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Centers for Medicare & Medicaid Services

National Coverage Determination (NCD) for Positron Emission Tomography (PET) Scans (220.6)

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Publication Number

100-3

Manual Section Number

220.6

Manual Section Title

Positron Emission Tomography (PET) Scans


Version Number

4

Effective Date of this Version

4/3/2009

Implementation Date

10/30/2009



Benefit Category
Diagnostic Tests (other)
Note: This may not be an exhaustive list of all applicable Medicare benefit categories for this item or service.

Item/Service Description

Positron Emission Tomography (PET) is a minimally invasive diagnostic imaging procedure used to evaluate metabolism in normal tissue as well as in diseased tissues in conditions such as cancer, ischemic heart disease, and some neurologic disorders. A radiopharmaceutical is injected into the patient that gives off sub-atomic particles, known as positrons, as it decays. PET uses a positron camera (tomograph) to measure the decay of the radiopharmaceutical. The rate of decay provides biochemical information on the metabolism of the tissue being studied.

NOTE: This manual section 220.6 lists all Medicare-covered uses of PET scans. Except as set forth below in cancer indications listed as "Coverage with Evidence Development," a particular use of PET scans is not covered unless this manual specifically provides that such use is covered. Although this section 220.6 lists some non-covered uses of PET scans, it does not constitute an exhaustive list of all non-covered uses.

(This NCD last reviewed March 2009.)


Indications and Limitations of Coverage
 
Cross Reference
See NCD for SPECT (§220.12).
Transmittal Number

120

Coverage Transmittal Link

http://www.cms.gov/transmittals/downloads/R120NCD.pdf

Revision History

05/1995 - Provided limited coverage for use in noninvasive imaging of perfusion of heart for diagnosis and management of patients with known or suspected coronary artery disease. Effective date 03/14/1995. (TN 76)

02/1999 - Added coverage for characterization of solitary pulmonary nodules and initial staging of lung cancer. Effective date 1/1/1998. (TN 106)

04/1999 - Added coverage for evaluation of recurrent colorectal cancer in patients with rising levels of carcinoembryonic antigen, staging of lymphoma (both Hodgkins and non-Hodgkins) when PET scan substitutes for gallium scan, and detection of recurrent melanoma. Effective July 1, 1999. (TN 113) (CR 861)

04/2001 - Expanded coverage to include diagnosis and staging/restaging of non-small cell lung cancer, esophageal cancer, colorectal cancer, lymphoma, melanoma, head and neck cancers, myocardial viability, and refractory seizures. Effective and implementation dates July 1, 2001. (TN 136) (CR 1603)

11/2001 - Clarified types of allowable PET scanners. Effective and implementation dates 01/01/2002. (TN 147) (CR 1886) Reduction in coverage announced in Federal Register, 66 FR 58741.

05/2002 - Provided coverage for breast cancer and broader coverage for myocardial viability. Effective and implementation dates 10/01/2002. (TN 156) (CR 2138)

06/2003 - Expanded coverage for noninvasive imaging of perfusion of heart using FDA-approved Ammonia N-13 tracer, and restaging of recurrent or residual thyroid cancers of follicular cell origin that have been previously treated by thyroidectomy and radioiodine ablation and have a serum thyroglobulin >10ng/ml and negative I-131 whole body scan. Also maintained national noncoverage determinations for all uses of FDG-PET for soft tissue sarcoma and dementia and neurogenerative diseases. Effective and implementation dates 10/01/2003. (TN 171) (CR 2687)

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 that are subject of this NCD, as well as other indications for cervical cancer not specifically mentioned, 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 01/28/2005. Implementation date 4/18/2005. (TN 31) (CR 3741)

09/2009 - 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 strategy 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) (CR6632)

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) (CR6632)

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) (CR6632)


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.

Other Versions
  • PET Scans - Version 3, Effective between 1/28/2005 - 4/3/2009
  • PET Scans - Version 2, Effective between 10/1/2003 - 1/28/2005
  • PET Scans - Version 1, Effective between 10/1/2002 - 10/1/2003
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