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

Response: We do not believe that the revisions<br />

included in this final rule with comment period will<br />

discourage significantly or negatively impact significantly<br />

legitimate, nonabusive arrangements. We believe that the<br />

revisions strike an appropriate balance between allowing<br />

billing physicians and other suppliers flexibility in<br />

structuring their arrangements while protecting against<br />

program abuse caused by unnecessary diagnostic testing. As<br />

explained in section II.I. of this final rule, we are not<br />

finalizing our proposals at this time to require physician<br />

offices to comply with the IDTF standards in §410.33.<br />

Comment: Some commenters stated that there is no<br />

evidence that bringing diagnostic services into a physician<br />

practice automatically leads to overutilization; rather,<br />

many practices do so in order to improve quality of patient<br />

care and efficiency and not for financial gain.<br />

Response: We disagree with the commenters’ statement<br />

that there is no evidence that self-referral of diagnostic<br />

services leads to overutilization. We cited several<br />

studies in the CY 2008 PFS final rule with comment period<br />

that supported the proposition that physician self-referral<br />

(that is, the referral of diagnostic tests provided within<br />

the physician practice) leads to overutilization (72 FR<br />

66311 through 66312). Additionally, since publication of<br />

434

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