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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 Centers for Medicare and Medicaid Services, Internet Only 
Manual, Publication 100-02, Medicare Benefit Policy Manual, Chapter 15, Section 50.4.1. 
The rules state that erythropoietin stimulating agents (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.  
The rules state 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: 1. Any anemia in cancer or cancer treatment patients due to folate deficiency, B-12 deficiency, iron 
deficiency, hemolysis, bleeding, or bone marrow fibrosis;  
2. The anemia associated with the treatment of acute and chronic myelogenous leukemias (CML, AML), 
or erythroid cancers;  
3. The anemia of cancer not related to cancer treatment;  
4. Any anemia associated only with radiotherapy;  
5. Prophylactic use to prevent chemotherapy-induced anemia;  
6. Prophylactic use to reduce tumor hypoxia;  
7. Patients with erythropoietin-type resistance due to neutralizing antibodies; and  
8. Anemia due to cancer treatment if patients have uncontrolled hypertension.  
You can find this rule in National Coverage Determination (NCD), Erythropoiesis Stimulating Agents (ESAs) 
in Cancer and Related Neoplastic Conditions, 110.21 
 
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.