Notification



Notification Issue Date:



Medical Policy Bulletin


Title:Saturation Needle Biopsy of the Prostate

Policy #:11.11.06h

This policy is applicable to the Company’s commercial products only. Policies that are applicable to the Company’s Medicare Advantage products are accessible via a separate Medicare Advantage policy database.


The Company makes decisions on coverage based on Policy Bulletins, benefit plan documents, and the member’s medical history and condition. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable.

When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.

This Medical Policy Bulletin document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy Bulletin will be reviewed regularly and be updated as scientific and medical literature becomes available. For more information on how Medical Policy Bulletins are developed, go to the About This Site section of this Medical Policy Web site.



Policy

Coverage is subject to the terms, conditions, and limitations of the member's contract.

Saturation needle biopsy of the prostate is considered medically necessary and, therefore, covered for individuals considered to be very high risk for prostate cancer (e.g., those with persistently elevated or rising PSA values) who have had negative results on previous conventional biopsies.

All other uses for saturation needle biopsy of the prostate are considered experimental/investigational and, therefore, not covered because their safety and/or effectiveness cannot be established by review of the available published peer-reviewed literature.

REQUIRED DOCUMENTATION

The individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to: records from the professional provider's office, hospital, nursing home, home health agencies, therapies, and test reports.

The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the service.
Guidelines

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable benefit contract, saturation needle biopsy of the prostate is covered under the medical benefits of the Company’s products when the medical necessity criteria listed in this medical policy are met.

Description

The incidence of prostate cancer is increasing yearly, and it is the second leading cause of cancer mortality in U.S. males, surpassed only by lung cancer. The advent of prostate-specific antigen (PSA) as a screening marker, combined with digital rectal examination (DRE), has allowed earlier and more frequent diagnoses of prostate cancer. A suspicious screening (e.g., abnormalities found on DRE, abnormalities found in individuals with PSA levels greater than 4 ng/dL, or abnormalities found in individuals with rising PSA levels) is commonly followed by transrectal ultrasound--directed (TRUS) biopsy. Unlike other image-directed biopsies, TRUS does not sample a specific lesion. Rather, samples are taken systematically from areas of the gland where tumors are most likely to occur. Ordinarily, six to eight prostate cores are obtained using the sextant or octet methods of sampling. Although the sextant approach avoids morbidity while minimizing detection of insignificant cancers, it is associated with a false-negative rate that is reported to be as high as 23 percent. This false-negative rate prompts repeat biopsies in men considered to be at high risk for cancer. Recently, an extended 10-core biopsy protocol has been shown to improve diagnosis by 20 to 30 percent. Additionally, a biopsy consisting of 12 cores that adds laterally directed cores to the standard sextant scheme has been proposed to strike a balance between the cancer detection rate and adverse events.

Saturation biopsy refers to a technique that employs more extensive prostate sampling, usually ranging from 20 or more cores, and can be as high as 80 cores, depending on the size of the prostate. Either the whole gland is sampled using TRUS without following a zonal pattern, or a systematic, transperineal grid-based method is used with a brachytherapy template and transrectal ultrasound guidance, which is called transperineal template-guided saturation biopsy (TTBS). TTBS may be performed using a stereotactic transperineal technique that uses a computer and a 3-dimensional scanning device to provide the precise localization of the region of interest on the template grid, and to guide the removal of the tissue cores for pathologic review. A saturation biopsy is usually performed in an outpatient setting under general anesthesia; however, office procedures have been reported.

Observational studies have shown that saturation biopsy has relatively high sensitivity in detecting prostate cancer in high-risk individuals with previously negative results on TRUS biopsies: Walz et al (2006) found a 41% detection proportion among 161 individuals, all of whom had previously had two negative biopsies; Merrick et al (2007) reported a 42.2% detection proportion among 122 high-risk individuals who had obtained negative results on an average of 2.1 prior biopsies with 22.4 cores; and, more recently, in a retrospective review of a single-center experience in the UK, Vyas et al (2014) found a 36% prevalence in a cohort of 174 men with previously negative TRUS biopsies. These results indicate that saturation biopsy has a significant role in the identification of previously missed cases, especially among high-risk individuals (e.g., those with rising or persistently high PSA values, or those with relatively large prostate volumes).

