May 14, 2009 -On May 8, 2009, CMS opened the reconsideration of the National Coverage Determination (NCD) on Positron Emission Tomography (FDG). The requestors have asked CMS to reconsider the NCD and broaden national coverage of FDG-PET (without CED restrictions) for the staging of cervical cancer (i.e. in those women who have been diagnosed with cervical cancer but who do not otherwise meet the coverage criteria). The requestors also ask that the use of FDG-PET be nationally noncovered to make the diagnosis of cervical cancer, as this imaging is not helpful to make the initial diagnosis.
Currently, Medicare covers, nationally, FDG-PET when it is used by the beneficiary’s physician to guide the subsequent management of cervical cancer in women who have undergone anticancer treatment. For example, FDG-PET is covered to determine whether or not the cancer has responded to treatment or to determine if the patient's symptoms are being caused by a recurrence or spreading of the cancer.
Additionally, FDG-PET is nationally covered for some uses in women diagnosed with cervical cancer who have not yet received anticancer treatment. Specifically, FDG-PET imaging is covered as an adjunct test for the detection of pre-treatment metastasis (i.e., staging) in newly diagnosed cervical cancers following conventional imaging that is negative for extra-pelvic metastasis.
Medicare coverage of all other uses of FDG-PET related to cervical cancer is restricted to beneficiaries who are enrolled in a prospective clinical study under a CED program, like NOPR.
Follow the link to see the NCA Tracking Sheet for Positron Emission Tomography (FDG) for Cervical Cancer (CAG-00181R2)
There will be a public comment period open from 5/8/2009 – 6/7/2009. To submit comments, go to this link:
CMS considers all public comments, and is particularly interested in clinical studies and other scientific information relevant to the technology under review.
CMS expects to release the proposed decision memo on November 8, 2009 and finalize their decision by February 6, 2010.