Article - Billing and Coding: Erythropoiesis Stimulating Agents (A58982)

CMS National Coverage PolicyTitle XVIII of the Social Security Act, 1833(e) prohibits Medicare payment for any claim which lacks the necessary information to process the claim.Title XVIII of the Social Security Act, 1842(u) Each request for payment, or bill submitted, for a drug furnished to an individual for the treatment of anemia in connection with the treatment of cancer shall include information on the hemoglobin or hematocrit levels for the individual.Title XVIII of the Social Security Act, 1881(b)(11)(B)(i) allows payment for erythropoietin provided by a physician.CMS Internet-Only Manual, Pub. 100-02, Medicare Benefit Policy Manual, Chapter 6, 10.2 Other Circumstances in Which Payment Cannot Be Made Under Part A and 30 Drugs and BiologicalsCMS Internet-Only Manual, Pub. 100-02, Medicare Benefit Policy Manual, Chapter 11, 20.3 Drugs and Biologicals, 30.1 Home Dialysis Items and Services, and 100.6 Applicability of Specific ESRD PPS Policies to AKI DialysisCMS Internet-Only Manual, Pub. 100-02, Medicare Benefit Policy Manual, Chapter 15, 50.5.2 Erythropoietin (EPO), 50.5.2.1 Requirements for Medicare Coverage for EPO, and 50.5.2.2 Medicare Coverage of Epoetin Alfa (Procrit) for Preoperative UseCMS Internet-Only Manual, Pub. 100-03, Medicare National Coverage Determinations (NCD) Manual, Chapter 1, Part 2, 110.21 Erythropoiesis Stimulating Agents (ESAs) in Cancer and Related Neoplastic ConditionsCMS Internet-Only Manual, Pub. 100-04, Medicare Claims Processing Manual, Chapter 4, 10 Hospital Outpatient Prospective Payment System (OPPS), 20 Reporting Hospital Outpatient Services Using Healthcare Common Procedure Coding System (HCPCS), 50.1 Outpatient Provider Specific File, and 200.2 Hospital Dialysis Services For Patients with and without End Stage Renal Disease (ESRD)CMS Internet-Only Manual, Pub. 100-04, Medicare Claims Processing Manual, Chapter 6, 20 Services Included in Part A PPS Payment Not Billable Separately by the SNF, 20.2.1 Dialysis and Dialysis Related Services to a Beneficiary With ESRD, and 20.2.1.1 ESRD ServicesCMS Internet-Only Manual, Pub. 100-04, Medicare Claims Processing Manual, Chapter 7, 100 Epoetin (EPO)CMS Internet-Only Manual, Pub. 100-04, Medicare Claims Processing Manual, Chapter 8, 10.5 Hospital Services, 40 Acute Kidney Injury (AKI) Claims, 50.2 Drugs and Biologicals Included in the End Stage Renal Disease Prospective Payment System (ESRD)(PPS), 50.3 Required Information for In-Facility Claims Paid Under the End Stage Renal Disease Prospective Payment System ESRD PPS, 60.2 Drugs Furnished in Dialysis Facilities, 60.2.1.1 Separately Billable ESRD Drugs, 60.2.1.2 Facilities Billing for ESRD Drugs and Biologicals Equivalent to Injectable Drugs, 60.4 Erythropoietin Stimulating Agents (ESAs), 60.4.1 ESA Claims Monitoring Policy, 60.4.2 Facility Billing Requirements for ESAs, 60.4.4 Payment Amount for Epoetin Alfa (EPO), 60.4.4.1 Payment for Epoetin Alfa (EPO) in Other Settings, 60.4.4.2 Epoetin Alfa (EPO) Provided in the Hospital Outpatient Departments, 60.4.6.1 Reserved for Future Use, 60.4.6.2 Reserved for Future Use, 60.4.6.3 Payment Amount for Darbepoetin Alfa (Aranesp), 60.4.6.4 Payment for Darbepoetin Alfa (Aranesp) in Other Settings, and 60.4.6.5 Payment for Darbepoetin Alfa (Aranesp) in the Hospital Outpatient DepartmentCMS Internet-Only Manual, Pub. 100-04, Medicare Claims Processing Manual, Chapter 17, 10 Payment Rules for Drugs and Biologicals, 20.5.8 Injections Furnished to ESRD Beneficiaries, 40.1 Discarded Erythropoietin Stimulating Agents for Home Dialysis, 80.5 Self-Administered Drugs, 80.8 Reporting of Hematocrit and/or Hemoglobin Levels, 80.9 Required Modifiers for ESAs Administered to Non-ESRD Patients, 80.10 Hospitals Billing for Epoetin Alfa (EPO) and Darbepoetin Alfa (Aranesp) for Non-ESRD Patients, 80.11 Requirements for Providing Route of Administration Codes for Erythropoiesis Stimulating Agents (ESAs), and 80.12 Claims Processing Rules for ESAs Administered to Cancer Patients for Anti-Anemia TherapyCMS Internet-Only Manual, Pub. 100-04, Medicare Claims Processing Manual, Chapter 30 Financial Liability ProtectionsMedicare Learning Network (MLN) Matters (MM5818); Effective Date July 30, 2007Medicare Learning Network (MLN) Matters (MM5699); Effective Date January 1, 2008Article TextThe 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 patients 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, ECAllnon-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 chemotherapyEB: ESA administered to treat anemia due to anticancer radiotherapyEC: ESA administered to treat anemia not due to anticancer radiotherapy or anticancer chemotherapyESA 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 deficiencyB-12 deficiencyIron deficiencyHemolysisBleedingBone marrow fibrosisAnemia associated with the treatment of acute and chronic myelogenous leukemias (CML, AML) or erythroid cancersAnemia of cancer not related to cancer treatmentProphylactic use to prevent chemotherapy-induced anemiaProphylactic use to reduce tumor hypoxiaPatients with erythropoietin (EPO)-type resistance due to neutralizing antibodiesAnemia due to cancer treatments if patients have uncontrolled hypertensionNon-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.zipNon-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 HCT30.0% or greater will be denied.-JA, JB, JERoute 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 GZAn 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 statutoryexclusions 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/HematocritClaims 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 Hbreading. 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 RequirementsThe medical record documentation for patients receiving ESA therapy must support the reasonable and necessary basis for such therapy.