CMS Pub. 100-03, ch. 1, § 260.7

CIM 45-22

The lymphocyte immune globulin preparations are biologic drugs not previously approved or

licensed for use in the management of renal allograft rejection. A number of other lymphocyte

immune globulin products of equine, lapine, and murine origin are currently under investigation

for their potential usefulness in controlling allograft rejections in human transplantation. These

biologic drugs are viewed as adjunctive to traditional immunosuppressive products such as

steroids and anti-metabolic drugs. At present, lymphocyte immune globulin preparations are not

recommended to replace conventional immunosuppressive drugs, but to supplement them and to

be used as alternatives to elevated or accelerated dosing with conventional immunosuppressive

agents.

The FDA has approved one lymphocyte immune globulin preparation for marketing, lymphocyte

immune globulin, anti-thymocyte globulin (equine). This drug is indicated for the management

of allograft rejection episodes in renal transplantation. It is covered under Medicare when used

for this purpose. Other forms of lymphocyte globulin preparation which the FDA approves for

this indication in the future may be covered under Medicare.