(Medicare Benefit Policy Manual)

Certain laboratory services will be subject to Part B consolidated billing requirements and will no longer be separately payable when provided to ESRD beneficiaries by providers other than the ESRD facil ity.  The list below includes the renal dialysis laboratory tests that are routinely performed for the treatment of ESRD.  Payment for the laboratory tests identified on this list is included in the ESRD PPS.  The laboratory tests listed in the table are u sed to enforce consolidated billing edits to ensure that payment is not made for renal dialysis laboratory tests outside of the ESRD PPS.  The list of renal dialysis laboratory tests is not an all-inclusive list.  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 through administrative issuances in the future.   LABS SUBJECT TO ESRD CONSOLIDATED BILLING  CPT/ HCPCS  Short Description  80047  Basic Metabolic Panel (Calcium, ionized)  80048  Basic Metabolic Panel (Calcium, total)  80051  Electrolyte Panel  80053  Comprehensive Metabolic Panel  80061*  Lipid Panel*  80069  Renal Function  Panel  80076  Hepatic Function Panel  82040  Assay of serum albumin  82108  Assay of aluminum  82306  Vitamin d, 25 hydroxy  82310  Assay of calcium  82330  Assay of calcium, Ionized  82374  Assay, blood carbon dioxide  82379  Assay of carnitine  82435  Assay of blood chloride  82565  Assay of creatinine  82570  Assay of urine creatinine  82575  Creatinine clearance test  82607  Vitamin B -12 82652  Vit d 1, 25 -dihydroxy  82668  Assay of erythropoietin  82728  Assay of ferritin  82746  Blood folic acid serum  83540  Assay of iron  83550  Iron binding test  83735  Assay of magnesium  83970  Assay of parathormone  84075  Assay alkaline phosphatase  84100  Assay of phosphorus  84132  Assay of serum potassium  84134  Assay of prealbumin  84155  Assay of protein, serum  84157  Assay of protein by other source  84295  Assay of serum sodium  84466  Assay of transferrin  84520  Assay of urea nitrogen  84540  Assay of urine/urea -n 84545  Urea -N clearance test  85014  Hematocrit  85018  Hemoglobin  85025  Complete (cbc), automated (HgB, Hct, RBC, WBC, and Platelet count) and automated differential WBC count.  85027  Complete (cbc), automated (HgB, Hct, RBC, WBC, and Platelet count)  85041  Automated rbc count  85044  Manual reticulocyte count  85045  Automated reticulocyte count  85046  Reticyte/hgb concentrate  85048  Automated leukocyte count  86704  Hep b core antibody, total  86705  Hep b core antibody, igm  86706  Hep b surface antibody  87040  Blood culture for bacteria  87070  Culture, bacteria, other  87071  Culture bacteri aerobic othr  87073  Culture bacteria anaerobic  87075  Cultr bacteria, except blood  87076  Culture anaerobe ident, each  87077  Culture aerobic identify  87081  Culture screen only  87340  Hepatitis b surface ag, eia  G0306  CBC/diff wbc w/o platelet  G0307  CBC without platelet   *  Effective January 1, 2016, the lipid panel is no longer considered to be a renal dialysis service. However, if the panel is furnished for the treatment of ESRD it is the responsibility of the ESRD facility and should be reported on the facilitys claim.   A.  Automated Multi -Channel Chemistry (AMCC) Tests   During the ESRD PPS transition period (see 70 of this chapter) ESRD facilities were  required to report the renal dialysis AMCC tests with the appropriate modifiers (CD, CE, or CF) on their claims for purposes of applying the 50/50 rule under the composite rate portion of the blended payment.  Refer to 70.B of this chapter for additional information regarding the composite rate portion of the blended payment during the transition.   The 50/50 rule is necessary for those ESRD facilities that chose to go through the transition period.  If the 50/50 rule allows for separate payment, then the laboratory tests are priced using the clinical laboratory fee schedule.  Information regarding the 50/50 rule can be found in 20.2.E of this chapter and in Pub. 100- 04, Medicare Claims Processing Manual, chapter 16, 40.6.  NOTE:   An ESRD facility billing a renal dialysis AMCC test must use the CF modifier when the AMCC is not in the composite rate but is a renal dial ysis service.  AMCC tests that are furnished to individuals for reasons other than for the treatment of ESRD should be billed with the AY modifier to Medicare directly by the entity furnishing the service with the AY modifier.   B.  Laboratory Services Furn ished for Reasons Other Than for the Treatment of ESRD   1.  Independent Laboratory   A patients physician or practitioner 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 patients 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 Act) that furnished the laboratory service that the test is not a renal dialysis service and 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.  2.  