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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 state that the following are covered Indications for erythropoiesis stimulating agents (ESAs): 
1. Treatment of significant anemia in patients with non-myeloid malignancies where anemia is specifically 
due to concomitantly administered chemotherapy; 
2. Treatment of symptomatic anemia related to end-stage renal disease (ESRD) and Stages IIIb, IV and V 
chronic kidney disease (CKD); 
3. Treatment of anemia induced by AZT (Zidovudine) used in HIV/AIDS therapy  
4. Treatment of selected patients with anemia related to low prognostic risk myelodysplastic syndrome 
and some myeloproliferative neoplasms; 
5. Peri-surgical adjuvant therapy for purposes of allogenic RBC transfusion reduction 
The following causes of anemia should be considered, documented, and corrected before starting or continuing 
erythropoiesis stimulating agent (ESA) therapy for any of the above covered indications: 
1. Iron deficiency; 
2. Underlying infection, inflammatory or malignant processes; 
3. Underlying hematological disease; 
4. Hemolysis; 
5. Vitamin deficiencies (e.g. folic acid or B12); 
6. Blood loss-overt or occult; 
7. Aluminum intoxication; 
8. Osteitis fibrosis cystica; or 
9. Pure Red Blood Cell Aplasia 
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 EPO-type resistance due to neutralizing antibodies; and 
8. anemia due to cancer treatment if patients have uncontrolled hypertension. 
Non-ESRD ESA services are not considered reasonable and necessary within the context of other medical 
conditions for which resolution would be reasonably expected prior to starting or continuing ESA 
administration. Such conditions would include, but not be limited to: iron/vitamin B12/folate deficiencies, 
G6PD deficiency, pyridoxine deficiency, various forms of hemolysis, hereditary spherocytosis, and pure red 
cell aplasias. The presence of any of these conditions would reduce the therapeutic impact and effectiveness of 
the ESA. Additionally, the presence of unspecified anemia suggests appropriate evaluation, to determine the 
nature of the treated anemia, has not been completed. 
There are very rare patients whose cardiac, pulmonary or other medical conditions warrant the use of ESAs to 
maintain a Hb/HCT higher than the FDA target levels discussed in this LCD. Documentation to support this 
practice must be available upon request. (This instruction does not apply to ESA therapy for anemia related to 
cancer chemotherapy, which follows the rules mandated by the NCD 110.21.) 
During therapy with an ESA, many patients will require supplemental iron. For these patients, stores of iron 
should be regularly monitored. Reference the companion billing and coding article for further detail. 
For patients receiving chemotherapy for non-myeloid malignancies, the goal of therapy is to avoid transfusions. 
ESA therapy will be reimbursed only when the Hb is less than 10 g/dL or the HCT is less than 30%. 
For all other indications, the goal of therapy is to maintain a stable Hb and HCT, with target ranges of 10-12 
g/dL and 30-36% respectively. Doses must be titrated according to the patients response. ESA therapy need 
not be stopped completely simply due to the achievement of the target Hb and/or HCT. However, judicious, 
appropriately timed dose adjustments are expected to prevent inappropriate increases in Hb and HCT levels. 
The likelihood of anemia associated with EPO deficiency increases as renal failure progresses and the diseased 
kidneys are unable to produce sufficient amounts of EPO. The anemia of CKD should not be confused with the 
anemia of chronic disease. In the latter, inflammatory cytokines suppress the endogenous production of 
EPO and erythropoiesis directly. Measurable levels of circulating cytokines may be found in stable dialysis 
patients, but, in the absence of inflammation, do not adversely affect the action of ESAs. In patients with 
impaired renal function and a normochromic, normocytic anemia, it is rare for the serum EPO level to be 
elevated. Therefore, measurement of EPO levels in such patients is not likely to guide clinical decision making 
or ESA therapy.  
ESAs may be administered by intravenous or subcutaneous routes. An intravenous route is generally 
recommended for an ESRD indication. Please see the accompanying billing and coding article for details 
related to required modifier use on claims for ESA administration reporting. 
