CMS Pub. 100-02, ch. 11, § 20.2

All laboratory services furnished to individuals for the treatment of ESRD are included in the ESRD PPS

and are not paid separately as of January 1, 2011. Payments for these services were incorporated into the

ESRD PPS base rate. The laboratory services include, but are not limited to:

• Laboratory tests included under the composite rate as of December 31, 2010 (discussed below); and

• Formerly separately billable Part B laboratory tests that were billed by ESRD facilities and

independent laboratories, for ESRD patients.

Composite rate laboratory tests are listed in §20.2.E of this chapter. More information regarding composite

rate laboratory tests can be found in Pub. 100-04, Medicare Claims Processing Manual, chapter 8, §50.1,

§60.1, and §80. As discussed below, composite rate laboratory services should not be reported on claims.

The following table lists the drug categories that were excluded from the ESRD PPS and the rationale for

their exclusion. Laboratory services furnished to monitor the medication levels of these drugs and biological

products would not be considered for the treatment of ESRD. For example, laboratory testing for anti-psychotics is not included in the ESRD PPS. However, laboratory testing for drugs that regulate bone and

mineral metabolism (e.g., calcimimetics) is included.

DRUG CATEGORIES EXCLUDED FROM THE ESRD PPS BASE RATE

FOR THE PURPOSE OF REPORTING LABORATORY TESTS

Drug Category Rationale for Exclusion

Anticoagulant Drugs labeled for non-renal dialysis conditions and not for

vascular access.

Antidiuretic Used to prevent fluid loss.

Antiepileptic Used to prevent seizures.

Anti-inflammatory May be used to treat kidney disease (glomerulonephritis) and

other inflammatory conditions.

Antipsychotic Used to treat psychosis.

Antiviral Used to treat viral conditions such as shingles.

Cancer management Includes oral, parenteral and infusions. Cancer drugs are

covered under a separate benefit category.

Cardiac management Drugs that manage blood pressure and cardiac conditions.

Cartilage Used to replace synovial fluid in a joint space.

Coagulants Drugs that cause blood to clot after anti-coagulant overdose or

factor VII deficiency.

Cytoprotective agents Used after chemotherapy treatment.

Endocrine/metabolic

management

Used for endocrine/metabolic disorders such as thyroid or

endocrine deficiency, hypoglycemia, and hyperglycemia.

Erectile dysfunction

management

Androgens were used prior to the development of ESAs for

anemia management and currently are not recommended

practice. Also used for hypogonadism and erectile

dysfunction.

Gastrointestinal management Used to treat gastrointestinal conditions such as ulcers and

gallbladder disease.

Immune system management Anti-rejection drugs covered under a separate benefit

category.

Migraine management Used to treat migraine headaches and symptoms.

Musculoskeletal management Used to treat muscular disorders such as prevent muscle

spasms, relax muscles, improve muscle tone as in myasthenia

gravis, relax muscles for intubation and induce uterine

contractions.

Pharmacy handling for oral anti-cancer, anti-emetics and

immunosuppressant drugs

Not a function performed by an ESRD facility.

Pulmonary system management Used for respiratory/lung conditions such as opening airways

and newborn apnea.

Radiopharmaceutical procedures Includes contrasts and procedure preparation.

Unclassified drugs Should only be used for drugs that do not have a HCPCS code

and therefore cannot be identified.

Vaccines Covered under a separate benefit category.

The distinction of what is considered to be a “renal dialysis laboratory test” is a clinical decision determined

by the ESRD patient’s ordering practitioner. If a laboratory test is ordered for the treatment of ESRD, then

the laboratory test is not paid separately.

Payment for all renal dialysis laboratory tests furnished under the ESRD PPS is included in the base rate,

which is paid directly to the ESRD facility responsible for the patient’s care. The ESRD facility must

furnish the laboratory tests directly, or under arrangement, and report such tests on the ESRD facility claim.

An ESRD facility must report renal dialysis laboratory services on its claims in order for the laboratory tests

to be included in the outlier payment calculation (with the exception of composite rate laboratory tests).

