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CMS-1403-FC
sleep tests, we shall prohibit payment to the supplier of
the CPAP device when such supplier, or its affiliate
defined as a person or organization that is related to
another person or organization through a compensation
arrangement or some type of ownership, is directly or
indirectly the provider or the interpreter of the
unattended out of facility sleep test 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 disease management models
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.
Therefore, we proposed to revise the durable medical
equipment, prosthetics, orthotics, and supplies (DMEPOS)
supplier enrollment safeguards set forth at §424.57 to
protect the Medicare program and its beneficiaries from
fraudulent or abusive practices that may be related to CPAP
devices. We also proposed to add new definitions to
paragraph (a) to define “Continuous positive airway
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