---
kind: "section"
citation: "42 C.F.R. § 414.508"
title: "42"
number: "414.508"
heading: "Payment for a new clinical diagnostic laboratory test."
url: "https://uscodex.org/cfr/42/414.508"
---

# §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)](/cfr/42/414.507.md?p=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](/cfr/42/414.507.md) of the comparable existing CDLT.
    - (ii) Payment for the new CDLT code is made at the payment amount established under [§ 414.507](/cfr/42/414.507.md).
  - (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.

## Notes

### Amendments

[81 FR 41100, June 23, 2016]

### Source

Source: 71 FR 69786, Dec. 1, 2006, unless otherwise noted.

### Authority

Authority: 42 U.S.C. 1302, 1395hh, and 1395rr(b)(l).

### Source

Source: 55 FR 23441, June 8, 1990, unless otherwise noted.

### Amendments

[81 FR 41100, June 23, 2016]