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CMS Pub. 100-04, ch. 16, § 40.6

Billing for End Stage Renal Disease (ESRD) Related Laboratory Tests

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

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.

40.6.1 - Automated Multi-Channel Chemistry (AMCC) Tests for ESRD Beneficiaries

Rev. 3116, Issued: 11-06-14, Effective: 04-01-15, Implementation: 04-06-15)

Instructions for Services Provided on and After January 1, 2011

Section 153b of the MIPPA requires that all ESRD-related laboratory tests must be reported by the ESRD

facility whether provided directly or under arrangements with an independent laboratory. When laboratory

services are billed by providers other than the ESRD facility and the laboratory test furnished is designated as

a laboratory test that is included in the ESRD PPS (ESRD-related), the claim will be rejected or denied. In the

event that an ESRD-related laboratory test was furnished to an ESRD beneficiary for reasons other than for the

treatment of ESRD, the provider may submit a claim for separate payment using 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. The items and services subject to consolidated billing located on

the CMS website includes the list of ESRD-related laboratory tests that are routinely performed for the

treatment of ESRD.

For services provided on or after January 1, 2011, the 50/50 rule no longer applies to independent laboratory

claims for AMCC tests furnished to ESRD beneficiaries. The 50/50 rule modifiers (CD, CE, and CF) are no

longer required for independent laboratories effective for dates of service on and after January 1, 2011.

However, for services provided between January 1, 2011 and March 31, 2015, the 50/50 rule modifiers are

still required for use by ESRD facilities that are receiving the transitional blended payment amount (the

transition ends in CY 2014). For services provided on or after April 1, 2015, the 50/50 rule modifiers are no

longer required for use by ESRD facilities.

Effective for dates of service on and after January 1, 2012, A/B MACs (B) shall allow organ disease panel

codes (i.e., HCPCS codes 80047, 80048, 80051, 80053, 80061, 80069, and 80076) to be billed by independent

laboratories for AMCC panel tests furnished to ESRD eligible beneficiaries if:

• The beneficiary is not receiving dialysis treatment for any reason (e.g., post-transplant beneficiaries),

or

• The test is not related to the treatment of ESRD, in which case the supplier would append modifier

“AY”.

A/B MACs (B) shall make payment for organ disease panels according to the Clinical Laboratory Fee

Schedule and shall apply the normal ESRD PPS editing rules for independent laboratory claims. The

aforementioned organ disease panel codes were added to the list of bundled ESRD PPS laboratory tests in

January 2012.

Effective for dates of service on and after April 1, 2015, A/B MACs (A) shall allow organ disease panel codes

(i.e., HCPCS codes 80047, 80048, 80051, 80053, 80061, 80069, and 80076) to be billed by ESRD facilities for

AMCC panel tests furnished to ESRD eligible beneficiaries if:

• These codes best describe the laboratory services provided to the beneficiary, which are paid under the

ESRD PPS, or

• The test is not related to the treatment of ESRD, in which case the ESRD facility would append

modifier “AY” and the service may be paid separately from the ESRD PPS.

Instructions for Services Provided Prior to January 1, 2011

For claims with dates of service prior to January 1, 2011, Medicare will apply the following rules to

Automated Multi-Channel Chemistry (AMCC) tests for ESRD beneficiaries:

• Payment is at the lowest rate for tests performed by the same provider, for the same beneficiary, for the

same date of service.

• The facility/laboratory must identify, for a particular date of service, the AMCC tests ordered that are

included in the composite rate and those that are not included. See Publication 100-02, Chapter 11,

Section 30.2.2 for the chart detailing the composite rate tests for Hemodialysis, Intermittent Peritoneal

Dialysis (IPD), Continuous Cycling Peritoneal Dialysis (CCPD), and Hemofiltration as well as a

second chart detailing the composite rate tests for Continuous Ambulatory Peritoneal Dialysis (CAPD).

• If 50 percent or more of the covered tests are included under the composite rate payment, then all

submitted tests are included within the composite payment. In this case, no separate payment in

addition to the composite rate is made for any of the separately billable tests.

• If less than 50 percent of the covered tests are composite rate tests, all AMCC tests submitted for that

Date of Service (DOS) for that beneficiary are separately payable.

• A noncomposite rate test is defined as any test separately payable outside of the composite rate or

beyond the normal frequency covered under the composite rate that is reasonable and necessary.

• For A/B MAC (B) processed claims, all chemistries ordered for beneficiaries with chronic dialysis for

ESRD must be billed individually and must be rejected when billed as a panel.

(See §100.6UH for details regarding pricing modifiers.)

