**

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 < 10 g/dL (or the hematocrit is < 30%). 
  * 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 < 30%) 4 weeks after initiation of therapy and the rise in hemoglobin is  1g/dL (hematocrit  3%); 
  * For patients whose hemoglobin rises < 1g/dl (hematocrit rise < 3%) compared to pretreatment baseline over 4 weeks of treatment and whose hemoglobin level remains < 10g/dL after the 4 weeks of treatment (or the hematocrit is < 30%), the recommended FDA label starting dose may be increased once by 25%. Continued use of the drug is not reasonable and necessary if the hemoglobin rises < 1g/dl (hematocrit rise < 3%) compared to pretreatment baseline by 8 weeks of treatment. 
  * 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 < 10g/dL (or the hematocrit is < 30%). Continuation and reinstitution of ESA therapy must include a dose reduction of 25% from the previously administered dose. 
  * 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](https://www.cms.gov/Regulations-and-
Guidance/Guidance/Manuals/Internet-Only-Manuals-IOMs-Items/CMS012673), chapter
11, section 90 and chapter 15, section 50.5.2 for coverage of ESAs for end-
stage renal disease-related anemia.