Complications associated with this procedure include urinary retention and bleeding, which have been reported at rates of 11 to 12 percent. These rates generally conform to the rates recorded for biopsies with fewer cores. The two main objectives of prostate saturation needle biopsies are to increase cancer detection and improve staging.

Saturation biopsy has also been proposed as a standard procedure in individuals with large prostates owing to concerns that conventional biopsies, i.e., TRUS, tend to under-sample in these individuals. However evidence from observational studies raises questions about whether such a strategy is optimal. For instance, Chen (1999) found that larger-volume prostates had proportionally smaller-volume tumors compared with smaller prostates, and Remzi et al. (2005) found that more cancers occurred in those with a lower prostate volume. Naughton (1998) recommended using more than six cores on prostates greater than 30 cc in volume but acknowledged that the optimum number of cores is unknown. According to Raja (2006), data on prostate volume--directed biopsy with any more than an extended biopsy (8-10 cores) have not been evaluated yet. More recently, a 2014 retrospective cohort study by Pietzak et al (2014) that stratified individuals by prostate volume (greater than 50 cm3 and 50 cm3 or less) found that prostate cancers detected in men with large prostates and initially negative biopsies were likely to have low-grade, clinically insignificant prostate cancer. They concluded that men with larger prostates who already had negative biopsies should be counseled regarding the risk of finding clinically insignificant prostate cancer.

The areas being sampled during a biopsy may be more important than the number of cores taken. The traditional sextant biopsy obtains cores in a parasagittal line drawn halfway between the lateral border and a midline drawn bilaterally from the base, mid gland, and apex. This strategy has been found to undersample the peripheral zone. The modified sextant biopsy, where middle samples are moved laterally, improves the detection rate from 80 percent to 89 percent. The extended biopsy protocol using 8 to 10 biopsies weighted to the lateral aspect of the prostate has been shown to increase the detection rate to 95 to 96 percent. In addition, standard biopsy with 10 cores was found to be as effective for cancer detection as 24 cores, and a large European study resulted in a recommendation of the 10-core pattern, because more extensive biopsy schemes have not been shown to improve survival rates.

The optimal biopsy technique has not yet been identified. The ideal number of cores is still under investigation, and factors such as age, prostate volume, comorbidity, and individual preference must be factored into decision making. In a recent study, the only significant variable correlated with saturation biopsy and prostate cancer was age. Currently, guidelines are lacking for the selection of men who should undergo saturation biopsy. Predictably, increasing the number of biopsy cores increases cancer detection by 30 to 35 percent. However, the degree to which morbidity and mortality are reduced or the extent to which men with insignificant disease are treated unnecessarily is not currently known.

Magnetic resonance imaging (MRI)/ultrasound (US) fusion biopsy is a targeted biopsy strategy that facilitates the direct targeting of suspicious areas detected on MRI. In this sampling procedure, information gained from MRI images is used to inform ultrasound-guided sampling, thereby increasing the odds of sampling regions in the prostate with higher probabilities of harboring high-grade neoplastic tissue. This improved precision, in theory, increases the positive predictive value of this diagnostic test, minimizing the detection of clinically insignificant cancers and possible over-treatment and distinguishing men more appropriately managed by active surveillance from men recommended for definitive intervention.

