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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 Group C: Indications other than Renal Disease 
 
1. Anemia associated with cancer and related Neoplastic conditions. 
This policy does not replace, modify or supersede existing Medicare applicable National Coverage 
Determinations (NCDs) and does not contain specific diagnosis codes related to CMS Pub 100-03 Medicare 
National Coverage Determination (NCD) Manual, Chapter 1  Coverage Determinations, Part 2 Section 110.21 
 Erythropoiesis Stimulating Agents (ESAs) in Cancer and Related Neoplastic 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 percent). 
 
2. Anemia related to therapy with Zidovudine (AZT) and/or other Nucleoside Reverse Transcriptase Inhibitors 
(NRTI) therapy for acquired immunodeficiency syndrome (AIDS) or AIDS-related complex (ARC) must meet 
the coverage requirements in CMS Pub 100-02 Medicare Benefit Policy Manual, Chapter 15  Covered 
Medical and Other Health Services, Section - 50.5.2.  Erythropoietin (EPO) (Rev. 1, 10-01-03). 
The hemoglobin level prior to initiation of ESA treatment is less than 10 g/dL (or the hematocrit is less than 
30%). 
 
3. Anemia associated with chemotherapeutic medications when medically necessary for a non-cancer diagnosis 
or following stem cell transplantation and associated immunosuppression. 
The hemoglobin level prior to initiation of ESA treatment is less than 10 g/dL (or the hematocrit is less than 30 
percent). 
 
4. Myelodysplastic Syndrome (MDS) 
Anemia is observed in 90 percent of individuals with MDS. Those MDS patients with an endogenous 
erythropoietin level of less than 500 mU/mL are more likely to respond to ESA therapy. 
ESA therapy is indicated for patients who meet the following: 
a. Have a confirmed diagnosis of MDS with a bone marrow biopsy, 
b. the anemia is symptomatic, 
c. there is reasonable expectancy of longer survival, d. therapy will end or reduce the need for transfusions, 
e. Anemia with Hgb is less than or equal to 10g/dL or HCT is less than or equal to 30 percent, one week before 
the initial injection. 
f. pretreatment erythropoietin levels of 500 or less 
If after two months of treatment, there is no significant increase in Hgb/HCT and/or a significant decrease in 
transfusion requirements, erythropoietin analogs therapy should be stopped. 
 
5. Anemia of Chronic disease (Anemia of inflammatory disease) 
In anemia of chronic disease, inflammatory cytokines suppress the endogenous production of erythropoietin 
and erythropoiesis directly. This anemia usually results from a combination of slightly shortened red blood cell 
survival, the sequestration of iron in the reticuloendothelial systems, and erythropoietin levels that are less than 
expected for the degree of anemia. The diagnosis is usually exclusionary, meaning other causes of the anemia 
have been ruled out. 
 
Anemia of cancer is not considered a chronic disease for this purpose and should not be billed as such. 
Medicare will cover the use of epoetin alfa or darbepoetin alfa for the refractory anemia of chronic disease for 
patients with Rheumatoid Arthritis, Systemic Lupus Erythematosis, Chronic Hepatitis C, Crohn's Disease and 
Ulcerative Colitis when one of the conditions listed below in A is met along with both B and C criteria: 
A. At least one of the conditions below: 
low or normal serum iron 
low or normal iron binding capacity 
normal or elevated serum ferritin 
adequate iron stores in bone marrow 
B. The pretreatment HCT level is 30 percent or less and/or if the patient has been transfusion dependent. 
C. The pretreatment erythropoietin level is 100 mU/mL or less. 
 
6. Prophylactic pre-operative use for reduction of allogenic blood transfusions prior to elective hip and knee 
replacement surgery. (CMS Pub 100-02 Medicare Benefit Policy Manual, Chapter 15  Covered Medical and 
Other Health Services, Section - 50.5.2.2 - Medicare Coverage of Epoetin Alfa (Procrit) for Preoperative Use 
(Rev. 1, 10-01-03).). 
 
Epoetin alfa or Darbepoetin alfa are covered for use in specific patients prior to surgery to reduce risk of 
transfusion: 
who are undergoing hip or knee surgery; 
have an anemia with a hemoglobin between 10 and 13 gm/dL. (this indication requires a lead time of at least 3 
weeks prior to surgery); 
are not candidates for autologous blood transfusion; 
are expected to lose more than 2 units of blood; and 
have had a work-up so that their anemia appears to be that of chronic disease. 
 
A weekly dosage regimen for 3 weeks prior to surgery (e.g., days 21, -14, -7) and on the day of surgery will be 
covered. The components listed above must be documented in the medical record. Patients receiving ESAs pre-
operatively for reduction of allogeneic red blood cell transfusions: A higher incidence of deep venous 
thrombosis was documented in patients receiving ESAs who were not receiving prophylactic anticoagulation. 
 
7. Prophylactic pre-operative use for reduction of allogenic blood transfusions prior to elective noncardiac or 
nonvascular surgery. 
Epoetin alfa-epbx (biosimilar) is covered for use in specific patients who are at high risk for perioperative 
blood loss prior to surgery to reduce risk of transfusion: 
who are undergoing elective, noncardiac or nonvascular surgery; 
have an anemia with a hemoglobin greater than 10 to less than 13 gm/dL; 
are not candidates for autologous blood transfusion.  
The recommended Epoetin alfa-epbx (biosimilar) regimens are: 
300 Units/kg per day subcutaneously for 15 days total: administered daily for 10 days before 
surgery, on the day of surgery, and for 4 days after surgery. 
600 Units/kg subcutaneously in 4 doses administered 21, 14, and 7 days before surgery and on the day of 
surgery. 
 
The components listed above must be documented in the medical record. 
Deep venous thrombosis prophylaxis is recommended during Epoetin alfa-epbx (biosimilar) therapy. 
 
8. Myelofibrosis 
Primary myelofibrosis (PMF) is a myeloproliferative neoplasm (MPN) associated with bone marrow fibrosis, 
cytopenias, constitutional symptoms, hepatosplenomegaly, and/or extramedullary hematopoiesis. 
 
Anemia is considered a negative prognostic risk factor for survival in patients with PMF. Symptomatic anemia 
is observed in more than 50 percent of the patients at the time of diagnosis. It is essential to rule out and treat 
the most commons cause of anemia before considering other treatment options. 
Leukoreduced RBC transfusion support is recommended for symptomatic anemia, EPO-stimulating agents 
(ESAs), danazol and immunomodulatory agents (lenalidomide, thalidomide, and pomalidomide) have also 
been evaluated for the management of PMF-associated anemia. 
The use of recombinant human EPO or darbepoetin alfa has resulted in anemia responses (transfusion 
independence with normal hemoglobin levels, sustained increase in hemoglobin level s[>2g/dl] within 12 
weeks, or greater than 50 percent reduction in transfusion requirements within 12 weeks) in 45% to 60% of 
patients. Lowered serum EPO levels (less than 125mU/ml), smaller spleen size, and low RBC transfusion 
requirements have been associated with favorable responses. 
 
Primary myelofibrosis is overlapping with Myelodysplastic Syndrome (MDS) on the spectrum, and like MDS, 
diagnosed by bone marrow pathology. You can find these rules in Local Coverage Determination (LCD) 
Erythropoiesis Stimulating Agents (ESAs) (L34633). 
 
If you want to read these Medicare rules, you can go to this website www.medicareappeal.com.