August 18, 2009 - The Centers for Medicare and Medicaid Services (CMS) recently announced a proposed decision to cover FDG-PET for initial staging of cervical cancer, but to exclude coverage for diagnosis of the disease.
The American College of Radiology (ACR) noted that this proposed decision is consistent with request made by the ACR and the Society of Nuclear Medicine in a joint letter sent to CMS in July 2009.
ACR believes that this coverage proposal is in the best interest of the PET community, and asked CMS to reconsider Section 220.6 of the National Coverage Determinations Manual to end the prospective data collection requirements for FDG-PET for initial staging of cervical cancer.
CMS proposes that the evidence is adequate to determine that the results of FDG-PET imaging for cervical cancer staging of beneficiaries diagnosed with cervical cancer are used by the treating physician to make meaningful changes in therapeutic management and improve health outcomes, and thus are reasonable and necessary.
Therefore, CMS proposes to cover only one FDG PET for staging in beneficiaries who have biopsy proven cervical cancer 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 tumor when the recommended anti-tumor treatment reasonably depends on the extent of the tumor.
The ACR, SNM, and others also noted that "CMS may find it appropriate to exclude coverage for diagnosis of cervical cancer since this disorder is initially diagnosed by biopsy." CMS reportedly agrees and proposes that there is no credible evidence that the results of FDG-PET imaging are useful to make the initial diagnosis of cervical cancer.
CMS is soliciting public comments on this proposed decision pursuant to §1862(l) of the Social Security Act. The public comment period is open until Sept. 14, 2009.
For more information: www.acr.org