Medical Device Daily Washington Editor

While sleep apnea is perhaps a “yawner” to some in med-tech – and always to those afflicted — it is no laughing matter for anyone who has struggled to stay asleep at night (and awake during the day). The potential for obstructive sleep apnea (OSA) leading to heart disease makes the condition all the more compelling for insurance coverage.

As a result of a recent request, the Centers for Medicare & Medicaid Services has proposed rewriting its standards for reimbursement for continuous positive airway pressure (CPAP) devices as well as for what the agency will accept as an OSA diagnostic.

Last January, CMS received a letter from the American Academy of Otolaryngology (AAO; Alexandria, Virginia) to take another look at whether home testing should be sufficient to diagnose the condition. According to the association’s Jan. 2, 2007, letter, in-lab polysomnography is “an expensive test that is not widely available.”

The AAO letter stated that 24% of men employed by the federal government in Wisconsin had OSA, as did 9% of women in that same group, with the threshold of five events per night as a diagnostic criterion. AAO also said that “several studies document the prevalence increases with age can certainly support a prevalence of 10% or more for Medicare patients 65 or older.” And “more than 800,000 drivers were involved in OSA-related motor vehicle collisions in 2000, costing $15.9 billion and 1,400 lives,” it said.

One testing paradigm recommended by AAO is to use CPAP machines in the home.”

Anyone who is suspected of suffering from a sleep-related breathing disorder but not able to tolerate the use of CPAP would then be forwarded to in-lab polysomnography, a test requiring extensive wiring and an overnight stay in a sleep lab.

The association’s request was supported by data from peer-reviewed literature.

The agency issued a decision in mid-December proposing that coverage for CPAP, as an in-home diagnostic, will be initially limited to 12 weeks to aid in the effort to positively identify those with OSA, and Medicare would pay off the device for any such patients who respond positively.

The proposed decision would also “remove the requirement for a minimum of two hours of continuous recorded sleep and instead recognize shorter periods of continuous recorded sleep if the total number of recorded events during that shorter period is at least the number that would have been required in a two-hour period.”

The agency also outlined conditions that a clinical study of OSA would have to be satisfied in order to obtain reimbursement, including the requirement that such a study not duplicate an ongoing or closed study. CMS said it expects to conclude its review on March 13.

Metabolic syndrome found as risk for stroke

If the database at clinicaltrials.gov is any indication, saying that medical science exhibits a strong interest in metabolic syndrome (MS) might be the under-statement of the year. A search of trials at the site using “metabolic syndrome” as a search term returns nearly 800 hits.

A recent paper published in the journal Stroke shows that the condition leaves sufferers at greater risk of stroke, and the distribution of this condition is not even, with women and minorities apparently more likely to acquire MS. (MS is defined differently by different organizations, but the definition by the American Heart Association [Dallas] includes waist circumference, trigylcerides, high-density lipoprotein, blood pressure, and fasting glucose reading data).

In a Jan. 1 article in Stroke, a team of authors led by Bernadette Boden-Albala, director of research of the Neurologic Institute at New York Presbyterian Medical Center, states that while cardiovascular risks associated with the syndrome are fairly well known, “the risk of stroke ... is less well established, with few prospective studies including ischemic stroke as a rigorously defined outcome measure.”

The Northern Manhattan Study, the basis for the article, enrolled almost 3,300 subjects in northern Manhattan to follow them between 1993 and 2001. Using telephone screening to determine whether the patient had been diagnosed with a stroke, the study lost only four patients to follow-up, with a median follow-up time of 6.4 years. Roughly 44% of the enrollees had the condition (48% of women, 38% of men), and half of Latino enrollees were diagnosed with MS, compared to 39% of whites, 37% of blacks.

Participants reported 176 ischemic strokes, 157 myocardial infarctions and 282 vascular deaths. The hazard ratio (HR) for ischemic stroke for the enrollees with MS was 1.5.

Women with MS had an HR for ischemic stroke of 2.0 compared to men, and Latinos also had a ratio of 2.0; whites and blacks both exhibited HRs of 1.3.

The authors conclude that MS “constitutes a major public health burden as defined by its prevalence [and] risk,” and due to the increasing prevalence of obesity, “the impact of the metabolic syndrome is likely to increase.” Consequently, “greater emphasis needs to be placed on the early diagnosis and treatment of [these] patients at risk for vascular disease.”

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