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CMS-1403-FC
as a DME supplier and personally furnishes all of the
services associated with the provision of the CPAP. In
addition, the commenter concludes that this rule is in
direct contradiction to the Stark law because, unlike the
Stark law, this rule does not contain an exception for
referrals made by a physician who has an ownership or
investment interest in a “rural provider.”
Response: We do not agree. Our authority for
promulgating this rule is supported by two different
provisions in the Act. First, we believe that section
1871(a)(1) of the Act, which authorizes the Secretary to
“prescribe such regulations as may be necessary to carry
out the administration of the insurance programs under this
title,” provides sufficient authority for this regulation.
We believe that the prevention of fraud and abuse in the
provision of CPAP devices is essential to the efficient
administration of the Medicare program. While the use of
unattended HSTs will provide more beneficiaries with access
to diagnosis and treatment of OSA, we are concerned that
the increased number of unattended HSTs will in turn
increase the potential for a test provider’s affiliation
with a CPAP supplier to lead to overutilization as we
discussed above. We believe that the administration of the
Medicare program includes a responsibility to protect the
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