CMS Pub. 100-04, ch. 8, § 120.1

Transplant Patients

(Rev. 1, 10-01-03)

A. General

Effective January 1, 1987, Medicare pays for FDA approved self-administered

immunosuppressive drugs. Generally, under this benefit, payment is made for self-administered immunosuppressive drugs that are specifically labeled and approved for

marketing as such by the FDA, as well as 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. This benefit

is subject to the Part B deductible and coinsurance provision. There is no time limitation

on the coverage of these drugs; however, if a beneficiary loses Medicare coverage as a

result of the transplant, the drugs are no longer covered. When the beneficiary reaches the

age of 65 and becomes entitled, that person can have the drugs covered again. The

hospital pharmacy must ask the physician to furnish the patient with a non-refillable 30-day prescription for the immunosuppressive drugs. This is because the dosage of these

drugs frequently diminishes over a period of time, and it is not uncommon for the

physician to change the prescription from one drug to another because of the patient’s

needs. Also, these drugs are expensive, and the coinsurance liability on unused drugs

could be a financial burden to the beneficiary. Unless there are special circumstances, the

A/B MAC (A) and A/B MAC (B) do not consider a supply of drugs in excess of 30 days

to be reasonable and necessary and limits payment accordingly.

B. Payment

Payment is made on a reasonable cost basis if the beneficiary is the outpatient of a

participating hospital. In all other cases, payment is made on an allowable charge basis.

C. FDA Approved Drugs

Some of the most commonly prescribed immunosuppressive drugs are:

• Sandimmune (cyclosporine), Sandoz Pharmaceutical (oral or parenteral),

• Imuran (azathioprine), Burroughs Wellcome Vial (oral),

• Atgam (antithymocyte/globulin), Upjohn (parenteral); and

• Orthoclone OKT3 (muromonab - CD3) Ortho Pharmaceutical (parenteral).

Also covered are prescription drugs used in conjunction with immunosuppressive drugs

as part of a therapeutic regimen reflected in FDA approved labeling for

immunosuppressive drugs.

The payment for the drug is limited to the cost of the most frequently administered

dosage of the drug (adjusted for medical factors as determined by the physician).

Consult such sources as the Drug Topics Red Book, American Druggists Blue Book, and

Medispan, realizing that substantial discounts are available.