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

We received a number of comments addressing issues<br />

outside the scope of this rulemaking, in particular, the<br />

in-office ancillary services exception to the physician<br />

self-referral law, which is codified in §411.355(b) of our<br />

regulations. Commenters believed that we must curtail the<br />

types of arrangements currently permitted under the in-<br />

office ancillary services exception in order to curb<br />

overutilization through the ordering of unnecessary<br />

diagnostic tests.<br />

After careful consideration of the comments that we<br />

received, we are adopting a flexible approach that<br />

incorporates both proposed alternatives. We are finalizing<br />

Alternative 1 with some modifications, and retaining with<br />

some modifications the present “site-of-service” approach<br />

(Alternative 2) to allow physicians to consider both<br />

approaches in determining if the anti-markup provisions<br />

apply to particular diagnostic testing services.<br />

Arrangements should be analyzed first under Alternative 1.<br />

Thus, where the performing physician (that is, the<br />

physician who supervises the TC or performs the PC, or<br />

both) performs substantially all (at least 75 percent) of<br />

his or her professional services for the billing physician<br />

or other supplier, none of the services furnished by the<br />

physician on behalf of the billing physician or other<br />

422

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