CMS Pub. 100-03, ch. 1, § 30.7

CIM 45-10

Not Covered

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.

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.