Legal Speak

CMS Releases NCD on Home Sleep Testing

• By Asela Cuervo
• May 01, 2008

As expected, on March 13, 2008, the Centers for Medicare & Medicaid Services (CMS) released a decision memo on a national coverage determination (NCD) for the use of home sleep tests to diagnose obstructive sleep apnea (OSA). CMS’ decision had been the subject of much speculation in the clinical and provider communities, and many expected CMS to approve home sleep studies for diagnosing OSA. In fact, CMS’ decision permits the use of home sleep tests, but CPAP is covered only for a trial period of up to 12 weeks regardless of the type of test performed, unless the beneficiary demonstrates that he is benefiting from therapy. The devices approved for home studies include Type II, III or IV with at least three channels.

The coverage analysis generated a lot of controversy, especially with respect to the circumstances surrounding a home study. In response to comments, CMS emphasized that home sleep studies would not replace facility-based studies. Rather, the patient’s physician will be responsible for determining whether a patient is an appropriate candidate for a home study. If not, CMS expects the physician to order a facility study for that patient. The physician’s assessment of the patient should include whether the patient is capable of “successfully completing” the home study. CMS also acknowledged that in some instances, the home-based study could have questionable results. The decision memorandum raises the possibility that, in some instances, a second test in a facility may be warranted. CMS makes it clear, however, that there would not be a medical need to perform two tests for most beneficiaries.

An important question that the decision memo does not address is how CMS will determine whether a beneficiary is benefiting from the use of CPAP therapy given that CPAP beyond the 12-week trial will not be covered unless beneficiaries can demonstrate “appropriate therapeutic use and response to the trial use of CPAP.” CMS anticipates that Medicare contractors will put in place appropriate policies to ensure that the use of CPAP is consistent with the national coverage determination and other regulations, such as those that govern Medicare payment for diagnostic tests. The agency also expects that the beneficiary’s medical record will contain “contemporaneous documentation” that will be “adequate to describe the beneficiary’s condition for services provided in the context of OSA treatment.”

In other words, the Medicare contractors will have a significant say in how the new coverage policy will be applied. This means that there will no doubt be requirements for respiratory providers to maintain extensive documentation.

Once CMS publishes the final NCD, the contractor medical directors will revise the local coverage determination (LCD) for CPAP consistent with the new CMS policy. The contractors have considerable leeway to address these issues so long as the local coverage policies remain consistent with the NCD and applicable laws and regulations. That process is likely to begin later this year.

This article originally appeared in the Respiratory Management May 2008 issue of HME Business.