Corporate Medical Policy Saturation Biopsy for Diagnosis, Staging, and Management of Prostate File Name: Origination: Last CAP Review: Next CAP Review: Last Review: saturation_biopsy_for_diagnosis_ staging_and_management_of_prostate_cancer 11/2009 11/2017 11/2018 11/2017 Description of Procedure or Service Prostate cancer is common 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 transrectal 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 subtotal 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 an office setting and allows for more extensive sampling of the lateral peripheral zone; sampling of the lateral horn may increase the cancer detection rate by approximately 25%. Another approach to increase the number of biopsy tissue cores is use of the saturation biopsy. In general, saturation biopsy is considered as more than 20 cores taken from the prostate, with improved sampling of the anterior zones of the gland, which may be undersampled in standard peripheral zone biopsy strategies and may lead to missed cancers. Saturation biopsy may be performed transrectally or with a transperineal approach; the transperineal approach is generally performed as a stereotactic template-guided procedure with general anesthesia. In addition to diagnosis of prostate cancer, some have suggested that saturation biopsy could be a part of active surveillance (a treatment approach for individuals with prostate cancer that involves surveillance with PSA, digital rectal exam, and routine prostate biopsies in individuals whose cancers are small and expected to behave indolently). Saturation biopsy has the potential to more accurately identify tumor grade compared with standard biopsy. ***Note: This Medical Policy is complex and technical. For questions concerning the technical language and/or specific clinical indications for its use, please consult your physician. Page 1 of 6
Policy Saturation biopsy of the prostate is considered investigational. BCBSNC does not cover investigational services. Benefits Application This medical policy relates only to the services or supplies described herein. Please refer to the Member's Benefit Booklet for availability of benefits. Member's benefits may vary according to benefit design; therefore member benefit language should be reviewed before applying the terms of this medical policy. When Saturation Biopsy for Diagnosis, Staging, and Management of Prostate is covered Not Applicable When Saturation Biopsy for Diagnosis, Staging, and Management of Prostate is not covered Saturation biopsy for diagnosis, staging and management of prostate cancer is considered investigational. Policy Guidelines For individuals who have suspected prostate cancer who receive initial saturation biopsy, the evidence includes randomized controlled trials (RCTs), observational studies and systematic reviews. Relevant outcomes are overall survival, disease-specific survival, test accuracy, and treatment-related morbidity. A 2013 systematic review found higher rates of cancer detection with saturation biopsy than extended biopsy overall, but in the subgroup of men with prostatespecific antigen (PSA) levels less than 10 ng/ml, the degree of difference was small and possibly not clinically significant. Health outcomes (e.g., survival rate) were not reported. Although several studies were published after the systematic review, none showed that initial saturation biopsy improves the detection of clinically significant cancers and none reported progression or survival outcomes. The evidence is insufficient to determine the effects of the technology on health outcomes. For individuals who have suspected prostate cancer who receive repeat saturation biopsy, the evidence includes observational studies and a systematic review. Relevant outcomes are overall survival, disease-specific survival, test accuracy, and treatment-related morbidity. Several studies have compared saturation and standard prostate biopsies in the repeat biopsy setting and have found significantly higher detection rates with saturation biopsy. However, at least one study found that about one-third of the positive findings with saturation biopsy were clinically insignificant cancers. Moreover, studies of saturation biopsy as the repeat prostate biopsy strategy focused on cancer detection rates and did not report health outcomes (e.g., progression or survival). Evidence is lacking as to whether saturation biopsy leads to improved health outcomes, including the possibility of detecting clinically insignificant cancers, which could lead to unnecessary treatment. The evidence is insufficient to determine the effects of the technology on health outcomes. For individuals who have prostate cancer and are candidates for active surveillance who receive saturation biopsy, the evidence includes two nonrandomized comparative studies. Relevant outcomes are overall survival, disease-specific survival, test accuracy, and treatment-related Page 2 of 6