A 2015 systematic review and meta-analysis by Schoots et al. assessed the diagnostic differences between magnetic resonance imaging (MRI)‒targeted biopsy (MRI-TBx) and transrectal ultrasound (TRUS)‒guided biopsy (TRUS-Bx) in detecting overall prostate cancer (primary objective) and clinically significant and insignificant prostate cancer (secondary objective). The authors selected studies including men with suspected prostate cancer scheduled for transrectal biopsy because of increased prostate-specific antigen and/or positive digital rectal exam. While the studies included were generally statistically under-powered and subject to publication biases, the authors reported that MRI-TBx had a 20% better detection rate for clinically significant prostate cancer than TRUS-Bx. A relative sensitivity of 0.56 was found for detection of insignificant prostate cancer, in that MRI-TBx showed an almost twofold better performance in avoiding detection of insignificant prostate cancer than TRUS-Bx.

In a separate systematic review, Schoots et al. (2015) evaluated the role of MRI in men on active surveillance for prostate cancer. Specifically, four studies performed MRI-targeted biopsies together with TRUS-guided biopsies, and 3 studies only performed repeat standard (TRUS) biopsy following MRI. MRI-targeted biopsies were performed using software-registered MRI/US fusion in 2 of the 4 studies, visual registered (cognitive) MRI/US fusion in 1 study, and direct in-bore in 1 study. The likelihood of a positive MRI in men undergoing active surveillance and an MRI and repeat standard (TRUS) biopsy was 70% (340/488). Following a positive MRI, reclassification occurred in 39% (115/298) of those who underwent MRI-targeted repeat biopsy with TRUS and those who underwent only TRUS for repeat biopsy versus 17% (18/107) reclassification in patients with a negative MRI before repeat biopsy. In the cases with a positive MRI and MRI-targeted and TRUS biopsy, reclassification occurred in 47% (84/179) of cases.

The National Comprehensive Cancer Network (NCCN) 2018 guidelines on the early detection of prostate cancer state that a saturation biopsy strategy (including transperineal techniques) and/or the use of multiparametric MRI followed by an appropriate biopsy technique based on results, can be considered for very high-risk men with previous negative biopsies.
References


American Cancer Society (ACS). Prostate cancer: early detection. [ACS Web site]. 07/06/10. Available at: http://www.cancer.org/cancer/prostatecancer/moreinformation/prostatecancerearlydetection/prostate-cancer-early-detection-tests. Accessed May 25, 2018.

American Urological Association (AUA). Prostate MRI and MRI-Targeted Biopsy in Patients with Negative Prior Biopsy. 2016. [AUA Web site]. Available at:
http://www.auanet.org/guidelines/prostate-mri-and-mri-targeted-biopsy. Accessed May 25, 2018.

American Urological Association (AUA). Prostate-specific antigen best practice statement: 2013 revision. [AUA Web site]. Available at:
https://www.auanet.org/education/guidelines/prostate-specific-antigen.cfm. Accessed May 25, 2018.

Ayres BE, Montgomery BS, Barber NJ, et al. The role of transperineal template prostate biopsies in restaging men with prostate cancer managed by active surveillance. BJU Int.2012; 109(8):1170-6.

Boccon-Gibod LM, de Longchamps NB, Toublanc M, et al. Prostate saturation biopsy in the reevaluation of microfocal prostate cancer. J Urol. 2006;176(3):961-4.

Brawer MK. Editorial: prostate cancer. J Urol. 1997;157:207-8.

Chen ME, Troncoso P, Johnson D, et al. Prostate cancer detection: relationship to prostate size. Urology. 1999;53:764-8.

Chon CH, Lai FC, McNeal JE, Presti JC JR. Use of extended systematic sampling in patients with a prior negative needle biopsy. J Urol. 2002;167:2457-60.

Delongchamps NB, Haas GP. Saturation biopsies for prostate cancer: current uses and future prospects. [Medscape Web site]. 11/10/2009. Available at: http://cme.medscape.com/viewarticle/711721 [via subscription only]. Accessed May 25, 2018.

Descazeaud A, Rubin M, Chemama S, et al. Saturation biopsy protocol enhances prediction of pT3 and surgical margin status on prostatectomy specimen. World J Urol. 2006;24(6):676-80.

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.

