CMS Pub. 100-03, ch. 1, § 110.2

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, is 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 Division 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 NCIs 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 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:

Chief, Investigational Drug Branch

Cancer Therapy Evaluation Program

Executive Plaza North, Suite 7134

National Cancer Institute

Rockville, Maryland 20852-7426