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

Response: We recognize the potential for arrangements<br />

that may be troublesome to be restructured so that the<br />

diagnostic testing is performed in the same building as<br />

where the testing is ordered; however, we are also<br />

concerned that adopting Alternative 1 without leaving in<br />

place the site-of-service approach of §414.50 (which we<br />

reproposed as Alternative 2) may unnecessarily disrupt some<br />

arrangements that do not appear problematic to us. We will<br />

continue to monitor arrangements and may propose further<br />

changes if necessary. Also, we continue to examine<br />

industry use of the in-office ancillary services exception<br />

of the physician self-referral rules, and may propose<br />

changes to that exception in a future rulemaking.<br />

Comment: Some commenters did not believe that site-<br />

of-service distinctions are relevant to determining the<br />

appropriate scope of section 1842(n) of the Act. According<br />

to the commenters, it should not matter if physicians are<br />

in a bona fide group practice that <strong>has</strong> one building or ten,<br />

and, if ten, the particular geographic configuration of the<br />

ten buildings should not matter. The commenters questioned<br />

the legal or policy justification for applying different<br />

site-of-service rules for purposes of the anti-markup<br />

provision than those that are employed in the physician<br />

self-referral regulations. Of particular concern for these<br />

461

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