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National Coverage Determination (NCD)

FDG PET for Brain, Cervical, Ovarian, Pancreatic, Small Cell Lung, and Testicular Cancers (Replaced with Section 220.6.17)

220.6.14

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Tracking Information

Publication Number
100-3
Manual Section Number
220.6.14
Manual Section Title
FDG PET for Brain, Cervical, Ovarian, Pancreatic, Small Cell Lung, and Testicular Cancers (Replaced with Section 220.6.17)
Version Number
2
Effective Date of this Version
04/03/2009
Ending Effective Date of this Version
04/10/2023
Implementation Date
10/30/2009
Implementation QR Modifier Date

Description Information

Benefit Category
No Benefit Category


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

(Replaced with Section 220.6.17)
Cross Reference

See NCD for PET Scans (§220.6).
Claims Processing Instructions

Transmittal Information

Transmittal Number
120
Coverage Transmittal Link
https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/Downloads/R120NCD.pdf
Revision History

05/2010 - Transmittal 108, dated October 16, 2009, is being rescinded and replaced with Transmittal 120. This transmittal restores language that was inadvertently removed from section 220.6. This transmittal also updates section 220.6.17, per Transmittal 110, Change Request 6753, dated December 18, 2009. All other information remains the same. (TN 120) (CR 6632)

10/2009 - This change request rescinds and replaces Transmittal 106, dated September 18, 2009. The effective date has been changed to April 3, 2009 and the implementation date has been changed to October 30, 2009. Business Requirements (BR) 6632.6.1 and 6632.6.2 have been revised to clarify that they are subsets of BR 6632.6 and are specific to CED. All other information remains the same. (TN 108) (CR 6632)

09/2009 - 220.6.14 - FDG PET for Brain, Cervical, Ovarian, Pancreatic, Small Cell Lung, and Testicular Cancers (Effective January 28, 2005) (Replaced with Section 220.6.17). CMS is adopting a coverage framework that replaces the four-part diagnosis, staging, restaging and monitoring response to treatment categories with a two-part framework that differentiates FDG PET imaging used to inform the initial antitumor treatment stategy from other uses related to guiding subsequent antitumor treatment strategies after the completion of initial treatment. CMS is making this change for all NCDs that address coverage of FDG PET for all oncologic conditions. Effective date 04/06/2009 Implementation date 10/19/2009. (TN 106) (CR 6632)

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)
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 Brain, Cervical, Ovarian, Pancreatic, Small Cell Lung, and Testicular Cancers (Replaced with Section 220.6.17) - RETIRED 3 04/10/2023 - N/A View
FDG PET for Brain, Cervical, Ovarian, Pancreatic, Small Cell Lung, and Testicular Cancers (Replaced with Section 220.6.17) 2 04/03/2009 - 04/10/2023 You are here
PET (FDG) for Brain, Cervical, Ovarian, Pancreatic, Small Cell Lung, and Testicular Cancers 1 01/28/2005 - 04/03/2009 View
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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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