morbidity. Both studies retrospectively compared standard biopsy and saturation biopsy for selecting patients for active surveillance; neither found that saturation biopsy improved the ability to select patients. In one study, biopsy method was not a significant predictor of upstaging and, in the other study, biopsy method was not significantly associated with selecting patients with a high Gleason score. The evidence is insufficient to determine the effects of the technology on health outcomes. Saturation biopsy is generally considered obtaining more than 20 biopsy tissue cores from the prostate in a systematic manner; it is occasionally defined as obtaining more than 18 biopsy tissue cores. Billing/Coding/Physician Documentation Information This policy may apply to the following codes. Inclusion of a code in this section does not guarantee that it will be reimbursed. For further information on reimbursement guidelines, please see Administrative Policies on the Blue Cross Blue Shield of North Carolina web site at www.bcbsnc.com. They are listed in the Category Search on the Medical Policy search page. Applicable service codes: 55706, G0416 BCBSNC may request medical records for determination of medical necessity. When medical records are requested, letters of support and/or explanation are often useful, but are not sufficient documentation unless all specific information needed to make a medical necessity determination is included. Scientific Background and Reference Sources External Specialty-Matched Consultant Review 12/08. Ashley RA, Inman BA, Routh JC et al. Reassessing the diagnostic yield of saturation biopsy of the prostate. Eur Urol 2008; 53(5):976-81. Simon J, Kuefer R, Bartsch G Jr et al. Intensifying the saturation biopsy technique for detecting prostate cancer after previous negative biopsies: a step in the wrong direction. BJU Int 2008; 102(4):459-62. Eichler K, Hempel S, Wilby J et al. Diagnostic value of systematic biopsy methods in the investigation of prostate cancer: a systematic review. J Urol 2006; 175(5):1605-12. Patel AR, Jones JS. Optimal biopsy strategies for the diagnosis and staging of prostate cancer. Curr Opin Urol 2009; 19(3):232-7. National Comprehensive Network (NCCN). Clinical Practice Guidelines in Oncology v.2.2009 Prostate. Retrieved on October 28, 2009 from http://www.nccn.org/professionals/physician_gls/pdf/prostate.pdf National Comprehensive Network (NCCN). Clinical Practice Guidelines in Oncology v.2.2010 Prostate Early Detection. Retrieved on October 28, 2009 from http://www.nccn.org/professionals/physician_gls/pdf/prostate_detection.pdf External Specialty-Matched Consultant review 1/09. Senior Medical Director review - 11/11/09. BCBSA Medical Policy Reference Manual [Electronic Version]. 7.01.121, 10/8/10. Page 3 of 6
Specialty Matched Consultant Advisory Panel review 12/2010 National Comprehensive Network. Clinical Practice Guidelines in Oncology: Prostate (V.1.2011). retrieved on November 3, 2011 from http://www.nccn.org/professionals/physician_gls/pdf/prostate_detection.pdf. BCBSA Medical Policy Reference Manual [Electronic Version]. 7.01.121, 10/04/11 Specialty Matched Consultant Advisory Panel review 11/2011 BCBSA Medical Policy Reference Manual [Electronic Version]. 7.01.121, 10/13/12 Medical Director review 11/2012 Specialty Matched Consultant Advisory Panel review 11/2012 National Comprehensive Network. (NCCN). Prostate Early Detection. (V2.2012) National Comprehensive Network. (NCCN) Clinical Practice Guidelines in Oncology: Prostate (V.4.2013). Medical Director review 11/2013 Specialty Matched Consultant Advisory Panel review 11/2013 Jiang X, Zhu S, Feng G et al. Is an initial saturation prostate biopsy scheme better than an extended scheme for detection of prostate cancer? A systematic review and meta-analysis. Eur Urol 2013; 63(6):1031-9. Linder BJ, Frank I, Umbreit EC et al. Standard and saturation transrectal prostate biopsy techniques are equally accurate among prostate cancer active surveillance candidates. Int J Urol 2013; 20(9):860-4. BCBSA Medical Policy Reference Manual [Electronic Version]. 