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

performing supplier for the TC or PC. As we indicated in<br />

the CY 2008 PFS final rule, it is the responsibility of the<br />

billing entity to ascertain the amount it paid for the TC<br />

or PC. The billing entity should maintain contemporaneous<br />

<strong>document</strong>ation of the methodology and information used to<br />

calculate the net charge, and may do so in any reasonable<br />

manner (72 FR 66318).<br />

(2) Direct billing<br />

Comment: In the CY 2009 PFS proposed rule, we<br />

solicited comments on whether, in addition to or in lieu of<br />

the anti-markup provisions, we should prohibit reassignment<br />

in certain situations and require the physician supervising<br />

the TC or performing the PC to bill Medicare directly (73<br />

FR 38548). One commenter opposed any requirement that a<br />

physicians performing either the TC or the PC of diagnostic<br />

tests directly bill for such services. The commenter<br />

stated that the Congress enacted the anti-markup provisions<br />

in section 1842(n) of the Act rather than adopt the already<br />

established direct billing requirement for clinical<br />

laboratory services. The commenter argued that we should<br />

not second-guess the Congress’ decision and choose to<br />

eliminate the system of assignment and reassignment that is<br />

currently in place. Another commenter agreed with the<br />

first commenter and stated that reassignment is beneficial<br />

505

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