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National Coverage Determination (NCD)

Certain Drugs Distributed by the National Cancer Institute

110.2

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Tracking Information

Publication Number
100-3
Manual Section Number
110.2
Manual Section Title
Certain Drugs Distributed by the National Cancer Institute
Version Number
1
Effective Date of this Version
10/01/1980
Ending Effective Date of this Version
Implementation Date
Implementation QR Modifier Date

Description Information

Benefit Category
Drugs and Biologicals
Inpatient Hospital Services
Oral Anticancer Drugs


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

Item/Service Description

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.
Indications and Limitations of Coverage

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:

Chief, Investigational Drug Branch
Cancer Therapy Evaluation Program
Executive Plaza North, Suite 7134
National Cancer Institute
Rockville, Maryland 20852-7426
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
Certain Drugs Distributed by the National Cancer Institute 1 10/01/1980 - N/A You are here
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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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