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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. 
  
Medicare rules also allow the plan to use step therapy. This is the process of beginning drug therapy for a 
medical condition with "preferred" (or more cost-effective) on-formulary drug alternative(s) and progressing to 
other drug therapies only as necessary. A plan must grant an exception to its step therapy rules if it determines 
that the requested drug is medically necessary, consistent with the prescriber's statement. The statement must 
show that the step therapy drugs: have been ineffective in treating the enrollee; or are likely to be ineffective or 
adversely affect the drug's effectiveness or patient compliance; or are likely to cause an adverse reaction or 
other harm to the enrollee.  
 
Medicare Advantage plans should ensure that new step therapy requirements do not disrupt ongoing Part B 
drug therapies for enrollees. Step therapy may only be applied to new prescriptions or administrations of Part B 
drugs for enrollees that are not actively receiving the affected medication. You can find this information at 42 
CFR Sections 422.2 and 422.136. 
 
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 (CMS), Internet-Only 
Manual, Publication 100-02, Medicare Benefit Policy Manual, Chapter 15, Section 50.4.1. 
  
Medicare rules also allow the plan to use step therapy. This is the process of beginning drug therapy for a 
medical condition with "preferred" (or more cost-effective) on-formulary drug alternative(s) and progressing to 
other drug therapies only as necessary. A plan must grant an exception to its step therapy rules if it determines 
that the requested drug is medically necessary, consistent with the prescriber's statement. The statement must 
show that the step therapy drugs: have been ineffective in treating the enrollee; or are likely to be ineffective or 
adversely affect the drug's effectiveness or patient compliance; or are likely to cause an adverse reaction or 
other harm to the enrollee.  
 Medicare Advantage plans should ensure that new step therapy requirements do not disrupt ongoing Part B 
drug therapies for enrollees. Step therapy may only be applied to new prescriptions or administrations of Part B 
drugs for enrollees that are not actively receiving the affected medication. You can find this information at 42 
CFR Sections 422.2 and 422.136. 
 
The rules say coverage indications: 
 
A. For ESRD patients on dialysis 
Diagnosis of end stage renal disease 
Anemia of ESRD with a Hb less than 10 gm/dL or a HCT less than 30 percent at initiation of therapy 
Most recent creatinine within the past month prior to initiation or next dosing of ESA 
Use of an ESA that is FDA approved for this indication 
B. For CKD patients NOT on dialysis 
Anemia of CKD with a Hb less than 10 g/dL or a HCT less than 30 percent at initiation of therapy 
Most recent creatinine within the past month prior to initiation or next dosing of ESA 
Glomerular filtration rate (GFR) less than 45 mL/min/1.73 m2 
Use of an ESA that is FDA approved for this indication 
C. For patients with non-myeloid malignancies with anemia due to chemotherapy 
This policy does not replace, modify or supersede existing Medicare applicable NCDs. 
Hb level immediately prior to initiation or maintenance of ESA treatment is less than 10 g/dL (or HCT is less 
than 30 percent) 
Use of an ESA that is FDA approved for this indication 
The starting dose for ESA treatment is the recommended FDA label starting dose. 
Maintenance of ESA therapy is the starting dose if the Hb level remains below 10 g/dL (or HCT is less than 30 
percent) 4 weeks 
 after initiation of therapy and the rise in Hb is greater than 1g/dL (HCT greater than 3 percent). 
For patients whose hemoglobin rises less than 1g/dL (HCT rise less than 3 percent) compared to pretreatment 
baseline over 4 weeks of treatment and whose Hb remains less than 10 g/dL afterwards (or HCT less than 30 
percent), 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 less than 1g/dL (HCT rise less than 3 percent) 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 Hb greater than 
1 g/dl (HCT greater than 3 percent) over 2 weeks of treatment unless the Hb or HCT remains below or 
subsequently falls to less than 10 g/dL or 30 percent respectively. Continuation and reinstitution of ESA 
therapy must include a dose reduction of 25 percent 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. 
D. For patients with anemia related to AZT treatment for HIV/AIDS 
Anemia with Hb less than 10 g/dL or a HCT less than 30 percent at initiation of therapy 
Use of an ESA that is FDA approved for this indication 
An AZT dose less than 4200 mg/week 
An endogenous baseline pre-transfusion serum EPO (sEPO) level less than 500mU/mL 
E. For Peri-surgical adjuvant therapy to reduce allogenic transfusion: 
Undergoing planned elective major hip or knee surgery 
Presurgical anemia with Hb between 10 and 13 g/dL at least 3 weeks prior to surgery 
Use of an ESA that is FDA approved for this indication 
Not a candidate for autologous blood transfusion 
Expectation for peri-operative blood loss of two units or more 
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) 
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* 
Pretreatment EPO levels of 500 or less 
Documented anemia related symptoms such as fatigue, pallor, infection, bleeding or bruising or transfusion 
 dependence 
Documentation of a reasonable expectancy of longer survival with a reduced need for transfusion support 
Diagnosis of MDS confirmed by bone marrow aspiration and/or biopsy report 
Anemia with Hb less than 10 g/dL or a HCT of less than 30 percent 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 information in the Local Coverage Determination (LCD): Erythropoiesis Stimulating Agents 
(L39237). 
 
If you want to read these Medicare rules, you can go to this website www.medicareappeal.com.