Current policy requires a sleep test, or polysomnography, to be performed in a facility-based sleep lab, but the agency has recommended changes, which, among others, would allow the use of home sleep testing.

Among those to weigh in was the American Academy of Sleep Medicine (AASM), which sent a four-page response to the proposed decision memorandum, issued Dec. 14. (See HomeCare Monday, Dec. 17, 2007.)

AASM challenged what it calls "inconsistencies and omissions" within the draft memo. In particular, the Academy said it is contesting "CMS' inclusion of Type IV portable monitoring devices as acceptable for home sleep testing, and raising concern over the vagaries regarding an acceptable CPAP trial, requirements for clinical evaluation and a paradigm for follow-up and long-term management."

In addition, the AASM pointed to concerns regarding the evidence CMS used as the base for its proposed decision, noting that "the studies cited in the proposed draft did not include the patient population covered by Medicare." AASM also said other important topics are not addressed in the proposed decision, including documentation of OSA and determination of severity, which, the Academy contends, is best measured through in-lab polysomnography.

Among issues the Academy addressed:

--"The proposal fails to define the measures by which any physician, especially those inexperienced and untrained in sleep medicine, would assess the benefit of therapy and also does not call for long-term management through programs that emphasize education and follow-up care."

--"While the AASM supports the use of Type II and III [home sleep testing] devices by board certified sleep specialists in patients with a high pre-test probability of moderate to severe [OSA], it does not support the indiscriminate use of HST by physicians untrained in sleep medicine."

--"Consistent with its clinical guidelines, the AASM supports Type II and III HST devices. However, the AASM does not support the inclusion of Type IV HST devices." Such devices have only one or two monitoring channels, the Academy said, the use of which "makes ripe the potential for substandard patient care and a substantial increase in unnecessary tests."

While AASM supports some of the recommendations in the CMS draft, the organization said CMS needs to clarify who exactly is covered by the NCD and answer additional questions before rendering its final coverage determination.

View CMS' proposed decision memo.