Renal dialysis laboratory services that were or would have been paid separately under Medicare Part B prior

to January 1, 2011, are priced for the outlier payment calculation using the Clinical Laboratory Fee

Schedule. Further information regarding the outlier policy can be found in §60.D of this chapter.

Certain laboratory services are subject to Part B consolidated billing requirements and are no longer

separately payable when provided to ESRD beneficiaries by providers other than the ESRD facility. The list

at the following website includes the renal dialysis laboratory tests that are routinely performed for the

treatment of ESRD and that are used to enforce consolidated billing edits to ensure that payment is not

made for renal dialysis laboratory tests outside of the ESRD PPS: <

https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ESRDpayment/Consolidated_Billing.>

Payment for the laboratory tests identified on this list is included in the ESRD PPS. If any laboratory test is

ordered for the treatment of ESRD, then the laboratory test is considered to be included in the ESRD PPS

and is the responsibility of the ESRD facility. Additional renal dialysis laboratory tests may be added to the

consolidated billing list through administrative issuances in the future.

A. Laboratory Services Furnished for Reasons Other Than for the Treatment of ESRD

1. Independent Laboratory

A patient’s physician or practitioner responsible for their ESRD care 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 patient’s physician or practitioner should notify the independent

laboratory or the ESRD facility (with the appropriate clinical laboratory certification in accordance with the

Clinical Laboratory Improvement Amendments) that furnished the laboratory service that the test is not a

renal dialysis service, so that entity may bill Medicare separately using the AY modifier. The AY modifier

serves as an attestation that the item or service is medically necessary for the patient but is not being used for

the treatment of ESRD.

NOTE: The ESRD PPS base rate accounts for all ESRD facility staff time during a dialysis session.

Therefore, ESRD facility staff time used to furnish laboratory services for reasons other than for the

treatment of ESRD is included in the ESRD PPS and is not billed separately.

2. Hospital-Based Laboratory

Hospital outpatient clinical laboratories furnishing renal dialysis laboratory tests to ESRD patients for

reasons other than the treatment of ESRD may submit a claim for separate payment using the AY modifier.

The AY modifier serves as an attestation that the item or service is medically necessary for the patient but is

not being used for the treatment of ESRD.

NOTE: The ESRD PPS base rate accounts for all ESRD facility staff time during a dialysis session.

Therefore, ESRD facility staff time used to furnish laboratory services for reasons other than for the

treatment of ESRD is included in the ESRD PPS and is not billed separately.

B. Laboratory Services Performed in Emergency Rooms or Emergency Departments

In an emergency room or emergency department, the ordering physician or practitioner may not know, at the

time the laboratory test is being ordered, if it is being ordered as a renal dialysis service. Consequently,

emergency rooms or emergency departments are not required to append an AY modifier to these laboratory

tests when submitting claims with dates of service on or after January 1, 2012.

When a renal dialysis laboratory service is furnished to an ESRD patient in an emergency room or

emergency department on a different date of service, hospitals can append an ET modifier to the laboratory

tests furnished to ESRD patients, to indicate that the laboratory test was furnished in conjunction with the

emergency visit. Appending the ET modifier indicates that the laboratory service being furnished on a day

other than the emergency visit is related to the emergency visit, and at the time, the ordering physician was

unable to determine if the test was ordered for reasons of treating the patient’s ESRD.

Allowing an emergency room or department to bypass consolidated billing edits for laboratory testing does

not mean that ESRD facilities should send patients to other settings for routine laboratory testing for the

purpose of avoiding financial responsibility for renal dialysis items and services. For additional information

regarding laboratory services furnished in a variety of settings, see Pub. 100-04, Medicare Claims

Processing Manual, chapter 16, §30.3 and §40.6.

C. Hepatitis B Laboratory Services for Transient Patients

Laboratory testing for hepatitis B is a renal dialysis service. Effective January 1, 2011, hepatitis B testing is

included in the ESRD PPS and therefore cannot be billed separately to Medicare.

