Medicare may soon begin providing coverage for continuous positive airway pressure devices for beneficiaries who have been diagnosed with obstructive sleep apnea using unattended home monitoring.
The coverage proposal is an expansion of Medicare's current policy, which provides coverage for CPAP only when a diagnosis of obstructive sleep apnea (OSA) has been confirmed using polysomnography in a sleep laboratory.
“Our proposed policy to extend coverage for continuous positive airway pressure provides more options for Medicare beneficiaries and their treating physicians,” Kerry Weems, acting administrator for the Centers for Medicare and Medicaid Services, said in a statement.
CMS plans to issue a final national coverage determination in March 2008. Medicare officials estimate that as many as 4 million Medicare beneficiaries have OSA.
The CMS proposal would extend coverage in cases where the diagnosis was made with a combination of a clinical evaluation and unattended home sleep monitoring. Medicare also is proposing to cover CPAP when the diagnosis of OSA is made through a clinical evaluation or another type of diagnostic test, as long as the patient is participating in a research study that meets CMS standards for clinical trial policy.
The current proposal “as is” is likely to result in a “wasteful use of resources” and could hurt patients, said Dr. Robert Thomas of Beth Israel Deaconess Medical Center in Boston. Single-channel sleep monitoring devices have many problems, including false-negative results, said Dr. Thomas, who holds patents for technology to estimate sleep quality from an ECG and for CO2 use in mixed sleep apnea treatment.
However, Dr. Thomas said, the CMS final policy is likely to be more sensible. “I do believe that doing all studies in the lab is not cost, time, or effort efficient,” he said. “So there is much merit in a sensible, best-science driven portable recording policy.”
The CMS also plans to limit coverage for the CPAP devices to an initial 12-week period to gauge whether the patient will respond to the treatment. Medicare will continue to cover use of the CPAP in those patients who respond to the treatment.
In addition, the CMS is planning to eliminate the requirement for a minimum 2 hours of continuous recorded sleep during testing, because patients with severe OSA may not be able to meet the requirement. Dr. Thomas praised this aspect of the proposal, because some patients with severe disease and badly fragmented sleep never reach the sleep threshold quickly enough to conduct an air pressure titration on the same night.
The CMS based its decision on advice from the Medicare Evidence Development and Coverage Advisory Committee, external technology assessments from the Agency for Healthcare Research and Quality, a review of individual clinical studies, and public comments. Agency officials concluded that the evidence was sufficient to allow for coverage based on diagnosis with type II, III, and IV home sleep testing monitors in appropriately selected patients.