Erythropoiesis Stimulating Agents (ESAs) in Cancer and Related Neoplastic Conditions

CMS National Coverage Determination | ncd_id=322 | manual_section=110.21 | coverage_level_code=2 | national_coverage_type=True | under_review=True | lab_ncd=False

B. Nationally Covered Indications ESA treatment for the anemia secondary to myelosuppressive anticancer chemotherapy in solid tumors, multiple myeloma, lymphoma, and lymphocytic leukemia is only reasonable and necessary under the following specified conditions: The hemoglobin level immediately prior to initiation or maintenance of ESA treatment is The starting dose for ESA treatment is the recommended FDA label starting dose, no more than 150 U/kg/3 times weekly for epoetin and 2.25 mcg/kg/1 time weekly for darbepoetin alpha. Equivalent doses may be given over other approved time periods. Maintenance of ESA therapy is the starting dose if the hemoglobin level remains below 10g/dL (or hematocrit is For patients whose hemoglobin rises Continued administration of the drug is not reasonable and necessary if there is a rapid rise in hemoglobin > 1g/dl (hematocrit > 3%) over 2 weeks of treatment unless the hemoglobin remains below or subsequently falls to ESA treatment duration for each course of chemotherapy includes the 8 weeks following the final dose of myelosuppressive chemotherapy in a chemotherapy regimen. C. Nationally Non-Covered Indications ESA treatment is not reasonable and necessary for beneficiaries with certain clinical conditions, either because of a deleterious effect of the ESA on their underlying disease or because the underlying disease increases their risk of adverse effects related to ESA use. These conditions include: Any anemia in cancer or cancer treatment patients due to folate deficiency, B-12 deficiency, iron deficiency, hemolysis, bleeding, or bone marrow fibrosis; The anemia associated with the treatment of acute and chronic myelogenous leukemias (CML, AML), or erythroid cancers; The anemia of cancer not related to cancer treatment; Any anemia associated only with radiotherapy; Prophylactic use to prevent chemotherapy-induced anemia; Prophylactic use to reduce tumor hypoxia; Patients with erythropoietin-type resistance due to neutralizing antibodies; and Anemia due to cancer treatment if patients have uncontrolled hypertension. D. Other Local Medicare Administrative Contractors may continue to make reasonable and necessary determinations on all other uses of ESAs not specified in this National Coverage Determination. See the Medicare Benefit Policy Manual , chapter 11, section 90 and chapter 15, section 50.5.2 for coverage of ESAs for end-stage renal disease-related anemia.