Editorial Note on Part 414
Editorial Note: Nomenclature changes to part 414 appear at 60 FR 50442, Sept. 29, 1995, and 60 FR 53877, Oct. 18, 1995.

§ 414.508 Payment for a new clinical diagnostic laboratory test. ( a ) For a new CDLT that is assigned a new or substantially revised code between January 1, 2005 and December 31, 2017, CMS determines the payment amount based on either of the following: ( 1 ) *Crosswalking.* Crosswalking is used if it is determined that a new CDLT is comparable to an existing test, multiple existing test codes, or a portion of an existing test code. ( i ) CMS assigns to the new CDLT code, the local fee schedule amounts and national limitation amount of the existing test.
( ii ) Payment for the new CDLT code is made at the lesser of the local fee schedule amount or the national limitation amount.
( 2 ) *Gapfilling.* Gapfilling is used when no comparable existing CDLT is available. ( i ) In the first year, Medicare Administrative Contractor-specific amounts are established for the new CDLT code using the following sources of information to determine gapfill amounts, if available: ( A ) Charges for the CDLT and routine discounts to charges;
( B ) Resources required to perform the CDLT;
( C ) Payment amounts determined by other payors; and
( D ) Charges, payment amounts, and resources required for other tests that may be comparable or otherwise relevant.
( ii ) In the second year, the test code is paid at the national limitation amount, which is the median of the contractor-specific amounts.
( iii ) For a new CDLT 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 contractor-specific amounts will pay for the test appropriately. If CMS determines that the contractor-specific amounts will not pay for the test appropriately, CMS may crosswalk the test.
( b ) For a new CDLT that is assigned a new or substantially revised HCPCS code on or after January 1, 2018, CMS determines the payment amount based on either of the following until applicable information is available to establish a payment amount under the methodology described in § 414.507(b): ( 1 ) *Crosswalking.* Crosswalking is used if it is determined that a new CDLT is comparable to an existing test, multiple existing test codes, or a portion of an existing test code. ( i ) CMS assigns to the new CDLT code, the payment amount established under § 414.507 of the comparable existing CDLT.
( ii ) Payment for the new CDLT code is made at the payment amount established under § 414.507.
( 2 ) *Gapfilling.* Gapfilling is used when no comparable existing CDLT is available. ( i ) In the first year, Medicare Administrative Contractor-specific amounts are established for the new CDLT code using the following sources of information to determine gapfill amounts, if available: ( A ) Charges for the test and routine discounts to charges;
( B ) Resources required to perform the test;
( C ) Payment amounts determined by other payors;
( D ) Charges, payment amounts, and resources required for other tests that may be comparable or otherwise relevant; and
( E ) Other criteria CMS determines appropriate.
( ii ) In the second year, the CDLT code is paid at the median of the Medicare Administrative Contractor-specific amounts.
[81 FR 41100, June 23, 2016]