Billing and Coding: Erythropoiesis Stimulating Agents

The information in this article contains billing, coding or other guidelines that complement the Local Coverage Determination (LCD) for Erythropoiesis Stimulating Agents L39237. Part A and B: General Information for Erythropoiesis Stimulating Agents (ESA) Claims: It is not appropriate to bill Medicare for services that are not covered as if they are covered. When billing for non-covered services, use the appropriate modifier. For services requiring a referring/ordering physician, the name and NPI of the referring/ordering physician must be reported on the claim. A claim submitted without a valid ICD-10-CM diagnosis code will be returned to the provider as an incomplete claim under Section 1833(e) of the Social Security Act. The diagnosis code(s) must best describe the patient's condition for which the service was performed. No ESA should be given within the context of uncontrolled hypertension. No ESA should be used to replace red blood cell (RBC) transfusions in patients who need immediate urgent correction of anemia. With any ESA, the patient’s medical record should reflect the clinical reason for dose changes and hematocrit (HCT) levels outside the range of 30.0-36.0% (hemoglobin (Hb) levels 10.0-12.0 g/dL). Medicare contractors may review medical records to assure appropriate dose reductions are applied and maintained and hematological target ranges are maintained. There may be instances when a patient has a chronic health condition not specifically addressed in this policy for which an ESA is useful treatment. Such scenarios would be expected to demonstrate considerable transfusion dependence and anemia-related symptoms. In the event of denials, an appeals process will allow the opportunity for the provider to substantiate a reasonable and necessary basis for ESA treatment based on medical literature, specialty organization best practice alignment, and the unique clinical circumstances for the beneficiary. Explanatory documentation within the medical record is crucial. HCPCS Drug Codes: Healthcare Common Procedure Coding System (HCPCS) codes J0881, J0885, J0888, and Q5106 are for use in patients with non-end stage renal disease (non-ESRD) conditions. HCPCS codes J0882, J0887, Q4081, and Q5105 are intended for use only with patients who have ESRD and are on dialysis. Modifiers: -EA, EB, EC All non-ESRD claims reporting HCPCS code J0881, J0885, J0888, or Q5106 and ESRD claims reporting J0882, J0887, Q4081, and Q5105 must report 1, and only 1, of the following modifiers: EA: ESA administered to treat anemia due to anticancer chemotherapy EB: ESA administered to treat anemia due to anticancer radiotherapy EC: ESA administered to treat anemia not due to anticancer radiotherapy or anticancer chemotherapy ESA claims, either institutional or professional, that do not report 1 of the above 3 modifiers will be returned to the provider. Non-ESRD ESA claims that report the ESA modifier EC and any of the following conditions will be denied as not reasonable and necessary: Any anemia in cancer or cancer treatment patients due to: Folate deficiency B-12 deficiency Iron deficiency Hemolysis Bleeding Bone marrow fibrosis Anemia associated with the treatment of acute and chronic myelogenous leukemias (CML, AML) or erythroid cancers Anemia of cancer not related to cancer treatment Prophylactic use to prevent chemotherapy-induced anemia Prophylactic use to reduce tumor hypoxia Patients with erythropoietin (EPO)-type resistance due to neutralizing antibodies Anemia due to cancer treatments if patients have uncontrolled hypertension Non-ESRD ESA services for J0881, J0885 or Q5106 billed with modifier -EC will be denied in the presence of various secondary ICD-10 codes that are non-covered per CMS. https://www.cms.gov/Medicare/Coverage/DeterminationProcess/downloads/CR12027.zip Non-ESRD ESA services for J0881, J0885 and Q5106 are not considered reasonable and necessary within the context of other medical conditions for which resolution would be expected prior to starting or to continue ESA administration. Such conditions would include, but not be limited to: iron/vitamin B12/folate deficiencies, G6PD deficiency, pyridoxine deficiency, various forms of hemolysis, hereditary spherocytosis, and pure red cell aplasias. The presence of any of these conditions would reduce the therapeutic impact and effectiveness of the ESA. Additionally, the presence of an unspecified anemia code suggests appropriate evaluation, to determine the nature of the treated anemia, has not been completed. Non-ESRD ESA claims that report HCPCS J0881, J0885, J0888 or Q5106 billed with ESA modifier EB (ESA, anemia, radio-induced) will be denied. Non-ESRD ESA claims that report HCPCS J0881, J0885, J0888 or Q5106 billed with modifier EA (ESA, anemia, chemo-induced) for anemia secondary to myelosuppressive anticancer chemotherapy in solid tumors, multiple myeloma, lymphoma, and lymphocytic leukemia when a Hb 10.0g/dL or greater or