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National Coverage Determination (NCD)

PET (FDG) for All Other Cancer Indications Not Previously Specified

220.6.15

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Tracking Information

Publication Number
100-3
Manual Section Number
220.6.15
Manual Section Title
PET (FDG) for All Other Cancer Indications Not Previously Specified
Version Number
1
Effective Date of this Version
01/28/2005
Ending Effective Date of this Version
04/03/2009
Implementation Date
04/18/2005
Implementation QR Modifier Date

Description Information

Benefit Category
Diagnostic Tests (other)


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

Item/Service Description
Indications and Limitations of Coverage

Effective for services performed on or after January 28, 2005: “coverage with evidence development” applies to all FDG PET indications for all other cancers not previously specified in Section 220.6 above in its entirety.

For cancer indications listed as “coverage with evidence development” CMS has determined that the evidence is sufficient to conclude that an FDG PET scan is reasonable and necessary only when the provider is participating in, and patients are enrolled in, one of the following types of prospective clinical studies that is designed to collect additional information at the time of the scan to assist in patient management:

  • A clinical trial of FDG PET that meets the requirements of Food and Drug Administration (FDA) category B investigational device exemption (42 CFR 405.201); or
  • An FDG PET clinical study that is designed to collect additional information at the time of the scan to assist in patient management. Qualifying clinical studies must ensure that specific hypotheses are addressed; appropriate data elements are collected; hospitals and providers are qualified to provide the PET scan and interpret the results; participating hospitals and providers accurately report data on all enrolled patients not included in other qualifying trials through adequate auditing mechanisms; and, all patient confidentiality, privacy, and other Federal laws must be followed.

Medicare shall notify providers and beneficiaries where these services can be accessed, as they become available, via the following:

(This NCD last reviewed March 2005.)
Cross Reference

See NCD for PET Scans (§200.6).
Claims Processing Instructions

Transmittal Information

Transmittal Number
31
Coverage Transmittal Link
https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/Downloads/R31NCD.pdf
Revision History

04/2005 - Covered only when providers are participating in, and patients are enrolled in, an approved FDG PET clinical study, or an FDG PET clinical trial meeting FDA category B IDE exemption status.   Effective date 01/28/05. Implementation date 04/18/05. (TN 31) (CR 3741)
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
FDG PET for All Other Cancer Indications Not Previously Specified (Replaced with Section 220.6.17) - RETIRED 3 04/10/2023 - N/A View
FDG PET for All Other Cancer Indications Not Previously Specified (Replaced with Section 220.6.17) 2 04/03/2009 - 04/10/2023 View
PET (FDG) for All Other Cancer Indications Not Previously Specified 1 01/28/2005 - 04/03/2009 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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