Appeal type: unknown
Decision: unknown

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 CFR 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 Medicare Benefit Policy Manual, Chapter 15, Section 50.4.1.The rules say that Epoetin alfa is covered for Food and Drug Administration (FDA) approved labeled indications. Please see the FDA druglabel for the FDA approved indications and dosages. In addition to the FDA labeled indications, epoetin alfa is covered for the following off-label indications: forthe treatment of anemia associated with myelodysplastic syndrome (MDS). Patients usually present with variable clinical features depending on the MDS classification and the degree of disordered hematopoiesis with anemia. Common complaints or symptoms are fatigue, pallor, infection and bleeding or bruising. Diagnosis is usually confirmed by bonemarrow aspiration and/or biopsy. For the purposes of this LCD, Chronic Myelomonocytic Leukemia (CMML) will be considered a form of MDS and as such the anemia associated with it may be eligible for coverage if the indications and limitations outlined in this LCDfor MDS are met. Providers must use the ICD-10 codes listed in the LCDfor MDS to code for CMML. If the physician cannot classify the patient with one of the MDS diagnosis codes, then the patient does not meet the criteria for CMML and coverage willnot have been met; for the treatment of anemia associated with the management of hepatitis C. The use of epoetin alfa has been shown to be effective in treatment of anemia in patients with hepatitis C virus infection who are being treated with the combination of ribavarin and interferon alfa or ribavarin and peginterferon alfa; for the treatment of chronic anemia associated Rheumatoid Arthritis (RA). The patient must have been previously diagnosed with RA using the American College of Rheumatology criteria. Patients are usually on antimetabolite (e.g., Methotrexate), which causes the anemia. You can find this in the Local Coverage Determination (LCD): Erythropoiesis Stimulating Agents (L36276).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 drugshave 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 Section 423.578(b)(5)(ii).If you want to read these Medicare rules, you can go to this web site www.medicareappeal.com.The Plan contract says that the Plan covers items and services in accordance with Medicare rules.