Notice: This CMS-approved document has been submitted - Philips ...
Notice: This CMS-approved document has been submitted - Philips ... Notice: This CMS-approved document has been submitted - Philips ...
CMS-1403-FC sleep tests, we shall prohibit payment to the supplier of the CPAP device when such supplier, or its affiliate defined as a person or organization that is related to another person or organization through a compensation arrangement or some type of ownership, is directly or indirectly the provider or the interpreter of the unattended out of facility sleep test that is used to diagnose a Medicare beneficiary with OSA. We considered several options. We considered whether a narrower prohibition could reasonably accomplish the purposes of this regulation at this time. Exceptions for providers that offer integrated disease management models were considered. We also considered allowing an exception for nationally accredited disease management programs but we are unaware of any current model that would encompass accreditation for both OSA diagnosis and CPAP supply under a single accreditation certificate. Therefore, we proposed to revise the durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) supplier enrollment safeguards set forth at §424.57 to protect the Medicare program and its beneficiaries from fraudulent or abusive practices that may be related to CPAP devices. We also proposed to add new definitions to paragraph (a) to define “Continuous positive airway 730
CMS-1403-FC pressure (CPAP)” and “sleep test” and to add a new paragraph (f), which would establish a specific payment prohibition that would not allow the supplier to receive Medicare payment for a CPAP device if that supplier, or its affiliate as defined above, is directly or indirectly related to the provider of the sleep test that would used to diagnose the beneficiary with OSA. In this final rule, in response to public comment, we are adding additional definitions for “affiliate”, and “attended facility-based polysomnogram”, and clarify the definitions of “Continuous positive airway pressure (CPAP)”, and “sleep test.” In addition, we are adding a new paragraph (g), which would create an exception to the prohibition contained in (f) if the sleep test is an attended facility-based PSG. The following is a summary of the comments we received and our responses. Comment: Many commenters maintained that the prohibition is unfair and that it “singles out” sleep diagnostics and therapies for a special payment prohibition. They maintain that there is no evidence that sleep tests promote “self interested” referrals any more than do referrals from any other diagnostic tests. 731
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<strong>CMS</strong>-1403-FC<br />
pressure (CPAP)” and “sleep test” and to add a new<br />
paragraph (f), which would establish a specific payment<br />
prohibition that would not allow the supplier to receive<br />
Medicare payment for a CPAP device if that supplier, or its<br />
affiliate as defined above, is directly or indirectly<br />
related to the provider of the sleep test that would used<br />
to diagnose the beneficiary with OSA.<br />
In this final rule, in response to public comment, we<br />
are adding additional definitions for “affiliate”, and<br />
“attended facility-based polysomnogram”, and clarify the<br />
definitions of “Continuous positive airway pressure<br />
(CPAP)”, and “sleep test.” In addition, we are adding a new<br />
paragraph (g), which would create an exception to the<br />
prohibition contained in (f) if the sleep test is an<br />
attended facility-based PSG.<br />
The following is a summary of the comments we received<br />
and our responses.<br />
Comment: Many commenters maintained that the<br />
prohibition is unfair and that it “singles out” sleep<br />
diagnostics and therapies for a special payment<br />
prohibition. They maintain that there is no evidence that<br />
sleep tests promote “self interested” referrals any more<br />
than do referrals from any other diagnostic tests.<br />
731