CMS Coverage Decision Specifies Allowable Sleep Tests

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.