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02-54000-22

Original Effective Date: 01/01/10

Reviewed: 06/23/11

Revised: 09/15/16

Subject: Prostate Saturation Biopsy

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

           
Position Statement Billing/Coding Reimbursement Program Exceptions Definitions Related Guidelines
           
Other References Other Update
           

DESCRIPTION:

Saturation biopsy involves obtaining 20 or more biopsy tissue cores from the prostate in a systematic manner. Use of saturation biopsy has been proposed in the diagnosis (for initial or repeat biopsy), staging, and management of patients with prostate cancer.

Many practitioners currently use a 12 to 14 core “extended” biopsy strategy for patients undergoing initial biopsy. This extended biopsy is done in an 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.

POSITION STATEMENT:

Transperineal stereotactic template-guided saturation prostate biopsy, taking tissue from more than 20 locations, meets the definition of medical necessity in men with persistently elevated PSA levels and two (2) or more previous negative prostate biopsies, which is performed under local, regional, or general anesthesia using a brachytherapy grid and transrectal ultrasound guidance. Like transrectal saturation biopsy, this technique is reserved for patients with elevated and/or rising PSA values and prior negative transrectal prostate biopsies.

BILLING/CODING INFORMATION:

The following codes may be used to describe the prostate saturation biopsy procedure:

CPT Coding:

55706

Biopsies, prostate, needle, transperineal, stereotactic template-guided saturation sampling, including imaging guidance

HCPCS Coding:

G0416

Surgical pathology, gross and microscopic examinations, for prostate needle biopsy, any method

REIMBURSEMENT INFORMATION:

Refer to section entitled POSITION STATEMENT.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Advantage Products: The following National Coverage Determination (NCD) was reviewed on the last guideline reviewed date: Prostate Cancer Screening Tests (210.1) located at cms.gov.

DEFINITIONS:

No guideline specific definitions apply.

RELATED GUIDELINES:

None applicable

OTHER:

None applicable

REFERENCES:

1. Abouassaly R, Lane BR, Jones JS. Staging saturation biopsy in patients with prostate cancer on active surveillance protocol. Urology. 2008 Apr;71(4):573-7.

2. AHRQ/National Guideline Clearinghouse. Effective Health Care. Comparative Effectiveness of Therapies for Clinically Localized Prostate Cancer, Executive Summary (02/08).

3. AHRQ/National Guideline Clearinghouse. NGC-7183, Guideline for Prostate Cancer, Diagnosis and Treatment (09/22/09).

4. American Cancer Society Guidelines for the Early Detection of Cancer. Prostate Cancer (01/15/09).

5. American Urological Association (AUA). Prostate cancer. Guidelines for the management of clinically localized prostate cancer: 2007 Update.

6. American Urological Association (AUA). Prostate-Specific Antigen Best Practice Statement: 2009 Update.

7. Ashley RA, Inman BA, Routh JC, Mynderse LA, Gettman MT, Blute ML. Reassessing the diagnostic yield of saturation biopsy of the prostate. Eur Urol. 2008 May;53(5):976-81. Epub 2007 Nov 5.

8. Blue Cross Blue Shield Association Medical Policy Reference Manual 7.01.121 Saturation Biopsy for Diagnosis and Staging of Prostate Cancer (10/06/09).

9. Carroll P, Coley C, McLeod D, Schellhammer P, Sweat G, Wasson J, Zietman A, Thompson I. Prostate-specific antigen best practice policy--part I: early detection and diagnosis of prostate cancer. Urology 2001 Feb;57(2):217-24.

10. Carroll P, Coley C, McLeod D, Schellhammer P, Sweat G, Wasson J, Zietman A, Thompson I. Prostate-specific antigen best practice policy--part II: prostate cancer staging and post-treatment follow-up. Urology 2001 Feb;57(2):225-9.

11. Centers for Medicare and Medicaid Services (CMS). NCD for Prostate Cancer Screening Tests (210.1). 06/19/06.

12. Delongchamps NB, de la Roza G, Jones R, Jumbelic M, Haas GP. Saturation biopsies on autopsied prostates for detecting and characterizing prostate cancer. BJU Int. 2009 Jan;103(1):49-54. Epub 2008 Aug 1.

13. 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.

14. First Coast Service Options (FCSO) Medicare A Bulletin, November 2009. “Billing and coding information for prostate biopsies.”

15. Kahl P, Wolf S, Adam A, Heukamp LC, Ellinger J, Vorreuther R, Solleder G, Buettner R. Saturation biopsy improves preoperative Gleason scoring of prostate cancer. Pathol Res Pract. 2009;205(4):259-64. Epub 2008 Dec 21.

16. Lane BR, Zippe CD, Abouassaly R, Schoenfield L, Magi-Galluzzi C, Jones JS. Saturation technique does not decrease cancer detection during followup after initial prostate biopsy. J Urol. 2008 May;179(5):1746-50; discussion 1750. Epub 2008 Mar 17.

17. Morgentaler A, Traish AM. Shifting the paradigm of testosterone and prostate cancer: the saturation model and the limits of androgen-dependent growth. Eur Urol. 2009 Feb;55(2):310-20. Epub 2008 Sep 24.

18. National Comprehensive Cancer Network (NCCN). Clinical Practice Guidelines in Oncology – Prostate Cancer Detection (V.2.2010).

19. National Comprehensive Cancer Network (NCCN). Clinical Practice Guidelines in Oncology – Prostate Cancer (V.3.2010).

20. National Institutes of Health (NIH): National Cancer Institute. Prostate Cancer Screening (PDQ®) – Health Professional Version (07/27/09).

21. Patel AR, Jones JS. Optimal biopsy strategies for the diagnosis and staging of prostate cancer. Curr Opin Urol. 2009 May;19(3):232-7.

22. Pepe P, Fraggetta F, Galia A, Grasso G, Piccolo S, Aragona F. Is quantitative histologic examination useful to predict nonorgan-confined prostate cancer when saturation biopsy is performed? Urology. 2008 Dec;72(6):1198-202.

23. 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 Aug;102(4):459-62. Epub 2008 Mar 5.

24. Stav K, Leibovici D, Sandbank J, Lindner A, Zisman A. Saturation prostate biopsy in high-risk patients after multiple previous negative biopsies. Urology. 2008 Mar;71(3):399-403.

25. U.S. Preventive Services Task Force (USPSTF). Screening for Prostate Cancer, Recommendation Statement (08/08).

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Medical Policy & Coverage Committee on 06/23/11.

GUIDELINE UPDATE INFORMATION:

01/01/10

New Medical Coverage Guideline.

03/15/10

Revision: Program Exception added for Medicare Advantage lines of business; updated references.

09/15/10

Scheduled review; Position Statement unchanged; references updated.

07/15/11

Review of Position Statement resulting in change in coverage; added ICD-9 and ICD-10 diagnosis codes; references updated.

01/01/13

Annual HCPCS coding update: revised descriptor for G0416.

01/01/14

Annual HCPCS coding update: revised descriptor for G0416, G0417, G0418, and G0419; Program Exceptions section updated.

01/01/15

Annual coding update: revised descriptor for G0416; deleted G0417, G0418, and G0419.

11/01/15

Revision: ICD-9 Codes deleted.

09/15/16

Revision; coding section updated.

Date Printed: June 24, 2017: 11:31 AM