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

“either/or” approach to the two proposed alternatives.<br />

That is, a billing physician or other supplier can avoid<br />

application of the anti-markup provisions by meeting either<br />

the “substantially all” professional services approach of<br />

Alternative 1 or, on a case-by-case basis, the “site-of-<br />

service” approach of Alternative 2, which are set forth in<br />

revised §414.50(a)(2)(ii) and (iii). We believe that<br />

compliance with either one of the two approaches finalized<br />

in this rule will further our goal of reducing the<br />

potential for overutilization and other program or patient<br />

abuse while providing sufficient flexibility for the<br />

industry.<br />

Comment: One commenter contended that a “one<br />

building” “site-of-service” standard is not a realistic<br />

means of ensuring proper billing arrangements, as large<br />

single specialty practices often span beyond one building.<br />

Another commenter remarked that the site-of-service<br />

alternative should not be finalized because it would be<br />

problematic for groups where specimens are collected at<br />

multiple sites but pathology diagnostic testing services<br />

are done at a separate location owned or leased by the<br />

group (the “hub-and-spoke” arrangement). Some<br />

cardiologists also expressed concern that interpretations<br />

of EKGs and other diagnostic testing services may be<br />

464

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