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Medical Policy: 02.04.17
Original Effective Date: July 2008
Reviewed:
Revised:
This policy applies to all products unless specific contract
limitations, exclusions or exceptions apply. Please refer to the member's coverage
manual for benefit availability. Managed care guidelines related to referral authorization,
and precertification of inpatient hospitalization, home health, home infusion and
hospice services apply.
Description:
In 2008 cancer statistics, cancers of the prostate, lung, and bronchus, and colon and rectum account for 50% of all newly diagnosed cancers, and are the most common fatal cancers among men. Prostate cancer alone accounts for 186,320 or 25% of new cases of cancer in men. New cases of prostate cancer are expected to be diagnosed at local or regional stages in an estimated 91% of the cases, for which the 5-year relative survival approaches 100%. Improvements in early detection and treatment of prostate cancer have decreased death rates for prostate cancer which is estimated to be 28,660 men.
The gold standard for diagnosis of prostate cancer is a prostate biopsy. Under local anesthesia, usually 10 to 12 biopsy samples of prostate tissue are taken. Approximately one-third of patients have undiagnosed prostate cancer following standard transrectal ultrasound-guided prostate biopsy. Researchers have increased detection rates of prostate cancer by 34% when increasing the number of core biopsies taken from at risk men who have had previous negative prostate biopsies.
Elevations in PSA (prostate-specific antigen) levels or abnormal DRE (digital rectal examination) may increase prostate cancer suspicion, but diagnosis must be confirmed with a prostate biopsy. Studies have been conducted using extensive saturation biopsy in men with prior negative prostate biopsies. Others have tried to evaluate the value of this diagnostic test in men with an elevated PSA level, rapidly rising PSA level, and prior negative biopsies. The entire gland is sampled since many cancers are not visible on ultrasound or are impossible to differentiate from benign prostatic hyperplasia.
Prostate saturation biopsy is a technique which is performed under general anesthesia using a transrectal ultrasound probe to image the prostate. A template or grid identifies the exact location of each biopsy core, and usually a total of 20 – 40 cores are taken. Each core is specifically marked so the exact location and size of the tumor can be mapped.
One study concluded there was no noted increase in cancer detection rate with saturation sampling over fewer cores. The impact of increasing number of prostate biopsies on disease is uncertain. In patients with 3 prior negative biopsies, prostate saturation biopsy found minor disease. One large analysis concluded taking more than 12 cores was of no increased benefit. When used an initial biopsy technique it did not appear to be beneficial.
Randomized controlled trials to determine the clinical utility of prostate saturation biopsy are needed.
Policy:
Prostate Saturation Biopsy is considered investigational.
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Procedure Codes and Billing
Guidelines:
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To report provider services, use appropriate CPT* codes, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or ICD-9-CM diagnostic codes.
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CPT 0137T Biopsy, prostate, needle, saturation sampling for prostate mapping (do not report 0137T with 76942)
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Selected References:
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Stewart CS, Leibovich BC, Weaver AL, Lieber MM. Prostate cancer diagnosis using a saturation needle biopsy technique after previous negative sextant biopsies. J Urol 2001 July;166(1):86-91.
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Jones JS, Patel A, Schoenfield L, Rabets JC, Zippe CD, Magi-Galluzzi C. Saturation technique does not improve cancer detection as an initial prostate biopsy strategy. J Urol 2006 Feb;175(2):485-8.
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Eichler K, Hempel S, Wilby J, Myers L, Bachmann LM, Kleijnen J. Diagnostic value of systematic biopsy methods in the investigation of prostate cancer: a systematic review. J Urol 2006 May;175(5):1605-12.
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Meng MV, Elkin EP, DuChane J, Carroll PR. Impact of increased number of biopsies on the nature of prostate cancer identified. J Urol 2006 Jul;176(1):63-9.
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Raja J, Ramachandran N, Munneke G, Patel U. Current status of transrectal ultrasound-guided prostate biopsy in a repeat biopsy in the diagnosis of prostate cancer. Clin Radiol 2006 Feb;61(2):142-153.
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Ashley RA, Inman BA, Routh JC, Mynderse LA, Gettman MT, Blute ML. Reassessing the Diagnostic Yield of Saturation Biopsy of the Prostate. Eur Urol 2007 Nov 5.
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National Comprehensive Cancer Network (NCCN). Prostate cancer early detection. Clinical Practice Guidelines in Oncology. Version 2.2007; Jenkintown, PA: NCCN. May 10, 2007. Available at URL address: http//www.nccn.org/professionals/physician_gls/PDR/prostate_detection.pdf Accessed July 18, 2008.
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Merrick GS, Gutman S, Adamovich E, Anderson R, Allen Z, et al. Prostate cancer distribution in patients diagnosed by transperineal template-guided saturation biopsy: Implications for brachytherapy treatment planning. Journal of Clinical Oncology 2007 ASCO Annual Meeting Proceedings (Post-Meeting Edition). Vol 25, No 18S (June 20 Supplement), 2007: 15533.
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Inman BA, Ashley R, Myers RP, Wilson T, et al. Saturation biopsy: Does it really detect more cancer? American Society of Clinical Oncology. 2007 Prostate Cancer Syposium. Abstract No 341.
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Lane BR, Zippe CD, Abouassaly R, Schoenfield L, et al. Saturation technique does not decrease cancer detection during follow-up after initial prostate biopsy. J Urol 2008 May; 179(5):1746-50.
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Stav K, Leibovici D, Sandbank J, Lindner A, Zisman A. Saturation prostate biopsy in high risk patients after multiple previous negative biopsies. Urology 2008 March;71(3):399-403.
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Simon J, Kuefer R, Bartsch G Jr, Volkmer BG, Hautmann RE, Gottfried HW. Intensifying the saturation biopsy technique for detecting prostate cancer after previous negative biopsies: a step in the wrong direction. BJU Int 2008 Mar 5. [Epub ahead of print].
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New information or technology that would be relevant for Wellmark to consider when this policy is next reviewed may be submitted to:
Wellmark Blue Cross and Blue Shield
Medical Policy Analyst
Station 304
636 Grand Ave
Des Moines, Iowa 50309
*Current Procedural Terminology © 2008 American Medical Association. All Rights Reserved.
Wellmark medical policies address the complex issue
of technology assessment of new and emerging treatments, devices,
drugs, etc. They are developed to
assist in administering plan benefits and constitute neither offers of
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partial, general description of plan or program benefits and do not
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and, therefore, cannot guarantee any results or outcomes.
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affiliates. Treating providers are solely responsible for medical
advice and treatment of members. Our medical policies may be updated
and therefore are subject to change without notice.
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