The Conditions for Coverage for ESRD facilities require routine hepatitis B testing (42 CFR §494.30(a)(1)).

The ESRD facility is responsible for the payment of the laboratory test, regardless of frequency. If an ESRD

patient wishes to travel, the patient’s home ESRD facility should have systems in place for communicating

hepatitis B test results to the destination ESRD facility.

D. Laboratory Services Routinely Furnished Under the Composite Rate Payment System

Historically (i.e., prior to the implementation of the ESRD PPS), the costs of certain ESRD laboratory

services furnished for outpatient maintenance dialysis by either the ESRD facility’s staff or an independent

laboratory were included in the composite rate. Therefore, payment for all of these laboratory tests was

included in the ESRD facility’s composite rate and the tests could not have been billed separately to the

Medicare program.

The following three sections discuss laboratory tests that, prior to the ESRD PPS, were furnished to ESRD

beneficiaries on a routine basis under the composite rate payment system. Some laboratory tests were

included in the composite payment rate and some were separately payable.

Under the ESRD PPS, to the extent any of the laboratory tests discussed below are furnished for the

treatment of ESRD and were included in the composite payment rate, these tests are not eligible for outlier

payment and are not reported on the ESRD claim.

Note: There are no requirements under the ESRD PPS regarding frequency, as it relates to payment for

renal dialysis laboratory tests. Laboratory tests should be ordered as medically necessary and should not

be restricted due to financial reasons.

1. Laboratory tests routinely furnished and included in the composite payment rate when they met

coverage requirements with regard to frequency

If any of these tests were performed at a frequency greater than that specified, the additional tests were

separately billable but covered only if they were reasonable and medically necessary.

a. Hemodialysis, IPD, CCPD, and Hemofiltration

• Per Treatment - All hematocrit, hemoglobin, and clotting time tests furnished incident to dialysis

treatments;

• Weekly - Prothrombin time for patients on anticoagulant therapy and Serum Creatinine;

• Weekly or Thirteen Per Quarter - BUN; and

• Monthly - Serum Calcium, Serum Potassium, Serum Chloride, CBC, Serum Bicarbonate, Serum

Phosphorous, Total Protein, Serum Albumin, Alkaline Phosphatase, aspartate amino transferase

(AST) (SGOT) and LDH.

b. CAPD

• Monthly – BUN, Creatinine, Sodium, Potassium, CO2, Calcium, Magnesium, Phosphate, Total

Protein, Albumin, Alkaline Phosphatase, LDH, AST, SGOT, HCT, Hbg, and Dialysate Protein.

2. Laboratory tests routinely furnished that were separately payable to the ESRD facility and not

included in the composite payment rate

• Hemodialysis, IPD, CCPD, and Hemofiltration

o Serum Aluminum - one every 3 months

o Serum Ferritin - one every 3 months

• CAPD

o WBC, RBC, and Platelet count – One every 3 months

o Residual renal function and 24-hour urine volume – One every 6 months

3. Automated Multi-Channel Chemistry (AMCC) Tests

Clinical diagnostic laboratory tests that comprise the AMCC (listed in Appendix A and B) could either be

considered included in the composite payment rate or considered to be non-composite rate (that is,

separately billable) laboratory services. To determine if separate payment was allowed for non-composite

rate tests for a particular date of service, 50 percent or more of the covered tests must be non-composite rate

tests.

Under the composite payment system prior to 2011, Medicare applied the following to AMCC tests for

ESRD beneficiaries:

• Payment was the lowest rate for services performed by the same provider, for the same beneficiary,

for the same date of service.

• The A/B Medicare Administrative Contractor (MAC) identified, for a particular date of service, the

AMCC tests ordered that were included in the composite rate and those that were not included. The

composite rate tests were defined for Hemodialysis, IPD, CCPD, and Hemofiltration (see Appendix

A) and for CAPD (see Appendix B).

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

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

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

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

that Date of Service (DOS) were separately payable.

• A non-composite rate test was defined as any test separately payable outside of the composite rate or

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