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Decision: unknown

The rules say that plans must pay for a medical service or item if regular Medicare would pay for it in this case. 
You can find this rule at 42 Code of Federal Regulations (CFR) Section 422.101. 
 
The rules say that Medicare may cover a drug or biological if it is safe and effective and otherwise reasonable 
and necessary. You can find this rule in the Medicare Benefit Policy Manual, Chapter 15, Section 50.4.1. 
 
The rules say that 
 
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: 
1. The hemoglobin level immediately prior to initiation or maintenance of ESA treatment is < 10 g/dL (or the 
hematocrit is < 30%). 
 
2. 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. 
 
3. 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%); 
 
4. 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. 
 
5. 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. 
 
6. ESA treatment duration for each course of chemotherapy includes the 8 weeks following the final dose of 
myelosuppressive chemotherapy in a chemotherapy regimen. 
 
You can find this rule in National Coverage Determination (NCD) for Erythropoiesis Stimulating Agents 
(ESAs) in Cancer and Related Neoplastic Conditions (110.21) - Effective July 30, 2007. 
 
The rules say that 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. 
 
You can find this rule in National Coverage Determination (NCD) for Erythropoiesis Stimulating Agents 
(ESAs) in Cancer and Related Neoplastic Conditions (110.21) - Effective July 30, 2007. 
 
If you want to read these Medicare rules, you can go to this website www.medicareappeal.com. 
 
The Plan contract says that the Plan covers items and services in accordance with Medicare rules.