative factors that only trained, registered and clinically experienced technologists can assess.

With minimal regulation of the effects of automatic scoring currently in place, the credibility of an entire industry rests on education and best practices. While sleep medicine awaits increased governance to prevent such fly-by-nights from infiltrating  a valuable healthcare service, automation could aid in the standardization of certain scoring processes. As long as laboratories incorporate the technology primarily as a labour-cutting device, it may prove to be detrimental.

Assist not Replace

Another area of concern lies in the homecare and sectors.  Level III sleep studies are being conducted and automatic analysis is being used for diagnosing patients going against the AASM recommendation to have a secondary review by a Registered Polysomnographic Technologist.

In such a case, automated scoring is not only the primary but the solitary mode of analysis. But scoring software can never comprehensively analyze a Level III study—results must be reviewed and assessed against clinical correlation. Software should be viewed as serving a complementary function in that it assists an RPSGT, who later verifies the automated scores manually and cross-references them with clinically-obtained observations.

Furthermore, one must consider the long-term impact of reliance on scoring software. Crucial information is gathered in the RPSGT’s current role as a front-line, integrated healthcare professional.  The knowledge and skills that arise from working with different patients and various symptoms and conditions could be lost should technologists be removed from the equation.

Know What You’re Getting Into

Pharmacists have also found their profession impacted by automated “advances”. The automated dispensing model they were recently introduced to have raised questions about accountability as dispensing errors can put patients (and businesses) at risk.

It goes without saying that human error can, has and will occur in any facet of healthcare. To be certain, accuracy is one of the dominant selling points of many automated systems used in other fields. However, the rush to market this form of technology may fail because the underlying technology is immature and needs time to evolve as it finds a permanent home within the sleep medicine industry. Even if automatic scoring technology matures to the point that algorithms can account for most variables, it still cannot contend with even the common clinical problems and complexities that come with sleep disorders in order to perform accurate scoring.

This is not to say that automatic scoring has no place in the streamlining of sleep laboratory operations. On the contrary, as time progresses and automated software has been tried and tested perhaps this may well become a fixture in sleep facilities. But with no current regulations governing the use of such software, it is imperative that we consider the following disclaimer: automatic scoring exists to assist technologists, not replace them.

Natalie Morin, RPSGT is president and CEO of Sleep Strategies Inc., a provider of professional scoring and consulting services for sleep disorders facilities worldwide.

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Senate Postpones Cut in Medicare Pay for Physicians

The move would postpone a 25% reduction in physician fees for another year.

AP: The Senate approved a measure Wednesday to avoid a steep cut in pay for doctors by shifting some money from President Barack Obama’s health care overhaul law.

The deal by Senate leaders of both parties was approved by a voice vote and appeared headed for passage by the House, which would send the measure to Obama for his signature. The president had urged lawmakers to move quickly.

“This agreement is an important step forward to stabilize ,” Obama said in a statement.

When Democrats passed the health care law, they used cuts to pay much of the cost of providing insurance to millions who lack coverage. Now, lawmakers are reversing the money flow to stave off a scheduled 25 percent cut to doctors on Jan. 1, tapping financing for the health care overhaul to keep from breaking down.

The $19 billion to pay doctors at current rates for another year will come mostly from tightening the rules on tax credits in the health care law to prevent waste. The credits will make premiums more affordable for millions.

It might seem like the proverbial robbing Peter to pay Paul, with a game of budget tag thrown in.

As bewildering as it sounds, the maneuver shows how federal health care funding is increasingly connected — even among programs serving different constituencies. Just last week, Obama’s deficit commission called for a single government health care budget, a step to getting costs under control.

“Health care spending is a significant part of the federal budget,” said Alex Vachon, a health policy consultant who has served as a Senate GOP aide. “So if they are going to go looking for health care money, they’re going to want to get it from another health care program.”

The move also indicates there could be billions more to be squeezed from such tweaks to the health care law.

Under the overhaul, millions of workers and their families will be eligible for tax credits to help pay insurance premiums. Those subsidies can add up to thousands of dollars per household, available up front each year starting in 2014. The aid is based on income, and people who make less will receive more.

But what if somebody gets a raise, a bonus or a higher paying job later in the year — and they keep quiet about it?

If the government finds out, the law as originally passed said individuals would have to pay back up to $250, and families up to $400.

The latest deal would replace that formula with a sliding scale. That means households with higher incomes would have to pay back a bigger chunk of their tax credit, subject to a limit.