Epstein JI, Sanderson H, Carter HB, Scharfstein DO. Utility of saturation biopsy to predict insignificant cancer at radical prostatectomy. Urology. 2005;66(2):356-60.

Eskew LA, Bare RL, McCullough DL. Systematic 5 region prostate biopsy is superior to sextant method for diagnosing carcinoma of the prostate. J Urol. 1997;157(1):199-203.

Fleshner N, Klotz L. Role of “saturation biopsy” in the detection of prostate cancer among difficult diagnostic cases. Urology. 2002;60(1):93-7.

Jones JS, Patel A, Schoenfield L, et al. Saturation technique does not improve cancer detection as an initial prostate biopsy strategy. J Urol. 2006;175(2):485-8.

Karakiewicz PI, Bazinet M, Aprikian AG, et al. Outcome of sextant biopsy according to gland volume. Urology. 1997;49(1):55-9.

Levine MA, Ittman M, Melamed J, Lepor H. Two consecutive sets of transrectal ultrasound guided sextant biopsies of the prostate for the detection of prostate cancer. J Urol. 1998;159(2):471-6.

Li YH, Elshafei A, Li J, et al. Transrectal saturation technique may improve cancer detection as an initial prostate biopsy strategy in men with prostate-specific antigen <10 ng/ml. Eur Urol.2013;65(6):1178-83.

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.

Merrick GS, Gutman S, Andreini H, et al. Prostate cancer distribution in patients diagnosed by transperineal template-guided saturation biopsy. Eur Urol. 2007;52:715-723.

Moran BJ, Braccioforte MH, Conterato DJ. Re-biopsy of the prostate using a steriotactic transperineal technique. J Urol. 2006;176(4 Pt 1):1376-81.

Morton RA, Lepor H. Prostate disorders: benign and malignant. In: Noble J, ed. Textbook of Primary Care Medicine. St. Louis, MO: Mosby; 2001:1426-7.

National Cancer Institute (NCI). Prostate Cancer Screening. [NCI Web site]. 08/04/17. Available at: https://www.cancer.gov/types/prostate/hp/prostate-screening-pdq/. Accessed May 25, 2018.

National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology™.Prostate cancer early detection. v.2.2018. [NCCN Web site]. 04/05/2018. Available at: https://www.nccn.org/professionals/physician_gls/pdf/prostate_detection.pdf.
Accessed May 25, 2018.

Naughton CK, Smith DS, Humphrey PA, et al. Clinical and pathologic tumor characteristics of prostate cancer as a function of the number of biopsy cores: a retrospective study. Urology. 1998;52(3):808-13.

Novitas, Inc. Local Coverage Determination (LCD). L35009 Prostate Mapping Biopsy. [Novitas, Inc. Web site]. Original 10/01/2015. Revised 10/01/16. https://www.cms.gov/medicare-coverage-database/details/lcd-details.aspx?LCDId=35009&ver=9&Keyword=prostate+mapping+biopsy&KeywordSearchType=Or&Date=&PolicyType=Both&ArticleType=SAD%7cEd&Cntrctr=323*1&KeyWordLookUp=Doc&SearchType=Advanced&CoverageSelection=Both&kq=true&bc=IAAAACAAAAAAAA%3d%3d&. Available at: Accessed May 25, 2018.

Pietzak EJ, Resnick MJ, Mucksavage P, et al. Multiple repeat prostate biopsies and the detection of clinically insignificant cancer in men with large prostate. Urology. 2014;84(2):380-5.

Pinkstaff DM, Igel TC, Petrou SP, et al. Systematic transperineal ultrasound-guided template biopsy of the prostate: three-year experience. Urology. 2005;65(4):735-9.

Presti JC JR, Chang JJ, Bhargava V, Shinohara K. The optimal systematic prostate biopsy scheme should include 8 rather than 6 biopsies: results of a prospective clinical trial. J Urol. 2000;163(1):163-7.