Implementation of this Policy:

ESRD facilities when ordering an ESRD-related AMCC must specify for each test within the AMCC whether

the test:

a. Is part of the composite rate and not separately payable;

b. Is a composite rate test but is, on the date of the order, beyond the frequency covered under the

composite rate and thus separately payable; or

c. Is not part of the ESRD composite rate and thus separately payable.

Laboratories must:

a. Identify which tests, if any, are not included within the ESRD facility composite rate payment

b. Identify which tests ordered for chronic dialysis for ESRD as follows:

1) Modifier CD: AMCC Test has been ordered by an ESRD facility or MCP physician that is part

of the composite rate and is not separately billable.

2) Modifier CE: AMCC Test has been ordered by an ESRD facility or MCP physician that is a

composite rate test but is beyond the normal frequency covered under the rate and is separately

reimbursable based on medical necessity.

3) Modifier CF: AMCC Test has been ordered by an ESRD facility or MCP physician that is not

part of the composite rate and is separately billable.

c. Bill all tests ordered for a chronic dialysis ESRD beneficiary individually and not as a panel.

The shared system must calculate the number of AMCC tests provided for any given date of service. Sum all

AMCC tests with a CD modifier and divide the sum of all tests with a CD, CE, and CF modifier for the same

beneficiary and provider for any given date of service.

If the result of the calculation for a date of service is 50 percent or greater, do not pay for the tests.

If the result of the calculation for a date of service is less than 50 percent, pay for all of the tests.

For A/B MAC (A) processed claims, all tests for a date of service must be billed on the monthly ESRD bill.

Providers that submit claims to an A/B MAC (A) must send in an adjustment if they identify additional tests

that have not been billed.

A/B MAC (B) shared systems shall adjust the previous claim when the incoming claim for a date of service is

compared to a claim on history and the action is adjust payment. A/B MAC (B) shared systems shall spread

the payment amount over each line item on both claims (the claim on history and the incoming claim).

The organ and disease oriented panels (80048, 80051, 80053, and 80076) are subject to the 50 percent rule.

However, clinical diagnostic laboratories shall not bill these services as panels, they must be billed

individually. Laboratory tests that are not covered under the composite rate and that are furnished to CAPD

end stage renal disease (ESRD) patients dialyzing at home are billed in the same way as any other test

furnished home patients.

A/B MAC (A) Business Requirements for ESRD Reimbursement of AMCC Tests:

Requirement

Number Requirement Responsibility

1.1 The A/B MAC (A) shared system must RTP a claim for AMCC

tests when a claim for that date of service has already been

submitted.

Shared system

1.2 Based upon the presence of the CD, CE and CF payment

modifiers, identify the AMCC tests ordered that are included and

not included in the composite rate payment.

Shared System

1.3 Based upon the determination of requirement 1.2, if 50 percent or

more of the covered tests are included under the composite rate, no

separate payment is made.

Shared System

1.4 Based upon the determination of requirement 1.2, if less than 50

percent are covered tests included under the composite rate, all

AMCC tests for that date of service are payable.

Shared System

1.5 Effective for claims with dates of service on or after January 1,

2006, include any line items with a modifier 91 used in

conjunction with the “CD,” “CE,” or “CF” modifier in the

calculation of the 50/50 rule.

Shared System

1.6 A/B MACs (A) must return any claims for additional tests for any

date of service within the billing period when the provider has

already submitted a claim. Instruct the provider to adjust the first

claim.

A/B MAC (A) or

Shared System

1.7 After the calculation of the 50/50 rule, services used to determine

the payment amount may never exceed 22. Effective for claims

with dates of service on or after January 1, 2006, accept all valid

line items submitted for the date of service and pay a maximum of

the ATP 22 rate.

Shared System

A/B MAC (B) Business Requirements for ESRD Reimbursement of AMCC Tests:

Requirement

Number Requirement Responsibility

1 The shared systems shall calculate payment at

the lowest rate for these automated tests even if

reported on separate claims for services

performed by the same provider, for the same

beneficiary, for the same date of service.

Shared Systems

2 Shared Systems shall identify the AMCC tests

ordered that are included and are not included

in the composite rate payment based upon the

presence of the “CD,” “CE” and “CF”

modifiers.

Shared Systems

3 Based upon the determination of requirement 2

if 50 percent or more of the covered services

are included under the composite rate payment,

Shared Systems shall indicate that no separate

payment is provided for the services submitted

for that date of service.

Shared Systems

4 Based upon the determination of requirement 2

if less than 50 percent are covered services

included under the composite rate, Shared

Systems shall indicate that all AMCC tests for

that date of service are payable under the 50/50

rule.

