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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. 
 
Medicare may cover the use of an FDA-approved drug or biological if it is safe and effective and otherwise 
reasonable and necessary for the patient. Food and Drug Administration (FDA) approved drugs used for 
indications other than what is indicated on the official label may be covered if the use is determined to be 
medically accepted, taking into consideration the major drug compendia, authoritative medical literature and/or 
accepted standards of medical practice. You can find this rule in the Centers for Medicare & Medicaid 
Services, Internet Only Manual, Publication 100-02, Medicare Benefit Policy Manual, Chapter 15, Sections 
50.4.1 and 50.4.2. 
 
The rules say that erythropoiesis stimulating agent (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 less than 10 
g/dL (or the hematocrit is less than 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 less than 30%) 4 weeks after initiation of therapy and the rise in hemoglobin is greater 
than or equal to 1g/dL (hematocrit greater than or equal to 3%); 
 For patients whose hemoglobin rises less than 1g/dl (hematocrit rise less than 3%) compared to 
pretreatment baseline over 4 weeks of treatment and whose hemoglobin level remains less than 10g/dL 
after the 4 weeks of treatment (or the hematocrit is less than 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 less than 1g/dl (hematocrit rise less than 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 greater than 1g/dl (hematocrit greater than 3%) over 2 weeks of treatment unless the 
hemoglobin remains below or subsequently falls to less than 10g/dL (or the hematocrit is less than 
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. 
 
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. You can find this rule in the 
Centers for Medicare & Medicaid Services, Internet Only Manual, Publication 100-03, Medicare National 
Coverage Determination for 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.