Centers for Medicare & Medicaid Services

Content Section

Publication Number

100-3

Manual Section Number

220.6.15

Version Number

Effective Date of this Version

1/28/2005

Ending Effective Date of this Version

4/3/2009

Implementation Date

4/18/2005

Benefit Category

Diagnostic Tests (other)

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

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:

Federal Register Notice
CMS coverage Web site at: www.cms.gov/coverage

(This NCD last reviewed March 2005.)

Cross Reference

See NCD for PET Scans (§200.6).

Transmittal Number

Transmittal Link

http://www.cms.hhs.gov/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)