April 5, 2007

With less than two weeks to go in a CMS comment period on a possible CPAP coverage criteria change that could open the door to home sleep diagnostic testing, the respiratory product company evo Medical Solutions, Adel, Iowa, is appealing directly to respiratory therapists (RTs) and home medical equipment (HME) providers to weigh in on the issue.

CMS is reconsidering whether to allow forms of diagnostic testing other than laboratory polysomnography when qualifying a patient for a Medicare or Medicaid provided CPAP device, and evo Medical Solutions wants to make it easier for health care providers to register their approval of the change with CMS. The company has developed a Web site featuring a draft letter to CMS and information about how to submit feedback to the agency before the comment period ends on April 13, 2007.

“evo Medical Solutions is in business to provide health care products, and we strive to stay on the forefront of new technology, new processes, and more efficient methods of serving the industry and its patients,” said Dan Bunting, COO and CFO of evo. “We believe if CMS would cover this new technology, it would provide an additional option for OSA diagnosis. evo believes HMEs and RTs should have their voice in what would be a paradigm shift in the care of this vastly under-diagnosed patient base.”

As previously reported in the e-newsletter "Sleep Report", CMS’ review of its National Coverage Determination (NCD) regarding diagnosis of patients with OSA was sparked by a request from the American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS), which asked CMS to consider including “multi-channel home sleep testing devices” as an option to facility-based PSG.

“We believe this allowance by CMS would benefit the entire sleep therapy industry and improve the quality of life for many patients currently suffering from OSA,” Bunting said. “For the HME providers, it opens a whole new area of service that is currently not available to them; for the respiratory therapists, it allows them to be more directly involved with their OSA patients; and for the sleep labs and sleep doctors, it allows them to pre-screen and connect with those not willing or geographically able to come to a lab. We just don’t see a negative with this initiative to ask CMS to cover in-home sleep testing.”

If CMS changed its position, it would be a shift from its 2005 ruling that decided against coverage for home testing. CMS previously ruled that there was insufficient evidence to conclude that unattended portable multi-channel sleep study testing is reasonable and necessary in the diagnosis of OSA for CPAP therapy.

“In-home testing proponents have long maintained the lobbying power of the American Academy of Sleep Medicine and their doctor members were largely responsible for defeating the measure, which they believed would negatively affect their financial model,” Bunting said. “In our experience, most sleep doctors/labs now understand this is not the case. We believe things will be different this time around because of the increasing awareness of the disease state, more acceptance and approval in the medical community as a whole, and a clear need to save money in the health care system by getting these patients help for their OSA sooner, thereby avoiding more costly and catastrophic health outcomes.”

To read Bunting’s full responses to questions posed by Sleep Review, click here.

—Franklin A. Holman