Positron emission tomography (PET) is a non-invasive imaging procedure used to assess metabolic activity and perfusion in various organs or tissues in the human body. Images are obtained by processing of emissions from positron-emitting radioisotopes that are usually administered intravenously. 2-[F18] fluoro-2-deoxy-D-glucose (FDG) is the radioisotope commonly used in oncologic FDG PET imaging procedures.

There are approximately 11,000 new cases of cervical cancer and almost 4000 deaths annually in the US. Widespread screening of cervical cytology (Papanicolaou screening) has significantly reduced the frequency and burden of this disease. Treatment recommendations for cervical cancer depend on the stage of the cancer, which in turn depends on its anatomic spread and other factors.

The cervix is easily accessible for routine examination, and the diagnosis of cancer is readily made by biopsy of the cervix. There are several methods to determine the extent of disease, and these may include surgical exploration, endoscopic procedures or complex medical imaging.

Medicare already nationally covers 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.

FDG PET is also already 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 Coverage with Evidence Development (CED).

The requestors have asked CMS to reconsider the NCD and nationally cover FDG PET more broadly (without the CED restriction) 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 FDG PET imaging is not helpful to make the initial diagnosis.