US · guidance
CMS Pub. 100-04, ch. 16, § 40.6
Billing for End Stage Renal Disease (ESRD) Related Laboratory Tests
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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