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National Coverage Determination (NCD)

Laetrile and Related Substances

30.7

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Tracking Information

Publication Number
100-3
Manual Section Number
30.7
Manual Section Title
Laetrile and Related Substances
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.
Ending Effective Date of this Version
Implementation Date
Implementation QR Modifier Date

Description Information

Benefit Category
Drugs and Biologicals
Incident to a physician's professional Service


Please 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.

Cross Reference
Claims Processing Instructions

Transmittal Information

Transmittal Number
Revision History
Other

National Coverage Analyses (NCAs)

This NCD has been or is currently being reviewed under the National Coverage Determination process. The following are existing associations with NCAs, from the National Coverage Analyses database.

Coding Analyses for Labs (CALs)

This NCD has been or is currently being reviewed under the National Coverage Determination process. The following are existing associations with CALs, from the Coding Analyses for Labs database.

Additional Information

Other Versions
Title Version Effective Between
Laetrile and Related Substances 1 01/01/1966 - N/A You are here
CPT Copyright Statement
CPT only copyright 2002-2011 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association. Applicable FARS/DFARS Apply to Government Use. Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein.
Reasons for Denial
Note: This section has not been negotiated by the Negotiated RuleMaking Committee. It includes CMS’s interpretation of it’s longstanding policies and is included for informational purposes. Tests for screening purposes that are performed in the absense of signs, symptoms, complaints, or personal history of disease or injury are not covered except as explicity authorized by statue. These include exams required by insurance companies, business establishments, government agencies, or other third parties. Tests that are not reasonable and necessary for the diagnosis or treatment of an illness or injury are not covered according to the statue. Failure to provide documentation of the medical necessity of tests may result in denial of claims. The documentation may include notes documenting relevant signs, symptoms, or abnormal findings that substantiate the medical necessity for ordering the tests. In addition, failure to provide independent verification that the test was ordered by the treating physician (or qualified nonphysician practitioner) through documentation in the physician’s office may result in denial. A claim for a test for which there is a national coverage or local medical review policy will be denied as not reasonable and necessary if it is submitted without an ICD-9-CM code or narrative diagnosis listed as covered in the policy unless other medical documentation justifying the necessity is submitted with the claim. If a national or local policy identifies a frequency expectation, a claim for a test that exceeds that expectation may be denied as not reasonable and necessary, unless it is submitted with documentation justifying increased frequency. Tests that are not ordered by a treating physician or other qualified treating nonphysician practitioner acting within the scope of their license and in compliance with Medicare requirements will be denied as not reasonable and necessary. Failure of the laboratory performing the test to have the appropriate Clinical Laboratory Improvement Act of 1988 (CLIA) certificate for the testing performed will result in denial of claims.
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