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<strong>CMS</strong>-1403-FC<br />

1, 2008), we stated that we planned to issue clarifying<br />

guidance as to what constitutes the “office of the billing<br />

physician or other supplier” within the following 12 months<br />

(73 FR 405). We proposed the clarification and other<br />

revisions in the CY 2009 PFS proposed rule in order to<br />

introduce the possible changes under consideration. The<br />

revisions being finalized in this regulation stem from that<br />

proposal and we believe that sufficient time <strong>has</strong> <strong>been</strong> given<br />

for consideration of and response to the anti-markup<br />

revisions.<br />

Irrespective of whether “pod lab” arrangements<br />

otherwise would continue to exist or proliferate, we<br />

believe that the anti-markup provisions are needed in order<br />

to address potential program and patient abuse through the<br />

ordering of unnecessary diagnostic tests. Although several<br />

commenters made mention of MIPPA and the impact that it may<br />

have, we are not swayed by these arguments. MIPPA is a<br />

separate authority with a different focus than that of the<br />

anti-markup provisions. If, in the future, the anti-markup<br />

provisions are impacted through our implementation of<br />

MIPPA, we will address this in subsequent rulemaking.<br />

j. Miscellaneous<br />

Comment: One commenter, a professional association of<br />

pathologists, suggested an exception from the anti-markup<br />

512

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