That’s all changing. In March, the Centers for Medicare and Medicaid Services, whose reimbursement rules are generally adopted by private insurers, dropped its long-standing opposition to home studies. According to the National Coverage Determination that was released that month, a diagnosis of obstructive sleep apnea can be made—and CPAP therapy covered—on the basis of a clinical evaluation coupled with a home study using a device that measures, at a minimum, airflow, heart rate, and oxygen saturation.
A positive diagnosis is established if: The apnea-hypopnea index as measured by the portable device is 15 or more (15 apneas or hypopneas an hour) or the AHI is between 5 and 14 and the patient has documented symptoms of excessive daytime sleepiness, impaired cognition, mood disorders, hypertension, ischemic heart disease, or history of stroke.
The NCD specifies that the home study must be ordered and supervised by the treating physician. It also limits the initial coverage of CPAP to a 12-week trial period.
Previous to its 2008 decision, the CMS had considered and rejected home studies on four occasions. In its last rejection, in 2005, the government body declared that there was insufficient evidence to support the contention that portable monitoring was a valid diagnostic tool.
It was asked to revisit the issue by the American Academy of Otolaryngology – Head and Neck Surgery. An association of specialists who treat conditions of the ear, nose, and throat, the AAO-HNS in its petition to the CMS maintained that
the prevalence of sleep disordered breathing, combined with a paucity of laboratories that could perform the required polysomnographic studies, resulted in unacceptable delays in diagnosis and treatment. Citing a number of studies, the organization stated that “home sleep testing is a validated alternative” to lab testing, and declared that “it is incumbent upon CMS to lead the way to improve diagnostic and treatment paradigms” by covering portable monitoring.
Clearly, the CMS found compelling the AAO-HNS argument, which was buttressed by testimony from numerous individuals and organizations, among them the ASAA. But the change in CMS policy does not reflect a consensus among practitioners. During the deliberative process, the CMS heard objections, some strenuous, from medical professionals and organizations (including the American Academy of Sleep Medicine) unconvinced that change was called for and that the new policy will prove to be in the best interest of patients.
Some of the disagreement revolves around how difficult it actually is for patients to access in-lab studies and consequent care. Another dispute has to do with how much data is needed to make a diagnosis. (Some doctors will tell you, off the record, that most of the time they don’t really need a sleep study of any sort – they can look around their waiting rooms and pick out the people with sleep apnea. They’re the ones who, rather than impatiently leafing through a magazine or talking on a cell phone, are taking a nap.)
But some physicians’ qualms about home studies go to the fundamental nature of sleep disorders, and of sleep itself. Dr. Steven Feinsilver, a specialist in sleep medicine who teaches at New York University, points out that while a portable device that measures airflow can detect disordered breathing, it can’t diagnose sleep-disordered breathing, since it can’t tell whether a person is, in fact, asleep.
“You can’t monitor sleep at home,” Dr. Feinsilver says flatly. “Without an EEG [an electroencephalogram, which measures brainwave activity], you have no way of knowing if somebody is asleep or awake.”
“A home study doesn’t take the place of a laboratory sleep study,” he continues. “Spending a night in a sleep lab has enormous benefits for relatively little cost. But the sleep community has not voiced that view. It’s just rolled over and played dead. It’s terrible.”
On the other hand, physician Michael Coppola, a board member of the ASAA, is delighted with the CMS decision. He himself, frustrated with the long waits his patients endured before they could schedule a lab study, and sympathetic with their anxieties about traveling long distances to sleep in a strange place, was using portable monitoring 20 years ago, as part of a collaboration with an HMO.
“It was my preferred methodology at the time,” he says. “I’d do a home test, and give the patient a CPAP set at the lowest pressure. I’d ask the wife if her husband was still snoring, and raise the pressure until he stopped. Lo and behold, it worked. I very quickly ended up with a lot of healthy, happy patients.”
Such a low-tech approach—which admittedly has the drawback of requiring a bed partner—is not likely to be the future of OSA therapy. At this point, however, it’s not possible to say what that future will be. It may be that portable monitoring will be used in appropriate, selected populations of comparatively healthy patients with relatively simple SDB, with laboratory studies reserved for more complex situations, increasing access to care for all. Or it may be that financial considerations—a lab study costs about three times as much as a home study—will become paramount, making polysomnography a luxury item for those who can afford Cadillac care. Or, in an even worse-case scenario, the market may be flooded with shoddy home devices that make proper diagnosis and treatment more elusive.
As mentioned earlier, the American Academy of Sleep Medicine is on record opposing the CMS coverage expansion. However, the academy, anticipating the rule change, convened a task force in 2007 to develop guidelines for the use of portable monitoring. These were published in the Journal of Clinical Sleep Medicine,Vol. 3, No., 7, 2007.
The guidelines, which are highly nuanced and complex, cannot be summarized in this article. But one of the major points can serve as the conclusion here: Portable monitoring “should be integrated into a comprehensive program of patient evaluation and treatment under the direction of a sleep specialist board certified in sleep medicine.”
Or perhaps we’ll give Coppola the last word. “One doesn’t get a test [i.e., a sleep study] the way one gets an x-ray,” he points out. “Success isn’t about the test, it’s how the patient is managed before, during, and after the test.”