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CMS-1403-FC
Moreover, given our general rulemaking authority and our
authority under section 1834(j)(1)(B)(ii)(IV) of the Act,
we are not prevented from regulating the provision of CPAP
in those unusual circumstances in which Stark is not
implicated because there has been no “referral.”
Similarly, we do not agree with the commenter’s
assertion that this rule conflicts with the Stark
prohibition because it does not contain an exception for
referrals made by a physician who has an ownership or
investment interest in a “rural provider.” Under the Stark
statute, section 1877(d)(2) of the Act, there “shall not be
considered to be an ownership or investment interest . . .
[i]n the case of designated health services [including DME,
such as CPAP] furnished in a rural area (as defined in
section 1886(d)(2)(D)) by an entity, if . . . substantially
all of the designated health services furnished by the
entity are furnished to individuals residing in such a
rural area.” Thus, Stark is not implicated in those
circumstances. Nevertheless, we are not precluded from
using other authority to limit or prohibit payment for
items and services that are provided in a manner that does
not implicate Stark. Notwithstanding Stark, we have
authority under sections 1871(a)(1) and 1834(j)(1)(B) of
the Act to issue this rule.
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