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 reasons described above to except attended facility-based PSG from the payment prohibition for CPAP. Comment: Several commenters stated that hospital-owned DME qualifies as a monopoly, and results in an unfair competitive advantage for hospitals and large sleep centers. The commenters favor the payment prohibition and state that such a prohibition is good for small businesses. Response: Business monopoly is beyond the scope of this regulation and we will not discuss it here. Comment: Several commenters stated that the term “affiliate” is ambiguous, and that the proposed rule is vague and overly broad in its use of the terms “affiliate” and “directly or indirectly”. The commenters requested that CMS provide a clear definition of “affiliate”. The commenters stated that without clear definitions from CMS it is impossible to discern what types of affiliations CMS intends to preclude under the rule or how the proposed rule would apply to any given set of circumstances. One commenter recommended that a definition of affiliate be common ownership of greater than 50 percent of the supplier of the CPAP device. Response: We define “affiliate” as a person or organization that is related to another person or 750
CMS-1403-FC organization through a compensation arrangement or some type of ownership. We have defined a provider of sleep test as an individual or entity that directly or indirectly administers and/or interprets the test and/or furnishes the sleep test device. By indirect we mean that one or more intermediary actors are used to accomplish the sleep test to its end. For example, if a DME supplier contracted with a sleep test provider to furnish HST, that supplier would indirectly provide the HST. Directly providing the test means there are no intermediary actors – no intervening persons or entities between them. Comment: One commenter requested that sleep labs be permitted to develop criteria to gauge the competency of the DME. Further, the commenter requested that sleep labs be permitted to use such criteria to discriminate against DME companies who fail to perform at an acceptable level of competency. Response: We believe that this concern can be addressed through the development and implementation of accreditation standards. Ideally, we would like to require that all entities furnishing sleep tests in any settings in addition to supplying CPAP be accredited. Once we are made 751
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<strong>CMS</strong>-1403-FC<br />
organization through a compensation arrangement or some<br />
type of ownership.<br />
We have defined a provider of sleep test as an<br />
individual or entity that directly or indirectly<br />
administers and/or interprets the test and/or furnishes the<br />
sleep test device. By indirect we mean that one or more<br />
intermediary actors are used to accomplish the sleep test<br />
to its end. For example, if a DME supplier contracted with<br />
a sleep test provider to furnish HST, that supplier would<br />
indirectly provide the HST. Directly providing the test<br />
means there are no intermediary actors – no intervening<br />
persons or entities between them.<br />
Comment: One commenter requested that sleep labs be<br />
permitted to develop criteria to gauge the competency of<br />
the DME. Further, the commenter requested that sleep labs<br />
be permitted to use such criteria to discriminate against<br />
DME companies who fail to perform at an acceptable level of<br />
competency.<br />
Response: We believe that this concern can be<br />
addressed through the development and implementation of<br />
accreditation standards. Ideally, we would like to require<br />
that all entities furnishing sleep tests in any settings in<br />
addition to supplying CPAP be accredited. Once we are made<br />
751