Proposed Decision Memo for CPAP for OSA

More at: http://www.cms.hhs.gov/mcd/viewdraftdec ... sp&id=204&

'We received a request to reconsider the 2005 National Coverage Determination (NCD) for CPAP Therapy for OSA (CAG-00093R) to allow coverage of CPAP based upon a diagnosis of OSA by home sleep testing (HST).

Medicare currently covers the use of CPAP in beneficiaries who have been diagnosed with moderate to severe OSA when ordered and prescribed by a licensed treating physician and confirmed by polysomnography (PSG) performed in a sleep laboratory in accordance with § 240.4 of the Medicare NCD Manual. There are currently a number of procedures used by physicians singly or in combination that contribute to a diagnosis of OSA:

* Clinical evaluation
* PSG performed in a sleep laboratory
* HST using Type II, III, & IV devices
* Other devices

In this decision, we are proposing changes to our NCD for CPAP.

1. We are proposing that, due to the evidence demonstrating that no combination of diagnostic procedures adequately identifies all of those beneficiaries who will benefit from CPAP, the coverage of CPAP is initially limited to a twelve week period to identify beneficiaries diagnosed with OSA as subsequently described who benefit from CPAP. CPAP is subsequently covered for those beneficiaries diagnosed with OSA who benefit from CPAP during this twelve week period.

2. We are proposing that the use of CPAP will be covered when diagnosed using a clinical evaluation and PSG performed in a sleep laboratory. In addition, we are proposing to expand coverage of CPAP to include those beneficiaries with a diagnosis of CPAP made using a combination of a clinical evaluation and unattended home sleep monitoring using a Type II, III or IV device.

3. We are proposing to modify the criteria for a positive sleep study to remove the requirement for a minimum two hours of continuous recorded sleep and instead recognize shorter periods of continuous recorded sleep if the total number of recorded events during that shorter period is at least the number of events that would have been required in a two hour period.

4. We are proposing to delete the current distinct requirements that an individual have moderate to severe OSA and that surgery is a likely alternative because these terms are not sufficiently precise.

5. Due to a lack of sufficient evidence that clinical diagnosis alone or clinical diagnosis in combination with devices other than Type I, II, III, or IV adequately identify beneficiaries with OSA that will benefit from CPAP, we are proposing to expand Medicare coverage for CPAP in these instances only when provided in the context of a clinical study when that study meets the following standards:

A clinical study seeking Medicare payment for CPAP provided to the beneficiary pursuant to Coverage with Evidence Development (CED) must address one or more of the following questions:
* In Medicare aged subjects with clinically identified risk factors for OSA, how does the diagnostic accuracy of a clinical trial of CPAP compare with PSG and Type II, III & IV HST in identifying subjects with OSA who will respond to CPAP?
* In Medicare aged subjects with clinically identified risk factors for OSA who have not undergone confirmatory testing with PSG or Type II, III & IV HST, does CPAP cause clinically meaningful harm?
* In Medicare aged subjects with clinically identified risk factors for OSA, how does the diagnostic accuracy of tests other than PSG or Type II, III & IV HST, such as oximetry, peripheral arterial tone and actigraphy, alone or in combination, compare with PSG and Type II, III & IV HST in confirming a diagnosis of CPAP-responsive OSA?"

Thanks for the additional info, James.