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CMS-1403-FC
the billing group and meet the “site-of-service”
requirements. Two other commenters recommended that we
finalize both approaches and allow arrangements to avoid
application of the anti-markup provisions if they comply
with either approach.
Response: We have adopted an “either or” approach to
the two proposed alternative approaches. Diagnostic
testing services furnished by physicians who meet the
requirements of Alternative 1 (the “substantially all”
services approach) will not be subject to an anti-markup
payment limitation. However, arrangements that do not meet
the requirements of the Alternative 1 approach nevertheless
will avoid application of the anti-markup provisions if
they comply with Alternative 2 (the “site-of-service”
approach), as clarified in this final rule. We believe
that compliance with either one of the two approaches
finalized in this rule will implement statutory intent and
address our concerns regarding overutilization and abusive
billing by establishing a sufficient nexus with the billing
entity to justify not applying an anti-markup payment
limitation.
Comment: One commenter noted that the application of
some of the proposed changes, both with respect to the
anti-markup provisions in §414.50 and with respect to the
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