BALTIMORE — In a move to standardize sleep test coverage nationwide, CMS issued its final coverage decision regarding obstructive sleep apnea diagnostic tests on Tuesday.
The approved tests include both those administered in a sleep facility as well as in a home setting. Previously, local Medicare contractors established their own coverage policies, and they often varied from state to state.
"This coverage decision establishes nationally consistent coverage and assures that beneficiaries who have sleep apnea can be appropriately diagnosed and referred for treatment," said acting CMS Administrator Charlene Frizzera in an agency statement.
In specifying which tests would be covered, CMS said it "finds that the evidence is sufficient to determine that the results of the sleep tests … can be used by a beneficiary's treating physician to diagnose OSA, [and] that the use of such sleep testing technologies demonstrates improved health outcomes in Medicare beneficiaries who have OSA and receive the appropriate treatment."
The following tests have been deemed "reasonable and necessary," according to CMS:
- Type I Polysomnography is covered when used to aid the diagnosis of obstructive sleep apnea (OSA) in beneficiaries who have clinical signs and symptoms indicative of OSA if performed attended in a sleep lab facility.
- A Type II or a Type III sleep testing device is covered when used to aid the diagnosis of obstructive sleep apnea in beneficiaries who have clinical signs and symptoms indicative of OSA if performed unattended in or out of a sleep lab facility or attended in a sleep lab facility.
- A Type IV sleep testing device measuring three or more channels, one of which is airflow, is covered when used to aid the diagnosis of obstructive sleep apnea in beneficiaries who have signs and symptoms indicative of OSA if performed unattended in or out of a sleep lab facility or attended in a sleep lab facility.
- A sleep testing device measuring three or more channels that include actigraphy, oximetry, and peripheral arterial tone is covered when used to aid the diagnosis of obstructive sleep apnea in beneficiaries who have signs and symptoms indicative of OSA if performed unattended in or out of a sleep lab facility or attended in a sleep lab facility.
In the March 3 decision memorandum, CMS also said certain sleep test devices have been given 510(k) marketing clearance by the Food and Drug Administration.
Under a Medicare ruling issued last July, however, HME providers are prohibited from administering sleep tests, although some providers do offer sleep testing for non-Medicare patients. (See "No MD? Then No Home Sleep Testing," HomeCare Monday, July 21, 2008.)
Read the March 3 CMS decision.