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Systems pathology, an approach that combines cellular and biological features to standard clinical parameters such as age, clinical or pathologic stage, grade, percent of cancer on biopsy cores, and prostate-specific antigen (PSA) or its derivatives, is proposed as a way to estimate the probability of disease progression or recurrence, either before or after prostatectomy.
Predicting 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.”
Aureon Laboratories offered two pathology tests called the Prostate Px+™ test and the Post-Op Px™ test (formerly called Prostate Px). Prostate Px+ was 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 estimated risk of PSA recurrence and disease progression after surgery. In October 2011, the company ceased operations and the tests are no longer offered.
Iris International offers the NADiA® ProsVue™ test, which received U.S. Food and Drug Administration 510(k) clearance in 2011.The NADiA ProsVue test evaluates risk of prostate cancer recurrence after radical prostatectomy when PSA levels are less than 0.1 ng/mL. The NADiA immunoassay, polymerase chain reaction test is used to determine PSA levels on 3 serum samples taken between 6 weeks and 20 months after radical prostatectomy. The PSA data are entered into the ProsVue software to ensure appropriate serum sample use and calculation of assay results and to determine the rate of PSA change, the PSA slope.
Also, see the Saturation Biopsy for Diagnosis and Staging of Prostate Cancer medical policy.
Use 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.
Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
07/22/2010: 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.
04/25/2014: Policy title changed from "Systems Pathology for Predicting Risk of Recurrence in Prostate Cancer" to "Systems Pathology in Prostate Cancer." Policy description updated regarding available tests. Policy statement unchanged.
04/01/2015: Policy description updated. Policy statement unchanged. Policy guidelines updated to revise investigative definition.
07/23/2015: Code Reference section updated for ICD-10.
12/31/2015: Code Reference section updated to add CPT codes 88346 and 88350.
Blue Cross Blue Shield Association policy # 2.04.64
This may not be a comprehensive list of procedure codes applicable to this policy.