The Centers for Medicare & Medicaid Services have proposed a national coverage determination to expand coverage for initial diagnostic testing with positron emission tomography for Medicare beneficiaries undergoing cancer treatment. 

This proposed decision would replace the four-part diagnosis, staging, restaging and monitoring response to treatment categories. In its place would be a two-part framework that differentiates FDG PET imaging used to inform the initial treatment strategy from other uses related to guiding subsequent treatment strategies after initial treatment.

According to CMS, this in effect removes a significant part of the Coverage with Evidence Development requirement for PET scans in cancer and allows coverage for one PET scan to guide the initial treatment strategy.  Because CMS feels that “the current evidence is not adequate to provide coverage for PET scans in guiding subsequent treatment,” CED will maintain as the requirement for PET scans for subsequent treatment strategies.
Specifically, CMS will cover one FDG PET study for beneficiaries who have solid tumors that are biopsy proven or strongly suspected based on other diagnostic testing after the physician indicates that it is needed to determine whether the beneficiary is an appropriate candidate for an invasive diagnostic or therapeutic procedure, the optimal anatomic location for an invasive procedure, or the anatomic extent of tumor when the recommended anti-tumor treatment reasonably depends on the extent of the tumor.

CMS proposes that the available evidence is not adequate to determine that FDG PET imaging improves physician decision making in the determination of subsequent anti-tumor treatment strategies in patients with tumor types other than breast, cervix, colorectal, esophagus, head and neck (non-CNS/thyroid), lymphoma, melanoma, non-small cell lung, and thyroid.
NOPR sponsors submitted a formal written request to reconsider the 2005 coverage determination to CMS, based on the evidence they had collected and published. According to CMS, this proposed expansion in coverage is the first time that CMS has reviewed medical evidence arising from its CED program.

CMS will accept public comments on the entire proposed decision through Feb. 5 and will issue a final national coverage determination in April 2009.

The public can submit comments on its proposed decision, which is available here. Instructions on how to submit comments are found at this link.