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CMS-1403-FC anti-markup provisions could be triggered under Alternative 1 as proposed. The commenter cited the CY 2008 PFS final rule with comment period, where we stated that independent laboratories and pathologists do not trigger the initial order for pathology services. Thus, the commenter suggested that we clarify that, under the CY 2009 PFS proposals, anti-markup provisions still would only apply if the physician billing for the services was also the physician or supplier who provided the initial order for the service. Several commenters were concerned that we did not mention this in our commentary on the proposal. Response: As finalized in the CY 2008 PFS final rule, and as retained in this final rule with comment period, the anti-markup provisions for the TC or PC of a diagnostic test apply only when the billing physician or other supplier has ordered the TC. For example, if a laboratory contracts with a pathologist instead of employing the pathologist to perform the PC of a diagnostic test (because the laboratory is located in a State that has a prohibition on the corporate practice of medicine), the anti-markup payment limitation would not apply to the lab if the lab chooses to bill for the pathologist’s interpretation, if the lab (or a party related to the lab by common ownership or control) did not order the test. For example, Physician 456
CMS-1403-FC Group A orders the TC and PC of a diagnostic test. Laboratory B performs TC and contracts with Physician C to perform the PC, and Laboratory B bills for the TC and the PC. In this example, the anti-markup provisions would not apply to the TC or the PC billed by Laboratory B. However, if the interpreting pathologist decides to order additional tests that are then performed and/or interpreted by another pathologist, the anti-markup payment limitation potentially would apply if the ordering pathologist wishes to bill for the additional interpretations performed by the different pathologist. Whether the anti-markup payment limitation in fact would apply would depend on whether the arrangement between the ordering/billing pathologist and the pathologist performing or supervising the TC/performing the PC satisfies the requirements of Alternative 1 (and, if not, whether it satisfies, on a case-by-case basis, the requirements of Alternative 2). Comment: Some commenters offered support for Alternative 1. The commenters believed that this alternative has greater potential to limit self-referral arrangements by requiring that a physician practice should not be able to mark up anatomic pathology tests unless the physician who performs and supervises the pathology services is dedicated solely to that physician practice. 457
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<strong>CMS</strong>-1403-FC<br />
Group A orders the TC and PC of a diagnostic test.<br />
Laboratory B performs TC and contracts with Physician C to<br />
perform the PC, and Laboratory B bills for the TC and the<br />
PC. In this example, the anti-markup provisions would not<br />
apply to the TC or the PC billed by Laboratory B. However,<br />
if the interpreting pathologist decides to order additional<br />
tests that are then performed and/or interpreted by another<br />
pathologist, the anti-markup payment limitation potentially<br />
would apply if the ordering pathologist wishes to bill for<br />
the additional interpretations performed by the different<br />
pathologist. Whether the anti-markup payment limitation in<br />
fact would apply would depend on whether the arrangement<br />
between the ordering/billing pathologist and the<br />
pathologist performing or supervising the TC/performing the<br />
PC satisfies the requirements of Alternative 1 (and, if<br />
not, whether it satisfies, on a case-by-case basis, the<br />
requirements of Alternative 2).<br />
Comment: Some commenters offered support for<br />
Alternative 1. The commenters believed that this<br />
alternative <strong>has</strong> greater potential to limit self-referral<br />
arrangements by requiring that a physician practice should<br />
not be able to mark up anatomic pathology tests unless the<br />
physician who performs and supervises the pathology<br />
services is dedicated solely to that physician practice.<br />
457