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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:

• single-nucleotide polymorphisms (SNPs) for risk assessment
• PCA3 for disease diagnosis and prognosis
• TMPRSS fusion genes for diagnosis and prognosis
• multiple gene tests (gene panels) for prostate cancer diagnosis
• gene hypermethylation for diagnosis and prognosis

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, SNP testing as part of genome scanning tests with risk assessments for prostate cancer are offered by a variety of laboratories including Navigenics, LabCorp (23andme), and ARUP (deCode) as laboratory-developed tests. The PCA3 test is offered in the U.S. by a number of reference laboratories including ARUP, Mayo Medical Laboratories, and LabCorp. The reagents used in testing are developed by Gen-Probe. The Prostate Gene Expression Profile was widely announced as available from Clarient, Inc. in January 2009; as of March 2011, the test no longer appears on the listing at the company web site. A test for hypermethylation of GSTP1 is currently available from LabCorp (“Glutathione S-transferase Gene [GSTP1, pi-class] Methylation Assay”) and the required specimen is formalin-fixed, paraffin-embedded tissue. The test is stated to be an adjunct to histopathology. Epigenomics AG (Frankfurt, Germany) has entered licensing agreements with two U.S. laboratories (Quest and Predictive Biosciences) to establish and commercialize laboratory-developed tests for its proprietary methylation biomarker GSTP1. This test is not yet available and it is unclear what matrices will be used.

Only PCA3 has been submitted to the U.S. Food and Drug Administration (FDA) for marketing clearance where it is currently under premarket review as a premarket approval application (PMA). It is expected to be discussed at a public panel meeting at some point in the near future. The others, if available, are offered as laboratory-developed tests under the Clinical Laboratory Improvement Amendments (CLIA) licensed laboratories.

• single-nucleotide polymorphisms (SNPs) for risk assessment;
• PCA3 for disease diagnosis and prognosis;
• TMPRSS fusion genes for diagnosis and prognosis;
• multiple gene tests (gene panels) for prostate cancer diagnosis; or
• gene hypermethylation for diagnosis and prognosis. 

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

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.

http://www.diagnocure.com/anglais/section3/sec33p.htm

All codes billed for this procedure are considered investigational and not eligible for coverage.

Non-Covered Codes