Hospital -Based Laboratory   Hospital outpatient clinical laboratories furnishing renal dialysis laboratory tests to ESRD patients for reasons other than for the treatment of ESRD may subm it 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.  C.  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, emergen cy 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. Append ing 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 treati ng the patients ESRD.   Allowing laboratory testing to bypass consolidated billing edits in the emergency room or department does not mean that ESRD facilities should send patients to other settings for routine laboratory testing for the purpose of not ass uming financial responsibility of 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.  D.  Hepatit is 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 Conditi ons 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 patients home ESR D facility should have systems in place for communicating hepatitis B test results to the destination ESRD facility.   E.  Laboratory Services Included Under Composite Rate   Prior to the implementation of the ESRD PPS, the costs of certain ESRD laboratory services furnished for outpatient maintenance dialysis by either the ESRD facilitys staff or an independent laboratory, were included in the composite rate calculations.  Therefore, payment for all of these laboratory tests was included in the ESRD facili tys composite rate and the tests could not have been billed separately to the Medicare program.   All laboratory services that were included under the composite rate are included under the ESRD PPS unless otherwise specified.  Payments for these laboratory  tests are included in the ESRD PPS and are not paid separately under the composite rate portion of the blended payment and are not eligible for outlier payments.  Therefore, composite rate laboratory services should not be reported on the claim.  Laboratory tests included in the composite payment rate are identified below.   1.  Routinely Covered Tests Paid Under Composite Rate   The tests listed below are usually performed for dialysis patients and were routinely covered at the frequency specified in the ab sence of indications to the contrary, (i.e., no documentation of medical necessity was required other than knowledge of the patients status as an ESRD beneficiary).  When any of these tests were performed at a frequency greater than that specified, the ad ditional tests were separately billable and were covered only if they were medically justified by accompanying documentation.  A diagnosis of ESRD alone was not sufficient medical evidence to warrant coverage of the additional tests.  The nature of the ill ness or injury (diagnosis, complaint, or symptom) requiring the performance of the test(s) must have been present, along with ICD diagnosis coding, on the claim for payment.   a. Hemodialysis, IPD, CCPD, and Hemofiltration    Per Treatment  - All hematocrit, h emoglobin, 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;    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; and    Automated Multi- Channel Chemistry (AMCC)  - If an automated battery of tests, such as the SMA -12, is performed and contains most of the tests listed in one of the weekly or monthly categories, it is not necessary to separately  identify any tests in the battery that are not listed.  Further informat ion concerning automated tests and the 50 percent rule can be found below and in Pub. 100- 04, Medicare Claims Processing Manual, chapter 16, 40.6.1.  b. CAPD   Monthly  BUN, Creatinine, Sodium, Potassium, CO2, Calcium, Magnesium, Phosphate, Total Protei n, Albumin, Alkaline Phosphatase, LDH, AST, SGOT, HCT, Hbg, and Dialysate Protein.   Under the ESRD PPS, frequency requirements do not apply for the purpose of payment.  However, laboratory tests should be ordered as necessary and should not be restricted because of financial reasons.   2.  Separately Billable Tests Under the Composite Rate   The following list identifies certain separately billable laboratory tests that were covered routinely and without documentation of medical necessity other than knowledge  of the patients status as an ESRD beneficiary, when furnished at specified frequencies.  If they were performed at a frequency greater than that specified, they were covered only if accompanied by medical documentation.  A diagnosis of ESRD alone was not  sufficient documentation.  The medical necessity of the test(s), the nature of the illness or injury (diagnosis, complaint or symptom) requiring the performance of the test(s) must have been furnished on claims using the ICD diagnosis coding system.    Separately Billable Tests for Hemodialysis, IPD, CCPD, and Hemofiltration   Serum Aluminum -  one every 3 months  Serum Ferritin -  one every 3 months    Separately Billable Tests for CAPD   WBC, RBC, and Platelet count  One every 3 months  Residual renal function and 24 hour urine volume  One every 6 months