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CMS-1403-FC
final rule’s provisions in this regard do not impose new
restrictions for Medicare beneficiaries located in rural
areas. Therefore we believe that a specific rural
exception is not needed at this time.
Comment: Many commenters state that existing fraud
and abuse laws adequately address abuses arising out of
affiliations. For example, the commenters stated that the
Stark regulations do not allow a physician who has a
financial relationship (ownership or compensation) with a
DME supplier to refer a patient to that DME supplier for
CPAP, unless an exception applies. In addition, commenters
stated that under many State regulations a physician cannot
have a substantial ownership interest in a DMEPOS supplier
and still refer Medicare patients for DME. The commenters
also state that fraud and abuse is prevented by other
Medicare provisions, such as those limiting coverage of
CPAP to a 12-week period to identify beneficiaries
diagnosed with OSA who benefit from CPAP.
Response: We disagree. While Stark and other
statutes and rules, including the Federal anti-kickback
statute, afford some protections, we believe this
regulation to be necessary in order to further protect
Medicare beneficiaries from potential abusive practices and
to further reduce the Medicare program’s vulnerability to
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