Page 75 - Medicare Benefit Policy Manual

Covered drugs include those immunosuppressive drugs that have been specifically
labeled as such and approved for marketing by the FDA. (This is an exception to the
standing drug policy which permits coverage of FDA approved drugs for nonlabeled
uses, where such uses are found to be reasonable and necessary in an individual case.)

Covered drugs also include those prescription drugs, such as prednisone, that are used in
conjunction with immunosuppressive drugs as part of a therapeutic regimen reflected in
FDA approved labeling for immunosuppressive drugs. Therefore, antibiotics,
hypertensives, and other drugs that are not directly related to rejection are not covered.

The FDA has identified and approved for marketing the following specifically labeled
immunosuppressive drugs. They are:

Sandimmune (cyclosporine), Sandoz Pharmaceutical;
Imuran (azathioprine), Burroughs Wellcome;
Atgam (antithymocyte globulin), Upjohn;
Orthoclone OKT3 (Muromonab-CD3), Ortho Pharmaceutical;
Prograf (tacrolimus), Fujisawa USA, Inc;
Celicept (mycophenolate mefetil, Roche Laboratories;
Daclizumab (Zenapax);
Cyclophosphamide (Cytoxan);
Prednisone; and
Prednosolone.

The CMS expects contractors to keep informed of FDA additions to the list of the
immunosuppressive drugs.

50.5.2 - Erythropoietin (EPO)
(Rev. 1, 10-01-03)
A3-3112.4.B.4, HO-230.4.B.4

The statute provides that EPO is covered for the treatment of anemia for patients with
chronic renal failure who are on dialysis. Coverage is available regardless of whether the
drug is administered by the patient or the patient’s caregiver. EPO is a biologically
engineered protein which stimulates the bone marrow to make new red blood cells.

NOTE: Non-ESRD patients who are receiving EPO to treat anemia induced by other
conditions such as chemotherapy or the drug zidovudine (commonly called AZT) must
meet the coverage requirements in §50.

EPO is covered for the treatment of anemia for patients with chronic renal failure who are
on dialysis when:

• It is administered in the renal dialysis facility; or