Medicare Claims Processing Manual (Pub. 100-04), Ch. 16 § 40.6
Billing for End Stage Renal Disease (ESRD) Related Laboratory Tests
40.6 - Billing for End Stage Renal Disease (ESRD) Related Laboratory Tests
(Rev. 2487, Issued: 06-08-12, Effective: 01-01-11, Implementation: 06-19-12)
With the implementation of the ESRD PPS, effective for claims with dates of service on or after January 1,
2011, all ESRD-related laboratory services are included in the ESRD PPS base rate and must be reported by
the ESRD facility and are not separately paid. For instructions on ESRD facility billing under ESRD PPS, see
Publication 100-04, Chapter 8. The list of items and services subject to consolidated billing located at
http://www.cms.gov/ESRDPayment/50_Consolidated_Billing.asp#TopOfPage includes the list of ESRD-
related laboratory tests that are routinely performed for the treatment of ESRD.
Laboratory services that are not related to the treatment of ESRD are separately billable under the ESRD PPS
and may be billed by either the ESRD facility or the independent laboratory. If the ESRD facility or
independent laboratory bills a laboratory service that was not related to the treatment of ESRD, the bill must
include the modifier AY. The AY modifier serves as an attestation that the item or service is medically
necessary for the dialysis patient but is not being used for the treatment of ESRD.