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DESCRIPTIONPredicting risk of recurrence in patients undergoing treatment for prostate cancer is difficult, as it is for most malignancies. Over time, risk models for patients with prostate cancer have evolved from early efforts that relied on grade, stage, and prostate-specific antigen (PSA) levels to complex multivariate models. A publication in 2008 indicates that there are more than 65 published, externally validated prostate cancer nomograms and other tools that use standard clinical parameters such as age, clinical or pathologic stage, grade, percent of cancer on biopsy cores, and PSA or its derivatives to predict various clinical and pathologic outcomes.
Recent studies have begun to study a different approach by adding both cellular and biologic features to the clinical and pathological information noted above. This approach has been called “Systems Pathology.”
Two commercially available systems pathology tests offered through Aureon Laboratories are the Prostate Px+ test and the Post-Op Px test (formerly called Prostate Px). Prostate Px+ is described as being useful at diagnosis to patients considering surgery (radical prostatectomy) or other treatment options by providing physicians with objective information regarding the probability of disease progression. Post-Op Px estimates risk of PSA recurrence and disease progression after surgery.
This testing has not been cleared (or reviewed) by the Food and Drug Administration (FDA). The company has indicated that Prostate Px does not require FDA approval. The test is considered a Laboratory Developed Test (LDT) and is currently performed in Aureon’s CLIA-certified, CAP-accredited, New York State-regulated laboratory.
Also, see the Saturation Biopsy of the Prostate medical policy.
POLICYUse of tests utilizing “Systems Pathology” that include cellular and biologic features of a tumor is considered investigational, including use in predicting risk of recurrence in patients with prostate cancer.
POLICY GUIDELINESInvestigative service is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized by certifying boards and/or approving or licensing agencies or published peer review criteria as standard, effective medical practice for the treatment of the condition being treated and as such therefore is not considered medically necessary.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
POLICY HISTORY07/22/2010: Approved by Medical Policy Advisory Committee
06/21/2011: Policy reviewed; no changes.
04/26/2012: Policy reviewed; no changes.
07/19/2013: Policy statement revised to change "uses" cellular and biologic features to "include" cellular and biologic features for clarity purposes. Intent of policy statement unchanged.
SOURCE(S)Blue Cross Blue Shield Association policy # 2.04.64
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.