Positron emission tomography (PET) is a non-invasive imaging procedure used to assess metabolic activity and perfusion in various organ systems in the human body. Images are obtained from positron-emitting radioisotopes that are usually administered intravenously. 2-[F18] fluoro-2-deoxy-D-glucose (FDG) is used in PET imaging procedures. The requestors asked that Medicare expand coverage of FDG-PET to include certain indications for the following cancers: brain, testicular, small cell lung, cervical, and pancreatic.

The following are the indications CMS has been asked to review for coverage:

FDG-PET for brain tumors
How does the diagnostic test performance of FDG-PET, as an adjunct to conventional imaging (e.g., CT, MRI), compare to conventional imaging alone with respect to the following clinical situations:

1. In performing guided lesion biopsy of recurrent low-grade brain tumors in patients with an indeterminate MRI?
2. In distinguishing high-grade from low-grade tumors and distinguishing tumor from radiation necrosis in recurrent brain lesions?

How does the diagnostic test performance of FDG-PET, as an adjunct to biopsy, compare to biopsy alone with respect to the following clinical situation:

1. In the initial grading of the degree of malignancy for patients with primary brain tumors when the initial biopsy result was indeterminate grade II/III glioma?

FDG-PET for cervical cancer
How does the diagnostic test performance of FDG-PET compare to conventional imaging (e.g., CT, lympangiography, chest radiograph, IV pyelography) in the detection of pre-treatment metastases in newly diagnosed cervical cancer?

How does the diagnostic test performance of FDG-PET compare to conventional imaging (e.g., CT, MRI) in the following clinical situations:

1. In detection of residual cervical cancer following treatment (surgery, radiation, chemotherapy, or combination)?
2. In detection of recurrent cervical cancer following treatment (surgery, radiation, chemotherapy, or combination)?

FDG-PET for ovarian cancer
How does the diagnostic test performance of FDG-PET as an adjunct to conventional imaging (e.g., CT, MRI) compare to conventional imaging alone in the following clinical situations:

1. In staging at the time of initial diagnosis?
2. In detecting recurrent disease following treatment (surgery, radiation, chemotherapy, or combination)?

   As a subset within this indication, does FDG-PET accurately and reliably detect recurrence in a patient with a history of ovarian cancer who has a rising CA-125 titre and a negative CT:

   a) In determining if there has been a recurrence of the tumor?
   b) In localizing, if present, such recurrence?
   c) In yielding appropriate staging of such recurrence?

3. In monitoring the effect of chemotherapy?

FDG-PET for pancreatic cancer
How does the diagnostic test performance of FDG-PET as an adjunct to conventional imaging (e.g., CT, MRI, ultrasound) compare to conventional imaging alone in the following clinical situations:

1. In differentiating benign from malignant pancreatic lesions?
2. In detecting metastatic pancreatic cancer?

If adjunctive use of FDG-PET is superior to conventional imaging alone for detection of metastatic pancreatic cancer, for what subpopulation(s) of patients has this superiority been shown?

How does FDG-PET compare to conventional imaging (e.g., MRI, CT, ultrasound) for detection of residual or recurrent disease following treatment of primary pancreatic cancer?

FDG-PET for small cell lung cancer
How does the diagnostic test performance of FDG-PET compare to conventional imaging modalities (e.g., CT, MRI) with respect to the following clinical situations:

1. In staging to determine the true extent of disease at initial diagnosis in patients with SCLC?
2. In restaging post treatment to evaluate the response to initial treatment (detect residual or new disease sites) in patients with SCLC?
3. In diagnosing occult small cell lung cancer in patients with paraneoplastic syndrome(s) commonly associated with this neoplasm?

FDG-PET for testicular cancer
In patients with an established diagnosis of pure seminomas or non-seminomatous germ cell tumors, how does the diagnostic test performance of FDG-PET compare to conventional imaging modalities (e.g., CT, MRI) or histology with respect to the following clinical situations:

1. For initial staging?
2. In evaluation of residual masses or suspected recurrent disease to reliably distinguish between viable tumor and fibrosis/necrosis?
3. In determining if there has been a recurrence of tumor in patients with rising serum tumor markers and a normal CT?

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