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There are a variety of gene-based biomarkers associated with prostate cancer. These tests have the potential to improve the accuracy of risk prediction, diagnosis, staging, or prognosis of prostate cancer.
Prostate cancer is a complex, heterogeneous disease. At the extremes of the spectrum, if left untreated, some prostate cancers behave aggressively, metastasize quickly, and cause mortality, while others are indolent and never progress to cause harm. Current challenges in prostate cancer care are risk assessment; early and accurate detection; monitoring low-risk patients undergoing surveillance only; prediction and detection of recurrence after initial treatment; and assessing efficacy of treatment for advanced disease.
In response to the need for better biomarkers for risk assessment, diagnosis, and prognosis, a variety of exploratory research is ongoing. Some products of this work have already been translated or are in the process of being translated into commercially available tests, including:
While studies using these tests generate much information that may help elucidate the biologic mechanisms of prostate cancer and eventually help design treatments, the above-mentioned tests are in a developmental phase. Examples are:
Only 1 PCA3 test has been submitted to the U.S. Food and Drug Administration (FDA) for premarket approval. The Gen-Probe Progensa® PCA3 Assay was approved by FDA on February 15, 2012, through the premarket approval process. According to the company’s press release, this assay is “indicated for use in conjunction with other patient information to aid in the decision for repeat biopsy in men 50 years of age or older who have had 1 or more previous negative prostate biopsies and for whom a repeat biopsy would be recommended by a urologist based on the current standard of care, before consideration of Progensa PCA3 assay results.”
Other tests mentioned in this policy, if available, are offered as laboratory-developed tests under the Clinical Laboratory Improvement Amendments (CLIA) licensed laboratories. Clinical laboratories may develop and validate tests in-house and market them as a laboratory service; laboratories offering such tests as a clinical service must meet general regulatory standards of the Clinical Laboratory Improvement Act (CLIA) and must be licensed by CLIA for high-complexity testing.
POLICYGenetic tests for the screening, detection and management of prostate cancer are considered investigational. This includes, but is not limited to the following:
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.
POLICY HISTORY11/18/2004: Approved by Medical Policy Advisory Committee (MPAC)
6/15/2005: Code Reference section completed
3/27/2006: Coding updated. CPT4 2006 revisions added to policy
3/28/2006: Policy reviewed, no changes
12/28/2006: Code Reference section updated per the 2007 CPT/HCPCS revisions
3/29/2007: Policy reviewed, no changes
12/18/2007: Coding updated per 2008 CPT/HCPCS revisions
12/24/2008: Coding reference section updated per the 2009 CPT/HCPCS revisions
5/6/2009: Policy reviewed, Policy statement expanded
08/03/2011: Policy description updated. Added "prognosis" to the policy statement regarding PCA3.
04/26/2012: Policy reviewed; no changes.
01/14/2013: Added CPT codes 81229, 81479, and S3721 to the Code Reference section.
07/19/2013: Policy reviewed; no changes.
06/11/2014: Policy reviewed; description updated. Policy statement revised to change "Gene-based tests" to "Genetic tests." Removed deleted CPT codes 83890, 83891, 83892, 83893, 83894, 83896, 83897, 83902, 83903, 83904, 83905, 83906, 83912, 83898, 83900, 83901, 83907, 83908, 83909, 83913, 83914, 88384, 88385, and 88386 from the Code Reference section.
12/31/2014: Added the following new 2015 CPT code to the Code Reference section: 81313.
07/20/2015: Code Reference section updated for ICD-10.
12/31/2015: Investigative definition updated in policy guidelines section.
06/08/2016: Policy number added.
Source(s)Blue Cross Blue Shield Association policy # 2.04.33
CODE REFERENCESThis may not be a comprehensive list of procedure codes applicable to this policy.