News | March 25, 2008

Watch-PAT From Itamar Medical To Be Included As An Accepted Ambulatory Device For Medicare And Medicaid Beneficiaries

Framingham, MA - Itamar Medical Inc. is pleased to report that the Centers for Medicare and Medicaid Services (CMS) has released in March 13th, 2008, its final National Coverage Decision (NCD) where it has decided to cover the Watch-PAT for home diagnosis of obstructive sleep apnea. This decision will make the Watch-PAT available to Medicare beneficiaries nationwide.

The CMS Final Decision Memorandum discussed the Watch-PAT and the clinical evidence supporting its efficacy in very positive detail. Of particular note is CMS's response to comments that asserted that the Watch-PAT is a useful diagnostic tool and should not be required to provide additional data under Coverage with Evidence Development.

"Today's decision will mean that Medicare beneficiaries in the United States will have access to one of the most accurate, convenient, and cost-effective home sleep testing diagnostic device for sleep apnea," said Itamar Medical CEO Israel Schreiber. "Medicare now joins the Department of Veterans Affairs, Kaiser Permanente, and other organizations and physicians nationwide in recognizing the usefulness and benefits of Watch-PAT in the diagnosis of sleep apnea."

In its announcement, Itamar Medical was pleased to have found that the CMS singled out the Watch-PAT and distinguished it from others by creating a special category to fit this unique technology. Medicare will not cover devices that are considered to be Level IV devices with one or two channels. This means that physicians will be reimbursed by Medicare for using the Watch-PAT to diagnose obstructive sleep apnea in Medicare beneficiaries and for any subsequent CPAP therapy ordered based on the Watch-PAT results.

"The Watch-PAT is already a widely used home sleep testing device and this coverage decision means that all Medicare beneficiaries suspected of having obstructive sleep apnea will have access to a device that was designed to provide uniquely convenient and comfortable use with proven accurate and reliable performance," said Gary J. Sagiv, Itamar Medical Inc's Vice President.

CMS will now issue instructions to the local insurance companies that home sleep testing with the Watch-PAT should be paid when it is medically necessary. Itamar will be working with CMS to obtain a temporary code (G code) to describe the Watch-PAT until a permanent Category I CPT code is approved. Itamar Medical has already submitted a CPT application for the June meeting of the CPT Panel.

SOURCE: Itamar Medical Inc.