On January 6, 2009, using a new treatment strategy framework, the Centers for Medicare & Medicaid Services (CMS) published a draft national coverage determination (NCD) to 1) expand coverage for initial diagnostic testing of solid tumors with positron emission tomography (PET) and 2) continue restricting coverage on subsequent treatment strategies.

New Coverage Framework

CMS proposes to replace the four current categories; diagnosis, staging, restaging and monitoring response to treatment, with a two-part approach that distinguishes between FDG PET imaging used to guide the initial treatment strategy from subsequent treatment strategies after completion of the initial treatment.

Initial Treatment Strategy Coverage Expanded

CMS proposes that the evidence is adequate to determine that the results of FDG PET imaging are useful in determining the appropriate initial treatment strategy for beneficiaries with suspected solid tumors and thus improve health outcomes and are reasonable and necessary.  As a result, 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 when the beneficiary's treating physician determines that the FDG PET study is needed to determine the location and/or extent of the tumor for the following therapeutic purposes related to the initial treatment strategy:

·     To determine whether or not the beneficiary is an appropriate candidate for an invasive diagnostic or therapeutic procedure; or

·     To determine the optimal anatomic location for an invasive procedure; or

·     To determine the anatomic extent of the tumor when the recommended anti-tumor treatment reasonably depends on the extent of the tumor.

There are exceptions to this decision regarding antitumor treatment in patients with adenocarcinoma of the prostate, breast cancer and imaging of regional lymph nodes in melanoma.  Please see details in the Proposed Decision Memo referenced below.

Continued Restricted Coverage on Subsequent Treatment Strategy

For tumor types other than breast, cervix, colorectal, esophagus, head and neck (non-CNS/thyroid), lymphoma, melanoma, non-small cell lung, and thyroid, 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 strategy and thus does not improve health outcomes and is not reasonable and necessary.  However, CMS proposes that the available evidence is adequate to determine that FDG PET imaging for subsequent anti-tumor treatment strategy is reasonable and necessary through Coverage with Evidence Development/Coverage with Study Participation (CED/CSP). 

Appendix A (below) summarizes the effect of these changes:

CMS is soliciting public comments on this proposed determination.  Of particular interest are comments that include new evidence CMS has not reviewed in this proposal or in past considerations of this NCD.

Comments on the following questions are of particular interest:

1.   Should the current framework for evaluating the use of FDG PET imaging be modified as proposed?

2.   Does the evidence support the broad expansion of coverage of FDG PET imaging in solid tumors when determining initial treatment strategy?

3.   Does the evidence support the restriction of coverage of FDG PET imaging in solid tumors when determining subsequent treatment strategy to coverage with evidence development?

4.   For breast cancer and melanoma that have noncoverage for initial treatment strategy, is there evidence that would support their removal from the list of exceptions to coverage for initial treatment strategy?

5.   For the nine cancers that have coverage for subsequent treatment strategy, is there evidence that would support restricting their coverage to CED?

Public Comments are due by February 5, 2009 and the Final National Coverage Determination will be released in April 2009.  Click here to submit a comment.