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:
- In performing guided lesion biopsy of recurrent low-grade brain tumors in patients with an indeterminate MRI?
- 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:
- 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:
- In detection of residual cervical cancer following treatment (surgery, radiation, chemotherapy, or combination)?
- 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:
- In staging at the time of initial diagnosis?
- 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?
- 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:
- In differentiating benign from malignant pancreatic lesions?
- 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:
- In staging to determine the true extent of disease at initial diagnosis in patients with SCLC?
- In restaging post treatment to evaluate the response to initial treatment (detect residual or new disease sites) in patients with SCLC?
- 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:
- For initial staging?
- In evaluation of residual masses or suspected recurrent disease to reliably distinguish between viable tumor and fibrosis/necrosis?
- 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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