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US · guidance

CMS Pub. 100-04, ch. 8, § 50.2

Drugs and Biologicals Included in the End Stage Renal Disease

activein force · 2026-08-25 – presentas-observed

Prospective Payment System (ESRD (PPS)

(Rev. 12979; Issued: 11-22-24; Effective: 01-01-25; Implementation: 01-06-25)

With the implementation of the End Stage Renal Disease Prospective Payment System

(ESRD PPS), effective for claims with dates of service on or after January 1, 2011, all

ESRD-related injectable drugs and biologicals and oral equivalents of those injectable

drugs and biologicals are included in the ESRD PPS.

If the renal dialysis facility needs to report a drug that was furnished to an ESRD

beneficiary that was not related to the treatment of ESRD, they must include the modifier

AY to indicate the item or service is not for the treatment of ESRD.

ESRD-related drugs and biologicals that were separately paid under the basic case-mix

composite rate payment system, and those that were included in the case-mix composite

rate payment system, are considered in the calculation of any applicable outlier payment

under the ESRD PPS.

Beginning January 1, 2025, ESRD facilities are required to report discarded billing units

on a separate claim line containing a JW modifier for all renal dialysis drugs and

biological products from single-dose containers or single-use packaging. When a renal

dialysis drug or biological product from a single-dose container or single-use packaging

is reported on an ESRD claim and there is no discarded amount, ESRD facilities are

required to attest that there is no discarded amount by reporting a JZ modifier on the

claim line along with the amount of drug or biological product administered.

A list of HCPCS codes that represent renal dialysis drugs and biological products subject

to the JW and JZ reporting requirement can be found here:

https://www.cms.gov/medicare/medicare-fee-for-service-

payment/esrdpayment/consolidated_billing.

History

(Rev. 12979; Issued: 11-22-24; Effective: 01-01-25; Implementation: 01-06-25)

Provenance

Source
cms.gov
Retrieved
2026-08-25
Edition
iom-2026-08-25
Content hash
06c9ac8b9d29973f7700a3574007fb758b4b402558c24d6cc973caf2da79705a
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