CMS Certain Drugs Distributed by the National Cancer Institute Form

Under its Cancer Therapy Evaluation, the Division of Cancer Treatment of the National Cancer Institute (NCI), in cooperation with the Food and Drug Administration, approves and distributes certain drugs for use in treating terminally ill cancer patients. One group of these drugs, designated as Group C drugs, unlike other drugs distributed by the NCI, are not limited to use in clinical trials for the purpose of testing their efficacy. Drugs are classified as Group C drugs only if there is sufficient evidence demonstrating their efficacy within a tumor type and that they can be safely administered.

A physician is eligible to receive Group C drugs from the Divison of Cancer Treatment only if the following requirements are met:

• A physician must be registered with the NCI as an investigator by having completed an FD-Form 1573;
• A written request for the drug, indicating the disease to be treated, must be submitted to the NCI;
• The use of the drug must be limited to indications outlined in the NCI's guidelines; and
• All adverse reactions must be reported to the Investigational Drug Branch of the Division of Cancer Treatment.

In view of these NCI controls on distribution and use of Group C drugs, A/B Medicare Administrative Contractors (MACs) may assume, in the absence of evidence to the contrary, that a Group C drug and the related hospital stay are covered if all other applicable coverage requirements are satisfied.

If there is reason to question coverage in a particular case, the matter should be resolved with the assistance of the Quality Improvement Organization (QIO), or if there is none, the assistance of the MAC's medical consultants.

Information regarding those drugs which are classified as Group C drugs may be obtained from: