§ 414.508Payment for a new clinical diagnostic laboratory test.
For a new clinical diagnostic laboratory test that is assigned a new or substantially revised code on or after January 1, 2005, CMS determines the payment amount based on either of the following:
(a)Crosswalking. Crosswalking is used if it is determined that a new test is comparable to an existing test, multiple existing test codes, or a portion of an existing test code.
(1) CMS assigns to the new test code, the local fee schedule amounts and national limitation amount of the existing test.
(2) Payment for the new test code is made at the lesser of the local fee schedule amount or the national limitation amount.
(b)Gapfilling. Gapfilling is used when no comparable existing test is available.
(1) In the first year, carrier-specific amounts are established for the new test code using the following sources of information to determine gapfill amounts, if available:
(i) Charges for the test and routine discounts to charges;
(ii) Resources required to perform the test;
(iii) Payment amounts determined by other payers; and
(iv) Charges, payment amounts, and resources required for other tests that may be comparable or otherwise relevant.
(2) In the second year, the test code is paid at the national limitation amount, which is the median of the carrier-specific amounts.
(3) For a new test for which a new or substantially revised HCPCS code was assigned on or before December 31, 2007, after the first year of gapfilling, CMS determines whether the carrier-specific amounts will pay for the test appropriately. If CMS determines that the carrier-specific amounts will not pay for the test appropriately, CMS may crosswalk the test.