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 aware of appropriate accrediting models, we will readdress the issue in future rulemaking. Based on section 1871(a)(1) of the Act, which provides the Secretary with the authority to “prescribe such regulations as may be necessary to carry out the administration of the insurance programs under this title,” and section 1834(j)(1)(B)(ii)(IV), which requires suppliers of equipment and supplies to “meet such other requirements as the Secretary may specify,” and due to our concerns with respect to the potential for unnecessary utilization of sleep tests, we shall prohibit payment to the supplier of the CPAP device when such supplier or its affiliate is directly or indirectly the provider of the HST 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 sleep management programs 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. 752
CMS-1403-FC After reviewing the public comments, we are finalizing the prohibition in §424.57 as proposed but with an exception for attended facility-based PSG. Excepting facility-based PSG from the prohibition on providing CPAP would not except HST performed by the same entity, that is, the exception is at the test level not the facility level. We plan to solicit public input on accreditation models that might support future exceptions to this prohibition. We add additional definitions for “affiliate”, “attended facility-based polysomnogram,” and clarify the definitions of “Continuous positive airway pressure (CPAP)” and “Sleep test”. 3. Beneficiary Signature for Nonemergency Ambulance Transport Services In the CY 2008 PFS final rule with comment period (72 FR 66406), we created an additional exception to the beneficiary signature requirements, applicable for emergency ambulance transports, in §424.36(b)(6). The exception allows ambulance providers and suppliers to sign on behalf of the beneficiary, at the time of transport (that is, the time during which the beneficiary is picked up and dropped off at the receiving facility), provided that certain documentation requirements are met. To take advantage of the exception at §424.36(b)(6), an ambulance 753
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<strong>CMS</strong>-1403-FC<br />
After reviewing the public comments, we are finalizing<br />
the prohibition in §424.57 as proposed but with an<br />
exception for attended facility-based PSG. Excepting<br />
facility-based PSG from the prohibition on providing CPAP<br />
would not except HST performed by the same entity, that is,<br />
the exception is at the test level not the facility level.<br />
We plan to solicit public input on accreditation models<br />
that might support future exceptions to this prohibition.<br />
We add additional definitions for “affiliate”, “attended<br />
facility-based polysomnogram,” and clarify the definitions<br />
of “Continuous positive airway pressure (CPAP)” and “Sleep<br />
test”.<br />
3. Beneficiary Signature for Nonemergency Ambulance<br />
Transport Services<br />
In the CY 2008 PFS final rule with comment period<br />
(72 FR 66406), we created an additional exception to the<br />
beneficiary signature requirements, applicable for<br />
emergency ambulance transports, in §424.36(b)(6). The<br />
exception allows ambulance providers and suppliers to sign<br />
on behalf of the beneficiary, at the time of transport<br />
(that is, the time during which the beneficiary is picked<br />
up and dropped off at the receiving facility), provided<br />
that certain <strong>document</strong>ation requirements are met. To take<br />
advantage of the exception at §424.36(b)(6), an ambulance<br />
753