HCT 30.0% or greater will be denied. -JA, JB, JE Route of administration is important information especially with drugs that can be given multiple different ways. All non-ESRD claims reporting HCPCS code J0881, J0885, J0888, or Q5106 and all ESRD claims reporting J0882, Q4081, and Q5105 must also be reported with 1, and only 1, of the following modifiers: JA-Administered intravenously (IV) JB-Administered subcutaneously (SQ) JE-Administered via dialysate -GA, GX, GY or GZ An Advance Beneficiary Notice of Noncoverage (ABN) may be used for services which are likely to be non-covered, whether for medical necessity or for other reasons. Non-covered services should be billed with modifier –GA (Waiver of liability statement issued as required by payer policy, individual case) when the provider wants to indicate that it is anticipated Medicare will deny a specific service as not reasonable and necessary and an ABN signed by the beneficiary is on file, with -GX (Notice of liability issued, voluntary under payer policy) when the beneficiary has signed an ABN, and a denial is anticipated based on provisions other than medical necessity, such as statutory exclusions of coverage or technical issues, with -GY (Item or service statutorily excluded, does not meet the definition of any Medicare benefit or, for non-Medicare insurers, is not a contract benefit, or with –GZ (Item or service expected to be denied as not reasonable and necessary) when the provider wants to indicate that it is expected that Medicare will deny a service as not reasonable and necessary and that an ABN has not been signed by the beneficiary, as appropriate. Claims Reporting-Hemoglobin/Hematocrit Claims billing for the administration of an ESA (HCPCS codes J0881, J0882, J0885, J0887, J0888, Q4081, Q5105 and Q5106) must report the most recent HCT or Hb reading. Claims not reporting this information will be returned to the provider. For institutional claims, the Hb reading is reported with a value code 48 and a HCT reading is reported with the value code 49. For professional paper claims, test results are reported in item 19 of the Form CMS-1500 claim form. For electronic claims (837P), providers report the Hb or Hct readings in Loop 2400 MEA segment. The specifics are mEA01=TR (for test results), MEA02=R1 (for Hb) or R2 (for HCT), and MEA03=the test results. Documentation Requirements The medical record documentation for patients receiving ESA therapy must support the reasonable and necessary basis for such therapy. All documentation must be maintained in the patient's medical record and made available to the contractor upon request. Every page of the record must be legible and include appropriate patient identification information (e.g., complete name, dates of service[s]). The documentation must include the legible signature of the physician or non-physician practitioner responsible for and providing the care to the patient. The submitted medical record must support the use of the selected ICD-10-CM code(s). The submitted CPT/HCPCS code must describe the service performed. For any ESA, the medical record must reflect that ESA therapy for the individualized patient is reasonable and necessary. The medical record must document the most recent blood pressure and demonstrate reasonable control not in significant excess of a baseline range for a given patient, weight in kilograms, date and results of HCT or Hb level prior to the administration of ESA therapy, evidence of assessment ruling out other causative factors of anemia or, if causative factors are present, that they have been managed and that it is still necessary to initiate ESA. The dosage and route of administration must be documented. ESRD on Dialysis ESA Claims with Modifier EC For patients with ESRD who are on dialysis, HCPCS codes J0882, J0887, Q4081, and Q5105 are not paid by Medicare Part B. ESAs for ESRD on dialysis are included in the composite rate for the ESRD facility. If an ESA is administered to a patient with ESRD on dialysis by a provider other than the patient’s ESRD provider, the administering provider must submit a claim to the ESRD provider for the service. The administering provider must not submit a claim to Medicare Part B. Required Documentation Elements: The ESA utilized: Darbepoetin alfa (J0882) or epoetin alfa (Q4081) or epoetin alfa-epbx biosimilar (Q5105) or epoetin beta (J0887) Use of the ESA for specific diagnoses indicating symptomatic anemia of chronic kidney disease (CKD) on dialysis For patients with ESRD who are on dialysis, a diagnosis of D63.1 and a diagnosis of N18.6 must be billed with HCPCS code J0882, J0887, Q4081, or Q5105. The EC modifier is also required. A JA, JB or JE modifier is required. Inclusion of any other ICD-10 diagnoses on the claim which are non-covered with an EC modifier per NCD 110.21, will preclude payment for the ESA. Use of an appropriate dose, route (IV administration is recommended for use in ESRD), and frequency. DOSING: For initial dosing of darbepoetin al