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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 medically accepted off-label uses for FDA-approved drugs used in an
anti-cancer chemotherapeutic regimen. Medicare maintains a list of compendia which define if a use is
medically accepted. The off-label use must be supported in one or more of these compendia or in published,
peer-reviewed medical literature. An off-label use must be supported in one or more of the compendia and the
use must not be listed as unsupported, not indicated, not recommended, or equivalent terms, in any of the
compendia. An off-label use may also be determined by the carrier in the state to be reasonable and necessary.
You can find these rules and the list of the Medicare-recognized compendia in the Centers for Medicare and
Medicaid Services, Internet Only Manual, Medicare Benefit Policy Manual, Chapter 15, Section 50.4.5.

The rules say that Erythropoiesis stimulating agent (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 more than
or equal to 1g/dL (hematocrit more 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 less than 1g/dl (hematocrit less 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 information 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.