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CMS-1403-FC
supplier. Our longstanding policy of having an anti-markup
payment limitation on purchased TCs was codified in
§414.50, and retained in the CY 2008 PFS final rule with
comment period. (Similarly, we imposed an anti-markup
payment limitation on purchased PCs in the CY 2008 PFS
final rule with comment period and we proposed in the CY
2009 PFS proposed rule to retain status as a purchased PC
as a separate basis imposing an anti-markup payment
limitation.) Based on our decision to adopt Alternative 1
and to allow arrangements that do not meet the requirements
of Alternative 1 to nevertheless avoid the anti-markup
payment limitation if diagnostic testing services meet the
requirements of Alternative 2, we believe that it is not
necessary, and unduly complex, to use purchased tests and
purchased interpretations as separate bases for imposing an
anti-markup payment limitation. We provide a fuller
explanation below, at section N.2.h., for deleting from
§414.50 references to TCs and PCs purchased from an
“outside supplier.”
We are not creating an exception for tests ordered by
a physician in a physician organization with no physician
owners who have the right to receive profit distributions.
By finalizing both proposed alternatives, we believe that
our concern that the Alternative 2 approach could
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