Legal Speak

CMS Reconsiders Coverage for Home Sleep Studies

• By Asela Cuervo
• Sep 01, 2007

Earlier this year, the Centers for Medicare & Medicaid Services (CMS) initiated a national coverage analysis (NCA) of the national coverage determination (NCD) for continuous positive airway pressure (CPAP) devices.

The current NCD covers CPAP as a treatment for individuals diagnosed with obstructive sleep apnea (OSA). The NCD, however, places limits on how patients may qualify for coverage of CPAP devices under Medicare. Current Medicare policy requires that the diagnosis of OSA be determined as the result of a facility-based polysomnography, or sleep study. The NCA for CPAP has generated much excitement because of the prospect that CMS may relax its prohibition on using home sleep studies.

This is not the first time that CMS has considered relaxing the prohibition on home sleep studies. In 2004, CMS also considered whether to relax the requirement for facility-based sleep studies under the CPAP NCD. In the end, CMS concluded that there was not sufficient evidence to support the use of home sleep studies for the OSA diagnosis.

CMS initiated the current NCA in April, only three years after initiating the last one. Advocates of home sleep studies are encouraged that CMS is willing to reconsider its decision so soon. They contend that portable sleep studies are safe and clinically reliable, that patients prefer to be tested at home, and that home sleep studies will improve access to testing. Advocates also point to significant Medicare savings from home studies, compared to facility-based studies. These advocates note that other public and private sector payors have successfully incorporated home testing into their OSA protocols.

These are powerful arguments. There is a considerable body of clinical data to support the adverse health effects of OSA. These include increased risk of heart attack and stroke. Untreated OSA also has been recognized as a factor in automobile accidents. Importantly, there is increasing awareness of the symptoms and consequences of untreated OSA among the public, prompting many individuals who might not have otherwise sought diagnosis and treatment to do so. Adequately diagnosing and treating OSA would save health care dollars in the long run. Covering home sleep studies under the Medicare program would immediately provide a cost-effective alternative to facility-based polysomnography.

As strong as the arguments are, not everyone supports expanding Medicare coverage to include home sleep studies. Opponents are concerned that unattended sleep studies may not be safe for patients and could be clinically unreliable. Although there are studies that support the safety and reliability of home sleep studies, it is nonetheless difficult to predict what CMS will decide.

In June, CMS published a notice announcing that the Medicare Evidence Development and Coverage Advisory Committee (MedCAC) will meet Sept. 12 to consider the CPAP NCD, including whether home sleep studies should be covered for the diagnosis of OSA under Medicare.

MedCAC provides advice and recommendations to CMS about whether scientific evidence is adequate to assess whether a device or service should be covered under Medicare. Given MedCAC’s role in advising CMS, its job will be to consider the scientific evidence that supports the safety and clinical reliability of home sleep studies, at least for certain patient populations. CMS will consider the MedCAC’s conclusions and recommendations and, as in the past, is likely to act on them.

We can expect a final NCA in March 2008.

This article originally appeared in the Respiratory Management Sept/Oct 2007 issue of HME Business.