For purposes of this subpart--
New test means any clinical diagnostic laboratory test for which a new or substantially revised Healthcare Common Procedure Coding System Code is assigned on or after January 1, 2005.
Substantially Revised Healthcare Common Procedure Coding System Code means a code for which there has been a substantive change to the definition of the test or procedure to which the code applies (such as a new analyte or a new methodology for measuring an existing analyte specific test). [71 FR 69786, Dec. 1, 2006, as amended at 72 FR 66401, Nov. 27, 2007] Sec. 414.504 [Reserved]