Revised Coverage of Erythropoiesis Stimulating Agents Effective March 26, 2007 National Government Services, Inc. will restrict coverage of erythropoiesis stimulating agents (ESA) darbepoetin and epoetin alfa to exclude reimbursement for treatment of anemia of neoplastic disease in patients not receiving concomitant chemotherapy. All other coverage remains unchanged. At the Food and Drug Administration’s (FDA) direction, the manufacturers and distributors of ESAs have changed the labeling of these drugs. This action was in response to recent studies demonstrating that the use of ESAs for treatment of anemia in neoplastic diseases demonstrated increased deaths and decreased time to progression; that in those patients undergoing noncardiac/nonvascular surgery there was an increased risk of thrombosis; and that risks may be increased when hemoglobin levels greater than 12g% occur. The revised labeling indicates that ESAs should not be started unless the hemoglobin levels are below 11g% and should be discontinued if the hemoglobin level exceeds 12g%. It may be restarted, at a dose reduced by 25 percent (for epoetin alfa) or 40 percent (for darbepoetin), once the hemoglobin again falls below 11g%. ESAs are approved only to reduce the potential for transfusion, and are not approved to treat the symptoms of anemia. These symptoms, however, may represent the indication for which a physician would consider transfusion to be needed. The ICD-9-CM codes 780.79 and 786.05, previously scheduled for deletion, will be retained for use when coding for anemia of chronic disease (285.29) not associated with malignancy. The FDA labeling states that ESAs are indicated for treatment of anemia of malignancy when receiving concomitant chemotherapy. National Government Services will interpret concomitant to mean during an established course of planned chemotherapy. It will also cover ESAs within three months after completing or stopping chemotherapy. When billing for ESAs administered to patients with anemia of neoplastic disease receiving chemotherapy, providers should use the diagnosis code 285.22 (Anemia in neoplastic disease) with the secondary diagnosis code E933.1 ( Antineoplastic and immunosuppressive drugs causing adverse effects in therapeutic use) or E930.7 ( Antineoplastic antibiotics causing adverse effects in therapeutic use). It will no longer be necessary to also code for the specific malignancy being treated. If a physician continues to administer ESAs to patients with malignancy not on chemotherapy, then the service may be billed for denial using the diagnosis code 285.22 but without the E933.1 or E930.7 diagnosis code. Whenever an advance beneficiary notice (ABN) is issued, an occurrence code 32 must be billed to signify all services on the claim are associated with one particular Advance Beneficiary Notice (ABN) given on a specific date. If all of the services do not relate to the occurrence code 32, then a modifier GA should be appended to only those services to which the ABN applies. If no ABN is obtained then the provider should use the GZ modifier.
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