Medicare has expanded its coverage of continuous positive airway pressure therapy for obstructive sleep apnea to include patients who were diagnosed using home sleep tests.
Officials at the Centers for Medicare and Medicaid Services handed down their final decision, after first proposing the change last December.
The new coverage policy is a significant departure from the agency's 2005 policy, which provided coverage for continuous positive airway pressure (CPAP) devices when the diagnosis was made using polysomnography in an attended sleep laboratory. The new policy will add coverage for CPAP following a clinical evaluation in combination with a positive result on an unattended home sleep monitoring device of type II, type III, or type IV measuring at least three channels.
CPAP therapy prescribed based only on a clinical evaluation or a test that is not specified by the CMS will be covered only in the context of a clinical study, according to the new coverage policy.
The CMS has also eliminated the requirements that individuals have moderate to severe obstructive sleep apnea and that surgery is a likely alternative, to be covered for CPAP therapy. The agency also eliminated its requirement for a minimum of 2 hours of continuous record sleep to make a diagnosis of obstructive sleep apnea.
But CMS officials are limiting coverage of CPAP devices to an initial 12-week trial period. Only those beneficiaries who improve on the devices will be able to continue to receive coverage.
The agency will also continue monitoring use of home testing for obstructive sleep apnea to detect potential fraud.
“[The] policy provides more options for Medicare beneficiaries and their treating physicians. At the same time, we remain vigilant to ensure that Medicare payments for these services do not create incentives for inappropriate use,” Kerry Weems, CMS acting administrator, said in a statement.
While experts say the revised policy does a lot to improve access, it could have unintended consequences for the more than 4 million Medicare beneficiaries who have some form of obstructive sleep apnea.
Dr. Robert Thomas, sleep medicine fellowship director at Beth Israel Deaconess Medical Center, Boston, said the final policy is an improvement over last year's proposal because it specifies that any type IV sleep test used must have at least three channels. Single-channel devices have numerous problems including false negative results, he said.
While the policy allows for greater access to CPAP therapy, there is no guarantee it will be followed by appropriate care, said Dr. Thomas, who holds patents for technology to estimate sleep quality from an ECG and for CO2 use in mixed sleep apnea treatment. “Sleep apnea management is not simple and many patients with sleep apnea have comorbid sleep disorders.”
Dr. Alex Chediak, president of the American Academy of Sleep Medicine, and a sleep specialist based in Miami, said that in the short run the policy could cause a lot of durable medical equipment vendors to jump into the market to reap the financial benefits without providing the proper level of support to patients. The equipment will show up on the patients' doorsteps but they won't know what to do with it and “physicians will be left holding the bag.” But in the long run, the policy will improve access and outcomes, he predicted.
Guidelines issued last year from the American Academy of Sleep Medicine outline the appropriate use of unattended portable monitors in diagnosing obstructive sleep apnea. They recommend that unattended portable monitors be used only for obstructive sleep apnea diagnosis in conjunction with a comprehensive sleep evaluation (J. Clin. Sleep. Med. 2007;3:737–47).
They also state that portable monitoring is not appropriate for the diagnosis of obstructive sleep apnea in patients with significant comorbid medical conditions that may interfere with the accuracy of the home test. Portable home tests are also inappropriate for diagnosing patients who may have comorbid sleep disorders.
The national coverage determination is available online at www.cms.hhs.gov/center/coverage.asp