Legal Speak

Questions Persist After Proposed Decision on Sleep Testing

At the end of last year, the Centers for Medicare & Medicaid Services (CMS) released a proposed decision memo on a national coverage determination (NCD) for the use of home-based sleep testing to diagnose obstructive sleep apnea (OSA). The decision had been the subject of much speculation in the clinical and provider communities with many expecting CMS to approve the use of home-based sleep studies for the diagnosis of obstructive sleep apnea (OSA) and subsequent treatment with CPAP devices. Current Medicare coverage policy for CPAP requires a diagnosis of OSA rendered in a "facility-based sleep study laboratory, and not in a home or mobile facility."

As expected, the proposed decision memo indicates that CMS will permit home-based studies for the diagnosis and treatment of OSA. CMS also has proposed changes in the apnea hypopnea index to diagnose OSA. The decision memo is preliminary; CMS has requested comments on its proposal and will issue a final NCD later this year. The proposed decision memo would permit Medicare coverage of:

  • a trial period of CPAP of up to 12 weeks duration when ordered and prescribed by a licensed treating physician to be used in beneficiaries who have a positive facility-based polysomnography (PSG); and
  • a trial period of CPAP of up to 12 weeks duration when ordered and prescribed by a licensed treating physician to be used in beneficiaries who have a positive home sleep test, including only Type II, III or IV machines.

CPAP beyond the 12-week trial period for beneficiaries who qualified on the basis of a positive PSG or a home sleep study would be covered only for those who demonstrate appropriate therapeutic use and response to the trial use of CPAP. Medicare contractors would be permitted to consider reports obtained via a compliance monitor as a factor in making this determination.

The proposed decision memo also would provide for coverage of CPAP in the absence of a PSG or home sleep test based on a clinical diagnosis only when the beneficiary is enrolled in a clinical trial of CPAP that meets CMS standards.

At press time, the decision memo was only a proposal and many questions remain about what the final coverage policy will include. One question is what type of devices might be approved for home studies in the final policy. Another significant question for respiratory providers is what evidence will be required to demonstrate a beneficiary's compliance and response to the trial use of CPAP. Because OSA is a chronic disease with serious co-morbidities, CMS policy should require additional education or other interventions, such as a change in the nasal/oral interface, before coverage is discontinued for non-compliant beneficiaries. Whether the final NCD will permit such interventions remains unclear. One likely scenario is that the Medicare contractors will determine what evidence qualifies a beneficiary for CPAP beyond the initial 12-week trial.

CMS is expected to issue a final decision in the spring.

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

About the Author

Asela M. Cuervo, Esq., specializes in legal/regulatory cases and issues concerning the HME industry, and is a member of CMS' Program Advisory and Oversite Committee regarding national competitive bidding. The Law Office of Asela M. Cuervo, located in Washington, D.C., can be reached at (202) 496-1281 or

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