The DME MACs have released revised Local Coverage Determinations (LCDs) for Positive Airway Pressure (PAP) Devices, adding coverage for the Watch-PAT, revising criteria for Type IV devices, issuing continued coverage criteria, and including coverage requirements for beneficiaries enrolling in Medicare who need replacement PAP devices and/or accessories.

“Type IV home sleep studies are acceptable when performed by devices that either directly or indirectly allow calculation of an apnea-hypopnea index (AHI) or respiratory disturbance index (RDI),” a DME MAC letter to physicians says. “Devices that allow direct calculation of AHI/RDI by measuring airflow or thoracoabdominal movement are acceptable. The only currently acceptable Type IV device that indirectly allows calculation of an AHI/RDI are the Watch-PAT devices (Itamar Medical), effective for tests conducted on or after January 1, 2009.”

Commenting on the recently revised LCD, Gary Sagiv, vice president, Itamar Medical Inc, expressed his hope that the new language will clarify coverage by Medicare carriers for sleep studies using the Watch-PAT. “Following the recent NCD published by CMS in 2008, many providers of sleep diagnostic services were seeking explicit clarification regarding coverage for a study utilizing a technology based on the PAT-signal, as it is one of the most effective devices to provide a determination of AHI and RDI as well as assessment of sleep architecture and quality in a study conducted in an unattended setting,” he said.  

Continued coverage criteria was also outlined in the letter:
"To continue coverage for the positive airway pressure (PAP) device (CPAP or RAD) beyond an initial 3 month trial period, there must be:
a) A face-to-face visit with the physician during the second or third month of the trial that documents an improvement of the beneficiary’s symptoms; and
b) A data report from the PAP device which documents use the PAP device for at least 4 hours per night on 70% of nights for a 30 consecutive day period during the trial.

Additionally, coverage requirements for beneficiaries enrolling in Medicare and needing replacement PAP devices and/or accessories are now also included in the LCD.

According to the letter to physicians from the DME MACs:
"For beneficiaries who received a PAP device prior to FFS Medicare enrollment and are now enrolled in Medicare and are seeking a new PAP device and/or accessories, both of the following coverage requirements must be met:
1. Sleep test – There must be documentation that the beneficiary had a sleep test, prior to FFS Medicare enrollment, that meets the FFS Medicare AHI/RDI coverage criteria in effect at the time that the beneficiary seeks a replacement PAP device and/or accessories; and,
2. Clinical Evaluation – Following enrollment in FFS Medicare, the beneficiary must have a face-to-face evaluation by their treating physician who documents in the beneficiary’s medical record that:
a. The beneficiary has a diagnosis of obstructive sleep apnea; and
b. The beneficiary continues to use the PAP device."

The full revised LCDs are available online and took effect January 1, 2009, for all DME MACs.
Cigna Government Services
National Government Services
Noridian Administrative Services

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