Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Prostate Cancer

Treatment: PET (positron emission tomography) scan (procedure code 78815)

The insurer denied coverage for PET (positron emission tomography) scan (procedure code 78815)

The denial is upheld

This is a patient who is newly diagnosed with Gleason 7-9 prostate cancer. There was a bone scan and computed tomography (CT) scan of the chest abdomen and pelvis done for gross hematuria, but apparently also for staging. The request is for a PET (positron emission tomography) scan (procedure code 78815), which is under review.

The positron emission tomography (PET) is an imaging procedure that is unique by virtue of its ability to image biochemical reactions and physiological functions. This is accomplished by measuring concentrations of radioactive chemicals that are partially metabolized in the body region of interest.

PET with fluorodeoxyglucose (FDG) has been quite successful in the imaging evaluation of a large number of tumor types. Prostate cancer, however, has variable accumulation of FDG, which is probably a reflection of the heterogeneous nature of the disease. Early studies of FDG-PET in prostate cancer have shown that FDG accumulation in primary prostate cancer may be low and overlap with the uptake in benign prostatic hyperplasia, normal glands, and postoperative scar or local recurrence. However, animal and preliminary clinical studies have demonstrated that FDG-PET may be useful in the evaluation of advanced disease in patients with high Gleason scores and serum prostate-specific antigen (PSA) levels, in the detection of active osseous and soft tissue metastases, and in the assessment of response after androgen ablation and treatment with novel chemotherapies.

The National Comprehensive Cancer Network (NCCN) now does recommend PET for prostate cancer staging and restaging. There has been a recent shift in this area with the availability of new contrast materials, including choline, prostate-specific membrane antigen (PSMA), and the recent approval of Axilium. NCCN now does recommend PET for prostate cancer staging and restaging. In the seminal publication leading to FDA approval in 2012, fluciclovine-PET/CT was found superior to CT alone at detecting local and distant recurrences, with a sensitivity of 88.6 percent (%) and accuracy of 78.4%. In another study, fluciclovine-PET/CT was compared with 11C-choline-PET/CT, and it showed superiority for detecting local (in-gland, nodal, and prostatectomy bed) recurrences, especially in those with low PSA values.

Since the staging had been appropriately done and did not find metastatic disease, to do PET based on high-grade alone is not supported by medical literature of NCCN guidelines.

"Worldwide, prostate cancer is the most commonly diagnosed malignancy and the sixth leading cause of cancer death in men. Diagnosis is primarily based on prostate-specific antigen (PSA) testing, magnetic resonance imaging (MRI) scans, and prostate tissue biopsies, although PSA testing for screening remains controversial. New diagnostic technologies including risk stratification bioassay tests, germline testing, and various PET scans are now available. When the cancer is limited to the prostate, it is considered localized and potentially curable" (Leslie SW, Soon-Sutton TL., 2023).

Based on the above, the insurer's denial must be upheld. The health care plan did act reasonably and with sound medical judgment and in the best interest of the patient. 

The medical necessity for PET (positron emission tomography) scan (procedure code 78815) is not substantiated.