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CMS-1403-FC
fraud and abuse. We believe that the payment prohibition
for CPAP in this rule will be applied to a broader set of
CPAP supplier relationships than would be prohibited under
Stark. We here address additional CPAP supplier
relationships that do not necessarily depend on a
relationship with the beneficiary’s treating physician who
makes a referral, for example, a relationship between a
sleep test provider and a DME supplier when the provider of
the sleep test is not the beneficiary’s treating physician
who made the referral for the test.
Comment: One commenter stated that this proposal is
unlawful. First, the commenter stated that general
rulemaking authority cannot support a “Stark-like” proposal
such as the one under consideration. Further, the
commenter states that the preamble lacks sufficient facts
or data to support the statutory predicate under section
1871(a)(1) that the rule must be “necessary to carry out
the administration” of the Medicare program. The commenter
summarizes their concerns by stating that the general grant
of rulemaking authority is not plenary. The commenter also
stated that the rule is inconsistent with the Stark statute
and it’s implementing regulations, which the commenter
asserted would not preclude a physician from selling a CPAP
device to his or her patient if the physician is enrolled
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