The change shouldn’t significantly affect how many people seek tax credits to buy a policy through new health insurance markets, a congressional aide familiar with the details said. Starting in 2014, most Americans will be required to carry coverage and insurance companies will no longer be able to turn away those in poor health, or charge them more.

For , the agreement by Senate Majority Leader Harry Reid of Nevada, Republican leader Mitch McConnell of Kentucky and other senior senators is likely to only buy time.

The doctor cuts are the result of a 1990s budget-balancing law that tried, but failed, to keep spending in line through automatic reductions. Congress repeatedly stepped in to waive the cuts. Lately, lawmakers have had to act every few months.

Congress was under tremendous pressure this time, with medical groups estimating that as many as two-thirds of doctors would stop taking new patients. Health care for military service members, their families and retirees was also in jeopardy, since Tricare payments are tied to ’s.

Congress will use the 12-month reprieve to try to come up with a new way of paying doctors that rewards quality care instead of sheer numbers of tests and procedures.

“For too long, we have confronted this recurring problem with temporary fixes and stopgap measures,” Obama said. “It’s time for a permanent solution that seniors and their doctors can depend on, and I look forward to working with Congress to address this matter once and for all in the coming year.”

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Compumedics Home Sleep Testing System Selected for Use in US National Institute of Health (NIH)-Sponsored Multi-Ethnic Study of Atherosclerosis (MESA) Sleep Study

CHARLOTTE, N.C. Compumedics USA, Inc. (CMP.ASX) today announced its new Somte® PSG portable sleep-testing systems were chosen as part of a major new study to further investigate the link between sleep disorders and cardio-vascular disease in various ethnic and racial populations.  Somte® PSG was chosen because of its ability to record complex sleep studies in the home environment with acceptable participant burden, according to Dr. Susan Redline, Professor of Medicine at Harvard Medical School and the senior investigator for the Multi-Ethnic Study of Atherosclerosis (MESA) Sleep Study.

The contract is worth approximately US $300 thousand and continues a long record of success for Compumedics in supplying NIH-funded studies.  Importantly it supports Compumedics’ technology and product offering for the relatively new home sleep study (HST) market, which is undergoing double digit growth with global HST revenues already exceeding US $20 million.  Patients enrolled in the MESA Sleep Study will be monitored from the Reading Center located at Brigham and Women’s Hospital in Boston, Mass.

“The Compumedics Somte® PSG systems allow us to record all of the parameters of sleep and breathing that we need to evaluate and quantify abnormal sleep patterns but in the more natural environment of the patients’ homes,” said Prof. Susan Redline, M.D., M.P.H.  ”The Somte® PSG systems also have the ability to capture and analyze heart rhythm data related to the sleep and breathing patterns, which is very important in studying this population.”

Dr. David Burton, chairman and chief executive officer of Compumedics noted, “The NIH MESA Sleep Study holds special significance to Compumedics.  It was Professor Redline’s team who led the original Sleep Heart Health Study (SHHS), during their important investigation into the cardio-vascular consequences of sleep-disordered breathing.  It is once again an honor to be working with Prof. Redline and her team.  Somte® PSG systems uniquely deliver uncompromised data recording with integrated waveform displays, but at the same time incorporate the user friendliness and trouble-free patient operation essential for reliable home sleep testing.  These factors will enable Prof. Redline’s team to collect high quality and meaningful data from these patients with a minimum of inconvenience. In addition, this project comes at an opportune time for Compumedics when the company is focusing its growth on its core product lines, including Somte® PSG, with the expansion of its global sales force.”

The MESA was established by the NIH in 2000 with the aims of identifying ethnic and racial differences in risk factors and subclinical and clinical cardiovascular disease. This new MESA Sleep Study has been funded to further understand these risks.

Over the last 15 years, Compumedics has been selected to supply sleep recorders for several NIH-funded studies, including the multi-center SHHS involving more than 6000 subjects. The Somte® incorporates advanced technology to record sleep studies in either the home or the sleep-lab settings.

Jeff Kuznia, Compumedics USA’s vice-president of sales and marketing, said, “Compumedics’ products successfully met the demanding specifications required to undertake this study and coupled with the unique expertise of the MESA research team, we will improve our understanding of the impact of sleep disorders on cardiovascular disease across a broad ethnic and racial mix of the US population.  This project is timely as we are in the process of expanding our US sales force and releasing our new range of Long Term Monitoring (LTM) EEG and HST products.”

Source: prnewswire

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