Laboratory Services

20.2 - Laboratory Services (Rev. 13599, Issued: 01-30-26 , Effective: 05-01-26, Implementation: 05-01-26 ) 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.