7.01.121, 1/9/14 Medical Director review 8/2014 Specialty Matched Consultant Advisory Panel review 11/2014 BCBSA Medical Policy Reference Manual [Electronic Version]. 7.01.121, 3/12/15 American Urological Association. Early Detection of Prostate : AUA Guideline. 2013; http://www.auanet.org/common/pdf/education/clinical-guidance/prostate--detection.pdf Accessed October 30, 2015. U.S. Preventive Services Task Force (USPSTF). Prostate Screening. http://www.uspreventiveservicestaskforce.org/page/topic/recommendation-summary/prostatecancer-screening Accessed October 30, 2015. Specialty Matched Consultant Advisory Panel 11/2015 For Policy titled Saturation Biopsy for Diagnosis, Staging, and Management of Prostate Page 4 of 6
BCBSA Medical Policy Reference Manual [Electronic Version]. 7.01.121, 7/14/16 Specialty Matched Consultant Advisory Panel 11/2016 BCBSA Medical Policy Reference Manual [Electronic Version]. 7.01.121, 7/13/2017 Specialty Matched Consultant Advisory Panel 11/2017 Policy Implementation/Update Information 12/7/09 New policy issued. Saturation biopsy for diagnosis, staging and management of prostate cancer is not covered. It is considered investigational and BCBSNC does not cover investigational services. In general, saturation biopsy is considered as a minimum of 20 cores taken from the prostate. (pmo) 6/22/10 Policy Number(s) removed (amw) 1/18/11 Specialty Matched Consultant Advisory Panel review 12/2010. References updated. (mco) 12/20/11 Specialty Matched Consultant Advisory Panel review 11/2011. References updated. No changes to Policy Statement. (mco) 1/15/13 Updated Description section. Updated references. Specialty Matched Consultant Advisory Panel review 11/2012. No changes to Policy Statements. (mco) 12/10/13 Specialty Matched Consultant Advisory Panel review 11/2013. Medical Director review 11/2013. References updated. No changes to Policy Statements. (mco) 2/25/14 Policy Guidelines updated. References updated. No changes to Policy Statement. (mco) 8/26/14 CPT code 88305 added to Billing/Coding section. The following statement added to Billing/Coding section: When CPT code 88305 is submitted for greater than 10 units with prostate related diagnoses, the corresponding G code will be substituted. Medical Director review 8/2014. Policy noticed on 8/26/2014 for effective date 10/28/2014. (mco) 12/30/14 Deleted codes G0417, G0418, and G0419 from Billing/Coding section. (sk) 2/24/15 Specialty Matched Consultant Advisory Panel review 11/25/14. Added Saturation biopsy is generally considered obtaining more than 20 biopsy tissue cores from the prostate in a systematic manner; it is occasionally defined as obtaining more than 18 biopsy tissue cores to Policy Guidelines. Removed When CPT code 88305 is submitted for greater than 10 units with prostate related diagnoses, the corresponding G code will be substituted from the Billing/Coding section. Removed code 88305 from the Billing/Coding section. (sk) 4/28/15 Reference added. (sk) 4/29/16 References added. Specialty Matched Consultant Advisory Panel review 11/18/2015. (sk) Page 5 of 6
For Policy titled Saturation Biopsy for Diagnosis, Staging, and Management of Prostate 8/30/16 Reference added. Policy Guidelines updated. Policy title changed from Saturation Biopsy for Diagnosis and Staging of Prostate to Saturation Biopsy for Diagnosis, Staging, and Management of Prostate. (sk) 1/27/17 References added. Specialty Matched Consultant Advisory Panel review 11/30/2016. (sk) 8/11/17 Reference added. Policy Guidelines updated. (sk) 12/15/17 Specialty Matched Consultant Advisory Panel review 11/29/2017. (sk) Medical policy is not an authorization, certification, explanation of benefits or a contract. Benefits and eligibility are determined before medical guidelines and payment guidelines are applied. Benefits are determined by the group contract and subscriber certificate that is in effect at the time services are rendered. This document is solely provided for informational purposes only and is based on research of current medical literature and review of common medical practices in the treatment and diagnosis of disease. Medical practices and knowledge are constantly changing and BCBSNC reserves the right to review and revise its medical policies periodically. Page 6 of 6