Prostate Cancer Research Institute (PCRI). PCRI Glossary of Prostate Cancer Related Terms. [PCRI Web site]. 02/07. Available at: http://prostate-cancer.org/glossary-of-prostate-cancer-related-terms. Accessed May 25, 2018.

Rabets JC, Jones JS, Patel A, Zippe CD. Prostate cancer detection with office based saturation biopsy in a repeat biopsy population. J Urol. 2004;172(1):94-7.

Raja J, Ramachandran N, Munneke G, Patel U. Current status of transrectal ultrasound-guided prostate biopsy in the diagnosis of prostate cancer. Clin Radiol. 2006;61(2):142-53.

Remzi M, Fong YK, Dobrovits M, et al. The Vienna nomogram: validation of a novel biopsy strategy defining the optimal number of cores based on patient age and total prostate volume. J Urol. 2005;174(4 Pt 1):1256-60.

Schoenfield L, Jones JS, Zippe CD, et al. The incidence of high-grade prostatic intraepithelial neoplasia and atypical glands suspicious for carcinoma on first-time saturation needle biopsy, and the subsequent risk of cancer. BJU Int. 2007;99(4):770-4.

Schoots IG, Petrides N, Giganti F, et al. Magnetic resonance imaging in active surveillance of prostate cancer: a systematic review. Eur Urol. Apr 2015;67(4):627-636.

Schoots IG, Roobol MJ, Nieboer D, et al. Magnetic resonance imaging-targeted biopsy may enhance the diagnostic accuracy of significant prostate cancer detection compared to standard transrectal ultrasound-guided biopsy: a systematic review and meta-analysis. Eur Urol. Sep 2015;68(3):438-450.

Small EJ. Prostate cancer. In: Goldman L, Ausiella D, eds. Cecil Textbook of Medicine. Philadelphia, PA: W.B. Saunders; 2004: 1244-5.

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;166(1):86-92.

Sur RL, Borboroglu PG, Roberts JL, Amling CL. A prospective randomized comparison of extensive prostate biopsy to standard biopsy with assessment of diagnostic yield, biopsy pain and morbidity. Prostate Cancer Prostatic Dis. 2004;7(2):126-31.

Taira AV, Merrick GS, Galbreath RW, et al. Performance of Transperineal template-guided mapping biopsy in detecting prostate cancer in the initial and repeat biopsy setting. Prostate Cancer Prostatic Dis. 2010; 13:71-77.

Thrasher JB. Refining prostate biopsy strategies. J Urol. 2006;175(2):419-20.

Uzzo RG, Wei JT, Waldbaum RS, et al. The influence of prostate size on cancer detection. Urology. 1995;46(6):831-6.

Vyas L, Archer P, Challacombe B, et al. Indications, results and safety profile of transperineal sector biopsises of the prostate: a single center experience of 634 cases. BJU Int. 2013. Available at: http://www.ncbi.nlm.nih.gov/pubmed/24053629. Accessed May 25, 2018.

Walz J, Graefen M, Chun FK, et al. High incidence of prostate cancer detected by saturation biopsy after previous negative biopsy series. Eur Urol. 2006;50(3):498-505.





Coding

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

CPT Procedure Code Number(s)

55706


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD - 10 Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD -10 Diagnosis Code Number(s)

C61 Malignant neoplasm of prostate

R97.20 Elevated prostate specific antigen [PSA]

R97.21 Rising PSA following treatment for malignant neoplasm of prostate



HCPCS Level II Code Number(s)

G0416 Surgical pathology, gross and microscopic examinations, for prostate needle biopsy, any method


Revenue Code Number(s)

N/A

Coding and Billing Requirements



Policy History

11.11.06h
07/03/2018Effective 07/03/2018 policy has been reviewed and reissued to communicate the Company’s continuing position on Saturation Needle Biopsy of the Prostate.

Effective 10/05/2017 this policy has been updated to the new policy template
format.
Version Effective Date: 10/01/2016
Version Issued Date: 09/30/2016
Version Reissued Date: 07/03/2018

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