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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 erythropoiesis stimulating agents (ESAs) stimulate the bone marrow to make more red blood cells and are United States Food and Drug Administration (FDA) approved for use in reducing the need for blood transfusion in patients with specific clinical indications. The FDA has issued alerts and warnings for ESAs administered for a number of clinical conditions, including cancer. Published studies report a higher risk of serious and life-threatening events associated with oncologic uses of ESAs.
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.
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:
- Any anemia in cancer or cancer treatment patients due to folate deficiency, B-12 deficiency, iron deficiency, hemolysis, bleeding, or bone marrow fibrosis;
- The anemia associated with the treatment of acute and chronic myelogenous leukemias (CML, AML), or erythroid cancers;
- The anemia of cancer not related to cancer treatment;
- Any anemia associated only with radiotherapy;
- Prophylactic use to prevent chemotherapy-induced anemia;
- Prophylactic use to reduce tumor hypoxia;
- Patients with erythropoietin-type resistance due to neutralizing antibodies; and
- Anemia due to cancer treatment if patients have uncontrolled hypertension.
You can find this rule in the National Coverage Determination (NCD) 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.