ESRD Laboratory Services

All Laboratory services furnished to renal dialysis patients for the treatment of End Stage Renal Disease (ESRD) are included in the ESRD Prospective Payment System (PPS) payment. Composite rate laboratory services/tests should not be reported on claims. ESRD facilities should only bill for laboratory tests related to the treatment of ESRD or other laboratory tests performed by the dialysis facility (i.e. CLIA waived lab tests). Lab tests that are not for the treatment of ESRD and are not performed by the ESRD facility are not to be reported on the ESRD facility claim.

An item or service furnished by an ESRD facility that is not for the treatment of ESRD must be submitted with an AY modifier to allow separate payment outside of the ESRD PPS.

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Routinely Covered Tests - Composite Rates

Under ESRD PPS, frequency requirements; however, laboratory tests should be ordered as necessary and should not be restricted because of financial reasons.

  • Hemodialysis, Intermittent Peritoneal Dialysis (IPD), Continuous cycling peritoneal dialysis (CCPD), and Hemofiltration - routine labs and frequency
    • 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 - Blood Urea Nitrogen (BUN);
    • Monthly - Serum Calcium, Serum Potassium, Serum Chloride, Complete Blood Count (CBC), Serum Bicarbonate, Serum Phosphorous, Total Protein, Serum Albumin, Alkaline Phosphatase, aspartate amino transferase (AST) (also known as Serum Glutamic-Oxaloacetic Transaminase) (SGOT) and (Lactate Dehydrogenase (LDH).
  • Continuous Ambulatory Peritoneal Dialysis (CAPD) - routine labs and frequency
    • Monthly - BUN, Creatinine, Sodium, Potassium, Carbon Dioxide (CO2), Calcium, Magnesium, Phosphate, Total Protein, Albumin, Alkaline Phosphatase, LDH, AST, SGOT, Hematocrit (HCT), Hemoglobin (Hbg), and Dialysate Protein.

Consolidated Billing Requirement - Laboratory

Under Consolidated Billing (CB), ESRD facilities are expected to furnish services, either directly, or under an arrangement with an outside supplier.

Renal dialysis services provided to an ESRD beneficiary by other providers; look to the ESRD facility for payment, as opposed to submitting a claim to the Medicare Administrative Contractor (MAC).

The Part B ESRD PPS CB list of renal dialysis laboratory tests routinely performed and not paid separately is not an all-inclusive list. The distinction of what is 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. ESRD PPS consolidated billing lists are updated annually.

Separately Billable Laboratory Tests

ESRD facilities must report renal dialysis laboratory services on its claims for the laboratory tests to be included in the outlier payment calculation. ESRD facilities that treat renal dialysis patients with unusually high resource requirements, as measured by use of identified services beyond a specified threshold, are entitled to outlier payments. ESRD PPS outlier services lists are updated annually.

Laboratory services furnished to monitor the medication levels or effects of drugs and biologicals must fall in categories listed in CMS "ESRD PPS Drug Designation Process." The laboratory test is then considered not furnished for the treatment of ESRD and excluded from ESRD PPS, these tests would be separately billable.



Last Updated Nov 17 , 2022