When it comes to respecting home sleep testing, the CEO of Itamar Medical believes the American Academy of Sleep Medicine (AASM) has finally come around. Evidence for the belief can be found in the AASM’s Accreditation of Out of Center Sleep Testing for Adult Patients, a program announced in February 2011.

With the stated purpose “to meet the changing needs of our members, sleep disorders centers, and the sleep medicine field,” the new program signals what Dov Rubin, PhD, believes is a growing acceptance of home sleep testing on the part of AASM.

“The potential patient benefits are enormous,” says Rubin. “The AASM is now actively preparing their members to capitalize on home testing and use it to their advantage. This occurred at the recent winter meeting in La Jolla [Calif] where they told membership that it is not a question of ‘if’ home sleep testing will come around, but ‘when’ and, more importantly, how the membership should capitalize on these developments.”

The newfound clinical respect coincides with a growing realization that home sleep testing can peacefully coexist with the business interests of in-lab testing. Working together to see and ultimately help more people is the idea, and the AASM’s new stance could go a long way toward this goal.

The 50% Rule

Rubin suspects that the AASM’s friendlier approach is likely driven by a realization that sleep laboratories have inherent limitations. “I like to say that 50% of the population would not walk into a sleep lab if their life depended on it,” says Rubin, who holds a doctorate in biomedical engineering from the University of Southern California. “The AASM realizes that they can now provide vital medical help for a larger percentage of the population just as we also know that home sleep testing is not for everyone. For more difficult cases, it is obvious that an in-lab sleep center will be more appropriate. This will convert the sleep lab into a true sleep health center. It took the leadership of the AASM to give the blessing, and they have really turned the corner.”

A shift in AASM philosophy is no small matter, and the change of heart could presage a day when many more CPAP prescriptions are given out based on home results alone. “That is always a question that concerns the insurance companies, because they are afraid of an explosion in the use of CPAP,” says Rubin. “I don’t know whether more home sleep testing acceptance will bring an increase in cost. Quite the opposite. Statistics show that for every dollar spent on preventive medicine, $12.50 is saved 10 years down the road. If insurance companies are looking at this as a long-term cost savings, it is well worth it.”

Devoted Following

DME providers with long-standing sleep lab partnerships have relied on the PAT® (peripheral arterial tone) signal technology found in Itamar’s WatchPAT device for a long time. Rubin attributes the loyalty to ease of use. “You get logical and simple usage with the WatchPAT,” says Rubin. “It makes good intuitive sense. It is not some sort of a tethered medical device, and it is not intimidating.”

Right now, WatchPAT is FDA-cleared only for people age 17 and above. Company officials have fielded a lot of requests from lab directors and sleep physicians, and they are providing data to regulators in an effort to expand the age range to include younger patients. Rubin estimates approval could materialize in the next 6 months, but it depends on the FDA.

Home Sleep Harmony

These days, there is a realization that sleep labs and home testing can work together harmoniously. For example, savvy DME providers can bring in those undiagnosed sleep apnea sufferers, and send the more complex cases to sleep labs. “My estimate is that home sleep testing will increase sleep lab business by at least 30% because there will be referrals,” explains Rubin. “To this, add Board-certified interpretation of results, patient treatment, and testing which will ultimately add up to more business for sleep labs.”

Reimbursement for home sleep testing has gone down, as has reimbursement for in-lab sleep tests. PAT technology received its own code (95800) this year, and with it what Rubin deems a “fairly good price” of about $205 per test. Since it is a new code, providers can count on this Medicare dollar amount remaining fixed for the next 2 years. Private payers, on the other hand, may be lower or higher depending on the company.

Future is Bright

The massive potential of the sleep market is now considered all but a sure thing among sleep labs and sleep industry manufacturers. And, as patient awareness grows, clinical knowledge and infrastructure inevitably rises to meet the challenge. Rubin believes the modern age of sleep medicine is quickly developing into an era where turf battles are tossed aside and patients take center stage. Telemedicine and physician- friendly, web-based access to sleep studies, as offered by WatchPAT, becomes yet another modality for patient ease of use and treatment.

Reimbursement wars have largely focused on the diagnostic utility of ambulatory sleep studies, but innovations such as the PAT signal technology have a distinct place among a variety of options. With hypertension affecting roughly 50 million Americans, and sleep apnea pegged as one of the causes, the stakes are high and cooperation is essential. “We want to start with the common understanding among sleep physicians that ambulatory sleep monitoring is their friend, not their enemy,” says Rubin. “We are trying to show sleep physicians that there is nothing to be afraid of here, and these ambulatory sleep studies are an adjunct to what they do — not much different from what they do today. Sleep physicians still have the 6 to 8 channels of polysomnographic data, and they analyze it just as they would any other polysomnogram.”

In a recent issue of Sleep Diagnosis and Therapy, Koby Sheffy, PhD, essentially agreed with Rubin, writing that the role of unattended sleep studies in the management of sleep apnea patients has substantially evolved in recent years. While PSG will continue to be recognized as the most comprehensive sleep study paradigm, Sheffy believes it will probably not remain as the only testing modality. “Increased clinical demands, shifts in health care environment, and technological developments will contribute to a growing acceptance of simpler diagnostic options,” writes Sheffy in a 2009 article entitled Shattering the Black Box Myth: PAT Technology in Action. “Thus, over the next few years, sleep labs will be required to assess their services and determine how to adapt to and benefit from the shifting landscape.”

Part of this landscape will undoubtedly include the physiological signals generated by PAT. “At first glance, systems incorporating PAT signals might be perceived as yet another black box,” adds Sheffy. “Understanding the simple physiological rationale upon which it is based shows that it is far from being a mystery.”

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Dov Rubin is President & CEO of Itamar Medical Caesarea, Israel.
For more information visit http://www.itamar-medical.com

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Out of Center Sleep Testing

AASM officials say that sleep service entities interested in obtaining accreditation as a provider of out of center sleep testing can go to http://www.aasmnet.org and download an application. Accompanying Standards for Accreditation of Out of Center Sleep Testing are also available for download at the Web site. The AASM’s accreditation department can be reached via e-mail: ocstaccreditation@aasmnet.org

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