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<strong>CMS</strong>-1403-FC<br />

by the Medicare program. We believe that in most cases the<br />

provider that would be submitting a claim for payment<br />

related to the sleep test will not be the beneficiary’s<br />

primary physician but will be another party, for example,<br />

another physician or a diagnostic testing entity. We note<br />

that only rarely would a Medicare participating physician<br />

also be enrolled as a Medicare DME supplier.<br />

b. Regulation<br />

In the CY 2009 PFS proposed rule, we proposed to<br />

prohibit DME supplier payment for a CPAP device if the<br />

provider of a sleep test that is used to diagnose<br />

obstructive sleep apnea (OSA) in the Medicare beneficiary<br />

is the DME supplier or an affiliate of the supplier of the<br />

CPAP machine used to treat the beneficiary’s sleep apnea.<br />

The proposal applied to all sleep testing from attended<br />

facility-based PSG to unattended HST.<br />

Based on section 1871(a)(1) of the Act, which provides<br />

the Secretary with the authority to “prescribe such<br />

regulations as may be necessary to carry out the<br />

administration of the insurance programs under this title,”<br />

and section 1834(j)(1)(B)(ii)(IV), which requires suppliers<br />

of equipment and supplies to “meet such other requirements<br />

as the Secretary may specify,” and due to our concerns with<br />

respect to the potential for unnecessary utilization of<br />

729

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