On June 11, 2013, the Centers for Medicare and Medicaid Services (CMS) posted a final decision to end the coverage with evidence development (CED) requirement for FDG PET for solid tumors.  CMS has concluded that 3 FDG PET scans will be covered when used to guide the subsequent management of an anti-tumor treatment strategy after the completion of the initial anti-cancer therapy.  Additional coverage of any FDG PET scans (beyond 3) used to instruct the subsequent management of a tumor treatment strategy after completion of initial anti-tumor therapy will be determined by local Medicare Administrative Contractors (MACs).

CMS decision applies only to the FDG-PET registry only.  Based upon this decision, the National Oncologic PET Registry -2009 (NOPR-2009) will no longer accept new FDG case registrations effective June 12, 2013.

The NaF-PET registry will remain open.  PET facilities that wish to continue participating in the NaF-PET registry (or to begin participating) do not need to take further action.

Any PET facility that is currently participating in the NOPR and no longer wishes to continue its participation may submit a request to withdraw from the NOPR and have the balance in its escrow account refunded.  PET facilities no longer interested in participating in the NOPR should send their request to OPTOUT_NOPR@acr.org.  Please see http://www.cancerpetregistry.org/ for additional information requirements or contact the project manager at 215-717-0859.

Click here for a full copy of the Decision Memo for Positron Emission Tomography (FDG) for Solid Tumors (CAG-00181R4) effective June 11, 2013.

Final Decision Summary:

• CMS has ended the requirement for coverage with evidence development (CED) for 18F fluorodeoxyglucose positron emission tomography (FDG PET) for oncologic indications as defined in Section 220.6.17 of the Medicare National Coverage Determinations Manual.  The requirement for prospective data collection by the National Oncologic PET Registry (NOPR) for these cancers or cancer types covered under the CED requirement (as listed in Appendix A of the Decision Memo) has been removed.
• Under §1862(a)(1)(A) of the Social Security Act (the "Act"), CMS has determined that 3 FDG PET scans are covered when used to guide subsequent management of the anti-tumor treatment strategy after completion of the initial anti-cancer therapy.
• Coverage of any additional FDG PET scans beyond 3 to guide the subsequent management of anti-tumor treatment strategies (after completion of the initial anti-tumor therapy) will be determined by the local MACs.
• Prostate Cancers:

• As noted in the Proposed Decision Memo (PDM), CMS concluded that there was limited evidence regarding the impact of FDG PET on clinical outcomes for patients who had completed their initial prostate cancer therapy. 
• Use of PET tracers in the literature for recurrence or tumor response primarily reflected the use of 11C choline, a different radiopharmaceutical.
• Based upon PDM public comments indicating that recent evidence of the effectiveness of FDG PET on patient clinical outcomes post completion of their initial prostate cancer therapy was in part provided in journal articles involving therapeutic studies, CMS concluded that there was a significant benefit of FDG PET scans in determining the effect of treatment, primarily when used with patients with certain types of progressive prostate disease.
• NOPR results (e.g. Hillner 2012) indicated that physicians would revise their planned treatment strategy for patients in about 40% of the cases reported.
• As a result, CMS concluded that selective use of FDG PET imaging in the assessment of the progression of prostate cancer (particularly certain types of progressive prostate disease) provided valuable additional information for managing patients therapy treatment.  Although, the glucose avidity of prostate cancer cells is recognized, as reported by Hillner 2009, other studies documented that FDG PET/CT could be invaluable when assessing prostate cancer bone metastases' activity in a significant/majority of studies (Meirelles 2010)
• CMS, therefore, considers the use of FDG PET/CT for subsequent treatment strategy planning to be reasonable and necessary.  This followed CMS' recognition that a rising PSA level, in many of these studies, was the indicator to the clinical suspicion of progressive or recurrent prostate cancer.
• CMS anticipates that post-coverage analysis (PCA) will confirm the NOPR public comments noting that physicians selectively employed FDG PET for subsequent anticancer treatment planning in appropriate patients.
• Therefore, CMS proposed the use of FDG PET/CT to be reasonable and necessary to instruct the subsequent anti-tumor treatment strategy for patients with prostate cancer.

The following Table summarizes the National FDG PET coverage for oncologic conditions effective June 11, 2013:

*Cervix: Nationally non-covered for the initial diagnosis of cervical cancer related to initial anti-tumor treatment strategy.  All other indications for initial anti-tumor treatment strategy for cervical cancer are nationally covered.

*Breast:  Nationally non-covered for initial diagnosis and/or staging of axillary lymph nodes.  Nationally covered for initial staging of metastatic disease.  All other indications for initial anti-tumor treatment strategy for breast cancer are nationally covered.

*Melanoma:  Nationally non-covered for initial staging of regional lymph nodes.  All other indications for initial anti-tumor treatment strategy for melanoma are nationally covered.