Shared Systems

Requirement

Number Requirement Responsibility

5 Effective for claims with dates of service on or

after January 1, 2006, include any line items

with a modifier 91 used in conjunction with the

“CD,” “CE,” or “CF” modifier in the

calculation of the 50/50 rule.

Shared Systems

6 Shared Systems shall adjust the previous claim

when the incoming claim is compared to the

claim on history and the action is to deny the

previous claim. Spread the payment amount

over each line item on both claims (the adjusted

claim and the incoming claim).

Shared Systems

7 Shared Systems shall spread the adjustment

across the incoming claim unless the adjusted

amount would exceed the submitted amount of

the services on the claim.

Shared System

8 After the calculation of the 50/50 rule, services

used to determine the payment amount may

never exceed 22. Accept all valid line items for

the date of service and pay a maximum of the

ATP 22 rate.

Shared Systems

Examples of the Application of the 50/50 Rule

The following examples are to illustrate how claims should be paid. The percentages in the action section

represent the number of composite rate tests over the total tests. If this percentage is 50 percent or greater, no

payment should be made for the claim.

Example 1: Provider Name: Jones Hospital

DOS 2/1/02, Claim/Services:

CPT Code- Modifier

82040 Mod CD

82310 Mod CD

82374 Mod CD

82435 Mod CD

82947 Mod CF

84295 Mod CF

82040 Mod CD (Returned as duplicate)

84075 Mod CE

82310 Mod CE

84155 Mod CE

ACTION: 9 services total, 2 non-composite rate tests, 3 composite rate tests beyond the frequency, 4

composite rate tests; 4/9 = 44.4%<50% pay at ATP 09

Example 2: Provider Name: Bon Secours Renal Facility

DOS 2/15/02, Claim/Services:

CPT Code Modifier

82040 Mod CE and Mod 91

84450 Mod CE

82310 Mod CE

82247 Mod CF

82465 No modifier present

CPT Code Modifier

82565 Mod CE

84550 Mod CF

82040 Mod CD

84075 Mod CE

82435 Mod CE

82550 Mod CF

82947 Mod CF

82977 Mod CF

ACTION: 12 services total, 5 non-composite rate tests, 6 composite rate tests beyond the frequency, 1

composite rate test; 1/12 = 8.3%<50% pay at ATP 12

Example 3: Provider Name: Sinai Hospital Renal Facility

DOS 4/02/02, Claim/Services:

CPT Code Modifier

82565 Mod CD

83615 Mod CD

82247 Mod CF

82248 Mod CF

82040 Mod CD

84450 Mod CD

82565 Mod CE

84550 Mod CF

82248 Mod CF (Duplicate

ACTION: 8 services total, 3 non-composite rate tests, 4 composite rate tests, 1 composite rate test beyond the

frequency; 4/8 = 50%, therefore no payment is made.

Example 4: Provider Name: Dr. Andrew Ross

DOS 6/01/02, Claim/Services:

CPT Code Modifier

84460 Mod CF

82247 Mod CF

82248 Mod CF

82040 Mod CD

84075 Mod CD

84450 Mod CD

ACTION: 6 services total, 3 non-composite rate tests and 3 composite rate tests; 3/6 = 50%, therefore no

payment.

Example 5: (A/B MAC (B) Processing Example Only)

Payment for first claim, second claim creates a no payment status for either claim.

Provider Name: Dr. Andrew Ross

DOS 6/01/06, Claim/Services - First claim

CPT Code Modifier

84460 Mod CF

82247 Mod CF

82248 Mod CF

ACTION: 3 services total, 3 non-composite rate tests, 0 composite rate tests beyond the frequency, and 0

composite rate tests, 0/3 = 0%, therefore ATP 03

Example 5: continued (A/B MAC (B) Processing Example Only)

Provider Name: Dr. Andrew Ross

DOS 6/01/06, Claim/Services - Second claim

CPT Code Modifier

82040 Mod CD

84075 Mod CD

84450 Mod CD

ACTION: An additional 3 services are billed, 0 non-composite rate tests, 8 composite rate tests beyond the

frequency, 3 composite rate tests. For both claims there are 6 services total, 3 non-composite rate tests and 3

composite rate tests; 3/6 = 50% U>U 50%, therefore no payment. An overpayment should be recovered for the

ATP 03 payment on the first claim.

History

(Rev. 2487, Issued: 06-08-12, Effective: 01-01-11, Implementation: 06-19-12)

Provenance

Source
cms.gov
Retrieved
2026-08-25
Edition
iom-2026-08-25
Content hash
f8d84b568823f544c05213fdd21a5fc1cdcc70f3742888d404e8f87cbca4ca53
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