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CMS-1403-FC
program and its beneficiaries from the harmful effects of
fraud and abuse. Second, we also believe that section
1834(j)(1)(B)(ii)(IV) of the Act, which requires suppliers
of equipment and supplies to “meet such other requirements
as the Secretary may specify,” provides sufficient
authority for this regulation.
We also disagree with the commenter’s assertion that a
physician’s furnishing of CPAP can easily escape the
purview of Stark and that this rule therefore conflicts
with the Stark law. As we stated in the “Phase III” Stark
final rule, although personally performed services are not
a “referral” for Stark purposes, “the dispensing of CPAP
equipment by a physician would almost always constitute a
“referral” . . ., as would the dispensing of CPAP equipment
by anyone else affiliated with the referring physician,
such as a nurse or physician assistant” (72 FR 51020).
This is because a referring physician claiming to
personally provide DME must personally furnish the CPAP
equipment as well as personally perform all activities
necessary to satisfy the DME supplier standards. Thus, in
all but the rarest of circumstances, the prohibition
promulgated under this final rule does not conflict with
the Stark prohibition as applied to physicians who refer
for and furnish CPAP in their own medical practices.
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