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DESCRIPTIONSaturation biopsy involves obtaining at least 20 biopsy tissue cores from the prostate in a systematic manner. Use of saturation biopsy has been proposed for use in the diagnosis (for initial or repeat biopsy), staging, and management of patients with prostate cancer.
Prostate cancer is a common cancer in men and is the second leading cause of cancer-related deaths in men in the US. The diagnosis of prostate cancer is made by biopsy of the prostate gland. The approach to biopsy has changed over time, especially with the advent of PSA (prostate-specific antigen) screening programs that identify cancer in prostates that are normal to palpation and to trans-rectal ultrasound. For patients with an elevated PSA-level but with a normal biopsy, questions exist about subsequent evaluation since repeat biopsy specimens may be positive for cancer in a substantial percentage of patients.
In the early 1990’s, use of sextant biopsies involving six random, evenly distributed biopsies became the standard approach to the diagnosis of prostate cancer. In the late 1990’s as studies showed high false-negative rates for this strategy (missed cancers), approaches were developed to increase the total number of biopsies and to change the location of the biopsies. While there is disagreement about the optimal strategy, most would agree that initial prostate biopsy strategies should include at least 10-14 cores. Additional concerns have been raised about drawing conclusions about the stage (grade) of prostate cancer based on limited biopsy material. Use of multiple biopsies has also been discussed as an approach to identify tumors that may be eligible for sub-total cryoablation therapy.
At present, many practitioners use a 12 to 14 core “extended” biopsy strategy for patients undergoing initial biopsy. This extended biopsy is done in office setting.
Another approach to increase the number of biopsy tissue cores is use of the “saturation” biopsy. In general, saturation biopsy is considered as a minimum of 20 cores taken from the prostate. While saturation biopsy can also be performed in an office-based setting, some perform this approach with general anesthesia.
Indications for Cryoablation of Prostate Cancer are addressed in another policy.
POLICYSaturation biopsy, taking 20 or more core tissue samples at one time, is considered medically necessary in the diagnosis, staging, and management of prostate cancer.
POLICY EXCEPTIONSFederal Employee Program (FEP): Saturation biopsy, taking 20 or more core tissue samples at one time, is considered investigational in the diagnosis, staging, and management of 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 HISTORY10/21/2009: Policy Added
11/19/2009: Approved by MPAC
12/13/2012: Policy reviewed; no changes.
SOURCESBlue Cross Blue Shield Association policy # 7.01.121
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.
The code(s) listed below are ONLY medically necessasry if the procedure is performed according to the "Policy" section of this document.