Publication Number

100-3

Manual Section Number

30.7

Version Number

1

Effective Date of this Version

This is a longstanding national coverage determination. The effective date of this version has not been posted.

Benefit Category

Drugs and Biologicals
Incident to a physician's professional Service

Note: This may not be an exhaustive list of all applicable Medicare benefit categories for this item or service.

Item/Service Description

Laetrile (and the other drugs called by the various terms mentioned below) have been used primarily in the treatment or control of cancer. Although the terms "Laetrile," "laetrile," "amygdalin," "Sarcarcinase," "vitamin B-17," and "nitriloside" have been used interchangeably, the chemical identity of the substances to which these terms refer has varied.

Indications and Limitations of Coverage

The FDA has determined that neither Laetrile nor any other drug called by the various terms mentioned above, nor any other product which might be characterized as a "nitriloside" is generally recognized (by experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs) to be safe and effective for any therapeutic use. Therefore, use of this drug cannot be considered to be reasonable and necessary within the meaning of §1862(a)(1) of the Act and program payment may not be made for its use or any services furnished in connection with its administration.

A hospital stay only for the purpose of having laetrile (or any other drug called by the terms mentioned above) administered is not covered. Also, program payment may not be made for laetrile (or other drug noted above) when it is used during the course of an otherwise covered hospital stay, since the FDA has found such drugs to not be safe and effective for any therapeutic purpose.

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Page Last Modified: 4/23/2009 7:26:58 AM

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