CMS Pub. 100-04, ch. 16, § 40.6.2.3

Separately Billed ESRD Laboratory Test Furnished to Patients of Renal Dialysis

Facilities

(Rev. 4227, Issued: 02-01-2019, Effective: 07-01-19, Implementation: 07-01-19 )

Effective April 1, 2003, for dates of service (DOS) on or after April 1, 2001 and ending June 30, 2019:

Effective April 1, 2003, for DOS on or after April 1, 2001, CWF will not apply the SNF CB edits to line items

that contain the CB modifier. A provider or supplier may use the “CB” modifier only when it has determined

that: (a) the beneficiary has ESRD entitlement, (b) the test is related to the dialysis treatment for ESRD, (c)

the test is ordered by a doctor providing care to patients in the dialysis facility, and (d) the test is not included

in the dialysis facility’s composite rate payment.

Those diagnostic tests that are presumptively considered to be dialysis-related and, therefore, appropriate for

submission with the “CB” modifier are identified in Exhibit 1. This list was not designed as an all- inclusive

list of Medicare covered diagnostic services. Additional diagnostic services related to the beneficiary’s ESRD

treatment/care may be considered dialysis-related. However, if these services are not included in our listing,

the A/B MAC (A) may require supporting medical documentation.

When a hospital laboratory is billing for laboratory services ordered by an ESRD facility and the patient

(beneficiary) is a SNF resident under a Part A stay, the hospital laboratory must use the “CB” modifier for

those services excluded from consolidated billing.

Beneficiaries in a SNF Part A stay are eligible for a broad range of diagnostic services as part of the SNF Part

A benefit. Physicians ordering medically necessary diagnostic test that are not directly related to the

beneficiary’s ESRD are subject to the SNF consolidated billing requirements. Physicians may bill the A/B

MAC (B) for the professional component of these diagnostic tests. In most cases, however, the technical

component of diagnostic tests is included in the SNF PPS rate and is not separately billable to the A/B MAC

(B). Physicians should coordinate with the SNF in ordering such tests since the SNF will be responsible for

bearing the cost of the technical component.

Effective for DOS on or after July 1, 2019:

Effective for claims with DOS on or after July 1, 2019, the CB modifier, previously used by Independent

Labs when billing for separate payment outside the SNF Consolidated Billing for ESRD dialysis-related

lab services, is no longer applicable.

With the January 1, 2011 implementation of the ESRD PPS and effective for DOS on or after July 1,

2019, Exhibit 1 is no longer recognized as the list of separately billable ESRD dialysis-related services.

Instead, a list of the recognized renal dialysis laboratory tests that are subject to Part B ESRD PPS

consolidated billing requirements, are considered routinely performed for the treatment of ESRD, and

are not separately paid when provided to ESRD beneficiaries by providers or suppliers other than the

ESRD facility, is located on the CMS Website: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ESRDpayment/Consolidated_Billing.html.

The list of renal dialysis laboratory tests provided in the Part B ESRD PPS consolidated billing

requirements is not an all-inclusive list. For laboratory tests not included in this list, the distinction of

what is considered to be a renal dialysis laboratory test is a clinical decision determined by the ESRD

beneficiary’s ordering practitioner. If any laboratory test is ordered for the treatment of ESRD, then

the laboratory test is considered to be included in the ESRD PPS, is the responsibility of the ESRD

facility and is excluded from the SNF PPS. More information regarding renal dialysis services payable

under the ESRD PPS is available in Pub. 100-02, chapter 11.

Beneficiaries in a SNF Part A stay are eligible for a broad range of diagnostic services as part of the

SNF Part A benefit. Physicians ordering medically necessary diagnostic tests that are not directly

related to the beneficiary’s ESRD are subject to the SNF consolidated billing requirements. Physicians

may bill the A/B MAC (B) for the professional component of these diagnostic tests. In most cases,

however, the technical component of diagnostic tests is included in the SNF PPS rate and is not

separately billable to the A/B MAC (B). Physicians should coordinate with the SNF in ordering such

tests since the SNF will be responsible for bearing the cost of the technical component.

A patient’s physician or practitioner may order a laboratory test that is included on the list of items and

services subject to consolidated billing edits for reasons other than for the treatment of ESRD. When

this occurs, the SNF CB applies.