Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Prostate Problem
Treatment: Pelvis MRI
The health plan denied: Pelvis MRI
The determination is: Overturned

The patient is a male with a history of rising prostate-specific antigen (PSA), most recently to 6.0. Magnetic resonance imaging (MRI) of the pelvis was ordered by the provider. At issue is the medical necessity of the pelvis MRI.
The health plan's determination of medical necessity is overturned in whole.
The requested health service/treatment of pelvis MRI is medically necessary for this patient.
The main trial looking at this question was a randomized controlled non-inferiority trial. The authors, in a multicenter, randomized, noninferiority trial, assigned men with a clinical suspicion of prostate cancer who had not undergone biopsy previously to undergo MRI, with or without targeted biopsy, or standard transrectal ultrasonography-guided biopsy. Men in the MRI-targeted biopsy group underwent a targeted biopsy (without standard biopsy cores) if the MRI was suggestive of prostate cancer; men whose MRI results were not suggestive of prostate cancer were not offered biopsy. Standard biopsy was a 10-to-12-core, transrectal ultrasonography-guided biopsy. The primary outcome was the proportion of men who received a diagnosis of clinically significant cancer. Secondary outcomes included the proportion of men who received a diagnosis of clinically insignificant cancer. A total of 500 men underwent randomization. In the MRI-targeted biopsy group, 71 of 252 men (28 percent [%]) had MRI results that were not suggestive of prostate cancer, so they did not undergo biopsy. Clinically significant cancer was detected in 95 men (38%) in the MRI-targeted biopsy group, as compared with 64 of 248 (26%) in the standard-biopsy group. MRI, with or without targeted biopsy, was noninferior to standard biopsy, and the 95% confidence interval indicated the superiority of this strategy over standard biopsy. Fewer men in the MRI-targeted biopsy group than in the standard-biopsy group received a diagnosis of clinically insignificant cancer. The authors concluded that the use of risk assessment with MRI before biopsy and MRI-targeted biopsy was superior to standard transrectal ultrasonography-guided biopsy in men at clinical risk for prostate cancer who had not undergone biopsy previously (Kasivisvanathan).
In single-center studies, the approach of obtaining MRI-targeted biopsy cores alone, without performing standard biopsies, has shown similar or higher rates of detection of clinically significant cancer (Baco, Siddiqui, Porpiglia, Schoots).
The National Comprehensive Cancer Network (NCCN) Guidelines on the early detection of prostate cancer recommend MRI-targeted prostate biopsy for patients with an abnormal MRI with elevated PSA (prior to systematic biopsy), such as with this patient.
The American Urological Association (AUA) also notes: When quality prostate imaging is obtained, current evidence now supports its use in men at risk of harboring prostate cancer and who have not undergone a previous biopsy. MRI prior to biopsy is recognized as a standard evaluation. Therefore, the pelvis MRI is medically necessary.