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

the ordering physician provides generally). Many of the<br />

potentially abusive pod lab arrangements that led to our<br />

extension of the anti-markup provisions to the PC of<br />

diagnostic testing services involved independent contractor<br />

pathologists who performed services in off-site pathology<br />

labs. Those arrangements did not have the type of nexus<br />

with the group practice required under §414.50(a)(2) (that<br />

is, the pod labs were not within the same building in which<br />

the ordering physician provided substantially the full<br />

range of patient care services).<br />

We do agree with the commenter’s analysis of Example 3<br />

given in the proposed rule.<br />

Comment: One commenter requested that, if adopted,<br />

the proposal for Alternative 2 should include detailed<br />

examples that provide clear definitions for several key<br />

terms, including “office of the billing physician or other<br />

supplier,” “conducting and supervising the TC,” and “full<br />

range of services.” The commenter believes that, without<br />

these definitions, our intent will be misconstrued and<br />

subject to potential abuse.<br />

Response: We do not provide a definition for<br />

“conducting and supervising the TC” in the regulation text,<br />

as we believe that the meaning of “conducting” is clear on<br />

its face; that is, the term “conducting the TC” refers to<br />

477

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