The following are coverage criteria:  
A. For ESRD patients on dialysis  
a) Diagnosis of end stage renal disease b) Anemia of ESRD with a Hb <10 gm/dL or a HCT < 30% at initiation of therapy 
c) Most recent creatinine within the past month prior to initiation or next dosing of ESA 
d) Use of an ESA that is FDA approved for this indication 
B. For CKD patients NOT on dialysis  
a) Anemia of CKD with a Hb less than 10 g/dL or a HCT less than 30% at initiation of therapy 
b) Most recent creatinine within the past month prior to initiation or next dosing of ESA 
c) Glomerular filtration rate (GFR) less than 45 mL/min/1.73 m
2
 
d) Use of an ESA that is FDA approved for this indication 
C. For patients with non-myeloid malignancies with anemia due to chemotherapy 
a) Hb level immediately prior to initiation or maintenance of ESA treatment is less than 10 g/dL 
(or HCT is less than 30%) 
b) Use of an ESA that is FDA approved for this indication 
c) The starting dose for ESA treatment is the recommended FDA label starting dose. 
d) Maintenance of ESA therapy is the starting dose if the Hb level remains below 10 g/dL (or HCT 
is <30%) 4 weeks after initiation of therapy and the rise in Hb is > 1g/dL (HCT > 3%). 
e) For patients whose hemoglobin rises < 1g/dL (HCT rise < 3%) compared to pretreatment 
baseline over 4 weeks of treatment and whose Hb remains < 10 g/dL afterwards (or HCT < 
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 Hb rises < 1g/dL (HCT rise < 3%) compared to 
pretreatment baseline by 8 weeks of treatment. 
f) Continued administration of the drug is not reasonable and necessary if there is a rapid rise in 
Hb greater than 1 g/dl (HCT greater than 3%) over 2 weeks of treatment unless the Hb or HCT 
remains below or subsequently falls to less than 10 g/dL or 30% respectively. Continuation and 
reinstitution of ESA therapy must include a dose reduction of 25% from the previously 
administered dose. 
g) ESA treatment duration for each course of chemotherapy includes the 8 weeks following the 
final dose of myelosuppressive chemotherapy in a chemotherapy regimen. 
D. For patients with anemia related to AZT treatment for HIV/AIDS  
a) Anemia with Hb less than 10 g/dL or a HCT less than 30% at initiation of therapy 
b) Use of an ESA that is FDA approved for this indication 
c) An AZT dose less than or equal to 4200 mg/week  
d) An endogenous baseline pre-transfusion serum EPO (sEPO) level less than or equal to 
500mU/mL 
E. For Peri-surgical adjuvant therapy to reduce allogenic transfusion:  
a) Undergoing planned elective major hip or knee surgery 
b) Presurgical anemia with Hb between 10 and 13 g/dL at least 3 weeks prior to surgery 
c) Use of an ESA that is FDA approved for this indication 
d) Not a candidate for autologous blood transfusion 
e) Expectation for peri-operative blood loss of two units or more 
f) Previous evaluation to ensure that the existing anemia is likely due to chronic disease rather than 
another reversible condition   
 In addition to the FDA labeled indications above, ESAs are covered for the following 
off-label indications. At this time, there is no clearly established dosing regimen for off 
label indications. F.  For patients with symptomatic anemia related to Very Low, Low or low score Intermediate risk 
Myelodysplastic syndrome (MDS)   
a) IPSS-R score correlating to Very Low, Low or a low score Intermediate risk or IPSS score of 
low or intermediate-1 risk or WPSS of very low, low or intermediate risk 
b) Pretreatment EPO levels of 500 or less 
c) Documented anemia related symptoms such as fatigue, pallor, infection, bleeding or bruising or 
transfusion dependence  
d) Documentation of a reasonable expectancy of longer survival with a reduced need for 
transfusion support 
e) Diagnosis of MDS confirmed by bone marrow aspiration and/or biopsy report  
f) Anemia with Hb less than 10 g/dL or a HCT of less than 30% at initiation of therapy. If after 
two months of treatment, there is no significant increase in Hb/HCT and/or a significant 
decrease in transfusion requirements, EPO analog therapy should be stopped.  
You can find this rule in the Local Coverage Determination (LCD) for Erythropoiesis Stimulating Agents, 
L39237. 
 
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.