Centers for Medicare & Medicaid Services

Content Section

Publication Number

100-3

Manual Section Number

220.6.14

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

A. Staging for Invasive Cervical Cancer as an Adjunct to Conventional Imaging

The CMS has determined that there is sufficient evidence to conclude that an FDG PET scan is reasonable and necessary for the detection of metastases during the pre-treatment management phase (i.e., staging) in patients with newly diagnosed and locally advanced cervical cancer with no extra-pelvic metastasis on conventional imaging tests, such as computed tomography (CT) or magnetic resonance imaging (MRI). Use of FDG PET as an adjunct may more accurately assist in the non-invasive detection of para-aortic, pelvic nodal involvement and other metastases in the pre-treatment phase of disease. The following conditions must be met:

A pathologic diagnosis of cervical cancer must have already been made before the FDG PET scan is performed,
The results of other imaging procedures used (e.g., MRI or CT) must be reported, and,
The available conventional imaging tests are negative for extra-pelvic metastasis.

NOTE: Other staging utilizing FDG PET (e.g., as a substitute for conventional structural imaging; when a previous MRI or CT is positive or inconclusive for para-aortic metastasis and negative for supra-clavicular nodal metastasis) are only covered as “coverage with evidence development”.

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

B. Brain, Ovarian, Pancreatic, Small Cell Lung, and Testicular Cancers, and other indications of Cervical Cancer not mentioned in Section A above

“Coverage with evidence development” applies to all FDG PET indications for brain, ovarian, pancreatic, small cell lung, testicular cancers, and other indications of cervical cancer not mentioned in Section A above.

For cancer indications listed as “coverage with evidence development” CMS determines 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 (§220.6).

Transmittal Number

Transmittal Link

http://www.cms.hhs.gov/transmittals/downloads/R31NCD.pdf

Revision History

04/2005 - Covered as an adjunct test for detection of pre-treatment metastases (i.e., staging) in newly diagnosed cervical cancer subsequent to conventional imaging that is negative for extra-pelvic metastasis. For all remaining indications, 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)

Claims Processing Instructions

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.