CMS Releases Final Decision Memo for Positron Emission Tomography (FDG) for Solid Tumors

June 11, 2013

On Tuesday, June 11, CMS released the final decision to end the coverage with evidence development requirement for FDG PET for solid tumors (CAG-00181R4).

CMS revised the proposed decision from a limit of one subsequent imaging to three.  Coverage of any additional scans beyond the three will be determined by local Medicare Administrative Contractors.  Additionally, CMS's decision states that use of FDG PET/CT when used to guide subsequent anti-tumor treatment strategy for patients with cancer of the prostate should remain at the local contractor level.  This is a positive development revised from the proposed rule.

Effective for claims with dates of service after June 11, 2013, the chart below summarizes national FDG PET coverage for oncologic conditions:

*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.

CMS’s full posting can be found here: http://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=263 

CMS's Decision Summary:

A. The Centers for Medicare & Medicaid Services (CMS) is ending the requirement for coverage with evidence development (CED) under §1862(a)(1)(E) of the Social Security Act (the “Act’) for 18F fluorodeoxyglucose positron emission tomography (FDG PET) for oncologic indications which are contained in section 220.6.17 of the Medicare National Coverage Determinations Manual.  This removes the requirement for prospective data collection by the National Oncologic PET Registry (NOPR) for those cancers or cancer types that had been covered under CED (as listed in Appendix A). 

B. CMS has determined that three FDG PET scans are covered under § 1862(a)(1)(A) when used to guide subsequent management of anti-tumor treatment strategy after completion of initial anticancer therapy.  Coverage of any additional FDG PET scans (that is, beyond three) used to guide subsequent management of anti-tumor treatment strategy after completion of initial anti-tumor therapy will be determined by local Medicare Administrative Contractors.

Prostate cancers

As reflected in the proposed decision memorandum (PDM), CMS found little evidence about effects of FDG PET on outcomes for patients whose initial therapy for prostate cancer had been completed.  Current literature on PET tracers for recurrence or tumor response seemed to focus mainly on a different radiopharmaceutical, 11C choline.

However, public comments about the PDM indicated that evidence of the value of FDG PET scans was in some cases provided in therapeutic studies and was also available in more recent articles.  After review of these important components of the evidence base, CMS agrees that a significant benefit of FDG PET scans is their use to determine effect of treatment, especially at certain types of progressive prostate disease. 

As examples of the importance of this, NOPR findings (e.g., Hillner 2012) indicate that in about 40% of instances, physicians would change their intended therapy for patients with prostate cancer.  Despite the known concerns about lack of glucose avidity of prostate cancer cells, as mentioned in Hillner 2009other studies indicated that FDG PET CT could be valuable even for assessing activity of bone metastases of prostate cancers in a large majority of patients (Meirelles 2010). 

Nevertheless, we are convinced that FDG PET/CT imaging’s selective use in assessing progression of prostate cancer does provide valuable additional information for managing treatment decisions, and therefore we consider its use for subsequent treatment strategy planning to be reasonable and necessary.  We note that in many of these studies, a rising PSA level was key to the clinical suspicion of progressive or recurrent prostate cancer.

We also agree with the NOPR public comments emphasizing that physicians were found to selectively employ FDG PET for subsequent anticancer treatment planning in appropriate patients.  We expect that post-coverage analysis (PCA) review by CMS will confirm this NOPR observation. 

Consequently, CMS proposes that use of FDG PET/CT when used to guide subsequent anti-tumor treatment strategy for patients with cancer of the prostate is reasonable and necessary under § 1862(a)(1)(A).